Safety Study of Abatacept to Treat Rheumatoid Arthritis (B)

Active, not recruiting

• Conditions: Rheumatoid Arthritis

• Registration Number: NCT01088360
• Lead Sponsor: Bristol-Myers Squibb

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-03-31
• Study First Submitted: 2010-03-12
• Study First Submitted QC: 2010-03-16
• Study First Posted: 2010-03-17
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-17
• Last Update Posted: 2019-01-18
• Primary Completion: 2029-06-30
• Study Completion: 2029-06-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 20000

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

• None

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Key safety outcomes (targeted infections, malignancies, mortality)	Every 6 months throughout the study

Secondary Outcome Measures

Name	Time	Method
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