Clinical Effectiveness and Safety of Vedolizumab Intravenous in Real World Clinical Practice in Ulcerative Colitis Korean Patients: a Multicenter Post-marketing Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 105
- 试验地点
- 15
- 主要终点
- Percentage of Participants With Clinical Response at Week 6 Based on Partial Mayo Score
研究概览
简要总结
The purpose of this study is to assess the clinical effectiveness by the clinical response at 6 weeks and the safety of vedolizumab intravenous in UC Korean participants.
详细描述
This is a post-marketing, non-interventional study of participants with moderate to severe UC. The study will review medical records of participants who have initiated medical treatment with vedolizumab intravenous during the defined eligibility period under routine clinical practice to provide the real world data on the effectiveness and safety of vedolizumab intravenous.
The study will enroll approximately 100 participants. All participants will be enrolled in one observational group: Vedolizumab
Both retrospective and prospective data will be collected in the index period, with prospective data collected for treatment baseline visit and follow up visits.
The multi-center trial will be conducted in Republic of Korea. The overall duration of study will be approximately 15 months.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Moderately to severely active UC and having failed TNF-alpha antagonist therapy.
排除标准
- •Was treated with vedolizumab intravenous outside of the locally approved label in South Korea.
- •Was enrolled in an Interventional Intestinal Bowel Disease clinical trial at time of using vedolizumab intravenous.
结局指标
主要结局
Percentage of Participants With Clinical Response at Week 6 Based on Partial Mayo Score
时间窗: Week 6
Clinical response based on partial Mayo score was defined as a reduction of at least 3 points and a decrease of at least 30 percent (%) from the baseline Mayo score, with a decrease of at least 1 point on the rectal bleeding subscale, or an absolute rectal bleeding score of 0 or 1. Mayo score was an instrument designed to measure disease activity of UC. Partial Mayo score consisted of 3 sub-scores: stool frequency, most severe rectal bleeding of the day, and global assessment by physician, each graded from 0 to 3 with higher scores indicating more severe disease. These scores were summed to give a total score range of 0 to 9; where higher score indicated more severe disease.
Percentage of Participants With Adverse Events of Special Interests (AESIs) and Serious Adverse Events (SAEs)
时间窗: From the index date (date when vedolizumab treatment was initiated) until the end of treatment, lost to follow-up or death (up to 15 months)
Percentage of Participants With Pregnancy During the Study
时间窗: From the index date (date when vedolizumab treatment was initiated) until the end of treatment, lost to follow-up or death (up to 15 months)
次要结局
- Percentage of Participants With Mucosal Healing at Weeks 6 and 14(Weeks 6 and 14)
- Percentage of Participants With Clinical Remission at Week 6 and Week 14 Based on Partial Mayo Score(Weeks 6 and 14)
- Percentage of Participants With Clinical Response at Week 14 Based on Partial Mayo Score(Week 14)