Vedolizumab Post Op Study
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|ClinicalTrials.gov Identifier: NCT02834754|
Recruitment Status : Withdrawn (Limited time for enrollment of required number of subjects)
First Posted : July 15, 2016
Last Update Posted : May 14, 2020
|Condition or disease||Intervention/treatment||Phase|
|Crohn's Disease||Drug: Vedolizumab Drug: placebo||Phase 2|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||A Randomized, Double-blind, Placebo Controlled Study of Vedolizumab for the Prevention of Post-operative Crohn's Disease Recurrence|
|Actual Study Start Date :||December 1, 2018|
|Actual Primary Completion Date :||May 1, 2019|
|Actual Study Completion Date :||May 1, 2019|
Vedolizumab infusions at weeks 0, 2, and 6 weeks, then every 8 weeks for 52 weeks
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
Other Name: entyvio
Placebo Comparator: placebo
Placebo infusions at weeks 0, 2, and 6 weeks, then every 8 weeks for 52 weeks
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.
- Endoscopic remission [ Time Frame: 54 weeks ]During a follow up colonoscopy, the Rutgeerts' score will be used to assess for endoscopic remission. An endoscopy score of i0 or i1 will be considered endoscopic remission and a score of i2 or higher denotes endoscopic recurrence. The endoscopic scoring system is as follows: Grade 0 normal distal ileum, Grade 1 up to 5 small aphthous ulcers, Grade 2 six or more aphthous ulcers with skip areas either at the ilocolonic anastomosis or proximal to it, Grade 3 diffuse aphthous ileitis with diffusely inflamed mucosa and Grade 4 diffuse inflammation with larger ulcers, nodules, and/or narrowing.
- clinical remission [ Time Frame: 54 weeks ]CDAI <150
- Histologic remission [ Time Frame: 54 weeks ]Geboes score
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02834754
|United States, Pennsylvania|
|University of Pittsburgh|
|Pittsburgh, Pennsylvania, United States, 15213|
|Principal Investigator:||Marc B Schwartz, MD||University of Pittsburgh|