Regulatory Post-Marketing Surveillance Study (Usage Results Study) of Kynteles Injection (Vedolizumab) for the Approved Indications in South Korea
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 688
- 试验地点
- 43
- 主要终点
- Percentage of Participants With Serious Adverse Drug Reactions (SADRs)
研究概览
简要总结
In this study, participants with ulcerative colitis or Crohn's disease or pouchitis will be treated with Kynteles injection (Vedolizumab) according to their clinic's standard practice.
The main aim of the study is to check for side effects from treatment with Kynteles injection (Vedolizumab). Another aim is to learn how many participants have improved symptoms after treatment with Kynteles injection (Vedolizumab).
详细描述
This is a non-interventional, prospective, post-marketing study of participants with inflammatory bowel disease (IBD) (ulcerative colitis (UC) or Crohn's disease (CD)), who have had an inadequate response with, lost response to, or were intolerant to conventional therapy or an TNF-alpha antagonist or participants with pouchitis, who have undergone proctocolectomy and ileal pouch anal anastomosis (IPAA) for UC, and have had an inadequate response with, or lost response to antibiotic therapy. This study will evaluate the safety and effectiveness of Kynteles injection (Vedolizumab) in a routine clinical practice setting under real world conditions.
This study will enroll approximately 600 participants. The data will be prospectively collected, at the centers from routinely scheduled follow-up visits and recorded into electronic case report forms (e-CRFs).
This multi-center trial will be conducted in South Korea. The overall time for data collection in the study will be approximately 6 years.
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
- •With moderately to severely active UC and CD, who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a TNF-α antagonist
- •With moderately to severely active chronic pouchitis, who have undergone proctocolectomy and IPAA for UC, and have had an inadequate response with, or lost response to antibiotic therapy.
排除标准
- •With hypersensitivity such as dyspnea, bronchospasm, urticaria, flushing and increased heart rate to the Kynteles Injection (Vedolizumab) or to any of its excipients
- •With active severe infections such as tuberculosis, cytomegalovirus, sepsis, listeriosis and opportunistic infections such as progressive multifocal leukoencephalopathy (PML)
- •Treated with Kynteles Injection (Vedolizumab) outside of the locally approved label in South Korea.
结局指标
主要结局
Percentage of Participants With Serious Adverse Drug Reactions (SADRs)
时间窗: Baseline up to 56 weeks
Percentage of Participants With Unexpected ADRs
时间窗: Baseline up to 56 weeks
Percentage of Participants With Serious Adverse Events (SAEs)
时间窗: Baseline up to 56 weeks
Percentage of Participants With Adverse Drug Reactions (ADRs)
时间窗: Baseline up to 56 weeks
Percentage of Participants With Adverse Events of Special Interest (AESIs)
时间窗: Baseline up to 56 weeks
Percentage of Participants With Unexpected Adverse Events (AEs)
时间窗: Baseline up to 56 weeks
次要结局
- Percentage of Participants With Mucosal Healing(Baseline up to 56 weeks)
- Percentage of Participants With Clinical Response(Baseline up to 56 weeks)
- Percentage of Participants With Clinical Remission(Baseline up to 56 weeks)