Korea Xeljanz Post-marketing Surveillance for Juvenile Idiopathic Arthritis
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age2-17
SponsorPfizer
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
None
Trial population
Patients with active polyarticular Juvenile Idiopathic Arthritis or juvenile Psoriatic Arthritis who are administered Xeljanz according to the approved label in Korea.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Xeljanz
DrugJuvenile Idiopathic Arthritis (JIA) patients with Xeljanz
Treatment groups
No treatment groups listed
Trial outcomes
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.
Time frame
Maximum of 12 months from the time of first administration of Xeljanz Source ClinicalTrials.gov