Korean Post-marketing Surveillance for Xeljanz

Pfizer

Status: Completed

Conditions: Psoriatic Arthritis; Rheumatoid Arthritis

Study type: Observational

Funder types: Industry

Identifiers

NCT02984020

A3921249

Details and patient eligibility

About

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.

Enrollment: 1,041 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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

1. Patients with a history of hypersensitivity to any ingredients of the product.
2. Patients with serious infection (eg, sepsis) or active infection including localized infection.
3. Patients with active tuberculosis.
4. Patients with severe hepatic function disorder.
5. Patients with an absolute neutrophil count (ANC) <500 cells/mm3.
6. Patients with a lymphocyte count <500 cells/mm3.
7. Patients with a hemoglobin concentration <8 g/dL.
8. Pregnant or possibly pregnant women.
9. 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

Trial design