EUCTR2012-001723-12-ES进行中（未招募）1 期
A randomized, double-blinded, placebo-controlled study on the effects of adalimumab intralesional intestinal strictures of Crohn's disease patients
Fundació Clínic per a la Recerca Biomèdica0 个研究点目标入组 102 人开始时间: 2013年8月14日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 102
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
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
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 1
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 1
排除标准
- •-Patients with large intestinal stenosis (more than 6cm) and multiples
- •-Patients with previous or actual treatment with anti-TNF drugs
- •-Patients with positive serology to HBV,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
研究者
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