NCT01986127终止3 期
A Randomized, Double-blinded, Placebo-controlled Study on the Effects of Adalimumab Intralesional Intestinal Strictures of Crohn's Disease Patients
Sara Varea13 个研究点 分布在 1 个国家目标入组 26 人开始时间: 2014年2月14日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 26
- 试验地点
- 13
- 主要终点
- Success of endoscopic dilatation
研究概览
简要总结
We study if the administration of intralesional Adalimumab (directly injected in the stricture) associated to endoscopic dilatation has a higher success rate at week 8 compared with placebo in patients with Crohn's disease who had confirmed intestinal stenosis (3 stenosis as maximum)
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
- Triple (Participant, Care Provider, Investigator)
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
- •Patients of both sexes older than 18 years
- •Patient diagnosed of CROHN´s disease
- •Patient with intestinal stenosis length equal or less than 5cm previously confirmed with bowel magnetic resonance imaging (3 stenosis as maximum)
- •Stenosis no permeable for endoscopy(12mm in case of accessible stenosis with conventional colonoscopy and 10mm in case of accessible stenosis with balloon enteroscopy)
- •Dilated stenosis according to endoscopist criteria (pass or no the endoscopy)
- •Patient capable of participate in the examinations required by the study
- •Patient after being informed, give his/her informed consent in writing
排除标准
- •Patients with large intestinal stenosis (more than 6cm) and multiples
- •Patients with previous or actual treatment with anti-tumor necrosis factor (anti-TNF) drugs
- •Patients with positive serology to hepatitis B virus(HBV),hepatitis C virus (HCV), or HIV
- •Patients with positive screening to Tuberculosis(positive PPD)
- •Established contraindication to anti-TNF drugs
- •Existence of fistulous tracts associated with intestinal stenosis
- •Neoplastic process associated with stenosis or in another location
- •Pregnancy or breastfeeding
研究组 & 干预措施
Adalimumab
Experimental
single administration of Adalimumab 80mg diluted in 5ml saline
干预措施: Adalimumab (Drug)
saline
Placebo Comparator
5 ml of saline
干预措施: placebo (Drug)
结局指标
主要结局
Success of endoscopic dilatation
时间窗: at week 8
Successful dilatation means the passage of the endoscope (or enteroscopy colonoscope) through the stenosis
次要结局
- success of endoscopic dilatation(at week 52)
- Mucosal healing(at week 8)
- Histological cure(at week 8)
- adverse events(at the end of the study)
- proportion of patients that develop anti-adalimumab antibodies(at the end of the study)
- Stenosis measure(baseline)
研究者
Sara Varea
Clinical Research Manager
Fundacion Clinic per a la Recerca Biomédica
研究点 (13)
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