[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100566415":3},{"organization":4,"outcomesModule":7,"designInfo":32,"detailedDescription":38,"studyPopulation":31,"armGroups":39,"interventions":61,"overallOfficials":31,"centralContacts":77,"locations":87,"responsibleParty":221,"collaborators":223,"id":226,"slug":227,"hasResults":228,"nctId":229,"briefTitle":230,"officialTitle":230,"acronym":231,"eligibilityCriteria":232,"healthyVolunteers":228,"sex":233,"minAge":234,"maxAge":235,"enrollmentInfo":236,"targetDuration":31,"studyType":239,"phases":240,"briefSummary":242,"conditions":243,"keywords":245,"overallStatus":90,"whyStopped":31,"lastUpdateSubmitDate":248,"lastUpdatePostDateStruct":249,"startDateStruct":252,"completionDateStruct":254,"leadSponsor":256,"locationsCount":257},{"fullName":5,"class":6},"Duke University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":31},[9],{"measure":10,"description":11,"timeFrame":12},"Number of participants with MiDA","Minimal disease activity (MiDA) at Month 6 as assessed by the cJADAS10 ≤5\n\nMiDA is low-disease activity and inactive disease in this protocol.\n\nScore range for the cJADAS10 (total): 0 - 30.\n\nDisease State cJADAS10 Score Inactive disease ≤2.5 Low-disease activity 2.6 - 5 Moderate-disease activity 5.1 - 16 High-disease activity \\>16\n\nMinimal disease activity (MiDA) is a state of low disease activity or remission that is considered a useful treatment target for both patients and physicians.\n\nThe clinical Juvenile Arthritis Disease Activity Score (cJADAS10) is a tool used to measure the level of disease activity in non-systemic juvenile idiopathic arthritis (JIA). It's a composite index that combines information from several sources, including:\n\n* The number of active joints, up to 10\n* The physician's global assessment of disease activity (PhGA)\n* The patient or parental global assessment of well-being (PaGA)","Month 6",[14,17,19,21,24,27],{"measure":15,"description":16,"timeFrame":12},"PROMIS® Pain Interference at Month 6","Patient-Reported Outcomes Measurement Information System (PROMIS).\n\nFor most PROMIS instruments, a score of 50 is the average for the United States general population with a standard deviation of 10 because calibration testing was performed on a large sample of the general population.\n\nFor PROMIS measures, higher scores equals more of the concept being measured (e.g., more Fatigue, more Physical Function). Thus a score of 60 is one standard deviation above the average referenced population. This could be a desirable or undesirable outcome, depending upon the concept being measured.",{"measure":18,"description":16,"timeFrame":12},"PROMIS® Fatigue at Month 6",{"measure":20,"description":16,"timeFrame":12},"PROMIS® Physical Function at Month 6",{"measure":22,"description":23,"timeFrame":12},"Change in arthritis disease activity (cJADAS10)","Minimal disease activity (MiDA) at Month 6 as assessed by the cJADAS10 ≤5\n\nMiDA is low-disease activity and inactive disease in this protocol.\n\nScore range for the cJADAS10 (total): 0 - 30.\n\nDisease State cJADAS10 Score Inactive disease ≤2.5 Low-disease activity 2.6 - 5 Moderate-disease activity 5.1 - 16 High-disease activity \\>16\n\nMinimal disease activity (MiDA) is a state of low disease activity or remission that is considered a useful treatment target for both patients and physicians.",{"measure":25,"description":26,"timeFrame":12},"Change in arthritis disease activity (JIA American College of Rheumatology Pediatric 70 [ACR 70]) at Month 6","The ACR score is a scale to measure change in rheumatoid arthritis symptoms.\n\nAn ACR70 response represents at least a 70% improvement in tender and swollen joint counts.",{"measure":28,"description":29,"timeFrame":30},"Number of participants with MiDA (Change in arthritis disease activity [cJADAS10] at Month 12)","Minimal disease activity (MiDA) at Month 12 as assessed by the cJADAS10 ≤5\n\nMiDA is low-disease activity and inactive disease in this protocol.\n\nScore range for the cJADAS10 (total): 0 - 30.\n\nDisease State cJADAS10 Score Inactive disease ≤2.5 Low-disease activity 2.6 - 5 Moderate-disease activity 5.1 - 16 High-disease activity \\>16\n\nMinimal disease activity (MiDA) is a state of low disease activity or remission that is considered a useful treatment target for both patients and physicians.","Month 12",null,{"allocation":33,"interventionModel":34,"interventionModelDescription":31,"primaryPurpose":35,"observationalModel":31,"timePerspective":31,"maskingInfo":36},"RANDOMIZED","SEQUENTIAL","TREATMENT",{"masking":37,"maskingDescription":31,"whoMasked":31},"NONE","The goal of the study is to provide an evidence base for selecting sequential medication(s) if a JIA patient fails initial bDMARD. SMART-JIA is a pragmatic, international, open-label, randomized trial comparing treatment with a second TNFi (active control) to each of 3 different medications (IL-6i, JAKi, or ABA) in children aged 2 to 17 years with pcJIA and inadequate response to initial TNFi. Leveraging sequential multiple assignment randomized trial (SMART) design methodology, we will implement a second randomization to assess the effectiveness of changing medication if there is inadequate response to the first study medication. This approach allows identification of optimal strategies for medication sequencing based on individual characteristics and provides critical insights to inform future studies.\n\nSMART-JIA will study the efficacy of a second TNFi (active control) compared to each of 3 other already US Food and Drug Administration (FDA)-approved and European Union (EU)-approved non-TNFi medications currently used to treat pcJIA (IL-6i, JAKi, and ABA). TNFi, IL-6i, and ABA are administered by subcutaneous (SQ) injection weekly, or every other week, or every three weeks, and JAKi (e.g., tofacitinib) is taken orally twice daily. All study treatments have similar safety profiles and are standard of care (SOC) worldwide. This in addition to the pragmatic and full-scale nature of the trial will ensure its completion. Successful completion of this trial will substantially impact the clinical care and outcomes of children with pcJIA, shifting the current trial-and-error treatment paradigm to a smart, precise approach.",[40,46,51,56],{"label":41,"type":42,"description":43,"interventionNames":44},"Second TNFi (Tumor Necrosis Factor inhibitor) medication","ACTIVE_COMPARATOR","Adalimumab originator or biosimilar; etanercept originator or biosimilar depending on which TNFi the participant had failed.",[45],"Drug: TNFi (Tumor Necrosis Factor inhibitor) medication",{"label":47,"type":42,"description":48,"interventionNames":49},"Abatacept","The 50 mg, 87.5 mg and 125 mg SQ doses will be available for weight-based dosing. All participants randomized to abatacept in the first or second stage randomization will receive abatacept SQ weekly at a dosage based on the participant's body weight",[50],"Drug: Abatacept",{"label":52,"type":42,"description":53,"interventionNames":54},"Tocilizumab originator or biosimilar","Tocilizumab will be provided in prefilled syringes (162 mg tocilizumab\u002F0.9 mL solution). All participants randomized to tocilizumab in the first or second stage randomization will be receiving 1 prefilled syringe (162 mg) with a dosing interval based on the body weight criteria.",[55],"Drug: Tocilizumab",{"label":57,"type":42,"description":58,"interventionNames":59},"Tofacitinib","Tofacitinib will be provided as oral tablets (tofacitinib citrate 5 mg) and as an oral solution (1 mg\u002FmL). All participants randomized to tofacitinib in the first or second stage randomization will receive tofacitinib oral tablets or oral solution twice daily, approximately 12 hours apart, in the morning and evening, at a dosage based on the participant's body weight .",[60],"Drug: Tofacitinib",[62,67,70,74],{"type":63,"name":64,"description":65,"armGroupLabels":66,"otherNames":31},"DRUG","TNFi (Tumor Necrosis Factor inhibitor) medication","Adalimumab 10 kg (22 lbs) to \\\u003C15 kg (33 lbs) 10 mg every other week\\* 15 kg (33 lbs) to \\\u003C30 kg (66 lbs) 20 mg every other week ≥30 kg (66 lbs) 40 mg every other week\n\nEtanercept\n\n≥63 kg (138 lb) 50 mg weekly \\\u003C63 kg (138 lb) 0.8 mg\u002Fkg weekly",[41],{"type":63,"name":47,"description":68,"armGroupLabels":69,"otherNames":31},"10 kg to \\\u003C25 kg 50 mg once weekly 25 kg to \\\u003C50 kg 87.5 mg once weekly\n\n≥50 kg 125 mg once weekly",[47],{"type":63,"name":71,"description":72,"armGroupLabels":73,"otherNames":31},"Tocilizumab","\\\u003C30 kg 162 mg once every 3 weeks\n\n≥30 kg 162 mg once every 2 weeks",[52],{"type":63,"name":57,"description":75,"armGroupLabels":76,"otherNames":31},"10 to \\\u003C20 kg 3.2 mg (3.2 mL oral solution) BID 20 to \\\u003C40 kg 4 mg (4 mL oral solution) BID\n\n≥40 kg 5 mg (one 5 mg tablet or 5 mL oral solution) BID",[57],[78,83],{"name":79,"role":80,"phone":81,"phoneExt":31,"email":82},"Laura E Schanberg (Contact PI)","CONTACT","919-373-3863","laura.schanberg@duke.edu",{"name":84,"role":80,"phone":85,"phoneExt":31,"email":86},"Huiman Barnhart (Dual PI)","919-668-8828","huiman.barnhart@duke.edu",[88,110,126,143,159,181,200],{"facility":89,"status":90,"city":91,"state":92,"zip":93,"country":94,"countryCode":95,"cosmosGeoPoint":96,"geoPoint":101,"contacts":102},"University of California San Francisco Pediatric Rheumatology","RECRUITING","San Francisco","California","94158","United States","US",{"type":97,"coordinates":98},"Point",[99,100],-122.41942,37.77493,{"lat":100,"lon":99},[103,107],{"name":104,"role":80,"phone":105,"phoneExt":31,"email":106},"Study Coordinator","415-353-1301","zilan.zheng@ucsf.edu",{"name":108,"role":109,"phone":31,"phoneExt":31,"email":31},"Susan Kim","PRINCIPAL_INVESTIGATOR",{"facility":111,"status":90,"city":112,"state":113,"zip":114,"country":94,"countryCode":95,"cosmosGeoPoint":115,"geoPoint":119,"contacts":120},"University of Florida","Gainesville","Florida","32610",{"type":97,"coordinates":116},[117,118],-82.32483,29.65163,{"lat":118,"lon":117},[121,124],{"name":104,"role":80,"phone":122,"phoneExt":31,"email":123},"352-294-8556","melissa.lingis@peds.ufl.edu",{"name":125,"role":109,"phone":31,"phoneExt":31,"email":31},"Melissa Elder",{"facility":127,"status":90,"city":128,"state":129,"zip":130,"country":94,"countryCode":95,"cosmosGeoPoint":131,"geoPoint":135,"contacts":136},"Hackensack Meridian Health - Joseph M. Sanzari Children's Hospital","Hackensack","New Jersey","07601",{"type":97,"coordinates":132},[133,134],-74.04347,40.88593,{"lat":134,"lon":133},[137,141],{"name":138,"role":80,"phone":139,"phoneExt":31,"email":140},"Clinical Research Coordinator","551-996-3345","kate.sidwell@hmhn.org",{"name":142,"role":109,"phone":31,"phoneExt":31,"email":31},"Ginger Janow",{"facility":144,"status":90,"city":145,"state":146,"zip":147,"country":94,"countryCode":95,"cosmosGeoPoint":148,"geoPoint":152,"contacts":153},"Nationwide Children's Hospital","Columbus","Ohio","43205",{"type":97,"coordinates":149},[150,151],-82.99879,39.96118,{"lat":151,"lon":150},[154,157],{"name":104,"role":80,"phone":155,"phoneExt":31,"email":156},"614-722-5525","joanne.drew@nationwidechildrens.org",{"name":158,"role":109,"phone":31,"phoneExt":31,"email":31},"Alysha Taxter",{"facility":160,"status":90,"city":161,"state":162,"zip":163,"country":164,"countryCode":165,"cosmosGeoPoint":166,"geoPoint":170,"contacts":171},"Asklepios Children's Hospital","Sankt Augustin","North Rhine-Westphalia","53757","Germany","DE",{"type":97,"coordinates":167},[168,169],7.197,50.77538,{"lat":169,"lon":168},[172,176,179],{"name":173,"role":80,"phone":174,"phoneExt":31,"email":175},"Jana Kipp","+49 (2241) 249-201","j.kipp@asklepios.com",{"name":177,"role":80,"phone":31,"phoneExt":31,"email":178},"Verena Lutz-Wiegers","v.lutz@asklepios.com",{"name":180,"role":109,"phone":31,"phoneExt":31,"email":31},"Gerd Horneff, Prof. Dr.",{"facility":182,"status":90,"city":183,"state":184,"zip":185,"country":186,"countryCode":187,"cosmosGeoPoint":188,"geoPoint":192,"contacts":193},"IRCCS Giannina Gaslini Institute","Genoa","Liguria","16147","Italy","IT",{"type":97,"coordinates":189},[190,191],8.94439,44.40478,{"lat":191,"lon":190},[194,198],{"name":195,"role":80,"phone":196,"phoneExt":31,"email":197},"Research Assistant","+39 010 56361","elisapatrone@gaslini.org",{"name":199,"role":109,"phone":31,"phoneExt":31,"email":31},"Alessandro Consolaro",{"facility":201,"status":90,"city":202,"state":202,"zip":203,"country":204,"countryCode":205,"cosmosGeoPoint":206,"geoPoint":210,"contacts":211},"University Medical Center Utrecht (Universitair Medisch Centrum Utrecht)","Utrecht","3584 CX","Netherlands","NL",{"type":97,"coordinates":207},[208,209],5.12222,52.09083,{"lat":209,"lon":208},[212,216,219],{"name":213,"role":80,"phone":214,"phoneExt":31,"email":215},"Sabine Michel Site Study Coordinator","+31 88 755 5555","S.Michel-2@umcutrecht.nl",{"name":217,"role":80,"phone":214,"phoneExt":31,"email":218},"Jojanneke J. Scheepstra Site Study Coordinator","J.Scheepstra@umcutrecht.nl",{"name":220,"role":109,"phone":31,"phoneExt":31,"email":31},"Joost Swart",{"type":222,"investigatorFullName":31,"investigatorTitle":31,"investigatorAffiliation":31,"oldNameTitle":31,"oldOrganization":31},"SPONSOR",[224],{"name":225,"class":6},"Patient-Centered Outcomes Research Institute","100566415","phase-3-trial-of-sequential-medications-after-tnfi-failure-in-juvenile-idiopathic-arthritis-100566415",false,"NCT06654882","Trial of Sequential Medications AfteR TNFi Failure in Juvenile Idiopathic Arthritis","SMART-JIA","Inclusion Criteria:\n\n* Polyarticular course JIA\n* Moderate or high-disease activity (cJADAS10 \\>5) despite treatment with an initial TNFi for ≥2 months\n* Age ≥2 years and \\\u003C21 years and weight ≥ 10kg\n* No systemic glucocorticoids or systemic glucocorticoids at a stable dose of ≤0.2 mg\u002Fkg\u002Fday (maximum 10 mg\u002Fday) for ≥2 weeks prior to baseline visit\n* Documented informed consent\u002Fassent obtained from the parent\u002Fcaregiver\u002Fpatient\n\nExclusion Criteria:\n\n* Systemic JIA\n* Enthesitis-related arthritis\u002Fjuvenile spondyloarthritis (2001 International League of Associations for Rheumatology \\[ILAR\\] criteria)30\n* History of or currently active inflammatory bowel disease\n* History of or currently active psoriasis\n* Active uveitis within 3 months of the baseline visit\n* History of or currently active sacroiliitis\n* History of or current malignancy\n* Active tuberculosis (TB) or a history of incompletely treated TB; Purified Protein derivative (PPD) or QuantiFERON-TB positive patients (without active TB) unless it is documented that the patient has been adequately treated for TB and can start treatment with a biologic agent, based on the medical judgment of the site investigator and\u002For an infectious disease specialist; suspected extrapulmonary TB infection; or at high risk of contracting TB, such as close contact with individual with active or latent TB\n* Prior treatment with more than one TNFi molecule; exposure to more than one biosimilar of the same TNFi molecule is allowed\n* Prior treatment with non-TNFi bDMARDs and\u002For any JAKi\n* Aspartate aminotransferase (AST) or alanine transaminase (ALT) ≥3 × upper limit of normal (ULN) for age and sex\n* Serum creatinine \\>1.5 × ULN for age and sex\n* Platelet count \\\u003C150 × 103\u002FμL (\\\u003C150,000\u002Fmm3)\n* Hemoglobin \\\u003C7.0 g\u002FdL (\\\u003C4.3 mmol\u002FL)\n* White blood cell (WBC) count \\\u003C3,000\u002Fmm3 (\\\u003C3.0 × 109\u002FL)\n* Neutrophil count \\\u003C1,500\u002Fmm3 (\\\u003C1.5 × 109\u002FL)\n* Any active acute, subacute, chronic, or recurrent bacterial, viral, or systemic fungal infection or any major episode of infection requiring hospitalization or treatment during screening or treatment with IV antibiotics completed within 4 weeks of the screening visit or oral antibiotics completed within 2 weeks of the screening visit\n* Any live attenuated vaccine, such as varicella-zoster, oral polio, measles, mumps or rubella vaccines, within 4 weeks prior to the baseline visit.\n* Any medical history that may be considered a contraindication\u002Fsafety concern with the use of adalimumab, etanercept, tofacitinib, ABA, or an IL-6 inhibitor or their biosimilars. In particular, subjects at known high risk for venous thromboembolism will be excluded, including recent heart failure or prior myocardial infarction, known inherited thrombotic risk factors, history of venous thromboembolism (deep venous thrombosis or pulmonary embolism, undergoing major surgery, or are chronically immobilized).\n* Pregnant or breastfeeding\n* Sexually active females of childbearing potential who refuse to use at least one required contraception method (See Contraception paragraph 8.9 for definition of childbearing potential and details).\n* History of hypersensitivity or allergic reaction to any study drug or any of its excipients (inactive ingredients).","ALL","2 Years","21 Years",{"count":237,"type":238},400,"ESTIMATED","INTERVENTIONAL",[241],"PHASE3","This study is an open-label, randomized, multicenter trial that incorporates a multi-arm design comparing each of 3 non-TNFi (Tumor Necrosis Factor inhibitor) medications to a second TNFi (active control) within a sequential multiple assignment randomized trial design with 2 randomization stages corresponding with clinical decision points. The first randomization addresses whether each of the 3 non-TNFi medications is superior to treatment with a second TNFi. The second randomization allows identification of optimal sequential use of biologics (treatment strategies).",[244],"Polyarticular Course Juvenile Idiopathic Arthritis (JIA)",[246,247],"JIA","Rheumatology","2026-09-22",{"date":250,"type":251},"2026-09-25","ACTUAL",{"date":253,"type":251},"2026-01-09",{"date":255,"type":238},"2029-11",{"name":5,"class":6},7]