MRI for early response prediction to anti-TNF therapy

Not Applicable

Completed

• Conditions: Crohn’s disease; Digestive System

• Registration Number: ISRCTN14481560
• Lead Sponsor: niversity College London

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-04-20
• Study Completion: 2023-12-31
• Last Update Posted: 8 January 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 219

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)

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Current primary outcome measure as of 07/01/2019:<br>Difference in sensitivity between stable or improved MRI-measured segmental small bowel motility versus normalisation of CRP at 20-28 weeks to predict response or remission (RoR) to anti-TNF? or anti-interleukin therapy at 1 year. <br><br>Previous primary outcome measure:<br>Difference in sensitivity between stable or improved segmental small bowel motility versus normalisation of CRP to predict response or remission (RoR) to anti-TNFa therapy at 1 year. Small bowel motility will be measured by MRI and CRP levels via a blood test at 0 and 20-28 weeks.