Actively Recruiting
Post Marketing Surveillance of Jyseleca Tablet (Filgotinib Maleate) in Korean Adults with Rheumatoid Arthritis and Ulcerative Colitis
Led by Eisai Korea Inc. · Updated on 2026-05-22
2040
Participants Needed
65
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are observing Korean adults prescribed Jyseleca tablets (Filgotinib Maleate) to evaluate the safety and effectiveness of 100 mg and 200 mg doses in real-world use. This study focuses on tracking serious and non-serious adverse events and drug reactions, including any unexpected occurrences, under typical treatment conditions in Korea. It also measures the impact of treatment on disease activity for rheumatoid arthritis and ulcerative colitis using specific scoring systems. Participants prescribed Jyseleca according to approved Korean guidelines will be monitored for up to 24 weeks or until they stop treatment due to side effects or other reasons. The study is non-interventional, meaning no experimental treatments are given; instead, patients receive their usual medication as prescribed. Data collection includes monitoring adverse events and changes in disease activity scores at baseline, 12 weeks, and 24 weeks. During the study, participants will be observed without additional intervention. Researchers will assess safety by counting the number of participants experiencing various types of adverse events and drug reactions. Effectiveness will be evaluated by changes in disease activity scores over time. The total observation period lasts up to 24 weeks, during which patients' health and treatment responses are tracked according to routine clinical care.
CONDITIONS
Brief Title
A Study of Jyseleca Tablet (Filgotinib Maleate) in Korean Participants
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- Currently prescribed Jyseleca tablet according to the Korean approved label for rheumatoid arthritis or ulcerative colitis
- For rheumatoid arthritis: moderately to severely active disease with inadequate response or intolerance to one or more disease-modifying anti-rheumatic drugs
- Jyseleca may be used alone or with methotrexate but not with biological DMARDs or other JAK inhibitors
- For ulcerative colitis: moderately to severely active disease with inadequate response, loss of response, or intolerance to conventional therapy or biological agents
- Jyseleca use in patients over 65 years, with high cardiovascular risk, or malignancy only if no appropriate response or intolerance to existing treatments
- Must follow local Korean label and contraindications
You will not qualify if you...
- Known hypersensitivity to Jyseleca or its ingredients
- Active infections including serious infections or sepsis
- Active tuberculosis
- Severe liver disorder
- End-stage kidney disease
- Absolute neutrophil count less than 1 x 10^9 cells/L
- Absolute lymphocyte count less than 0.5 x 10^9 cells/L
- Hemoglobin level less than 8 g/dL
- Pregnant or breastfeeding women
- Genetic conditions like galactose intolerance, total lactase deficiency, or glucose-galactose malabsorption prohibiting Jyseleca use
- Participation in other clinical studies involving Filgotinib
- Judged unsuitable for participation by the investigator due to other medical reasons
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 24 weeks or until discontinuation of treatment due to adverse events or other reasons
Participants who are prescribed Jyseleca tablet according to the approved label are observed in the post marketing setting.
Visits at Baseline, Week 12, and Week 24
Trial Site Locations
Total: 65 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
Withdrawn
60
Samsung Medical Center
Seoul, South Korea
Actively Recruiting
61
Seoul National University Hospital
Seoul, South Korea
Actively Recruiting
62
Seoul St. Mary's Hospital
Seoul, South Korea
Actively Recruiting
63
Severance Hospital
Seoul, South Korea
Actively Recruiting
64
SNU Boramae Medical Center
Seoul, South Korea
Actively Recruiting
65
Soonchunhyang University Hospital Seoul
Seoul, South Korea
Actively Recruiting
Research Team
S
Serena SoYoun Kwon
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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