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New study tracks Real-World safety of arthritis and colitis drug in korea

NCT ID NCT06246123

Disease control Sponsor: Eisai Korea Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jul 07, 2026 · Updated 2 times

Summary

This study is monitoring the safety and effectiveness of the drug Jyseleca (filgotinib) in Korean patients with rheumatoid arthritis or ulcerative colitis. Researchers will track side effects and disease activity over 24 weeks. About 2,040 participants are being observed during routine treatment.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 2,040 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2024

Expected to finish

Jul 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Korean participants who are prescribed with Jyseleca (Filgotinib Maleate) tablet 100 mg and 200 mg per the approved prescribing information will be enrolled in the study.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1\. Individuals who are being administered with Jyseleca tablet in accordance with the Korean approved label therapeutic indications. * Korean local label therapeutic indications of Jyseleca tablet. In the following participants, Jyseleca tablet should be used only if they do not respond appropriately or are intolerant to existing treatments. * Following: 1. Participants over 65 years of age. 2. Participants with a high cardiovascular risk. 3. Participants with malignancy. * Rheumatoid arthritis: 1. For treatment of moderately to severely active rheumatoid arthritis in adults who have responded inadequately to, or who are intolerant to one or more disease-modifying anti-rheumatic drugs (DMARDs). 2. Jyseleca tablet may be used as monotherapy or in combination with methotrexate (MTX). 3. Jyseleca tablet should not be used in combination with biological DMARDs (bDMARDs) or other Janus kinase (JAK) inhibitors. * Ulcerative colitis: a. For treatment of moderately to severely active ulcerative colitis in adults who have an inadequate response with, lost response to, or were intolerant to either conventional therapy (corticosteroids, immunosuppressants, etc.) or biological agents. * The investigator should refer to local label and contraindications in Korea regarding the inclusion criteria. Exclusion Criteria: 1. Individuals who fall under contraindications to the administration of Jyseleca tablet in accordance with the local label by the medical judgment of the investigator. * Contraindication for Jyseleca tablet in accordance with the Korean label: 1. Participants with hypersensitivity to the active ingredient or other ingredients of the Jyseleca tablet. 2. Participants with active infections, including serious (example, sepsis) or local infections. 3. Participants with active tuberculosis. 4. Participants with severe hepatic disorder. 5. Participants with end-stage renal disorder. 6. Participants with absolute neutrophil count (ANC) \<1\*10\^9 cells/liters (L) 7. Participants with absolute lymphocyte count (ALC) \<0.5\*10\^9 cells/L 8. Participants with hemoglobin level \<8 grams per deciliter (g/dL) 9. Pregnant or potentially pregnant women, lactating women 10. Jyseleca tablet should not be administered to participants with genetic problems such as galactose intolerance, total lactase deficiency, or glucose-galactose malabsorption as it contains lactose. 2. Individuals who are administered Filgotinib in a clinical study other than this post marketing surveillance. 3. Individuals who are considered incompatible with participate in this surveillance by the medical judgment of the investigator. * The investigator should refer to local label and contraindications in Korea regarding the exclusion criteria.

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Conditions

The condition(s) this trial relates to.

rheumatoid arthritis ulcerative colitis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Arthritis rheumatoid Colitis ulcerative

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    57 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Ajou University Medical Center

    RECRUITING

    Suwon, Gyeonggi-do, South Korea

  • Asan Medical Center

    RECRUITING

    Seoul, South Korea

  • CHA Bundang Medical Center

    RECRUITING

    Seongnam-si, Gyeonggi-do, South Korea

  • Catholic Kwandong University International St. Mary's Hospital

    RECRUITING

    Incheon, South Korea

  • Catholic University of Korea Seoul St. Mary's Hospital

    RECRUITING

    Seoul, South Korea

  • Catholic University of Korea, Daejeon ST. Mary's Hospital

    RECRUITING

    Daejeon, South Korea

  • Catholic University of Korea, Yeouido ST. Mary's Hospital

    RECRUITING

    Seoul, South Korea

  • Changwon Fatima Hospital

    WITHDRAWN

    Changwon, Gyeongsangnam-do, South Korea

  • Changwon Gyeongsang National University Hospital

    RECRUITING

    Changwon, Gyeongsangnam-do, South Korea

  • Chosun University Hospital

    RECRUITING

    Gwangju, South Korea

  • Chung-Ang University Gwangmyeong Hospital

    RECRUITING

    Gwangmyeong, Gyeonggi-do, South Korea

  • Chung-Ang University Hospital

    RECRUITING

    Seoul, South Korea

  • Chungbuk National University Hospital

    RECRUITING

    Cheongju-si, North Chungcheong, South Korea

  • Chungnam National University Hospital

    RECRUITING

    Daejeon, South Korea

  • Daegu Fatima Hospital

    RECRUITING

    Daegu, South Korea

  • Daegu Koo Hospital

    RECRUITING

    Daegu, South Korea

  • Deagu Catholic University Medical Center

    RECRUITING

    Daegu, South Korea

  • Dong-A University Hospital

    RECRUITING

    Busan, South Korea

  • Eulji University Hospital Daejeon

    RECRUITING

    Daejeon, South Korea

  • Gachon University Gil Medical Center

    RECRUITING

    Incheon, South Korea

  • Gangnam Severance Hospital

    RECRUITING

    Seoul, South Korea

  • Gyeongsang National University Hospital

    RECRUITING

    Jinju, Gyeongsangnam-do, South Korea

  • Haeundae Bumin Hospital

    RECRUITING

    Busan, South Korea

  • Hanyang University Medical Center

    RECRUITING

    Seoul, South Korea

  • HoYounKim's Clinic

    RECRUITING

    Seoul, South Korea

  • Inje University Haeundae Paik Hospital

    RECRUITING

    Busan, South Korea

  • Inje University Ilsan Paik Hospital

    RECRUITING

    Goyang-si, Gyeonggi-do, South Korea

  • Inje University Pusan Paik Hospital

    RECRUITING

    Busan, South Korea

  • Jeju National University Hospital

    RECRUITING

    Jeju City, South Korea

  • Jeonbuk National University Hospital

    RECRUITING

    Jeonju, Jeollabuk-do, South Korea

  • Jeonnam National University Hospital

    RECRUITING

    Gwangju, South Korea

  • KYUNG HEE University Hospital

    RECRUITING

    Seoul, South Korea

  • Kangbuk Samsung Hospital

    RECRUITING

    Seoul, South Korea

  • Kangwon National University Hospital

    RECRUITING

    Chuncheon, Gangwon-do, South Korea

  • Keimyung University Dongsan Hospital

    RECRUITING

    Daegu, South Korea

  • Konkuk University Medical Center

    RECRUITING

    Seoul, South Korea

  • Konyang University Hospital

    RECRUITING

    Daejeon, South Korea

  • Korea University Ansan Hospital

    RECRUITING

    Ansan, Gyeonggi-do, South Korea

  • Korea University Guro Hospital

    TERMINATED

    Seoul, South Korea

  • Kosin University Gospel Hospital

    RECRUITING

    Busan, South Korea

  • Kyung Hee University Hospital At Gangdong

    RECRUITING

    Seoul, South Korea

  • Kyungpook National University Chilgok Hospital

    RECRUITING

    Daegu, South Korea

  • Kyungpook National University Hospital

    RECRUITING

    Daegu, South Korea

  • Nowon Eulji Hospital

    RECRUITING

    Uijeongbu-si, Gyeonggi-do, South Korea

  • Pusan National University Yangsan Hospital

    RECRUITING

    Yangsan, Gyeongsangnam-do, South Korea

  • SNU Boramae Medical Center

    RECRUITING

    Seoul, South Korea

  • Samsung Medical Center

    RECRUITING

    Seoul, South Korea

  • Sejong Chungnam National University Hospital

    RECRUITING

    Sejong, South Korea

  • Seoul National University Bundang Hospital

    RECRUITING

    Seongnam-si, Gyeonggi-do, South Korea

  • Seoul National University Hospital

    RECRUITING

    Seoul, South Korea

  • Severance Hospital

    RECRUITING

    Seoul, South Korea

  • Soonchunhyang University Cheonan Hospital

    RECRUITING

    Cheonan, Chungcheongnam-do, South Korea

  • Soonchunhyang University Hospital Seoul

    RECRUITING

    Seoul, South Korea

  • The Catholic University of Korea Bucheon St. Mary's Hospital

    RECRUITING

    Bucheon-si, Gyeonggi-do, South Korea

  • The Catholic University of Korea St. Vincent's Hospital

    RECRUITING

    Suwon, Gyeonggi-do, South Korea

  • Uijeongbu Eulji Medical Center

    RECRUITING

    Uijeongbu-si, Gyeonggi-do, South Korea

  • Wonju Severance Christian Hospital

    RECRUITING

    Wŏnju, Gangwon-do, South Korea

  • Yeungnam University Medical Center

    RECRUITING

    Daegu, South Korea

  • Yongin Severance Hospital

    RECRUITING

    Yongin, Gyeonggi-do, South Korea

More trials for these conditions

Other studies related to the condition(s) this trial covers.