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

Официальное название

Post Marketing Surveillance of Jyseleca Tab. (Filgotinib Maleate) in Korean Subjects

Обзор

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.

Вмешательства

• Другое Non-interventional
  No intervention will be administered.

Первичные конечные точки

• Number of Participants With Serious Adverse Events (SAEs) [Срок оценки: From the date of enrollment up to 24 weeks]
• Number of Participants With Adverse Drug Reactions (ADRs) [Срок оценки: From the date of enrollment up to 24 weeks]
• Number of Participants With Unexpected AEs [Срок оценки: From the date of enrollment up to 24 weeks]
• Number of Participants With Unexpected ADRs [Срок оценки: From the date of enrollment up to 24 weeks]
• Number of Participants With Known ADRs [Срок оценки: From the date of enrollment up to 24 weeks]
• Number of Participants With Non-serious AEs [Срок оценки: From the date of enrollment up to 24 weeks]
• Number of Participants With Non-serious ADRs [Срок оценки: 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 [Срок оценки: Baseline, Week 12 and Week 24]
• Change From Baseline in the Mayo Clinic Score (MCS) at Week 12 and Week 24 [Срок оценки: Baseline, Week 12 and Week 24]

Критерии участия

Критерии включения

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:

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

South Korea · 59 центров

• Soonchunhyang University Cheonan Hospital — Cheonan
• Kangwon National University Hospital — Chuncheon
• Wonju Severance Christian Hospital — Wŏnju
• Korea University Ansan Hospital — Ansan
• The Catholic University of Korea Bucheon St. Mary's Hospital — Bucheon-si
• Inje University Ilsan Paik Hospital — Goyang-si
• Chung-Ang University Gwangmyeong Hospital — Gwangmyeong
• CHA Bundang Medical Center — Seongnam-si
• … и ещё 51 центр

Идентификаторы

NCT: NCT06246123 · FIL-M082-501

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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