PATHFINDER: Evaluating the Optimal First-Line Treatment Strategy for Moderate-to-Severely
There are currently three classes of biologic treatments approved in Canada for the management of moderate-to-severe Crohn's disease: anti-tumor necrosis factor \[TNF\] alpha, anti-integrin, and anti-interleukin \[IL\]-23 targeted agents. The purpose of this trial is to determine which of these three classes of biologi
| Condition(s) | Crohn Disease |
|---|---|
| Status | Recruiting |
| Phase | Phase 4 |
| Study type | Interventional |
| Summary | There are currently three classes of biologic treatments approved in Canada for the management of moderate-to-severe Crohn's disease: anti-tumor necrosis factor \[TNF\] alpha, anti-integrin, and anti-interleukin \[IL\]-23 targeted agents. The purpose of this trial is to determine which of these three classes of biologics results in the highest percentage of patients with small bowel (ileal) Crohn's disease entering into endoscopic remission without needing corticosteroids at 1 year. Endoscopic remission means that the ulcers in the small bowel from Crohn's disease have healed. All treatments in this trial are approved by Health Canada. No experimental drugs will be included. |
| Who can participate | Inclusion Criteria: 1. Male or nonpregnant, nonlactating females, 18 years of age or older. Females of childbearing potential must have a negative serum or urine pregnancy test prior to randomization 2. Established CD diagnosis by conventional criteria 3. Baseline colonoscopy within 3 months of the first day of the screening period, with photo or video documentation of at least one large ileal ulcer \>5 mm and ileal segment SES-CD ≥4 (eligibility will be determined by local endoscopist, with subsequent confirmation by a CR at a later time, post enrolment) 4. HBI ≥5 5. Biologic-treatment naïve for CD-related therapies 6. Would otherwise have been eligible to start a biologic for moderate-to-severely active CD as part of their routine clinical care and for whom there is equipoise around whic |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | University of Calgary |
| Locations | Calgary, Alberta, Canada; Edmonton, Alberta, Canada; Vancouver, British Columbia, Canada; Vancouver, British Columbia, Canada; Halifax, Nova Scotia, Canada; Brampton, Ontario, Canada (+14 more sites) |
| Start date | 2023-10-25 |
| NCT ID | NCT05928039 |
| Official listing | https://clinicaltrials.gov/study/NCT05928039 |