NCT05754710 Korea Xeljanz Post-marketing Surveillance for Juvenile Idiopathic Arthritis
| NCT ID | NCT05754710 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Pfizer |
| Condition | Psoriatic Arthritis, Juvenile |
| Study Type | OBSERVATIONAL |
| Enrollment | 10 participants |
| Start Date | 2024-04-12 |
| Primary Completion | 2026-09-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 10 participants in total. It began in 2024-04-12 with a primary completion date of 2026-09-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Contact & Investigator
Pfizer CT.gov Call Center
STUDY DIRECTOR
Pfizer
Frequently Asked Questions
Who can join the NCT05754710 clinical trial?
This trial is open to participants of all sexes, aged 2 Years or older, up to 17 Years, studying Psoriatic Arthritis, Juvenile. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05754710 currently recruiting?
Yes, NCT05754710 is actively recruiting participants. Contact the research team at ClinicalTrials.gov_Inquiries@pfizer.com for enrollment information.
Where is the NCT05754710 trial being conducted?
This trial is being conducted at Seoul, South Korea.
Who is sponsoring the NCT05754710 clinical trial?
NCT05754710 is sponsored by Pfizer. The principal investigator is Pfizer CT.gov Call Center at Pfizer. The trial plans to enroll 10 participants.