Ignite Creation Date:
2025-12-24 @ 4:25 PM
Ignite Modification Date:
2026-02-26 @ 2:15 AM
Study NCT ID:
NCT03755466
Status:
UNKNOWN
Last Update Posted:
2021-09-21
First Post:
2018-11-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Examination of Efficacy and Safety of Baricitinib in RA Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001172', 'term': 'Arthritis, Rheumatoid'}], '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': 'C000596027', 'term': 'baricitinib'}, {'id': 'D001688', 'term': 'Biological Products'}, {'id': 'C479163', 'term': 'tofacitinib'}], 'ancestors': [{'id': 'D045424', 'term': 'Complex Mixtures'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 90}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-11-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2025-11-20', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-09-20', 'studyFirstSubmitDate': '2018-11-21', 'studyFirstSubmitQcDate': '2018-11-23', 'lastUpdatePostDateStruct': {'date': '2021-09-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-11-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-11-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Assessment of Disease Activity in rheumatoid patients for 1 year treated by baricitinib (N=30), biologics (N=30), or tofacitinib (N=30). Also, the efficacy and adverse event of each drug for 1 year in the RA patients.', 'timeFrame': 'Change from Baseline Values of DAS28-CRP at 1 year in each group'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Rheumatoid Arthritis']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to examine the efficacy and adverse events in the following 3 groups in rheumatoid arthritis patients:\n\n1. Baricitinib treatment for 12 months\n2. Biologics treatment for 12 months\n3. Tofacitinib treatment for 12 months'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* RA patients\n\nExclusion Criteria:\n\n* Not RA patients\n* RA patients who are allergic to the drugs, refused to do this research, or who are pregnant'}, 'identificationModule': {'nctId': 'NCT03755466', 'briefTitle': 'Examination of Efficacy and Safety of Baricitinib in RA Patients', 'organization': {'class': 'OTHER', 'fullName': 'Shinshu University'}, 'officialTitle': 'Efficacy and Safety of Baricitinib in Rheumatoid Arthritis Patients Compared With Those Treated by Biologics or Tofacitinib', 'orgStudyIdInfo': {'id': 'BARI2018'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'BARI', 'interventionNames': ['Drug: "Biologics"', 'Drug: Tofacitinib 5 MG [Xeljanz]']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Bio', 'interventionNames': ['Drug: "Baricitinib", "olumiant®"', 'Drug: Tofacitinib 5 MG [Xeljanz]']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Tofa', 'interventionNames': ['Drug: "Baricitinib", "olumiant®"', 'Drug: "Biologics"']}], 'interventions': [{'name': '"Baricitinib", "olumiant®"', 'type': 'DRUG', 'description': 'To examine the effects of baricitinib in RA patients', 'armGroupLabels': ['Bio', 'Tofa']}, {'name': '"Biologics"', 'type': 'DRUG', 'description': 'To examine the effects of biologics in RA patients', 'armGroupLabels': ['BARI', 'Tofa']}, {'name': 'Tofacitinib 5 MG [Xeljanz]', 'type': 'DRUG', 'description': 'To examine the effects of tofacitinib in RA patients', 'armGroupLabels': ['BARI', 'Bio']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3908621', 'city': 'Matsumoto', 'state': 'Nagano', 'status': 'RECRUITING', 'country': 'Japan', 'contacts': [{'name': 'Yukio Nakamura, MD, PhD', 'role': 'CONTACT', 'email': 'yxn14@aol.jp', 'phone': '+81-263-37-2659'}, {'name': 'Yukio Nakamura, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Yukio Nakamura', 'geoPoint': {'lat': 36.23333, 'lon': 137.96667}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shinshu University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer at Shinshu University School of Medicine', 'investigatorFullName': 'Yukio Nakamura', 'investigatorAffiliation': 'Shinshu University'}}}}