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Safety Study of Abatacept in Rheumatoid Arthritis Participants

Completed
Conditions
Rheumatoid Arthritis
Interventions
Other: Non-Interventional
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
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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

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Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Arm && Interventions
GroupInterventionDescription
Participants taking abataceptNon-Interventional-
Participants taking abatacept with methotrexateNon-Interventional-
Primary Outcome Measures
NameTimeMethod
Incidence of increased risk of serious infection while taking abataceptApproximately 7 years

Without methotrexate

Incidence of malignancy while taking abataceptApproximately 7 years

Without methotrexate

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Local Institution

🇺🇸

Princeton, New Jersey, United States

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