Clinical trial NCT03142321: Defining Predictors of RT Response to Vedolizumab in IBD
Official title: Defining Predictors of Radiological Transmural Response to Vedolizumab in Small Bowel Crohn's Disease Through Serum Proteomic Biomarkers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Crohn Disease of Small Intestine
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2017-05-05
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


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.

Primary outcomes:
measure: Radiological response
timeFrame: 16±2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Parakkal Deepak, MBBS, MS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Deepak P, Fletcher JG, Fidler JL, Barlow JM, Sheedy SP, Kolbe AB, Harmsen WS, Loftus EV, Hansel SL, Becker BD, Bruining DH. Radiological Response Is Associated With Better Long-Term Outcomes and Is a Potential Treatment Target in Patients With Small Bowel Crohn's Disease. Am J Gastroenterol. 2016 Jul;111(7):997-1006. doi: 10.1038/ajg.2016.177. Epub 2016 May 10.