Korean Post-marketing Surveillance for Xeljanz XR

NCT04876781 · tracked via the Priya Life Science South Korea tracker

Sponsor

Pfizer

Phase

Observational

Started

2022-01-12

Last updated

2026-08-03

Condition(s) studied

Active Moderate to Severe Rheumatoid ArthritisActive Ankylosing SpondylitisActive Psoriatic Arthritis

Investigational drug(s) / intervention(s)

Tofacitinib XR →

Tofacitinib XR: Tofacitinib XR 11mg

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

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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 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 2. Patients who have previously been given Xeljanz 5mg, who have changed Xeljanz® XR, are also eligible for registration in the study 3. 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: 1. Patients with a history of hypersensitivity to any ingredients of this product. 2. Patients with serious infection (sepsis, etc.) or active infection including localized 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 following cases: ANC; absolute neutrophil count \<1,000 cells/mm3 ALC; absolute lymphocyte count \<500 cells/mm3 Hemoglobin\<9 g/dL

Primary outcome measure(s)

Number of Participants With Treatment Emergent Adverse Events (AEs) — Maximum of 52 weeks from the time of initial administration of Xeljanz XR
AE is any untoward medical occurrence attributed to study drug in a participant who received study drug. Serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to end of this PMS after last dose that were absent before treatment or that worsened relative to pretreatment state. Relatedness to Xeljanz XR was assessed by the investigator (Yes/No). Participants with multiple occurrences of an AE within a category were counted once within the category.

Trial sites (1)

Facility	City	Region	Status
Pfizer	Seoul	South Korea	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04876781 on ClinicalTrials.gov ↗ ← All trials in South Korea