RecruitingNCT05754710

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


Sponsor

Pfizer

Enrollment

10 participants

Start Date

Apr 12, 2024

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Min Age: 2 YearsMax Age: 17 Years

Plain Language Summary

Simplified for easier understanding

This is a post-marketing surveillance study in South Korea to monitor the real-world safety and effectiveness of Xeljanz (tofacitinib) in children with juvenile idiopathic arthritis (JIA) — a chronic inflammatory joint disease that can severely limit movement and quality of life in young patients. Post-marketing surveillance is required after a new medication receives approval to ensure it continues to perform safely when used in everyday clinical practice outside of controlled trials. Participants must be children aged 2 to under 18 years who are receiving Xeljanz as prescribed by their doctor, in line with the approved medication label. A parent or legal guardian must provide signed informed consent. Children who have a contraindication to Xeljanz as per the current approved labelling are excluded. No experimental treatment is given — the study simply collects data from routine clinical care. This research matters because children are not always well-represented in the original drug approval trials, and ongoing safety surveillance ensures that the medication continues to be used safely and effectively in the broadest range of real-world paediatric patients.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGXeljanz

Juvenile Idiopathic Arthritis (JIA) patients with Xeljanz


Locations(1)

Pfizer

Seoul, South Korea

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NCT05754710


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