Post Marketing Surveillance of Jyseleca Tab. (Filgotinib Maleate) in Korean Subjects
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 2,040
- 试验地点
- 101
- 主要终点
- Number of Participants With Unexpected AEs
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Non-interventional (Other)
结局指标
主要结局
Number of Participants With Unexpected AEs
时间窗: From the date of enrollment up to 24 weeks
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.
Change From Baseline in the Mayo Clinic Score (MCS) at Week 12 and Week 24
时间窗: Baseline, 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.
Number of Participants With Known ADRs
时间窗: From the date of enrollment up to 24 weeks
Known AEs are those listed in product licensure/notification of the drug and are also considered as known ADRs.
Number of Participants With Non-serious ADRs
时间窗: From the date of enrollment up to 24 weeks
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.
Number of Participants With Non-serious AEs
时间窗: From the date of enrollment up to 24 weeks
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.
Number of Participants With Serious Adverse Events (SAEs)
时间窗: From the date of enrollment up to 24 weeks
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.
Number of Participants With Unexpected ADRs
时间窗: From the date of enrollment up to 24 weeks
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.
Number of Participants With Adverse Drug Reactions (ADRs)
时间窗: From the date of enrollment up to 24 weeks
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.
Change From Baseline in Disease Activity Score 28 Based on C-Reactive Protein (DAS28-CRP) at Week 12 and Week 24
时间窗: Baseline, 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.
次要结局
未报告次要终点