Ignite Creation Date:
2025-12-24 @ 1:07 PM
Ignite Modification Date:
2025-12-24 @ 1:07 PM
Study NCT ID:
NCT03784261
Status:
UNKNOWN
Last Update Posted:
2021-09-21
First Post:
2018-12-17
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Usefulness of Non TNF Usage 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': 'D000069594', 'term': 'Abatacept'}], 'ancestors': [{'id': 'D018796', 'term': 'Immunoconjugates'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D005916', 'term': 'Globulins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 90}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-12-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2024-12-16', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-09-20', 'studyFirstSubmitDate': '2018-12-17', 'studyFirstSubmitQcDate': '2018-12-20', 'lastUpdatePostDateStruct': {'date': '2021-09-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-12-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-16', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from Baseline Values of DAS28-CRP', 'timeFrame': 'Baseline and 1 year', 'description': 'Assessment of efficacy in rheumatoid arthritis patients for 1 year treated by salirumab (N=30), tocilizumab (N=30), or abatacept (N=30).'}, {'measure': 'Assessment of adverse event in rheumatoid arthritis patients for 1 year treated by salirumab (N=30), tocilizumab (N=30), or abatacept (N=30).', 'timeFrame': 'at 1 year'}]}, '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. Sarilumab treatment for 12 months\n2. Tocilizmab treatment for 12 months\n3. Abatacept treatment for 12 months'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', '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': 'NCT03784261', 'briefTitle': 'Usefulness of Non TNF Usage in RA Patients', 'organization': {'class': 'OTHER', 'fullName': 'Shinshu University'}, 'officialTitle': 'Usefulness of Non TNF Usage in Rheumatoid Arthritis Patients', 'orgStudyIdInfo': {'id': 'NonTNF 2018'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'SAR, usually subucutaneous injection every 2 weeks', 'interventionNames': ['Drug: Drug: "Salirumab"', 'Drug: Drug: "Tocilizmab"', 'Drug: Drug: "Abatacept"']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'TCZ, usually subucutaneous injection every 2 weeks', 'interventionNames': ['Drug: Drug: "Salirumab"', 'Drug: Drug: "Tocilizmab"', 'Drug: Drug: "Abatacept"']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'ABT, usually subucutaneous injection every week', 'interventionNames': ['Drug: Drug: "Salirumab"', 'Drug: Drug: "Tocilizmab"', 'Drug: Drug: "Abatacept"']}], 'interventions': [{'name': 'Drug: "Salirumab"', 'type': 'DRUG', 'description': 'To examine the effects of salirumab in RA patients', 'armGroupLabels': ['ABT, usually subucutaneous injection every week', 'SAR, usually subucutaneous injection every 2 weeks', 'TCZ, usually subucutaneous injection every 2 weeks']}, {'name': 'Drug: "Tocilizmab"', 'type': 'DRUG', 'description': 'To examine the effects of tocilizmab in RA patients', 'armGroupLabels': ['ABT, usually subucutaneous injection every week', 'SAR, usually subucutaneous injection every 2 weeks', 'TCZ, usually subucutaneous injection every 2 weeks']}, {'name': 'Drug: "Abatacept"', 'type': 'DRUG', 'description': 'To examine the effects of abatacept in RA patients', 'armGroupLabels': ['ABT, usually subucutaneous injection every week', 'SAR, usually subucutaneous injection every 2 weeks', 'TCZ, usually subucutaneous injection every 2 weeks']}]}, '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': 'Principle Investigator', 'investigatorFullName': 'Yukio Nakamura', 'investigatorAffiliation': 'Shinshu University'}}}}