An Observational Cohort to Assess Safety and Outcomes in Patients Treated With Abatacept and Other Anti-Rheumatic Therapies

Bristol-Myers Squibb0 sites20,000 target enrollmentMarch 31, 2005

ConditionsRheumatoid Arthritis

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Rheumatoid Arthritis
Sponsor: Bristol-Myers Squibb
Enrollment: 20000
Primary Endpoint: Key safety outcomes (targeted infections, malignancies, mortality)
Status: Active, not recruiting
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

March 31, 2005

End Date

June 30, 2029

Last Updated

7 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Bristol-Myers Squibb

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Signed informed consent
•Diagnosis of rheumatoid arthritis
•\> 18 years at index treatment initiation or switch
•Starting treatment with abatacept or new disease-modifying anti-rheumatic drug (including switching or adding) or biologic disease modifying drug.
•Read/write English

Exclusion Criteria

Not provided

Outcomes

Primary Outcomes

Key safety outcomes (targeted infections, malignancies, mortality)

Time Frame: Every 6 months throughout the study

Secondary Outcomes

Adverse events in subjects on abatacept who receive concomitant biologics(Every 6 months throughout the study)
Patient-reported infusion reactions(Every 6 months throughout the study)
Multiple sclerosis, lupus, and psoriasis(Every 6 months throughout the study)
Adverse events in pregnant women who receive abatacept(Every 6 months throughout the study)