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

Korean Post-marketing Surveillance for Xeljanz XR (Registered)

This study is testing how safe and effective the medication Xeljanz XR is for people in Korea with certain types of arthritis, including rheumatoid arthritis, ankylosing spondylitis, and psoriatic arthritis.

Quick facts

• Study type: Observational
• Enrollment: 200 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Pfizer (Industry-sponsored)
• Drugs / interventions: methotrexate, Tofacitinib
• Locations: 1 site (Seoul)
• Trial ID: NCT04876781 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with moderate to severe active rheumatoid arthritis, psoriatic arthritis, or ankylosing spondylitis who have not responded adequately to previous treatments.

Not a fit: Patients who are not experiencing inadequate responses to existing treatments or who are not eligible for Xeljanz XR based on the study criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide valuable insights into the safety and effectiveness of Xeljanz XR, potentially improving treatment options for patients with these types of arthritis.

How similar studies have performed: Other studies have shown success in evaluating the safety and effectiveness of similar medications, making this approach relevant and potentially beneficial.

Eligibility criteria

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 this trial is running

Seoul

• Pfizer — Seoul, South Korea (Recruiting)

Study contacts

• Study coordinator: Pfizer CT.gov Call Center

Conditions Active Moderate to Severe Rheumatoid Arthritis; Active Ankylosing Spondylitis; Active Psoriatic Arthritis