This trial is active, not recruiting.

Condition rheumatoid arthritis
Sponsor Bristol-Myers Squibb
Collaborator Arthritis Research Centre of Canada
Start date December 2010
End date November 2018
Trial size 8000 participants
Trial identifier NCT01247766, IM101-213


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
biologic disease-modifying (BDM)
disease-modifying anti-rheumatic drugs (DMARDs)

Primary Outcomes

Serious infection
time frame: Every 2 years throughout the study
Incidence rates of malignancy
time frame: Every 2 years throughout the study
Total mortality
time frame: Every 2 years throughout the study

Secondary Outcomes

Multiple sclerosis
time frame: Every 2 years throughout the study

Eligibility Criteria

Male or female participants at least 18 years old.

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 Exclusion Criteria: - Below 18 years of age

Additional Information

Official title Post-marketing Observational Study Assessing the Long-term Safety of Abatacept Using a Population-based Cohort of Rheumatoid Arthritis Patients in the Province of British Columbia
Trial information was received from ClinicalTrials.gov and was last updated in November 2015.
Information provided to ClinicalTrials.gov by Bristol-Myers Squibb.