Corticosteroids as Co-Induction Agents With Vedolizumab in Crohn's Disease: a Double-blind Placebo Controlled Randomized Trial
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- Crohn's Disease Activity Index (CDAI)
研究概览
简要总结
Use of co-induction with corticosteroid therapies may accelerate the remission rate when used with vedolizumab. Further, this may lead to higher rates of response and remission at week 10 than would be seen with vedolizumab monotherapy.
详细描述
This study will examine prednisone co-induction with vedolizumab in patients with Crohn's disease. To address questions regarding the effect of co-induction on mucosal healing, the study will include colonoscopic assessment of mucosal healing. Finally, colonic biopsies in this study will allow to elucidate further the mechanism of action of vedolizumab in Crohn's disease through immune phenotyping studies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age at entry 18 to 70
- •CDAI score > 220
- •Concomitant azathioprine, methotrexate, or mercaptopurine permitted if dose has been stable for > 8 weeks. Prior anti-TNFα antibody use permitted but must be discontinued (>2 weeks from last dose) prior to initiation of vedolizumab.
- •Documented ulceration on colonoscopy done at screening of 3 or more large ulcers or 10 or more aphthous ulcers
- •Able to provide written informed consent.
- •Patient is planned for or eligible to initiate vedolizumab
排除标准
- •Concurrent use of anti-TNFα antibodies.
- •No corticosteroids within prior 3 months (other than budesonide controlled ileal release)
- •No stoma at the time of enrollment
- •No absolute contraindication to systemic corticosteroid use such as hypersensitivity to any part of the formulation, systemic fungal infection, or recent administration of live or live attenuated vaccine within prior two weeks.
- •Pregnant women or plans for pregnancy within 3 months of study inclusion
- •Presence of stoma, more than three small-bowel resections, or documented history of short bowel syndrome
- •Intestinal stricture requiring surgery
- •Abdominal abscess
- •Inability or unwillingness to provide informed consent
- •Any other condition, which, in the opinion of the investigators would impede competence or compliance or possibly hinder completion of the study
研究组 & 干预措施
Prednisone co-inductive therapy
Prednisone 40 mg/day starting at week 0 for 2 weeks, tapered by 10 mg weekly to achieve 0 mg by end of week 5
干预措施: Prednisone (Drug)
Prednisone co-inductive therapy
Prednisone 40 mg/day starting at week 0 for 2 weeks, tapered by 10 mg weekly to achieve 0 mg by end of week 5
干预措施: Vedolizumab (Drug)
Placebo
Identical placebo taper
干预措施: Placebo (Drug)
Placebo
Identical placebo taper
干预措施: Vedolizumab (Drug)
结局指标
主要结局
Crohn's Disease Activity Index (CDAI)
时间窗: baseline, week 6, week 10
Clinical remission, defined as CDAI \< 150, in group with steroid co-induction vs. placebo co-induction. The purpose of this crohn's disease activity index (CDAI) calculator is to gauge the progress or lack of progress for people with crohn's disease. CDAI scores below 150 indicate a better prognosis than higher scores
次要结局
- Change in C-Reactive Protein (CRP)(baseline and week 10)
- Change in Calprotectin(baseline, week 6 and week 10)
- Change in Simple Endoscopic Score for Crohn's Disease (SES-CD)(baseline and week 10)
研究者
Bruce E. Sands
Professor of Medicine Division of Gastroenterology
Icahn School of Medicine at Mount Sinai