Korean Post-marketing Surveillance for Xeljanz
- Conditions
- Rheumatoid ArthritisPsoriatic Arthritis
- Registration Number
- NCT02984020
- Lead Sponsor
- Pfizer
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 1041
Inclusion Criteria:<br><br>To be included in the study all patients will have received at least 1 dose of Xeljanz<br>for the treatment of the following indication as per local labelling. Moderately to<br>severely active RA in adult patients who have had an inadequate response or intolerance<br>to previous therapy with at least 1 biological DMARD. Or Active psoriatic arthritis (PsA)<br>who have had an inadequate response or intolerance to previous antirheumatic drugs<br>(DMARDs)<br><br>Exclusion Criteria:<br><br> 1. Patients with a history of hypersensitivity to any ingredients of the product.<br><br> 2. Patients with serious infection (eg, sepsis) or active infection including localized<br> infection.<br><br> 3. Patients with active tuberculosis.<br><br> 4. Patients with severe hepatic function disorder.<br><br> 5. Patients with an absolute neutrophil count (ANC) <500 cells/mm3.<br><br> 6. Patients with a lymphocyte count <500 cells/mm3.<br><br> 7. Patients with a hemoglobin concentration <8 g/dL.<br><br> 8. Pregnant or possibly pregnant women.<br><br> 9. Because of lactose contained in this drug, it should not be administered to patients<br> with hereditary problems of galactose intolerance, Lapp lactase deficiency or<br> glucose-galactose malabsorption.<br><br>According to Contraindication on label, the investigator should discontinue the patient's<br>treatment if the laboratory test results are as below Patients with an absolute<br>neutrophil count (ANC) <500 cells/mm3 Patients with a hemoglobin level <8 g/dL
Not provided
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method