[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"rheumatoid-arthritis\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:rheumatoid-arthritis":28},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,170,0,25,[9,42,70,103,127,157,184,206,250,287,325,349,370,399,427,451,483,502,524,553,574,598,620,642,665],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":16,"eligibilityCriteria":17,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100640867","phase-2-an-extension-study-to-assess-long-term-safety-and-efficacy-of-afimkibart-in-participants-with-rheumatoid-arthritis-100640867",false,"NCT07620392","An Extension Study to Assess Long-Term Safety and Efficacy of Afimkibart in Participants With Rheumatoid Arthritis","An Extension Study to Evaluate the Long-term Safety and Efficacy of Afimkibart (RO7790121) in Patients With Rheumatoid Arthritis Who Participated in Previous Afimkibart Clinical Trials","dRAvite-LTE","Inclusion Criteria:\n\n* Completed the treatment period of the parent study\n* Agreement to adhere to the contraception requirements\n* Continued to be evaluated at the follow-up visit of the parent study and achieved improvement in the SJC66\u002FTJC68 relative to baseline\n\nExclusion Criteria:\n\n* Withdrawal of consent and\u002For premature discontinuation from parent study\n* Any permanent discontinuation of study drug in parent study\n* Use of a prohibited therapy during the parent study\n* Evidence of any new or uncontrolled concomitant disease that, in the investigator's judgment, would preclude participant participation in the trial","ALL","18 Years",{"count":21,"type":22},120,"ESTIMATED","INTERVENTIONAL",[25],"PHASE2","The study will evaluate the long-term safety and efficacy of Afimkibart (also known as RO7790121) in participants with moderate to severe Rheumatoid Arthritis (RA) who have an inadequate response or intolerance to tumor necrosis factor (TNF) and\u002For Janus kinase (JAK) inhibitors, and who were previously treated with Afimkibart.",[28],"Rheumatoid Arthritis","RECRUITING","2026-08-20",{"date":32,"type":33},"2026-08-21","ACTUAL",{"date":35,"type":33},"2026-06-03",{"date":37,"type":22},"2033-07-08",{"name":39,"class":40},"Hoffmann-La Roche","INDUSTRY",9,{"id":43,"slug":44,"hasResults":12,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":4,"eligibilityCriteria":48,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":49,"enrollmentInfo":50,"targetDuration":4,"studyType":23,"phases":52,"briefSummary":53,"conditions":54,"keywords":55,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":4},"100652898","phase-2-study-of-ptc844-in-participants-with-active-rheumatoid-arthritis-100652898","NCT07779616","Study of PTC844 in Participants With Active Rheumatoid Arthritis","A Phase 2A, Proof-of-Concept, Randomized, Parallel, Double-Blind, Placebo-Controlled Study to Assess the Safety, Pharmacokinetics, and Pharmacodynamics of PTC844 in Participants With Active Rheumatoid Arthritis","Key Inclusion Criteria:\n\n* Historical diagnosis of RA as per the American College of Rheumatology (ACR)\u002FEuropean Alliance of Associations for Rheumatology (EULAR) diagnostic criteria.\n* Active RA disease with a threshold of moderate activity or higher as confirmed via DAS28-CRP (score of ≥3.2) at screening.\n* Naïve to disease-modifying treatments for RA or have had an inadequate response to background treatment for RA and\u002For inability to tolerate disease-modifying antirheumatic drugs, as per investigator's discretion.\n* Disease-modifying antirheumatic drugs should be stable and unchanged from 30 days prior to the start of the Screening Period and intend to remain stable and unchanged throughout the course of the study.\n* CRP of ≥5 milligrams (mg)\u002Fliter (L) at screening.\n\nKey Exclusion Criteria:\n\n* Presence of any clinically significant abnormality at screening, or prior or ongoing medical condition (for example, concomitant illness, psychiatric condition), surgical procedure, medical history, or physical findings that, in the investigator's opinion, could adversely affect the safety of the participant or could impair the assessment of study results.\n* Participants with Class IV RA.\n* Past medical history of blood dyscrasia, bone marrow abnormality and\u002For suppression, drug induced thrombocytopenia or idiopathic thrombocytopenia, or bleeding diathesis.\n* Past medical history of inflammatory joint disease other than RA or fibromyalgia.\n* Rheumatoid arthritis onset at \\\u003C17 years of age.\n* Past medical history of malignancy within 5 years prior to screening, except for nonmelanoma skin cancers cursed via local resection.\n* Participant has a known hypersensitivity to any of the ingredients of PTC844 or to any excipients of the study drug.\n* Use or intended use of any prescribed disease-modifying treatments for RA within 30 days or 5 half-lives (whichever is longer) before the Screening Period until completion of the Follow-Up Visit, except for methotrexate, low dose prednisone (\\\u003C10 mg\u002Fday), hydroxychloroquine, or sulfasalazine, which are permitted as established background single-therapy medications.\n* Use or intended use of a combination of methotrexate, low dose prednisone (\\\u003C10 mg\u002Fday), hydroxychloroquine, or sulfasalazine within 30 days or 5 half-lives (whichever is longer) before the Screening Period until completion of the Follow-Up Visit.\n\nNote: Other protocol-defined inclusion\u002Fexclusion criteria may apply.","70 Years",{"count":51,"type":22},75,[25],"This study is designed to assess the safety, pharmacokinetics (PK), and biomarker effects of PTC844 compared to placebo in participants with active rheumatoid arthritis (RA).",[28],[56,57,58,59,60],"Immune-mediated disease","Autoimmune disease","Dihydroorotate dehydrogenase (DHODH) inhibitors","PTC844","Rheumatoid arthritis","NOT_YET_RECRUITING","2026-08-18",{"date":32,"type":33},{"date":65,"type":22},"2026-08-31",{"date":67,"type":22},"2027-10-29",{"name":69,"class":40},"PTC Therapeutics",{"id":71,"slug":72,"hasResults":12,"nctId":73,"briefTitle":74,"officialTitle":74,"acronym":4,"eligibilityCriteria":75,"healthyVolunteers":12,"sex":18,"minAge":4,"maxAge":4,"enrollmentInfo":4,"targetDuration":4,"studyType":76,"phases":4,"briefSummary":77,"conditions":78,"keywords":92,"overallStatus":99,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":100,"startDateStruct":4,"completionDateStruct":4,"leadSponsor":101,"locationsCount":4},"100374756","expanded-access-to-upadacitinib-100374756","NCT04159597","Expanded Access to Upadacitinib","Exclusion Criteria:\n\n* There are other suitable treatment options.\n* The participant qualifies for ongoing clinical trials.","EXPANDED_ACCESS","This is an expanded access program (EAP) for eligible participants. This program is designed to provide access to upadacitinib prior to approval by the local regulatory agency. Availability will depend on territory eligibility. A medical doctor must decide whether the potential benefit outweighs the risk of receiving an investigational therapy based on the individual patient's medical history and program eligibility criteria.",[79,80,81,82,28,83,84,85,86,87,88,89,90,91],"Crohn Disease","Ulcerative Colitis","Idiopathic Arthritis (Including sJIA, pJIA, or JPsA)","Atopic Dermatitis","Psoriatic Arthritis","Axial Spondyloarthritis","Non-radiographic Axial","Spondyloarthritis","Giant Cell Arteritis","Systemic Lupus Erythematosus","Alopecia Areata","Non Segmental Vitiligo","Hidradenitis Suppurativa",[93,94,95,96,97,98],"Expanded Access","Pre-approval Access","Compassionate Use","Special Access Program","Named Patient Basis","Special Access Scheme","AVAILABLE",{"date":30,"type":33},{"name":102,"class":40},"AbbVie",{"id":104,"slug":105,"hasResults":12,"nctId":106,"briefTitle":107,"officialTitle":107,"acronym":4,"eligibilityCriteria":108,"healthyVolunteers":109,"sex":18,"minAge":19,"maxAge":49,"enrollmentInfo":110,"targetDuration":4,"studyType":112,"phases":4,"briefSummary":113,"conditions":114,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":116,"lastUpdatePostDateStruct":117,"startDateStruct":119,"completionDateStruct":121,"leadSponsor":123,"locationsCount":126},"100460545","pain-processing-in-inflammatory-and-non-inflammatory-chronic-pain-syndromes-100460545","NCT05277025","Pain Processing in Inflammatory and Non-Inflammatory Chronic Pain Syndromes","Inclusion Criteria:\n\n* Ages 18-70\n* Fulfills the 1990 and 2011 American College of Rheumatology Criteria for FM\n* Fulfills the 2010 ACR-EULAR classification criteria for RA\n* Healthy volunteers: No significant pain\u002Ffatigue\u002Fdepression\u002Fanxiety.\n\nExclusion Criteria:\n\n* Diabetes\n* Cancer\n* Advanced liver, kidney or cardiovascular disease\n* Neuropathic pain",true,{"count":111,"type":22},150,"OBSERVATIONAL","Fibromyalgia (FM) is a chronic musculoskeletal pain disorder that afflicts up to 4% of the general population. The evaluation of pain mechanisms in FM has shown predominant central abnormalities and therefore has been designated as nociplastic pain syndrome. Rheumatoid arthritis (RA) is characterized by polyarthritis and pain from inflamed tissues, consistent with nociceptive pain. FM and RA patients may utilize overlapping pain mechanisms resulting in nociceptive and nociplastic pain.",[115,28],"Fibromyalgia","2026-08-17",{"date":118,"type":33},"2026-08-19",{"date":120,"type":33},"2022-03-22",{"date":122,"type":22},"2027-07-28",{"name":124,"class":125},"University of Florida","OTHER",1,{"id":128,"slug":129,"hasResults":12,"nctId":130,"briefTitle":131,"officialTitle":131,"acronym":4,"eligibilityCriteria":132,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":133,"targetDuration":4,"studyType":23,"phases":135,"briefSummary":137,"conditions":138,"keywords":141,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":148,"lastUpdatePostDateStruct":149,"startDateStruct":151,"completionDateStruct":153,"leadSponsor":155,"locationsCount":4},"100650912","development-and-evaluation-of-the-effectiveness-of-the-smart-hand-protocol-for-hand-rehabilitation-in-patients-with-rheumatoid-arthritis-100650912","NCT07754552","Development and Evaluation of the Effectiveness of the SMART-HAND Protocol for Hand Rehabilitation in Patients With Rheumatoid Arthritis","Inclusion Criteria:\n\n* Participants will be 18 years of age or older.\n* Participants will have a diagnosis of rheumatoid arthritis for at least five years.\n* Participants will be referred by a rheumatologist.\n* Participants will have been on a stable medication regimen for the past three months.\n* Participants will have no history of diabetes mellitus.\n* Participants will have no other conditions affecting sensory function.\n* Participants will provide informed consent to participate in the study.\n\nExclusion Criteria:\n\n* Individuals who have undergone hand surgery within the past six months.\n* Individuals with a history of upper extremity fracture within the past six months.\n* Individuals with other musculoskeletal pain conditions involving the muscles and\u002For joints.\n* Individuals diagnosed with a neurological disease that may affect sensory or motor function.\n* Individuals who are unable to fully cooperate with the assessment procedures.\n* Individuals who have received corticosteroid treatment within the past month.\n* Individuals diagnosed with another rheumatic disease.\n* Pregnant women.\n* Individuals who are illiterate.\n\nWithdrawal\u002FDiscontinuation Criteria\n\n* Participants who miss more than 10% of the intervention sessions will be excluded from the study.\n* Participants who change their medication dosage or medication class during the study period will be excluded from the study.\n* Participants will have the right to withdraw from the study at any time and for any reason.",{"count":134,"type":22},132,[136],"NA","Rheumatoid arthritis (RA) frequently affects the hand and wrist, resulting in pain, reduced joint stability, impaired proprioception, muscle weakness, and limitations in daily activities. Although conventional rehabilitation primarily focuses on range of motion and strengthening exercises, sensorimotor impairments such as proprioceptive deficits are often underaddressed. The SMART-HAND (Sensory, Massage, Approximation, ROM, Training = Strengthening + Perturbation) protocol was developed as a structured, mechanism-based rehabilitation program to improve proprioception, joint stability, motor control, and hand function. This randomized controlled trial aims to evaluate the effectiveness of the SMART-HAND protocol in individuals with RA by comparing its effects on hand function, proprioception, pain, dexterity, muscle strength, and functional performance with conventional rehabilitation and a control group.",[28,139,140],"Rheumatoid Arthritis (RA","Rheumatoid Arthritis (RA) Prevention",[28,142,143,144,145,146,147],"Hand Rehabilitation","Hand Function","Proprioception","Neuromuscular Control","Grip Strength","Joint Stability","2026-08-13",{"date":150,"type":33},"2026-08-14",{"date":152,"type":22},"2026-10-01",{"date":154,"type":22},"2027-12-30",{"name":156,"class":125},"Istanbul University - Cerrahpasa",{"id":158,"slug":159,"hasResults":12,"nctId":160,"briefTitle":161,"officialTitle":162,"acronym":163,"eligibilityCriteria":164,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":165,"enrollmentInfo":166,"targetDuration":4,"studyType":23,"phases":168,"briefSummary":170,"conditions":171,"keywords":173,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":175,"lastUpdatePostDateStruct":176,"startDateStruct":178,"completionDateStruct":180,"leadSponsor":182,"locationsCount":126},"100577655","phase-1-efficacy-and-safety-of-hn2301-in-autoimmune-diseasesaids-100577655","NCT06801119","Efficacy and Safety of HN2301 in Autoimmune Diseases（AIDs）","Dose-escalation Study to Assess the Safety, Tolerability, and Preliminary Efficacy of HN2301 in Patients With Autoimmune Diseases Including Systemic Lupus Erythematosus（SLE）, Systemic Sclerosis (SSc) and Rheumatoid Arthritis （RA）","SLE，SSc，RA","Inclusion Criteria:\n\n* Patients aged between 18 and 69 (inclusive), of any gender;\n* Appropriate bone marrow, coagulation, cardiopulmonary, liver, and kidney functions. Bone marrow function: ANC ≥1.5×10\\^9\u002FL, ALC ≥0.8×10\\^9\u002FL, Hb ≥80g\u002FL. No use of transfusions and growth factors allowed within 7 days prior to screening to meet these requirements. Coagulation function: INR or APTT ≤1.5×ULN. Cardiac function: Echocardiography (ECHO) assessment of left ventricular ejection fraction (LVEF) ≥40%. Lung function: ≤CTCAE grade 1 dyspnea and SpO2 ≥92% (measured by pulse oximetry) while breathing indoor air. Liver function: ALT and AST ≤2.5×ULN, total bilirubin \\\u003C2.0mg\u002FdL (Gilbert syndrome subjects total bilirubin \\\u003C3.0mg\u002FdL). Kidney function: defined as creatinine clearance rate (Cockcroft-Gault) ≥50mL\u002Fmin without need for fluid assistance;\n* Non-pregnant\u002Fnon-lactating participants, willing to adopt contraceptive measures within 12 months after drug infusion;\n* Diagnosed with SLE according to the 2019 EULAR\u002FACR SLE diagnostic criteria; A history of SLE for at least 6 months, having used a stable standard treatment regimen for at least 8 weeks; Oral corticosteroids are prednisone (or equivalent drug) ≥7.5mg\u002Fday and ≤30mg\u002Fday. At least two immunosuppressants have been used in a standardized manner (including hydroxychloroquine); Screening period tests meet: positive blood antinuclear antibody (ANA), and\u002For positive anti-ds-DNA antibodies, and\u002For hypocomplementemia;\n* SSc-meets the classification criteria of ACR and EULAR, 10-35 in mRSS score;\n* RA-meets the classification criteria of ACR and EULAR, DAS28-ESR\\>3.2, ACPA possitive.\n\nExclusion Criteria:\n\n* Individuals with positive Hepatitis B surface antigen (HBsAg) and\u002For Hepatitis B core antibody (HBcAb), and Hepatitis B virus (HBV) DNA positivity or titers above the detection threshold; those with positive Hepatitis C virus (HCV) antibodies and HCV RNA positivity or titers above the detection threshold; individuals with Human Immunodeficiency Virus (HIV) antibodies positivity, CMV DNA positivity or above the detection limit; those with positive syphilis antigen or antibodies;\n* Presence of other uncontrolled active infections;\n* History of major organ transplantation (such as heart, lung, liver, kidney) or bone marrow\u002Fhematopoietic stem cell transplantation;\n* Pregnant or breastfeeding women;\n* Receiving any mRNA-LNP product or other LNP medications within the past two years;\n* History of any of the following cardiovascular diseases within the last 6 months before screening: Class III or IV heart failure defined by the New York Heart Association (NYHA), myocardial infarction, unstable angina, uncontrolled or symptomatic atrial arrhythmias, any ventricular arrhythmias, or other clinically significant cardiac diseases;\n* History of live vaccine administration within the last 30 days;\n* Individuals with asthma, severe allergies;\n* Other conditions deemed inappropriate for participation in this clinical study by the investigator.","69 Years",{"count":167,"type":22},30,[169],"PHASE1","This is an open lable and single arm study, is designed to evaluate the safety and preliminary efficacy of HN2301 in Autoimmune Disease（AID）",[88,172,28],"Scleroderma",[174],"SLE, SSc,RA","2026-08-11",{"date":177,"type":33},"2026-08-12",{"date":179,"type":33},"2025-03-16",{"date":181,"type":22},"2028-06-30",{"name":183,"class":40},"Shenzhen MagicRNA Biotechnology Co., Ltd",{"id":185,"slug":186,"hasResults":12,"nctId":187,"briefTitle":188,"officialTitle":189,"acronym":190,"eligibilityCriteria":191,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":192,"targetDuration":4,"studyType":23,"phases":194,"briefSummary":195,"conditions":196,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":197,"lastUpdatePostDateStruct":198,"startDateStruct":199,"completionDateStruct":201,"leadSponsor":203,"locationsCount":205},"100647072","phase-1-phase-1b2-study-of-iv-sarilumab-in-adult-with-ra-100647072","NCT07704580","Phase 1b\u002F2 Study of IV Sarilumab in Adult With RA","A Randomized Open Label, Phase 1b\u002F2 Study to Evaluate Intravenous Administration With Long Dosing Interval Regimens of Sarilumab in Adult Participants With Rheumatoid Arthritis","OPALS","Inclusion Criteria:\n\n* Participant must be 18 years old or the legal age of consent in the jurisdiction in which the study is taking place or older, at the time of signing the informed consent.\n* Diagnosis of RA, according to the American College of Rheumatology (ACR)\u002FEuropean Alliance of Associations for Rheumatology (EULAR) 2010 RA Classification Criteria with ≥3 months disease duration.\n* ACR Class I to III functional status, based on the 1991 revised criteria\n* Moderate-to-severely active RA, defined as: DAS28-ESR\\>3.2.\n* Inability to continue treatment with a RA DMARD approved for first line use because of intolerance or inadequate response.\n* Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.\n\nExclusion Criteria:\n\n* Any prior (within the defined periods below) or concurrent use of immunosuppressive:\n\n  * Janus kinase (JAK) inhibitor (eg, tofacitinib) within 4 weeks of baseline.\n  * Cell-depletion agents (eg, anti CD20) without evidence of recovery of B cells to baseline level.\n  * Anakinra within 1 week of baseline.\n  * Abatacept within 8 weeks of baseline.\n  * Tumor necrosis factor (TNF) inhibitors within 2 to 8 weeks.\n  * Alkylating agents including cyclophosphamide (CYC) within 6 months of baseline.\n  * Cyclosporine (CsA), azathioprine (AZA) or mycophenolate mofetil (MMF) or leflunomide within 4 weeks of baseline.\n* Therapeutic failure, including inadequate response or intolerance, or contraindication, to biological IL-6 antagonist (prior IL-6 antagonist treatment that was terminated for reasons unrelated to therapeutic failure at least 3 months before baseline is not exclusionary).\n* Unstable methotrexate (MTX) dose (if participant is on concomitant MTX).\n* Concurrent use of systemic corticosteroids (CS) of more than 10 mg\u002Fday.\n* Pregnant or breastfeeding woman.\n* Exclusion related to tuberculosis (TB): active TB or a history of incompletely treated TB regardless of screening Quantiferon® result.\n* History of invasive opportunistic infections, including but not limited to histoplasmosis, listeriosis, coccidioidomycosis, candidiasis, pneumocystis jirovecii, aspergillosis despite resolution or John Cunningham virus (progressive multifocal leukoencephalopathy).\n* Uncontrolled diabetes mellitus.\n* History of prior articular or prosthetic joint infection.\n* Prior or current history of malignancy, including lymphoproliferative diseases, other than adequately-treated carcinoma in-situ of the cervix, non-metastatic squamous cell or basal cell carcinoma of the skin, within 5 years prior to the baseline visit.\n* History of inflammatory bowel disease or severe diverticulitis or previous gastrointestinal perforation.\n* History of juvenile idiopathic arthritis or arthritis onset prior to age 16.\n* Severe systemic RA, including but not limited to vasculitis, pulmonary fibrosis, and\u002For Felty's syndrome.\n\nThe above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.",{"count":193,"type":22},140,[169,25],"This is a Phase 1\u002FPhase 2 study with:\n\n* 5-arms design for Part A;\n* and a single arm for Part B.\n\nThe purpose of this study is to measure PK parameters and safety with sarilumab intravenous (IV) with or without concomitant oral conventional synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) in male and female participants with moderately to severely active rheumatoid arthritis aged 18 years of age or older.\n\nStudy details include:\n\n* The study duration will be up to 64 weeks.\n* The treatment duration will be up to 6 months for each study phase.\n* Part A has 10 visits, including a post-treatment end of study (EOS) follow-up visit.\n\n  * For participants entering the open label extension to receive the approved 200 mg sarilumab every two weeks (Q2W) dose, there will be 3 additional study visits.\n  * For the intra-study sarilumab 200 mg Q2W subcutaneous (SC) arm, participants will be evaluated over the course of 24 weeks plus post-treatment EOS follow-up visit following the schedule of activities (SoA) of Part A from Day -1 to Day 29 (total of 8 visits) and the SoA of Part B from Week 4 to Week 24 (total of 8 visits) and a post-treatment end of study (EOS) follow-up visit at Week 30 (Part B) for a total of 17 visits, including a post-treatment EOS follow-up visit.\n* Part B has 13 visits, including a post-treatment EOS follow-up visit.",[28],"2026-08-07",{"date":175,"type":33},{"date":200,"type":33},"2026-07-02",{"date":202,"type":22},"2028-10-26",{"name":204,"class":40},"Sanofi",4,{"id":207,"slug":208,"hasResults":12,"nctId":209,"briefTitle":210,"officialTitle":211,"acronym":212,"eligibilityCriteria":213,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":214,"targetDuration":4,"studyType":112,"phases":4,"briefSummary":216,"conditions":217,"keywords":230,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":241,"lastUpdatePostDateStruct":242,"startDateStruct":244,"completionDateStruct":246,"leadSponsor":248,"locationsCount":4},"100649638","inflammatory-disease-biobank-for-immunophenotyping-and-cardiovascular-research-100649638","NCT07737470","Inflammatory Disease Biobank for Immunophenotyping and Cardiovascular Research","INFLAMMATORY AND IMMUNE-MEDIATED DISEASES BIOBANKING FOR IMMUNOPHENOTYPING AND CARDIOVASCULAR RESEARCH","INFLAME-BANK","Inclusion Criteria:\n\n* Patient enrolled in EACVI-INFLAME study\n* The patient consents\n\nExclusion Criteria:\n\n* Patients with a history of heart transplant\n* Patient unable to provide informed consent\n* Patient under complete or limited guardianship\n* Patient affected by pre-existing immunodeficiency, including HIV (not including immunosuppressive treatment)",{"count":215,"type":22},300,"INFLAME-BANK is a French multicenter prospective observational ancillary study of the international EACVI-INFLAME project. It aims to establish a biobank and perform immunophenotyping and proteomic analyses in patients with suspected inflammatory cardiovascular diseases and autoimmune rheumatic diseases (ICARDs).\n\nThe primary objective is to identify immune biomarkers associated with cardiovascular prognosis and develop disease-specific prognostic scores to predict 1-year major adverse cardiovascular events (MACE). Secondary objectives include evaluating the diagnostic and prognostic value of immunoproteomic biomarkers, assessing the role of photon-counting CT (PCCT) imaging, and investigating immune signatures associated with genetic variants in acute myocarditis.\n\nThe study plans to enroll 300 patients from French centers participating in EACVI-INFLAME. Blood samples will be collected during routine clinical care at inclusion, with optional follow-up sampling at 12 months and optional PCCT imaging and genetic analyses depending on each center's participation. Patients will be followed for 12 months to monitor cardiovascular outcomes.\n\nThe expected impact is to improve understanding of the immune mechanisms underlying ICARDs, facilitate earlier diagnosis and risk stratification, identify new therapeutic targets, and ultimately support more personalized management of patients with inflammatory cardiovascular diseases.",[218,219,220,221,222,223,224,225,28,86,226,227,87,228,229],"Pericarditis","Tako-TSUBO Cardiomyopathy","Myocarditis","Inflammatory Cardiomyopathies","Lupus","Systemic Sclerosis","Antiphospholipid Syndrome","Idiopathic Inflammatory Myopathies","ANCA-associated Vasculitis","Takayasu Arteritis","Behçet Disease","Still Disease",[231,232,233,234,235,236,237,238,239,240],"Inflammatory cardiovascular diseases (ICARDs)","Autoimmune rheumatic diseases","Cardiovascular involvement","Immunophenotyping","roteomics","Biomarkers","Biobanking","Major adverse cardiovascular events (MACE)","Cardiovascular imaging","Prospective observational study","2026-08-06",{"date":243,"type":33},"2026-08-10",{"date":245,"type":22},"2026-09-01",{"date":247,"type":22},"2028-10-01",{"name":249,"class":125},"Assistance Publique - Hôpitaux de Paris",{"id":251,"slug":252,"hasResults":12,"nctId":253,"briefTitle":254,"officialTitle":255,"acronym":4,"eligibilityCriteria":256,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":257,"enrollmentInfo":258,"targetDuration":4,"studyType":23,"phases":260,"briefSummary":261,"conditions":262,"keywords":269,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":241,"lastUpdatePostDateStruct":280,"startDateStruct":281,"completionDateStruct":283,"leadSponsor":285,"locationsCount":126},"100606821","creating-health-course-study-for-people-with-rheumatological-conditions-and-mood-disorders-100606821","NCT07180537","Creating Health Course Study for People With Rheumatological Conditions and Mood Disorders","Transforming Health Habits: Evaluating an Online Wellness Program for Individuals With Rheumatological Conditions and Mood Disorders","Inclusion criteria:\n\n1. A diagnosis of one of the following: Rheumatoid Arthritis (RA), Sjogren's Syndrome, Systemic lupus erythematosus (SLE), Mixed connective tissue disease (MCTD), or Psoriatic Arthritis (PsA), as documented by their treating specialist or primary care provider, as reported by the participant.\n2. Must be age 18 and older, at time of consent.\n3. Must be fluent in both speaking and reading English.\n\n   \\*Study participant must be able to read and comprehend informed consent document and speak with study staff about study document content. Study staff will use discretion in determining whether the study participant can clearly communicate with staff and comprehend the study material during the consent call or prior to the call.\n4. Must have access to high-speed internet with devices capable of audio\u002Fvideo streaming.\n5. Must be willing to participate in an online health course designed to improve dietary intake and self-care routines to help improve cellular function and health, and complete online surveys over the course of a 6-month period.\n6. Individuals must pass the Short Portable Mental Status Questionnaire with scores for normal mental functioning (up to 2 errors). Cognitive impairment as measured by the SPMS Questionnaire could interfere with the completion of the online course.\n\nSCORING\\* 0-2 errors: normal mental functioning 3-4 errors: mild cognitive impairment 5-7 errors: moderate cognitive impairment 8-10 errors: severe cognitive impairment\n\n\\*Allow one more error for a subject with only a grade school education. Allow one less error for a subject with education beyond high school.\n\nSource: Pfeiffer, E. (1975). A short portable mental status questionnaire for the assessment of organic brain deficit in elderly patients. Journal of American Geriatrics Society. 23, 433-41.\n\nExclusion criteria:\n\n1. Inability to provide informed consent, including participation in a consent call conducted via Zoom with the study team during business hours (8:00 a.m. to 5:00 p.m. Central Time (Chicago)).\n2. Participation in another research study investigating an intervention (treatments, medications, diet, or exercise). Participation in observation-only studies are not excluded.\n3. Currently following a modified Paleolithic, low-fat nutrient-dense vegetarian, or Mediterranean diet with 75% OR greater reported compliance.\n4. Any diagnosis or condition that is contraindicated from starting a gentle exercise program (ex. poorly controlled diseases of the heart, kidney, or liver in the prior 12 months, or severe psychiatric disease, e.g., schizophrenia, making adherence to study procedures difficult.","100 Years",{"count":259,"type":22},400,[136],"The goal of this project is to critically evaluate the effectiveness of an online health program designed to improve diet and self-care in patients with rheumatological conditions, including rheumatoid arthritis (RA), Sjogren's syndrome (SS), systemic lupus erythematosus (SLE), mixed connective tissue disease (MCTD), psoriatic arthritis (PsA), anxiety disorders, depressive disorders and moderate depression.\n\nAdditionally, investigators will assess the program's effectiveness, as well as the challenges and facilitators involved in using an online wellness program to reduce fatigue and enhance the quality of life in patients suffering from these conditions.",[28,263,88,264,83,265,266,267,268],"Sjogren's Syndrome","Mixed Connective Tissue Disease","Anxiety Disorders","Depressive Disorders","Moderate Depression","Moderate Anxiety",[270,271,272,273,274,275,276,277,278,279],"diet","self-care","internet course","anxiety","depression","Sjogren's","rheumatoid arthritis","lupus","fatigue","arthritis",{"date":243,"type":33},{"date":282,"type":33},"2025-12-01",{"date":284,"type":22},"2027-12-31",{"name":286,"class":125},"Terry L. Wahls",{"id":288,"slug":289,"hasResults":12,"nctId":290,"briefTitle":291,"officialTitle":292,"acronym":4,"eligibilityCriteria":293,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":294,"enrollmentInfo":295,"targetDuration":4,"studyType":23,"phases":297,"briefSummary":298,"conditions":299,"keywords":301,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":316,"lastUpdatePostDateStruct":317,"startDateStruct":318,"completionDateStruct":320,"leadSponsor":322,"locationsCount":324},"100572489","phase-1-a-phase-12-study-of-nkx019-in-subjects-with-immune-mediated-diseases-ntrust-2-100572489","NCT06733935","A Phase 1\u002F2 Study of NKX019 in Subjects With Immune-Mediated Diseases (Ntrust-2)","A Phase 1\u002F2 Study of NKX019, a CD19 Chimeric Antigen Receptor Natural Killer (CAR NK) Cell Therapy, in Subjects With Immune-Mediated Diseases","General Inclusion Criteria:\n\n1. Age ≥18 and ≤75\n2. Signed informed consent form and ability to adhere to the study visit schedule and comply with other protocol requirements\n3. Women of childbearing potential must have negative pregnancy tests at screening and baseline, and agree to abstinence or acceptable birth control from 2 weeks prior to the first dose through 1 year after the last dose\n4. For participants taking corticosteroids, the prednisone (or equivalent) dose must be ≤20 mg\u002Fday at 2 weeks prior to Screening and stable for ≥ 14 days before start of Screening\n5. For participants on immunosuppressives or immunomodulators (other than corticosteroids), all doses must be stable for ≥ 4 weeks prior to Screening\n6. eGFR as calculated by the 2021 Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation of ≥45 mL\u002Fmin\u002F1.73 m2 at screening\n\nSSc Inclusion Criteria:\n\n1. Meets the 2013 American College of Rheumatology (ACR)\u002FEuropean Alliance of Associations for Rheumatology (EULAR) classification criteria for SSc\n2. Meet criteria a and\u002For b:\n\n   a. Severe skin involvement defined as mRSS ≥ 30 or active skin disease defined as mRSS ≥ 15 at screening and one or more of the following within the prior 6 months of screening:\n\n   i. An increase in mRSS of ≥ 3 units\n\n   ii. Involvement of 1 new body area with ≥ 2 mRSS units\n\n   iii. 2 new body areas with ≥ 1 mRSS unit\n\n   b. Moderate to severe Interstitial Lung Disease (ILD) defined by evidence of ILD on High-resolution computed tomography (HRCT) and FVC \\\u003C 70% of predicted or DLCO (hemoglobin or alveolar volume corrected) \\\u003C 70% of predicted or ILD on HRCT and progressive ILD meeting at least 2 of the following 3 criteria within the prior 6 months of screening:\n\n   i. Worsening respiratory symptoms\n\n   ii. Evidence of progression on HRCT, or\n\n   iii. Evidence of absolute decline in FVC ≥ 5%\n3. 10 years or less since the first non-Raynaud's sign or symptom\n4. Inadequate response or intolerance to at least one treatment, including cyclophosphamide, methotrexate, MMF\u002Fmycophenolic acid, nintedanib, rituximab, or tocilizumab\n\nIIM Inclusion Criteria:\n\n1. Diagnosis for IIM as per 2017 ACR\u002FEULAR Classification Criteria\n2. One positive myositis antibody\n3. Activity defined as manual muscle testing (MMT-8) score \\\u003C136\u002F150\n4. Creatinine kinase or aldolase ≥ 1.5 x ULN and Clinician Global Assessment ≥ 2 cm with at least one of the following:\n\n   1. Evidence on magnetic resonance imaging (MRI) of active myositis within the last 6 months\n   2. Electromyography (EMG) with active myositis within the last 6 months\n   3. Muscle Biopsy of active myositis within last 6 months\n   4. Global extramuscular activity score ≥2 cm per Clinician global assessment (CGA) using a visual analog scale (VAS) (0-100 mm)\n\n   Note: Participants with DM or ASyS may be eligible despite CK or aldolase \\\u003C1.5 × ULN, provided they have a Clinician Global Assessment ≥2 cm and meet at least one of criteria (a)-(d) above OR have a CDASI score of ≥20.\n5. Inadequate response to treatment defined as ≥ 3 months failure (or intolerance) to at least 2 immunosuppressive therapies (including glucocorticoids)\n\nAAV:\n\n1. Meets the 2022 ACR\u002FEULAR classification criteria for Granulomatosis with Polyangiitis (GPA) (Robson 2022) or Microscopic Polyangiitis (MPA) (Suppiah 2022)\n2. Relapsed or refractory AAV despite repeated treatment with immunosuppressive agents or requiring prolonged and\u002For repeated courses of unacceptable doses of glucocorticoids to maintain disease control\n3. Positive test for anti-proteinase-3 (PR3-ANCA) or anti-myeloperoxidase (MPO-ANCA) at screening\n4. Have at least one \"major\" item, or at least 3 other items, or at least 2 renal items on the BVAS version 3\n\nRA Inclusion Criteria:\n\n1. Documented diagnosis of RA, meeting the 2010 ACR\u002FEULAR classification criteria\n2. Rheumatoid Factor (RF) or Anti-Citrullinated Protein Antibody (ACPA) positive\n3. CRP \\>3 mg\u002FL\n4. Inadequate response, defined as failure to achieve a clinically meaningful improvement (eg, ACR50 response or DAS28-low disease activity \\[ie, DAS28 \\>3.2\\]) after at least 12 weeks of therapy with the following:\n\n   1. At least 1 conventional synthetic DMARD (csDMARD) (eg, methotrexate, leflunomide, sulfasalazine, hydroxychloroquine) AND\n   2. Either of the following:\n\n   i. At least 2 biologic (b) DMARDs (eg, TNF inhibitors, abatacept, anti-IL-6 or anti-IL-6R, rituximab) with distinct mechanisms of action (MoAs)\n\n   OR\n\n   ii. At least 1 bDMARD and at least 1 targeted synthetic DMARD (tsDMARD) (eg, JAK inhibitor)\n\n   AND\n\n   c. Have failed no more than 3 biologics or tsDMARDs with unique mechanisms of action\n5. Minimum of 6 swollen joint counts (SJCs) and 6 tender joint counts (TJCs) according to joint assessment\n\nGeneral Exclusion Criteria:\n\n1. eGFR \\\u003C 45 ml\u002Fmin\u002F1.73m2\n2. Currently requiring renal dialysis or expected to require dialysis during the study period\n3. Previous solid organ or hematopoietic cell transplant or planned transplant within study treatment period\n4. Congenital or acquired immunodeficiency resulting in severe infection or those receiving chronic immunoglobulin replacement therapy\n5. Liver disease or dysfunction, including cirrhosis and\u002For bilirubin ≥ 3 times the upper limit of normal\n6. Pulmonary comorbidity including chronic obstructive pulmonary disease or asthma requiring daily oral steroids, resting hypoxemia (\\\u003C92% oxygen saturation via pulse oximetry) on room air, or significant smoking history (i.e. \\>10 pack\u002Fyear) with active pulmonary disease\n7. Participants with ILD with any of the following:\n\n   1. Requires supplemental oxygen therapy\n   2. FVC \\\u003C45% of predicted\n   3. Diffusing capacity of the lung (DLCO) corrected for alveolar volume (AV) or Hemoglobin (Hgb) ≤ 40% of predicted at screening (per Investigator or Sponsor judgement)\n\n   i. If the participant has a historical FVC value within the last year that exceeds the 45% threshold, discuss with the Medical Monitor should the Screening FVC be \\\u003C45% predicted\n8. Bone marrow insufficiency unrelated to active underlying autoimmune disease with white blood cell count \\\u003C 3,000\u002Fmm\\^3; hemoglobin levels ≤ 9 g\u002FdL; absolute neutrophil count (ANC) ≤ 1500\u002Fmm\\^3; platelet count ≤ 100,000\u002Fmm\\^3, and blood transfusion within 60 days prior to LD\n9. Major cardiac disease, abnormalities, or interventions as defined by, but not limited to:\n\n   1. Uncontrolled angina or unstable life-threatening arrhythmias\n   2. History of myocardial infarction within 12 weeks prior to the first dose of NKX019\n   3. Any prior coronary artery bypass graft surgery\n   4. ≥ Class III New York Heart Association (NYHA) congestive heart failure (CHF), significantly decreased ejection fraction (EF ≤ 40%), or severe cardiac insufficiency\n   5. Prolongation of the QT interval corrected for heart rate (QTc) (Fridericia) interval of \\> 480 msec\n   6. Peripheral artery bypass graft surgery, pulmonary embolism, or other ≥ Grade 2 thrombotic or embolic events within 12 weeks prior to the first dose of NKX019\n10. Active bleeding disorders\n11. Any overlapping autoimmune condition for which the condition or the treatment of the condition may affect the study assessments or outcomes (eg, anti-GBM antibody glomerulonephritis or any condition for additional immunosuppression is indicated); clinically significant conditions that could cause a secondary nephropathy (eg, infections, liver disease, tumors or drugs); or kidney biopsy-confirmed significant renal disease other than disease under study (eg, diabetic nephropathy, hypertensive nephropathy). Overlapping conditions for which the condition or treatment is not expected to affect assessments or outcomes (eg, Sjögren's syndrome, rheumatoid arthritis) are not excluded\n12. Pregnancy, breast feeding or, if of childbearing potential, not using adequate contraceptive precautions\n13. Current infection requiring active systemic anti-infective therapy or recent acute infection requiring systemic therapy within 30 days of planned LD\n14. History of positive HIV test at screening, Hepatitis B or C positive at screening, active tuberculosis (TB) or latent TB requiring suppressive therapy\n15. Major surgery within 28 days prior to the first dose of NKX019 or any surgery from which the participant has not recovered or has ongoing complications\n16. Malignancy within 5 years of screening, with the exception of basal and squamous cell carcinomas treated by complete excision. Participants with cervical dysplasia that is cervical intraepithelial neoplasia but have been treated with conization or loop electrosurgical excision procedure and have had a normal repeat Papanicolaou test are allowed\n17. Prior cellular therapy including mesenchymal, CAR-T or CAR-NK cells\n18. Central nervous system (CNS) comorbidity or any autoimmune disease with CNS involvement within 90 days prior to the first dose of NKX019 as well as evidence of CNS related autoimmune manifestations within 1 year prior to screening\n\nSSc Exclusion Criteria:\n\n1. Moderate-to-severe Pulmonary arterial hypertension (PAH) on right heart catheterization requiring PAH specific treatment. Those participants with mild PAH (as defined by the 2022 ECS\u002FERS Guidelines, \\[Humbert 2023\\]) well controlled on therapy can be enrolled\n2. Gastrointestinal (GI) dysmotility requiring total parenteral nutrition (TPN)\n3. Renal crisis or Pericardial tamponade within 6 months prior to enrollment\n4. Current gangrene of a digit\n\nIIM Exclusion Criteria:\n\n1. Evidence of severe chronic proximal muscle involvement of upper or lower extremities, based on Magnetic Resonance Imaging (MRI) defined as:\n\n   1. ≥15% fibro-fatty replacement in core muscle groups (including gluteus and vastus musculature), and\u002For\n   2. ≥15% muscle atrophy in these regions Participants will also be excluded if the combined extent of fibro-fatty replacement and muscle atrophy exceeds 30% in aggregate\n2. MMT-8 of ≤ 80\n3. Findings of muscular inflammation or myopathy due to another cause, such as inclusion body myositis, cancer-associated myositis (myositis diagnosed within 2 years of cancer), amyloid myopathy, muscular dystrophy, metabolic myopathies, or myositis in the context of significant overlap with another systemic IIM rheumatologic disease (overlap myositis), except with Sjögren's syndrome\n4. Generalized severe musculoskeletal or neuro-muscular conditions other than IIM\n5. Immune-mediated necrotizing myopathy\n\nAAV Exclusion Criteria:\n\n1. Alveolar hemorrhage requiring invasive pulmonary ventilation support\n2. Required dialysis or plasma exchange within 12 weeks prior to screening\n3. Any other known disease that may interfere with the assessments including eosinophilic GPA (Churg-Strauss), anti-glomerular basement membrane, systemic lupus erythematosus, IgA vasculitis (Henoch Schönlein), rheumatoid vasculitis, or cryoglobulinemic vasculitis","75 Years",{"count":296,"type":22},240,[169,25],"This is a Phase 1\u002F2, open-label, multi-center, multi-cohort, non-randomized dose escalation and dose expansion basket study to determine the safety and tolerability of NKX019 (allogeneic CAR NK cells targeting CD19) in participants with autoimmune diseases.",[223,225,300,28],"Antineutrophil Cytoplasmic Antibody-Associated Vasculitis",[302,303,304,305,306,307,308,309,310,311,172,312,313,223,225,314,315,28],"CD19","CAR","Allogeneic","NKX019","Natural Killer Cells","Interleukin-15","IL-15","Cell Therapy","Immunotherapy","Adoptive cell therapy","Myositis","AAV","Antineutrophil Cytoplasmic Antibody (ANCA)-Associated Vasculitis","Ntrust-2","2026-08-05",{"date":197,"type":33},{"date":319,"type":33},"2024-11-04",{"date":321,"type":22},"2028-10",{"name":323,"class":40},"Nkarta, Inc.",18,{"id":326,"slug":327,"hasResults":12,"nctId":328,"briefTitle":329,"officialTitle":330,"acronym":4,"eligibilityCriteria":331,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":332,"targetDuration":4,"studyType":23,"phases":334,"briefSummary":335,"conditions":336,"keywords":337,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":339,"lastUpdatePostDateStruct":340,"startDateStruct":342,"completionDateStruct":344,"leadSponsor":346,"locationsCount":348},"100610651","phase-1-a-phase-1b-open-label-study-to-evaluate-safety-of-plamotamab-in-participants-with-rheumatoid-arthritis-100610651","NCT07230353","A Phase 1b Open-label Study to Evaluate Safety of Plamotamab in Participants With Rheumatoid Arthritis","A Phase 1b, Open-label, Dose-Escalation Trial to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Plamotamab in Participants With Rheumatoid Arthritis","Inclusion Criteria: Adult participants with moderately to severely active RA.\n\n* Documented diagnosis of RA and meeting the 2010 American College of Rheumatology\u002FEuropean Alliance of Associations for Rheumatology classification criteria for RA at least 3 months prior to screening\n* Inadequate response to, loss of response to, or intolerance to available RA therapies.\n* Stable doses of RA medications prior to screening\n* Use of highly effective methods of contraception\n\nExclusion Criteria:\n\n* Major surgery within 12 weeks prior to screening or planned within 12 months after dosing\n* Recurrent infections or active clinically significant infection\n* Active or untreated latent tuberculosis\n* Cancer or history of cancer or lymphoproliferative disease within the previous 5 years\n* Uncontrolled cardiovascular, pulmonary, renal, hepatic, endocrine, or gastrointestinal disease\n\nNote: Additional, more specific inclusion\u002Fexclusion criteria are defined in the protocol.",{"count":333,"type":22},68,[169],"The purpose of this study is to determine the safety and tolerability of plamotamab in patients with rheumatoid arthritis. Participants will be given XmAb13676 subcutaneously (SC) by injection under the skin.",[28],[338],"Rheumatoid Arthritis, Arthritis Rheumatoid, Arthritis","2026-07-31",{"date":341,"type":33},"2026-08-03",{"date":343,"type":33},"2025-10-21",{"date":345,"type":22},"2028-06",{"name":347,"class":40},"Xencor, Inc.",3,{"id":350,"slug":351,"hasResults":12,"nctId":352,"briefTitle":353,"officialTitle":354,"acronym":4,"eligibilityCriteria":355,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":294,"enrollmentInfo":356,"targetDuration":4,"studyType":23,"phases":358,"briefSummary":359,"conditions":360,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":361,"lastUpdatePostDateStruct":362,"startDateStruct":363,"completionDateStruct":365,"leadSponsor":367,"locationsCount":369},"100620897","phase-1-a-clinical-study-of-mk-1045-in-people-with-lupus-or-rheumatoid-arthritis-mk-1045-004-100620897","NCT07363590","A Clinical Study of MK-1045 in People With Lupus or Rheumatoid Arthritis (MK-1045-004)","A Dose Escalation Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of MK-1045 in Participants With Systemic Lupus Erythematosus and Rheumatoid Arthritis","Inclusion Criteria:\n\n* Has a body mass index between 18 and 32 kg\u002Fm\\^2, inclusive\n* Systemic lupus erythematosus (SLE): Has a diagnosis of SLE for at least 6 months and met the European Alliance of Associations for Rheumatology (EULAR)\u002F American College of Rheumatology (ACR) 2019 classification criteria\n* SLE: Is taking at least one background therapy for SLE\n* RA: Has a diagnosis of RA for at least 6 months and meets the 2010 ACR-EULAR classification criteria for RA\n\nExclusion Criteria:\n\n* Has a known active infection (excluding fungal infection of nail beds), or any major episode of infection requiring hospitalization or treatment with anti-infectives within 8 weeks prior to the Day 1 dosing\n* History of serious recurrent or chronic infection\n* Is known to be infected with hepatitis B virus, hepatitis C virus, or human immunodeficiency virus\n* Has evidence of active tuberculosis (TB), latent TB, or inadequately treated TB\n* Has a significant or uncontrolled medical disease in any organ system not related to RA or SLE\n* For RA participants, has a history of any arthritis with onset before age 17 years\n* Has a current inflammatory condition other than SLE or RA that could interfere with disease activity assessments\n* History of cancer (except fully treated nonmelanoma skin cancers or cervical carcinoma in situ after complete surgical removal) and is disease free for \\\u003C5 years before Day 1 dosing\n* Has had a major surgery within 3 months prior to Screening or has a major surgery planned during the study.\n* Has symptomatic heart failure (New York Heart Association class III or IV) or myocardial infarction or unstable angina pectoris within 6 months prior to Screening\n* Has a severe chronic pulmonary disease requiring oxygen therapy\n* Has current active lymphoproliferative disease, including lymphoma, or signs and symptoms suggestive of possible lymphoproliferative disease",{"count":357,"type":22},21,[169],"This study looks at a study medicine called MK-1045 in people with lupus and rheumatoid arthritis (RA). The main goal of the study is to learn about the safety of MK-1045 and if people tolerate it when they receive it at different dose levels (amounts).",[88,28],"2026-07-30",{"date":339,"type":33},{"date":364,"type":33},"2026-02-19",{"date":366,"type":22},"2029-07-16",{"name":368,"class":40},"Merck Sharp & Dohme LLC",19,{"id":371,"slug":372,"hasResults":12,"nctId":373,"briefTitle":374,"officialTitle":375,"acronym":4,"eligibilityCriteria":376,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":377,"targetDuration":4,"studyType":23,"phases":378,"briefSummary":379,"conditions":380,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":361,"lastUpdatePostDateStruct":390,"startDateStruct":391,"completionDateStruct":393,"leadSponsor":395,"locationsCount":398},"100348403","phase-1-testing-an-immunotherapy-anti-cancer-drug-nivolumab-for-advanced-cancers-in-patients-with-autoimmune-disorders-aim-nivo-100348403","NCT03816345","Testing an Immunotherapy Anti-cancer Drug, Nivolumab, for Advanced Cancers in Patients With Autoimmune Disorders, AIM-NIVO","A Phase Ib Study of Nivolumab in Patients With Autoimmune Disorders and Advanced Malignancies (AIM-NIVO)","Inclusion Criteria:\n\n* Patients can have either histologically confirmed malignancy that is radiologically evaluable and metastatic or unresectable, or have a malignancy for which a PD-1\u002FPD-L1 inhibitor has been approved in the adjuvant setting, as well as the neoadjuvant or perioperative setting in which such treatment is considered standard of care or has been approved. Eligible tumor types include solid tumors and malignancies in which there is known evidence of clinical activity for single agent PD-1 or PD-L1 antibodies. Nivolumab or other PD1\u002FPD-L1 inhibitors are FDA-approved for the treatment of melanoma, non-small cell lung cancer (NSCLC), Merkel cell cancer, bladder cancer, renal cell carcinoma (RCC), gastric cancer, hepatocellular carcinoma (HCC), cervical cancer, head and neck cancer, Hodgkin lymphoma (HL), metastatic small cell lung cancer (SCLC), and any solid tumor with microsatellite instability (MSI)-high status confirmed. Patients with HL are eligible but must follow standard response criteria. Additional tumor types may be eligible on a case by case basis upon discussion with principal investigator (PI)\n\n  * Patients enrolling on the trial for adjuvant use will be restricted to those with histology for which a PD-1\u002FPD-L1 inhibitor has been approved in the adjuvant setting including but not limited to NSCLC, melanoma, RCC, cervical cancer, and bladder cancer\n  * Patients enrolled on the study can receive Nivolumab with other FDA-approved combinations according to the FDA package insert, including, but not limited to ipilimumab, cabozantinib or chemotherapy\n* Patients who have previously received other forms of immunotherapy (high-dose \\[HD\\] IL-2, IFN, CTLA-4) are allowed. Patients must not have received cytokine immunotherapy for at least 4 weeks before nivolumab administration. Patients who have received prior anti-CTLA4 will be allowed and the washout period is 6 weeks\n* Age \\>= 18 years; children are excluded from this study but may be eligible for future pediatric phase 1 combination trials\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 (Karnofsky \\>= 60)\n* Life expectancy of greater than 12 weeks\n* Leukocytes \\>= 1,000\u002FmcL\n* Absolute neutrophil count \\>= 500\u002FmcL\n* Platelets \\>= 50,000\u002FmcL\n* Total bilirubin =\\\u003C 2 x institutional upper limit of normal (ULN)\n* Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase \\[SGOT\\])\u002Falanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \\[SGPT\\]) =\\\u003C 5 x institutional ULN or =\\\u003C 8 x institutional ULN for patients with liver metastases or an autoimmune disease that is contributing to the elevation of these values\n* Creatinine ULN OR glomerular filtration rate (GFR) \\>= 30 mL\u002Fmin (if using the Cockcroft-Gault formula)\n* Human immunodeficiency virus (HIV)-infected patients on effective antiretroviral therapy with undetectable viral load within 6 months are eligible for this trial\n* If evidence of chronic hepatitis B virus (HBV) infection, HBV viral load must be undetectable on suppressive therapy if indicated\n* If history of hepatitis C virus (HCV) infection, must be treated with undetectable HCV viral load\n* Patients with new or progressive brain metastases (active brain metastases) or leptomeningeal disease are eligible if the treating physician determines that immediate central nervous system (CNS) specific treatment is not required and is unlikely to be required for at least 4 weeks (or scheduled assessment after the first cycle of treatment), and a risk-benefit analysis (discussion) by the patient and the investigator favors participation in the clinical trial\n* The effects of nivolumab on the developing human fetus are unknown. For this reason, women of child-bearing potential (WOCBP) and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. WOCBP receiving nivolumab will be instructed to adhere to contraception for a period of 5 months after the last dose of investigational product. Men receiving nivolumab and who are sexually active with WOCBP will be instructed to adhere to contraception for a period of 7 months after the last dose of investigational product\n\n  * Women of childbearing potential must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU\u002FL or equivalent units of human chorionic gonadotropin \\[HCG\\]) within 24 hours prior to the start of nivolumab. Women must not be breastfeeding. Women who are not of childbearing potential (i.e., who are postmenopausal or surgically sterile as well as azoospermic men) do not require contraception\n  * WOCBP is defined as any female who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy), tubal ligation, or who is not postmenopausal. Menopause is defined clinically as 12 months of amenorrhea in a woman over 45 in the absence of other biological or physiological causes. In addition, women under the age of 55 must have a documented serum follicle stimulating hormone (FSH) level less than 40 mIU\u002FmL\n  * These durations have been calculated using the upper limit of the half-life for nivolumab (25 days) and are based on the protocol requirement that WOCBP use contraception for 5 half-lives plus 30 days, and men who are sexually active with WOCBP use contraception for 5 half-lives plus 90 days\n  * Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she (or the participating partner) should inform the treating physician immediately. Patients can resume treatment upon termination of a pregnancy or the completion of a successful pregnancy\n* Ability to understand and the willingness to sign a written informed consent document\n* Patients with more than one autoimmune disease are eligible. The treating physician would determine which autoimmune disease is dominant and the patient would be treated under that specific cohort (Please note: Patients with more than one autoimmune disease should receive assessments for all previously diagnosed autoimmune diseases. For example, a patient with psoriasis and IBD might be enrolled in the IBD cohort. Disease assessments for both psoriasis and IBD should be obtained, as per protocol. Case report forms \\[CRFs\\] for all relevant autoimmune diseases should be utilized. However, all additional cohort requirements will be considered optional and only the assessments from the assigned cohort will be considered mandatory)\n* DM\u002FSSc-SPECIFIC INCLUSION: Patients with known SSc or DM according to updated classification criteria (Van den Hoogan et al., Arthritis Rheum 2013;65(11):2737-47; Lundberg et al., A\\&R in press). Overlap features are permitted, but patients must meet criteria for a \"primary diagnosis\" of DM or SSc\n* DM\u002FSSc-SPECIFIC INCLUSION: Patients may be on any concurrent therapy for DM or SSc unless specifically excluded\n* DM\u002FSSc-SPECIFIC INCLUSION: Patients must have a baseline computed tomography (CT) of the chest (within 6 months of study entry)\n* RA-SPECIFIC INCLUSION: Rheumatologist-diagnosed RA requiring prior treatment with disease-modifying antirheumatic drugs (DMARDs) before patient was diagnosed with current malignancy. We recommend, but do not require, documentation for meeting 2010 American College of Rheumatology (ACR)\u002FEuropean League Against Rheumatism (EULAR) classification criteria for RA\n* RA-SPECIFIC INCLUSION: Prednisone up to 10 mg\u002Fday will be allowed. Intraarticular steroids will be allowed for the treatment of new symptomatic joints\n* RA-SPECIFIC INCLUSION: Nonsteroidal anti-inflammatory drugs (NSAIDs) will be allowed\n* SLE-SPECIFIC INCLUSION: SLE diagnosed by a rheumatologist. The patient should meet the revised 1997 American College of Rheumatology (ACR) classification criteria for SLE, but this is not mandatory\n* ULCERATIVE COLITIS (UC)-SPECIFIC INCLUSION: Diagnosis of UC must be made by endoscopy with biopsies\n* UC-SPECIFIC INCLUSION: Complete colonoscopy with biopsies during study screening, within 8 weeks before initial nivolumab administration, or within 4 weeks after initial nivolumab administration\n* UC-SPECIFIC INCLUSION: Patients must test negative for hepatitis B (antigen \\[Ag\\] negative, antibody \\[core (c)Ab\\] negative, antibody \\[surface (s)Ab\\] positive or negative) and Mycobacterium tuberculosis (purified-protein- derivative \\[PPD\\] or enzyme-linked immunospot assay \\[ELISpot or T-spot\\]) or be on appropriate anti-microbial treatment for these infections\n* UC-SPECIFIC INCLUSION: Mild Disease Cohort: Patients must be in clinical remission, defined as a Mayo Clinic score (MCS) of 2 or lower and no subscore higher than 1, and an endoscopic subscore of 0 or 1 either without medications, or treated with 5-ASA derivative, probiotic, or prior fecal transplant\n* UC-SPECIFIC INCLUSION: Moderate Disease Cohort: Patients must be in clinical remission, defined as a MCS of 2 or lower and no subscore higher than 1, and an endoscopic subscore of 0 or 1 on 6-mercaptopurine, azathioprine, methotrexate, or rectal hydrocortisone, budesonide, or one of these medications in combination with any of the medications listed in the Mild cohort\n* UC-SPECIFIC INCLUSION: Severe Disease Cohort (A or B): Patients must either be A) in clinical remission, defined as a MCS of 2 or lower and no subscore higher than 1, and an endoscopic subscore of 0 or 1 on a biologic therapy targeting tumor necrosis alpha (TNF-α) (infliximab, adalimumab, golimumab), α4β7 integrin (vedolizumab), or one of these biologic therapies in combination with any of the medications listed in the Mild or Moderate cohort, or B) have mild active disease defined as a MCS of 3-5 and no subscore higher than 2, and an endoscopic subscore of \\\u003C 2 on one of the medications or combination of medications defined for the Moderate or Mild cohort\n* CROHN'S DISEASE (CD)-SPECIFIC INCLUSION: Complete colonoscopy with biopsies during study screening, within 8 weeks before initial nivolumab administration, or within 4 weeks after initial nivolumab administration\n* CD-SPECIFIC INCLUSION: If patients have prior known disease in the stomach or small intestines, appropriate endoscopic evaluation (esophagogastroduodenoscopy\u002Fvideo capsule endoscopy) and\u002For imaging (computed tomography or magnetic resonance enterography) must also be current within 4 weeks prior to nivolumab administration\n* CD-SPECIFIC INCLUSION: Deep enteroscopy techniques, such as double balloon enteroscopy, will not be required\n* CD-SPECIFIC INCLUSION: Patients must test negative for hepatitis B (sAg negative, cAb negative, sAb positive or negative) and M. tuberculosis (PPD or ELISpot or T-spot) or be on appropriate anti-microbial treatment for these infections\n* CD-SPECIFIC INCLUSION: Mild Disease Cohort: Patients must be in clinical remission as defined by a Crohn's Disease Activity Index (CDAI) \\\u003C 150 either without treatment or on a 5-ASA derivative, probiotic, antibiotics, or following fecal transplant\n* CD-SPECIFIC INCLUSION: Moderate Disease Cohort: Patients must be in clinical remission as defined by a CDAI \\\u003C 150 on 6-mercaptopurine, azathioprine, methotrexate, rectal hydrocortisone, budesonide, or one of these medications in combination with any of the medications listed in the Mild cohort\n* CD-SPECIFIC INCLUSION: Severe Disease Cohort (A or B): Patients must either A) be in clinical remission as defined by a CDAI \\\u003C 150 on biologic therapy targeting TNF-α (infliximab, adalimumab, certolizumab pegol), IL-12\u002F23p40 (ustekinumab), α4β7 integrin (vedolizumab), or one of these biologic therapies in combination with any of the medications listed in the Mild or Moderate cohort, or B) have mild active disease as defined by a CDAI of 150 to 220 on one of medications or combination of medications defined for the Moderate or Mild cohort\n* OTHER AUTOIMMUNE DISEASES- NS-SPECIFIC INCLUSION: For other autoimmune diseases that cannot be classified, the eligibility criteria will be determined by the managing rheumatologist or other autoimmune disease specialist, based on the clinical judgement and current American College of Radiology (ACR) classification guidelines or other relevant guidelines, as per the disease category in question\n* OTHER AUTOIMMUNE DISEASES- NS-SPECIFIC INCLUSION: For giant cell arteritis (GCA), patients must have had positive temporal artery biopsy for GCA and abnormal erythrocyte sedimentation rate (ESR) at time of diagnosis\n* OTHER AUTOIMMUNE DISEASES- NS-SPECIFIC INCLUSION: For polymyalgia rheumatica (PMR), patients must have clinical diagnosis in addition to elevated inflammatory markers including (ESR, C reactive protein \\[CRP\\])\n* OTHER AUTOIMMUNE DISEASES- NS-SPECIFIC INCLUSION: Patients can be in remission (with no glucocorticoids or immunosuppressive medications) or have low-moderate activity, which is defined as being on prednisone ≤ 10 mg or equivalent\n* MS-SPECIFIC INCLUSION: Patients must meet 2017 McDonald criteria for the diagnosis of MS (Thompson AJ, et al. Diagnosis of multiple sclerosis: 2017 revision of the McDonald criteria. Lancet Neurol. 17(2):162-173.)\n* MS-SPECIFIC INCLUSION: Patients with MS can be in remission and can have a history of being on immunomodulatory agents, but at the time of entry into the clinical trial, patients should be off any concurrent MS therapy for at least 2 weeks. Patients receiving concomitant interferon gamma (IFN-γ treatment) will be permitted in the study\n* SJS-SPECIFIC INCLUSION: SjS diagnosed by a rheumatologist or oral medicine provider. The patient should meet the American-European Consensus Criteria for Sjögren's Syndrome (Vitali, et al., 2002). If on treatment, the patient may only be on hydroxychloroquine and prednisone ≤ 10 mg or equivalent\n* PSO\u002FPSA-SPECIFIC INCLUSION: Patients with known PsO as diagnosed by a dermatologist or PsA by a rheumatologist and\u002For by Classification for Psoriatic Arthritis (CASPAR) criteria (Tillett et al., 2012)\n* PSO\u002FPSA-SPECIFIC INCLUSION: Patients must have stable disease as determined by the investigator with no change in systemic therapy and\u002For biologic therapy for at least 3 months, except for those on tumor necrosis factor (TNF) inhibitors. In the case of TNF inhibition, patients may have transitioned to an alternative biologic therapy with stable disease for at least 4 weeks. For PsA, no change in corticosteroid therapy for at least 1 month prior to baseline and dose must be 10 mg or less\n* PSO\u002FPSA-SPECIFIC INCLUSION: Patients may be on any concurrent therapy for PsO or PsA unless specifically excluded\n\nExclusion Criteria:\n\n* Patients who have had chemotherapy or radiotherapy within 2 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events (AEs) due to agents administered more than 4 weeks earlier have not resolved or stabilized. Palliative (limited-field) radiation therapy (RT) is permitted (2 week washout from start of treatment), if all of the following criteria are met:\n\n  * Repeat imaging demonstrates no new sites of bone metastases\n  * The lesion being considered for palliative radiation is not a target lesion\n* Patients with prior therapy with an anti-PD-1 or anti-PD-L1\n* Patients with prior allogeneic hematologic transplant\n* Patients who are receiving any other anticancer investigational agents\n* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements\n* UC-SPECIFIC EXCLUSION: Patients who have received ipilimumab treatment\n* UC-SPECIFIC EXCLUSION: Prior colectomy\n* UC-SPECIFIC EXCLUSION: Concurrent primary sclerosing cholangitis (PSC). Patients with PSC can be enrolled on the Other Autoimmune Diseases Cohorts\n* UC-SPECIFIC EXCLUSION: Patients on empiric immunosuppressive treatment without any clinical workup\n* CD-SPECIFIC EXCLUSION: Known untreated abscesses, untreated and symptomatic strictures, short gut physiology, or isolated jejunal disease\n* CD-SPECIFIC EXCLUSION: Patients who have received ipilimumab treatment\n* CD-SPECIFIC EXCLUSION: Patients on empiric immunosuppressive treatment without any clinical workup\n* MS-SPECIFIC EXCLUSION: Patients with MS cannot have medical contraindications to gadolinium-enhanced magnetic resonance imaging (MRI)",{"count":215,"type":22},[169],"This phase Ib trial studies the side effects of nivolumab and to see how well it works alone and in combination with other treatments, such as ipilimumab, cabozantinib, platinum containing therapy, and fluoropyrimidine, in treating patients with autoimmune disorders and cancer that has spread from where it first started (primary site) to nearby tissue, lymph nodes, or distant parts of the body (advanced), to other places in the body (metastatic) or cannot removed by surgery (unresectable). Immunotherapy with monoclonal antibodies, such as nivolumab and ipilimumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Cabozantinib blocks certain proteins, which may help keep tumor cells from growing. It may also prevent the growth of new blood vessels that tumors need to grow. Cabozantinib is a type of tyrosine kinase inhibitor and a type of angiogenesis inhibitor. Chemotherapy drugs, such as platinum containing therapies and fluoropyrimidine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving nivolumab alone and in combination with other treatments, including ipilimumab, cabozantinib, platinum containing therapy, or fluoropyrimidine, may be safe, tolerable, and\u002For effective in treating patients with autoimmune disorders and advanced, metastatic, or unresectable cancer.",[381,79,382,383,384,385,386,387,83,28,388,88,389,80],"Autoimmune Disease","Dermatomyositis","Hematopoietic and Lymphoid Cell Neoplasm","Inflammatory Bowel Disease","Malignant Solid Neoplasm","Multiple Sclerosis","Psoriasis","Sjogren Syndrome","Systemic Scleroderma",{"date":339,"type":33},{"date":392,"type":33},"2019-07-16",{"date":394,"type":22},"2028-03-30",{"name":396,"class":397},"National Cancer Institute (NCI)","NIH",52,{"id":400,"slug":401,"hasResults":12,"nctId":402,"briefTitle":403,"officialTitle":404,"acronym":405,"eligibilityCriteria":406,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":407,"enrollmentInfo":408,"targetDuration":4,"studyType":23,"phases":410,"briefSummary":411,"conditions":412,"keywords":413,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":417,"lastUpdatePostDateStruct":418,"startDateStruct":420,"completionDateStruct":422,"leadSponsor":424,"locationsCount":426},"100608438","phase-1-study-evaluating-safety-tolerability-pkpd-of-surovatamig-in-adult-ra-or-sle-participants-100608438","NCT07201558","Study Evaluating Safety, Tolerability, PK\u002FPD of Surovatamig in Adult RA or SLE Participants","An Open-label, Phase I Study to Assess Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Surovatamig Following Single-ascending Dose and Step-up Dose Administration to Adult Participants With Rheumatoid Arthritis or Systemic Lupus Erythematosus","ASSURO","Inclusion Criteria:\n\n1. Participant must be 18 (or the legal age of consent in the jurisdiction in which the study is taking place) to 65 years of age, inclusive, at the time of signing the informed consent.\n2. For RA participants, only:\n\n\u003C!-- -->\n\n1. Diagnosis of RA as defined by the 2010 EULAR\u002FACR classification criteria\n2. Positive for ≥ 1 disease-specific autoantibody performed by the central laboratory.\n\n   (a) RF (b) ACPA\n3. Moderate or severe disease activity defined as:\n\nDAS28-CRP \\> 3.2 AND\n\n* 4 tender joints and ≥ 4 swollen joints\n\n  (a) US-Specific Criterion: DAS28-CRP \\> 3.2 AND ≥ 6 tender joints and ≥ 6 swollen joints 4. Intolerance to or inadequate response following approximately 3 month's treatment or longer to ≥2 b\u002FtsDMARDs (with different mechanisms of action) after failing csDMARD therapy (unless csDMARD therapy is contraindicated). There is no minimum duration for taking a treatment in cases of intolerance.\n\n  5\\. Background standard of care is not a requirement for participation, however, the following therapies are permitted and may be continued during the study (alone or in combination). Any other systemic immunosuppressive treatment or immune modulating biologic drug must be discontinued in line with the washout periods listed in Inclusion Criterion 12:\n\n  (a) Oral prednisone (or equivalent). Dose must be stable and ≤ 10mg a day for ≥ 2 weeks prior to Day 1. (b) Oral anti-malarial (e.g. hydroxychloroquine ≤ 400 mg a day). Dose must be stable for ≥ 4 weeks prior to Day 1. (c) Treatment with one of the following csDMARDs for ≥ 3 months and at a stable dose for ≥ 4 weeks prior to Day 1. (i) Methotrexate ≤ 25 mg per week, without change of route of administration for 8 weeks prior to Day 1 (ii) Sulfasalazine ≤ 3g\u002Fday (iii) Leflunomide ≤ 20 mg\u002Fday 3. For SLE participants, only:\n  1. Diagnosis of SLE as defined by the 2019 EULAR\u002FACR classification criteria\n  2. Positive for ≥ 1 disease-specific autoantibody performed by the central laboratory. If autoantibodies are negative on central laboratory test, documented history of test results may be used. (a) ANA immunofluorescent assay test (titer ≥ 1:80) (a) Anti-dsDNA (b) Anti-Sm.\n  3. Moderate or severe disease activity defined as clinical SLEDAI-2K \\> 4\n\n     (a) US-specific criterion: clinical SLEDAI-2K ≥ 6\n  4. Intolerance to or inadequate response following approximately 3 months treatment or longer ≥ 3 SoC (includes: corticosteroids, anti-malarial drugs, calcineurin inhibitor, methotrexate, azathioprine, leflunomide, mycophenolic acid or its derivatives, cyclophosphamide, belimumab, anifrolumab, telitacicept, or B-cell depleting monoclonal antibodies). There is no minimum duration for taking a treatment in cases of intolerance.\n  5. Background standard of care is not a requirement for participation, however, the following therapies are permitted and may be continued during the study (alone or in combination). Any other systemic immunosuppressive treatment or immune modulating biologic drug must be discontinued in line with the washout periods listed in Inclusion Criterion 12: (a) Oral prednisone (or equivalent. Dose must be stable and ≤ 20mg a day for ≥ 2 weeks prior to Day 1. (b) Oral anti-malarial (eg, hydroxychloroquine ≤ 400 mg a day). Dose must be stable for ≥ 4 weeks prior to Day 1. (c) Treatment with one of the following immunosuppressive treatments. for ≥ 3 months and at a stable dose for ≥ 4 weeks prior to Day 1. (i) Methotrexate ≤ 25 mg\u002Fweek, without change of route of administration for 8 weeks prior to Day 1 (ii) Mycophenolate mofetil or equivalent ≤ 2 g\u002Fday (dose must be ≤ 2 g\u002Fday for 3 months prior to Day 1) (iii) Azathioprine ≤ 200 mg\u002Fday (iv) Leflunomide ≤ 20 mg\u002Fday (v) Tacrolimus ≤ 0.1 mg\u002Fkg\u002Fday with maximum dose of 5 mg\u002Fday (vi) Cyclosporin ≤ 3 mg\u002Fkg\u002Fday with maximum dose of 200 mg\u002Fday\n\n  4\\. Blood B cells ≥ 50 cells\u002FμL at screening. 5. IgG levels ≥ 6 g\u002FL at screening. 6. Eligibility for re-treatment of previously treated participants only. The following criterion applies only to participants being considered for re-treatment and is not applicable to participants undergoing initial screening for study entry.\n\n  1\\. Participants treated in prior study cohorts who did not experience an IMP-related DLT or discontinue treatment and\u002For participation due to an IMP-related AE are eligible for re-treatment in Parts 2 and 3. Participants must otherwise meet all protocol-defined eligibility criteria, with the exception of Inclusion Criterion 17 (B cell count), and meet one of the 2 criteria below:\n  1. Completed the 6-month treatment period OR\n  2. Completed a minimum of 90 days in the treatment period and have peripheral B cell counts that are ≥ 90% of baseline or above lower limit of normal (LLN)\n\n     Exclusion Criteria:\n     1. Any complications of disease under study that are judged by the Investigator to be life or organ threatening or to require treatments which are not permitted in the protocol, including but not limited to: (a) Active severe SLE-driven renal disease. (b) Severe lung or cardiac involvement. (c) History of, or current diagnosis of, catastrophic or severe APS (eg, diagnosis of an arterial or central\u002Fpulmonary venous clot) within 1 year prior to signing the ICF. Participants with clinically evident APS which is adequately controlled by anticoagulants or aspirin for at least 12 weeks can be recruited into the study. (d) Rapidly progressive and\u002For severe ILD or ILD that requires oxygen supplementation\u002Ftherapy (of any type). (e) Felty's syndrome\n     2. History of HLH\u002FMAS.\n     3. For RA participants, only:\n\n     \u003C!-- -->\n\n     1. Juvenile idiopathic arthritis or idiopathic arthritis diagnosed before the age of 16.\n     2. Axial spondylarthritis or any other disease associated with inflammatory arthritis\n\n     4\\. For SLE participants, only:\n\n     1.History of active, severe or unstable neuropsychiatric SLE, except for headache and peripheral neuropathies. 5. Other active or prior documented severe, complex, autoimmune or inflammatory disorders. Exceptions to this exclusion criteria include: (a) Vitiligo or alopecia (b) Hypothyroidism stable on hormone replacement (c) Controlled type I diabetes mellitus on insulin (d) Any chronic skin condition that does not require systemic immunosuppressant or biologic therapy (e) Celiac disease, controlled by diet alone (f) Participants with secondary Sjögren's disease are eligible provided that immunosuppression is primarily prescribed for the disease under study (ie, SLE or RA) and not for secondary Sjögren's. 6. Significant CNS co-morbidity (eg, Parkinson's, stroke, CNS vasculitis, severe brain injury, dementia, neurodegenerative diseases, cerebellar disease, epilepsy\u002Fseizure disorders, PML, severe uncontrolled mental illness, psychosis, CNS involvement of autoimmune diseases).\n\n     7\\. Known history of a primary immunodeficiency, splenectomy, or any underlying condition that predisposes the participant to infection.\n\n     8\\. Exclusion Criteria Related to Infection:\n\n     1\\. Any clinical suspicion or diagnosis of active infection at screening. 2. Opportunistic infection that meets criteria to be an SAE within 3 years. 3. Clinically significant chronic infection (for example osteomyelitis, bronchiectasis) with treatment completed less than 2 months prior to signing the ICF (except for chronic nail infections which are not exclusionary) 4. Any infection requiring hospitalisation or treatment with IV anti-infectives with treatment completed less than 4 weeks prior to signing the ICF.\n\n     5\\. Any infection requiring oral anti-infectives within 2 weeks prior to signing the ICF.\n\n     6\\. History of recurrent infection requiring hospitalisation or IV antibiotics (eg, 3 or more of the same type of infection, including systemic fungal infections, over the previous 52 weeks).\n\n     9\\. Participants who, as judged by the Investigator, have evidence of active TB, or latent TB or have a household contact with known diagnosis of current active TB.\n\n  \u003C!-- -->\n\n  1. TB evaluation will be performed according to the local SoC as determined by local guidelines and may include history and physical examinations, chest X-ray, or TB test (eg, purified protein derivative or QuantiFERON® test).\n  2. Participants with a prior diagnosis of active or latent TB who have documented evidence they have completed a full course of appropriate treatment are not excluded.\n\n     However, a previous history of multidrug-resistant or extensively drug-resistant TB is exclusionary regardless of treatment status. 10. Participant with human immunodeficiency virus infection (confirmed by central laboratory at screening) 11. Participant with active EBV or CMV, assessed clinically. 12. Participant with evidence of chronic or active hepatitis B defined as HBsAg positive or HBcAB positive (tested at screening visit).\n\n     13\\. Participant with evidence of chronic or active Hepatitis C, meeting any of the criteria below: (a) HCV RNA positive or detectible at screening (b) HCV antibody positive at screening (apart from those with negative HCV RNA \\>12 weeks after completion of curative antiviral treatment for HCV or those with sustained negative HCV RNA 12 weeks apart following resolution of HCV infection if not treated).\n\n     14\\. Participant positive with COVID-19 PCR at screening. If patients test positive at screening or Day 1 but meet other eligibility criteria, they may be re-tested after ≥ 2 weeks. If this falls within the screening window, then they do not require re-screening.\n\n     15\\. Receipt of any of the following treatments or interventions ever: (a) TCEs, with the exception of surovatamig under the conditions specified in Inclusion Criterion 19 (b) Bone marrow transplant (c) Stem cell transplant (d) Total lymphoid irradiation (e) CAR-T cell therapy (f) Alemtuzumab 16. For females only - currently pregnant (confirmed with positive pregnancy test), planning to become pregnant within the study period, or breast feeding.","65 Years",{"count":409,"type":22},48,[169],"This open-label, Phase I study will assess the safety and tolerability of surovatamig and characterise its PK and PD following subcutaneous administration to participants with RA or SLE.",[28,88],[414,276,415,416],"adult participants","systemic lupus erythematosus","surovatamig","2026-07-28",{"date":419,"type":33},"2026-07-29",{"date":421,"type":33},"2025-12-02",{"date":423,"type":22},"2028-06-27",{"name":425,"class":40},"AstraZeneca",34,{"id":428,"slug":429,"hasResults":12,"nctId":430,"briefTitle":431,"officialTitle":432,"acronym":433,"eligibilityCriteria":434,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":294,"enrollmentInfo":435,"targetDuration":4,"studyType":23,"phases":437,"briefSummary":438,"conditions":439,"keywords":440,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":443,"lastUpdatePostDateStruct":444,"startDateStruct":445,"completionDateStruct":447,"leadSponsor":449,"locationsCount":450},"100615687","phase-1-a-study-of-azd0120-in-autoimmune-diseases-100615687","NCT07295847","A Study of AZD0120 in Autoimmune Diseases","A Phase 1b, Open-label, Multi-cohort Study of AZD0120, an Autologous CD19\u002FBCMA Targeting Chimeric Antigen Receptor T-cell, in Adults With Autoimmune Diseases","AURORA","Inclusion Criteria:\n\n* Capable of giving signed informed consent.\n* Adequate physiological function and reserve at screening.\n* Able to comply with recommended medication washout period.\n* Participants who are suitable for the study as determined by medical evaluation and at the discretion of the investigator.\n* Willingness to remain on\u002Fstart appropriate, highly effective methods of birth control or other acceptable criteria.\n\nExclusion Criteria:\n\n* BMI at screening \\\u003C 18 or \\> 35kg\u002Fm2.\n* Any prior CAR T exposure.\n* Unable or unwilling to remain within proximity (\\~2 hours travel time) of the administering investigational site for the first 28 days post study drug administration.\n* Received a bone marrow or solid organ transplant at any time or on an active transplant waiting list.\n* Received any investigational drug within ≥ 5 half-lives or 4 weeks, whichever is longer, prior to screening.\n* Has certain heart conditions that could make it unsafe or unsuitable to take part in the study.\n* Requirement for supplemental oxygen at rest (except at night for sleep apnea) or mechanical ventilation.\n* Uncontrolled hypertension (\\> 160\u002F100 mmHg) or symptomatic hypertension.\n* Any central nervous system disease that may impact participants safety in the investigator's opinion.\n* Other concurrent autoimmune or autoinflammatory disease. Certain autoimmune\u002Fautoinflammatory diseases may be included after discussion with the medical monitor.\n* Evidence of clinically significant bleeding or active bleeding conditions within 90 days before screening\n* History of malignancy or ongoing treatment for prior malignancy. Certain malignancies may be excepted.\n* Known genetic inborn error of immunity and\u002For primary immunodeficiency.\n* Active viral, bacterial, or fungal infection, or any ongoing infection that requires systemic antimicrobial therapy in the 4 weeks prior to screening.\n* Seropositive for HIV.\n* Active viral hepatitis are excluded.\n* Active syphilis, positive for Treponema pallidum antibody.\n* Vaccinated with live, attenuated vaccine within 4 weeks prior to apheresis or lymphodepletion.\n* Not up-to-date on vaccinations per local\u002Fnational health authority or institutional guidelines for immune-compromised individuals.\n* Known life threatening allergies, hypersensitivity, or intolerance to AZD0120 or its excipients, including dimethyl sulfoxide.\n* Contraindications or hypersensitivity to fludarabine and cyclophosphamide.\n* Major surgery, or has surgery planned during the study.\n* Pregnant, breastfeeding, or planning to become pregnant while enrolled in this study or within 1 year after receiving study treatment (whichever is later).\n* Plans to father a child while enrolled in this study or within 1 year after receiving study treatment (whichever is later).\n* Any issue that would impair the ability of the participant to receive or tolerate the planned treatment at the investigational site, to provide informed consent or any condition in the opinion of the investigator, participation would not be in the best interest of the participant.\n\nOther protocol-defined eligibility criteria may apply.",{"count":436,"type":22},27,[169],"This trial is a Phase 1b, open-label, multi-center, clinical study of AZD0120, a BCMA\u002FCD19 dual targeting CAR+ T-cell therapy, to evaluate the safety and tolerability in adult participants with systemic sclerosis (SSc), idiopathic inflammatory myopathies (IIM), or difficult-to-treat rheumatoid arthritis (D2T RA).",[223,225,28],[223,225,28,441,442,302],"CAR-T","BCMA","2026-07-27",{"date":417,"type":33},{"date":446,"type":33},"2026-01-09",{"date":448,"type":22},"2028-02-22",{"name":425,"class":40},22,{"id":452,"slug":453,"hasResults":12,"nctId":454,"briefTitle":455,"officialTitle":456,"acronym":4,"eligibilityCriteria":457,"healthyVolunteers":109,"sex":18,"minAge":19,"maxAge":294,"enrollmentInfo":458,"targetDuration":4,"studyType":23,"phases":460,"briefSummary":461,"conditions":462,"keywords":463,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":474,"lastUpdatePostDateStruct":475,"startDateStruct":476,"completionDateStruct":478,"leadSponsor":480,"locationsCount":482},"100608930","phase-1-study-of-lfd-200-in-healthy-adults-and-adults-with-moderate-to-severe-rheumatoid-arthritis-100608930","NCT07207954","Study of LFD-200 in Healthy Adults and Adults With Moderate to Severe Rheumatoid Arthritis","A Phase 1a\u002F1b, Randomized, Double-Blind, Placebo- and Active-Controlled, Single and Multiple Ascending Dose Study Evaluating the Comparative Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of LFD-200 in Adult Participants Who Are Healthy or Have Moderate to Severe Rheumatoid Arthritis","Inclusion Criteria for Healthy Participants:\n\n* Age 18-55\n* BMI - 18-32\n* Participants must be deemed by the Investigator to be generally healthy individuals based on a medical evaluation that includes a physical examination, medical history, vital signs, and the results from clinical labs and other safety assessments collected during the Screening period.\n\nExclusion Criteria for Healthy Participants:\n\n* Participants with any current or previous illness that, in the opinion of the investigator, might confound the results of the study or pose an additional, unacceptable risk to the participant or that could prevent, limit, or confound the protocol specified assessments or study results' interpretation.\n* Recent serious or ongoing infection\n* Known\u002Fsuspected primary immunodeficiency\n* Receipt of injected or systemic glucocorticoids within 6 weeks prior to screening\n* Use of prohibited medications\n* Any of the following lab abnormalities:\n\n  * White blood cell (WBC) count \\\u003C3.0 x 109\u002FL\n  * Absolute neutrophil count (ANC) \\\u003C2.0 x 109\u002FL\n  * Hemoglobin (Hgb) \\\u003C12.5 g\u002FdL for males and \\\u003C11.5 g\u002FdL for females\n  * Platelet count \\\u003C140 x 109\u002FL\n  * Alanine transaminase (ALT) ≥1.2x upper limit of normal (ULN)\n  * Total bilirubin ≥1.2x ULN (except if Gilbert's disease is suspected etiology)\n  * Estimated glomerular filtration rate (eGFR) \\\u003C80 mL\u002Fmin\u002F1.73m2 based on Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI 2021) formula.\n  * International normalized ratio (INR) ≥1.2 × ULN\n  * Glycated hemoglobin (HbA1c) \\>6%\n  * Positive urine cotinine test (Day -1 only), alcohol breath test or urine drug screen for substances of abuse. Positive tetrahydrocannabinol (THC) is not exclusionary.\n  * A Screening thyroid stimulating hormone (TSH) level that is \\\u003C0.9 × lower limit normal (LLN) or ≥1.2 × ULN\n  * Cortisol level \\\u003C1.0 × LLN (Collected in the AM at the Baseline Visit)\n\nInclusion Criteria for RA Participants:\n\n* Adults of age 18 to 75 years, inclusive, at the time of signing the ICF.\n* BMI within the range of 18.0- to 35.0 kg\u002Fm² (inclusive).\n* Has RA for ≥6 months.\n* Positive rheumatoid factor (RF) or anti-citrullinated protein antibody (ACPA) test at Screening (low or high positive acceptable).\n* A high-sensitivity C-reactive protein (hsCRP) level at Screening must be \\>ULN.\n* Has active RA disease defined as follows:\n\n  * Disease Activity Score of 28 joints-CRP (DAS28-CRP) \\>3.2 at Screening and Baseline\n  * Has ≥4 swollen and ≥4 tender joints on a 28-joint count at Screening and Baseline\n* On MTX orally or subcutaneously for at least 12 weeks prior to Screening. Dose of MTX (including route of administration) must have been stable at 15 to 25 mg weekly (or 10 to15mg in case of documented intolerance) for ≥ 12weeks at Randomization with plans to continue it at the same dose and route of administration for the duration of the study.\n\nExclusion Criteria for RA Participants:\n\n* Clinical evidence of significant unstable or uncontrolled acute or chronic diseases (e.g., cardiac \\[including congestive heart failure, angina, or history of myocardial infarction\\], pulmonary \\[including chronic obstructive pulmonary disease, asthma requiring systemic GC therapy, pulmonary hypertension, or pulmonary fibrosis\\], hematologic, gastrointestinal, hepatic, renal, neurological, psychiatric, dermatologic, musculoskeletal, or infectious diseases) that, in the opinion of the Investigator or Sponsor, constitutes an inappropriate risk or contraindication for participation in study or that could interfere with study objectives, conduct, or evaluation\n* Any other autoimmune or autoinflammatory disorder, which in the opinion of Investigator\u002FSponsor would constitute an inappropriate risk or a contraindication for participation in the study or that could interfere with the study objectives, conduct, or evaluation.\n* Recent serious or ongoing infection, or risk for serious infection, or acute or chronic infection\n* Known seropositivity for or active infection by HIV or strongyloides (if at risk of exposure (e.g., travel from\u002Freside in endemic area))\n* Active or latent TB infection, as suggested by a positive chest radiograph OR positive\u002Findeterminate QFT-TB Gold Plus or T-SPOT within the 12 weeks prior to Screening or a positive Screening CXR or QFT test. Indeterminate screening QFT tests are also exclusionary but may be repeated once and will be considered positive if retest results are positive or indeterminate\u002Fborderline.\n* Clinically significant abnormalities on ECG per the Investigator or Sponsor or any of the following mean ECG parameters on screening\u002Fbaseline (triplicate) ECG:\n\n  * HR \\\u003C40 or \\>100 beats per minute\n  * QTcF (Fridericia corrected QT) interval \\>450 ms (males) or \\>470 ms (females)\n  * QRS interval \\>120 ms\n  * PR interval \\>220 ms\n* Use or anticipated use of medications for the timeframes specified below:\n\n  * Unstable use of any herbal medicines (e.g., St. John's wort) and supplements within 4 weeks prior to Screening through Baseline or anticipated changes in use during study.\n  * Systemic or local (e.g., topical, oral, ophthalmic) corticosteroid (CS) use within 6 weeks prior to randomization or anticipated use during the study (other than as study intervention).\n  * Any intra-articular injection within 4 weeks prior to Screening through Baseline or anticipated use during the study.\n  * Use of cyclophosphamide, chlorambucil, leflunomide for \\\u003C6 months or cyclosporine, mycophenolic acid, azathioprine, tacrolimus, or gold \\\u003C8 weeks prior to Screening through Baseline or anticipated use during the study.\n  * Receipt of rituximab or any other cell depleting biologic therapy within 1 year of Screening through Baseline or anticipated use during the study.\n  * Use of any other commercial injectable biologic (including those for other non- arthritic conditions such as asthma, osteoporosis, lipids, atopic dermatitis) within 12 weeks or 5 half-lives (whichever is longer) prior to Screening through Baseline, or anticipated use during the study.\n  * Use of any other oral DMARD, including JAK-inhibitors, within 12 weeks prior to Screening through Baseline or anticipated used during the study. MTX or HCQ use is permitted as specified in the Inclusion Criteria\n  * Use of \\>1 systemic biologic therapy for the treatment of RA prior to Screening or Baseline. For those participants that have used no more than one systemic biologic therapy, the systemic biologic therapy must have been discontinued at least 12 weeks or 5 half-lives (whichever is longer) prior to Screening with no use through Baseline or anticipated use during the study.\n  * Receiving or has received any investigational drug (or is currently using an investigational device) within 30 days or 5 half-lives (whichever is longer), prior to Screening.\n  * Unstable use of topical or systemic nonsteroidal anti-inflammatory drugs (NSAIDs) OR use above the maximum allowed doses OR use of more than 1 systemic NSAID (other than prophylactic aspirin ≤325mg daily) in the 2 weeks prior to Screening through Baseline or anticipated use during the study.\n* The presence at Screening of any laboratory values of concern in the opinion of the Investigator or Sponsor or of any of the below based on central laboratory testing at Screening:\n\n  * WBC count \\\u003C3.0 × 10⁹\u002FL\n  * ANC \\\u003C2.0 × 10⁹\u002FL\n  * Hgb \\\u003C10 g\u002FdL\n  * Platelet count \\\u003C100 × 10⁹\u002FL\n  * ALT \\>2 × ULN\n  * Total bilirubin ≥1.5 × ULN (unless Gilbert's disease is suspected)\n  * eGFR \\\u003C45 mL\u002Fmin\u002F1.73m² estimated based on CKD-EPI 2021 formula\n  * International normalized ratio \\>1.2 × ULN\n  * HbA1c \\>8%\n  * AM cortisol level at Baseline Visit \\\u003C0.9 × LLN\n  * Positive alcohol breath test or urine drug screen for substances of abuse. Positive THC or positivity for other substances due to ongoing use of these drugs under physician supervision (e.g., prescription narcotics for known pain disorder) are not exclusionary.\n  * A Screening TSH level that is \\\u003C0.9 × LLN or \\> 1.1 × ULN.",{"count":459,"type":22},176,[169],"This is a double-blind, randomized, placebo- and active-controlled study investigating the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of subcutaneous (SC) doses of LFD-200. The study design includes: a single ascending dose (SAD) study in up to 66 adult healthy participants (HPs) to investigate the effects of a single SC dose, with a 30-day follow-up; a multiple ascending dose (MAD) study in up to 40 HPs to assess up to 4 weekly SC doses, with a 30-day follow-up after the last dose; and a MAD study in up to 70 participants with moderate to severe rheumatoid arthritis (RA) to evaluate up to 13 weekly SC doses, with a 30-day follow-up after the last dose.",[28],[464,28,465,466,467,468,469,470,471,472,473],"RA","Healthy Participants","Phase 1a\u002F1b","Safety","Tolerability","Pharmacokinetics","Pharmacodynamics","First in human","Single Ascending Dose","Multiple Ascending Dose","2026-07-24",{"date":417,"type":33},{"date":477,"type":33},"2025-10-06",{"date":479,"type":22},"2027-07-16",{"name":481,"class":40},"Lifordi Immunotherapeutics, Inc.",7,{"id":484,"slug":485,"hasResults":12,"nctId":486,"briefTitle":487,"officialTitle":488,"acronym":4,"eligibilityCriteria":489,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":490,"targetDuration":4,"studyType":23,"phases":492,"briefSummary":493,"conditions":494,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":474,"lastUpdatePostDateStruct":495,"startDateStruct":496,"completionDateStruct":498,"leadSponsor":500,"locationsCount":501},"100603521","phase-2-a-study-to-assess-the-efficacy-and-safety-of-ro7790121-in-participants-with-moderate-to-severe-rheumatoid-arthritis-who-have-not-responded-to-or-who-cannot-tolerate-tumor-necrosis-factor-tnf-andor-janus-kinase-jak-inhibitors-100603521","NCT07137598","A Study to Assess the Efficacy and Safety of RO7790121 in Participants With Moderate to Severe Rheumatoid Arthritis Who Have Not Responded to or Who Cannot Tolerate Tumor Necrosis Factor (TNF) and\u002For Janus Kinase (JAK Inhibitors)","A Phase II, Multicenter, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of RO7790121 in Participants With Moderate to Severe Rheumatoid Arthritis Who Have an Inadequate Response or Intolerance to TNF and\u002For JAK Inhibitors","Inclusion Criteria:\n\n* Has moderate to severe active RA defined by the presence of \\>=6 swollen joints and \\>=6 tender joints at screening and baseline (based on 66\u002F68-joint count)\n* Diagnosis of RA for \\>=3 months and also fulfills the 2010 American College of Rheumatology (ACR)\u002FEuropean Alliance of Associations for Rheumatology (EULAR) classification criteria for RA\n* Demonstrated an inadequate response or loss of response to or intolerance to \\>=1 conventional synthetic disease-modifying antirheumatic drug (csDMARD)\n\nExclusion Criteria:\n\n* Have failed more than two TNF inhibitors or JAK inhibitors\n* Class IV RA according to ACR revised response criteria (Hochberg et al. 1992)\n* Past or current use of other biologic disease-modifying antirheumatic drugs (bDMARDs) (excluding TNF inhibitors) or rituximab\n* Treatment with investigational therapy within 4 weeks or within 5 half-lives of the investigational therapy, whichever is longer, prior to initiation of study treatment.\n* History of any arthritis with onset prior to age 17 years or current diagnosis of inflammatory joint disease other than RA\n* Has been treated with intra-articular, intramuscular, intravenous, trigger point or tender point, intra-bursa, or intra-tendon sheath corticosteroids in the preceding 8 weeks prior to the first dose of study drug\n* History of a severe allergic reaction or anaphylactic reaction or known hypersensitivity to any component of the study drug (or its excipients) and\u002For other products in the same class\n* Any major surgery within 6 weeks prior to screening or a major surgery planned during the study\n* Any serious, chronic and\u002For unstable pre-existing medical, psychiatric, or other- condition\n* History of malignancy, with the exception non-metastatic basal cell or cutaneous squamous cell cancer adequately treated with electrodesiccation and curettage or resection or in situ cervical cancer adequately treated and cured\n* Participants with severe chronic or recurrent viral, bacterial, parasitic, or fungal infections\n* History of active hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency virus (HIV) infection\n* History of organ transplant\n* Any identified confirmed congenital or acquired immunodeficiency\n* Abnormal laboratory values and liver function test",{"count":491,"type":22},160,[25],"This study will assess the efficacy and safety of Afimkibart (also known as RO7790121) compared with placebo in participants with moderate to severe rheumatoid arthritis (RA) who have an inadequate response or intolerance to TNF and\u002For JAK inhibitors.",[28],{"date":443,"type":33},{"date":497,"type":33},"2025-12-05",{"date":499,"type":22},"2027-10-08",{"name":39,"class":40},56,{"id":503,"slug":504,"hasResults":12,"nctId":505,"briefTitle":506,"officialTitle":507,"acronym":4,"eligibilityCriteria":508,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":294,"enrollmentInfo":509,"targetDuration":4,"studyType":23,"phases":511,"briefSummary":512,"conditions":513,"keywords":4,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":516,"lastUpdatePostDateStruct":517,"startDateStruct":518,"completionDateStruct":520,"leadSponsor":522,"locationsCount":126},"100634026","phase-2-disulfiram-in-rheumatoid-arthritis-100634026","NCT07534332","Disulfiram in Rheumatoid Arthritis","Therapeutic Targeting of Gasdermin D-Mediated Pyroptosis to Attenuate Joint Inflammation in Rheumatoid Arthritis","Inclusion Criteria:\n\nAge 18-75 years Body mass index (BMI) ≥25 kg\u002Fm² Diagnosis of rheumatoid arthritis (RA) according to ACR\u002FEULAR classification criteria Active disease defined as Clinical Disease Activity Index (CDAI) \\>10 Stable disease-modifying antirheumatic drug (DMARD) therapy for ≥3 months prior to enrollment Willingness to abstain from alcohol for the duration of the study Ability and willingness to comply with study procedures\n\n\\-\n\nExclusion Criteria:\n\nSignificant liver dysfunction (ALT or AST \\>2.5× upper limit of normal) Current or recent alcohol dependence (based on screening, e.g., AUDIT) Known hypersensitivity to disulfiram or other thiuram derivatives Pregnancy or breastfeeding Severe cardiovascular disease (e.g., myocardial infarction, arrhythmia, coronary occlusion) Severe psychiatric illness (e.g., psychosis, suicidal ideation) Neurologic disorders (e.g., epilepsy, peripheral neuropathy, cerebral damage) Chronic or acute renal disease (e.g., nephritis) Hepatic cirrhosis or hepatic insufficiency Use of contraindicated medications (e.g., metronidazole, phenytoin, paraldehyde, alcohol-containing preparations, warfarin) Other autoimmune diseases or active\u002Fchronic infections Diabetes mellitus or hypothyroidism Allergy to topical iodine Any condition that, in the opinion of the investigator, would pose undue risk or interfere with study participation",{"count":510,"type":22},20,[25],"Rheumatoid arthritis (RA) is a chronic autoimmune disease characterized by persistent joint inflammation and systemic immune activation. Obesity is common among individuals with RA and is associated with increased disease activity, reduced treatment response, and worse functional outcomes. Inflammation in adipose tissue, driven in part by activation of the NLRP3 inflammasome and downstream gasdermin D (GSDMD)-mediated pathways, may contribute to systemic inflammation and RA disease severity.\n\nDisulfiram (DSF), an FDA-approved medication for alcohol use disorder, has recently been identified as an inhibitor of GSDMD-mediated inflammatory signaling and pyroptosis. Preclinical studies suggest that DSF reduces inflammasome activation, inflammatory cytokine release, and metabolic dysfunction.\n\nThis study is a 12-week, randomized, double-blind, placebo-controlled pilot trial designed to evaluate the safety, tolerability, and preliminary efficacy of DSF in overweight and obese adults with active RA despite stable disease-modifying antirheumatic drug (DMARD) therapy. Participants will be randomized to receive either DSF (250 mg daily) or placebo.\n\nThe primary objective is to assess safety and tolerability. Secondary and exploratory objectives include evaluating the effects of DSF on systemic inflammation, RA disease activity, metabolic parameters, and adipose tissue inflammasome activation. Findings from this study will inform the feasibility and design of larger clinical trials targeting GSDMD-mediated inflammation in RA.",[28,514,515],"Inflammation","Obesity","2026-07-23",{"date":443,"type":33},{"date":519,"type":22},"2026-09",{"date":521,"type":22},"2028-04-30",{"name":523,"class":125},"University of Oklahoma",{"id":525,"slug":526,"hasResults":12,"nctId":527,"briefTitle":528,"officialTitle":529,"acronym":530,"eligibilityCriteria":531,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":49,"enrollmentInfo":532,"targetDuration":4,"studyType":23,"phases":534,"briefSummary":535,"conditions":536,"keywords":537,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":545,"lastUpdatePostDateStruct":546,"startDateStruct":547,"completionDateStruct":549,"leadSponsor":551,"locationsCount":552},"100586548","phase-1-a-study-to-investigate-safety-tolerability-pharmacokinetics-and-pharmacodynamics-of-azd5492-in-adult-participants-with-systemic-lupus-erythematosus-or-idiopathic-inflammatory-myopathies-or-rheumatoid-arthritis-100586548","NCT06916806","A Study to Investigate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AZD5492 in Adult Participants With Systemic Lupus Erythematosus or Idiopathic Inflammatory Myopathies or Rheumatoid Arthritis.","An Open-label, Phase I Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AZD5492 Following Single-ascending Dose and Step-up Dose Administration to Adult Participants With Systemic Lupus Erythematosus or Idiopathic Inflammatory Myopathies or Rheumatoid Arthritis","TITAN","Inclusion Criteria:\n\n1. Participant must be 18 to 70 years of age inclusive, at the time of signing the informed consent.\n2. Diagnosis of SLE:\n\n   1. Diagnosis of SLE according to the 2019 EULAR\u002FACR classification criteria for SLE\n   2. Positive for one or more of: anti-nuclear antibodies (titre ≥ 1:80), anti-dsDNA or anti-Sm at screening.\n   3. Active, moderate-severe disease at screening, defined as clinical SLEDAI-2K ≥ 4.\n   4. Intolerance to, or inadequate response following at least 3 months of use to, ≥ 3 available treatments, such as the following: corticosteroids, anti-malarial drugs, calcineurin inhibitor, methotrexate, azathioprine, leflunomide, mycophenolic acid or its derivatives, cyclophosphamide, belimumab, anifrolumab, telitacicept, or B-cell depleting monoclonal antibodies.\n3. Diagnosis of IIM:\n\n   1. Must have \"probable\" or \"definite\" diagnosis of PM or DM (excluding IBM and cancer associated myositis) according to the 2017 EULAR\u002FACR classification criteria for adult myositis.\n   2. Positive for ≥ 1 disease-specific autoantibody at screening.\n   3. MMT-8 score of ≤ 142\u002F150 and\u002For CDASI-A ≥ 6\n   4. Fulfill at least one of the following criteria of active disease at screening:\n\n   (i) One or more muscle enzyme elevation (CK, AST, ALT, aldolase, LDH) ≥ 1.3 × ULN (ii) If criterion 3(d)(i) is not met, then at least one of the following criteria must be met: a. Report from MRI performed within 3 months prior to screening with evidence of muscle inflammation b. Report from muscle biopsy performed within 3 months prior to screening that demonstrates active inflammation c. Report from electromyography performed within 3 months prior to screening that exhibits irritable myopathic pattern.\n\n   (e) Intolerance or inadequate response to corticosteroids and ≥2 other SoC treatments, used for at least 3 months each, for which at least one must be a biologic SoC, immunoglobulin or cyclophosphamide.\n4. Diagnosis of RA:\n\n   (a) Diagnosis of RA as defined by the 2010 EULAR\u002FACR classification criteria (b) Positive for ≥ 1 disease-specific autoantibody performed by the central laboratory at screening: RF or ACPA (c) Moderate or severe disease activity defined as: (i) ≥6 tender joints and ≥6 swollen joints AND (ii) DAS28-CRP \\>3.2. (d) Intolerance to or inadequate response following approximately 3 month's treatment or longer to ≥2 b\u002FtsDMARDs (with different mechanisms of action) after failing csDMARD therapy (unless csDMARD therapy is contraindicated). There is no minimum duration for taking a treatment in cases of intolerance.\n\nExclusion Criteria:\n\n1. Any complications of the disease under study which are judged by the investigator to be life or organ threatening or to require treatments which are not permitted in the protocol, including but not limited to:\n\n   1. Active severe SLE-driven renal disease.\n   2. History of, or current diagnosis of, catastrophic or severe APS (for example diagnosis of an arterial or central\u002Fpulmonary venous clot) within 1 year prior to signing the ICF.\n   3. Rapidly progressive and\u002For severe ILD or ILD that requires oxygen supplementation\u002Ftherapy (of any type).\n   4. Inclusion Body Myositis or cancer associated myositis.\n2. Active severe, unstable or history of neuropsychiatric SLE.\n3. IIM: Pulmonary function tests at screening (or within one month of screening, provided participant confirms no change in respiratory symptoms in the interim) which meet any of the following criteria:\n\n   1. FVC ≤60% of predicted\n   2. DLCO ≤70% of predicted\n   3. Deterioration in either FVC or DLCO at screening compared to pulmonary function tests performed ≥3 months previously.\n4. Significant history of or at risk of severe infections.\n5. Participants with HIV infection.\n6. Participants with evidence of chronic or active hepatitis B defined as HBsAg positive or HBcAB positive\n7. Participants with evidence of chronic or active hepatitis C\n8. Participants with positive COVID-19 PCR.\n9. Known history of a primary immunodeficiency, splenectomy, or any underlying condition that predisposes the participant to infection.\n10. Significant CNS pathology.\n11. Receipt of B-cell-depleting therapy including CD19 or CD20 directed monoclonal antibodies (including but not limited to, ocrelizumab, ofatumumab, obinutuzumab, or rituximab) \\\u003C3 months prior to Day 1.",{"count":533,"type":22},72,[169],"The purpose of this study is to measure the safety, tolerability, PK, and PD of AZD5492 administered subcutaneously in adult participants with SLE or IIM or RA\n\nStudy details include:\n\n• The study duration will be a minimum of 180 days in addition to the screening period.\n\nAdditional follow-up visits may be required up to 12 months from study start.\n\n* Depending on the study part they are assigned to, participants will be administered AZD5492 once (Part 1) or twice (Part 2).\n* Study visits will occur at:\n\nScreening, Days 1-4, 8, 15, 22, 30, 60, 90, 120, 150, and 180 in Part 1, Screening, Days 1-4, 8-11, 15, 22, 29, 43, 60, 90, 120, 150, and 180 in Part 2.",[88,225,28],[222,538,539,540,541,542,312,382,543,544],"Inflammatory Myopathy","Musculoskeletal Diseases","Neuromuscular Diseases","Nervous System Diseases","Muscular Diseases","Polymyositis","Arthritis","2026-07-22",{"date":516,"type":33},{"date":548,"type":33},"2025-05-01",{"date":550,"type":22},"2027-09-15",{"name":425,"class":40},37,{"id":554,"slug":555,"hasResults":12,"nctId":556,"briefTitle":557,"officialTitle":558,"acronym":4,"eligibilityCriteria":559,"healthyVolunteers":109,"sex":18,"minAge":19,"maxAge":407,"enrollmentInfo":560,"targetDuration":4,"studyType":23,"phases":562,"briefSummary":563,"conditions":564,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":566,"lastUpdatePostDateStruct":567,"startDateStruct":568,"completionDateStruct":570,"leadSponsor":572,"locationsCount":126},"100647808","phase-1-a-phase-1-first-in-human-study-of-cnd319-in-healthy-participants-and-patients-with-rheumatic-diseases-100647808","NCT07712939","A Phase 1, First-in-Human Study of CND319 in Healthy Participants and Patients With Rheumatic Diseases","A Phase 1, First-In-Human, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of CND319 in Healthy Participants and Patients With Rheumatic Diseases","Inclusion Criteria (SAD):\n\n1. 18 to 65 years old\n2. Body mass index 18-30 kg\u002Fm2 and weight 55-100 kg\n3. Individuals in good health\n4. Agree to abstain from consumption of alcohol 48 hours prior to study visits\n5. Agree to the use of highly effective contraception as defined in the protocol\n\nInclusion Criteria (MAD and Part 2 Expansion):\n\nPatients with RA:\n\n1. 18 to 75 years old\n2. Diagnosis of adult-onset RA\n3. Class I-III RA\n4. Moderately to severely active RA\n\nPatients with SjD:\n\n1. 18 to 75 years old\n2. Diagnosis of primary SjD\n\nExclusion Criteria (SAD):\n\n1. Inadequate clinical laboratory parameters at Screening\n2. Active infection\n3. Receipt of or inability to discontinue any excluded therapies\n4. Individuals with immediate household contact with your children (eg, ≤ 6 years old) or immunocompromised persons\n5. History of alcohol or drug abuse within last 12 months\n6. Positive alcohol breathalyzer or drug screen prior to dosing\n7. Inability to comply with protocol-mandated requirements\n8. History of severe allergic or anaphylactic reactions to mAb therapy (or recombinant anti-body-related fusion proteins) or any constituents of study drug\n9. Major surgery requiring use of general anesthesia within 12 weeks or planned or expected major surgery during the study\n10. Blood donation or significant blood loss within 30 days\n11. Individuals considered to be part of a vulnerable population (eg, incarceration)\n12. Individuals that in the opinion of the Investigator, are not suitable for participation in the trial\n\nExclusion Criteria for patients with RA or SjD:\n\n1. Inadequate clinical laboratory parameters at Screening\n2. Active infection\n3. Receipt of or inability to discontinue any excluded therapies\n4. History of progressive multifocal leukoencephalopathy\n5. Central nervous system disease\n6. Presence of 1 or more significant concurrent medical conditions\n7. Have a diagnosis or history of malignant disease within 5 years\n8. History of severe allergic or anaphylactic reactions to mAb therapy (or recombinant antibody-related fusion proteins) or any constituents of study drug\n9. Women who are pregnant or breastfeeding\n10. Patients who do not agree to the use of highly effective contraception as defined by the protocol",{"count":561,"type":22},105,[169],"The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity, and preliminary clinical activity of CND319 in healthy adult participants and patients with rheumatic diseases.",[565,28,263],"Healthy Participants Study","2026-07-21",{"date":545,"type":33},{"date":569,"type":22},"2026-07-20",{"date":571,"type":22},"2028-03-31",{"name":573,"class":40},"Candid Therapeutics",{"id":575,"slug":576,"hasResults":12,"nctId":577,"briefTitle":578,"officialTitle":579,"acronym":4,"eligibilityCriteria":580,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":407,"enrollmentInfo":581,"targetDuration":4,"studyType":23,"phases":583,"briefSummary":584,"conditions":585,"keywords":586,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":590,"lastUpdatePostDateStruct":591,"startDateStruct":592,"completionDateStruct":594,"leadSponsor":596,"locationsCount":41},"100606163","phase-1-a-study-to-evaluate-the-safety-tolerability-and-drug-levels-of-bms-986454-in-participants-with-rheumatoid-arthritis-100606163","NCT07171983","A Study to Evaluate the Safety, Tolerability, and Drug Levels of BMS-986454 in Participants With Rheumatoid Arthritis","A 2-Part, Phase 1b Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BMS-986454 in Participants With Rheumatoid Arthritis","Inclusion Criteria:\n\n* Participants with Rheumatoid Arthritis must have onset after age 18.\n* Participants who meet 2010 American College of Rheumatology\u002FEuropean League Against Rheumatism (ACR\u002FEULAR) classification criteria for RA.\n* Participants must have evidence of swelling in at least 1 joint of the hand or wrist by clinical examination at screening and Day -1.\n* Participants must have been an incomplete responder to prior methotrexate (MTX) treatment.\n\nExclusion Criteria:\n\n* Participants must not have any significant medical condition, with the exception of Rheumatoid Arthritis (including but not limited to, neurological, GI, renal, hepatic, cardiovascular, psychological, pulmonary, metabolic, endocrine, hematological, allergic disease, drug allergies, or other major disorders) that, in the Investigator's judgment, will substantially increase the risk to the participant if he or she participates in the study.\n* Participants must not have any condition aside from RA that confounds the ability to interpret data from the study.\n* Participants must not have severe Rheumatoid Arthritis as assessed by Disease Activity Score 28 c-reactive protein (DAS28-CRP) at screening or Day -1.\n* Other protocol-defined Inclusion\u002FExclusion criteria apply.",{"count":582,"type":22},46,[169],"The purpose of this study is to evaluate the safety, tolerability, and drug levels of BMS-986454 in participants with Rheumatoid Arthritis",[28],[587,381,588,589],"Rheumatoid Arthritis (RA)","Chronic Inflammatory Disease","Methotrexate-Inadequate Responders (MTX-IR)","2026-07-17",{"date":569,"type":33},{"date":593,"type":33},"2026-02-27",{"date":595,"type":22},"2027-08-25",{"name":597,"class":40},"Bristol-Myers Squibb",{"id":599,"slug":600,"hasResults":12,"nctId":601,"briefTitle":602,"officialTitle":603,"acronym":4,"eligibilityCriteria":604,"healthyVolunteers":109,"sex":18,"minAge":19,"maxAge":605,"enrollmentInfo":606,"targetDuration":4,"studyType":23,"phases":608,"briefSummary":609,"conditions":610,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":612,"lastUpdatePostDateStruct":613,"startDateStruct":614,"completionDateStruct":616,"leadSponsor":618,"locationsCount":41},"100614235","phase-1-a-study-of-ly4298445-in-healthy-participants-and-participants-with-systemic-lupus-erythematosus-sle-or-rheumatoid-arthritis-ra-100614235","NCT07276958","A Study of LY4298445 in Healthy Participants and Participants With Systemic Lupus Erythematosus (SLE) or Rheumatoid Arthritis (RA)","A Phase 1, Multicenter, Randomized, Placebo-Controlled, Participant-Blind, Single-Ascending Dose Study of LY4298445 in Healthy Participants and an Open-Label Single-Ascending Dose and Multiple-Ascending Dose Study of LY4298445 in Participants With Systemic Lupus Erythematosus or Rheumatoid Arthritis","Inclusion Criteria: Healthy Participants\n\nHealthy participants between the ages of 18 and 55 years.\n\n* Have body weight of at least 50 kilograms (kg) and body mass index (BMI) between 18 and 32 kilogram per square meter (kg\u002Fm²), inclusive.\n\nParticipants with Systemic Lupus Erythematosus (SLE)\n\n* Are 18 to 75 years of age, inclusive.\n* Have body weight between 45 and 145 kg, inclusive, and BMI between 18 and 35 kg\u002Fm², inclusive.\n* Have a clinical diagnosis of SLE according to the 2019 European League Against Rheumatism\u002FAmerican College of Rheumatology (EULAR\u002FACR) classification criteria at least 6 months prior to screening.\n\nParticipants with Rheumatoid Arthritis (RA)\n\n* Are 18 to 75 years of age, inclusive.\n* Have body weight between 45 and 145 kg, inclusive, and BMI between 18 and 35 kg\u002Fm², inclusive.\n* Have a diagnosis of adult-onset RA for at least 6 months prior to screening, as defined by the 2010 ACR\u002FEULAR classification criteria\n* Have Disease Activity Score in 28 joints (DAS28)-high-sensitivity C-reactive protein (hsCRP) greater than or equal to 4.4.\n* Have positive test results for rheumatoid factor or anti-citrullinated peptide antibodies\n* Have had a history of failure (an inadequate response, intolerance, or loss of response) to at least 2 advanced therapies (biological disease-modifying antirheumatic drug \\[bDMARD\\] or targeted synthetic DMARD \\[tsDMARD\\]) after failing a conventional synthetic DMARD (csDMARD).\n\nExclusion Criteria:\n\n* Have known allergies to LY4298445, related compounds, or any components of the formulation\n* Are individuals assigned female at birth (AFAB) who are lactating or have a positive pregnancy test at screening or Day -1.\n* Have severe active lupus-associated renal disease (lupus nephritis) defined clinically and\u002For by\n\n  * urine protein\u002Fcreatinine ratio greater than 200 milligrams per millimole (mg\u002Fmmol) (as an estimate of approximate proteinuria greater than 2 reams (g) per day) or\n  * an estimated glomerular filtration rate (eGFR) less than 40 milliliters per minute (mL\u002Fmin)\u002F1.73 m² at screening, as calculated by the Chronic Kidney Disease Epidemiology Collaboration (CKD EPI) 2021.\n  * requiring hemodialysis within 6 months prior to screening\n* Have active central nervous system lupus as defined by ACR nomenclature for neuropsychiatric lupus syndromes and as captured by Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K); seizure, psychosis, organic brain syndrome, visual disturbance, cranial nerve disorder, lupus headache, and cerebrovascular accident, within 2 months prior to screening\n* Have a Class 4 RA according to the ACR revised criteria","55 Years",{"count":607,"type":22},63,[169],"The purpose of this study is to investigate the safety and tolerability of LY4298445 in healthy participants and in participants with systemic lupus erythematosus (SLE) or rheumatoid arthritis (RA). Participation in the study will last up to approximately 52 weeks.",[611,88,28],"Healthy","2026-07-16",{"date":590,"type":33},{"date":615,"type":33},"2026-02-04",{"date":617,"type":22},"2028-03",{"name":619,"class":40},"Eli Lilly and Company",{"id":621,"slug":622,"hasResults":12,"nctId":623,"briefTitle":624,"officialTitle":625,"acronym":626,"eligibilityCriteria":627,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":628,"targetDuration":4,"studyType":23,"phases":630,"briefSummary":632,"conditions":633,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":612,"lastUpdatePostDateStruct":634,"startDateStruct":635,"completionDateStruct":637,"leadSponsor":639,"locationsCount":641},"100415658","phase-3-ra-pro-pragmatic-trial-100415658","NCT04692493","RA-PRO PRAGMATIC TRIAL","A Real-World Comparative Effectiveness Trial of Treatment Strategies in Patients With Rheumatoid Arthritis: The RA-PRO Pragmatic Trial (RA-PROPR)","RA-PROPR","Inclusion Criteria:\n\n1. Patients with active, disabling RA (CDAI ≥10 and HAQ ≥0.5) despite the use\u002Fexperience of a TNFi-biologic OR discontinued the medication(s) due to intolerability or toxicity irrespective of treatment duration prior to the first dose of study drug ;\n2. If receiving glucocorticoids (≤10 mg\u002Fday of prednisone of equivalent) or NSAIDs, on stable doses for ≥2 weeks prior to randomization; and\n3. Insurance plan or patient assistance program allows access to at least 1 drug in each of the two treatment strategies, TNFi-biologic vs. tsDMARD.(TNFi-biologic and tsDMARD) will be obtained through insurance plan or a patient assistance program\u002Fplan.\n\nParticipants will be allowed to continue their conventional synthetic DMARD (csDMARD) therapy if they had been using it for ≥ 3 months and on a stable dose for ≥ 4 weeks prior to the first dose of study drug. The following csDMARDs are allowed: methotrexate (MTX), sulfasalazine, hydroxychloroquine, and leflunomide\n\nExclusion Criteria:\n\n1. Prior treatment with more than three biologics, defined as TNFi-biologic or non-TNFi biologic\n2. Prior treatment with targeted synthetic DMARD\n3. Concomitant use of leflunomide, sulfasalazine, cyclosporine, or azathioprine within 2-months before randomization;\n4. History of sensitivity to all 4 non-TNF-biologic or a targeted synthetic DMARD;\n5. Glucocorticoid injection (intravenous, intramuscular, or intraarticular) within 1 month of study entry;\n6. Live vaccine within 90 days of study entry;\n7. Acute or chronic infections with parenteral antibiotics or hospitalization (including tuberculosis, bacterial sepsis; invasive fungal infections (such as histoplasmosis)) within 1 month or oral antibiotics within 2 weeks of study entry;\n8. History of HIV or any opportunistic infection;\n9. New York Heart Association Class III or IV heart failure;\n10. Latent TB for which anti-tubercular treatment has not been started;\n11. Untreated Hepatitis B or C infection;\n12. History of deep venous thrombosis or pulmonary embolism; or\n13. Pregnant or nursing women; or\n14. History of herpes zoster or shingles in the previous 12 months and not subsequently vaccinated with herpes zoster vaccine.",{"count":629,"type":22},924,[631],"PHASE3","The 2021 ACR RA treatment guideline, based on widely acknowledged low to moderate quality evidence, recommends switching to a non-tumor necrosis factor (TNFi) biologic (choose among existing medications, currently, rituximab, abatacept, tocilizumab, or sarilumab) or a targeted synthetic DMARD arm (tsDMARD; choose among existing medications, currently, tofacitinib, baricitinib, upadacitinib) in patients with active RA despite the use of a TNFi-biologic. In practice, most patients receive another TNFi-biologic, i.e., a second TNFi-biologic first. This is not based on solid evidence, but on arbitrary algorithms often proposed by health insurance plans, and\u002For physician experience and habit (TNFis launched 22 yrs ago vs. the first tsDMARD 8 years ago vs. first non-TNF-biologic launched 17 years ago). This study will fill a critical knowledge gap by generating CER data for important PROs between these treatment options, switching to a non-TNFi biologic or a tsDMARD in patients with active RA despite the use of a TNFi-biologic.",[28],{"date":590,"type":33},{"date":636,"type":33},"2021-09-22",{"date":638,"type":22},"2029-07-31",{"name":640,"class":125},"University of Alabama at Birmingham",49,{"id":643,"slug":644,"hasResults":12,"nctId":645,"briefTitle":646,"officialTitle":647,"acronym":4,"eligibilityCriteria":648,"healthyVolunteers":109,"sex":18,"minAge":19,"maxAge":407,"enrollmentInfo":649,"targetDuration":4,"studyType":23,"phases":651,"briefSummary":652,"conditions":653,"keywords":655,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":657,"lastUpdatePostDateStruct":658,"startDateStruct":659,"completionDateStruct":661,"leadSponsor":663,"locationsCount":348},"100586620","phase-1-a-study-of-intravenous-cptx2309-in-healthy-participants-and-participants-with-moderate-to-severe-rheumatoid-arthritis-ra-or-systemic-lupus-erythematosus-sle-100586620","NCT06917742","A Study of Intravenous CPTX2309 in Healthy Participants and Participants With Moderate to Severe Rheumatoid Arthritis (RA) or Systemic Lupus Erythematosus (SLE)","A First-in-Human, Phase 1, Open-Label, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of CPTX2309 by Intravenous Administration in Healthy Volunteers and Subjects With Moderate to Severe Rheumatoid Arthritis (RA) or Systemic Lupus Erythematosus (SLE)","Inclusion Criteria:\n\n* Male and female participants who are healthy as determined by the investigator based on review of medical history, physical examination, and clinical laboratory tests obtained during the screening period.\n* Participant is willing and able to adhere to the study visit schedule and other protocol requirements.\n\nRA Only:\n\n* Clinical diagnosis of RA and fulfilling the 2010 ACR\u002FEULAR classification criteria for RA\n* Presence of rheumatoid factor or ACPA above the ULN\n* Confirmation of at least moderate active disease at screening with the presence of at least 6 swollen and 6 tender joints at screening using the 68 (tender)\u002F66 (swollen) joint count OR the presence of at least 3 joints with active synovitis via MRI assessment.\n\nSLE Only:\n\n* Clinical diagnosis of SLE and fulfilling the 2019 EULAR\u002FACR classification criteria for SLE\n* Positive ANA\\>=1:80 and the presence of at least one of the following autoantibodies above the upper limit of normal (ULN): anti-double standard DNA (dsDNA) or anti-Smith (Sm).\n\nExclusion Criteria:\n\n* Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, or clinical laboratory tests beyond what is consistent with a healthy population in the region in which the study is conducted.\n* Use of any investigational medical device or investigational drug within 30 days or 5 half-lives of the investigational drug (whichever is longer) prior to the first administration of CPTX2309.\n\nRA Only:\n\n\\- Participants diagnosed with Felty's syndrome\n\nSLE Only:\n\n* Active neuropsychiatric SLE, as defined by the CNS portion of SLEDAI at Screening, or signs of symptoms of neuropsychiatric SLE within 6 months prior to Screening (lupus headache permissible)\n* Note: Other protocol-defined inclusion\u002Fexclusion criteria apply",{"count":650,"type":22},64,[169],"The purpose of this study is to assess the safety and tolerability of CPTX2309 in healthy adult participants and adult participants with moderate to severe rheumatoid arthritis or systemic lupus erythematosus.",[654,28,88],"Healthy Volunteers",[654,28,88,656],"CPTX2309","2026-07-14",{"date":612,"type":33},{"date":660,"type":33},"2025-04-09",{"date":662,"type":22},"2027-11",{"name":664,"class":40},"Capstan Therapeutics",{"id":666,"slug":667,"hasResults":12,"nctId":668,"briefTitle":669,"officialTitle":670,"acronym":4,"eligibilityCriteria":671,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":672,"targetDuration":4,"studyType":23,"phases":674,"briefSummary":675,"conditions":676,"keywords":677,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":678,"lastUpdatePostDateStruct":679,"startDateStruct":681,"completionDateStruct":683,"leadSponsor":684,"locationsCount":685},"100590824","phase-2-a-study-to-evaluate-different-targeted-therapies-for-patients-with-rheumatoid-arthritis-100590824","NCT06972446","A Study to Evaluate Different Targeted Therapies for Patients With Rheumatoid Arthritis","A Phase 2, Multicenter, Platform Study of Targeted Therapies for the Treatment of Adult Subjects With Moderately to Severely Active Rheumatoid Arthritis","Inclusion Criteria:\n\n* At any time prior to the Screening Visit, participant must have been treated for \\> or = 3 months with at least 1 b\u002FtsDMARD therapy but continued to exhibit active RA, or had to discontinue due to intolerability or toxicity, irrespective of treatment duration. The maximum cap for prior use of b\u002FtsDMARD is 2.\n* Participant must be on a stable dose of methotrexate (MTX)\n\nExclusion Criteria:\n\n* Participant is taking nonsteroidal anti-inflammatory drugs (NSAIDs), acetaminophen\u002Fparacetamol, low-potency opioids (tramadol, codeine, hydrocodone, alone or in combination with acetaminophen), oral corticosteroids (equivalent to ≤ 10 mg\u002Fday of prednisone), or inhaled corticosteroids for stable medical conditions unless they have been on stable doses for ≥ 1 week prior to Baseline Visit.\n* History of any arthritis with onset prior to age 17 years or current diagnosis of inflammatory joint disease other than rheumatoid arthritis.",{"count":673,"type":22},180,[25],"Rheumatoid Arthritis (RA) is a chronic inflammatory disease causing pain, stiffness, swelling and loss of joint function. This study will evaluate the efficacy and safety of targeted therapies through a series of substudies for the treatment of moderately to severely active Rheumatoid Arthritis (RA).\n\nThis study currently includes 3 substudies evaluating different treatments in participants with RA. Substudy 1 will evaluate lutikizumab monotherapy (treatment given alone) compared to placebo (looks like the study treatment but contains no medicine). Substudy 2 will evaluate ravagalimab monotherapy compared to placebo and Substudy 3 will evaluate lutikizumab and ravagalimab combination therapy (treatments given together) compared to placebo. Approximately 180 participants who have failed 1 or 2 biologic\u002Ftargeted synthetic disease-modifying antirheumatic drug (tsDMARD) therapies will be enrolled in the study at approximately 65 sites worldwide.\n\nThere may be higher treatment burden for participants in this trial compared to their standard of care treatment without participating in this study. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.",[28],[28],"2026-07-08",{"date":680,"type":33},"2026-07-10",{"date":682,"type":33},"2025-06-20",{"date":662,"type":22},{"name":102,"class":40},104]