Arthritis, RheumatoidNCT06246123
A Study of Jyseleca Tablet (Filgotinib Maleate) in Korean Participants
An observational study of Arthritis, Rheumatoid and Colitis, Ulcerative, run by Eisai Korea Inc. at 59 sites in South Korea.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arthritis, Rheumatoid, Colitis, Ulcerative
- What is being tested?
- Non-interventional
- Type of treatment
- Pill or oral medicine
- How many people
- 2,040 participants
- Where
- 59 sitesSouth Korea
- Study dates
- 27 Feb 2024to 30 Jul 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Korean participants who are prescribed with Jyseleca (Filgotinib Maleate) tablet 100 mg and 200 mg per the approved prescribing information will be enrolled in the study.
Who may be able to join
- 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:
- Participants over 65 years of age.
- Participants with a high cardiovascular risk.
- Participants with malignancy.
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- Rheumatoid arthritis:
- 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).
- Jyseleca tablet may be used as monotherapy or in combination with methotrexate (MTX).
- Jyseleca tablet should not be used in combination with biological DMARDs (bDMARDs) or other Janus kinase (JAK) inhibitors.
- Ulcerative colitis:
- 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.
Who cannot join
- 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:
- Participants with hypersensitivity to the active ingredient or other ingredients of the Jyseleca tablet.
- Participants with active infections, including serious (example, sepsis) or local infections.
- Participants with active tuberculosis.
- Participants with severe hepatic disorder.
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- Participants with end-stage renal disorder.
- Participants with absolute neutrophil count (ANC) <1*10^9 cells/liters (L)
- Participants with absolute lymphocyte count (ALC) <0.5*10^9 cells/L
- Participants with hemoglobin level <8 grams per deciliter (g/dL)
- Pregnant or potentially pregnant women, lactating women
- 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.
- Individuals who are administered Filgotinib in a clinical study other than this post marketing surveillance.
- 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.
Trial locations and contacts
59 sites in 1 country. Contact the study team or a site near you to ask about taking part.
59 sites in 1 country
South Korea59 sites, 57 recruiting
- Recruiting
Korea University Ansan Hospital
Ansan, Gyeonggi-do
- Recruiting
The Catholic University of Korea Bucheon St. Mary's Hospital
Bucheon-si, Gyeonggi-do
- Recruiting
Dong-A University Hospital
Busan
- Recruiting
Haeundae Bumin Hospital
Busan
- Recruiting
Inje University Haeundae Paik Hospital
Busan
- Recruiting
Inje University Pusan Paik Hospital
Busan
- Recruiting
Kosin University Gospel Hospital
Busan
- Withdrawn
Changwon Fatima Hospital
Changwon, Gyeongsangnam-do
- Recruiting
Changwon Gyeongsang National University Hospital
Changwon, Gyeongsangnam-do
- Recruiting
Soonchunhyang University Cheonan Hospital
Cheonan, Chungcheongnam-do
- Recruiting
Chungbuk National University Hospital
Cheongju-si, North Chungcheong
- Recruiting
Kangwon National University Hospital
Chuncheon, Gangwon-do
- Recruiting
Daegu Fatima Hospital
Daegu
- Recruiting
Daegu Koo Hospital
Daegu
- Recruiting
Deagu Catholic University Medical Center
Daegu
- Recruiting
Keimyung University Dongsan Hospital
Daegu
- Recruiting
Kyungpook National University Chilgok Hospital
Daegu
- Recruiting
Kyungpook National University Hospital
Daegu
- Recruiting
Yeungnam University Medical Center
Daegu
- Recruiting
Catholic University of Korea, Daejeon ST. Mary's Hospital
Daejeon
- Recruiting
Chungnam National University Hospital
Daejeon
- Recruiting
Eulji University Hospital Daejeon
Daejeon
- Recruiting
Konyang University Hospital
Daejeon
- Recruiting
Inje University Ilsan Paik Hospital
Goyang-si, Gyeonggi-do
- Recruiting
Chosun University Hospital
Gwangju
- Recruiting
Jeonnam National University Hospital
Gwangju
- Recruiting
Chung-Ang University Gwangmyeong Hospital
Gwangmyeong, Gyeonggi-do
- Recruiting
Catholic Kwandong University International St. Mary's Hospital
Incheon
- Recruiting
Gachon University Gil Medical Center
Incheon
- Recruiting
Jeju National University Hospital
Jeju City
- Recruiting
Jeonbuk National University Hospital
Jeonju, Jeollabuk-do
- Recruiting
Gyeongsang National University Hospital
Jinju, Gyeongsangnam-do
- Recruiting
Sejong Chungnam National University Hospital
Sejong
- Recruiting
CHA Bundang Medical Center
Seongnam-si, Gyeonggi-do
- Recruiting
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do
- Recruiting
Asan Medical Center
Seoul
- Recruiting
Catholic University of Korea Seoul St. Mary's Hospital
Seoul
- Recruiting
Catholic University of Korea, Yeouido ST. Mary's Hospital
Seoul
- Recruiting
Chung-Ang University Hospital
Seoul
- Recruiting
Gangnam Severance Hospital
Seoul
- Recruiting
Hanyang University Medical Center
Seoul
- Recruiting
HoYounKim's Clinic
Seoul
- Recruiting
Kangbuk Samsung Hospital
Seoul
- Recruiting
Konkuk University Medical Center
Seoul
- Terminated
Korea University Guro Hospital
Seoul
- Recruiting
Kyung Hee University Hospital At Gangdong
Seoul
- Recruiting
KYUNG HEE University Hospital
Seoul
- Recruiting
Samsung Medical Center
Seoul
- Recruiting
Seoul National University Hospital
Seoul
- Recruiting
Severance Hospital
Seoul
- Recruiting
SNU Boramae Medical Center
Seoul
- Recruiting
Soonchunhyang University Hospital Seoul
Seoul
- Recruiting
Ajou University Medical Center
Suwon, Gyeonggi-do
- Recruiting
The Catholic University of Korea St. Vincent's Hospital
Suwon, Gyeonggi-do
- Recruiting
Nowon Eulji Hospital
Uijeongbu-si, Gyeonggi-do
- Recruiting
Uijeongbu Eulji Medical Center
Uijeongbu-si, Gyeonggi-do
- Recruiting
Wonju Severance Christian Hospital
Wŏnju, Gangwon-do
- Recruiting
Pusan National University Yangsan Hospital
Yangsan, Gyeongsangnam-do
- Recruiting
Yongin Severance Hospital
Yongin, Gyeonggi-do
About this study
Official title: Post Marketing Surveillance of Jyseleca Tab. (Filgotinib Maleate) in Korean Subjects
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
- Arthritis, Rheumatoid, Colitis, Ulcerative
- Being tested
- Non-interventional
- Keywords
- Filgotinib Maleate, Rheumatoid arthritis, Ulcerative colitis, FIL-M082-501
- Medical subject headings
- Arthritis, Rheumatoid, Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-interventionalOther
No intervention will be administered.
| Study group | Role | What they receive |
|---|---|---|
| All Participants | Korean participants who are prescribed with Jyseleca (Filgotinib Maleate) tablet 100 mg and 200 mg per approved prescribing information of Filgotinib Maleate in the post marketing setting will be enrolled and observed for up to 24 weeks or until discontinuation of treatment due to AEs or any other reason, whichever occurs first. Receives: Other: Non-interventional |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Serious Adverse Events (SAEs)
A SAE is defined as any undesirable medical occurrence: resulting in death; life threatening; requiring hospitalization or extension of hospitalization; resulting in persistent or significant disability or functional impairment; resulting in congenital malformation or abnormality or other medically significant events than above mentioned criteria.
Measured: From the date of enrollment up to 24 weeks
Number of Participants With Adverse Drug Reactions (ADRs)
An ADR is defined as harmful and unintended reaction to the proper administration/use of drugs, in which a causal relationship with the drug in question cannot be ruled out. Adverse events (AEs) with unknown causality to the drug among those voluntarily reported will be also considered ADRs.
Measured: From the date of enrollment up to 24 weeks
Number of Participants With Unexpected AEs
An unexpected AE is an AE with a difference in nature, severity, specificity, or outcome, which have not been mentioned in the product licensure/safety notification of the drug.
Measured: From the date of enrollment up to 24 weeks
Number of Participants With Unexpected ADRs
Unexpected ADR is also an unexpected AE, where unexpected AE is an AE with a difference in nature, severity, specificity, or outcome, which have not been mentioned in the product licensure/safety notification of the drug.
Measured: From the date of enrollment up to 24 weeks
Number of Participants With Known ADRs
Known AEs are those listed in product licensure/notification of the drug and are also considered as known ADRs.
Measured: From the date of enrollment up to 24 weeks
Number of Participants With Non-serious AEs
Non-serious AEs are other than SAE among AEs. An AE is defined as any undesirable and unintended signs (example, abnormalities in laboratory test) or symptoms/diseases occurring during administration/use of drugs, which do not need causal relationship with relevant study drug.
Measured: From the date of enrollment up to 24 weeks
Number of Participants With Non-serious ADRs
Non-serious ADRs are other than SAE among ADR. An ADR is defined as harmful and unintended reaction to the proper administration/use of drugs, in which a causal relationship with the drug in question cannot be ruled out.
Measured: From the date of enrollment up to 24 weeks
Change From Baseline in Disease Activity Score 28 Based on C-Reactive Protein (DAS28-CRP) at Week 12 and Week 24
The DAS28 index for rheumatoid arthritis participants was a composite score of weighted components including tender joint counts of 28, swollen joint counts of 28, participant global assessment of disease activity score, and CRP value. A DAS28-CRP score of 5.1 or above =high disease activity, a value between greater than (>) 3.2 and 5.1 =moderate disease activity and value between 2.6 and 3.2 =low disease activity, value less than (<) 2.6 =disease remission.
Measured: Baseline, Week 12 and Week 24
Change From Baseline in the Mayo Clinic Score (MCS) at Week 12 and Week 24
The Mayo Clinic Score for ulcerative colitis participants is comprised of 4 parts: stool frequency, rectal bleeding, endoscopic findings, and physician's global assessment, each scored from 0 to 3, where 0=normal, 3=severe. The total score ranges from 0 to 12, with higher scores indicating increased severity of disease.
Measured: Baseline, Week 12 and Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2024
- Study start27 Feb 2024
- Primary completion30 Jul 2027 (estimated)
- Study completion30 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arthritis, RheumatoidStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,040 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eisai Korea Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06246123
- Sponsor's protocol ID
- FIL-M082-501
- Status last verified
- Mar 2026
- First submitted
- 30 Jan 2024
- Last updated
- 6 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Eisai's data sharing commitment and further information on how to request data can be found on our website http://eisaiclinicaltrials.com/.
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post Marketing Surveillance of Jyseleca Tab. (Filgotinib Maleate) in Korean Subjects
- ClinicalTrials.gov ID
- NCT06246123
- Acronym / sponsor ID
- FIL-M082-501
- Conditions
- Arthritis, Rheumatoid, Colitis, Ulcerative
- Keywords
- Filgotinib Maleate, Rheumatoid arthritis, Ulcerative colitis, FIL-M082-501
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,040 participants (estimated)
- Lead sponsor
- Eisai Korea Inc.Industry (pharma, biotech, devices)
- Study start
- 27 Feb 2024 (actual)
- Primary completion
- 30 Jul 2027 (estimated)
- Study completion
- 30 Jul 2027 (estimated)
- First posted
- 7 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All Participants | – | Other: Non-interventionalKorean participants who are prescribed with Jyseleca (Filgotinib Maleate) tablet 100 mg and 200 mg per approved prescribing information of Filgotinib Maleate in the post marketing setting will be enrolled and observed for up to 24 weeks or until discontinuation of treatment due to AEs or any other reason, whichever occurs first. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Korean participants who are prescribed with Jyseleca (Filgotinib Maleate) tablet 100 mg and 200 mg per the approved prescribing information will be enrolled in the study.
Key inclusion criteria (13 listed)
- 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:
- Rheumatoid arthritis:
- Ulcerative colitis:
Key exclusion criteria (15 listed)
- Individuals who fall under contraindications to the administration of Jyseleca tablet in accordance with the local label by the medical judgment of the investigator.
- Individuals who are administered Filgotinib in a clinical study other than this post marketing surveillance.
- Individuals who are considered incompatible with participate in this surveillance by the medical judgment of the investigator.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non-interventionalNo intervention will be administered. | Other | All Participants |
Primary outcome
Number of Participants With Serious Adverse Events (SAEs)
Time frame: From the date of enrollment up to 24 weeks
A SAE is defined as any undesirable medical occurrence: resulting in death; life threatening; requiring hospitalization or extension of hospitalization; resulting in persistent or significant disability or functional impairment; resulting in congenital malformation or abnormality or other medically significant events than above mentioned criteria.
Number of Participants With Adverse Drug Reactions (ADRs)
Time frame: From the date of enrollment up to 24 weeks
An ADR is defined as harmful and unintended reaction to the proper administration/use of drugs, in which a causal relationship with the drug in question cannot be ruled out. Adverse events (AEs) with unknown causality to the drug among those voluntarily reported will be also considered ADRs.
Number of Participants With Unexpected AEs
Time frame: From the date of enrollment up to 24 weeks
An unexpected AE is an AE with a difference in nature, severity, specificity, or outcome, which have not been mentioned in the product licensure/safety notification of the drug.
Number of Participants With Unexpected ADRs
Time frame: From the date of enrollment up to 24 weeks
Unexpected ADR is also an unexpected AE, where unexpected AE is an AE with a difference in nature, severity, specificity, or outcome, which have not been mentioned in the product licensure/safety notification of the drug.
Number of Participants With Known ADRs
Time frame: From the date of enrollment up to 24 weeks
Known AEs are those listed in product licensure/notification of the drug and are also considered as known ADRs.
Number of Participants With Non-serious AEs
Time frame: From the date of enrollment up to 24 weeks
Non-serious AEs are other than SAE among AEs. An AE is defined as any undesirable and unintended signs (example, abnormalities in laboratory test) or symptoms/diseases occurring during administration/use of drugs, which do not need causal relationship with relevant study drug.
Number of Participants With Non-serious ADRs
Time frame: From the date of enrollment up to 24 weeks
Non-serious ADRs are other than SAE among ADR. An ADR is defined as harmful and unintended reaction to the proper administration/use of drugs, in which a causal relationship with the drug in question cannot be ruled out.
Change From Baseline in Disease Activity Score 28 Based on C-Reactive Protein (DAS28-CRP) at Week 12 and Week 24
Time frame: Baseline, Week 12 and Week 24
The DAS28 index for rheumatoid arthritis participants was a composite score of weighted components including tender joint counts of 28, swollen joint counts of 28, participant global assessment of disease activity score, and CRP value. A DAS28-CRP score of 5.1 or above =high disease activity, a value between greater than (>) 3.2 and 5.1 =moderate disease activity and value between 2.6 and 3.2 =low disease activity, value less than (<) 2.6 =disease remission.
Change From Baseline in the Mayo Clinic Score (MCS) at Week 12 and Week 24
Time frame: Baseline, Week 12 and Week 24
The Mayo Clinic Score for ulcerative colitis participants is comprised of 4 parts: stool frequency, rectal bleeding, endoscopic findings, and physician's global assessment, each scored from 0 to 3, where 0=normal, 3=severe. The total score ranges from 0 to 12, with higher scores indicating increased severity of disease.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2026.
- Individual participant dataSharing planned: Yes. Eisai's data sharing commitment and further information on how to request data can be found on our website http://eisaiclinicaltrials.com/.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
59 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Arthritis, Rheumatoid and Colitis, Ulcerative, run by Eisai Korea Inc. at 59 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 59 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Serena SoYoun Kwon (+82-2-3451-5533, s-kwon@eisaikorea.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Serious Adverse Events (SAEs) (time frame: From the date of enrollment up to 24 weeks). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2026.