Phase 4
Completed N=48
Defining Predictors of RT Response to Vedolizumab in IBD
Crohn Disease of Small Intestine
Source: ClinicalTrials.gov NCT03142321 ↗
Enrolled (actual)
48
Serious AEs
0.0%
Results posted
Sep 2025
Primary outcomePrimary: Radiological Response — 21; 16 participants
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Radiological Response |
12; 9 | — |
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- Pregnancy
- Age <18
- Planned surgery prior to the first follow-up MRE
- 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
- Contraindications for MRE including chronic kidney disease that precludes contrast administration, implanted medical devices that are contraindicated for MRE.
Data sourced from ClinicalTrials.gov (NCT03142321). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.