Korean Post-marketing Surveillance for Xeljanz

  • STATUS
    Recruiting
  • End date
    Jun 1, 2022
  • participants needed
    1000
  • sponsor
    Pfizer
Updated on 28 January 2021
DMARD
anti-rheumatic drugs
psoriatic arthritis
antirheumatics

Summary

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.

Details
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
SponsorPfizer
Last Modified on28 January 2021

Eligibility

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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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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