Overview

This trial is active, not recruiting.

Condition rheumatoid arthritis
Sponsor Bristol-Myers Squibb
Collaborator Karolinska Institutet
Start date March 2011
End date October 2017
Trial size 100000 participants
Trial identifier NCT01094795, IM101-125

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm

Primary Outcomes

Measure
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

Measure
Autoimmune disorders (lupus, psoriasis, multiple sclerosis)
time frame: Every 6 months throughout the study

Eligibility Criteria

Male or female participants of any age.

Inclusion Criteria: - Resident of Sweden Exclusion Criteria:

Additional Information

Official title A Nationwide Post-marketing Study on the Safety of Abatacept Treatment in Sweden Using the ARTIS Register
Trial information was received from ClinicalTrials.gov and was last updated in January 2016.
Information provided to ClinicalTrials.gov by Bristol-Myers Squibb.