Defining Predictors of RT Response to Vedolizumab in IBD

  • STATUS
    Recruiting
  • End date
    Jun 28, 2023
  • participants needed
    80
  • sponsor
    Washington University School of Medicine
Updated on 4 March 2022

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.

Details
Condition Crohn Disease of Small Intestine
Treatment Vedolizumab 300 MG Injection [Entyvio]
Clinical Study IdentifierNCT03142321
SponsorWashington University School of Medicine
Last Modified on4 March 2022

Eligibility

Yes No Not Sure

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
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
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