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

Sponsor
University of Calgary
Study ID
NCT05928039
Phase
PHASE4
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • TNFa Antagonist - Infliximab — BIOLOGICAL
    • Infliximab 5 mg/kg intravenously \[IV\] at weeks 0, 2, 6, then 5 mg/kg every 8 weeks
  • TNFa Antagonist - Adalimumab — BIOLOGICAL
    • Adalimumab subcutaneously \[SC\] 160 mg at week 0, 80 mg at week 2, then 40 mg every 2 weeks
  • Anti-IL12/23 or anti-IL23 - Ustekinumab — BIOLOGICAL
    • Ustekinumab \~6 mg/kg IV x1, then 90 mg SC every 8 weeks
  • Anti-IL12/23 or anti-IL23 - Risankizumab — BIOLOGICAL
    • Risankizumab 600 mg IV at weeks 0, 4, and 8, then 360 mg SC every 8 weeks
  • Anti-integrin - Vedolizumab IV — BIOLOGICAL
    • Vedolizumab 300 mg IV at weeks 0, 2, and 6, then every 8 weeks
  • Anti-integrin - Vedolizumab IV and SC — BIOLOGICAL
    • Vedolizumab 300 mg IV at weeks 0 and 2, then 108 mg SC every 2 weeks

Study Details

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.

Key Dates

Start date
Oct 25, 2023
Status verified
Jun 2025
Primary completion
Jul 30, 2027
Completion
Dec 31, 2028

Study Design

Enrollment
297 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: TNFα antagonist
    Participants will receive either: * Infliximab 5 mg/kg intravenously \[IV\] at weeks 0, 2, 6, then 5 mg/kg every 8 weeks; OR * Adalimumab subcutaneously \[SC\] 160 mg at week 0, 80 mg at week 2, then 40 mg every 2 weeks
  • Active Comparator: Anti-IL12/23 or anti-IL23
    Participants will receive either: * Ustekinumab \~6 mg/kg IV x1, then 90 mg SC every 8 weeks; OR * Risankizumab 600 mg IV at weeks 0, 4, and 8, then 360 mg SC every 8 weeks
  • Active Comparator: Anti-integrin
    Participants will receive either: * Vedolizumab 300 mg IV at weeks 0, 2, and 6, then every 8 weeks; OR * Vedolizumab 300 mg IV at weeks 0 and 2, then 108 mg SC every 2 weeks

Primary Outcome Measure

Corticosteroid-free endoscopic remission [ Time Frame: 1 year ]

Central Contacts

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