Korean Post-marketing Surveillance for Xeljanz XR
NCT04876781 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 200
Last updated 2026-03-27
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.
Conditions
- Active Moderate to Severe Rheumatoid Arthritis
- Active Ankylosing Spondylitis
- Active Psoriatic Arthritis
Interventions
- DRUG
-
Tofacitinib XR
Tofacitinib XR 11mg
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Pfizer CT.gov Call Center · Pfizer
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-01-12
- Primary Completion
- 2026-06-30
- Completion
- 2026-06-30
- FDA Drug
- Yes
Countries
- South Korea
Study Locations
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