Korea Xeljanz Post-marketing Surveillance for Juvenile Idiopathic Arthritis

Sponsor
Pfizer
Study ID
NCT05754710
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
2 Years - 17 Years
Healthy Volunteers
Not accepted

Interventions

  • Xeljanz — DRUG
    Juvenile Idiopathic Arthritis (JIA) patients with Xeljanz

Study Details

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.

Key Dates

Start date
Apr 12, 2024
Status verified
Mar 2026
Primary completion
Sep 30, 2026
Completion
Sep 30, 2026

Study Design

Enrollment
10 participants (estimated)

Primary Outcome Measure

Number of patients with treatment emergent treatment-related adverse events [ Time Frame: Maximum of 12 months from the time of first administration of Xeljanz ]

Central Contacts