Korea Xeljanz Post-marketing Surveillance for Juvenile Idiopathic Arthritis

NCT ID: NCT05754710

Last Updated: 2026-01-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

10 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-04-12

Study Completion Date

2026-10-01

Brief Summary

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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.

Detailed Description

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Conditions

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Psoriatic Arthritis, Juvenile Polyarticular Juvenile Idiopathic Arthritis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Xeljanz

Juvenile Idiopathic Arthritis (JIA) patients with Xeljanz

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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
Minimum Eligible Age

2 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer

Seoul, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Pfizer CT.gov Call Center

Role: CONTACT

1-800-718-1021

Related Links

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https://pmiform.com/clinical-trial-info-request?StudyID=A3921400

To obtain contact information for a study center near you, click here.

Other Identifiers

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A3921400

Identifier Type: -

Identifier Source: org_study_id

Xeljanz JIA PMS

Identifier Type: OTHER

Identifier Source: secondary_id

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