Vedolizumab Post Op Study

Vedolizumab is a monoclonal antibody developed by Millennium Pharmaceuticals, Inc for the treatment of ulcerative colitis and Crohn's disease. It binds to integrin α₄β₇. Blocking the α₄β₇ integrin results in gut-selective anti-inflammatory activity. Vedolizumab was been approved by the Food and Drug Administration (FDA) in 2014 for achieving clinical response, achieving clinical remission, and achieving corticosteroid-free remission in adult patients with moderately to severely active Crohn's disease. We believe that use of vedolizumab constitutes a non-significant risk to the research subject. The dose of vedolizumab administered is 300mg IV

Currently there are no clinical guidelines and no standard of care for the maintenance of surgically induced remission. There are no medications that have consistently been proven to be efficacious at preventing recurrent Crohn's disease and as such, no active equivalent arm is being used. Due to the lack of effective prophylactic therapy, many physicians and patients opt not to initiate medical therapy after surgery, rather wait until Crohn's disease recurs, or wait to perform a post-operative colonoscopy within 6-12 months of surgery, and decide on initiating Crohn's disease therapy based on endoscopic Rutgeerts; score. Therefore, acknowledging that many patients are not administered post-operative maintenance medications, we feel the placebo arm is justified.