Crohn’s disease Digestive System Crohn’s disease
Conditions
Interventions
Current interventions as of 07/01/2019:
Eligible patients will be recruited consecutively. All patients will undergo all tests at baseline (prior to beginning the standard biological therapy), at 20 –
a blood test that measures plasma concentration of a protein produced by the body in response to inflammation
Secondary comparator: Faecal calprotectin
a stool sample that measures the level of a granulocyte protein that is released into the bowel in response to inflammation
Patients will be followed up for 1 year after starting biological therapy.
Sponsors
University College London
Eligibility
Sex/Gender
All
Inclusion criteria
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
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measure as of 07/01/2019: 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. Previous primary outcome measure: 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 07/01/2019: 1. Difference in specificity between stable or improved small bowel motility versus normalisation of C-reactive protein to predict RoR at 1 year. Small bowel motility will be measured by MRI and CRP levels via a blood test at 0 and 20-28 weeks 2. Difference in area under the receiver operating characteristic curve (ROC AUC) in continuous small bowel motility and in C-reactive protein levels to predict RoR at 1 year. Small bowel motility will be measured by MRI and CRP levels via blood test at 0 and 20-28 weeks 3. Difference in prognostic accuracy to predict clinically significant improvements in each quality of life measure at 1 year between continuous small bowel motility MR score versus changes in C-reactive protein levels . Quality of life will be measured by EQ-5D-5L, CUCQ-8 and IBD-Control 8 questionnaires at 20-28 weeks and 1 year. Small bowel motility will be measured by MRI and CRP levels via blood test at 0 and 20-28 weeks 4. Difference in both sensitivity, specificity and ROC AUC between stable or improved small bowel motility versus normalisation of Faecal Calprotectin predict RoR at 1 year. Small bowel motility will be measured by MRI and calprotectin levels via a stool test at 0 and 20-28 weeks 5. Difference in prognostic accuracy to predict clinically significant improvements in each quality of life measure at 1 year between continuous small bowel motility MR score versus changes in faecal calprotectin levels. Quality of life will be measured by EQ-5D-5L, CUCQ-8 and IBD-Control 8 questionnaires at 0, 20-28 and 52 weeks. Small bowel motility will be measured by MRI and calprotectin levels via a stool test at 0, 20-28 weeks and 52 weeks 6. Difference in prognostic accuracy and incremental prognostic value of multivariate prognostic models including MRI-measured small bowel motility versus those including (i) C-reactive protein and (ii) faecal calprotectin for response to anti-TNFa or anti-interleukin | — |
Countries
England, United Kingdom
Outcome results
None listed