NCT05817942进行中（未招募）不适用
A Prospective, Non-interventional, Multi-country Cohort Study of the Effectiveness and Safety of Filgotinib in Adult Patients With Moderately to Severely Active Ulcerative Colitis
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 509
- 试验地点
- 81
- 主要终点
- Treatment Persistence Rate at week 52.
研究概览
简要总结
To describe the effectiveness, treatment patterns, quality of life, and safety of participants with moderately or severely active UC treated with filgotinib in a real-world setting.
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. Filgotinib-naïve participants with moderately or severely active UC as judged by the physician and starting filgotinib treatment according to local treatment guidelines, routine practices and product information.
排除标准
- •Participation in any interventional or non-interventional study without prior approval from the medical leader. This does not preclude inclusion of participants enrolled to national registries.
- •Participant is diagnosed with Crohn's disease.
研究组 & 干预措施
Arm A: Filgotinib
Participants diagnosed with moderately or severely active UC taking filgotinib according to local treatment guidelines or routine clinical practice and product information.
干预措施: Filgotinib (Drug)
结局指标
主要结局
Treatment Persistence Rate at week 52.
时间窗: Week 52
The persistence rate is defined as the percentage of participants who have continued filgotinib treatment since initiation.
次要结局
- Change from Baseline in HRQoL as measured by the Urgency Numeric Rating Scale (NRS)(Baseline, Weeks 10, 24, 52)
- Number of Participants with Adverse Events (AEs)(Up to 104 Weeks)
- Treatment Persistence Rate at weeks 10, 24, 76 and 104(Weeks 10, 24, 76 and 104)
- Clinical Response Rate(Weeks 10, 24, 52, 76 and 104)
- Clinical Remission Rate(Weeks 10, 24, 52, 76 and 104)
- Change from Baseline in Health-Related Quality of Life (HRQoL) as measured by the Short Inflammatory Bowel Disease Questionnaire (SIBDQ)(Baseline, Weeks 10, 24, 52, 76 and 104)
- Change from Baseline in HRQoL as measured by the Functional Assessment of Chronic Illness Therapy-Fatigue score (FACIT-F)(Baseline, Weeks 10, 24, 52, 76 and 104)
- Number of Participants with Serious Adverse Events (SAEs)(Up To 104 Weeks)
研究者
研究点 (81)
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