NCT04876781
Korean Post-marketing Surveillance for Xeljanz XR
Recruiting · Not specified · Pfizer · registry updated 2026-08-03
Inclusion and exclusion lines below are quoted from ClinicalTrials.gov. No match score is shown, because a score needs a person's age, biomarkers, and treatment dates. Confirm the record with the study team.
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.
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.
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. \*