NCT03142321

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Washington University School of Medicine · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Crohn Disease of Small Intestine

Interventions

Type	Name	Description
DRUG	Vedolizumab 300 MG Injection [Entyvio]	Vedolizumab Injection

Timeline

• Start date: 2018-06-08
• Primary completion: 2024-05-22
• Completion: 2024-10-28
• First posted: 2017-05-05
• Last updated: 2025-09-17
• Results posted: 2025-09-17

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study