Small Bowel Mucosal Healing Induced by Adalimumab in Crohn's Disease Patients as Assessed by Capsule Endoscopy
试验速览
- 阶段
- 不适用
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Complete mucosal healing
研究概览
简要总结
The study hypothesis is that adalimumab induces mucosal healing in the small bowel and that mucosal healing correlates with disease activity. 30 Patients with isolated active small bowel Crohn's disease which are candidates to receive anti-TNF treatment will be included in the study. All patients will undergo patency capsule examination and capsule endoscopy afterwards. Small bowel endoscopic disease severity will be assessed by the capsule endoscopy Crohn's disease activity index (CECDAI). The patients will receive Adalimumab (Humira)injections (160mg,80mg and 40mg every 2 weeks ) for 12 weeks. on week 14 a second capsule endoscopy will be performed and CECDAI calculated again. The patients clinical condition, CDAI,IBDQ and laboratory results including CRP, CBC and fecal calprotectin will be assessed on weeks o, 7 and 14 and results will be compared with the endoscopic score.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Isolated small bowel Crohn's disease.
- •Active disease (CDAI≥220).
排除标准
- •Known fixed stricture in the small intestine.
- •Former small bowel obstruction or obstructive symptoms.
- •Patients expected to undergo small bowel surgery in the near future or had intestinal surgery in the previous 6 months.
- •Colonic disease (except ileocecal valve area).
- •Anti-TNF treatment in the last 3 months.
- •Sensitivity or lack of response to previous adalimumab treatment.
- •Current gastrointestinal infection.
- •History of malignant disease (except BCC of skin).
- •Congestive heart failure, severe renal or hepatic dysfunction.
- •Patients suffering from tuberculosis, hepatitis B or C.
- •Pregnancy or unwillingness to use contraception during study period.
- •Dysphagia or swallowing disorders
- •Gastroparesis or severe gastrointestinal motility dysfunction.
- •Patients with cardiac pacemaker or implanted cardioverter devices.
- •Unable to sign informed consent.
结局指标
主要结局
Complete mucosal healing
时间窗: After 14 weeks of treatment
Complete mucosal healing of active inflammatory lesions in the small intestine, as assessed by capsule endoscopy
次要结局
- Partial mucosal healing(After 14 weeks of treatment)
- Correlation with clinical activity(After 14 weeks of treatment)