Monitoring the safety and effectiveness of Xeljanz XR in patients with certain types of arthritis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to evaluate the safety and effectiveness of Xeljanz XR (Tofacitinib citrate) in patients with active moderate to severe rheumatoid arthritis, active ankylosing spondylitis, and active psoriatic arthritis under routine clinical practice in Korea. The study will enroll at least 200 patients over a period of four years, focusing on adverse events and efficacy endpoints such as the modified Disease Activity Score and EULAR response. It is an open-label, non-comparative, and non-interventional study designed to gather real-world data on the drug's performance.

Why it matters

Who can join: the full rules

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

Where it's running

• Pfizer
  Seoul, South Korea Recruiting

Study contacts

• Study coordinator: Pfizer CT.gov Call Center
• Email: ClinicalTrials.gov_Inquiries@pfizer.com
• Phone: 1-800-718-1021

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.