Safety Study of Abatacept to Treat Rheumatoid Arthritis (B)

Bristol-Myers Squibb (BMS)

Status: Active, not recruiting

Conditions: Rheumatoid Arthritis

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT01088360

IM101-045B

Details and patient eligibility

About

The purpose of this study is to compare the incidence rates of targeted infections, malignancies and mortality among patients with rheumatoid arthritis who are treated with abatacept and those who are treated with other anti-rheumatic medications.

Enrollment: 20,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Signed informed consent
• Diagnosis of rheumatoid arthritis
• > 18 years at index treatment initiation or switch
• Starting treatment with abatacept or new disease-modifying anti-rheumatic drug (including switching or adding) or biologic disease modifying drug.
• Read/write English

Exclusion criteria

• None

Trial design

20,000 participants in 3 patient groups

Patients with rheumatoid arthritis initiating abatacept

Pts with RA initiating other biologic disease-modifying drugs

Pts w/ RA non-biologic disease-modifying anti-rheumatic drugs