NCT04876781

Korean Post-marketing Surveillance for Xeljanz XR

Korean Post-marketing Surveillance for Xeljanz XR (Registered)

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 200 (estimated)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a open-label, non-comparative, non-interventional, prospective, and multi-center study to further evaluate the safety and effectiveness of Xeljianz XR in routine clinical practice in Korea. Safety is the primary interest of this study, which will be assessed based on adverse events (AEs) that occur during the 6 months from the first dose of Xeljanz XR. The efficacy endpoints will be the modified Disease Activity Score using 28 joint counts (DAS28) change from baseline, European League Against Rheumatism (EULAR) response, and American College of Rheumatology 20% improvement criteria (ACR20) response after treatment.

Conditions

• Active Moderate to Severe Rheumatoid Arthritis
• Active Ankylosing Spondylitis
• Active Psoriatic Arthritis

Interventions

Type	Name	Description
DRUG	Tofacitinib XR	Tofacitinib XR 11mg

Timeline

• Start date: 2022-01-12
• Primary completion: 2026-06-30
• Completion: 2026-06-30
• First posted: 2021-05-06
• Last updated: 2026-03-27

Locations

1 site across 1 country: South Korea

Regulatory

• FDA-regulated drug study