Comparing 3 approaches for crohn disease
Official title: PATHFINDER: Evaluating the Optimal First-Line Treatment Strategy for Moderate-to-Severely Active Ileal-dominant Crohn's Disease
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
Interventions
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
Canadian Sites (20)
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
Eligibility Criteria
See who this study is looking for21 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +Established CD diagnosis by conventional criteria
- +BaselineBaselineYour starting measurements, taken before treatment begins.Read more → colonoscopy within 3 months of the first day of the screening periodScreeningThe checks done before joining, to see whether a study fits.Read more →, with photo or video documentation of at least one large ileal ulcer \>5 mm and ileal segment SES-CD ≥4 (eligibilityEligibility criteriaThe full list of requirements for taking part in a study.Read more → will be determined by local endoscopist, with subsequent confirmation by a CR at a later time, post enrolmentEnrolmentThe number of participants a study plans to include, or has included.Read more →)
- +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 trialInterventional studyA study where participants are given something to see what happens.Read more →, including adherence to study protocolProtocolThe detailed plan a study must follow.Read more → and treatment algorithm
- +Written informed consentInformed consentThe process of being told what taking part involves, then choosing freely.Read more → must be obtained and documented
- +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 randomizationRandomisedWhich group you go into is decided by chance, not by you or your doctor.Read more →
Exclusion
- −Known active hepatitis B, hepatitis C, or human immunodeficiency virus infection
- −Condition(s) for which the biologics included in this study is contraindicated
- −Participants with current or history of colonic dysplasia or neoplasia, toxic megacolon, or fulminant colitis
- −Recent bowel resection \<3 months before screeningScreeningThe checks done before joining, to see whether a study fits.Read more →
- −Active enteric infection (positive stool culture), including but not limited to bacterial (including C. difficile), viral, or parasitic enteric infections
- −Active COVID-19 infection during the screening period
- −Tested positive as part of SOCStandard of careThe treatment normally given for a condition outside a study.Read more → for tuberculosis (TB) at screening by QuantiFERON® TB Gold Test, tuberculin skin test, or history of untreated latent or active TB
- −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
- −Active chronic or acute infections requiring treatment with systemic antibiotics, antivirals, antifungals, antiparasitics, or antiprotozoals during the screening period
- −Serious underlying disease other than CD that, in the opinion of the investigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more →, may interfere with the participant's ability to participate fully in the study
- −Not willing to withhold protocolProtocolThe detailed plan a study must follow.Read more →-prohibited medications during the trial, or planned or anticipated use of any prohibited medications during screening
- −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)
- −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
- −CD-related complications such as symptomatic, endoscopically impassable strictures or abscesses that require imminent surgery (at investigator's discretion)
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is testing a treatment for a condition.
Phase 4Phase 4A study of a treatment that is already approved and in use.Read more → — a study of a treatment already approved for use, following it in everyday practice.
What is being given or done in this study: TNFa Antagonist - Infliximab, TNFa Antagonist - Adalimumab, Anti-IL12/23 or anti-IL23 - Ustekinumab, Anti-IL12/23 or anti-IL23 - Risankizumab, and 2 more.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
- armsInterventionsModule.interventions[].name
How the study is run
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
One group of people involved — usually the participants — is not told which treatment is which.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
One group receives an existing treatment, so the two can be compared.
There are 3 groups in this study.
From the trial registry
Built from this field:
- armsInterventionsModule.armGroups[].type
Who the study is looking for
The study lists a minimum age of 18 years, with no upper limit given.
The study is open to people of any sex.
The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 297 people.
The study is currently expected to finish around December 2028.
The main measurement is taken over: 1 year.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Corticosteroid-free endoscopic remission — measured over 1 year.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT05928039 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About TNFa Antagonist - InfliximabBiological
• Infliximab 5 mg/kg intravenously \[IV\] at weeks 0, 2, 6, then 5 mg/kg every 8 weeks
From the trial registry — its own words, unedited.
What a biological is here: A treatment made from or by living systems — such as antibodies, vaccines, or cell-based therapies.
Read the full explanation → · in clinical review
About TNFa Antagonist - AdalimumabBiological
• Adalimumab subcutaneously \[SC\] 160 mg at week 0, 80 mg at week 2, then 40 mg every 2 weeks
From the trial registry — its own words, unedited.
What a biological is here: A treatment made from or by living systems — such as antibodies, vaccines, or cell-based therapies.
Read the full explanation → · in clinical review
About Anti-IL12/23 or anti-IL23 - UstekinumabBiological
• Ustekinumab \~6 mg/kg IV x1, then 90 mg SC every 8 weeks
From the trial registry — its own words, unedited.
What a biological is here: A treatment made from or by living systems — such as antibodies, vaccines, or cell-based therapies.
Read the full explanation → · in clinical review
About Anti-IL12/23 or anti-IL23 - RisankizumabBiological
• Risankizumab 600 mg IV at weeks 0, 4, and 8, then 360 mg SC every 8 weeks
From the trial registry — its own words, unedited.
What a biological is here: A treatment made from or by living systems — such as antibodies, vaccines, or cell-based therapies.
Read the full explanation → · in clinical review
About Anti-integrin - Vedolizumab IVBiological
• Vedolizumab 300 mg IV at weeks 0, 2, and 6, then every 8 weeks
From the trial registry — its own words, unedited.
What a biological is here: A treatment made from or by living systems — such as antibodies, vaccines, or cell-based therapies.
Read the full explanation → · in clinical review
About Anti-integrin - Vedolizumab IV and SCBiological
• Vedolizumab 300 mg IV at weeks 0 and 2, then 108 mg SC every 2 weeks
From the trial registry — its own words, unedited.
What a biological is here: A treatment made from or by living systems — such as antibodies, vaccines, or cell-based therapies.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: a minimum age of 18 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
One group receives an existing treatment so the two can be compared.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
One group of people involved — usually the participants — is not told which treatment is which.
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists a minimum age of 18 years, with no upper limit given.
It is open to people of any sex.
It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: 1 year.
The study as a whole is currently expected to finish around 2028-12-31.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 297 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists 16 locations, including: Calgary, Alberta, Canada; Edmonton, Alberta, Canada; Vancouver, British Columbia, Canada; Halifax, Nova Scotia, Canada; Brampton, Ontario, Canada; Brantford, Ontario, Canada, and 10 more.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
About This Trial
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.
Think this trial might be right for you?
Complete a quick intake form and we will match you with this and other relevant trials based on your medical profile.
See if this trial could fit youThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.