Grant: Project Grant

Crohn's disease (CD) is a chronic, life-long, bowel disease without a cure. Most patients with CD have inflammation in the last portion of the small bowel, called the ileum. Patients with inflammation predominantly in the ileum (ileal CD) are at higher risk for bowel damage resulting in complications that require surgery. Early and appropriate treatment of this type of CD is critical to preventing these poor outcomes. Over the past 20 years, several advanced medical treatments for CD called biologics have been approved. Currently, three classes of biologics are available in Canada (anti-TNF, anti-integrin, and anti-IL12/23). While all three classes are effective and safe, there is no data to guide which of these therapies is the best first option treatment in ileal CD. This is an important decision but currently, factors such as insurance coverage or personal preference are used to make this choice, rather than data about which therapy is most effective and safe. PATHFINDER is a Canadian trial done at multiple centers that will evaluate which of these classes of biologic treatment is best for achieving bowel healing. Patients with ileal CD who need a biologic will be randomly prescribed treatment with anti-TNF, anti-integrin, or anti-IL12/23. Patients will then have bloodwork and stool testing for inflammation at 4, 8, and 12 months, and undergo a colonoscopy to evaluate bowel healing at one year. Prior to embarking on PATHFINDER, we propose conducting a smaller preliminary pilot study to ensure that there are enough patients who would participate, that the trial procedures are acceptable to patients, and that the participating sites can successfully conduct the study. PATHFINDER will be adjusted based on feedback from this preliminary study, maximizing the chances that the full PATHFINDER trial will be able to inform one of the most important clinical decisions for patients, providers, and payors.