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

Last updated: May 21, 2026
Sponsor: Eisai Korea Inc.
Overall Status: Active - Recruiting

Phase

N/A

Condition

Joint Injuries

Inflammatory Bowel Disease

Crohn's Disease

Treatment

Non-interventional

Clinical Study ID

NCT06246123
FIL-M082-501
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 followingparticipants, Jyseleca tablet should be used only if they do not respondappropriately 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 adultswho have responded inadequately to, or who are intolerant to one or moredisease-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 whohave an inadequate response with, lost response to, or were intolerant to eitherconventional therapy (corticosteroids, immunosuppressants, etc.) or biologicalagents.

  • The investigator should refer to local label and contraindications in Korearegarding the inclusion criteria.

Exclusion

Exclusion Criteria:

  1. Individuals who fall under contraindications to the administration of Jyselecatablet in accordance with the local label by the medical judgment of theinvestigator.
  • Contraindication for Jyseleca tablet in accordance with the Korean label:
  1. Participants with hypersensitivity to the active ingredient or otheringredients 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 geneticproblems such as galactose intolerance, total lactase deficiency, orglucose-galactose malabsorption as it contains lactose.

  11. Individuals who are administered Filgotinib in a clinical study other than this postmarketing surveillance.

  12. Individuals who are considered incompatible with participate in this surveillance bythe medical judgment of the investigator.

  • The investigator should refer to local label and contraindications in Korearegarding the exclusion criteria.

Study Design

Total Participants: 2040
Treatment Group(s): 1
Primary Treatment: Non-interventional
Phase:
Study Start date:
February 27, 2024
Estimated Completion Date:
July 30, 2027

Connect with a study center

  • Site #28

    Ansan,
    Korea, Republic of

    Site Not Available

  • Site #10

    Busan,
    Korea, Republic of

    Site Not Available

  • Site #11

    Busan,
    Korea, Republic of

    Active - Recruiting

  • Site #15

    Busan,
    Korea, Republic of

    Site Not Available

  • Site #16

    Busan,
    Korea, Republic of

    Site Not Available

  • Site #17

    Busan,
    Korea, Republic of

    Site Not Available

  • Site #5

    Busan,
    Korea, Republic of

    Active - Recruiting

  • Site #7

    Busan,
    Korea, Republic of

    Active - Recruiting

  • Site #22

    Changwon,
    Korea, Republic of

    Site Not Available

  • Site #14

    Cheongju,
    Korea, Republic of

    Site Not Available

  • Site #2

    Choonchen,
    Korea, Republic of

    Site Not Available

  • Site #12

    Daegu,
    Korea, Republic of

    Active - Recruiting

  • Site #20

    Daegu,
    Korea, Republic of

    Active - Recruiting

  • Site #21

    Daegu,
    Korea, Republic of

    Site Not Available

  • Site #26

    Daegu,
    Korea, Republic of

    Site Not Available

  • Site #3

    Daegu,
    Korea, Republic of

    Site Not Available

  • Site #36

    Daegu,
    Korea, Republic of

    Site Not Available

  • Site #6

    Daejeon,
    Korea, Republic of

    Site Not Available

  • Site #9

    Gwangju,
    Korea, Republic of

    Site Not Available

  • Site #35

    Gyeonggi,
    Korea, Republic of

    Site Not Available

  • Site #13

    Jeju,
    Korea, Republic of

    Site Not Available

  • Site #29

    Jeonbuk,
    Korea, Republic of

    Site Not Available

  • Site #18

    Jeonju,
    Korea, Republic of

    Active - Recruiting

  • Site #37

    Jeonnam,
    Korea, Republic of

    Site Not Available

  • Site #23

    Jinju,
    Korea, Republic of

    Active - Recruiting

  • Site #31

    Kyungpook,
    Korea, Republic of

    Site Not Available

  • Site #33

    Kyungpook,
    Korea, Republic of

    Site Not Available

  • Site #1

    Seoul,
    Korea, Republic of

    Site Not Available

  • Site #19

    Seoul,
    Korea, Republic of

    Active - Recruiting

  • Site #27

    Seoul,
    Korea, Republic of

    Site Not Available

  • Site #30

    Seoul,
    Korea, Republic of

    Site Not Available

  • Site #32

    Seoul,
    Korea, Republic of

    Site Not Available

  • Site #34

    Seoul,
    Korea, Republic of

    Site Not Available

  • Site #38

    Seoul,
    Korea, Republic of

    Site Not Available

  • Site #39

    Seoul,
    Korea, Republic of

    Site Not Available

  • Site #40

    Seoul,
    Korea, Republic of

    Site Not Available

  • Site #41

    Seoul,
    Korea, Republic of

    Site Not Available

  • Site #42

    Seoul,
    Korea, Republic of

    Site Not Available

  • Site #8

    Seoul,
    Korea, Republic of

    Active - Recruiting

  • Site #24

    Wonju,
    Korea, Republic of

    Site Not Available

  • Site #4

    Wonju,
    Korea, Republic of

    Active - Recruiting

  • Site #25

    Yongin,
    Korea, Republic of

    Active - Recruiting

  • Soonchunhyang University Cheonan Hospital

    Cheonan, Chungcheongnam-do
    South Korea

    Active - Recruiting

  • Kangwon National University Hospital

    Chuncheon, Gangwon-do
    South Korea

    Active - Recruiting

  • Wonju Severance Christian Hospital

    Wŏnju, Gangwon-do
    South Korea

    Active - Recruiting

  • Korea University Ansan Hospital

    Ansan, Gyeonggi-do
    South Korea

    Active - Recruiting

  • The Catholic University of Korea Bucheon St. Mary's Hospital

    Bucheon-si, Gyeonggi-do
    South Korea

    Active - Recruiting

  • Inje University Ilsan Paik Hospital

    Goyang-si, Gyeonggi-do
    South Korea

    Active - Recruiting

  • Chung-Ang University Gwangmyeong Hospital

    Gwangmyeong, Gyeonggi-do
    South Korea

    Active - Recruiting

  • CHA Bundang Medical Center

    Seongnam-si, Gyeonggi-do
    South Korea

    Active - Recruiting

  • Seoul National University Bundang Hospital

    Seongnam-si, Gyeonggi-do
    South Korea

    Active - Recruiting

  • Ajou University Medical Center

    Suwon, Gyeonggi-do
    South Korea

    Active - Recruiting

  • The Catholic University of Korea St. Vincent's Hospital

    Suwon, Gyeonggi-do
    South Korea

    Active - Recruiting

  • Nowon Eulji Hospital

    Uijeongbu-si, Gyeonggi-do
    South Korea

    Active - Recruiting

  • Uijeongbu Eulji Medical Center

    Uijeongbu-si, Gyeonggi-do
    South Korea

    Active - Recruiting

  • Yongin Severance Hospital

    Yongin, Gyeonggi-do
    South Korea

    Active - Recruiting

  • Changwon Gyeongsang National University Hospital

    Changwon, Gyeongsangnam-do
    South Korea

    Active - Recruiting

  • Changwon fatima hospital

    Changwon, Gyeongsangnam-do
    South Korea

    Site Not Available

  • Gyeongsang National University Hospital

    Jinju, Gyeongsangnam-do
    South Korea

    Active - Recruiting

  • Pusan National University Yangsan Hospital

    Yangsan, Gyeongsangnam-do
    South Korea

    Active - Recruiting

  • Jeonbuk National University Hospital

    Jeonju, Jeollabuk-do
    South Korea

    Active - Recruiting

  • Chongbuk National University Hospital

    Cheongju-si, North Chungcheong
    South Korea

    Active - Recruiting

  • Dong-A University Hospital

    Busan,
    South Korea

    Active - Recruiting

  • Haeundae Bumin Hospital

    Busan,
    South Korea

    Active - Recruiting

  • Inje University Haeundae Paik Hospital

    Busan,
    South Korea

    Active - Recruiting

  • Inje University Pusan Paik Hospital

    Busan,
    South Korea

    Active - Recruiting

  • Kosin University Gospel Hospital

    Busan,
    South Korea

    Active - Recruiting

  • Daegu Fatima Hospital

    Daegu,
    South Korea

    Active - Recruiting

  • Daegu Koo Hospital

    Daegu,
    South Korea

    Active - Recruiting

  • Deagu Catholic University Medical Center

    Daegu,
    South Korea

    Active - Recruiting

  • Keimyung University Dongsan Hospital

    Daegu,
    South Korea

    Site Not Available

  • Kyungpook National University Chilgok Hospital

    Daegu,
    South Korea

    Active - Recruiting

  • Kyungpook National University Hospital

    Daegu,
    South Korea

    Active - Recruiting

  • Yeungnam University Medical Center

    Daegu,
    South Korea

    Active - Recruiting

  • Catholic University of Korea, Daejeon ST. Mary's Hospital

    Daejeon,
    South Korea

    Active - Recruiting

  • Chungnam National University Hospital

    Daejeon,
    South Korea

    Active - Recruiting

  • Eulji University Hospital Daejeon

    Daejeon,
    South Korea

    Active - Recruiting

  • Konyang University Hospital

    Daejeon,
    South Korea

    Active - Recruiting

  • Chosun University Hospital

    Gwangju,
    South Korea

    Active - Recruiting

  • Jeonnam National University Hospital

    Gwangju,
    South Korea

    Active - Recruiting

  • Catholic Kwandong University International St. Mary's Hospital

    Incheon,
    South Korea

    Active - Recruiting

  • Gachon University Gil Medical Center

    Incheon,
    South Korea

    Active - Recruiting

  • Jeju National University Hospital

    Jeju City,
    South Korea

    Active - Recruiting

  • Sejong Chungnam National University Hospital

    Sejong,
    South Korea

    Active - Recruiting

  • Asan Medical Center

    Seoul,
    South Korea

    Active - Recruiting

  • Catholic University of Korea, Yeouido ST. Mary�s Hospital.

    Seoul,
    South Korea

    Active - Recruiting

  • Catholic university of korea seoul st. mary's hospital

    Seoul,
    South Korea

    Active - Recruiting

  • Chung-Ang University Hospital

    Seoul,
    South Korea

    Active - Recruiting

  • Gangnam Severance Hospital

    Seoul,
    South Korea

    Active - Recruiting

  • Hanyang University Medical Center

    Seoul,
    South Korea

    Active - Recruiting

  • HoYounKim's Clinic

    Seoul,
    South Korea

    Active - Recruiting

  • Kangbuk Samsung Hospital

    Seoul,
    South Korea

    Active - Recruiting

  • Konkuk University Medical Center

    Seoul,
    South Korea

    Active - Recruiting

  • Korea University Guro Hospital

    Seoul,
    South Korea

    Terminated

  • Kyung Hee University Hospital

    Seoul,
    South Korea

    Active - Recruiting

  • Kyung Hee University Hospital At Gangdong

    Seoul,
    South Korea

    Active - Recruiting

  • SNU Boramae Medical Center

    Seoul,
    South Korea

    Active - Recruiting

  • Samsung Medical Center

    Seoul,
    South Korea

    Active - Recruiting

  • Seoul National University Hospital

    Seoul,
    South Korea

    Active - Recruiting

  • Seoul St. Mary's Hospital

    Seoul,
    South Korea

    Active - Recruiting

  • Severance Hospital

    Seoul,
    South Korea

    Active - Recruiting

  • Soonchunhyang University Hospital Seoul

    Seoul,
    South Korea

    Active - Recruiting

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