Korean Post-marketing Surveillance for Xeljanz XR (NCT04876781) | Clinical Trial Compass
RecruitingNot Applicable
Korean Post-marketing Surveillance for Xeljanz XR
South Korea200 participantsStarted 2022-01-12
Plain-language 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.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Xeljanz® XR is administered according to indications on the approved labeling
✓. 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 criteria
✕. 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. \*
What they're measuring
1
Number of Participants With Treatment Emergent Adverse Events (AEs)
Timeframe: Maximum of 52 weeks from the time of initial administration of Xeljanz XR
✕. 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