Safety Study of Abatacept in Sweden

Completed

• Conditions: Rheumatoid Arthritis

• Registration Number: NCT01094795
• Lead Sponsor: Bristol-Myers Squibb

Brief Summary

The primary purpose of this study is to assess incidence rates of targeted infections, malignancies and mortality among patients with rheumatoid arthritis who are treated with abatacept.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study First Submitted: 2010-03-24
• Study First Submitted QC: 2010-03-26
• Study First Posted: 2010-03-29
• Study Start: 2011-03-31
• Primary Completion: 2019-06-24
• Study Completion: 2019-06-24
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-14
• Last Update Posted: 2022-06-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 92635

Inclusion Criteria

• Resident of Sweden

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Exclusion Criteria

• None

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Malignancy (total, lymphoma, lung cancer, breast cancer, colorectal cancer, prostate cancer)	Every 6 months throughout the study
Total mortality	Every 6 months throughout the study
Hospitalized infection	Every 6 months throughout the study

Secondary Outcome Measures

Name	Time	Method
Autoimmune disorders (lupus, psoriasis, multiple sclerosis)	Every 6 months throughout the study