Status:
RECRUITING
Korean Post-marketing Surveillance for Xeljanz XR
Lead Sponsor:
Pfizer
Conditions:
Active Moderate to Severe Rheumatoid Arthritis
Active Ankylosing Spondylitis
Eligibility:
All Genders
18+ years
Brief 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....
Detailed 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. S...
Eligibility Criteria
Inclusion
- Patients must meet all of the following inclusion criteria to be eligible for inclusion in the study:
- 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 or older) 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 inadequate response or who have been intolerant to a prior DMARD therapy.
- Treatment of active ankylosing spondylitis (AS) in adult patients (18 years of age or older) who have responded inadequately to conventional therapy
- In the following patients, Xeljanz® XR should be used only for patients who have had an inadequate response or are intolerant to the existing treatment.
- A. Patients aged 65 or older B. Cardiovascular high-risk patients C. Patients at risk for malignancy
- 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
- 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
Key Trial Info
Start Date :
January 12 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 30 2026
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT04876781
Start Date
January 12 2022
End Date
June 30 2026
Last Update
November 19 2025
Active Locations (1)
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1
Pfizer
Seoul, South Korea