A Phase 4 interventional study of Filgotinib Maleate in Rheumatoid Arthritis, sponsored by Eisai Korea Inc.. Completed at 15 sites in South Korea. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2026-05-11.
Sponsored by Eisai Korea Inc. · Phase 4, Interventional, and Treatment
The primary purpose of this study is to assess the percentage of participants achieving an American College of Rheumatology (ACR) 20 percent (%) Improvement (ACR20) response at Week 12 of the administration of the investigational product.
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:
Exclusion Criteria:
Drug: Filgotinib Maleate
Administered as oral tablets.
Also known as: Jyseleca
Percentage of Participants Achieving ACR20 Response at Week 12
Time frame: At Week 12
Percentage of Participants Achieving Disease Activity Score for 28 (DAS28) C-reactive Protein (CRP) Less Than or Equal to (<=) 3.2 at Weeks 12 and 24
Time frame: At Weeks 12 and 24
Change From Baseline in DAS28 (CRP) at Weeks 12 and 24
Time frame: Baseline, Weeks 12 and 24
Percentage of Participants Achieving DAS28 (CRP) Less Than (<) 2.6 at Weeks 12 and 24
Time frame: At Weeks 12 and 24
Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) at Weeks 12 and 24
Time frame: Baseline, Weeks 12 and 24
Percentage of Participants Achieving an ACR20 Response at Week 24
Time frame: At Week 24
Percentage of Participants Achieving an ACR50 and ACR70 Responses at Weeks 12 and 24
Time frame: At Weeks 12 and 24
Percentage of Participants Achieving an ACR20, ACR50 and ACR70 Responses at Week 12 and Week 24 Depending on the Prior Treatment Therapy
Time frame: At Weeks 12 and 24
Percentage of Participants Achieving an ACR20, ACR50 and ACR70 Responses at Weeks 12 and 24 Depending on Monotherapy With the Investigational Product and Combination Therapy With Methotrexate (MTX)
Time frame: At Weeks 12 and 24
Percentage of Participants Achieving an ACR20 Response at Week 12 Depending on Demographic Characteristics
Time frame: At Weeks 12
Number of Participants With Adverse Events (AEs)
Time frame: Baseline up to 28 weeks
Plan to share: Yes — Eisai's data sharing commitment and further information on how to request data can be found on our website http://eisaiclinicaltrials.com/.
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This study is completed, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.
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Eisai Korea Inc.