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

Recruiting now

Conditions studied: Arthritis, Rheumatoid, Colitis, Ulcerative

In brief

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.

Key facts

Study ID

NCT06246123

Run by

Eisai Korea Inc.

People needed

2040

Starts

2024-02-27

Expected to finish

2027-07-30

Last updated by the study team

2026-07-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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

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

Where it is running

• Kangwon National University Hospital — Chuncheon, Gangwon-do, South Korea (enrolling)
• Soonchunhyang University Cheonan Hospital — Cheonan, Chungcheongnam-do, South Korea (enrolling)
• Korea University Ansan Hospital — Ansan, Gyeonggi-do, South Korea (enrolling)
• The Catholic University of Korea Bucheon St. Mary's Hospital — Bucheon-si, Gyeonggi-do, South Korea (enrolling)
• Inje University Ilsan Paik Hospital — Goyang-si, Gyeonggi-do, South Korea (enrolling)
• Wonju Severance Christian Hospital — Wŏnju, Gangwon-do, South Korea (enrolling)
• CHA Bundang Medical Center — Seongnam-si, Gyeonggi-do, South Korea (enrolling)
• Seoul National University Bundang Hospital — Seongnam-si, Gyeonggi-do, South Korea (enrolling)
• Ajou University Medical Center — Suwon, Gyeonggi-do, South Korea (enrolling)
• The Catholic University of Korea St. Vincent's Hospital — Suwon, Gyeonggi-do, South Korea (enrolling)
• Nowon Eulji Hospital — Uijeongbu-si, Gyeonggi-do, South Korea (enrolling)
• Uijeongbu Eulji Medical Center — Uijeongbu-si, Gyeonggi-do, South Korea (enrolling)
• Yongin Severance Hospital — Yongin, Gyeonggi-do, South Korea (enrolling)
• Chung-Ang University Gwangmyeong Hospital — Gwangmyeong, Gyeonggi-do, South Korea (enrolling)
• Changwon Gyeongsang National University Hospital — Changwon, Gyeongsangnam-do, South Korea (enrolling)
• Gyeongsang National University Hospital — Jinju, Gyeongsangnam-do, South Korea (enrolling)
• Pusan National University Yangsan Hospital — Yangsan, Gyeongsangnam-do, South Korea (enrolling)
• Jeonbuk National University Hospital — Jeonju, Jeollabuk-do, South Korea (enrolling)
• Chungbuk National University Hospital — Cheongju-si, North Chungcheong, South Korea (enrolling)
• Dong-A University Hospital — Busan, South Korea (enrolling)
• Haeundae Bumin Hospital — Busan, South Korea (enrolling)
• Inje University Haeundae Paik Hospital — Busan, South Korea (enrolling)
• Inje University Pusan Paik Hospital — Busan, South Korea (enrolling)
• Kosin University Gospel Hospital — Busan, South Korea (enrolling)
• Daegu Fatima Hospital — Daegu, South Korea (enrolling)

Full record on ClinicalTrials.gov

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