A Cluster Randomized Controlled Trial of an Enhanced Treatment Algorithm for the Management of Crohn's Disease
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 1,095
- 试验地点
- 22
- 主要终点
- Risk of Crohn's Disease-related complications at two years
研究概览
简要总结
Assess if the implementation of an enhanced treatment algorithm will improve the management Crohn's Disease compared to a conventional Step-care approach.
详细描述
Crohn's disease (CD) is a chronic inflammatory disorder of the gastrointestinal tract. During disease exacerbations, pharmacological or surgical intervention is usually needed to re-establish remission. Ideally, strategies should be employed to maintain patients in long-term remission while minimizing exposure to corticosteroids and reduce therapy-related toxicity.
Nevertheless, in reality many patients with CD do not receive effective therapy and their disease often remains active, leading to uncontrolled inflammation and complications from either the underlying disease or corticosteroids.
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
- None
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
- •Documented diagnosis of CD
- •Written informed consent must be obtained and documented.
- •Willing to utilize study supply of adalimumab provided in syringe format, if indicated according to treatment algorithm.
排除标准
- •Any conditions (e.g., history of alcohol or substance abuse) which, in the opinion of the investigator, may interfere with the patient's ability to comply with study procedures.
- •Latex allergy or other conditions in which adalimumab syringes are contraindicated
- •Currently participating, or planning to participate in a study involving investigational product within 24 months that may interfere with the patient's ability to comply with study procedures.
- •Previously failed all classes of tumor necrosis factor (TNF) antagonists for the treatment of CD.
- •Diagnosis of short bowel syndrome
研究组 & 干预措施
Enhanced Treatment Algorithm
The Enhanced algorithm features the early use of combined antimetabolite/adalimumab therapy, and treatment intensification based on ileocolonoscopic findings. Failure to achieve or sustain Deep Remission, which includes sustained normalization of the imaging studies, will result in treatment intensification, according to the steps outlined in the algorithm, irrespective of symptoms.
干预措施: Enhanced Treatment Algorithm (Other)
Conventional Step-care Algorithm
Step-care algorithm that specifies treatment escalation solely on the basis of symptoms quantified using the Harvey Bradshaw Index (HBI).
干预措施: Conventional Step-care Algorithm (Other)
结局指标
主要结局
Risk of Crohn's Disease-related complications at two years
时间窗: 2 years
Crohn''s Disease (CD)-related complications include (1) CD-related surgeries and non-surgical CD events (such as disease flare, bowel obstruction, and bowel damage events (such as symptomatic bowel obstruction, fistula, abscess and CD related hospitalizations and 2) complications and hospitalizations related to CD medications or procedures.
次要结局
- Risk of Crohn's Disease-related complications, Crohn's Disease-related hospitalizations, and all cause hospitalizations at 6 months and 12 months.(six months, 12 months)
- Time to first Crohn's Disease-related complication, first Crohn's Disease-related hospitalizations, and first all cause hospitalizations at 6 months and 12 months.(six months, 12 months)