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RECRUITING

NCT06246123

A Study of Jyseleca Tablet (Filgotinib Maleate) in Korean Participants

Sponsor: Eisai Korea Inc.

View on ClinicalTrials.gov

Summary

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

2040

Start Date

2024-02-27

Completion Date

2027-07-30

Last Updated

2026-04-07

Healthy Volunteers

Conditions

Arthritis, Rheumatoid Colitis, Ulcerative

Interventions

OTHER

Non-interventional

No intervention will be administered.

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.

Locations (64)

Soonchunhyang University Cheonan Hospital

Cheonan, Chungcheongnam-do, South Korea

Kangwon National University Hospital

Chuncheon, Gangwon-do, South Korea

Wonju Severance Christian Hospital

Wŏnju, Gangwon-do, South Korea

Korea University Ansan Hospital

Ansan, Gyeonggi-do, South Korea

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

Bucheon-si, Gyeonggi-do, South Korea

Inje University Ilsan Paik Hospital

Goyang-si, Gyeonggi-do, South Korea

Chung-Ang University Gwangmyeong Hospital

Gwangmyeong, Gyeonggi-do, South Korea

CHA Bundang Medical Center

Seongnam-si, Gyeonggi-do, South Korea

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, South Korea

Ajou University Medical Center

Suwon, Gyeonggi-do, South Korea

The Catholic University of Korea St. Vincent's Hospital

Suwon, Gyeonggi-do, South Korea

Nowon Eulji Hospital

Uijeongbu-si, Gyeonggi-do, South Korea

Uijeongbu Eulji Medical Center

Uijeongbu-si, Gyeonggi-do, South Korea

Yongin Severance Hospital

Yongin, Gyeonggi-do, South Korea

Changwon fatima hospital

Changwon, Gyeongsangnam-do, South Korea

Changwon Gyeongsang National University Hospital

Changwon, Gyeongsangnam-do, South Korea

Gyeongsang National University Hospital

Jinju, Gyeongsangnam-do, South Korea

Pusan National University Yangsan Hospital

Yangsan, Gyeongsangnam-do, South Korea

Jeonbuk National University Hospital

Jeonju, Jeollabuk-do, South Korea

Jeonbuk National University Hospital

Jeonju, Jeollabuk-do, South Korea

Chongbuk National University Hospital

Cheongju-si, North Chungcheong, South Korea

Dong-A University Hospital

Busan, South Korea

Haeundae Bumin Hospital

Busan, South Korea

Inje University Haeundae Paik Hospital

Busan, South Korea

Inje University Pusan Paik Hospital

Busan, South Korea

Kosin University Gospel Hospital

Busan, South Korea

Daegu Fatima Hospital

Daegu, South Korea

Daegu Koo Hospital

Daegu, South Korea

Deagu Catholic University Medical Center

Daegu, South Korea

Keimyung University Dongsan Hospital

Daegu, South Korea

Keimyung University Dongsan Hospital

Daegu, South Korea

Kyungpook National University Chilgok Hospital

Daegu, South Korea

Kyungpook National University Hospital

Daegu, South Korea

Yeungnam University Medical Center

Daegu, South Korea

Yeungnam University Medical Center

Daegu, South Korea

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

Daejeon, South Korea

Chungnam National University Hospital

Daejeon, South Korea

Eulji University Hospital Daejeon

Daejeon, South Korea

Konyang University Hospital

Daejeon, South Korea

Chosun University Hospital

Gwangju, South Korea

Jeonnam National University Hospital

Gwangju, South Korea

Catholic Kwandong University International St. Mary's Hospital

Incheon, South Korea

Gachon University Gil Medical Center

Incheon, South Korea

Jeju National University Hospital

Jeju City, South Korea

Sejong Chungnam National University Hospital

Sejong, South Korea

Asan Medical Center

Seoul, South Korea

Catholic university of korea seoul st. mary's hospital

Seoul, South Korea

Catholic University of Korea, Yeouido ST. Mary�s Hospital.

Seoul, South Korea

Chung-Ang University Hospital

Seoul, South Korea

Gangnam Severance Hospital

Seoul, South Korea

Hanyang University Medical Center

Seoul, South Korea

HoYounKim's Clinic

Seoul, South Korea

Kangbuk Samsung Hospital

Seoul, South Korea

Konkuk University Medical Center

Seoul, South Korea

Konkuk University Medical Center

Seoul, South Korea

Korea University Guro Hospital

Seoul, South Korea

Kyung Hee University Hospital At Gangdong

Seoul, South Korea

Kyung Hee University Hospital

Seoul, South Korea

Samsung Medical Center

Seoul, South Korea

Seoul National University Hospital

Seoul, South Korea

Seoul St. Mary's Hospital

Seoul, South Korea

Severance Hospital

Seoul, South Korea

SNU Boramae Medical Center

Seoul, South Korea

Soonchunhyang University Hospital Seoul

Seoul, South Korea

Clinical Research Directory

A Study of Jyseleca Tablet (Filgotinib Maleate) in Korean Participants

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (64)