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
Status: Recruiting
Location: See all (20) locations...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 4
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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
• Established CD diagnosis by conventional criteria
• 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)
• HBI ≥5
• Biologic-treatment naïve for CD-related therapies
• 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 which biologic class to start
• Willing and able to participate fully in all aspects of this clinical trial, including adherence to study protocol and treatment algorithm
• Written informed consent must be obtained and documented
Locations
Other Locations
Canada
GNRR Digestive Clinics and Research Center Inc.
NOT_YET_RECRUITING
Brampton
Rajbir Rai Medical Corporation
NOT_YET_RECRUITING
Brantford
University of Calgary
RECRUITING
Calgary
University of Alberta IBD Clinic
RECRUITING
Edmonton
Nova Scotia Health Victoria
ACTIVE_NOT_RECRUITING
Halifax
McMaster University
RECRUITING
Hamilton
London Health Sciences Centre
ACTIVE_NOT_RECRUITING
London
West GTA Research Inc.
NOT_YET_RECRUITING
Mississauga
Centre Hospitalier de l'Université de Montréal (CHUM)
RECRUITING
Montreal
Hôpital du Sacré-Cœur-de-Montréal
RECRUITING
Montreal
Research Institute of the McGill University Health Centre (MUHC)
RECRUITING
Montreal
ABP Research Services Corp.
NOT_YET_RECRUITING
Oakville
Taunton Surgical Center
NOT_YET_RECRUITING
Oshawa
The Ottawa Hospital Research Institute
RECRUITING
Ottawa
Université de Sherbrooke
NOT_YET_RECRUITING
Sherbrooke
Thunder Bay Regional Health Research Institute
ACTIVE_NOT_RECRUITING
Thunder Bay
Mount Sinai Hospital
RECRUITING
Toronto
TIDHI Clinic
ACTIVE_NOT_RECRUITING
Toronto
GI Research Institute (G.I.R.I)
NOT_YET_RECRUITING
Vancouver
West Coast Gastroenterology
NOT_YET_RECRUITING
Vancouver
Contact Information
Primary
Harsha Ashton
harsha.ashton@alimentiv.com
226-919-6959
Backup
Christopher Ma, MD MPH
christopher.ma@ucalgary.ca
4035925013
Time Frame
Start Date:2023-10-25
Estimated Completion Date:2028-12-31
Participants
Target number of participants:297
Treatments
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