Recruiting

NCT Number: NCT05754710

Korea Xeljanz Post-marketing Surveillance for Juvenile Idiopathic Arthritis

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.

Recruiting

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Key information

Conditions

Psoriatic Arthritis, Juvenile Arthritis Arthritis, Juvenile Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Polyarticular Juvenile Idiopathic Arthritis Rheumatic Diseases Skin and Connective Tissue Diseases

Age range

2 year–17 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Pfizer

Seoul, South Korea

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

Subjects meeting any of the following criteria will not be included in the study:

Subjects who are contraindicated from taking Xeljanz according to approved labeling*

*Refer to most recently approved label

Treatment and study plan

Xeljanz

Drug

Juvenile Idiopathic Arthritis (JIA) patients with Xeljanz

Primary outcomes

Number of patients with treatment emergent treatment-related adverse events

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

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.

Study contacts

Contact information is provided by the study sponsor or research team.

Pfizer CT.gov Call Center

CONTACT

[email protected]

1-800-718-1021

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study 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

Acronym: KRXeljanzJIA

Important dates

Study start: 2024
Primary completion: 2026
Study completion: 2026
First posted: Mar 6, 2023
Registry last updated: Mar 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Recruiting