Ignite Creation Date:
2025-12-24 @ 4:42 PM
Ignite Modification Date:
2025-12-28 @ 12:58 AM
Study NCT ID:
NCT01247766
Status:
COMPLETED
Last Update Posted:
2025-03-21
First Post:
2010-11-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety Study of Abatacept to Treat Rheumatoid Arthritis
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': 'ACTUAL', 'count': 6367}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-12-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2014-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-19', 'studyFirstSubmitDate': '2010-11-23', 'studyFirstSubmitQcDate': '2010-11-23', 'lastUpdatePostDateStruct': {'date': '2025-03-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2010-11-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Serious infection', 'timeFrame': 'Every 2 years throughout the study'}, {'measure': 'Incidence rates of malignancy', 'timeFrame': 'Every 2 years throughout the study', 'description': '(total, lymphoma, lung cancer, breast cancer, colorectal cancer)'}, {'measure': 'Total mortality', 'timeFrame': 'Every 2 years throughout the study'}], 'secondaryOutcomes': [{'measure': 'Multiple sclerosis', 'timeFrame': 'Every 2 years throughout the study', 'description': 'To determine the incidence rate of multiple sclerosis (MS) in RA patients treated with abatacept and to compare this rate with the rate in RA patients matched for age, gender, RA duration and DMARD use, after adjusting for other potential confounders.'}]}, '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': 'https://www.bms.com/researchers-and-partners/investigator-inquiry-form.html', 'label': 'Investigator Inquiry Form'}, {'url': 'https://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm', 'label': 'FDA Safety Alerts and Recalls'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare the incidence rates of infection, malignancy and death among patients with rheumatoid arthritis who are treated with abatacept and those who are treated with other anti-rheumatic medications for rheumatoid arthritis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Residents of British Columbia who have received health care service for rheumatoid arthritis', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Rheumatoid arthritis\n* Receipt of abatacept, other biologic disease-modifying drug, or any non- biologic disease-modifying anti-rheumatic drug\n* Age 18 years or older\n\nExclusion Criteria:\n\n* Below 18 years of age'}, 'identificationModule': {'nctId': 'NCT01247766', 'briefTitle': 'Safety Study of Abatacept to Treat Rheumatoid Arthritis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bristol-Myers Squibb'}, 'officialTitle': 'Post-marketing Observational Study Assessing the Long-term Safety of Abatacept Using a Population-based Cohort of Rheumatoid Arthritis Patients in the Province of British Columbia', 'orgStudyIdInfo': {'id': 'IM101-213'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with rheumatoid arthritis (RA) who receive abatacept'}, {'label': 'Patients with RA who receive BDM drugs', 'description': 'biologic disease-modifying (BDM)'}, {'label': 'Patients with RA who receive non-biologic DMARDs', 'description': 'disease-modifying anti-rheumatic drugs (DMARDs)'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Bristol-Myers Squibb', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bristol-Myers Squibb'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bristol-Myers Squibb', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Arthritis Research Centre of Canada', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}