UCRecruiting

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

Observational · No treatment assigned · 59 sites · Eisai Korea Inc.

Official record & contacts on ClinicalTrials.gov ↗

In plain English

What this trial is testing

Condition(s) listed: Arthritis, Rheumatoid and Colitis, Ulcerative. This is an observational study: researchers collect information (for example questionnaires, samples, or scans) but the study does not assign a treatment.

Who can join

Ages 18 and older
Any sex

Some of the main requirements, copied from the record:

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:

Plus 10 more requirement(s). There are also 15 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.

What's involved

About 2040 participants are expected to take part.
Start date: 2024-02-27.
Main results expected around 2027-07-30 (estimate from the record).
59 study sites listed (57 marked recruiting) in South Korea.

Main thing being measured

Number of Participants With Serious Adverse Events (SAEs) (From the date of enrollment up to 24 weeks)

In the researchers’ words

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)…

This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.

Questions to ask your doctor and the trial team

Am I likely to qualify, given my health history?
What would I have to do, and how often would I need to visit?
Could I get a placebo? What happens to my current treatment?
What are the possible risks and benefits?
Are travel or other costs covered?
What happens after the trial ends?

Official details

Status	Recruiting
Phase	Observational
Study type	Observational
Conditions	Arthritis, Rheumatoid; Colitis, Ulcerative
Lead sponsor	Eisai Korea Inc.
Enrollment	2040 (estimated)
Start date	2024-02-27
Primary completion (est.)	2027-07-30
First posted	2024-02-07
Last updated	2026-07-06
Official title	Post Marketing Surveillance of Jyseleca Tab. (Filgotinib Maleate) in Korean Subjects
ClinicalTrials.gov ID	NCT06246123

Interventions

Non-interventional (Other)
No intervention will be administered.

Full eligibility criteria (from the record)

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 (59)

Show all 59 sites

Site	City	Country	Site status
Dong-A University Hospital	Busan	South Korea	Recruiting
Haeundae Bumin Hospital	Busan	South Korea	Recruiting
Inje University Haeundae Paik Hospital	Busan	South Korea	Recruiting
Inje University Pusan Paik Hospital	Busan	South Korea	Recruiting
Kosin University Gospel Hospital	Busan	South Korea	Recruiting
Daegu Fatima Hospital	Daegu	South Korea	Recruiting
Daegu Koo Hospital	Daegu	South Korea	Recruiting
Deagu Catholic University Medical Center	Daegu	South Korea	Recruiting
Keimyung University Dongsan Hospital	Daegu	South Korea	Recruiting
Kyungpook National University Chilgok Hospital	Daegu	South Korea	Recruiting
Kyungpook National University Hospital	Daegu	South Korea	Recruiting
Yeungnam University Medical Center	Daegu	South Korea	Recruiting
Catholic University of Korea, Daejeon ST. Mary's Hospital	Daejeon	South Korea	Recruiting
Chungnam National University Hospital	Daejeon	South Korea	Recruiting
Eulji University Hospital Daejeon	Daejeon	South Korea	Recruiting
Konyang University Hospital	Daejeon	South Korea	Recruiting
Chosun University Hospital	Gwangju	South Korea	Recruiting
Jeonnam National University Hospital	Gwangju	South Korea	Recruiting
Catholic Kwandong University International St. Mary's Hospital	Incheon	South Korea	Recruiting
Gachon University Gil Medical Center	Incheon	South Korea	Recruiting
Jeju National University Hospital	Jeju City	South Korea	Recruiting
Sejong Chungnam National University Hospital	Sejong	South Korea	Recruiting
Asan Medical Center	Seoul	South Korea	Recruiting
Catholic University of Korea Seoul St. Mary's Hospital	Seoul	South Korea	Recruiting
Catholic University of Korea, Yeouido ST. Mary's Hospital	Seoul	South Korea	Recruiting
Chung-Ang University Hospital	Seoul	South Korea	Recruiting
Gangnam Severance Hospital	Seoul	South Korea	Recruiting
Hanyang University Medical Center	Seoul	South Korea	Recruiting
HoYounKim's Clinic	Seoul	South Korea	Recruiting
Kangbuk Samsung Hospital	Seoul	South Korea	Recruiting
Konkuk University Medical Center	Seoul	South Korea	Recruiting
Korea University Guro Hospital	Seoul	South Korea	Terminated
Kyung Hee University Hospital At Gangdong	Seoul	South Korea	Recruiting
KYUNG HEE University Hospital	Seoul	South Korea	Recruiting
Samsung Medical Center	Seoul	South Korea	Recruiting
Seoul National University Hospital	Seoul	South Korea	Recruiting
Severance Hospital	Seoul	South Korea	Recruiting
SNU Boramae Medical Center	Seoul	South Korea	Recruiting
Soonchunhyang University Hospital Seoul	Seoul	South Korea	Recruiting
Soonchunhyang University Cheonan Hospital	Cheonan, Chungcheongnam-do	South Korea	Recruiting
Kangwon National University Hospital	Chuncheon, Gangwon-do	South Korea	Recruiting
Wonju Severance Christian Hospital	Wŏnju, Gangwon-do	South Korea	Recruiting
Korea University Ansan Hospital	Ansan, Gyeonggi-do	South Korea	Recruiting
The Catholic University of Korea Bucheon St. Mary's Hospital	Bucheon-si, Gyeonggi-do	South Korea	Recruiting
Inje University Ilsan Paik Hospital	Goyang-si, Gyeonggi-do	South Korea	Recruiting
Chung-Ang University Gwangmyeong Hospital	Gwangmyeong, Gyeonggi-do	South Korea	Recruiting
CHA Bundang Medical Center	Seongnam-si, Gyeonggi-do	South Korea	Recruiting
Seoul National University Bundang Hospital	Seongnam-si, Gyeonggi-do	South Korea	Recruiting
Ajou University Medical Center	Suwon, Gyeonggi-do	South Korea	Recruiting
The Catholic University of Korea St. Vincent's Hospital	Suwon, Gyeonggi-do	South Korea	Recruiting
Nowon Eulji Hospital	Uijeongbu-si, Gyeonggi-do	South Korea	Recruiting
Uijeongbu Eulji Medical Center	Uijeongbu-si, Gyeonggi-do	South Korea	Recruiting
Yongin Severance Hospital	Yongin, Gyeonggi-do	South Korea	Recruiting
Changwon Fatima Hospital	Changwon, Gyeongsangnam-do	South Korea	Withdrawn
Changwon Gyeongsang National University Hospital	Changwon, Gyeongsangnam-do	South Korea	Recruiting
Gyeongsang National University Hospital	Jinju, Gyeongsangnam-do	South Korea	Recruiting
Pusan National University Yangsan Hospital	Yangsan, Gyeongsangnam-do	South Korea	Recruiting
Jeonbuk National University Hospital	Jeonju, Jeollabuk-do	South Korea	Recruiting
Chungbuk National University Hospital	Cheongju-si, North Chungcheong	South Korea	Recruiting

For contacts at each site, use the official record.

Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.