Safety Study of Abatacept in Rheumatoid Arthritis Participants
Completed
- Conditions
- Rheumatoid Arthritis
- Registration Number
- NCT03696173
- Lead Sponsor
- Bristol-Myers Squibb
- Brief Summary
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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 5800
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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Incidence of increased risk of serious infection while taking abatacept Approximately 7 years Without methotrexate
Incidence of malignancy while taking abatacept Approximately 7 years Without methotrexate
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Local Institution
🇺🇸Princeton, New Jersey, United States
Local Institution🇺🇸Princeton, New Jersey, United States