Ignite Creation Date:
2025-12-24 @ 9:44 PM
Ignite Modification Date:
2026-01-01 @ 11:09 AM
Study NCT ID:
NCT07211932
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-11-26
First Post:
2025-10-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Tofacitinib in Juvenile Idiopathic Arthritis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001171', 'term': 'Arthritis, Juvenile'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C479163', 'term': 'tofacitinib'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 58}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-21', 'studyFirstSubmitDate': '2025-10-01', 'studyFirstSubmitQcDate': '2025-10-01', 'lastUpdatePostDateStruct': {'date': '2025-11-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-10-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'JADAS-10', 'timeFrame': 'Baseline and 12 months', 'description': 'Change in the Juvenile Arthritis Disease Activity Score (JADAS-10) score at 12 months of treatment with tofacitinib. Range score: 0 to 10, the less score the better'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Arthritis, Juvenile', 'tofacitinib [Supplementary Concept]', 'Janus Kinase Inhibitors'], 'conditions': ['Juvenile Idiopathic Arthritis (JIA)']}, 'descriptionModule': {'briefSummary': 'This study aims to evaluate, using real-world clinical practice data, the efficacy of tofacitinib in improving the clinical control of juvenile idiopathic arthritis (JIA) after 12 months of treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with JIA', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\nDiagnosis of juvenile idiopathic arthritis (JIA) documented in the medical record by the treating rheumatologist.\n\nDocumentation in the medical record of the medical indication for tofacitinib treatment, with a diagnostic justification related to JIA.\n\nAge under 18 years at the time of the treatment indication with tofacitinib.\n\nExclusion criteria:\n\nParticipants diagnosed with any of the following conditions:\n\nReactive arthritis\n\nArthritis associated with inflammatory bowel disease\n\nArthritis associated with another autoimmune disease'}, 'identificationModule': {'nctId': 'NCT07211932', 'briefTitle': 'Tofacitinib in Juvenile Idiopathic Arthritis', 'organization': {'class': 'OTHER', 'fullName': "Consorci Sanitari de l'Alt Penedès i Garraf"}, 'officialTitle': 'Efficacy of Tofacitinib in Patients With Juvenile Idiopathic Arthritis: A Study Based on Real-world Clinical Practice Data.', 'orgStudyIdInfo': {'id': 'CSAPG-78'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Tofacitinib', 'description': 'Patients affected by JIA and treated with tofacitinib', 'interventionNames': ['Drug: Tofacitinib']}], 'interventions': [{'name': 'Tofacitinib', 'type': 'DRUG', 'description': 'Patients received tofacitinib for the treatment of juvenile idiopathic arthritis (JIA).', 'armGroupLabels': ['Tofacitinib']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Barcelona', 'state': 'Barcelona', 'country': 'Spain', 'contacts': [{'name': 'Andrea Zacarías Crovato', 'role': 'CONTACT', 'email': 'recerca@csapg.cat', 'phone': '+34 93 253 21 00'}, {'name': 'Andrea Zacarías Crovato', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hospital Sant Joan de Déu Barcelona', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'city': 'Sabadell', 'state': 'Barcelona', 'country': 'Spain', 'contacts': [{'name': 'Judith Sánchez Manubens', 'role': 'CONTACT', 'email': 'recerca@csapg.cat', 'phone': '+34937231010'}, {'name': 'Judith Sánchez Manubens', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Corporació Sanitària Parc Taulí de Sabadell', 'geoPoint': {'lat': 41.54329, 'lon': 2.10942}}, {'zip': '08720', 'city': 'Vilafranca del Penedès', 'state': 'Barceona', 'country': 'Spain', 'contacts': [{'name': 'Noemí Casaponsa', 'role': 'CONTACT', 'email': 'recerca@csapg.cat', 'phone': '+34938960025', 'phoneExt': '43197'}, {'name': 'Vicenç Torrente, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hospital de Vilafranca', 'geoPoint': {'lat': 41.34618, 'lon': 1.69713}}], 'centralContacts': [{'name': 'Noemí Casaponsa', 'role': 'CONTACT', 'email': 'recerca@csapg.cat', 'phone': '+34938960025', 'phoneExt': '43197'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'After publication of main results of the study.', 'ipdSharing': 'YES', 'description': 'IPD (without personal identification data) could be shared by requirement from other researchers after the end of the study, and only for research purposes and previous approval of promotor center of the study (CSAPG). Anyway, Spanish and European Union legal policy about data protection will strictly be followed (IPD will not be transferred outside European Union).', 'accessCriteria': 'IPD will be shared only for scientific research purposes and following the Spanish and European Union normative law about data protection. The requirements will be directed to the IP of the study. The IP will evaluate the request to verify and evaluate the data that is requested and the purposes for which it is requested. Next, the IP will transfer the request to the promotor center the study for the final decision.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Consorci Sanitari de l'Alt Penedès i Garraf", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}