RecruitingNCT04876781

Korean Post-marketing Surveillance for Xeljanz XR

Korean Post-marketing Surveillance for Xeljanz XR (Registered)


Sponsor

Pfizer

Enrollment

200 participants

Start Date

Jan 12, 2022

Study Type

OBSERVATIONAL

Conditions

Summary

Xeljanz XR extended-release tablets 11 mg (Tofacitinib citrate) is a drug subject to the risk management plan in accordance with Article 4-1-11 of the "Regulation on Safety of Medicinal Products, etc." in Korea. As part of additional pharmacovigilance activity, this Post-marketing Surveillance (PMS) was planned to evaluate safety and effectiveness of Xeljanz XR under routine clinical practice. At least 200 patients with Rheumatoid Arthritis, Psoriatic Arthritis, or Ankylosing Spondylitis who were treated with Xeljanz XR will be enrolled about four years.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This is a post-marketing surveillance study in Korea monitoring the real-world safety and effectiveness of Xeljanz XR (tofacitinib extended-release), a medication used to treat rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis. Researchers collect data on how the drug performs outside of clinical trial conditions. **You may be eligible if...** - You are an adult (18+) being prescribed Xeljanz XR for rheumatoid arthritis, psoriatic arthritis, or ankylosing spondylitis according to the approved Korean labeling - You have had an inadequate response or intolerance to prior standard treatments (e.g., methotrexate or other DMARDs) - You have provided written informed consent - You may also be eligible if you are switching from the regular Xeljanz 5mg tablet to the XR formulation **You may NOT be eligible if...** - You are allergic to any ingredient of Xeljanz XR - You are in a special caution group (age 65+, cardiovascular risk, or cancer risk) and no other treatments have been tried first - You are pregnant or nursing Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGTofacitinib XR

Tofacitinib XR 11mg


Locations(1)

Pfizer

Seoul, South Korea

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NCT04876781


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