NCT07553182招募中3 期
Open-label Extension (OLE), Multiple Dose Study to Evaluate Safety, Tolerability, and Efficacy of Filgotinib in Children and Adolescents From 8 Years to Less Than 18 Years of Age With Juvenile Idiopathic Arthritis (JIA)
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 5
- 主要终点
- Frequency and severity of treatment-emergent adverse events (TEAEs), treatment-emergent serious adverse events (SAEs), and TEAEs leading to treatment discontinuation at each visit throughout the duration of the study.
研究概览
简要总结
This OLE study is designed to evaluate long-term safety, tolerability, and efficacy of filgotinib in patients with polyarticular or systemic juvenile idiopathic arthritis (pJIA-sJIA) who have completed the treatment period/prolonged treatment period of the parent studies and demonstrated clinical benefit defined as control of disease activity through improvement in signs and symptoms as per Investigator judgement.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 8 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject must have completed treatment with filgotinib in at least one parent study and achieved a clinical benefit at the end of the parent protocols
- •Subject and/or parent/legal guardian must be able and willing to comply with the clinical study protocol requirements and must sign and date the informed consent form and assent (if required per local regulation) as approved by the Independent Ethics Committee/ Institutional Review Board, prior to any protocol evaluations
- •Female or male subject 8 to <18 years of age, on the date of signing the informed consent and assent (per local regulation) form
- •Female subject of childbearing potential who is sexually active and at risk for pregnancy must agree to use contraception/preventive exposure measures as described in the clinical study protocol.
排除标准
- •Development of any condition during the parent study that would preclude safe continuation
- •Pregnancy
- •Active infection that is clinically significant, as per Investigator's judgement
- •Subject with known hypersensitivity to the components of potential study therapy
- •Subjects with any condition or circumstances (including abnormalities in laboratory parameters) that, in the opinion of the investigator, may make a subject unlikely or unable to complete the study or comply with study procedures and requirements
研究组 & 干预措施
Filgotinib
Experimental
Filgotinib
干预措施: Filgotinib (Drug)
结局指标
主要结局
Frequency and severity of treatment-emergent adverse events (TEAEs), treatment-emergent serious adverse events (SAEs), and TEAEs leading to treatment discontinuation at each visit throughout the duration of the study.
时间窗: From baseline (Day 1) up to Week 78
次要结局
- Incidence of treatment-emergent uveitis (including severity).(Week 1, Week 26, Week 52, Week 78)
- Percentage of subjects with JIA American College of Rheumatology (ACR) 30 response over time.(Week 1, Week 26, Week 52 and Week 78)
- Percentage of subjects with JIA ACR inactive disease.(Week 1, Week 26, Week 52 and Week 78)
- Percentage of subjects with JIA ACR clinical remission over time.(Week 1, Week 26, Week 52 and Week 78)
研究者
研究点 (5)
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