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CompletedNCT06625242Updated May 11, 2026

A Study of Filgotinib in Korean Participants With Rheumatoid Arthritis

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

Phase
Phase 4
Study type
Interventional
Enrollment
118
Allocation
Not applicable
Ages
19 Years and older
Sex
All
01

Study summary

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.

02

Conditions studied

  • Rheumatoid Arthritis

Keywords

  • Rheumatoid Arthritis
  • Filgotinib Maleate
03

Who can participate

Ages eligible
19 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
04

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
118 participants (actual)

Study arms

  • Experimental
    Filgotinib Maleate 100 or 200 milligram

    Drug: Filgotinib Maleate

Interventions

  • DrugFilgotinib Maleate

    Administered as oral tablets.

    Also known as: Jyseleca

05

What researchers measure

Primary outcomes

  1. Percentage of Participants Achieving ACR20 Response at Week 12

    Time frame: At Week 12

Secondary outcomes

  1. 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

  2. Change From Baseline in DAS28 (CRP) at Weeks 12 and 24

    Time frame: Baseline, Weeks 12 and 24

  3. Percentage of Participants Achieving DAS28 (CRP) Less Than (<) 2.6 at Weeks 12 and 24

    Time frame: At Weeks 12 and 24

  4. Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) at Weeks 12 and 24

    Time frame: Baseline, Weeks 12 and 24

  5. Percentage of Participants Achieving an ACR20 Response at Week 24

    Time frame: At Week 24

  6. Percentage of Participants Achieving an ACR50 and ACR70 Responses at Weeks 12 and 24

    Time frame: At Weeks 12 and 24

  7. 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

  8. 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

  9. Percentage of Participants Achieving an ACR20 Response at Week 12 Depending on Demographic Characteristics

    Time frame: At Weeks 12

  10. Number of Participants With Adverse Events (AEs)

    Time frame: Baseline up to 28 weeks

06

Study locations

15 sites
  • Eisai site #11
    Anyang-si, South Korea
  • Eisai site #01
    Busan, South Korea
  • Eisai site #09
    Daegu, South Korea
  • Eisai site #12
    Daegu, South Korea
  • Eisai site #06
    Daejeon, South Korea
  • Eisai site #15
    Guri-si, South Korea
  • Eisai site #02
    Gwangju, South Korea
  • Eisai site #13
    Incheon, South Korea
  • Eisai site #03
    Seoul, South Korea
  • Eisai site #04
    Seoul, South Korea
  • Eisai site #05
    Seoul, South Korea
  • Eisai site #07
    Seoul, South Korea
  • Eisai site #08
    Seoul, South Korea
  • Eisai site #10
    Seoul, South Korea
  • Eisai site #14
    Seoul, South Korea
07

References and documents

Individual participant data

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/.

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT06625242
Lead sponsor
Eisai Korea Inc.
Responsible party
Sponsor
First posted
Oct 3, 2024
Start date
Oct 22, 2024
Primary completion
Jan 21, 2026
Completion
Feb 25, 2026
Last update
May 11, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
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