Safety Study of Abatacept to Treat Rheumatoid Arthritis

• Conditions: Rheumatoid Arthritis

• Registration Number: NCT01247766
• Lead Sponsor: Bristol-Myers Squibb

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-11-23
• Study First Submitted QC: 2010-11-23
• Study First Posted: 2010-11-24
• Study Start: 2010-12-31
• Status Verified: 2018-03
• Last Update Submitted: 2018-03-26
• Last Update Posted: 2018-03-29
• Primary Completion: 2019-06-30
• Study Completion: 2019-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 8000

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

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Exclusion Criteria

• Below 18 years of age

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Serious infection	Every 2 years throughout the study
Incidence rates of malignancy	Every 2 years throughout the study	(total, lymphoma, lung cancer, breast cancer, colorectal cancer)
Total mortality	Every 2 years throughout the study

Secondary Outcome Measures

Name	Time	Method
Multiple sclerosis	Every 2 years throughout the study	To determine the incidence rate of multiple sclerosis (MS) in RA patients treated with abatacept and to compare this rate with the rate in RA patients matched for age, gender, RA duration and DMARD use, after adjusting for other potential confounders.