Safety Study of Abatacept to Treat Rheumatoid Arthritis (A)

Bristol-Myers Squibb81,332 enrolled

Overview

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

Study Type

OBSERVATIONAL

Enrollment

81,332

Conditions

Rheumatoid Arthritis

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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

Outcomes

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

Data from ClinicalTrials.gov

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