A Study of Jyseleca Tablet (Filgotinib Maleate) in Korean Participants
Post Marketing Surveillance of Jyseleca Tab. (Filgotinib Maleate) in Korean Subjects
1 other identifier
observational
2,040
1 country
42
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Feb 2024
Typical duration for all trials
42 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 30, 2024
CompletedFirst Posted
Study publicly available on registry
February 7, 2024
CompletedStudy Start
First participant enrolled
February 27, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 30, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 30, 2027
May 13, 2025
April 1, 2025
3.4 years
January 30, 2024
May 12, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (9)
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.
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.
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.
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.
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.
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.
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.
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.
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.
Baseline, Week 12 and Week 24
Study Arms (1)
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.
Interventions
Eligibility Criteria
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.
You may qualify if:
- \. 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.
- 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:
- 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.
You may not qualify if:
- 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.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Eisai Korea Inc.lead
Study Sites (42)
Site #28
Ansan, South Korea
Site #10
Busan, South Korea
Site #11
Busan, South Korea
Site #15
Busan, South Korea
Site #16
Busan, South Korea
Site #17
Busan, South Korea
Site #5
Busan, South Korea
Site #7
Busan, South Korea
Site #22
Changwon, South Korea
Site #14
Cheongju-si, South Korea
Site #2
Choonchen, South Korea
Site #12
Daegu, South Korea
Site #20
Daegu, South Korea
Site #21
Daegu, South Korea
Site #26
Daegu, South Korea
Site #36
Daegu, South Korea
Site #3
Daegu, South Korea
Site #6
Daejeon, South Korea
Site #9
Gwangju, South Korea
Site #35
Gyeonggi-do, South Korea
Site #13
Jeju City, South Korea
Site #29
Jeonbuk, South Korea
Site #18
Jeonju, South Korea
Site #37
Jeonnam, South Korea
Site #23
Jinju, South Korea
Site #31
Kyungpook, South Korea
Site #33
Kyungpook, South Korea
Site #19
Seoul, South Korea
Site #1
Seoul, South Korea
Site #27
Seoul, South Korea
Site #30
Seoul, South Korea
Site #32
Seoul, South Korea
Site #34
Seoul, South Korea
Site #38
Seoul, South Korea
Site #39
Seoul, South Korea
Site #40
Seoul, South Korea
Site #41
Seoul, South Korea
Site #42
Seoul, South Korea
Site #8
Seoul, South Korea
Site #24
Wŏnju, South Korea
Site #4
Wŏnju, South Korea
Site #25
Yŏngin, South Korea
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 30, 2024
First Posted
February 7, 2024
Study Start
February 27, 2024
Primary Completion (Estimated)
July 30, 2027
Study Completion (Estimated)
July 30, 2027
Last Updated
May 13, 2025
Record last verified: 2025-04
Data Sharing
- IPD Sharing
- Will share
- Time Frame
- NOTE: IPD Sharing Time Frame has not been entered.
- Access Criteria
- NOTE: IPD Sharing Access Criteria has not been entered.
Eisai's data sharing commitment and further information on how to request data can be found on our website http://eisaiclinicaltrials.com/.