This trial has been completed.

Condition rheumatoid arthritis
Sponsor Bristol-Myers Squibb
Start date March 2005
End date November 2016
Trial size 81332 participants
Trial identifier NCT01088321, IM101-045A


The purpose of this study is to compare the incidence rates of infection among patients with rheumatoid arthritis who are treated with abatacept and those who are treated with other anti-rheumatic medications

United States No locations recruiting
Other countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective

Primary Outcomes

Infections, specifically hospitalized infection, hospitalized pneumonia, hospitalized and/or IV treated pneumonia, tuberculosis, herpes zoster, and opportunistic infection
time frame: Every four months throughout the study

Secondary Outcomes

Anaphylactic reactions
time frame: Every four months throughout the study
Multiple sclerosis, lupus, and psoriasis
time frame: Every four months throughout the study
Concomitant biologic use
time frame: Every four months throughout the study

Eligibility Criteria

Male or female participants of any age.

Inclusion Criteria: - Diagnosis of rheumatoid arthritis - Claims indicating infusion, injection, or dispensing of abatacept, a DMARD, or a BDM - Age 18 years or older at the time of drug initiation - Enrollment in the health plan at least 6 continuous months leading up to the time of study drug initiation Exclusion Criteria: - Below 18 years of age at the time of BDM or DMARD initiation - Lacking six months of continuous enrollment prior to the initiation of one of the study drugs

Additional Information

Official title Safety of Disease Modifying Antirheumatic Drug (DMARD) and Biologic Treatment of Rheumatoid Arthritis
Trial information was received from ClinicalTrials.gov and was last updated in December 2016.
Information provided to ClinicalTrials.gov by Bristol-Myers Squibb.