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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Non-interventional | Other | No intervention will be administered. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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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 following participants, Jyseleca tablet should be used only if they do not respond appropriately or are intolerant to existing treatments.
Following:
Rheumatoid arthritis:
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:
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.
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Serena SoYoun Kwon | Contact | +82-2-3451-5533 | s-kwon@eisaikorea.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Soonchunhyang University Cheonan Hospital | Recruiting | Cheonan | Chungcheongnam-do | South Korea | ||
Eisai's data sharing commitment and further information on how to request data can be found on our website http://eisaiclinicaltrials.com/.
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NOTE: IPD Sharing Time Frame has not been entered.
NOTE: IPD Sharing Access Criteria has not been entered.
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| 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 |
| Kangwon National University Hospital |
| Recruiting |
| Chuncheon |
| Gangwon-do |
| South Korea |
| Wonju Severance Christian Hospital | Recruiting | Wŏnju | Gangwon-do | South Korea |
| Korea University Ansan Hospital | Recruiting | Ansan | Gyeonggi-do | South Korea |
| The Catholic University of Korea Bucheon St. Mary's Hospital | Recruiting | Bucheon-si | Gyeonggi-do | South Korea |
| Inje University Ilsan Paik Hospital | Recruiting | Goyang-si | Gyeonggi-do | South Korea |
| Chung-Ang University Gwangmyeong Hospital | Recruiting | Gwangmyeong | Gyeonggi-do | South Korea |
| CHA Bundang Medical Center | Recruiting | Seongnam-si | Gyeonggi-do | South Korea |
| Seoul National University Bundang Hospital | Recruiting | Seongnam-si | Gyeonggi-do | South Korea |
| Ajou University Medical Center | Recruiting | Suwon | Gyeonggi-do | South Korea |
| The Catholic University of Korea St. Vincent's Hospital | Recruiting | Suwon | Gyeonggi-do | South Korea |
| Nowon Eulji Hospital | Recruiting | Uijeongbu-si | Gyeonggi-do | South Korea |
| Uijeongbu Eulji Medical Center | Recruiting | Uijeongbu-si | Gyeonggi-do | South Korea |
| Yongin Severance Hospital | Recruiting | Yongin | Gyeonggi-do | South Korea |
| Changwon Fatima Hospital | Withdrawn | Changwon | Gyeongsangnam-do | South Korea |
| Changwon Gyeongsang National University Hospital | Recruiting | Changwon | Gyeongsangnam-do | South Korea |
| Gyeongsang National University Hospital | Recruiting | Jinju | Gyeongsangnam-do | South Korea |
| Pusan National University Yangsan Hospital | Recruiting | Yangsan | Gyeongsangnam-do | South Korea |
| Jeonbuk National University Hospital | Recruiting | Jeonju | Jeollabuk-do | South Korea |
| Chungbuk National University Hospital | Recruiting | Cheongju-si | North Chungcheong | South Korea |
| Dong-A University Hospital | Recruiting | Busan | South Korea |
| Haeundae Bumin Hospital | Recruiting | Busan | South Korea |
| Inje University Haeundae Paik Hospital | Recruiting | Busan | South Korea |
| Inje University Pusan Paik Hospital | Recruiting | Busan | South Korea |
| Kosin University Gospel Hospital | Recruiting | Busan | South Korea |
| Daegu Fatima Hospital | Recruiting | Daegu | South Korea |
| Daegu Koo Hospital | Recruiting | Daegu | South Korea |
| Deagu Catholic University Medical Center | Recruiting | Daegu | South Korea |
| Keimyung University Dongsan Hospital | Recruiting | Daegu | South Korea |
| Kyungpook National University Chilgok Hospital | Recruiting | Daegu | South Korea |
| Kyungpook National University Hospital | Recruiting | Daegu | South Korea |
| Yeungnam University Medical Center | Recruiting | Daegu | South Korea |
| Catholic University of Korea, Daejeon ST. Mary's Hospital | Recruiting | Daejeon | South Korea |
| Chungnam National University Hospital | Recruiting | Daejeon | South Korea |
| Eulji University Hospital Daejeon | Recruiting | Daejeon | South Korea |
| Konyang University Hospital | Recruiting | Daejeon | South Korea |
| Chosun University Hospital | Recruiting | Gwangju | South Korea |
| Jeonnam National University Hospital | Recruiting | Gwangju | South Korea |
| Catholic Kwandong University International St. Mary's Hospital | Recruiting | Incheon | South Korea |
| Gachon University Gil Medical Center | Recruiting | Incheon | South Korea |
| Jeju National University Hospital | Recruiting | Jeju City | South Korea |
| Sejong Chungnam National University Hospital | Recruiting | Sejong | South Korea |
| Asan Medical Center | Recruiting | Seoul | South Korea |
| Catholic University of Korea Seoul St. Mary's Hospital | Recruiting | Seoul | South Korea |
| Catholic University of Korea, Yeouido ST. Mary's Hospital | Recruiting | Seoul | South Korea |
| Chung-Ang University Hospital | Recruiting | Seoul | South Korea |
| Gangnam Severance Hospital | Recruiting | Seoul | South Korea |
| Hanyang University Medical Center | Recruiting | Seoul | South Korea |
| HoYounKim's Clinic | Recruiting | Seoul | South Korea |
| Kangbuk Samsung Hospital | Recruiting | Seoul | South Korea |
| Konkuk University Medical Center | Recruiting | Seoul | South Korea |
| Korea University Guro Hospital | Terminated | Seoul | South Korea |
| Kyung Hee University Hospital At Gangdong | Recruiting | Seoul | South Korea |
| KYUNG HEE University Hospital | Recruiting | Seoul | South Korea |
| Samsung Medical Center | Recruiting | Seoul | South Korea |
| Seoul National University Hospital | Recruiting | Seoul | South Korea |
| Severance Hospital | Recruiting | Seoul | South Korea |
| SNU Boramae Medical Center | Recruiting | Seoul | South Korea |
| Soonchunhyang University Hospital Seoul | Recruiting | Seoul | South Korea |
| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| D003093 | Colitis, Ulcerative |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D003092 | Colitis |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D015212 | Inflammatory Bowel Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
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