Vedolizumab Post Op Study

Status Withdrawn

Clinical Trial Summary

This is a pilot study that will determine the endoscopic recurrence of Crohn's disease 12 months after curative, resective ileal or ileocolonic surgery in patients receiving post-operative vedolizumab (Entyvio) or placebo. The investigators hypothesize that the administration of post-operative vedolizumab will decrease the endoscopic recurrence of Crohn's disease.

Clinical Trial Description

Study aims: To determine the efficacy of vedolizumab in preventing mucosal recurrence of Crohn's disease in patients undergoing resective surgery.

Methods: This is a randomized, placebo-controlled pilot study that will determine the endoscopic recurrence of Crohn's disease 12 months after curative, resective ileal or ileocolonic surgery in patients receiving post-operative vedolizumab or placebo. Patients will receive the first infusion of vedolizumab (300 mg) or placebo (1:1 randomization) 2-4 weeks after surgery. Subsequent infusions of vedolizumab or placebo will occur at 2, 6, 14, 22, 30, 38, 46, and 54 weeks after the first infusion. The primary assessment for determination of drug efficacy will be presence or absence of mucosal inflammation (representing active Crohn's disease) at the ileocolonic anastomosis and neo-terminal ileum. This assessment will be made by colonoscopic inspection one year after surgery. Patients with an elevated fecal calprotectin at week 22 will undergo a 6-month post-operative clinical colonoscopy to assess for endoscopic recurrence.

Subject population: Patients scheduled for resectional surgery for ileal or ileocolonic Crohn's disease will be eligible for the study. Subjects will be male or female who are 18 years of age or older. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02834754
Study type	Interventional
Source	University of Pittsburgh
Contact
Status	Withdrawn
Phase	Phase 2
Start date	December 1, 2018
Completion date	May 1, 2019

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