NCT04876781Recruiting
Korean Post-marketing Surveillance for Xeljanz XR
KOREAN POST-MARKETING SURVEILLANCE FOR XELJANZ XR (REGISTERED)
Source: ClinicalTrials.gov · Last updated 3 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 200 (estimated)
- First submitted
- 20 Apr 2021
- Start date
- 12 Jan 2022
- Primary completion date
- 22 Sept 2026
- Lead sponsor
- Pfizer
- NCT number
- NCT04876781
What you commit to
- Study type: Observational
- Planned participants: 200
- From 12 Jan 2022 to the primary completion date, 22 Sept 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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.
Lab values
- 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
Other
- Patients meeting any of the following criteria will not be included in the study:
Who the study is looking for
- 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.
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Pfizer Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.