Assessing small bowel Crohn's disease response to biologic therapy
Triangular Phenotyping and Response Assessment in Small Bowel Crohn's Disease Using Magnetic Resonance Enterography (MRE) and Novel Proteomic Biomarkers
This study is testing whether a new biologic therapy can help people with small bowel Crohn's disease feel better and stay off steroids after one year.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Washington University School of Medicine Academic / other |
| Drugs / interventions | vedolizumab, ustekinumab |
| Locations | 1 site (Saint Louis, Missouri) |
| Trial ID | NCT03646708 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the inflammatory activity of small bowel Crohn's disease (SBCD) by utilizing radiologic transmural response and a novel proteomic biomarker. A cohort of patients starting a new biologic therapy will be followed prospectively, with comprehensive phenotyping through advanced imaging techniques and clinical assessments. The study seeks to determine if corticosteroid-free remission can be achieved at 52 weeks post-initiation of biologic therapy, providing insights into effective management strategies for SBCD.
Who should consider this trial
Good fit: Ideal candidates include adults with confirmed small bowel Crohn's disease who are starting a new biologic therapy.
Not a fit: Patients who are pregnant or under 18 years of age will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more accurate assessments of Crohn's disease activity and improved treatment outcomes for patients.
How similar studies have performed: Other studies have shown promise in using similar imaging and biomarker approaches for assessing Crohn's disease, indicating potential for success in this novel application.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion: * Patient who have had a prior standard of care (SOC) ileocolonoscopy with biopsies confirming SBCD * And with active disease visible on a baseline MRE (small bowel only or ileocolonic disease) * And are being initiated on a biologic (anti-TNFs, vedolizumab and ustekinumab) approved for CD, regardless of their prior biologic exposure, will be recruited. * Prior studies have confirmed active SBCD noted on MRE as consistent with active disease using histopathology as reference standard.45 Exclusion: * Patients who are pregnant: Subjects will not be tested for pregnancy on protocol outside of standard of care and is usually done prior to clinical radiological and endoscopic testing for patients of childbearing potential per standard of care standard operating procedures. If any subject is found to be pregnant during the study they will be discontinued from the study visit protocol and managed by primary gastroenterologist per standard of care. * Less than 18 years of age * Unable to provide informed consent * Chronic kidney disease that precludes contrast administration * Implanted medical devices that are contraindicated for MRI * Individuals with colonic involvement without SB disease will also be excluded * Planned surgery prior to the first follow-up MRE * Inpatient scans will only be included if this is an MRE and adequate small bowel distension with appropriate contrast has been achieved, in the opinion of the radiology co-investigator. * Any subject condition or situation which, in the opinion of the Investigator or regulatory authorities, interferes with optimal study participation of the participant or produces/could produce significant risk to the subject.
Where this trial is running
Saint Louis, Missouri
- Washington University School of Medicine — Saint Louis, Missouri, United States (Recruiting)
Study contacts
- Principal investigator: Parakkal Deepak, MBBS, MS — Washington University School of Medicine
- Study coordinator: Darren Nix
- Email: nixd@wustl.edu
- Phone: 314-362-3201
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.