Defining Predictors of RT Response to Vedolizumab in IBD
| Status: | Recruiting |
|---|---|
| Conditions: | Crohns Disease |
| Therapuetic Areas: | Gastroenterology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 6/14/2018 |
| Start Date: | June 8, 2018 |
| End Date: | June 2021 |
| Contact: | Billy D Nix |
| Email: | nixd@wustl.edu |
| Phone: | 314-362-3201 |
Defining Predictors of Radiological Transmural Response to Vedolizumab in Small Bowel Crohn's Disease Through Serum Proteomic Biomarkers
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.
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.
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.
We found this trial at
1
site
660 S Euclid Ave
Saint Louis, Missouri 63110
Saint Louis, Missouri 63110
(314) 362-5000
Phone: 314-362-3201
Washington University School of Medicine Washington University Physicians is the clinical practice of the School...
Click here to add this to my saved trials
