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Rheumatoid ArthritisPhase 4NCT06625242

A Study of Filgotinib in Korean Participants With Rheumatoid Arthritis

A Phase 4 study testing Filgotinib Maleate in people with Rheumatoid Arthritis, run by Eisai Korea Inc. at 15 sites in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 19 years and older
Conditions the study is for
Rheumatoid Arthritis
What is being tested?
Filgotinib Maleate
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
118 participants
Where
15 sitesSouth Korea
Study dates
22 Oct 2024to 25 Feb 2026
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Participants who voluntarily provided written consent to participate in this study
  • Male or female, aged greater than or equal to (>=) 19 years at the time of written informed consent
  • 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
  • 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:
  • DAS28 score exceeding 5.1.
  • DAS28 score between 3.2 and 5.1, with diagnostic imaging showing progression of joint damage.

Who cannot join

  • Participants with hypersensitivity reactions to the active ingredient or other components of the investigational product
  • Participants with serious infections (for example [e.g.], sepsis) or active infections including localized infections
  • Participants with active tuberculosis (TB)
  • Participants with severe hepatic impairment (e.g., Child-Pugh C)
  • Participants with end-stage renal disease (<creatinine clearance [CrCl] 15 milliliters per minute [mL/min])
  • Participants with absolute neutrophil count (ANC) <1*10^9 cells per liter (/L)
Show all 15Show fewer
  • Participants with absolute lymphocyte count (ALC) <0.5*10^9 cells/L
  • Participants with hemoglobin <8 grams per deciliter (g/dL)
  • Pregnant or lactating women
  • Women of childbearing potential who are not willing to consent to using effective contraception
  • Participants with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicinal product
  • Participants who received Janus kinase (JAK) inhibitors for the treatment of rheumatoid arthritis
  • Participants who have participated in other clinical studies for investigational product/medical device within 4 weeks prior to screening
  • 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
  • Participants for whom follow-up deems impossible

Trial locations and contacts

15 sites in 1 country.

15 sites in 1 country

South Korea15 sites

  • Eisai site #11

    Anyang-si

  • Eisai site #01

    Busan

  • Eisai site #09

    Daegu

  • Eisai site #12

    Daegu

  • Eisai site #06

    Daejeon

  • Eisai site #15

    Guri-si

  • Eisai site #02

    Gwangju

  • Eisai site #13

    Incheon

  • Eisai site #03

    Seoul

  • Eisai site #04

    Seoul

  • Eisai site #05

    Seoul

  • Eisai site #07

    Seoul

  • Eisai site #08

    Seoul

  • Eisai site #10

    Seoul

  • Eisai site #14

    Seoul

Other trials in South Korea

About this study

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

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.

Being tested
Filgotinib Maleate
Keywords
Rheumatoid Arthritis, Filgotinib Maleate
Medical subject headings
Arthritis, Rheumatoid

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Filgotinib MaleateDrug

    Also called Jyseleca

    Administered as oral tablets.

Study groups in NCT06625242
Study groupRoleWhat they receive
Filgotinib Maleate 100 or 200 milligramExperimentalNot described
Receives: Drug: Filgotinib Maleate

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Participants Achieving ACR20 Response at Week 12

    Measured: At Week 12

Secondary outcomes (10)

  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

    Measured: At Weeks 12 and 24

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

    Measured: Baseline, Weeks 12 and 24

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

    Measured: At Weeks 12 and 24

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

    Measured: Baseline, Weeks 12 and 24

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

    Measured: At Week 24

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

    Measured: 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

    Measured: 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)

    Measured: At Weeks 12 and 24

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

    Measured: At Weeks 12

  10. Number of Participants With Adverse Events (AEs)

    Measured: Baseline up to 28 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Oct 2024
  2. Study start22 Oct 2024
  3. Primary completion21 Jan 2026
  4. Study completion25 Feb 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
118 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06625242
Sponsor's protocol ID
GS6034-M082-401
Status last verified
Aug 2025
First submitted
30 Sep 2024
Last updated
11 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Eisai's data sharing commitment and further information on how to request data can be found on our website http://eisaiclinicaltrials.com/.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Filgotinib Maleate in people with Rheumatoid Arthritis, run by Eisai Korea Inc. at 15 sites in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants Achieving ACR20 Response at Week 12 (time frame: At Week 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06625242.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2026.

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