A Prospective, Multicenter, Single-arm, Observational Study to Evaluate the Safety and Effectiveness of Vedolizumab in Real-World Clinical Practice in China
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 500
- 试验地点
- 40
- 主要终点
- Percentage of Participants With Adverse Events (AEs)
研究概览
简要总结
Vedolizumab is a medicine that is currently prescribed for adults with moderately to severely active ulcerative colitis or Crohn's disease.
In this study, adults with ulcerative colitis or Crohn's disease will be treated with vedolizumab according to their clinic's standard practice. The main aim of the study is to check if participants have side effects from vedolizumab.
The study sponsor will not be involved in how participants are treated but will provide instructions on how the clinics will record what happens during the study.
详细描述
This is a non-interventional, prospective study of participants with UC or CD who are prescribed and will start vedolizumab in the real word setting for the first time.
This study will evaluate the safety and effectiveness of vedolizumab in a routine clinical practice setting under real world conditions.
The study will enroll approximately 500 participants. The data will be prospectively collected, at the centers from routinely scheduled follow-up visits and recorded into electronic data capture (eDC). All participants will be enrolled in a single observational group:
• Participants with UC or CD
This multi-center trial will be conducted in China. The overall duration of the study will be approximately 72 weeks.
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
- •Diagnosed with UC or CD
- •Firstly prescribed with vedolizumab
排除标准
- •Currently enrolled in or plan to participate in any other clinical trials (that is, interventional study)
- •Contraindicated for vedolizumab according to product package insert
结局指标
主要结局
Percentage of Participants With Adverse Events (AEs)
时间窗: Up to Week 72
Percentage of Participants With Adverse Events of Special Interests (AESIs)
时间窗: Up to Week 72
Percentage of Participants With Serious Adverse Events (SAEs)
时间窗: Up to Week 72
Percentage of Participants With Adverse Drug Reactions (ADRs)
时间窗: Up to Week 72
次要结局
- Percentage of Participants With UC Achieving Endoscopic Remission(Week 54)
- Percentage of Participants With Crohn's Disease (CD) Achieving Clinical Response Based on Harvey-Bradshaw Index (HBI)(Week 14)
- Percentage of Participants With Ulcerative Colitis (UC) Achieving Clinical Response Based on Partial Mayo Score(Week 14)
- Percentage of Participants With CD Achieving Endoscopic Remission(Week 54)
- Percentage of Participants With UC Achieving Clinical Remission Based on Partial Mayo Score(Week 54)
- Percentage of Participants With CD Achieving Clinical Remission Based on HBI(Week 54)