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Clinical Trial for Perianal Fistulizing Crohn’s Disease

Details of Research

Contact: Joanne Stempak, Project Manager
416-586-4800 ext 8399
joanne.stempak@sinaihealth.ca

Primary Investigator: Mark Silverberg, MD

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 with perianal fistulas.

We are looking for individuals:

  • With Crohn’s Disease and perianal fistula(s).
  • Experiencing symptoms related to their Crohn’s Disease and perianal fistulas.
  • Have previously and/or currently not responded to the following standard treatments:
    - Antibiotics (e.g., Ciprofloxacin, Flagyl)
    - Immunosuppressants (e.g., Imuran, 6-MP)
    - Biologic Therapy (e.g., Remicade, Humira, Simponi)

Description of Clinical Trial:

This study will last up to 24 weeks, during which you will see the study doctor and/or coordinator 10 times. Your Crohn’s Disease and perianal fistula(s) will be assessed and, if eligible, participants will be randomized in a 2:2:1 ratio to receive either high dose study medication, low dose study medication, or placebo ("dummy" drug) for 24 weeks. If your Crohn’s Disease has not improved by week 10 of the study, you may be eligible for future studies done by the sponsor. Reimbursement will be provided for study-related travel expenses.

Please contact Joanne Stempak (phone 416-586-4800 x8399) if you are interested in participating in this study.