Korean Post-marketing Surveillance for Xeljanz

Study Overview
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Brief Summary
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The objective of this study is to identify any problems and questions with respect to the safety and efficacy of Xeljanz during the post-marketing period as required by the regulation of MFDS.

Official Title
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Korean Post-marketing Surveillance for Xeljanz(Registered) in Rheumatoid Arthritis and Psoriatic Arthritis Patients

Conditions
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Rheumatoid Arthritis, Psoriatic Arthritis

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: To be included in the study all patients will have received at least 1 dose of Xeljanz for the treatment of the following indication as per local labelling. Moderately to severely active RA in adult patients who have had an inadequate response or intolerance to previous therapy with at least 1 biological DMARD. Or Active psoriatic arthritis (PsA) who have had an inadequate response or intolerance to previous antirheumatic drugs (DMARDs) Exclusion Criteria: Patients with a history of hypersensitivity to any ingredients of the product. Patients with serious infection (eg, sepsis) or active infection including localized infection. Patients with active tuberculosis. Patients with severe hepatic function disorder. Patients with an absolute neutrophil count (ANC) <500 cells/mm3. Patients with a lymphocyte count <500 cells/mm3. Patients with a hemoglobin concentration <8 g/dL. Pregnant or possibly pregnant women. Because of lactose contained in this drug, it should not be administered to patients with hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption. According to Contraindication on label, the investigator should discontinue the patient's treatment if the laboratory test results are as below Patients with an absolute neutrophil count (ANC) <500 cells/mm3 Patients with a hemoglobin level <8 g/dL

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Adverse Events (AE) | incidence of AEs investigated during the re-examination period presented with 95% confidence interval. | Up to 6 months from time of first treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in Disease Activity Score based on 28-joints Count (DAS28) | DAS28, a modified version of the original Disease Activity Score (DAS), is a quantitative measure of disease activity used to monitor the treatment of RA. | Baseline, 6 months after treatment or within 30 days after last dose of medicinal product | 
| Percentage of Participants With European League Against Rheumatism (EULAR) Response Based on DAS28 | The Disease Activity Score Based on 28-joints Count based (DAS28-based) EULAR response criteria is used to measure individual response as none, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached. | Baseline, 6 months after treatment or within 30 days after last dose of medicinal product | 
| In case of PsA, Number of active joints, including number of tender and swollen joints | In the case of PsA, DAS28 calculation is the same as calculation of RA above. | Baseline, 3months after treatment or within 30 days after last dose of medicinal product |