A Study of Filgotinib in Korean Participants With Rheumatoid Arthritis

Launched by EISAI KOREA INC. · Sep 30, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a medication called Filgotinib for people in Korea who have rheumatoid arthritis, a condition that causes joint pain and inflammation. The main goal of the study is to see how many participants experience a significant improvement in their symptoms after 12 weeks of treatment. The trial is currently recruiting participants who are at least 19 years old and have been diagnosed with rheumatoid arthritis. To be eligible, participants should have already tried at least two different treatments for their arthritis but didn’t get enough relief or had to stop due to side effects.

If you join this study, you will receive regular check-ups and assessments to monitor your progress. It’s important to note that certain people, such as those with serious infections or severe liver or kidney issues, cannot participate. Additionally, women who are pregnant or breastfeeding, or those who are unable to use effective birth control, are also excluded. This trial is a chance to potentially benefit from a new treatment while contributing to research that could help others with similar conditions in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Participants who voluntarily provided written consent to participate in this study
• • 2. Male or female, aged greater than or equal to (\>=) 19 years at the time of written informed consent
• • 3. Participants diagnosed with rheumatoid arthritis according to the 2010 ACR/ European League Against Rheumatism (EULAR) classification criteria and who have an ACR functional class of I to III
• • 4. Participants who meet the following criteria are eligible for the specified treatment protocol; those who have been treated with two or more type types (including MTX) of Disease-Modifying Antirheumatic Drugs (DMARDs) for at least 6 months (at least 3 months each) but have experienced insufficient therapeutic effects or have had to discontinue treatment due to adverse events of these medications (However, in cases where MTX is contraindicated due to conditions such as liver disease or renal failure, the participant must have been treated with at least two types of DMARDs, excluding MTX).
• * Furthermore, in participants over 65 years of age, those at high risk of cardiovascular diseases, and those with a potential risk of malignancy, this protocol applies if they have not adequately responded to or tolerated conventional therapies, including Tumor Necrosis Factor (TNF) inhibitors or other biologic agents. Eligibility is confirmed if one of the following criteria is met:
• • 1. DAS28 score exceeding 5.1.
• • 2. DAS28 score between 3.2 and 5.1, with diagnostic imaging showing progression of joint damage.
• Exclusion Criteria:
• • 1. Participants with hypersensitivity reactions to the active ingredient or other components of the investigational product
• • 2. Participants with serious infections (for example \[e.g.\], sepsis) or active infections including localized infections
• • 3. Participants with active tuberculosis (TB)
• • 4. Participants with severe hepatic impairment (e.g., Child-Pugh C)
• • 5. Participants with end-stage renal disease (\<creatinine clearance \[CrCl\] 15 milliliters per minute \[mL/min\])
• • 6. Participants with absolute neutrophil count (ANC) \<1\*10\^9 cells per liter (/L)
• • 7. Participants with absolute lymphocyte count (ALC) \<0.5\*10\^9 cells/L
• • 8. Participants with hemoglobin \<8 grams per deciliter (g/dL)
• • 9. Pregnant or lactating women
• • 10. Women of childbearing potential who are not willing to consent to using effective contraception
• • 11. Participants with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicinal product
• • 12. Participants who received Janus kinase (JAK) inhibitors for the treatment of rheumatoid arthritis
• • 13. Participants who have participated in other clinical studies for investigational product/medical device within 4 weeks prior to screening
• • 14. Participants in whom the administration of Jyseleca Tablet is contraindicated according to the product label approved in Korea or based on certain medical conditions that have been identified in previous clinical studies
• • 15. Participants for whom follow-up deems impossible