PATHFINDER: Evaluating the Optimal First-Line Treatment Strategy for Moderate-to-Severely Active Ileal-dominant Crohn's Disease
NCT ID: NCT05928039
Last Updated: 2025-06-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
297 participants
INTERVENTIONAL
2023-10-25
2028-12-31
Brief Summary
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Detailed Description
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The dosing will be as follows:
TNFα antagonist
* 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
Anti-integrin
* 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
Anti-IL23 targeted agents
* 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
All treatments will be administered as part of the participant's routine care. All participants will be monitored per standard of care. Participants on corticosteroids at baseline will begin a steroid taper within 6 weeks of starting their biologic. At months 4, 8 and 12 participants will be evaluated for the Harvey Bradshaw Index (HBI), EuroQOL 5-domain questionnaire (EQ-5D), and be tested for C-reactive protein and fecal calprotectin concentrations. At month 12 patients will undergo a video-recorded ileocolonoscopy to determine if they have achieved endoscopic remission.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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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
TNFa Antagonist - Infliximab
• Infliximab 5 mg/kg intravenously \[IV\] at weeks 0, 2, 6, then 5 mg/kg every 8 weeks
TNFa Antagonist - Adalimumab
• 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
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
Anti-IL12/23 or anti-IL23 - Ustekinumab
• Ustekinumab \~6 mg/kg IV x1, then 90 mg SC every 8 weeks
Anti-IL12/23 or anti-IL23 - Risankizumab
• Risankizumab 600 mg IV at weeks 0, 4, and 8, then 360 mg SC every 8 weeks
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
Anti-integrin - Vedolizumab IV
• Vedolizumab 300 mg IV at weeks 0, 2, and 6, then every 8 weeks
Anti-integrin - Vedolizumab IV and SC
• Vedolizumab 300 mg IV at weeks 0 and 2, then 108 mg SC every 2 weeks
Interventions
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TNFa Antagonist - Infliximab
• Infliximab 5 mg/kg intravenously \[IV\] at weeks 0, 2, 6, then 5 mg/kg every 8 weeks
TNFa Antagonist - Adalimumab
• 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
• Ustekinumab \~6 mg/kg IV x1, then 90 mg SC every 8 weeks
Anti-IL12/23 or anti-IL23 - Risankizumab
• Risankizumab 600 mg IV at weeks 0, 4, and 8, then 360 mg SC every 8 weeks
Anti-integrin - Vedolizumab IV
• Vedolizumab 300 mg IV at weeks 0, 2, and 6, then every 8 weeks
Anti-integrin - Vedolizumab IV and SC
• Vedolizumab 300 mg IV at weeks 0 and 2, then 108 mg SC every 2 weeks
Eligibility Criteria
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Inclusion Criteria
2. Established CD diagnosis by conventional criteria
3. 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)
4. HBI ≥5
5. Biologic-treatment naïve for CD-related therapies
6. 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
7. Willing and able to participate fully in all aspects of this clinical trial, including adherence to study protocol and treatment algorithm
8. Written informed consent must be obtained and documented
Exclusion Criteria
2. CD-related complications such as symptomatic, endoscopically impassable strictures or abscesses that require imminent surgery (at investigator's discretion)
3. Participants with current or history of colonic dysplasia or neoplasia, toxic megacolon, or fulminant colitis
4. Recent bowel resection \<3 months before screening
5. Active enteric infection (positive stool culture), including but not limited to bacterial (including C. difficile), viral, or parasitic enteric infections
6. Known active hepatitis B, hepatitis C, or human immunodeficiency virus infection
7. Active COVID-19 infection during the screening period
8. Tested positive as part of SOC for tuberculosis (TB) at screening by QuantiFERON® TB Gold Test, tuberculin skin test, or history of untreated latent or active TB
9. History of malignancy within 5 years of screening, except fully treated carcinoma in-situ of the cervix, fully treated and resolved nonmetastatic squamous or basal cell carcinoma of the skin
10. Active chronic or acute infections requiring treatment with systemic antibiotics, antivirals, antifungals, antiparasitics, or antiprotozoals during the screening period
11. Serious underlying disease other than CD that, in the opinion of the investigator, may interfere with the participant's ability to participate fully in the study
12. Not willing to withhold protocol-prohibited medications during the trial, or planned or anticipated use of any prohibited medications during screening
13. Received previously or currently receiving a TNF antagonist, anti-integrin, monoclonal antibody targeting IL-12/23 or IL-23, Janus kinase (JAK) inhibitors, or sphingosine 1 phosphate (S1P) receptor modulators (irrespective of indication)
14. History of alcohol or drug abuse that, in the opinion of the investigator, may interfere with the participant's ability to comply with the study procedures
18 Years
ALL
No
Sponsors
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Alimentiv Inc.
OTHER
University of Calgary
OTHER
Responsible Party
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Locations
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University of Calgary
Calgary, Alberta, Canada
University of Alberta IBD Clinic
Edmonton, Alberta, Canada
GI Research Institute (G.I.R.I)
Vancouver, British Columbia, Canada
West Coast Gastroenterology
Vancouver, British Columbia, Canada
Nova Scotia Health Victoria
Halifax, Nova Scotia, Canada
GNRR Digestive Clinics and Research Center Inc.
Brampton, Ontario, Canada
Rajbir Rai Medical Corporation
Brantford, Ontario, Canada
McMaster University
Hamilton, Ontario, Canada
London Health Sciences Centre
London, Ontario, Canada
West GTA Research Inc.
Mississauga, Ontario, Canada
ABP Research Services Corp.
Oakville, Ontario, Canada
Taunton Surgical Center
Oshawa, Ontario, Canada
The Ottawa Hospital Research Institute
Ottawa, Ontario, Canada
Thunder Bay Regional Health Research Institute
Thunder Bay, Ontario, Canada
Mount Sinai Hospital
Toronto, Ontario, Canada
TIDHI Clinic
Toronto, Ontario, Canada
Centre Hospitalier de l'Université de Montréal (CHUM)
Montreal, Quebec, Canada
Hôpital du Sacré-Cœur-de-Montréal
Montreal, Quebec, Canada
Research Institute of the McGill University Health Centre (MUHC)
Montreal, Quebec, Canada
Université de Sherbrooke
Sherbrooke, Quebec, Canada
Countries
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Central Contacts
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Facility Contacts
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References
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Hasskamp J, Meinhardt C, Timmer A. Anti-IL-12/23p40 antibodies for induction of remission in Crohn's disease. Cochrane Database Syst Rev. 2025 May 13;5(5):CD007572. doi: 10.1002/14651858.CD007572.pub4.
Other Identifiers
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REB22-1641/RCT-01741
Identifier Type: -
Identifier Source: org_study_id
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