Korean Post-marketing Surveillance for Xeljanz XR

Last updated: June 27, 2025
Sponsor: Pfizer
Overall Status: Active - Recruiting

Phase

N/A

Condition

Joint Injuries

Psoriatic Arthritis

Treatment

Tofacitinib XR

Clinical Study ID

NCT04876781
A3921369
  • Ages > 18
  • All Genders

Study Summary

Xeljanz XR extended-release tablets 11 mg (Tofacitinib citrate) is a drug subject to the risk management plan in accordance with Article 4-1-11 of the "Regulation on Safety of Medicinal Products, etc." in Korea. As part of additional pharmacovigilance activity, this Post-marketing Surveillance (PMS) was planned to evaluate safety and effectiveness of Xeljanz XR under routine clinical practice. At least 200 patients with Rheumatoid Arthritis, Psoriatic Arthritis, or Ankylosing Spondylitis who were treated with Xeljanz XR will be enrolled about four years.

Eligibility Criteria

Inclusion

Inclusion Criteria:

Patients must meet all of the following inclusion criteria to be eligible for inclusion in the study:

  1. Xeljanz® XR is administered according to indications on the approved labeling

  • Treatment of moderate to severe active RA in adult patients (18 years of age orolder) who have had an inadequate response or are intolerant to methotrexate

  • In combination with methotrexate, treatment of active psoriatic arthritis (PsA)in adult patients (18 years of age or older) who have had an inadequateresponse or who have been intolerant to a prior DMARD therapy.

  • Treatment of active ankylosing spondylitis (AS) in adult patients (18 years ofage or older) who have responded inadequately to conventional therapy

  • In the following patients, Xeljanz® XR should be used only for patients whohave had an inadequate response or are intolerant to the existing treatment. A. Patients aged 65 or older B. Cardiovascular high-risk patients C. Patients atrisk for malignancy

  1. Patients who have previously been given Xeljanz 5mg, who have changed Xeljanz® XR,are also eligible for registration in the study

  2. Evidence of a personally signed and dated informed consent document indicating thatthe patient (or a legally acceptable representative) has been informed of allpertinent aspects of the study

Exclusion

Exclusion Criteria:

Patients meeting any of the following criteria will not be included in the study:

  1. Patients with a history of hypersensitivity to any ingredients of this product.

  2. Patients with serious infection (sepsis, etc.) or active infection includinglocalized infection.

  3. Patients with active tuberculosis.

  4. Patients with severe hepatic function disorder.

  5. Patients with an absolute neutrophil count (ANC) <1,000 cells/mm3. *

  6. Patients with a lymphocyte count <500 cells/mm3. *

  7. Patients with a hemoglobin level <9 g/dL. *

  8. Pregnant or possibly pregnant women. * Do not initiate Xeljanz XR in the followingcases: ANC; absolute neutrophil count <1,000 cells/mm3 ALC; absolute lymphocytecount <500 cells/mm3 Hemoglobin<9 g/dL

Study Design

Total Participants: 200
Treatment Group(s): 1
Primary Treatment: Tofacitinib XR
Phase:
Study Start date:
January 12, 2022
Estimated Completion Date:
December 06, 2026

Study Description

This is a open-label, non-comparative, non-interventional, prospective, and multi-center study to further evaluate the safety and effectiveness of Xeljianz XR in routine clinical practice in Korea.

Safety is the primary interest of this study, which will be assessed based on adverse events (AEs) that occur during the 6 months from the first dose of Xeljanz XR. The efficacy endpoints will be the modified Disease Activity Score using 28 joint counts (DAS28) change from baseline, European League Against Rheumatism (EULAR) response, and American College of Rheumatology 20% improvement criteria (ACR20) response after treatment.

Connect with a study center

  • Pfizer

    Seoul,
    Korea, Republic of

    Active - Recruiting

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