Actively Recruiting
A Study of Jyseleca Tablet (Filgotinib Maleate) in Korean Participants
Led by Eisai Korea Inc. · Updated on 2026-04-07
2040
Participants Needed
64
Research Sites
178 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study of Jyseleca Tablet (Filgotinib Maleate) in Korean Participants
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Individuals currently taking Jyseleca tablet according to the Korean approved therapeutic indications.
- Participants over 65 years of age, or with high cardiovascular risk, or with malignancy can be included if they meet label criteria.
- Adults with moderately to severely active rheumatoid arthritis who have not responded well or are intolerant to one or more disease-modifying anti-rheumatic drugs.
- Jyseleca may be used alone or with methotrexate in rheumatoid arthritis, but not with biological DMARDs or other JAK inhibitors.
- Adults with moderately to severely active ulcerative colitis who have inadequate response, lost response, or intolerance to conventional or biological therapies.
- Investigator must refer to local label and contraindications in Korea for inclusion.
You will not qualify if you...
- Individuals with contraindications to Jyseleca tablet as per Korean label and investigator judgment.
- Participants with hypersensitivity to Jyseleca ingredients.
- Those with active infections, including serious or local infections.
- Participants with active tuberculosis.
- Individuals with severe liver disorder or end-stage renal disorder.
- Those with absolute neutrophil count less than 1x10^9 cells/L.
- Those with absolute lymphocyte count less than 0.5x10^9 cells/L.
- Participants with hemoglobin less than 8 g/dL.
- Pregnant, potentially pregnant, or lactating women.
- Individuals with genetic disorders like galactose intolerance, total lactase deficiency, or glucose-galactose malabsorption.
- Participants enrolled in other clinical studies using Filgotinib.
- Individuals considered unsuitable by investigator judgment.
- Investigator should refer to local label and contraindications in Korea for exclusion.
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 64 locations
1
Soonchunhyang University Cheonan Hospital
Cheonan, Chungcheongnam-do, South Korea
Actively Recruiting
2
Kangwon National University Hospital
Chuncheon, Gangwon-do, South Korea
Actively Recruiting
3
Wonju Severance Christian Hospital
Wŏnju, Gangwon-do, South Korea
Actively Recruiting
4
Korea University Ansan Hospital
Ansan, Gyeonggi-do, South Korea
Actively Recruiting
5
The Catholic University of Korea Bucheon St. Mary's Hospital
Bucheon-si, Gyeonggi-do, South Korea
Actively Recruiting
6
Inje University Ilsan Paik Hospital
Goyang-si, Gyeonggi-do, South Korea
Actively Recruiting
7
Chung-Ang University Gwangmyeong Hospital
Gwangmyeong, Gyeonggi-do, South Korea
Actively Recruiting
8
CHA Bundang Medical Center
Seongnam-si, Gyeonggi-do, South Korea
Actively Recruiting
9
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, South Korea
Actively Recruiting
10
Ajou University Medical Center
Suwon, Gyeonggi-do, South Korea
Actively Recruiting
11
The Catholic University of Korea St. Vincent's Hospital
Suwon, Gyeonggi-do, South Korea
Actively Recruiting
12
Nowon Eulji Hospital
Uijeongbu-si, Gyeonggi-do, South Korea
Actively Recruiting
13
Uijeongbu Eulji Medical Center
Uijeongbu-si, Gyeonggi-do, South Korea
Actively Recruiting
14
Yongin Severance Hospital
Yongin, Gyeonggi-do, South Korea
Actively Recruiting
15
Changwon fatima hospital
Changwon, Gyeongsangnam-do, South Korea
Withdrawn
16
Changwon Gyeongsang National University Hospital
Changwon, Gyeongsangnam-do, South Korea
Actively Recruiting
17
Gyeongsang National University Hospital
Jinju, Gyeongsangnam-do, South Korea
Actively Recruiting
18
Pusan National University Yangsan Hospital
Yangsan, Gyeongsangnam-do, South Korea
Actively Recruiting
19
Jeonbuk National University Hospital
Jeonju, Jeollabuk-do, South Korea
Actively Recruiting
20
Jeonbuk National University Hospital
Jeonju, Jeollabuk-do, South Korea
Withdrawn
21
Chongbuk National University Hospital
Cheongju-si, North Chungcheong, South Korea
Actively Recruiting
22
Dong-A University Hospital
Busan, South Korea
Actively Recruiting
23
Haeundae Bumin Hospital
Busan, South Korea
Actively Recruiting
24
Inje University Haeundae Paik Hospital
Busan, South Korea
Actively Recruiting
25
Inje University Pusan Paik Hospital
Busan, South Korea
Actively Recruiting
26
Kosin University Gospel Hospital
Busan, South Korea
Actively Recruiting
27
Daegu Fatima Hospital
Daegu, South Korea
Actively Recruiting
28
Daegu Koo Hospital
Daegu, South Korea
Actively Recruiting
29
Deagu Catholic University Medical Center
Daegu, South Korea
Actively Recruiting
30
Keimyung University Dongsan Hospital
Daegu, South Korea
Withdrawn
31
Keimyung University Dongsan Hospital
Daegu, South Korea
Actively Recruiting
32
Kyungpook National University Chilgok Hospital
Daegu, South Korea
Actively Recruiting
33
Kyungpook National University Hospital
Daegu, South Korea
Actively Recruiting
34
Yeungnam University Medical Center
Daegu, South Korea
Actively Recruiting
35
Yeungnam University Medical Center
Daegu, South Korea
Withdrawn
36
Catholic University of Korea, Daejeon ST. Mary's Hospital
Daejeon, South Korea
Actively Recruiting
37
Chungnam National University Hospital
Daejeon, South Korea
Actively Recruiting
38
Eulji University Hospital Daejeon
Daejeon, South Korea
Actively Recruiting
39
Konyang University Hospital
Daejeon, South Korea
Actively Recruiting
40
Chosun University Hospital
Gwangju, South Korea
Actively Recruiting
41
Jeonnam National University Hospital
Gwangju, South Korea
Actively Recruiting
42
Catholic Kwandong University International St. Mary's Hospital
Incheon, South Korea
Actively Recruiting
43
Gachon University Gil Medical Center
Incheon, South Korea
Actively Recruiting
44
Jeju National University Hospital
Jeju City, South Korea
Actively Recruiting
45
Sejong Chungnam National University Hospital
Sejong, South Korea
Actively Recruiting
46
Asan Medical Center
Seoul, South Korea
Actively Recruiting
47
Catholic university of korea seoul st. mary's hospital
Seoul, South Korea
Actively Recruiting
48
Catholic University of Korea, Yeouido ST. Mary�s Hospital.
Seoul, South Korea
Actively Recruiting
49
Chung-Ang University Hospital
Seoul, South Korea
Actively Recruiting
50
Gangnam Severance Hospital
Seoul, South Korea
Actively Recruiting
51
Hanyang University Medical Center
Seoul, South Korea
Actively Recruiting
52
HoYounKim's Clinic
Seoul, South Korea
Actively Recruiting
53
Kangbuk Samsung Hospital
Seoul, South Korea
Actively Recruiting
54
Konkuk University Medical Center
Seoul, South Korea
Actively Recruiting
55
Konkuk University Medical Center
Seoul, South Korea
Withdrawn
56
Korea University Guro Hospital
Seoul, South Korea
Terminated
57
Kyung Hee University Hospital At Gangdong
Seoul, South Korea
Actively Recruiting
58
Kyung Hee University Hospital
Seoul, South Korea
Actively Recruiting
59
Samsung Medical Center
Seoul, South Korea
Actively Recruiting
60
Seoul National University Hospital
Seoul, South Korea
Actively Recruiting
61
Seoul St. Mary's Hospital
Seoul, South Korea
Actively Recruiting
62
Severance Hospital
Seoul, South Korea
Actively Recruiting
63
SNU Boramae Medical Center
Seoul, South Korea
Actively Recruiting
64
Soonchunhyang University Hospital Seoul
Seoul, South Korea
Actively Recruiting
Research Team
S
Serena SoYoun Kwon
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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