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Clinical Trial 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.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT03142321
Study type Interventional
Source Washington University School of Medicine
Contact
Status Active, not recruiting
Phase Phase 4
Start date June 8, 2018
Completion date January 31, 2025

See also
  Status Clinical Trial Phase
Not yet recruiting NCT05636657 - Comparative Study of Intestinal Color Ultrasound and Capsule Endoscopy in Monitoring Crohn's Disease