Study to Assess Mucosal Healing in Subjects With Moderately to Severely Active Crohn’s Disease Treated With Vedolizumab IV

What we are studying

The purpose of this study is to investigate the efficacy and safety of Vedolizumab on mucosal healing in subjects with moderate to severe active CD. Vedolizumab has been approved in several regions, including the United States (US), European Union (EU), and Australia for the treatment of adult patients with moderately to severely active CD or Ulcerative Colitis (UC) who have failed conventional treatment, (eg, immunomodulators, corticosteroids, or tumor necrosis factor-alpha (TNF-?) antagonists). The use of vedolizumab in this study is investigational. This study will look at how effective vedolizumab is at treating CD by viewing the gut using a multiple approach.

Who we are studying

  • Men and Women
  • Races:
    • White
    • African American
    • Asian
    • American Indian or Alaska Native
    • Native Hawaiian or Pacific Islander
    • Other
  • Hispanic or Latino
  • Ages 18 - 80

Eligibility Criteria

  • A diagnosis of moderate to severe Crohn's Disease for at least 3 months

What is involved

  • 1 year study involving 8 visits with a telephone followup
  • 3 colonoscopies
  • 6 bloods draws
  • Keep stool diary throughout
  • Agree to study prescribed methods of birth control

Compensation

$50.00 per visit issued as check at end of study or early withdrawal

Contact Information

Study Coordinator
Barbara Lasater
Email
blasater@wakehealth.edu
Phone
336-713-7319
Principal Investigator
Richard S Bloomfeld, MD

Disclaimer: The information on this website is for general informational purposes only and SHOULD NOT be relied upon as a substitute for sound professional medical advice, evaluation or care from your physician or other qualified health care provider.