ISRCTN14481560已完成未知
MOTILITY: Small bowel motility quantified by cine MRI as a predictor of long term response in patients with Crohn’s disease commencing biological therapy: A prognostic accuracy study
niversity College London0 个研究点目标入组 219 人开始时间: 2017年4月20日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 219
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 性别
- All
入选标准
- •Current participant inclusion criteria as of 07/01/2019:
- •1. Patients aged 16 years or more with active luminal small bowel Crohn’s disease, with or without colonic disease
- •2. Disease distribution and activity documented by ileocolonoscopy or (for patients with endoscopically-inaccessible disease) magnetic resonance enterography (MRE), enteric ultrasound (US), computed tomography (CT), barium fluoroscopic follow – through (BaFT) or video capsule endoscopy (VCE) performed as part of usual clinical care within the previous 3 months of starting eligible biological therapy
- •3. Scheduled to commence or recommence eligible biological treatment (including biosimilars); specifically anti-TNF and anti-interleukin agents.
- •4. The primary target of therapy, in the opinion of the treating physician, is small bowel disease (with or without treatment of concomitant colonic disease).
- •Previous participant inclusion criteria:
- •1. Patients aged 16 years or more with active luminal small bowel Crohn’s disease, with or without colonic disease
- •2. Disease distribution and activity documented by ileocolonoscopy or (for patients with endoscopically-inaccessible disease) magnetic resonance enterography (MRE) performed as part of usual clinical care within the previous 3 months
- •3. Scheduled to commence anti-TNFa treatment (including biosimilars) for the first time
- •4. The primary target of therapy, in the opinion of the treating physician, is small bowel disease (with or without treatment of concomitant colonic disease)
排除标准
- •Current participant exclusion criteria as of 07/01/2019:
- •1. Biological therapies other than anti-TNF and anti-interleukin agents, such as anti – integrin therapy (e.g. vedolizumab)
- •2. Primary target of therapy is limited to colonic or perianal fistulising disease
- •3. mMRI contraindicated (e.g. MRI-incompatible cardiac pacemaker, unable to lie flat, pregnancy)
- •4. Any psychiatric or other disorder precluding informed consent
- •5. Small bowel surgery within the preceding 3 months
- •6. Small bowel stricture causing upstream dilatation on imaging or endoscopy (defined as a >50% increase in diameter in comparison to the adjacent small bowel segment)
- •Previous participant exclusion criteria:
- •1. Primary target of therapy is limited to colonic or perianal fistulising disease
- •2. mMRI contraindicated (e.g. MRI-incompatible cardiac pacemaker, unable to lie flat, pregnancy)
- •3. Any psychiatric or other disorder precluding informed consent
- •4. Small bowel surgery within the preceding 3 months
- •5. Small bowel stricture causing upstream dilatation on imaging or endoscopy (defined as a >50% increase in diameter in comparison to the adjacent small bowel segment)
研究者
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