Safety Study of Abatacept to Treat Rheumatoid Arthritis (A)

Completed

• Conditions: Rheumatoid Arthritis

• Registration Number: NCT01088321
• Lead Sponsor: Bristol-Myers Squibb

Brief Summary

The purpose of this study is to compare the incidence rates of infection 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
• Study First Submitted: 2010-03-12
• Study First Submitted QC: 2010-03-16
• Study First Posted: 2010-03-17
• Primary Completion: 2016-11
• Study Completion: 2016-11
• Status Verified: 2016-12
• Last Update Submitted: 2016-12-07
• Last Update Posted: 2016-12-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 81332

Inclusion Criteria

• Diagnosis of rheumatoid arthritis
• Claims indicating infusion, injection, or dispensing of abatacept, a DMARD, or a BDM
• Age 18 years or older at the time of drug initiation
• Enrollment in the health plan at least 6 continuous months leading up to the time of study drug initiation

Exclusion Criteria

• Below 18 years of age at the time of BDM or DMARD initiation
• Lacking six months of continuous enrollment prior to the initiation of one of the study drugs

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Infections, specifically hospitalized infection, hospitalized pneumonia, hospitalized and/or IV treated pneumonia, tuberculosis, herpes zoster, and opportunistic infection	Every four months throughout the study

Secondary Outcome Measures

Name	Time	Method
Anaphylactic reactions	Every four months throughout the study
Concomitant biologic use	Every four months throughout the study
Multiple sclerosis, lupus, and psoriasis	Every four months throughout the study