Psoriatic Arthritis, JuvenileKRXeljanzJIANCT05754710

Korea Xeljanz Post-marketing Surveillance for Juvenile Idiopathic Arthritis

An observational study of Psoriatic Arthritis, Juvenile and Polyarticular Juvenile Idiopathic Arthritis, run by Pfizer at 1 site in South Korea.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 2 to 17 years
Conditions the study is for: Psoriatic Arthritis, Juvenile, Polyarticular Juvenile Idiopathic Arthritis
What is being tested?: Xeljanz
How many people: 10 participants
Where: 1 siteSouth Korea
Study dates: 12 Apr 2024to 30 Sep 2026
Phase: Observational

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 2 to 17 years
All sexes
No healthy volunteers
Child

Study population: Patients with active polyarticular Juvenile Idiopathic Arthritis or juvenile Psoriatic Arthritis who are administered Xeljanz according to the approved label in Korea.

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Pfizer CT.gov Call Center contact

1-800-718-1021

ClinicalTrials.gov_Inquiries@pfizer.com

South Korea1 site, 1 recruiting

Pfizer
Seoul
Recruiting

Other trials in South Korea

About this study

Official title: 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

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.

Conditions: Psoriatic Arthritis, Juvenile, Polyarticular Juvenile Idiopathic Arthritis
Being tested: Xeljanz
Medical subject headings: Arthritis, Juvenile

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

XeljanzDrug
Juvenile Idiopathic Arthritis (JIA) patients with Xeljanz

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of patients with treatment emergent treatment-related adverse events
Incidence of each adverse event (AE) will be presented with 95% confidence interval. Serious, related, and/or unexpected AEs will be summarized separately. Additionally, in the event that AEs designated as important potential risks and important identified risks are reported, or if a patient in the missing information group is recruited, related safety information will be provided separately.
Measured: Maximum of 12 months from the time of first administration of Xeljanz

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

12 Apr 202430 Sep 2026

First posted6 Mar 2023
Study start12 Apr 2024
Primary completion30 Sep 2026 (estimated)
Study completion30 Sep 2026 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Psoriatic Arthritis, JuvenileStudies of the same condition, open and under way.
More trials run by PfizerThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 10 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05754710
Sponsor's protocol ID: A3921400
Other IDs: Xeljanz JIA PMS
Acronym: KRXeljanzJIA
Status last verified: Jul 2026
First submitted: 22 Feb 2023
Last updated: 3 Aug 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
Individual data sharing: No: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.