NCT05754710

Korea Xeljanz Post-marketing Surveillance for Juvenile Idiopathic Arthritis

Korean Post-marketing Surveillance for Xeljanz® 5 mg Film-coated Tablets and Xeljanz® 1 mg/mL Oral Solution in Patients With Active pJIA and jPsA

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 10 (estimated)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 2 Years – 17 Years
• Healthy volunteers: Not accepted

Summary

This study is to assess the safety and effectiveness of Xeljanz in Juvenile Idiopathic Arthritis (JIA) patients in routine clinical practice in Korea. JIA patients experience persistent joint pain, swelling and stiffness. This is a prospective observational study. Xeljanz is a JAK inhibitor. It was first approved in 2014 for rheumatoid arthritis patients in Korea. The ministry of Food and Drug Safety in Korea mandates for a drug manufacturer to report the post-marketing surveillance after drug's approval or indication extension. This study is to see the safety and effectiveness of Xeljanz in Juvenile Idiopathic Arthritis patients in routine clinical practice in Korea. This study is seeking patients who: * Are 2 to less than 18 years of age; * Are given Xeljanz for the treatment of JIA. The study sponsor will monitor patients' treatment experience for up to 44 weeks. This will help assess the safety and effects of this study medicine.

Conditions

• Psoriatic Arthritis, Juvenile
• Polyarticular Juvenile Idiopathic Arthritis

Interventions

Type	Name	Description
DRUG	Xeljanz	Juvenile Idiopathic Arthritis (JIA) patients with Xeljanz

Timeline

• Start date: 2024-04-12
• Primary completion: 2026-09-30
• Completion: 2026-09-30
• First posted: 2023-03-06
• Last updated: 2026-03-13

Locations

1 site across 1 country: South Korea