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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05754710
Other study ID # A3921400
Secondary ID Xeljanz JIA PMS
Status Active, not recruiting
Phase
First received
Last updated
Start date April 12, 2024
Est. completion date January 24, 2027

Study information

Verified date May 2024
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority
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 Active, not 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

Study Design


Related Conditions & MeSH terms


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
See also
  Status Clinical Trial Phase
Recruiting NCT05411211 - An Observational Study to Assess Change in Disease Activity and Adverse Events of Adalimumab in Chinese Pediatric Participants With Polyarticular Juvenile Idiopathic Arthritis (pJIA)
Completed NCT02141984 - Surveillance of Humira in Korean JIA Patients N/A
Completed NCT04018599 - Comparison of PK and Tolerability of MSB11022 Administered by AI or PFS Phase 1
Completed NCT00144625 - Long-term Treatment Study of MRA for Polyarticular Juvenile Idiopathic Arthritis (pJIA) Phase 3