Korean Post-marketing Surveillance for Xeljanz XR

Launched by PFIZER · May 4, 2021

Keywords

ClinConnect Summary

This clinical trial is studying the safety and effectiveness of a medication called Xeljanz XR (tofacitinib citrate) for patients with moderate to severe rheumatoid arthritis, ankylosing spondylitis, or psoriatic arthritis. The trial aims to gather more information about how well this medication works in everyday medical practice. The researchers plan to enroll at least 200 participants over about four years. To be eligible, participants must be adults aged 18 or older who have not responded well to previous treatments or cannot tolerate them. This includes patients aged 65 and older, those with a high risk of heart problems, and individuals at risk for cancer.

If you join the study, you will receive Xeljanz XR as part of your treatment plan, and you will be closely monitored by the medical team. It’s important to know that some people cannot participate, such as those with serious infections, certain blood disorders, or severe liver problems. If you are pregnant or think you might be, you are also not eligible. The trial will help gather important data about the use of Xeljanz XR, which may benefit many patients like you in the future.

Gender

ALL

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