Entyvio (Vedolizumab) Long-term Safety Study: An International Observational Prospective Cohort Study Comparing Vedolizumab to Other Biologic Agents in Patients With Ulcerative Colitis or Crohn's Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 5,302
- 试验地点
- 284
- 主要终点
- Percentage of Participants with Adverse Events of Special Interest
研究概览
简要总结
The purpose of this study is to assess the long-term safety of vedolizumab versus other biologic agents in participants with Ulcerative Colitis (UC) or Crohn's Disease (CD).
详细描述
The drug being tested in this prospective, observational study is called vedolizumab. Vedolizumab is being used to treat people who have UC or CD. This study will look at the long-term safety of vedolizumab versus other biologic agents in participants with UC or CD. The study will enroll approximately 5000 participants. All participants enrolled in this will belong to one of the two treatment group:
- Vedolizumab
- Other Biologic Agents -adalimumab, certolizumab pegol.
Golimumab and infliximab. Study drugs will be prescribed by the physician according to local prescribing information in the participating countries. This multi-centre trial will be conducted worldwide. The overall time to participate in this study is 7 years. Participants will make visits at every 6 months to their treating physician.
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
- •Signed informed consent, by the participant or a legally acceptable representative.
- •Aged at least 18 years.
- •Initiating vedolizumab or another biologic agent for UC or CD.
- •Signed release form, by the participant or a legally acceptable representative, permitting abstraction of the participant's medical records at Baseline and during participation in the study.
排除标准
- •The participant is enrolled in a clinical trial in which treatment for CD or UC is managed through a protocol.
- •Prior treatment with vedolizumab.
- •Any other reason that, in the Investigator's opinion, makes the participant unsuitable to participate in this study.
研究组 & 干预措施
Vedolizumab
干预措施: Vedolizumab (Drug)
Other Biologic Agents
干预措施: Other Biologic Agents (Other)
结局指标
主要结局
Percentage of Participants with Adverse Events of Special Interest
时间窗: 7 years
Adverse events of special interest in this study includes serious and opportunistic infections, gastrointestinal infections, respiratory infections, other clinically significant infections: malignancies; infusion-related reactions and hypersensitivity, hepatic injury; psoriasis and other skin events, other SAEs and adverse reactions.
次要结局
- Disease Severity in Ulcerative Colitis (UC) Participants(Baseline and at every 6 months (up to 7 years))
- Disease Severity in Crohn's Disease (CD) Participants(Baseline and at every 6 months (up to 7 years))
- Participant Reported Quality of Life Assessment Using Short Inflammatory Bowel Disease Questionnaire (SIBDQ)(Baseline and at every 6 months (up to 7 years))
- Participant Reported Quality of Life Assessment Using 12-Item Short Form Health Survey (SF-12)(Baseline and at every 6 months (up to 7 years))
- Time to Treatment Discontinuation(Baseline and at every 6 months (up to 7 years))
- Reasons for Treatment Discontinuation(Baseline and at every 6 months (up to 7 years))