[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"relapsing-remitting-multiple-sclerosis-rrms\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:relapsing-remitting-multiple-sclerosis-rrms":95},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,7,0,[8,47,80,113,140,165,189],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100652654","phase-2-a-study-of-rocbrutinib-in-prl-positive-relapsing-remitting-multiple-sclerosis-100652654",false,"NCT07776743","A Study of Rocbrutinib in PRL-Positive Relapsing-Remitting Multiple Sclerosis","A Phase IIa Clinical Study to Evaluate the Efficacy and Safety of Rocbrutinib (LP-168), an Oral BTK Inhibitor, in Patients With Relapsing-Remitting Multiple Sclerosis (RRMS)","Inclusion Criteria:\n\n1. Age 18 to 65 years (inclusive), male or female.\n2. Diagnosis of relapsing-remitting multiple sclerosis (RRMS) according to the 2017 revised McDonald criteria.\n3. Disease activity, meeting at least one of the following: (a) at least 2 documented relapses within 2 years, or at least 1 relapse within 1 year prior to signing the ICF; OR (b) at least 1 T1 gadolinium-enhancing (Gd+) lesion confirmed by brain MRI within 180 days prior to signing the ICF.\n4. Measurable lesions: at least 4 paramagnetic rim lesions (PRL) in the CNS observed by 7T MRI within 4 weeks prior to randomization.\n5. Concomitant medication: subjects with RRMS may receive stable-dose dimethyl fumarate (DMF); other treatments require discontinuation and washout (see Exclusion Criterion #13).\n6. EDSS score ≥0 and ≤5.5 at screening and baseline assessments prior to randomization.\n7. Neurological status stable for at least 30 days prior to randomization.\n8. Adequate hepatic and renal function: AST and ALT ≤2.0 × ULN; serum total bilirubin ≤1.2 × ULN (≤3.0 × ULN if documented Gilbert's syndrome); serum creatinine ≤1.5 × ULN or creatinine clearance ≥60 mL\u002Fmin (Cockcroft-Gault formula).\n9. All male subjects and female subjects of childbearing potential must use medically acceptable contraception throughout the treatment period and for 1 week after the last dose; female subjects of childbearing potential must have a negative serum pregnancy test within 7 days before start of treatment and must not be lactating; male subjects must not donate sperm during the study and for 1 week after the last dose.\n10. Willing and able to provide written informed consent and to comply with the study treatment schedule and visit plan.\n\nExclusion Criteria:\n\n1. Subjects with a disease duration of RRMS \\>10 years and an EDSS score ≤2.\n2. Neurological or autoimmune diseases other than RRMS that, in the investigator's judgment, may affect efficacy evaluation due to clinical symptoms or concomitant medication.\n3. Contraindications to MRI or allergy to gadolinium-based contrast agents.\n4. Currently diagnosed with or suspected of progressive multifocal leukoencephalopathy (PML), or a history of PML.\n5. History of malignancy within 2 years prior to randomization, except adequately treated basal cell carcinoma of the skin, carcinoma in situ of the cervix, carcinoma in situ of the breast, localized squamous cell carcinoma, and malignancies confirmed by the investigator to have been cured by surgery or other treatments.\n6. History of serious infection or potential risk of serious infection, including: HIV infection; syphilis or tuberculosis infection (except previously infected subjects judged cured by the investigator or specialist); HBsAg- or HBcAb-positive with HBV-DNA above the upper limit of normal of the study site (subjects with HBsAg- or HBcAb-positive but HBV-DNA negative may be enrolled and require anti-HBV therapy during the study); HCV antibody-positive with HCV-RNA above the ULN or qualitatively positive (HCV-RNA-negative subjects may be enrolled).\n7. Prior organ, allogeneic stem cell or bone marrow transplantation and\u002For anti-rejection therapy.\n8. Systemic chronic, recurrent or serious infection within 90 days prior to randomization (e.g., pneumonia, sepsis).\n9. Uncontrolled active systemic bacterial, fungal or viral infection within 4 weeks prior to randomization.\n10. Receipt of live attenuated vaccines within 4 weeks prior to randomization, or planned during the study or within 4 weeks after the end of study treatment.\n11. Prior treatment with BTK inhibitors for malignant or autoimmune indications.\n12. Any other medical condition or complication that adversely affects participation in the study, including but not limited to: short expected survival due to pre-existing health conditions; inability to undergo primary efficacy endpoint evaluation; severe and\u002For uncontrolled systemic diseases judged unsuitable for the study by the investigator (including uncontrolled hypertension or diabetes ≥CTCAE Grade 2, unstable angina, congestive heart failure, respiratory diseases requiring continuous oxygen, severe thromboembolism, uncontrolled major bleeding or bleeding from vital organs, known platelet dysfunction, severe hepatic\u002Frenal or metabolic diseases such as cirrhosis or renal failure).\n13. Poor cardiac function: NYHA class ≥2, or LVEF \\\u003C50% by echocardiography, or significant abnormalities on screening ECG (atrial fibrillation\u002Fflutter, second-degree type II or third-degree atrioventricular block, CTCAE ≥Grade 2 bradycardia, or mean QTcF ≥450 ms on ≥3 independent ECGs).\n14. History of cerebral infarction or intracranial hemorrhage (except lacunar infarction judged by the investigator as not affecting enrollment).\n15. History of myocardial infarction within 180 days.\n16. Receipt of any investigational drug within 3 months or 5 half-lives (whichever is longer) prior to randomization.\n17. Receipt of the following MS treatments within the specified periods prior to randomization: systemic corticosteroids within 4 weeks; intravenous immunoglobulin or S1P receptor modulators (e.g., fingolimod) within 2 months; azathioprine, mycophenolate mofetil or methotrexate within 3 months; anti-CD20 monoclonal antibodies (e.g., ofatumumab, ocrelizumab, rituximab) within 6 months, or if the last dose was \\>6 months before screening but peripheral blood B cells have not recovered to normal levels; teriflunomide within 6 months (washout may be shortened to 1 month if plasma teriflunomide concentration \\\u003C0.02 mg\u002FL after rapid clearance); anti-α4-integrin antibody (natalizumab) within 6 months; anti-CD52 antibody (alemtuzumab) within 4 years; prior total lymphoid irradiation, mitoxantrone (with cardiotoxicity or cumulative dose ≥120 mg\u002Fm²), or other potent immunosuppressive therapy with long-lasting effects.\n18. Major surgery (usually defined as Grade III or above per institutional regulations) or serious trauma within 4 weeks prior to randomization.\n19. Planned long-term use during the study of: strong or moderate CYP3A inhibitors or inducers, OATP1B3 sensitive substrates, or proton pump inhibitors (see Appendices 2 and 3).\n20. Receipt of anticoagulants or antiplatelet agents within 7 days or 5 half-lives (whichever is longer) prior to randomization.\n21. Conditions affecting the ability to swallow the drug, or conditions seriously affecting drug absorption or pharmacokinetics (e.g., refractory nausea\u002Fvomiting, short bowel syndrome).\n22. Disease symptoms unfavorable for oral administration of the study drug; unresolved toxicity from prior treatment affecting AE assessment; underlying disease leading to poor compliance; or alcohol\u002Fdrug abuse or dependence.\n23. Hypersensitivity to rocbrutinib tablets\u002Fdimethyl fumarate capsules or any of their excipients.\n24. Any other condition judged by the investigator as unsuitable for participation in this study.","ALL","18 Years","65 Years",{"count":20,"type":21},30,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","This is a randomized, controlled, multicenter, open-label Phase IIa clinical study to evaluate the efficacy and safety of rocbrutinib (LP-168), an oral BTK inhibitor, in subjects with paramagnetic rim lesion (PRL)-positive relapsing-remitting multiple sclerosis (RRMS). Approximately 30 subjects with RRMS will be enrolled and randomized 2:1 to receive rocbrutinib 25 mg once daily (experimental arm) or dimethyl fumarate (DMF) delayed-release capsules 120 mg twice daily, escalated to 240 mg twice daily after 7 days (active control arm). The treatment period is 24 weeks; subjects in the experimental arm who remain relapse-free and are assessed by the investigator as having potential benefit may enter an open-label extension and continue rocbrutinib until Week 48 after randomization. The primary endpoint is the change from screening\u002Fbaseline in the number, new number, and volume of PRL lesions detected by 7T MRI at Week 24.",[27],"Relapsing-remitting Multiple Sclerosis (RRMS)",[29,30,31,32,33],"multiple sclerosis","rocbrutinib","BTK inhibitor","paramagnetic rim lesions","dimethyl fumarate","RECRUITING","2026-08-17",{"date":37,"type":38},"2026-08-20","ACTUAL",{"date":40,"type":21},"2026-08",{"date":42,"type":21},"2028-12",{"name":44,"class":45},"Guangzhou Lupeng Pharmaceutical Company LTD.","INDUSTRY",1,{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":51,"acronym":52,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":16,"minAge":54,"maxAge":4,"enrollmentInfo":55,"targetDuration":4,"studyType":22,"phases":57,"briefSummary":59,"conditions":60,"keywords":63,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":46},"100607497","phase-3-a-prospective-randomized-non-inferiority-trial-comparing-anti-cd20-maintenance-versus-de-escalation-strategy-in-relapsing-remitting-multiple-sclerosis-100607497","NCT07189325","A Prospective Randomized Non-inferiority Trial Comparing Anti-CD20 Maintenance Versus De-Escalation Strategy In Relapsing-Remitting Multiple Sclerosis","DESIRE MS","Inclusion criteria :\n\n* Patients ≥40 years at inclusion\n* Patients with relapsing remitting multiple sclerosis at inclusion (according to 2017 McDonald criteria) treated with anti-CD20 for at least the last 3 years. For patients treated with IV ocrelizumab or rituximab at extended interval dosing, a maximum interval of 12 months between perfusions during the year before inclusion visit is required.\n* No evidence of disease activity for the last 3 years on anti-CD20 (No relapse AND no new\u002Fenlarged MRI lesion)\n* Brain MRI performed according to OFSEP protocol within a maximum of 6 months before randomization\n\nNon-inclusion criteria :\n\n* Secondary or primary progressive MS at inclusion\n* Previous experience of treatment failure in patients treated with natalizumab, fingolimod, rituximab, ocrelizumab, mitoxantrone, alemtuzumab or cladribine\n* Treatment with high dose corticosteroids during the 30 days preceding inclusion\n* Contraindication to MRI\n* Severely immunocompromised state\n* Current severe active infection\n* Known active malignancy\n* Severe heart failure (New York Heart Association Class IV) or severe, uncontrolled cardiac disease\n* Severe hepatic impairment (Child-Pugh class C)\n* Significantly impaired bone marrow function or significant anaemia, leukopenia, neutropenia or thrombocytopenia\n* Severe renal impairment undergoing dialysis\n* Severe hypoproteinaemia, e.g. in nephrotic syndrome\n* Current severe depression and\u002For suicidal ideation\n* Suspected or confirmed progressive multifocal leukoencephalopathy (PML)\n* Any condition that, in the opinion of the investigator, would interfere with the interpretation of patient safety or place the patient at high risk for treatment-related complications\n* Participation in another therapeutic trial in the last 6 months\n* Protected population according to articles of the French Public Health Code (e.g. patients under law protection, prisoners, pregnant, parturient or lactating women, and patients under guardianship\u002Fcuratorship)\n* All women of childbearing age not using effective contraception during the study\n* Subjects not covered by public health insurance\n* Failure to obtain written informed consent after a reflection period","40 Years",{"count":56,"type":21},250,[58],"PHASE3","Multiple sclerosis (MS), the main central nervous system autoimmune disorder, is the first cause of non-traumatic disability in young adults and has thus significant individual consequences with elevated public health cost. It commonly starts during the third and fourth decades. Over the last twenty years, several disease-modifying therapies with variable benefit\u002Frisk profiles have been introduced leading to dramatic changes in the prognosis of MS.\n\nFirst, several moderately effective therapies , with good safety profile, have allowed to decrease the frequency of relapses along with a possible, albeit limited, effect on medium- and long-term disability.\n\nMore recently highly effective therapies (HET), with immunosuppressive properties, have dramatically reduced clinical and MRI disease activity and significantly improved patient's prognosis.\n\nAnti-CD20 therapies (B-cells depleting therapies, given either intravenous or subcutaneous), one of the main HET, have demonstrated higher efficacy than platform therapies in several phase 3 randomized clinical trials and their use within the very first years of the disease seems to be associated with improved long-term outcomes.\n\nTaking all of this into account, the investigators hypothesize that RRMS patients who experience a de-escalation from anti-CD20 therapies to platform therapies after 40 years will not experience disease activity accrual and disability worsening.",[61,62],"Relapsing-Remitting Multiple Sclerosis (RRMS)","Anti-CD20 Therapy",[64,65,66,67,68,69],"Multiple Sclerosis","High efficacy therapies","de-escalation","adverse events","relapses","escalation","2026-06-22",{"date":72,"type":38},"2026-06-23",{"date":74,"type":38},"2026-06-15",{"date":76,"type":21},"2031-06",{"name":78,"class":79},"University Hospital, Montpellier","OTHER",{"id":81,"slug":82,"hasResults":11,"nctId":83,"briefTitle":84,"officialTitle":85,"acronym":86,"eligibilityCriteria":87,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":88,"enrollmentInfo":89,"targetDuration":4,"studyType":22,"phases":91,"briefSummary":93,"conditions":94,"keywords":96,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":103,"lastUpdatePostDateStruct":104,"startDateStruct":106,"completionDateStruct":108,"leadSponsor":110,"locationsCount":112},"100572488","phase-4-elios---investigational-biomarkers-to-track-disease-modification-in-active-rrms-100572488","NCT06733922","ELIOS - Investigational Biomarkers to Track Disease Modification in Active RRMS","Exploratory Evaluation of Novel Investigational Eye Movement Biomarkers to Track Ofatumumab Treatment Response in Canadian Patients With Active Relapsing-Remitting Multiple Sclerosis (ELIOS)","ELIOS","Inclusion criteria\n\nPatients eligible for inclusion in the study must fulfill all of the following criteria:\n\n1. Adult patients who are prescribed ofatumumab as part of routine clinical care as per the PM but who have not yet received their first dose. The decision to prescribe ofatumumab must be made prior to and independent of study participation.\n2. Patients or their legally authorized representatives who sign the Institutional Review Boards\u002FIndependent Ethics Committee (IRB\u002FIEC)-approved informed consent form.\n3. Patients who meet the EDSS score range of 0 up to 7 at the time of screening and enrollment for ofatumumab treatment.\n4. Patients with a diagnosis of active RRMS according to the 2017 Revised McDonald criteria2.\n5. Patients who can provide blood samples.\n6. Patients who can understand written and spoken Canadian English or French.\n7. Patients who have sufficient corrected visual acuity to allow for accurate reading of the on-screen visual task instructions, in the judgement of the Investigator. If a relapse temporarily affects a patient's corrected visual acuity, the Baseline Visit may be postponed until the patient can accurately read the on-screen visual task instructions, if deemed acceptable by the Investigator and the patient.\n8. Patients with a confirmed diagnosis of MS with no signs of progressive increase in physical disability independent of relapse activity within the past six months, as assessed by a physician.\n\nExclusion criteria\n\nIn order to ensure that the study population will be representative of all eligible patients, no additional exclusions may be applied by the Investigator. Patients meeting any of the following criteria are not eligible for inclusion in this study:\n\n1. Patients with primary progressive MS, secondary progressive MS without disease activity, clinically isolated syndrome, or radiologically isolated syndrome.\n2. Any disease or condition that could interfere with participation in the study according to the study protocol, or with the ability of the patients to cooperate and comply with the study procedures.\n3. Pregnant or nursing (lactating) women.\n4. Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using effective methods of contraception while taking ofatumumab and for six months after stopping medication. Effective contraception methods include:\n\n   * Total abstinence (when this is in line with the preferred and usual lifestyle of the participant). Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception\n   * Female sterilization (have had surgical bilateral oophorectomy with or without hysterectomy), total hysterectomy, or tubal ligation at least six weeks prior to enrollment. In case of oophorectomy alone, the reproductive status of the woman must be confirmed by follow-up hormone level assessment\n   * Male sterilization at least six months prior to enrollment. For female participants on the study, the vasectomized male partner should be the sole partner for that participant\n   * Use of oral (estrogen and progesterone), injected or implanted hormonal methods of contraception, placement of an intrauterine device or intrauterine system, or other forms of hormonal contraception that have comparable efficacy (failure rate \\\u003C1%) such as hormone vaginal ring or transdermal hormone contraception\n   * Use of barrier methods of contraception (male or female condom, occlusive cap, diaphragm or cervical\u002Fvault caps)\n   * In case of use of hormonal contraception women participants should have been stable on the same method for a minimum of three months before taking study treatment.\n   * If local regulations are more stringent than the contraception methods listed above, local regulations apply and will be described in the ICF.\n   * Women are considered post-menopausal if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g., age-appropriate history of vasomotor symptoms). Women participants are considered not of child-bearing potential if they are post-menopausal or have had bilateral tubal ligation, surgical bilateral oophorectomy (with or without hysterectomy), total hysterectomy or bilateral salpingectomy at least six weeks prior to first dose of study treatment on study. In the case of oophorectomy alone, a woman is not considered to be of child-bearing potential only when the reproductive status has been confirmed by follow-up hormone level assessment.\n5. Patients with hypersensitivity to ofatumumab or to any ingredient in the formulation, active hepatitis B virus, progressive multifocal leukoencephalopathy (PML), severe active infections, in a severely immunocompromised state or with known active malignancies.\n6. Patients with an active chronic disease (or stable but treated with immune therapy) of the immune system other than MS (e.g., rheumatoid arthritis, scleroderma, Sjögren's syndrome, Crohn's disease, ulcerative colitis, etc.) or with immunodeficiency syndrome (hereditary immune deficiency, drug-induced immune deficiency).\n7. Patients who are using other investigational drugs within 30 days prior to or at the Baseline Visit, or within a period corresponding to five elimination half-lives, whichever is longer, or who are using other investigational drugs for which the expected pharmacodynamic effect has not returned to baseline.\n8. Contraindication or inability to undergo regular testing (e.g., MRI, blood tests) as per standard of care.\n9. Patients who have been treated with cladribine or with alemtuzumab at any time within the 12 months prior to the Baseline Visit.\n10. Patients who have had any prior exposure to anti-CD20 B-cell therapy (i.e., ocrelizumab, ofatumumab) or natalizumab.\n11. Medical history or evidence of health issues that, in the opinion of the Investigator, may affect movements and oculomotor control.","99 Years",{"count":90,"type":21},224,[92],"PHASE4","The exploratory ELIOS study aims to assess the value of novel investigational Eye Movement Biomarkers (EMBs) in tracking disease-related changes among a real-world cohort of Canadian patients with active RRMS, within the context of disease-modifying treatment (i.e., ofatumumab). To that end, the study will use the patented investigational, Eye Tracking Neurological Assessment (ETNA-ProgMS) SaMD (v1.0.11 or later), which has not yet received Health Canada approval, to reliably and accurately track eye movements with precision.",[95],"Relapsing Remitting Multiple Sclerosis (RRMS)",[97,98,99,100,101,102],"Ofatumumab","Eye Movement Biomarkers (EMB)","Patient-Reported Outcomes (PRO)","Active Relapsing-Remitting MS (RRMS)","Real-World, Neurofilament Light Chain (NfL)","Digital, Eye-Tracking","2026-05-14",{"date":105,"type":38},"2026-05-15",{"date":107,"type":38},"2024-11-27",{"date":109,"type":21},"2028-11-30",{"name":111,"class":45},"Novartis Pharmaceuticals",14,{"id":114,"slug":115,"hasResults":11,"nctId":116,"briefTitle":117,"officialTitle":118,"acronym":119,"eligibilityCriteria":120,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":121,"targetDuration":4,"studyType":22,"phases":123,"briefSummary":125,"conditions":126,"keywords":127,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":132,"lastUpdatePostDateStruct":133,"startDateStruct":135,"completionDateStruct":136,"leadSponsor":138,"locationsCount":46},"100617400","indole-3-propionic-acid-clinical-trials---multiple-sclerosis-100617400","NCT07318129","Indole-3-PROpionic Acid Clinical Trials - Multiple Sclerosis","Indole-3-PROpionic Acid Clinical Trials - Multiple Sclerosis (iPROACT-MS)","iPROACT-MS","Inclusion Criteria:\n\n* Women and men ≥18 and ≤65 years of age\n* Diagnosed with RRMS according to the 2017 McDonald criteria (or newer updates)\n* Routinely treated and monitored for MS\n* Speak and read Danish\n* Deemed physically and mentally able to participate in this study\n\nExclusion Criteria:\n\n* Active malignancy\n* Diagnosis of Crohn's disease and ulcerative colitis\n* Other comorbidities deemed to be relevant\n* Haematopoietic stem cell transplantation\n* Current or past treatment with non-MS related treatments deemed to be relevant\n* Pregnancy or lactation\n* People with MR contraindications:\n\n  * Severe claustrophobia\n  * Incompatible implants\u002F foreign objects, including implanted pacemakers, heart valve prostheses, prostheses in the middle ear, implanted devices (e.g., insulin pump), metal debris, e.g., metal splinters in the eyes, miscellaneous shunts and catheters, metal clips from operations",{"count":122,"type":21},220,[124],"NA","This study, iPROACT-MS, is part of the iPROACT group of clinical trials aiming to investigate the effects of oral supplementation with indole-3-propionic acid (IPA) in humans. IPA is naturally produced as a gut bacterial metabolite with the amino acid tryptophan as substrate. The primary aim of iPROACT-MS is to investigate whether patients with relapsing-remitting multiple sclerosis (RRMS) can benefit from supplementation with IPA. The hypothesis is that supplementation with IPA will protect against MS-related disease activity, neurodegeneration and metabolic abnormalities. Secondary, iPROACT-MS aims at elucidating the complex relationships between lifestyle, gut microbial factors, inflammation, oxidative stress, metabolic health, MS disease severity and MS disease activity.",[95],[128,29,129,130,131],"indole-3-propionic acid","gut bacterial metabolite","dietary supplement","gut-brain axis","2026-01-26",{"date":134,"type":38},"2026-01-28",{"date":132,"type":38},{"date":137,"type":21},"2028-07-15",{"name":139,"class":79},"Glostrup University Hospital, Copenhagen",{"id":141,"slug":142,"hasResults":11,"nctId":143,"briefTitle":144,"officialTitle":145,"acronym":146,"eligibilityCriteria":147,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":148,"enrollmentInfo":149,"targetDuration":4,"studyType":22,"phases":151,"briefSummary":152,"conditions":153,"keywords":154,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":157,"lastUpdatePostDateStruct":158,"startDateStruct":160,"completionDateStruct":162,"leadSponsor":163,"locationsCount":46},"100617628","phase-3-a-study-of-the-efficacy-and-safety-of-bcd-281-in-patients-with-relapsing-remitting-multiple-sclerosis-100617628","NCT07321093","A Study of the Efficacy and Safety of BCD-281 in Patients With Relapsing-Remitting Multiple Sclerosis","A Double-blind, Randomized Clinical Study of the Efficacy and Safety of BCD-281 in Patients With Relapsing-Remitting Multiple Sclerosis","MUSCAT","Inclusion Criteria:\n\n* Provided written ICF to participate in the study.\n* Male and female subjects aged 18 to 55 years inclusive at the time of signing the ICF.\n* Diagnosis of multiple sclerosis, established in accordance with the McDonald criteria for the diagnosis of multiple sclerosis (2017 revision).\n* Relapsing-remitting multiple sclerosis.\n* The total EDSS score 0-5.5 inclusive.\n* Documentary evidence of the following at the time of signing the ICF:\n\n  1. at least one relapse within the last12 months, and\u002For\n  2. 2 relapses within the last 24 months, and\u002For\n  3. at least 1 T1 Gd+ lesion detected on brain MRI and 1 relapse within 24 months prior to signing the ICF.\n* Presence of IgG antibodies to the Varicella-Zoster virus.\n* Neurological stability for 30 days prior to signing the ICF.\n* Subject's willingness to discontinue previously prescribed DMTs from the day of the first administration of the IP and throughout the study.\n* The ability of the subject to follow the Protocol procedures, according to the Investigator.\n* Willingness of subjects of both sexes and their sexual partners of childbearing potential to use reliable methods of contraception from the time of signing ICF, throughout the study and for 5 months after the last dose of the drug in this study.\n\nExclusion Criteria:\n\n* Primary progressive or secondary progressive MS.\n* MS duration of more than 10 years with EDSS score of ≤2.0 at screening.\n* Malignant form of MS.\n* Other medical conditions that can affect the assessment of clinical picture of the MS.\n* Inability to obtain high-quality MRI images and\u002For the presence of contraindications to MRI and the administration of gadolinium-containing contrast agents.\n* Any comorbidities requiring treatment with systemic glucocorticoids and\u002For immunosuppressive drugs for the duration of the study, with the exception of MS.\n* History of progressive multifocal leukoencephalopathy.\n* Any acute or exacerbated chronic infections detected during screening that may have a negative impact on subject's safety during the study therapy.\n* Concomitant diseases and\u002For conditions that may affect the assessment of the clinical picture of the underlying disease and\u002For significantly increase the risk of AEs during the study.\n* Known alcohol or drug addiction, or current signs of alcohol\u002Fdrug addiction.\n* History of severe depression and\u002For a Beck Depression Inventory score of ≥16 at screening examination.\n* History of a malignant disease within 5 years prior to screening.\n* A diagnosis of HIV infection, hepatitis B or C .\n* Inability to provide the subject with venous access.\n* Pregnancy or breastfeeding, pregnancy planning and oocyte donation throughout the study and for 5 months after the last dose of ocrelizumab.\n* A history of severe allergic or anaphylactic reactions to humanized and\u002For murine monoclonal antibodies.\n* A history of using any prohibited medications or treatments defined in the study protocol.\n* Abnormal laboratory blood values, as specified in the study protocol.","55 Years",{"count":150,"type":21},292,[58],"The aim of this study is to compare the efficacy, safety profile, pharmacokinetics, pharmacodynamics, and immunogenicity of BCD-281 and the reference drug in subjects with relapsing multiple sclerosis.",[27],[64,155,156],"anti CD20","monoclonal antibody","2025-12-26",{"date":159,"type":38},"2026-01-06",{"date":161,"type":38},"2025-11-01",{"date":42,"type":21},{"name":164,"class":45},"Biocad",{"id":166,"slug":167,"hasResults":11,"nctId":168,"briefTitle":169,"officialTitle":170,"acronym":171,"eligibilityCriteria":172,"healthyVolunteers":11,"sex":16,"minAge":148,"maxAge":4,"enrollmentInfo":173,"targetDuration":4,"studyType":22,"phases":175,"briefSummary":176,"conditions":177,"keywords":4,"overallStatus":178,"whyStopped":4,"lastUpdateSubmitDate":179,"lastUpdatePostDateStruct":180,"startDateStruct":182,"completionDateStruct":184,"leadSponsor":186,"locationsCount":188},"100567054","phase-3-disease-modifying-therapies-withdrawal-in-inactive-relapsing-remitting-multiple-sclerosis-patients-aged-55-and-over-twins--therapies-withdrawal-in-relapsing-multiple-sclerosis-100567054","NCT06663189","Disease Modifying Therapies Withdrawal in Inactive Relapsing-remitting Multiple Sclerosis Patients Aged 55 and Over (TWINS : Therapies Withdrawal IN Relapsing Multiple Sclerosis)","Disease Modifying Therapies Withdrawal in Inactive Relapsing-remitting Multiple Sclerosis Patients Aged 55 and Over: A Multicentric, Randomized, Controlled, Open-label Clinical Trial (TWINS : Therapies Withdrawal IN Relapsing Multiple Sclerosis)","TWINS","Inclusion Criteria:\n\n1. Patient (male or female) aged 55 and over\n2. RRMS diagnosis according to revised McDonald 2017 criteria\n3. First MS symptom \\>5 years ago. If the date is unknown, RRMS diagnosis \\>5 years ago\n4. Stable disease in the last 5 years according to the revised Lublin and Reingold classification characterized by :\n\n   Stable T2 lesions documented by MRI performed at least 5 years prior to inclusion versus MRI performed within 6 months prior to the inclusion visit, AND Stable EDSS documented at least 5 years prior to inclusion versus EDSS documented within 6 months prior to inclusion visit, according to the investigator's judgment, AND The absence of relapses within 5 years prior to the inclusion visit\n5. Treated with a Moderate Efficacy Therapy (MET) for at least 5 consecutive years (IFN-β, glatiramer acetate, dimethyl fumarate, teriflunomide, diroximel fumarate); switching from one first-line treatment to another is accepted if the reason for the change is related to personal convenience or intolerance to the first treatment.\n6. Patient with affiliation to a social security regimen\n7. Patient able to understand the objectives and risks associated with the research and to give informed consent to the study\n8. Patient willing and able to comply with study procedures for the duration of the study\n\nExclusion Criteria:\n\n1. Primary progressive or secondary progressive with or without relapse as defined by the revised Lublin and Reingold classification\n2. Previous or ongoing treatment with a High Efficacy therapy (HET), with the exception of induction therapy (mitoxantrone, stem cell transplantation, alemtuzumab) provided that the last administration took place at least 10 years prior to inclusion.\n3. Contraindication to MRI (claustrophobia, weight ≥ 140 kg, pacemaker, cochlear implants, foreign body in eye, intracranial vascular clips, surgery in the 6 weeks prior to the beginning of the study, coronary stent implanted in the 8 weeks prior to the beginning of the study,…).\n\n   NB : Gadolinium contraindication will not prevent recruitment of the patient; in this case MRI will be carried out without contrast product injection\n4. History of neurological disease affecting the central nervous system: hereditary degenerative CNS disease, degenerative cognitive disease, systemic autoimmune disease, sarcoidosis, Lyme disease…\n5. Chronic disease which requires chronic treatment with corticoids or immunosuppressors\n6. Uncontrolled cardiac, renal or hepatic disease\n7. Patient participating in another interventional trial (drug or a medical device) or patient who are still within an exclusion period\n8. Patient wishing to discontinue background therapy, whether or not they are experiencing adverse effects.\n9. Patient not considering discontinuing background therapy, whether or not they are experiencing adverse effects.\n10. Pregnant or breastfeeding woman\n11. Patient with difficulty to read or understand French,\n12. Patient subject to a legal protection measure",{"count":174,"type":21},200,[58],"Multiple sclerosis (MS) is a chronic disease of the central nervous system (CNS) characterized by loss of motor and sensory function, that results from immune-mediated inflammation, demyelination and subsequent axonal damage. It is the most common cause of neurological disability in young adults, involving a long-term therapeutic follow-up. 85% of the patients are diagnosed with Relapsing-Remitting form of MS (RRMS). This form is characterized by clearly defined acute or subacute neurological symptoms (relapses) followed by periods of partial to complete recovery.\n\nDisease-modifying therapies (DMT) used to treat RRMS are immunomodulatory or suppressor molecules which have proven efficacy in limiting disease activity (decreasing relapse rate and delaying time to disease progression).\n\nHowever, the long-term safety of DMT is uncertain, as there is an increased risk of developing adverse events or infections (sometimes severe) such as observed in the last pandemic of COVID-19 (higher risk of infection), highlighting the need to reassess the benefit\u002Frisk ratio of maintaining immunomodulatory or suppressive therapy in the MS population. In elderly patients with comorbidity, this risk is further increased. To date, few studies on the discontinuation of treatment in elderly RRMS patients have been conducted. However, those available demonstrate that there was no difference in relapse rates between patients who continued or discontinued treatment. These results are consistent with immunosenescence studies in RRMS that suggested a negative correlation between relapse rate\u002Finflammatory processes and age. On the contrary, there is evidence indicating a positive correlation between age and the number of infections.\n\nIn addition, in the current context in France, it is important to take into account the medico-social cost associated with long-term treatments. In France, the average estimated annual cost per patient is 12,000€, more than half of which is attributed to medications.Furthermore, with age progression, an inversion of the benefit\u002Fcost assessment has been observed in treated patients.\n\nConsidering these medical and medico-social factors, it is reasonable to question the value of continuing treatment in stable patients with RRMS over 55 years.\n\nThis is a randomized, controlled, multicentric, open-label, parallel groups, 1:1 ratio non-inferiority clinical trial, comparing (1) a group that will stop treatment, to (2) a group that will continue treatment, over the course of 2 years, to determine the survival rate without MS activity defined clinically or by imaging.\n\nThe patients in both arms will be followed over 2 years after randomization. 5 visits will be performed for all patients: inclusion\u002Frandomization visit (M0) and 4 follow-up visits every 6 months (M6, M12, M18, and M24). An additional phone call at M3 is planned.",[27],"NOT_YET_RECRUITING","2025-01-02",{"date":181,"type":38},"2025-01-03",{"date":183,"type":21},"2025-01",{"date":185,"type":21},"2029-06",{"name":187,"class":79},"University Hospital, Strasbourg, France",22,{"id":190,"slug":191,"hasResults":11,"nctId":192,"briefTitle":193,"officialTitle":194,"acronym":195,"eligibilityCriteria":196,"healthyVolunteers":197,"sex":16,"minAge":17,"maxAge":198,"enrollmentInfo":199,"targetDuration":4,"studyType":201,"phases":4,"briefSummary":202,"conditions":203,"keywords":207,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":224,"lastUpdatePostDateStruct":225,"startDateStruct":227,"completionDateStruct":229,"leadSponsor":230,"locationsCount":46},"100452900","imaging-the-interplay-between-axonal-damage-and-repair-in-multiple-sclerosis-100452900","NCT05177523","Imaging the Interplay Between Axonal Damage and Repair in Multiple Sclerosis","INsIDER: Imaging the Interplay Between Axonal Damage and Repair in Multiple Sclerosis","INsIDER","Inclusion Criteria for patients:\n\n* Patients may be diagnosed with:\n\n  1. active RRMS (n=100): Relapsing-remitting course and \\> 1 clinical relapse and\u002For signs of MRI activity (\\> 1 Gd enhancing lesion) during the last year before study enrollment.\n  2. non-active PMS (n=100): Progressive course (PPMS or SPMS) and no clinical relapses and\u002For signs of MRI activity during the last year before study enrollment.\n* Age 18-80 years old\n* No other neurological or psychiatric disorder\n\nInclusion criteria for healthy controls:\n\n* Age 18-80 years old\n* No other neurological or psychiatric disorder\n\nExclusion Criteria for patients and healthy controls:\n\n* Pregnancy\n* Contraindication to MRI (eg, claustrophobia, metallic implants, pacemaker etc).\n* Inability to give consent",true,"80 Years",{"count":200,"type":21},300,"OBSERVATIONAL","This project is to:\n\n1. Quantify differences in axonal integrity and organization in aMS versus naPMS patients.\n2. Quantify changes in axonal integrity and organization in aMS versus naPMS patients over a two-year period.\n3. Validate the combination of imaging parameters that best differentiate aMS versus naPMS patients using histopathology.",[204,27,205,206],"Multiple Sclerosis (MS)","Secondary-progressive Multiple Sclerosis (SPMS)","Primary Progressive Multiple Sclerosis (PPMS)",[208,209,210,211,212,213,214,215,216,217,218,219,220,221,222,223],"axonal damage","axonal demyelination","axonal degeneration","axonal loss","axonal disorganization","axonal repair","axonal remyelination","axonal reorganization","Advanced MRI (aMRI)","Neurite Orientation Dispersion and Density Imaging (NODDI)","Diffusion Kurtosis (DK)","Magnetization Transfer Imaging (MTI)","Multi-echo Susceptibility-Based imaging (SBI)","Myelin Water Imaging (MWI)","T1 relaxometry (quantitative T1, qT1)","machine learning technique","2024-12-13",{"date":226,"type":38},"2024-12-16",{"date":228,"type":38},"2018-09-04",{"date":42,"type":21},{"name":231,"class":79},"University Hospital, Basel, Switzerland"]