NCT05754710Recruiting
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
Source: ClinicalTrials.gov · Last updated 3 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 10 (estimated)
- First submitted
- 22 Feb 2023
- Start date
- 12 Apr 2024
- Primary completion date
- 30 Sept 2026
- Lead sponsor
- Pfizer
- Diseases
- Psoriatic arthritis
- NCT number
- NCT05754710
What you commit to
- Study type: Observational
- Planned participants: 10
- From 12 Apr 2024 to the primary completion date, 30 Sept 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- Subjects meeting any of the following criteria will not be included in the study:
- 1\) Subjects who are contraindicated from taking Xeljanz according to approved labeling\*
- \*Refer to most recently approved label
Who the study is looking for
- Subjects must meet all of the following inclusion criteria to be eligible for inclusion in the study:
- Pediatric subjects aged from 2 years to less than 18 years
- Xeljanz administered according to efficacy/effectiveness on the approved labeling
- Patients who will administer Xeljanz based on the medical judgement of the investigator
- Evidence of a personally signed and dated informed consent document indicating that the subject (and a legally acceptable representative) has been informed of all pertinent aspects of the study
Age in the registry: 2 years to 17 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Pfizer Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.