Korean Post-marketing Surveillance for Xeljanz XR (XRPMS)

  • STATUS
    Recruiting
  • End date
    May 31, 2025
  • participants needed
    200
  • sponsor
    Pfizer
Updated on 27 May 2022

Summary

Xeljanz(tofacitinib) is a potent, oral janus kinase inhibitor. Xeljanz Tab 5mg was approved by MFDS in 2014 for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response or intolerance to methotrexate. It may be used as monotherapy or in combination with methotrexate or other nonbiologic disease modifying anti rheumatic drugs (DMARDs).

The dosage of Xeljanz 5mg is twice-daily immediate-release (IR) formulation, and Xeljanz XR provides a once-daily (QD) dosing with extended-release (XR) formulation.

Xeljanz 5mg PMS collected approximately 750 patients in 6 years since it was approved in Korea. Althought Xeljanz XR extended-release tablet is an addition of formulation within the approved indication of Xeljanx 5mg, Pfizer Korea decided to conduct PMS of Xeljanz XR extended-release tablet to establish safety and effectiveness in Korean population. At least 200 patients will be enrolled in this study over the next four years after Xeljanz XR is approved.

Details
Condition Active Moderate to Severe Rheumatoid Arthritis, Active Ankylosing Spondylitis
Treatment Tofacitinib XR
Clinical Study IdentifierNCT04876781
SponsorPfizer
Last Modified on27 May 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Patients who have been administered Xeljanz XR for the first time according to the current Korean local labeling (indication, dosage and administration)
Patients who have previously been given Xeljanz 5mg, who have changed Xeljanz XR, are also eligible for registration in the study
Evidence of a personally signed and dated informed consent document indicating that the patient (or a legally acceptable representative) has been informed of all pertinent aspects of the study

Exclusion Criteria

Patients meeting any of the following criteria will not be included in the
study
Patients with a history of hypersensitivity to any ingredients of this product
Patients with serious infection (sepsis, etc.) or active infection including localized infection
Patients with active tuberculosis
Patients with severe hepatic function disorder
Patients with an absolute neutrophil count (ANC) <1,000 cells/mm3
Patients with a lymphocyte count <500 cells/mm3
Patients with a hemoglobin level <9 g/dL
Pregnant or possibly pregnant women. Do not initiate Xeljanz XR in the following cases: ANC; absolute neutrophil count <1,000 cells/mm3 ALC; absolute lymphocyte count <500 cells/mm3 Hemoglobin<9 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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