A Study of Jyseleca Tablet (Filgotinib Maleate) in Korean Participants
Recruiting · NCT06246123 · Observational (researchers observe without assigning treatment) · Lead sponsor: Eisai Korea Inc.
View the official record on ClinicalTrials.gov →Interventions studied
Non-interventional
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
Inclusion criteria
- \. 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.
Exclusion criteria
- 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
60 locations listed.
- Dong-A University Hospital - Busan, South Korea
- Haeundae Bumin Hospital - Busan, South Korea
- Inje University Haeundae Paik Hospital - Busan, South Korea
- Inje University Pusan Paik Hospital - Busan, South Korea
- Kosin University Gospel Hospital - Busan, South Korea
- Dong-A University Hospital - Busan, South Korea
- Haeundae Bumin Hospital - Busan, South Korea
- Inje University Haeundae Paik Hospital - Busan, South Korea
- Inje University Pusan Paik Hospital - Busan, South Korea
- Kosin University Gospel Hospital - Busan, South Korea
- Daegu Fatima Hospital - Daegu, South Korea
- Daegu Koo Hospital - Daegu, South Korea
- Deagu Catholic University Medical Center - Daegu, South Korea
- Keimyung University Dongsan Hospital - Daegu, South Korea
- Kyungpook National University Chilgok Hospital - Daegu, South Korea
- Kyungpook National University Hospital - Daegu, South Korea
- Yeungnam University Medical Center - Daegu, South Korea
- Daegu Fatima Hospital - Daegu, South Korea
- Daegu Koo Hospital - Daegu, South Korea
- Deagu Catholic University Medical Center - Daegu, South Korea
- Keimyung University Dongsan Hospital - Daegu, South Korea
- Kyungpook National University Chilgok Hospital - Daegu, South Korea
- Kyungpook National University Hospital - Daegu, South Korea
- Yeungnam University Medical Center - Daegu, South Korea
- Catholic University of Korea, Daejeon ST. Mary's Hospital - Daejeon, South Korea
- Chungnam National University Hospital - Daejeon, South Korea
- Eulji University Hospital Daejeon - Daejeon, South Korea
- Konyang University Hospital - Daejeon, South Korea
- Catholic University of Korea, Daejeon ST. Mary's Hospital - Daejeon, South Korea
- Chungnam National University Hospital - Daejeon, South Korea
- Eulji University Hospital Daejeon - Daejeon, South Korea
- Konyang University Hospital - Daejeon, South Korea
- Chosun University Hospital - Gwangju, South Korea
- Jeonnam National University Hospital - Gwangju, South Korea
- Chosun University Hospital - Gwangju, South Korea
- Jeonnam National University Hospital - Gwangju, South Korea
- Catholic Kwandong University International St. Mary's Hospital - Incheon, South Korea
- Gachon University Gil Medical Center - Incheon, South Korea
- Catholic Kwandong University International St. Mary's Hospital - Incheon, South Korea
- Gachon University Gil Medical Center - Incheon, South Korea
- Jeju National University Hospital - Jeju City, South Korea
- Jeju National University Hospital - Jeju City, South Korea
- Sejong Chungnam National University Hospital - Sejong, South Korea
- Sejong Chungnam National University Hospital - Sejong, South Korea
- Asan Medical Center - Seoul, South Korea
- Catholic University of Korea Seoul St. Mary's Hospital - Seoul, South Korea
- Catholic University of Korea, Yeouido ST. Mary's Hospital - Seoul, South Korea
- Chung-Ang University Hospital - Seoul, South Korea
- Gangnam Severance Hospital - Seoul, South Korea
- Hanyang University Medical Center - Seoul, South Korea
- HoYounKim's Clinic - Seoul, South Korea
- Kangbuk Samsung Hospital - Seoul, South Korea
- Konkuk University Medical Center - Seoul, South Korea
- Korea University Guro Hospital - Seoul, South Korea
- Kyung Hee University Hospital At Gangdong - Seoul, South Korea
- KYUNG HEE University Hospital - Seoul, South Korea
- Samsung Medical Center - Seoul, South Korea
- Seoul National University Hospital - Seoul, South Korea
- Severance Hospital - Seoul, South Korea
- SNU Boramae Medical Center - Seoul, South Korea
Showing 60 of 118 listed sites. See the official record for the complete list.
Read the full protocol, contacts and eligibility on ClinicalTrials.gov →