ISRCTN14481560Completed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 sites219 target enrollmentStarted: April 20, 2017Last updated:
Conditions
Trial Snapshot
- Phase
- 未知
- Status
- Completed
- Sponsor
- Enrollment
- 219
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Observational
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •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)
Exclusion Criteria
- •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)
Investigators
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