Korea Xeljanz Post-marketing Surveillance for Juvenile Idiopathic Arthritis

NCT05754710 | Recruiting

• 2 other identifiers: A3921400Xeljanz JIA PMS
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Psoriatic Arthritis, Juvenile; Polyarticular Juvenile Idiopathic Arthritis

Outcome Measures

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.

  Maximum of 12 months from the time of first administration of Xeljanz

Interventions

Xeljanz DRUG

Juvenile Idiopathic Arthritis (JIA) patients with Xeljanz

Eligibility Criteria

• Age: 2 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

Pfizer

Seoul, South Korea

RECRUITING

Related Links

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

MeSH Terms

Conditions

Arthritis, Juvenile

Interventions

tofacitinib

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Central Study Contacts

Pfizer CT.gov Call Center

CONTACT

1-800-718-1021; ClinicalTrials.gov_Inquiries@pfizer.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 22, 2023
• First Posted: March 6, 2023
• Study Start: April 12, 2024
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: August 3, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)