Rheumatoid Arthritis
Conditions
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
Interventions
OTHERNon-Interventional
Non-Interventional
Sponsors
Bristol-Myers Squibb
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of increased risk of serious infection while taking abatacept | Approximately 7 years | With methotrexate |
| Incidence of malignancy while taking abatacept | Approximately 7 years | With methotrexate |
Countries
United States
Outcome results
None listed