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

Last updated: April 8, 2025
Sponsor: Eisai Korea Inc.
Overall Status: Active - Recruiting

Phase

N/A

Condition

Inflammatory Bowel Disease

Rheumatoid Arthritis

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 theKorean 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:
November 01, 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

    Active - Recruiting

  • Site #2

    Choonchen,
    Korea, Republic of

    Active - Recruiting

  • 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

    Active - Recruiting

  • 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

    Active - Recruiting

  • Site #4

    Wonju,
    Korea, Republic of

    Active - Recruiting

  • Site #25

    Yongin,
    Korea, Republic of

    Active - Recruiting

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