NCT03142321CompletedPhase 4
Defining Predictors of RT Response to Vedolizumab in IBD
Defining Predictors of Radiological Transmural Response to Vedolizumab in Small Bowel Crohn's Disease Through Serum Proteomic Biomarkers
Source: ClinicalTrials.gov · Last updated 17 Sept 2025
Brief summary (registry, in English)
The overall goal of the study is to develop data that can convincingly guide clinicians on the use and efficacy of vedolizumab in patients with small bowel CD. There is an unmet need to identify response to vedolizumab in small bowel CD using objective endpoints. Current data suggest that MR enterography may meet this unmet need. There is an additional unmet need to develop predictive models incorporating both clinical and baseline radiological and endoscopic variables with higher discriminatory performance in identifying longer term clinical remission with vedolizumab. Finally, this proposal is strengthened by the exploratory studies which may identify new proteomic biomarkers that correlate with longer term radiological response with vedolizumab reflecting its latency of response. If successful, these serum biomarkers may guide a personalized approach to the treatment of small bowel CD with vedolizumab, allowing early identification of PNR, monitoring disease activity and the pharmacodynamics of vedolizumab.
- Status (registry)
- Completed
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 48 (actual)
- First submitted
- 3 May 2017
- Start date
- 8 Jun 2018
- Primary completion date
- 22 May 2024
- Lead sponsor
- Washington University School of Medicine
- Diseases
- Crohn's disease
- NCT number
- NCT03142321
What you commit to
- Study type: Interventional · Phase 4
- Participants enrolled: 48
- From 8 Jun 2018 to the primary completion date, 22 May 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Planned surgery prior to the first follow-up MRE
Other illness
- Contraindications for MRE including chronic kidney disease that precludes contrast administration, implanted medical devices that are contraindicated for MRE.
Age
- Age \<18
Other
- Pregnancy
- Inability to provide informed consent.
- Perianal CD will be excluded since assessment requires performance of additional MRI of the pelvis.
- Individuals with colonic involvement other than involvement of the ascending colon and cecum.
- Inpatient scans will only be included if this is a MRE and adequate small bowel distension with appropriate contrast has been achieved
- If unable to provide informed consent
Who the study is looking for
- Moderate to severe disease activity small bowel CD (small bowel only or ileocecal only) visible on MRE
- Initiated on Vedolizumab with/without thiopurines or methotrexate
- ≥18 years old
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Washington University School of Medicine Coordinator of this site? Confirm its status | St Louis | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.