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Evaluating Filgotinib for Rheumatoid Arthritis in Korean Patients

A Multicenter, Open-label, Single-arm, Phase 4 Study to Evaluate the Efficacy and Safety of Filgotinib in Korean Patients With Rheumatoid Arthritis

PHASE4 · Eisai Inc. · NCT06625242

This study is testing if a medication called Filgotinib can help Korean patients with rheumatoid arthritis feel better after not responding well to other treatments.

Quick facts

PhasePHASE4
Study typeInterventional
Enrollment150 (estimated)
Ages19 Years and up
SexAll
SponsorEisai Inc. (industry)
Locations15 sites (Anyang-si and 14 other locations)
Trial IDNCT06625242 on ClinicalTrials.gov

What this trial studies

This study aims to evaluate the effectiveness of Filgotinib Maleate in treating rheumatoid arthritis among Korean participants. The primary endpoint is to measure the percentage of participants achieving a 20% improvement in symptoms, as defined by the American College of Rheumatology (ACR20), after 12 weeks of treatment. Participants must have a history of inadequate response to previous treatments with Disease-Modifying Antirheumatic Drugs (DMARDs). The study is interventional and is conducted in a Phase 4 setting.

Who should consider this trial

Good fit: Ideal candidates include Korean adults aged 19 and older with a diagnosis of rheumatoid arthritis who have not responded adequately to previous DMARD treatments.

Not a fit: Patients who have not been treated with multiple DMARDs or those with contraindications to Filgotinib may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide significant relief and improved quality of life for patients suffering from rheumatoid arthritis.

How similar studies have performed: Previous studies have shown promising results with Filgotinib in treating rheumatoid arthritis, indicating a potential for success in this approach.

Eligibility criteria

Show full inclusion / exclusion 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

Where this trial is running

Anyang-si and 14 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Rheumatoid Arthritis, Filgotinib Maleate

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.