Safety Study of Abatacept in Rheumatoid Arthritis Participants

Bristol-Myers Squibb (BMS)

Status: Completed

Conditions: Rheumatoid Arthritis

Treatments: Other: Non-Interventional

Study type: Observational

Funder types: Industry

Identifiers

NCT03696173

IM101-605

Details and patient eligibility

About

A observational study to assess whether biologic disease-modifying (BDM) treatment initiation with abatacept for rheumatoid arthritis is associated with an increased risk of serious infection and cancer

Enrollment: 5,800 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patient initiates BDM treatment with at least one claim for the treatment. Patients will be presumed to be new users of a treatment if there is no claim for the drug or any other BDM in the 180 days prior to the cohort entry date
• Patient has at least two diagnoses for RA in the patient's history prior to and including the entry date or within the 180 days after the entry date
• Patient is aged 18 years or older on the entry date
• Patient was enrolled in the database for at least 180 days before the entry date

Exclusion criteria

• Patient is younger than 18 years on the entry date
• Patients who receive abatacept and another biologic simultaneously
• Patients who have an outcome diagnosis in the baseline period will be excluded from the cohort analyses for that outcome

Other protocol defined inclusion/exclusion criteria could apply

Trial design

5,800 participants in 2 patient groups

Participants taking abatacept

Treatment:

Other: Non-Interventional

Other: Non-Interventional

Participants taking abatacept with methotrexate

Treatment:

Other: Non-Interventional

Other: Non-Interventional