Effectiveness and Safety of Tofacitinib in Korean Patients With Rheumatoid Arthritis

Sponsor
Hanyang University
Study ID
NCT03011281
Status
Unknown

Conditions

Eligibility Criteria

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

Interventions

Study Details

The objectives of this single center, prospective, non-interventional inception cohort is to understand patient characteristics, general treatment patterns, effectiveness, and safety of Tofacitinib for rheumatoid arthritis patients in the real-world setting. 1. To evaluate the baseline characteristics of Korean RA patients treated with Tofacitinib 2. To evaluate the effectiveness and safety of Tofacitinib in clinical practice in Korean RA patients. 3. To further evaluate safety, effectiveness and demographic characteristics of the patients treated with Tofacitinib matched with and compared to biologic DMARDs from the BIOPSY registry database.

Key Dates

Start date
Sep 30, 2016
Status verified
Jun 2020
Primary completion
Dec 31, 2020
Completion
Dec 31, 2021

Study Design

Enrollment
378 participants (estimated)

Arms

  • Arm: RA patients who start Tofacitinib
    Korean RA patients who start Tofacitinib with moderately to severely active RA who have had an inadequate response or intolerance to methotrexate or biologics.

Primary Outcome Measure

DAS28-ESR (erythrocyte sedimentation rate) remission (DAS28 < 2.6) rate (%) [ Time Frame: 5 years ]

Central Contacts

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