Korean Post-marketing Surveillance for Xeljanz XR

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.

NCT Number	NCT04876781
Lead Sponsor	Pfizer
Conditions	Active Moderate to Severe Rheumatoid Arthritis, Active Ankylosing Spondylitis, Active Psoriatic Arthritis
Enrollment	200 participants
Start Date	2022-01-12
Primary Completion	2026-09-22 (estimated)
Study Completion	2026-09-22 (estimated)
Updated on ClinicalTrials.gov	2026-08-03