Xeljanz safety and effects in Korean children with 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
This will try Xeljanz in children and teens (ages 2 to under 18) with juvenile idiopathic arthritis in Korea to see how safe and helpful it is during routine care.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 10 (estimated) |
| Ages | 2 Years to 17 Years |
| Sex | All |
| Sponsor | Pfizer Industry-sponsored |
| Locations | 1 site (Seoul) |
| Trial ID | NCT05754710 on ClinicalTrials.gov |
What this trial studies
This is a prospective, observational post‑marketing surveillance program in Korea monitoring pediatric patients prescribed Xeljanz for juvenile idiopathic arthritis for up to 44 weeks. Patients aged 2 to less than 18 who receive Xeljanz per approved labeling and investigator judgment are followed during their routine clinical visits to record safety events and treatment effects. The study is sponsored by Pfizer and collects real‑world data to supplement existing clinical trial evidence. Data collection focuses on adverse events, tolerability, and measures of disease control as observed in clinical practice.
Who should consider this trial
Good fit: Children and adolescents aged 2 to less than 18 in Korea with juvenile idiopathic arthritis who are prescribed Xeljanz by their physician are the intended participants.
Not a fit: Patients who are contraindicated for Xeljanz, outside the specified age range, or not prescribed Xeljanz by their doctor are unlikely to benefit from participating.
Why it matters
Potential benefit: If successful, the study could provide clearer real‑world information on Xeljanz safety and effectiveness in Korean children with JIA to help guide clinicians and caregivers.
How similar studies have performed: Xeljanz and other JAK inhibitors have demonstrated effectiveness in adults and in some pediatric trials, but real‑world post‑marketing data specifically from Korean children are limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Subjects must meet all of the following inclusion criteria to be eligible for inclusion in the study: 1. Pediatric subjects aged from 2 years to less than 18 years 2. Xeljanz administered according to efficacy/effectiveness on the approved labeling 3. Patients who will administer Xeljanz based on the medical judgement of the investigator 4. 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 Exclusion Criteria: 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
Where this trial is running
Seoul
- Pfizer — Seoul, South Korea (Recruiting)
Study contacts
- Study coordinator: Pfizer CT.gov Call Center
- Email: ClinicalTrials.gov_Inquiries@pfizer.com
- Phone: 1-800-718-1021
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.