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RecruitingNCT05754710KRXeljanzJIAUpdated Aug 3, 2026

Korea Xeljanz Post-marketing Surveillance for Juvenile Idiopathic Arthritis

An observational study in Psoriatic Arthritis, Juvenile and Polyarticular Juvenile Idiopathic Arthritis, sponsored by Pfizer. Recruiting at 1 site in South Korea. Open to participants aged 2 Years to 17 Years. Per ClinicalTrials.gov, last updated 2026-08-03.

Sponsored by Pfizer · Observational

From the registry’s dates

  • Started Apr 2024; still recruiting 2 years 5 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
10
Ages
2 Years to 17 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Psoriatic Arthritis, Juvenile
  • Polyarticular Juvenile Idiopathic Arthritis

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03

In context

Arthritis, Juvenile

352 studies on the registry are indexed under Arthritis, Juvenile; 92 are open to participants now.

This study's planned enrollment of 10 is below the median of 120 across 113 observational studies indexed under Arthritis, Juvenile.

Browse Arthritis, Juvenile studies →

Lead sponsor

Pfizer is the lead sponsor of 3,244 studies on the registry; 139 are open to participants now.

Of its 582 completed or terminated interventional studies of FDA-regulated products, 381 (65%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
2 Years to 17 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

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

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

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
10 participants (estimated)
Patient registry
No

Interventions

  • DrugXeljanz

    Juvenile Idiopathic Arthritis (JIA) patients with Xeljanz

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Maximum of 12 months from the time of first administration of Xeljanz

07

Study locations

1 of 1 sites recruiting
  • Pfizer
    Seoul, South Korea
    Recruiting
08

References and documents

Individual participant data

Plan to share: 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.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 3, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05754710
Lead sponsor
Pfizer
Responsible party
Sponsor
First posted
Mar 6, 2023
Start date
Apr 12, 2024
Primary completion
Sep 30, 2026 (estimated)
Completion
Sep 30, 2026 (estimated)
Last update
Aug 3, 2026

Study contacts

Pfizer CT.gov Call Center
Contact
ClinicalTrials.gov_Inquiries@pfizer.com
1-800-718-1021
Pfizer CT.gov Call Center
study director · Pfizer

Oversight

Data monitoring committee
No
FDA-regulated drug
No
View the source record on ClinicalTrials.gov ↗

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