Under construction – not a live service
Sign in
Taking people in South KoreaNo phase

Observes safety of filgotinib in Korean adults with arthritis or colitis

Watches filgotinib use in adults with rheumatoid arthritis or ulcerative colitis.

Plain-language title generated from the registry record
Registry title: A Study of Jyseleca Tablet (Filgotinib Maleate) in Korean Participants

Key facts

Where
Ansan, Bucheon-si, Busan, Changwon, Cheonan, Cheongju-si, Chuncheon, Daegu, Daejeon, Goyang-si, Gwangju, Gwangmyeong, Incheon, Jeju City, Jeonju, Jinju, Sejong, Seongnam-si, Seoul, Suwon, Uijeongbu-si, Wŏnju, Yangsan, and Yŏngin, South KoreaSee the 59 sites

Where in South Korea

  • Korea University Ansan HospitalAnsan, South KoreaTaking people
  • The Catholic University of Korea, Bucheon St. Mary's HospitalBucheon-si, South KoreaTaking people
  • Dong-A University HospitalBusan, South KoreaTaking people
  • Haeundae Bumin HospitalBusan, South KoreaTaking people
  • Inje University Haeundae Paik HospitalBusan, South KoreaTaking people
  • Inje university Pusan Paik hospitalBusan, South KoreaTaking people
  • Kosin University Gospel HospitalBusan, South KoreaTaking people
  • Changwon Gyeongsang National University HospitalChangwon, South KoreaTaking people
  • Changwon Fatima HospitalChangwon, South KoreaNo longer taking part
  • Soonchunhyang University Cheonan HospitalCheonan, South KoreaTaking people
  • Chungbuk National University HospitalCheongju-si, South KoreaTaking people
  • Kangwon National University HospitalChuncheon, South KoreaTaking people
  • Daegu Fatima HospitalDaegu, South KoreaTaking people
  • Daegu Koo HospitalDaegu, South KoreaTaking people
  • Deagu Catholic University Medical CenterDaegu, South KoreaTaking people
  • Keimyung University Dongsan HospitalDaegu, South KoreaTaking people
  • Kyungpook National University Chilgok HospitalDaegu, South KoreaTaking people
  • Kyungpook National University HospitalDaegu, South KoreaTaking people
  • Yeungnam University Medical CenterDaegu, South KoreaTaking people
  • Catholic University of Korea Daejeon St. Mary's HospitalDaejeon, South KoreaTaking people
  • Chungnam National University HospitalDaejeon, South KoreaTaking people
  • Eulji University Hospital, DaejeonDaejeon, South KoreaTaking people
  • Konyang University HospitalDaejeon, South KoreaTaking people
  • Inje University Ilsan Paik HospitalGoyang-si, South KoreaTaking people
  • Chosun University HospitalGwangju, South KoreaTaking people
  • Jeonnam National University HospitalGwangju, South KoreaTaking people
  • Chung-Ang University Gwangmyeong HospitalGwangmyeong, South KoreaTaking people
  • Catholic Kwandong University International St.Mary's HospitalIncheon, South KoreaTaking people
  • Gachon University Gil Medical CenterIncheon, South KoreaTaking people
  • Jeju National University HospitalJeju City, South KoreaTaking people
  • jeonbuk National University HospitalJeonju, South KoreaTaking people
  • Gyeongsang National University HospitalJinju, South KoreaTaking people
  • Sejong Chungnam National University HospitalSejong, South KoreaTaking people
  • CHA Bundang Medical CenterSeongnam-si, South KoreaTaking people
  • Seoul National University Bundang HospitalSeongnam-si, South KoreaTaking people
  • Asan Medical CenterSeoul, South KoreaTaking people
  • Catholic University of Korea Seoul ST. Mary's HospitalSeoul, South KoreaTaking people
  • Catholic University of Korea Yeouido St. Mary's HospitalSeoul, South KoreaTaking people
  • Chung ang University HospitalSeoul, South KoreaTaking people
  • Gangnam Severance HospitalSeoul, South KoreaTaking people
  • Hanyang University Medical CenterSeoul, South KoreaTaking people
  • HoYounKim's ClinicSeoul, South KoreaTaking people
  • Kangbuk Samsung HospitalSeoul, South KoreaTaking people
  • Konkuk University Medical CenterSeoul, South KoreaTaking people
  • Kyung Hee University HospitalSeoul, South KoreaTaking people
  • Kyung Hee University Hospital at GangdongSeoul, South KoreaTaking people
  • Samsung Medical CenterSeoul, South KoreaTaking people
  • Seoul National University HospitalSeoul, South KoreaTaking people
  • Severance hospitalSeoul, South KoreaTaking people
  • SNU Boramae Medical CenterSeoul, South KoreaTaking people
  • SoonChunHyang University Hospital SeoulSeoul, South KoreaTaking people
  • Korea University Guro HospitalSeoul, South KoreaNo longer taking part
  • Ajou University Medical CenterSuwon, South KoreaTaking people
  • The Catholic University of Korea St. Vincent's HospitalSuwon, South KoreaTaking people
  • Nowon Eulji HospitalUijeongbu-si, South KoreaTaking people
  • Uijeongbu Eulji Medical CenterUijeongbu-si, South KoreaTaking people
  • Wonju Severance Christian HospitalWŏnju, South KoreaTaking people
  • Pusan National University Yangsan HospitalYangsan, South KoreaTaking people
  • Yongin Severance HospitalYŏngin, South KoreaTaking people

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?
Print a page for my doctor

Trial details

Who runs it
Eisai Korea Inc.
Trial code
NCT06246123
Record updated
6 July 2026
Original description
The purpose of this study is to collect and evaluate the following information in relation to the safety and the efficacy of Jyseleca tablet (Filgotinib Maleate) 100 milligram (mg) and 200 mg in this post marketing setting: (1) Serious adverse events and adverse drug reactions (2) Unexpected adverse events and adverse drug reactions not reflected in precautions for use (3) Known adverse drug reactions (4) Non-serious adverse events and adverse drug reactions (5) Other safety and effectiveness related information will be evaluated in accordance with the permitted articles under the actual conditions of use in Korea.Read full original descriptionShow less

Post Marketing Surveillance of Jyseleca Tab. (Filgotinib Maleate) in Korean Subjects

The purpose of this study is to collect and evaluate the following information in relation to the safety and the efficacy of Jyseleca tablet (Filgotinib Maleate) 100 milligram (mg) and 200 mg in this post marketing setting: (1) Serious adverse events and adverse drug reactions (2) Unexpected adverse events and adverse drug reactions not reflected in precautions for use (3) Known adverse drug reactions (4) Non-serious adverse events and adverse drug reactions (5) Other safety and effectiveness related information will be evaluated in accordance with the permitted articles under the actual conditions of use in Korea.

Inclusion: 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:; Participants over 65 years of age; Participants with a high cardiovascular risk; Participants with malignancy; Rheumatoid arthritis:; 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); Jyseleca tablet may be used as monotherapy or in combination with methotrexate (MTX); Jyseleca tablet should not be used in combination with biological DMARDs (bDMARDs) or other Janus kinase (JAK) inhibitors; Ulcerative colitis:; 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: 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:; Participants with hypersensitivity to the active ingredient or other ingredients of the Jyseleca tablet; Participants with active infections, including serious (example, sepsis) or local infections; Participants with active tuberculosis; Participants with severe hepatic disorder; Participants with end-stage renal disorder; Participants with absolute neutrophil count (ANC) <1*10\^9 cells/liters (L); Participants with absolute lymphocyte count (ALC) <0.5*10\^9 cells/L; Participants with hemoglobin level <8 grams per deciliter (g/dL); Pregnant or potentially pregnant women, lactating women; 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; Individuals who are administered Filgotinib in a clinical study other than this post marketing surveillance; 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.

ClinicalTrials.gov NCT06246123