A Study of Jyseleca Tablet (Filgotinib Maleate) in Korean Participants

Launched by EISAI KOREA INC. · Jan 30, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the safety and effectiveness of Jyseleca tablets (Filgotinib Maleate) in people with certain types of arthritis and ulcerative colitis in Korea. The researchers want to learn about any serious side effects or unexpected reactions that may occur when people take Jyseleca, especially in older adults or those with high cardiovascular risk. To be eligible for the study, participants should be over 65 years old, have rheumatoid arthritis that hasn’t responded well to other treatments, or have ulcerative colitis that hasn’t improved with standard therapies.

If you choose to participate, you will be monitored closely for any side effects while taking the medication. The trial is currently recruiting, and all genders are welcome to apply. It’s important to note that certain individuals may not qualify, such as those with severe infections or specific health conditions, so the medical team will review each participant’s health history carefully. This study aims to gather more information about Jyseleca’s use in real-life settings to help improve treatment options for patients like you.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Individuals who are being administered with Jyseleca tablet in accordance with the Korean approved label therapeutic indications.
• • Korean local label therapeutic indications of Jyseleca tablet. In the following participants, Jyseleca tablet should be used only if they do not respond appropriately or are intolerant to existing treatments.
• * Following:
• • 1. Participants over 65 years of age.
• • 2. Participants with a high cardiovascular risk.
• • 3. Participants with malignancy.
• * Rheumatoid arthritis:
• • 1. For treatment of moderately to severely active rheumatoid arthritis in adults who have responded inadequately to, or who are intolerant to one or more disease-modifying anti-rheumatic drugs (DMARDs).
• • 2. Jyseleca tablet may be used as monotherapy or in combination with methotrexate (MTX).
• • 3. Jyseleca tablet should not be used in combination with biological DMARDs (bDMARDs) or other Janus kinase (JAK) inhibitors.
• * Ulcerative colitis:
• • a. For treatment of moderately to severely active ulcerative colitis in adults who have an inadequate response with, lost response to, or were intolerant to either conventional therapy (corticosteroids, immunosuppressants, etc.) or biological agents.
• • The investigator should refer to local label and contraindications in Korea regarding the inclusion criteria.
• Exclusion Criteria:
• • 1. Individuals who fall under contraindications to the administration of Jyseleca tablet in accordance with the local label by the medical judgment of the investigator.
• * Contraindication for Jyseleca tablet in accordance with the Korean label:
• • 1. Participants with hypersensitivity to the active ingredient or other ingredients of the Jyseleca tablet.
• • 2. Participants with active infections, including serious (example, sepsis) or local infections.
• • 3. Participants with active tuberculosis.
• • 4. Participants with severe hepatic disorder.
• • 5. Participants with end-stage renal disorder.
• • 6. Participants with absolute neutrophil count (ANC) \<1\*10\^9 cells/liters (L)
• • 7. Participants with absolute lymphocyte count (ALC) \<0.5\*10\^9 cells/L
• • 8. Participants with hemoglobin level \<8 grams per deciliter (g/dL)
• • 9. Pregnant or potentially pregnant women, lactating women
• • 10. Jyseleca tablet should not be administered to participants with genetic problems such as galactose intolerance, total lactase deficiency, or glucose-galactose malabsorption as it contains lactose.
• • 2. Individuals who are administered Filgotinib in a clinical study other than this post marketing surveillance.
• • 3. Individuals who are considered incompatible with participate in this surveillance by the medical judgment of the investigator.
• • The investigator should refer to local label and contraindications in Korea regarding the exclusion criteria.