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Clinical Trials/NCT01094795
NCT01094795
Completed
Not Applicable

A Nationwide Post-marketing Study on the Safety of Abatacept Treatment in Sweden Using the ARTIS Register

Bristol-Myers Squibb0 sites92,635 target enrollmentMarch 31, 2011
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ConditionsRheumatoid Arthritis

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Rheumatoid Arthritis
Sponsor
Bristol-Myers Squibb
Enrollment
92635
Primary Endpoint
Hospitalized infection
Status
Completed
Last Updated
3 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 31, 2011
End Date
June 24, 2019
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • •Resident of Sweden

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Hospitalized infection

Time Frame: Every 6 months throughout the study

Malignancy (total, lymphoma, lung cancer, breast cancer, colorectal cancer, prostate cancer)

Time Frame: Every 6 months throughout the study

Total mortality

Time Frame: Every 6 months throughout the study

Secondary Outcomes

  • Autoimmune disorders (lupus, psoriasis, multiple sclerosis)(Every 6 months throughout the study)

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