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

Primary Investigator: Mark Silverberg, MD
Enrolment: Ongoing

Objective: The objective is to identify differentially expressed genes between responders and non-responders to Infliximab therapy and to examine if significant gene expression differences exist between Infliximab-treated ulcerative colitis and Crohn’s Disease patients.

Expectation: This research will lead to a better understanding of why some people respond well to Infliximab and why others may not respond as well. This may lead to a better understanding of Crohn’s disease and ulcerative colitis and possibly help doctors decide if someone should start Infliximab therapy.

Eligibility: Anyone over the age of 18 who has a confirmed diagnosis of IBD (either Crohn's Disease or ulcerative colitis) and is about to start Infliximab in the near future (for the first time) and scheduled for a colonoscopy PRIOR to their first infusion. If you’re taking steroids, you must have been on oral steroids for at least 2 weeks or 7 days for intravenous steroids and be on a stable dose for at least one week prior to study start.

You are not eligible for this study if:

• You’ve had a prior history of colectomy
• You are pregnant
• You have been on Infliximab before
• You have an infection or inflammation not associated with IBD.

Participation:

Participation involves:

• Providing us with information regarding your family history and disease specifics
• A blood sample for research purposes
• Providing us with permission to review your medical information regarding IBD
• If you are scheduled to have a colonoscopy already as part of your routine clinical care, you may be asked if you're willing to provide tissue biopsies for research purposes during your colonoscopy
• Allowing us to follow you for up to 30 weeks after your first infusion with data and samples collected at the time of your routine check ups with your gastroenterologist. 

Background information:
Tumour necrosis factor-alpha blocking agents encompass some of the available therapies for Inflammatory Bowel Disease patients. Infliximab is one of the most popular and effective amongst them and is used in both Crohn’s Disease and Ulcerative colitis. Studies show that the majority of Inflammatory Bowel Disease patients undergoing Infliximab therapy experience beneficial effects from the drug. Nevertheless, a small number of patients experience moderate to severe adverse effects to Infliximab infusions. The potential risk for patients and the high cost of Infliximab therapy demand further research into the factors pertaining to therapy response. To date, there are no reliable predictors of Infliximab therapy outcome. With this study, we aim to identify differentially expressed genes between responders and non-responders to Infliximab therapy and to examine if significant gene expression differences exist between Infliximab-treated Ulcerative colitis and Crohn’s Disease patients.

We would like to sincerely thank all of our study participants. This research couldn't be possible without your cooperation.

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