Ignite Creation Date:
2025-12-26 @ 2:39 PM
Ignite Modification Date:
2026-03-11 @ 5:24 PM
Study NCT ID:
NCT02593006
Status:
COMPLETED
Last Update Posted:
2021-02-05
First Post:
2015-10-29
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Start Time Optimization of Biologics in Polyarticular JIA
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001171', 'term': 'Arthritis, Juvenile'}, {'id': 'D007592', 'term': 'Joint Diseases'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'yukiko.kimura@hackensackmeridian.org', 'phone': '551-996-5306', 'title': 'Yukiko Kimura MD', 'organization': 'Hackensack University Medical Center'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Adverse Events were collected from Baseline through Study completion. For each participant, the time period was on average 1 year', 'eventGroups': [{'id': 'EG000', 'title': 'Step-Up CTP', 'description': 'Initial therapy with a non biologic Disease Modifying Anti-Rheumatic Drug (DMARD) stepping up to a biologic treatment if needed', 'otherNumAtRisk': 257, 'deathsNumAtRisk': 257, 'otherNumAffected': 19, 'seriousNumAtRisk': 257, 'deathsNumAffected': 0, 'seriousNumAffected': 12}, {'id': 'EG001', 'title': 'Early Combination CTP', 'description': 'Initial therapy with a non-biologic DMARD and biologic treatment at the start of treatment', 'otherNumAtRisk': 100, 'deathsNumAtRisk': 100, 'otherNumAffected': 5, 'seriousNumAtRisk': 100, 'deathsNumAffected': 0, 'seriousNumAffected': 3}, {'id': 'EG002', 'title': 'Biologic First CTP', 'description': 'Initial therapy with a biologic treatment without a non-biologic DMARD', 'otherNumAtRisk': 43, 'deathsNumAtRisk': 43, 'otherNumAffected': 1, 'seriousNumAtRisk': 43, 'deathsNumAffected': 0, 'seriousNumAffected': 5}], 'otherEvents': [{'term': 'Hepatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 100, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 43, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MeDRA 21.0'}, {'term': 'Hypersensitivity Reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 100, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 43, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MeDRA 21.0'}, {'term': 'Inflammatory Bowel Disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 100, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 43, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MeDRA 21.0'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 100, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 43, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MeDRA 21.0'}, {'term': 'Psoriasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 100, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 43, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MeDRA 21.0'}, {'term': 'Uveitis (New Onset)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 100, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 43, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MeDRA 21.0'}], 'seriousEvents': [{'term': 'Hip Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 100, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 43, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MeDRA 21.0'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 100, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 43, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MeDRA 21.0'}, {'term': 'Cervical Spine Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 100, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 43, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MeDRA 21.0'}, {'term': 'Compund Fracture Ulna & Radius', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 100, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 43, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MeDRA 21.0'}, {'term': 'Depression with Suicidal Ideation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 100, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 43, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MeDRA 21.0'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 100, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 43, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MeDRA 21.0'}, {'term': 'Infections treated with IV antibiotics', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 100, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 43, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MeDRA 21.0'}, {'term': 'Inflammatory Bowel Disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 100, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 43, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MeDRA 21.0'}, {'term': 'Drug induced Lupus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 100, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 43, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MeDRA 21.0'}, {'term': 'hip effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 100, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 43, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MeDRA 21.0'}, {'term': 'Shingles', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 100, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 43, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MeDRA 21.0'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 100, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 43, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MeDRA 21.0'}, {'term': 'Worsening Bipolar Affective Disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 100, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 43, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MeDRA 21.0'}, {'term': 'Macrophage Activation Syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 100, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 43, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MeDRA 21.0'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants With Clinically Inactive Disease (CID) Off Glucocorticoids', 'denoms': [{'units': 'Participants', 'counts': [{'value': '217', 'groupId': 'OG000'}, {'value': '78', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Step-Up Consensus Treatment Plan (CTP)', 'description': 'Initial therapy with a non biologic Disease Modifying Anti-Rheumatic Drug (DMARD) stepping up to a biologic treatment if needed'}, {'id': 'OG001', 'title': 'Early Combination CTP', 'description': 'Initial therapy with a non-biologic DMARD and biologic treatment at the start of treatment'}, {'id': 'OG002', 'title': 'Biologic First CTP', 'description': 'Initial therapy with a biologic treatment without a non-biologic DMARD'}], 'classes': [{'categories': [{'measurements': [{'value': '32.3', 'groupId': 'OG000', 'lowerLimit': '26.2', 'upperLimit': '39.0'}, {'value': '37.2', 'groupId': 'OG001', 'lowerLimit': '26.7', 'upperLimit': '48.9'}, {'value': '24.2', 'groupId': 'OG002', 'lowerLimit': '11.7', 'upperLimit': '42.6'}]}]}], 'analyses': [{'pValue': '>0.05', 'groupIds': ['OG000', 'OG001', 'OG002'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '10.3', 'ciLowerLimit': '-3.2', 'ciUpperLimit': '23.8', 'statisticalMethod': 'Propensity weighted regression model', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': '12 months after baseline', 'description': 'This is a provisional criteria which describes a state of complete disease inactivity in Juvenile Idiopathic Arthritis (JIA). We will assess the proportion of patients achieving CID off glucocorticoids in each treatment arm.', 'unitOfMeasure': 'percentage of participants achieving CID', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects are children and adolescents between the ages of 2 and 18 who are newly diagnosed with a polyarticular form of JIA and treated for 12 months with one of the consensus treatment plans.\n\n328 participants had complete data for the primary CID endpoint at 12 months'}, {'type': 'SECONDARY', 'title': 'Comparison of PROMIS Pain and Mobility Scores Between the 3 Consensus Treatment Plan Groups', 'denoms': [{'units': 'Participants', 'counts': [{'value': '257', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}, {'value': '43', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Step-Up CTP', 'description': 'Initial therapy with a non biologic Disease Modifying Anti-Rheumatic Drug (DMARD) stepping up to a biologic treatment if needed'}, {'id': 'OG001', 'title': 'Early Combination CTP', 'description': 'Initial therapy with a non-biologic DMARD and biologic treatment at the start of treatment'}, {'id': 'OG002', 'title': 'Biologic First CTP', 'description': 'Initial therapy with a biologic treatment without a non-biologic DMARD'}], 'classes': [{'title': 'Pain Interference', 'denoms': [{'units': 'Participants', 'counts': [{'value': '188', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '53.1', 'spread': '10.0', 'groupId': 'OG000'}, {'value': '55.5', 'spread': '9.2', 'groupId': 'OG001'}, {'value': '55.9', 'spread': '9.3', 'groupId': 'OG002'}]}]}, {'title': 'Mobility', 'denoms': [{'units': 'Participants', 'counts': [{'value': '195', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '38.6', 'spread': '10.3', 'groupId': 'OG000'}, {'value': '35.8', 'spread': '9.1', 'groupId': 'OG001'}, {'value': '37.5', 'spread': '9.1', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.04', 'groupIds': ['OG000', 'OG001', 'OG002'], 'pValueComment': 'Global test of interaction between time and treatment group.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '12 months after baseline', 'description': 'The Patient Reported Outcomes Measurement Information System (PROMIS) pain interference and mobility scores will be compared between the 3 CTP groups. Pain interference scores range from 0-100 and higher scores are worse. Mobility scores also range from 0-100 and higher scores are better.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Same description as above for the population for the primary outcome'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Step-Up CTP', 'description': 'Consensus Treatment Plan where subjects begin non biologic DMARD (methotrexate, sulfasalazine, or leflunomide) stepping up to biologic if not improved by 3 months'}, {'id': 'FG001', 'title': 'Early Combination CTP', 'description': 'Consensus Treatment Plan where patients start a DMARD(methotrexate, sulfasalazine, or leflunomide) and biologic treatment within one month of each other.'}, {'id': 'FG002', 'title': 'Biologic Frist CTP', 'description': 'Consensus Treatment Plan where patients begin Biologic treatment'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '257'}, {'groupId': 'FG001', 'numSubjects': '100'}, {'groupId': 'FG002', 'numSubjects': '43'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '250'}, {'groupId': 'FG001', 'numSubjects': '93'}, {'groupId': 'FG002', 'numSubjects': '38'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '5'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '257', 'groupId': 'BG000'}, {'value': '100', 'groupId': 'BG001'}, {'value': '43', 'groupId': 'BG002'}, {'value': '400', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Step-Up CTP', 'description': 'Consensus Treatment Plan where subjects begin non biologic DMARD (methotrexate, sulfasalazine, or leflunomide) stepping up to biologic if not improved by 3 months'}, {'id': 'BG001', 'title': 'Early Combination CTP', 'description': 'Consensus Treatment Plan where patients start a DMARD(methotrexate, sulfasalazine, or leflunomide) and biologic treatment within one month of each other.'}, {'id': 'BG002', 'title': 'Biologic Frist CTP', 'description': 'Consensus Treatment Plan where patients begin Biologic treatment'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '257', 'groupId': 'BG000'}, {'value': '99', 'groupId': 'BG001'}, {'value': '43', 'groupId': 'BG002'}, {'value': '399', 'groupId': 'BG003'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '11.07', 'groupId': 'BG000', 'lowerLimit': '1.10', 'upperLimit': '17.85'}, {'value': '11.38', 'groupId': 'BG001', 'lowerLimit': '1.15', 'upperLimit': '18.41'}, {'value': '12.34', 'groupId': 'BG002', 'lowerLimit': '1.40', 'upperLimit': '17.95'}, {'value': '11.28', 'groupId': 'BG003', 'lowerLimit': '1.10', 'upperLimit': '18.41'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '192', 'groupId': 'BG000'}, {'value': '75', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}, {'value': '294', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '65', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}, {'value': '106', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '21', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '23', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '188', 'groupId': 'BG000'}, {'value': '68', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}, {'value': '283', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '17', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '52', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Canada', 'categories': [{'measurements': [{'value': '32', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '35', 'groupId': 'BG003'}]}]}, {'title': 'United States', 'categories': [{'measurements': [{'value': '225', 'groupId': 'BG000'}, {'value': '98', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}, {'value': '365', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Clinical Juvenile Arthritis Disease Activity Score', 'classes': [{'categories': [{'measurements': [{'value': '17.08', 'spread': '4.55', 'groupId': 'BG000'}, {'value': '20.18', 'spread': '4.37', 'groupId': 'BG001'}, {'value': '19.05', 'spread': '4.29', 'groupId': 'BG002'}, {'value': '18.08', 'spread': '4.67', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'The cJADAS-10 is a clinical measure of disease activity that is a sum of the active joint count (up to 10), physician global assessment of disease activity measured on a 0 to 10 visual analog scale where 0=no activity and 10 =maximum activity; patient/parent rating of well-being assessed on a 0 to 10 visual analog scale where 0=very well and 10= very poor; cJADAS-10 Score range is 0-30, where composite score \\< or = 2.5 - low disease activity; 2.51-8.5 -Moderate disease activity, \\> 8.5- High disease activity.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-12-15', 'size': 1237400, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2019-12-11T14:11', 'hasProtocol': True}, {'date': '2019-12-15', 'size': 119403, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2020-07-20T13:21', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 400}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2019-09-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-02-04', 'studyFirstSubmitDate': '2015-10-29', 'resultsFirstSubmitDate': '2019-12-12', 'studyFirstSubmitQcDate': '2015-10-29', 'lastUpdatePostDateStruct': {'date': '2021-02-05', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-02-04', 'studyFirstPostDateStruct': {'date': '2015-10-30', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-02-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-09-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants With Clinically Inactive Disease (CID) Off Glucocorticoids', 'timeFrame': '12 months after baseline', 'description': 'This is a provisional criteria which describes a state of complete disease inactivity in Juvenile Idiopathic Arthritis (JIA). We will assess the proportion of patients achieving CID off glucocorticoids in each treatment arm.'}], 'secondaryOutcomes': [{'measure': 'Comparison of PROMIS Pain and Mobility Scores Between the 3 Consensus Treatment Plan Groups', 'timeFrame': '12 months after baseline', 'description': 'The Patient Reported Outcomes Measurement Information System (PROMIS) pain interference and mobility scores will be compared between the 3 CTP groups. Pain interference scores range from 0-100 and higher scores are worse. Mobility scores also range from 0-100 and higher scores are better.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Joint Diseases', 'Juvenile Arthritis', 'treatment', 'biologic therapy', 'comparative effectiveness'], 'conditions': ['Polyarticular Juvenile Rheumatoid Arthritis', 'Arthritis, Juvenile Idiopathic']}, 'referencesModule': {'references': [{'pmid': '34105312', 'type': 'DERIVED', 'citation': 'Kimura Y, Schanberg LE, Tomlinson GA, Riordan ME, Dennos AC, Del Gaizo V, Murphy KL, Weiss PF, Natter MD, Feldman BM, Ringold S; CARRA STOP-JIA Investigators. Optimizing the Start Time of Biologics in Polyarticular Juvenile Idiopathic Arthritis: A Comparative Effectiveness Study of Childhood Arthritis and Rheumatology Research Alliance Consensus Treatment Plans. Arthritis Rheumatol. 2021 Oct;73(10):1898-1909. doi: 10.1002/art.41888. Epub 2021 Sep 3.'}, {'pmid': '34105303', 'type': 'DERIVED', 'citation': 'Ong MS, Ringold S, Kimura Y, Schanberg LE, Tomlinson GA, Natter MD; CARRA Registry Investigators. Improved Disease Course Associated With Early Initiation of Biologics in Polyarticular Juvenile Idiopathic Arthritis: Trajectory Analysis of a Childhood Arthritis and Rheumatology Research Alliance Consensus Treatment Plans Study. Arthritis Rheumatol. 2021 Oct;73(10):1910-1920. doi: 10.1002/art.41892. Epub 2021 Aug 27.'}], 'seeAlsoLinks': [{'url': 'https://www.clinicaltrials.gov/ct2/show/NCT02418442?term=carra&rank=2', 'label': 'Click here for more information on the Observational Study of Pediatric Rheumatic Diseases: The CARRA Registry'}]}, 'descriptionModule': {'briefSummary': 'STOP-JIA is a PCORI funded prospective observational study which compared the clinical effectiveness and impact on patient reported outcomes of 3 Childhood Arthritis \\& Rheumatology Research Alliance (CARRA) consensus derived treatment strategies (CTPs) in new-onset polyarticular JIA (pJIA) patients to answer the critical question of when is the best time to begin biologic medications to achieve the optimal clinical and patient reported outcomes. Because the CARRA Registry will be used for data collection, all patients will be enrolled in the CARRA Registry. The standard of care treatments are chosen by the treating physician and patient/caregiver and are not randomized.', 'detailedDescription': "STOP-JIA is a prospective, observational study comparing the clinical effectiveness and impact on patient reported outcomes of 3 different treatment strategies (CTPs) in new onset pJIA patients to answer the critical question of when to start biologic medications. All participants will be enrolled in the CARRA Registry and started on one of the CTPs, which will be decided by the treating physician and patient/caregiver. Subjects will be enrolled at one of 60 participating CARRA sites across the US and Canada. Total anticipated enrollment was 400 and this was completed in 9/19.\n\nSpecific Aim 1:\n\nTo compare the clinical effectiveness of different strategies (CTPs) for using biologic medications in achieving clinically inactive disease (CID) at 12 months in new-onset pJIA. Three common strategies that differ in the timing of biologic medication introduction will be compared: 1) Step-Up: disease modifying anti-rheumatic drug (DMARD) monotherapy stepping up by addition of a biologic medication if needed; 2) Early Combination: DMARD plus biologic medication at treatment onset; and 3) Biologic First: biologic medication monotherapy at treatment onset.\n\nHypothesis 1: A significantly higher proportion of children started on a biologic medication at onset (CTP 2 or 3) will achieve CID after 12 months of therapy compared to standard therapy (CTP 1).\n\nSpecific Aim 2:\n\nTo compare patient and caregiver reported outcomes between the different strategies.\n\nHypothesis 2: There will be statistically significant differences in patient/caregiver reported outcomes (PROs) between treatment strategies that can inform future patients and providers in selecting optimal treatments.\n\nThe CARRA Registry will be housed at CARRA's clinical and data coordinating center, Duke Clinical Research Institute (DCRI). The CARRA Registry Protocol documents that the CARRA Registry fulfills all PCOR standards for registries. STOP-JIA will utilize data collection, storage, and management processes, systems requirements, and security processes already established for the CARRA Registry at DCRI.\n\nSTOP-JIA used Web-based electronic CRFs (eCRFs) developed for the CARRA Registry that are already familiar to site personnel. The eCRF platform, RAVE, is 21CFR part11 compliant and meets regulatory requirements. Database and Web servers are secured by a firewall and through controlled physical access. eCRFs will be monitored for completeness, accuracy, and attention to detail throughout the study by DCRI data and site management teams using processes developed for the CARRA Registry and consistent with DCRI's internal SOPs. Use of electronic data capture will allow for immediate prompts/queries if entered values are out of expected ranges or there are incomplete data fields. The design of the data collection instrument will allow centers to record a planned assessment of a patient was missed and to enter any known reasons for the assessment being missed. DCRI will regularly provide reports detailing data completion metrics to the sites. Stakeholder engagement is also an important aspect of this study, and patients/caregivers as well as other stakeholders are serving as research partners and advisors in this study."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '2 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Children with new onset, untreated Poly JIA enrolled in the CARRA Registry.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age less than 19 at baseline (if 18 or older, agrees to be followed for at least one year)\n* Diagnosis of Arthritis per ACR definition.\n* Arthritis present in one joint for a least six weeks\n* At least 5 active joints at baseline\n* Contraception if sexually active (male and female)\n\nMay have any of the following:\n\n* RF+ polyarticular JIA\n* RF- polyarticular JIA\n* Extended oligoarticular JIA\n* Psoriatic JIA\n* Enthesitis related JIA\n* Undifferentiated JIA\n* Psoriasis\n* Sacroiliitis\n* Uveitis\n* Enthesitis\n* Prior treatments permitted:\n\n * NSAIDS\n * Hydroxychloroquine\n * Intraocular / topical / intraarticular glucocorticoids\n * IV or PO steroids if one of the below criteria are met:\n\n --If treated ≤ 3 months prior to baseline: treatment cannot exceed 2 weeks\n\n --If treated \\> 3 months prior to baseline: any treatment course is permitted as long as treatment was completed 90 days prior to baseline\n * Methotrexate started no more than 1 month prior to the baseline visit\n * Biologics - received only 1 dose within 1 week of the baseline visit\n\nExclusion Criteria:\n\n* Features consistent with systemic JIA\n* Treatment with any medications for JIA aside from those listed above.\n* Known inflammatory bowel disease\n* Known celiac disease\n* Known Trisomy 21\n* History of or current malignancy\n* Concomitant serious active or recurrent chronic bacterial, fungal or viral infection\n* Significant organ system disorder limiting use of treatments for pJIA\n* Live vaccine within a month prior to baseline'}, 'identificationModule': {'nctId': 'NCT02593006', 'acronym': 'STOP-JIA', 'briefTitle': 'Start Time Optimization of Biologics in Polyarticular JIA', 'organization': {'class': 'OTHER', 'fullName': 'Hackensack Meridian Health'}, 'officialTitle': 'Start Time Optimization of Biologics in Polyarticular JIA', 'orgStudyIdInfo': {'id': 'Pro5835'}}, 'contactsLocationsModule': {'locations': [{'zip': '35233', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'University of Alabama at Birmingham', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '94304', 'city': 'Palo Alto', 'state': 'California', 'country': 'United States', 'facility': 'Stanford University Medical Center', 'geoPoint': {'lat': 37.44188, 'lon': -122.14302}}, {'zip': '92123', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': "Rady Children's Hospital-San Diego", 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '94143', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'University of California at San Francisco Medical Center', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': "Children's Hospital Colorado", 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '06106', 'city': 'Hartford', 'state': 'Connecticut', 'country': 'United States', 'facility': "Connecticut Children's Medical Center", 'geoPoint': {'lat': 41.76371, 'lon': -72.68509}}, {'zip': '32608', 'city': 'Gainesville', 'state': 'Florida', 'country': 'United States', 'facility': "University of Florida Shand's Children's Hospital", 'geoPoint': {'lat': 29.65163, 'lon': -82.32483}}, {'zip': '30322', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': "Emory Children's Center", 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '30912', 'city': 'Augusta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Georgia Regents University Medical Center', 'geoPoint': {'lat': 33.47097, 'lon': -81.97484}}, {'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': "Ann & Robert H. Lurie Children's Hospital of Chicago", 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '60637', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'University of Chicago Medical Center', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '46202', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Indiana University School of Medicine', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '52242', 'city': 'Iowa City', 'state': 'Iowa', 'country': 'United States', 'facility': 'University of Iowa Hospitals and Clinics', 'geoPoint': {'lat': 41.66113, 'lon': -91.53017}}, {'zip': '66160', 'city': 'Kansas City', 'state': 'Kansas', 'country': 'United States', 'facility': 'University of Kansas Medical Center', 'geoPoint': {'lat': 39.11417, 'lon': -94.62746}}, {'zip': '40202', 'city': 'Louisville', 'state': 'Kentucky', 'country': 'United States', 'facility': 'University of Louisville School of Medicine', 'geoPoint': {'lat': 38.25424, 'lon': -85.75941}}, {'zip': '02111', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Tufts Medical Center', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': "Boston Children's Hospital", 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '01105', 'city': 'Springfield', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Baystate Medical Center, High Street Health Center', 'geoPoint': {'lat': 42.10148, 'lon': -72.58981}}, {'zip': '48109', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'University of Michigan Medical Center', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}, {'zip': '55455', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'University of Minnesota', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}, {'zip': '55902', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}, {'zip': '64108', 'city': 'Kansas City', 'state': 'Missouri', 'country': 'United States', 'facility': "Children's Mercy Hospital", 'geoPoint': {'lat': 39.09973, 'lon': -94.57857}}, {'zip': '63104', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Saint Louis University School of Medicine', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': "Saint Louis Children's Hospital", 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '07601', 'city': 'Hackensack', 'state': 'New Jersey', 'country': 'United States', 'facility': 'HackensackUniversity Medical Center', 'geoPoint': {'lat': 40.88593, 'lon': -74.04347}}, {'zip': '07960', 'city': 'Morristown', 'state': 'New Jersey', 'country': 'United States', 'facility': "Goryeb Children's Hospital", 'geoPoint': {'lat': 40.79677, 'lon': -74.48154}}, {'zip': '07052', 'city': 'West Orange', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Pediatric Specialty Center at Saint Barnabas', 'geoPoint': {'lat': 40.79871, 'lon': -74.23904}}, {'zip': '12208', 'city': 'Albany', 'state': 'New York', 'country': 'United States', 'facility': 'Albany Medical College', 'geoPoint': {'lat': 42.65258, 'lon': -73.75623}}, {'zip': '11042', 'city': 'Lake Success', 'state': 'New York', 'country': 'United States', 'facility': "Cohen Children's Medical Center of New York", 'geoPoint': {'lat': 40.77066, 'lon': -73.71763}}, {'zip': '10016', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'New York University Langone Medical Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10021', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Hospital for Special Surgery', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10032', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Columbia University Medical Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10467', 'city': 'The Bronx', 'state': 'New York', 'country': 'United States', 'facility': "Children's Hospital at Montefiore", 'geoPoint': {'lat': 40.84985, 'lon': -73.86641}}, {'zip': '28203', 'city': 'Charlotte', 'state': 'North Carolina', 'country': 'United States', 'facility': "Levine Children's Hospital", 'geoPoint': {'lat': 35.22709, 'lon': -80.84313}}, {'zip': '27705', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': "Duke Children's Hospital & Health Center", 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '45229', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': "Cincinnati Children's Hospital Medical Center", 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '044109', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'MetroHealth Medical Center', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '44106', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': "UH Rainbow Babies and Children's Hospital", 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '44195', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Clevland Clinic Foundation', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '43205', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': "Nationwide Children's Hospital", 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '97227', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': "Randall Children's Hospital at Legacy Emanuel", 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': "Children's Hospital of Philadelphia", 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '19134', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': "St. Christopher's Hospital for Children", 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '15224', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': "Children's Hospital of Pittsburgh of UPMC", 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '29425', 'city': 'Charleston', 'state': 'South Carolina', 'country': 'United States', 'facility': "Medical University of South Carolina Children's Hospital", 'geoPoint': {'lat': 32.77632, 'lon': -79.93275}}, {'zip': '37232', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': "Monroe Carell Jr. Children's Hospital at Vanderbilt", 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '75390', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'University of Texas Southwestern Medical Center Dallas', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '77030-2399', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Baylor College of Medicine Pediatric Immunology, Allergy and Rheumatology', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '84112', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'University of Utah Hospitals and Clinics', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}, {'zip': '05401', 'city': 'Burlington', 'state': 'Vermont', 'country': 'United States', 'facility': 'University of Vermont Medical Center', 'geoPoint': {'lat': 44.47588, 'lon': -73.21207}}, {'zip': '98105', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': "Seattle Children's Hospital", 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'zip': '53792', 'city': 'Madison', 'state': 'Wisconsin', 'country': 'United States', 'facility': "University of Wisconsin-American Family Children's Hospital", 'geoPoint': {'lat': 43.07305, 'lon': -89.40123}}, {'zip': 'AB T3B', 'city': 'Calgary', 'state': 'Alberta', 'country': 'Canada', 'facility': "University of Calgary- Alberta Children's Hospital", 'geoPoint': {'lat': 51.05011, 'lon': -114.08529}}, {'zip': 'NS B3K 6R8', 'city': 'Halifax', 'state': 'Nova Scotia', 'country': 'Canada', 'facility': 'IWK Health Center', 'geoPoint': {'lat': 44.64269, 'lon': -63.57688}}, {'zip': 'M5G 1X8', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'The Hospital for Sick Children', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'overallOfficials': [{'name': 'Yukiko Kimura, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hackensack Meridian Health'}, {'name': 'Sarah Ringold, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Seattle Children's Hospital"}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR', 'ANALYTIC_CODE'], 'timeFrame': 'IPD will be available for requests through the CARRA data and sample request portal once the PCORI Final Research Report has been approved and is publicly available. There is no time limit.', 'ipdSharing': 'YES', 'description': 'Key outcome data, treatment data and baseline characteristics will be shared with other researchers upon request and are subject to the CARRA data and sample sharing policy (https://carragroup.org/UserFiles/file/CARRA-DATA-SAMPLE-SHARING-POLICY-04November2016.pdf). Documentation of appropriate IRB/ethics board approval will be required.', 'accessCriteria': 'Investigators may request data through the CARRA data and sample share request portal. Inquiries may be sent to research@carragroup.org.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hackensack Meridian Health', 'class': 'OTHER'}, 'collaborators': [{'name': 'Patient-Centered Outcomes Research Institute', 'class': 'OTHER'}, {'name': 'Childhood Arthritis and Rheumatology Research Alliance', 'class': 'OTHER'}, {'name': 'Duke Clinical Research Institute', 'class': 'OTHER'}, {'name': "Seattle Children's Hospital", 'class': 'OTHER'}, {'name': "Children's Hospital of Philadelphia", 'class': 'OTHER'}, {'name': "Boston Children's Hospital", 'class': 'OTHER'}, {'name': 'The Hospital for Sick Children', 'class': 'OTHER'}, {'name': 'University Health Network, Toronto', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}