Korea Xeljanz Post-marketing Surveillance for Juvenile Idiopathic Arthritis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Xeljanz.
- Who it may be relevant to
- Registry conditions: Psoriatic Arthritis, Juvenile, Polyarticular Juvenile Idiopathic Arthritis. Basic parameters: 2 years — 17 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- South Korea
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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
Overview
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.
Interventions
- Drug Xeljanz
Juvenile Idiopathic Arthritis (JIA) patients with Xeljanz
Primary outcome measures
- Number of patients with treatment emergent treatment-related adverse events [Time frame: Maximum of 12 months from the time of first administration of Xeljanz]
Eligibility criteria
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:
1\) Subjects who are contraindicated from taking Xeljanz according to approved labeling\*
\*Refer to most recently approved label
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
South Korea · 1 center
- Pfizer — Seoul
Identifiers
NCT: NCT05754710 · A3921400 · Xeljanz JIA PMS