Complete Remission in Patients With Moderately to Severely Active Crohn's Disease Treated With Vedolizumab - A Multicenter, Prospective Observational Cohort Study in Canada, Italy, and Israel
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 72
- 试验地点
- 10
- 主要终点
- Percentage of Participants Who Achieve Complete Remission 12 Months After Initiation of Vedolizumab Therapy
研究概览
简要总结
The main aim of this study is to see if adults with CD treated with vedolizumab have less symptoms and inflammation of the bowel assessed by ultrasonography.
Participants will be treated with vedolizumab according to their clinic's standard practice.
详细描述
This is a non-interventional, prospective study of participants with moderately to severely active CD who are initiating treatment with vedolizumab according to the current summary of product characteristics (SmPC) in the real world setting.
The study will enroll approximately 100 participants. The data will be collected prospectively at the study sites and will be recorded into electronic case report forms (e-CRFs). All the participants will be assigned to a single observational cohort:
Participants with CD
This multi-center study will be conducted in Canada, Italy, and Israel at specialized gastroenterology centers. The overall duration of the study will be 18 months.
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
- •Has moderately to severely active CD with a BWT of >3 mm, based on IUS performed within the previous 4 weeks from baseline.
- •Newly initiating IV vedolizumab induction treatment in accordance with the current SmPC either at enrolment or within 2 weeks after enrolment (switch to SC is acceptable at maintenance treatment stage).
排除标准
- •Prior history of intolerability, hypersensitivity to the active substance or to any of the excipients of vedolizumab.
- •Active severe infections such as tuberculosis (TB), sepsis, cytomegalovirus, listeriosis, and opportunistic infections such as Progressive Multifocal Leukoencephalopathy (PML).
- •Cognitive incapacity, unwillingness or language barriers precluding adequate understanding or cooperation.
- •Current or previous participation in an interventional clinical trial for CD within the past 30 days, or planned to be enrolled in an interventional clinical trial for CD.
- •Ongoing or planned pregnancy or breastfeeding participants.
- •Active perforating complications or significant current strictures (assessed by IUS, with or without pre-stenotic dilatation) as per clinical judgement.
- •Characteristics precluding IUS visualization of affected bowel segments or normal BWT of <=3 mm for all segments.
结局指标
主要结局
Percentage of Participants Who Achieve Complete Remission 12 Months After Initiation of Vedolizumab Therapy
时间窗: Baseline up to 12 months
Complete remission will be measured by corticosteroid-free clinical, biochemical and transmural remission.Corticosteroid-free defined as no usage of any systemic or locally acting steroid.Corticosteroid-free clinical remission defined as Harvey Bradshaw Index (HBI) less than (\<) 5 points and no concomitant corticosteroids.HBI score measures disease activity of CD. Clinical parameters:general well-being (0-4,higher score lower well being),abdominal pain(0-3,higher score more severe pain),number of liquid stools/day, abdominal mass (0-3),higher score presence of swelling in abdomen),complications (score 1/item).Total is sum of individual parameters.Score:minimum 0-no pre-specified maximum score,depends on number of liquid stools, higher scores indicating more severe disease.Biochemical remission defined as C-reactive protein(CRP) and fecal calprotectin (FCal) normalization.Transmural remission defined as bowel wall thickness(BWT) of \<3 millimeter (mm) for all bowel segments upon IUS.
次要结局
- Percentage of Participants Who Discontinued Vedolizumab Treatment and Reason for Discontinuation(Up to Month 18)
- Number of Participants Reporting one or More Adverse Events of Special Interest (AESIs)(Up to Month 18)
- Percentage of Participants Who Achieve Corticosteroid-free Clinical Remission(Up to Month 18)
- Percentage of Participants Who Achieve Biochemical Remission(Up to Month 18)
- Percentage of Participants Who Achieve Transmural Response(Up to Month 18)
- Percentage of Participants Who Achieve Complete Remission(Up to Month 18)
- Percentage of Participants Who Achieve Transmural Remission(Up to Month 18)
- Percentage of Participants Who Achieve Clinical Response(Up to Month 18)
- Percentage of Participants With Prior Treatments for CD, and Reason for Discontinuation(Up to Month 18)
- Percentage of Participants With Change, and Reason for Change in Vedolizumab Dosing Frequency(Up to Month 18)
- Percentage of Participants Who Switched to Other CD Therapy After Vedolizumab Discontinuation(Up to Month 18)
- Percentage of Participants With Acceptance of IUS Monitoring and Assessment(Up to Month 18)
- Percentage of Participants With CD-related hospitalizations, CD-related emergency room (ER) visits, CD-related surgeries, CD-related flares requiring IV Induction Therapy or IV Corticosteroid Therapy(Up to Month 18)
- Percentage of Participants Who Switched to Vedolizumab SC Formulation(Up to Month 18)
- Percentage of Participants With Improved Quality of Life Based on Health-related Quality of Life (HRQoL) as Measured by Short Inflammatory Bowel Disease Questionnaire (SIBDQ)(Baseline up to Month 18)
- Number of Participants Reporting one or More Serious Adverse Events (SAEs)(Up to Month 18)
- Percentage of Participants With Concomitant Therapies for CD(Up to Month 18)
- Number of Participants Reporting one or More Adverse Drug Reactions (ADRs)(Up to Month 18)