Clinical Trial: Vedolizumab Induction May Prevent Celiac Enteritis

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: Vedolizumab Induction May Prevent Celiac Enteritis After Gluten Challenge in Established Celiac Patients in Histological Remission

Brief Summary: Celiac disease (CD) is characterized as an autoimmune disorder whereby gluten (a protein found in wheat, barley, rye, malt) induces an immunological response in genetically susceptible individuals. The prevalence of CD has been estimated to affect 0.5-1% of the population worldwide. Long term sequelae are numerous and include risk of lymphoma, malabsorption leading to weight loss, anemia, multiple vitamin deficiencies, osteoporosis/osteopenia, secondary autoimmunity, etc. (1)

Detailed Summary: Adult subjects with CD will be recruited through our clinic. All patients enrolled will have established CD diagnosed > 6 months. All patients will have history of abnormal MARSH score on initial duodenal biopsy at diagnosis and MARSH 0 on repeat biopsy following a gluten free diet (GFD). All patients will also have positive celiac serologies (anti-TTG, anti-gliadin, etc.) at diagnosis, as well as, positive HLA DQ2/DQ8 genetic profile. At enrollment, all patients will have negative celiac serologies, indicative of serologic remission on a gluten free diet. Female subjects of childbearing potential (does not include those with history of tubal ligation/surgical sterilization, hysterectomy and/or oophorectomy) who are sexually active with a non-sterilized male partners agree to routinely use adequate contraception from signing informed consent, during study process and for an additional 18 weeks after the last dose of vedolizumab. A male subject who is non-sterilized and sexually active with a female partner of childbearing potential agrees to use adequate contraception from signing informed consent throughout the duration of the study and for 18 weeks after the last dose.
Sponsor: AGA Clinical Research Associates, LLC

Current Primary Outcome:

• Normal histopathology following induction dosing with vedolizumab [ Time Frame: 12 weeks ]
  Remission is defined in this study of negative celiac antibodies and normal duodenal biopsies
• Normal histopathology following induction dosing with vedolizumab after 2 week gluten challange [ Time Frame: 12 weeks ]
  Remission is defined in this study as negative celiac antibodies and normal duodenal biopsies

Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: AGA Clinical Research Associates, LLC

Dates:
Date Received: October 5, 2016
Date Started: October 2016
Date Completion: December 2017
Last Updated: October 7, 2016
Last Verified: October 2016