Safety Study of Abatacept in Rheumatoid Arthritis Participants

Completed

Conditions studied: Rheumatoid Arthritis

In brief

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

Key facts

Study ID

NCT03696173

Run by

Bristol-Myers Squibb

People needed

5800

Starts

2015-12-17

Expected to finish

2018-06-29

Last updated by the study team

2018-10-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Local Institution — Princeton, New Jersey, United States

Full record on ClinicalTrials.gov

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