Stricture Definition and Treatment (STRIDENT) Drug Therapy Study
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 78
- 试验地点
- 1
- 主要终点
- Improvement in obstructive symptoms.
研究概览
简要总结
Two thirds of patients with Crohn's disease require intestinal surgery at some time in their life. Intestinal strictures, that is narrowing of the bowel due to inflammation and scarring, are the most common reason for surgery. Despite the high frequency, associated disability, and cost there are no are no treatment strategies that aim to improve the outcome of this disease complication. The STRIDENT (stricture definition and treatment) studies aim to develop such strategies.
详细描述
Prospective randomised controlled study. Patients with Crohn's Disease who have symptomatic inflammatory intestinal strictures will be randomised to receive standard drug therapy (Anti-TNF monotherapy at standard dose) or intensive drug therapy (Intense Anti-TNF dose induction and escalation for continued inflammation in combination with thiopurine) for 12 months.
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
盲法说明
Open label study
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
- •Inflammatory bowel disease patients with intestinal stricture(s) identified on CT, MRI or endoscopy.
排除标准
- •Acute bowel obstruction requiring urgent surgical intervention
- •Deemed by treating physician to have high risk of acute bowel obstruction
- •Concurrent active perianal sepsis
- •Internal fistulising disease in association with strictures (entero-enteric stulas)
- •Low rectal or anal strictures
- •Evidence of dysplasia or malignancy from stricture biopsies or adjacent mucosal biopsies
- •Patients for whom endoscopy is not suitable due to co-morbidities or clinical state
- •Inability to give informed consent
- •Suspected perforation of the gastrointestinal tract
- •Pregnancy
- •Inability to undergo MRI small bowel due to a contraindication.
研究组 & 干预措施
Standard drug therapy
Adalimumab monotherapy, Standard Dose induction (160mg at week 0, 80mg week 2 and 40mg fortnightly thereafter)
干预措施: Adalimumab Injection (Drug)
Standard drug therapy
Adalimumab monotherapy, Standard Dose induction (160mg at week 0, 80mg week 2 and 40mg fortnightly thereafter)
干预措施: Endoscopic balloon dilatation (Procedure)
Intensive drug therapy
Adalimumab in combination with dose optimized thiopurine, Intensive induction (160mg weekly for 4 weeks then 40mg fortnightly). Anti-TNF dose may be increased if ongoing inflammation every 4 months until study endpoint.
干预措施: Adalimumab Injection (Drug)
Intensive drug therapy
Adalimumab in combination with dose optimized thiopurine, Intensive induction (160mg weekly for 4 weeks then 40mg fortnightly). Anti-TNF dose may be increased if ongoing inflammation every 4 months until study endpoint.
干预措施: Thiopurine (Drug)
Intensive drug therapy
Adalimumab in combination with dose optimized thiopurine, Intensive induction (160mg weekly for 4 weeks then 40mg fortnightly). Anti-TNF dose may be increased if ongoing inflammation every 4 months until study endpoint.
干预措施: Endoscopic balloon dilatation (Procedure)
结局指标
主要结局
Improvement in obstructive symptoms.
时间窗: 12 months
Improved pain and or frequency of pain compared to baseline. Obstructive symptoms determined by prospective diary documenting number of episodes of pain in previous 2 weeks and severity of the pain episodes using four-level Likert scale.
次要结局
- Improvement in imaging parameters(12 months)
- Surgery(12 months)
- Improvement in patient reported outcomes (PROs)(12 months)
- Improvement in symptoms(4, 8 and 12 months)
- Improvement in biochemical inflammatory parameters(12 months)
- Improvement in imaging parameters (Intestinal ultrasound)(12 months)
研究者
Michael Kamm
Professor of Gastroenterology
St Vincent's Hospital Melbourne