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Korean Post-marketing Surveillance for Xeljanz

CompletedN/A

Sponsor: Pfizer

Conditions: Rheumatoid Arthritis, Psoriatic Arthritis

Countries: South Korea

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.

Eligibility overview

Sex: ALL

Age: 19 Years to —

Healthy volunteers: No

Study type: OBSERVATIONAL

Eligibility criteria

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

Locations (49)

Chunan-si, Chungcheongnam-do, South Korea
Jung-Gu, Daegu, South Korea
Seogu, Daejon, South Korea
Goyang-si, Deogyang-gu, South Korea
Seoul, Gangdong-gu, South Korea
Seoul, Gangdong-gu, South Korea
Chuncheon, Gangwon-do, South Korea
Donggu, Gwang JU, South Korea
Seongnam-si, Gyeongg-do, South Korea
Seongnam-si, Gyeonggi-do, South Korea
Seongnam-si, Gyeonggi-do, South Korea
Yangsan, Gyeongsangnam-do, South Korea
Yangsan, Gyeongsangnam-do, South Korea
Jeonju, Jeollabuk-do, South Korea
Iksan, Jeonlabuk-do, South Korea
Suwon, Kyeongki-do, South Korea
Ansan, Gyeonggi-do, South Korea
Busan, South Korea
Busan, South Korea
Busan, South Korea
Chungcheongbuk-do, South Korea
Daegu, South Korea
Daejeon, South Korea
Giheung-gu, Yongin-si, Gyeonggi-do, South Korea
Goyang-si, Gyeonggi-do, South Korea
Gyeonggi-do, South Korea
Incheon, South Korea
Incheon, South Korea
Jeju Special Self-Goverming Province, South Korea
Metropolitan City, Daejeon, South Korea
+ 19 more on CT.gov