Korean Post-marketing Surveillance for Xeljanz

  • End date
    Jun 1, 2022
  • participants needed
  • sponsor
Updated on 28 January 2021
anti-rheumatic drugs
psoriatic arthritis


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.

Condition Psoriasis, PSORIATIC ARTHRITIS, Rheumatoid Arthritis, Arthritis, Arthritis and Arthritic Pain, Psoriasis and Psoriatic Disorders, Rheumatoid Arthritis (Pediatric), Arthritis and Arthritic Pain (Pediatric)
Clinical Study IdentifierNCT02984020
Last Modified on28 January 2021


Yes No Not Sure

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
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