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. (part of Eisai Co., Ltd.) · Phase 4, Interventional, and Treatment
Among 188 studies in Arthritis, Rheumatoid with a site in Korea, Republic of — 10 open to participants now, 16 under way, 2 of them phase 3. Arthritis, Rheumatoid · Korea, Republic of.
Among the 188 studies in Arthritis, Rheumatoid with a site in Korea, Republic of, this one is the 110th largest by enrollment of the 155 interventional ones that give a count, is one of 3 that started in 2024, is one of 20 in phase 4, and was the 184th registered.
3,334 studies on the registry are indexed under Arthritis, Rheumatoid; 444 are open to participants now.
Browse Arthritis, Rheumatoid studies →10 of the 188 studies in Arthritis, Rheumatoid with a site in Korea, Republic of are open now. Recruiting first, the newest first:
AbbVie · Sites in Korea, Republic of, United States, Canada and 9 more countries
Ages 18+
Seoul National University Bundang Hospital · Sites in Korea, Republic of
Ages 18+
Konkuk University Medical Center · Sites in Korea, Republic of
Ages 19+
Eisai Korea Inc. · Sites in Korea, Republic of
Ages 18+
Gangnam Severance Hospital · Sites in Korea, Republic of
Ages 19+
A study can be open while its sites in Korea, Republic of have not opened yet or have stopped. Only those recruiting at a site in Korea, Republic of →
Of the 293 Arthritis, Rheumatoid studies recruiting now, 150 (51%) set no upper age limit and 109 (37%) stop at 75 or younger; 15 take children under 18; 36 take healthy volunteers.
This study: 19 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
188 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 21 · Phase 2 32 · Phase 3 74 · Phase 4 20
First in 2002; this study’s year is marked. 3 started in 2024.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 118 is above the median of 95 across 2,221 interventional studies indexed under Arthritis, Rheumatoid.
Median enrollment 300 across the 155 interventional studies, 425 across the 33 observational. Of the 155 that completed or were terminated, 93 (60%) have results posted.
This tab as a report to print or save as PDF → With an account.
166 of 188 have an industry lead sponsor. The 10 most frequent:
This study is registered under Eisai Korea Inc., one of the names counted as Eisai Co., Ltd.. Under that name alone:
Eisai Korea Inc. is the lead sponsor of 31 studies on the registry; 2 are open to participants now.
Eisai Co., Ltd. has 9 studies filed under Arthritis, Rheumatoid — fewer than ten, so there is no comparison to draw.
4 of the studies in Arthritis, Rheumatoid with a site in Korea, Republic of that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT03626038Zimmer BiometPost Market Clinical Follow-up (PMCF) Study of the A.L.P.S. Proximal Humerus Plating System | 2026-12 |
| NCT07675226Oscotec Inc.Bioequivalence Study of SKI-O-703 in Healthy Adults Under Fed Conditions | 2026-12-31 |
| NCT06972446AbbVieA Study to Evaluate Different Targeted Therapies for Patients With Rheumatoid Arthritis | 2027-02 |
| NCT06246123Eisai Korea Inc.A Study of Jyseleca Tablet (Filgotinib Maleate) in Korean Participants | 2027-07-30 |
Add all 4 to your calendar (.ics) → With an account.
Among the 188 studies in Arthritis, Rheumatoid with a site in Korea, Republic of, from their registry updates:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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 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 , 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:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Child-Pugh class
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Absolute neutrophil count (ANC)
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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/.
No publications or documents are linked to this record.
Ran from Oct 2024 to primary completion in Jan 2026, 14 months.
Of 25 industry-sponsored phase 4 interventional studies under Arthritis, Rheumatoid, half reached primary completion within 26 months of starting (the median); a quarter within 16 and three quarters within 44. This study's 14 months is below that.
Counting every sponsor, half of 104 studies reached it within 42 months; a quarter within 25 and three quarters within 74.
How these figures are worked out, and which studies are left out of them.
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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