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Clinical Trial for a new medication in Crohn's Disease

Details of Research

Contact:
Shlomit Boguslavsky, Clinical Research Coordinator
416-586-4800 ext. 4989
Shlomit.Boguslavsky@sinaihealth.ca

Primary Investigator: Dr. Hillary Steinhart

Enrolment: Ongoing

Mount Sinai Hospital is participating in a research study to understand the safety and effectiveness of a investigational medication for treating Crohn’s Disease.
This medicaion is given both intravenously and subcutaneously (by injection)

We are looking for individuals:

  • With Crohn’s Disease.
  • Experiencing symptoms related to their Crohn’s Disease.
  • Have previously and/or currently not responded to one of the following standard treatments:
    - Aminosalicylates (e.g. 5-ASA – Mezavant, Pentasa, Salofalk etc)
    - Corticosteroids (e.g. Prednisone, Budesonide)
    - Immunosuppressants (e.g., Imuran, Methotrexate, 6-MP)
    - Biologic Therapy (e.g., Remicade, Humira, vedolizumab, natalizumab)

Description of Clinical Trial:

This study will last up to 24 weeks. Your Crohn’s Disease will be assessed and, if eligible, participants will be randomized in a 2:2:1 ratio to receive either high dose study medication or low dose study medication or placebo ("dummy" drug). If your Crohn’s Disease has not improved by week 12 of the study, you may be eligible for the open-label (no placebo) portion of the study. Reimbursement will be provided for study-related travel expenses.