Ignite Creation Date:
2025-12-24 @ 1:12 PM
Ignite Modification Date:
2026-01-18 @ 8:18 PM
Study NCT ID:
NCT01094795
Status:
COMPLETED
Last Update Posted:
2022-06-16
First Post:
2010-03-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety Study of Abatacept in Sweden
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': 92635}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-03-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-06', 'completionDateStruct': {'date': '2019-06-24', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-06-14', 'studyFirstSubmitDate': '2010-03-24', 'studyFirstSubmitQcDate': '2010-03-26', 'lastUpdatePostDateStruct': {'date': '2022-06-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2010-03-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-06-24', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hospitalized infection', 'timeFrame': 'Every 6 months throughout the study'}, {'measure': 'Malignancy (total, lymphoma, lung cancer, breast cancer, colorectal cancer, prostate cancer)', 'timeFrame': 'Every 6 months throughout the study'}, {'measure': 'Total mortality', 'timeFrame': 'Every 6 months throughout the study'}], 'secondaryOutcomes': [{'measure': 'Autoimmune disorders (lupus, psoriasis, multiple sclerosis)', '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': '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 primary purpose of this study is to assess incidence rates of targeted infections, malignancies and mortality among patients with rheumatoid arthritis who are treated with abatacept.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Residents of Sweden', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Resident of Sweden\n\nExclusion Criteria:\n\n* None'}, 'identificationModule': {'nctId': 'NCT01094795', 'briefTitle': 'Safety Study of Abatacept in Sweden', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bristol-Myers Squibb'}, 'officialTitle': 'A Nationwide Post-marketing Study on the Safety of Abatacept Treatment in Sweden Using the ARTIS Register', 'orgStudyIdInfo': {'id': 'IM101-125'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients initiating abatacept'}, {'label': 'Patients receiving other biologic disease-modifying drugs'}, {'label': 'Patients with early rheumatoid arthritis (RA)'}, {'label': 'Patients with prevalent RA identified by hospitalization'}, {'label': 'General population'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Bristol-Myers Squibb', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bristol-Myers Squibb'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bristol-Myers Squibb', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Karolinska Institutet', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}