RecruitingNCT06246123

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

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

Sponsor

Eisai Korea Inc.

Enrollment

2,040 participants

Start Date

Feb 27, 2024

Study Type

OBSERVATIONAL

Conditions

Arthritis, Rheumatoid

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This is a post-marketing observational study — meaning it collects real-world data on patients already prescribed filgotinib (brand name Jyseleca) in South Korea. Filgotinib is a JAK inhibitor, a type of oral medication that reduces inflammation. This study tracks how the drug is used and how patients respond in everyday clinical practice. **You may be eligible if...** - You are a Korean patient already prescribed Jyseleca (filgotinib) by your doctor according to its approved indications - You have moderate to severe rheumatoid arthritis that has not responded to other disease-modifying drugs, OR - You have moderately to severely active ulcerative colitis that has not responded to other treatments - You are in one of the special monitoring groups: over 65, have cardiovascular risk factors, or have a history of cancer **You may NOT be eligible if...** - You are not being prescribed filgotinib as part of your routine care - You are participating in another interventional clinical trial - You have a known hypersensitivity to filgotinib - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERNon-interventional

No intervention will be administered.

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

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