Evaluating the Best First Treatment Choice Among Approved Biologics for Moderate-to-Severe Ileal Crohns Disease

What this Trial Is About

Researchers are evaluating which of three types of approved biologic treatmentsanti-tumor necrosis factor TNF alpha, anti-integrin, or anti-interleukin IL-23 agentsis most effective for patients with moderate-to-severe Crohns disease that primarily affects the small bowel ileal region. The study aims to find out which treatment leads to the highest number of patients achieving healing of small bowel ulcers without needing corticosteroids after one year. This phase 4 trial uses treatments already approved by Health Canada. Participants will be randomly assigned to one of three treatment groups TNF alpha antagonists infliximab given intravenously or adalimumab injected under the skin, anti-integrin agents vedolizumab administered intravenously or intravenously plus subcutaneously, or anti-IL23 agents ustekinumab or risankizumab given intravenously then subcutaneously. All treatments follow standard care dosing schedules with initial doses followed by maintenance doses at regular intervals. Those on corticosteroids will begin tapering within six weeks of starting biologics. During the 12-month study, participants will be monitored at months 4, 8, and 12 for clinical symptoms, quality of life, and biomarkers like C-reactive protein and fecal calprotectin. At the end of the study, a video-recorded ileocolonoscopy will assess healing of ileal ulcers. Other outcomes include tracking Crohns disease complications, treatment persistence, and safety. Participants will be followed according to routine care guidelines throughout the trial.

PATHFINDER: Evaluating the Optimal First-Line Treatment Strategy for Moderate-to-Severely Active Ileal-dominant Crohn's Disease