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Clinical Trials/NCT01247766
NCT01247766
Completed
Not Applicable

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

Bristol-Myers Squibb0 sites6,367 target enrollmentDecember 31, 2010
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ConditionsRheumatoid Arthritis

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Rheumatoid Arthritis
Sponsor
Bristol-Myers Squibb
Enrollment
6367
Primary Endpoint
Serious infection
Status
Completed
Last Updated
last year
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
December 31, 2010
End Date
December 31, 2014
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • •Rheumatoid arthritis
  • •Receipt of abatacept, other biologic disease-modifying drug, or any non- biologic disease-modifying anti-rheumatic drug
  • •Age 18 years or older

Exclusion Criteria

  • •Below 18 years of age

Outcomes

Primary Outcomes

Serious infection

Time Frame: Every 2 years throughout the study

Incidence rates of malignancy

Time Frame: Every 2 years throughout the study

(total, lymphoma, lung cancer, breast cancer, colorectal cancer)

Total mortality

Time Frame: Every 2 years throughout the study

Secondary Outcomes

  • Multiple sclerosis(Every 2 years throughout the study)

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