Korea Xeljanz Post-marketing Surveillance for Juvenile Idiopathic Arthritis

Polyarticular Juvenile Idiopathic Arthritis Clinical Trial

— KRXeljanzJIA  

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05754710
• Other study ID #: A3921400
• Secondary ID: Xeljanz JIA PMS
• Status: Not yet recruiting
• Start date: December 31, 2024
• Est. completion date: January 24, 2027

Study information

• Verified date: March 2024
• Source: Pfizer
• Contact: Pfizer CT.gov Call Center
• Phone: 1-800-718-1021
• Email: ClinicalTrials.gov_Inquiries[@]pfizer.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 375
• Est. completion date: January 24, 2027
• Est. primary completion date: January 24, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 17 Years

Eligibility

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: 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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Juvenile
• Arthritis, Psoriatic
• Polyarticular Juvenile Idiopathic Arthritis

Intervention

Drug:
• Xeljanz
Juvenile Idiopathic Arthritis (JIA) patients with Xeljanz

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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