Actively Recruiting
PATHFINDER: Evaluating the Optimal First-Line Treatment Strategy for Moderate-to-Severely Active Ileal-dominant Crohn's Disease
Led by University of Calgary · Updated on 2025-06-11
297
Participants Needed
20
Research Sites
270 weeks
Total Duration
On this page
Sponsors
U
University of Calgary
Lead Sponsor
A
Alimentiv Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
PATHFINDER: Evaluating the Optimal First-Line Treatment Strategy for Moderate-to-Severely Active Ileal-dominant Crohn's Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or nonpregnant, nonlactating females, 18 years of age or older
- Negative pregnancy test for females of childbearing potential before randomization
- Confirmed diagnosis of Crohn's disease by standard criteria
- Baseline colonoscopy within 3 months showing at least one large ileal ulcer >5 mm and ileal segment SES-CD ≥4
- Harvey Bradshaw Index score of 5 or higher
- No prior biologic treatment for Crohn's disease
- Eligible to start biologic therapy for moderate-to-severe Crohn's disease with clinical equipoise
- Willing and able to follow all study procedures and treatment plans
- Provided written informed consent
You will not qualify if you...
- Any condition that contraindicates the biologics used in this study
- Crohn's complications such as symptomatic, endoscopically impassable strictures or abscesses requiring imminent surgery
- Current or past colonic dysplasia or cancer, toxic megacolon, or fulminant colitis
- Bowel surgery within 3 months before screening
- Active enteric infections including bacterial, viral, or parasitic infections
- Known active hepatitis B, hepatitis C, or HIV infection
- Active COVID-19 infection during screening
- Positive tuberculosis test or history of untreated latent or active tuberculosis
- History of cancer within 5 years except certain fully treated skin or cervical cancers
- Active infections needing systemic antimicrobial treatment during screening
- Serious diseases besides Crohn's that interfere with study participation
- Unwillingness to avoid prohibited medications during the trial
- Previous or current treatment with TNF antagonists, anti-integrin, anti-IL12/23 or IL-23 antibodies, JAK inhibitors, or S1P receptor modulators
- History of alcohol or drug abuse impacting study compliance
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 20 locations
1
University of Calgary
Calgary, Alberta, Canada
Actively Recruiting
2
University of Alberta IBD Clinic
Edmonton, Alberta, Canada
Actively Recruiting
3
GI Research Institute (G.I.R.I)
Vancouver, British Columbia, Canada
Not Yet Recruiting
4
West Coast Gastroenterology
Vancouver, British Columbia, Canada
Not Yet Recruiting
5
Nova Scotia Health Victoria
Halifax, Nova Scotia, Canada
Active, Not Recruiting
6
GNRR Digestive Clinics and Research Center Inc.
Brampton, Ontario, Canada
Not Yet Recruiting
7
Rajbir Rai Medical Corporation
Brantford, Ontario, Canada
Not Yet Recruiting
8
McMaster University
Hamilton, Ontario, Canada
Actively Recruiting
9
London Health Sciences Centre
London, Ontario, Canada
Active, Not Recruiting
10
West GTA Research Inc.
Mississauga, Ontario, Canada
Not Yet Recruiting
11
ABP Research Services Corp.
Oakville, Ontario, Canada
Not Yet Recruiting
12
Taunton Surgical Center
Oshawa, Ontario, Canada
Not Yet Recruiting
13
The Ottawa Hospital Research Institute
Ottawa, Ontario, Canada
Actively Recruiting
14
Thunder Bay Regional Health Research Institute
Thunder Bay, Ontario, Canada
Active, Not Recruiting
15
Mount Sinai Hospital
Toronto, Ontario, Canada
Actively Recruiting
16
TIDHI Clinic
Toronto, Ontario, Canada
Active, Not Recruiting
17
Centre Hospitalier de l'Université de Montréal (CHUM)
Montreal, Quebec, Canada
Actively Recruiting
18
Hôpital du Sacré-Cœur-de-Montréal
Montreal, Quebec, Canada
Actively Recruiting
19
Research Institute of the McGill University Health Centre (MUHC)
Montreal, Quebec, Canada
Actively Recruiting
20
Université de Sherbrooke
Sherbrooke, Quebec, Canada
Not Yet Recruiting
Research Team
H
Harsha Ashton
CONTACT
C
Christopher Ma, MD MPH
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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