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NCT01094795 Clinical Trial

Safety Study of Abatacept in Sweden

Rheumatoid Arthritis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01094795
Other study ID # IM101-125
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 31, 2011
Est. completion date June 24, 2019

Study information
Verified date June 2022
Source Bristol-Myers Squibb
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 92635
Est. completion date June 24, 2019
Est. primary completion date June 24, 2019
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - Resident of Sweden Exclusion Criteria: - None

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
n/a

Sponsors (2)
Lead Sponsor Collaborator
Bristol-Myers Squibb Karolinska Institutet

Outcome
Type Measure Description Time frame Safety issue
Primary Hospitalized infection Every 6 months throughout the study
Primary Malignancy (total, lymphoma, lung cancer, breast cancer, colorectal cancer, prostate cancer) Every 6 months throughout the study
Primary Total mortality Every 6 months throughout the study
Secondary Autoimmune disorders (lupus, psoriasis, multiple sclerosis) Every 6 months throughout the study
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