PATHFINDER: Evaluating the Optimal First-Line Treatment Strategy for Moderate-to-Severely Active Ileal-dominant Crohn's Disease
PATHFINDER: A Pragmatic, Active-comparator, Parallel-group, Randomized Trial to Evaluate the Optimal First-line Treatment Strategy for Moderate-to-Severely Active Ileal-dominant Crohn's Disease
University of Calgary
297 participants
Oct 25, 2023
INTERVENTIONAL
Conditions
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.
Eligibility
Plain Language Summary
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Interventions
• Infliximab 5 mg/kg intravenously \[IV\] at weeks 0, 2, 6, then 5 mg/kg every 8 weeks
• Adalimumab subcutaneously \[SC\] 160 mg at week 0, 80 mg at week 2, then 40 mg every 2 weeks
• Ustekinumab \~6 mg/kg IV x1, then 90 mg SC every 8 weeks
• Risankizumab 600 mg IV at weeks 0, 4, and 8, then 360 mg SC every 8 weeks
• Vedolizumab 300 mg IV at weeks 0, 2, and 6, then every 8 weeks
• Vedolizumab 300 mg IV at weeks 0 and 2, then 108 mg SC every 2 weeks
Locations(20)
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NCT05928039