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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1972 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-10-10

Study Completion Date

2022-10-10

Brief Summary

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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.

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Detailed Description

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Conditions

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Arthritis, Rheumatoid

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Rheumatoid Arthritis (RA) patients treated with biologic and nonbiologic DMARDs

to include all Japanese patients taking Tofacitinib

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Diagnosed with Rheumatoid Arthritis (RA) according to the 1987 American College of Rheumatology (ACR) or the ACR/European Lead Against Rheumatism (EULAR) 2010 RA Classification Criteria;
* At least 18 years of age or older;
* Was / Must be prescribed or switching to the following eligible medication for the first time ever at the enrollment visit:
* csDMARD: methotrexate (closed in February 2018);
* Anti-TNF bDMARD: adalimumab (originator or biosimilar), certolizumab pegol, etanercept (originator or biosimilar), golimumab, infliximab (originator or biosimilar), or any other anti-TNF biosimilar approved during the study;
* Non-TNF bDMARD: abatacept, tocilizumab, sarilumab (closed in June 2020);
* JAK inhibitor: tofacitinib, baricitinib, peficitinib, filgotinib, upadacitinib.