A Prospective and Observational Study for Effectiveness and Safety Evaluation of VedAryo® (Vedolizumab) in Patients With Inflammatory Bowel Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 12
- 主要终点
- Percentage of Participants Achieving Clinical Response at Week 52
研究概览
简要总结
The aim of this observational study is to evaluate Effectiveness and safety of VedAryo® (Vedolizumab) in male or female participants with clinical diagnosis of Inflammatory Bowel Disease. The main questions are aim to answer:
- Is VedAryo® (Vedolizumab) effective in the treatment of Inflammatory Bowel Disease?
- Is VedAryo® (Vedolizumab) safe in the treatment of Inflammatory Bowel Disease?
In this study, there is no comparison group. Participants received VedAryo® (Vedolizumab)
详细描述
This research was conducted as a phase IV, post-marketing, observational cohort study, in which VedAryo® (Vedolizumab) was prescribed as part of routine clinical practice, and no study-related intervention was introduced. The study aimed to evaluate the real-world effectiveness and safety of VedAryo® in Iranian patients diagnosed with Inflammatory Bowel Disease (IBD).
The primary objective was to assess the effectiveness of VedAryo® based on clinical response, measured using the Mayo Scoring Index for ulcerative colitis and the Harvey-Bradshaw Index for Crohn's disease during the observation period.
The secondary objective focused on safety, including the incidence of adverse events (AEs) and serious adverse events (SAEs) recorded over the 52-week observational follow-up.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients diagnosed with Inflammatory bowel disease, including Ulcerative Colitis and Crohn's disease
- •Patients with an indication of vedolizumab therapy
- •Ability to comprehend and willingness to sign the informed consent form for this study.
排除标准
- 未提供
研究组 & 干预措施
Participants received VedAryo® (Vedolizumab)
干预措施: Vedolizumab (Drug)
结局指标
主要结局
Percentage of Participants Achieving Clinical Response at Week 52
时间窗: Baseline, week 52
Clinical response is defined as a decrease from baseline in HBI score of ≥3 points in CD participants and a decrease from baseline in Mayo Score of ≥3 points, ≥30%, and either a decrease from baseline in the rectal bleeding sub score of ≥ 1 or a rectal bleeding sub score of 0 or 1 in UC participants.
次要结局
- Safety Assessment During 52 Weeks(Up to 52 weeks)
- Percentage of Participants Achieving Clinical Remission at Week 52(Baseline, week 52)