Study to Evaluate Safety and Effects of Tofacitinib and Biologic Disease Modifying Antirheumatic Drugs in People Treated for Rheumatoid Arthritis

Sponsor
Pfizer
Study ID
NCT05572567
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Study Details

This is a secondary structured database observational study conducted in Rheumatoid Arthritis (RA) patients treated with biologic and nonbiologic DMARDs, including tofacitinib, collected as part of the CorEvitas Japan RA Registry. The data as of September 2022 will be used for this study. The study will include data from March 2016 to the latest data cut available in 2022 for both effectiveness and safety outcomes.

Key Dates

Start date
Oct 10, 2022
Status verified
Jun 2025
Primary completion
Oct 10, 2022
Completion
Oct 10, 2022

Study Design

Enrollment
1,972 participants (actual)

Arms

  • Arm: Rheumatoid Arthritis (RA) patients treated with biologic and nonbiologic DMARDs
    to include all Japanese patients taking Tofacitinib

Primary Outcome Measure

Mean Incidence Rate of Total Cardiovascular Disease (CVD) Events [ Time Frame: Retrospective data collection from index visit date up to follow-up or latest data cut on 30 June 2022 (Approximately up to 75 months) ]

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