Ignite Creation Date:
2025-12-25 @ 2:11 AM
Ignite Modification Date:
2025-12-29 @ 4:42 AM
Study NCT ID:
NCT01088360
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2019-01-18
First Post:
2010-03-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety Study of Abatacept to Treat Rheumatoid Arthritis (B)
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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20000}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2005-03-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-01', 'completionDateStruct': {'date': '2029-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-01-17', 'studyFirstSubmitDate': '2010-03-12', 'studyFirstSubmitQcDate': '2010-03-16', 'lastUpdatePostDateStruct': {'date': '2019-01-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2010-03-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2029-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Key safety outcomes (targeted infections, malignancies, mortality)', 'timeFrame': 'Every 6 months throughout the study'}], 'secondaryOutcomes': [{'measure': 'Patient-reported infusion reactions', 'timeFrame': 'Every 6 months throughout the study'}, {'measure': 'Multiple sclerosis, lupus, and psoriasis', 'timeFrame': 'Every 6 months throughout the study'}, {'measure': 'Adverse events in pregnant women who receive abatacept', 'timeFrame': 'Every 6 months throughout the study'}, {'measure': 'Adverse events in subjects on abatacept who receive concomitant biologics', 'timeFrame': 'Every 6 months throughout the study'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Rheumatoid Arthritis']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html', 'label': 'BMS Clinical Trial Information'}, {'url': 'http://www.bms.com/clinical_trials/Pages/Investigator_inquiry_form.aspx', 'label': 'Investigator Inquiry Form'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare the incidence rates of targeted infections, malignancies and mortality among patients with rheumatoid arthritis who are treated with abatacept and those who are treated with other anti-rheumatic medications.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients being treated for rheumatoid arthritis in the US', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Signed informed consent\n* Diagnosis of rheumatoid arthritis\n* \\> 18 years at index treatment initiation or switch\n* Starting treatment with abatacept or new disease-modifying anti-rheumatic drug (including switching or adding) or biologic disease modifying drug.\n* Read/write English\n\nExclusion Criteria:\n\n* None'}, 'identificationModule': {'nctId': 'NCT01088360', 'briefTitle': 'Safety Study of Abatacept to Treat Rheumatoid Arthritis (B)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bristol-Myers Squibb'}, 'officialTitle': 'An Observational Cohort to Assess Safety and Outcomes in Patients Treated With Abatacept and Other Anti-Rheumatic Therapies', 'orgStudyIdInfo': {'id': 'IM101-045B'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with rheumatoid arthritis initiating abatacept'}, {'label': 'Pts with RA initiating other biologic disease-modifying drugs'}, {'label': 'Pts w/ RA non-biologic disease-modifying anti-rheumatic drugs'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Bristol-Myers Squibb', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bristol-Myers Squibb'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bristol-Myers Squibb', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'National Data Bank for Rheumatic Diseases (NDB)', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}