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

PHASE4RecruitingINTERVENTIONAL
Enrollment

297

Participants

Timeline

Start Date

October 25, 2023

Primary Completion Date

July 30, 2027

Study Completion Date

December 31, 2028

Conditions
Crohn Disease
Interventions
BIOLOGICAL

TNFa Antagonist - Infliximab

• Infliximab 5 mg/kg intravenously \[IV\] at weeks 0, 2, 6, then 5 mg/kg every 8 weeks

BIOLOGICAL

TNFa Antagonist - Adalimumab

• Adalimumab subcutaneously \[SC\] 160 mg at week 0, 80 mg at week 2, then 40 mg every 2 weeks

BIOLOGICAL

Anti-IL12/23 or anti-IL23 - Ustekinumab

• Ustekinumab \~6 mg/kg IV x1, then 90 mg SC every 8 weeks

BIOLOGICAL

Anti-IL12/23 or anti-IL23 - Risankizumab

• Risankizumab 600 mg IV at weeks 0, 4, and 8, then 360 mg SC every 8 weeks

BIOLOGICAL

Anti-integrin - Vedolizumab IV

• Vedolizumab 300 mg IV at weeks 0, 2, and 6, then every 8 weeks

BIOLOGICAL

Anti-integrin - Vedolizumab IV and SC

• Vedolizumab 300 mg IV at weeks 0 and 2, then 108 mg SC every 2 weeks

Trial Locations (20)

Unknown

RECRUITING

University of Calgary, Calgary

RECRUITING

University of Alberta IBD Clinic, Edmonton

NOT_YET_RECRUITING

GI Research Institute (G.I.R.I), Vancouver

NOT_YET_RECRUITING

West Coast Gastroenterology, Vancouver

ACTIVE_NOT_RECRUITING

Nova Scotia Health Victoria, Halifax

NOT_YET_RECRUITING

GNRR Digestive Clinics and Research Center Inc., Brampton

NOT_YET_RECRUITING

Rajbir Rai Medical Corporation, Brantford

RECRUITING

McMaster University, Hamilton

ACTIVE_NOT_RECRUITING

London Health Sciences Centre, London

NOT_YET_RECRUITING

West GTA Research Inc., Mississauga

NOT_YET_RECRUITING

ABP Research Services Corp., Oakville

NOT_YET_RECRUITING

Taunton Surgical Center, Oshawa

RECRUITING

The Ottawa Hospital Research Institute, Ottawa

ACTIVE_NOT_RECRUITING

Thunder Bay Regional Health Research Institute, Thunder Bay

RECRUITING

Mount Sinai Hospital, Toronto

ACTIVE_NOT_RECRUITING

TIDHI Clinic, Toronto

RECRUITING

Centre Hospitalier de l'Université de Montréal (CHUM), Montreal

RECRUITING

Hôpital du Sacré-Cœur-de-Montréal, Montreal

RECRUITING

Research Institute of the McGill University Health Centre (MUHC), Montreal

NOT_YET_RECRUITING

Université de Sherbrooke, Sherbrooke

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Alimentiv Inc.

OTHER

lead

University of Calgary

OTHER

NCT05928039 - PATHFINDER: Evaluating the Optimal First-Line Treatment Strategy for Moderate-to-Severely Active Ileal-dominant Crohn's Disease | Biotech Hunter | Biotech Hunter