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Crohn DiseasePhase 4PATHFINDERNCT05928039

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

A Phase 4 study testing TNFa Antagonist - Infliximab, TNFa Antagonist - Adalimumab and Anti-IL12/23 or anti-IL23 - Ustekinumab in people with Crohn Disease, run by University of Calgary at 23 sites in Canada.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Crohn Disease
What is being tested?
TNFa Antagonist - Infliximab, TNFa Antagonist - Adalimumab and Anti-IL12/23 or anti-IL23 - Ustekinumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
210 participants
Where
23 sitesCanada
Study dates
25 Oct 2023to 31 Dec 2028
Phase
Phase 4
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)
  • 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
  • 8. Written informed consent must be obtained and documented

Who cannot join

  • Condition(s) for which the biologics included in this study is contraindicated
  • CD-related complications such as symptomatic, endoscopically impassable strictures or abscesses that require imminent surgery (at investigator's discretion)
  • Participants with current or history of colonic dysplasia or neoplasia, toxic megacolon, or fulminant colitis
  • Recent bowel resection <3 months before screening
  • Active enteric infection (positive stool culture), including but not limited to bacterial (including C. difficile), viral, or parasitic enteric infections
  • Known active hepatitis B, hepatitis C, or human immunodeficiency virus infection
Show all 15Show fewer
  • Active COVID-19 infection during the screening period
  • 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
  • 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 investigator, may interfere with the participant's ability to participate fully in the study
  • Pregnancy or breastfeeding
  • Not willing to withhold protocol-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

Trial locations and contacts

23 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Harsha Ashton contact

226-919-6959

harsha.ashton@alimentiv.com

Christopher Ma, MD MPH contact

4035925013

christopher.ma@ucalgary.ca

23 sites in 1 country

Canada23 sites, 23 recruiting

  • GNRR Digestive Clinics and Research Center Inc.

    Brampton, Ontario

    Girsh Bajaj, MD

    Not yet recruiting

  • GNRR Digestive Clinics and Research Center Inc

    Brampton, Ontario

    Girish Bajaj

    Recruiting

  • Rajbir Rai Medical Corporation

    Brantford, Ontario

    Rajbir Rai, MD

    Recruiting

  • University of Calgary

    Calgary, Alberta

    Ashley Clarke, MSc, 4032109141, anclarke@ucalgary.ca

    Heather Baylis, hbaylis@ucalgary.ca

    Recruiting

  • University of Alberta IBD Clinic

    Edmonton, Alberta

    Frank Hoentjen, MD

    Recruiting

  • Nova Scotia Health Victoria

    Halifax, Nova Scotia

    Michael Stewart, MD

    Recruiting

  • McMaster University

    Hamilton, Ontario

    Neeraj Narula, MD

    Recruiting

  • London Digestive Disease Institute

    London, Ontario

    Vipul Jairath

    Not yet recruiting

  • London Health Sciences Centre

    London, Ontario

    Vipul Jairath, MD

    Recruiting

  • West GTA Research Inc.

    Mississauga, Ontario

    Callum Dargavel

    Recruiting

  • West GTA Research Inc

    Mississauga, Ontario

    Callum Dargavel

    Recruiting

  • Centre Hospitalier de l'Université de Montréal (CHUM)

    Montreal, Quebec

    Robert Battat, MD

    Recruiting

  • Hôpital du Sacré-Cœur-de-Montréal

    Montreal, Quebec

    Jean-Frédéric LeBlanc, MD

    Recruiting

  • Research Institute of the McGill University Health Centre (MUHC)

    Montreal, Quebec

    Talat Bessisow, MD

    Recruiting

  • ABP Research Services Corp.

    Oakville, Ontario

    Naveen Arya, MD

    Not yet recruiting

  • Taunton Surgical Center

    Oshawa, Ontario

    Daniel Green, MD

    Recruiting

  • The Ottawa Hospital Research Institute

    Ottawa, Ontario

    Sanjay Murthy, MD

    Recruiting

  • Université de Sherbrooke

    Sherbrooke, Quebec

    Maxime Delisle, MD

    Recruiting

  • Thunder Bay Regional Health Research Institute

    Thunder Bay, Ontario

    Shahin Merat, MD

    Recruiting

  • Sinai Health System

    Toronto, Ontario

    Hillary Steinhart

    Recruiting

  • TIDHI Clinic

    Toronto, Ontario

    Mark Silverberg, MD

    Recruiting

  • GI Research Institute (G.I.R.I)

    Vancouver, British Columbia

    Yvette Leung, MD

    Recruiting

  • West Coast Gastroenterology

    Vancouver, British Columbia

    Sunny Singh

    Recruiting

Other trials in Canada

About this study

Official title: 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

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.

Read the detailed description

This is a pragmatic, real-world trial of patients with moderate-to-severe, ileal-dominant Crohn's disease. At week 0, participants who meet the eligibility criteria will be randomized in a 1:1:1 ratio to a TNF antagonist; anti-integrin; or anti-IL23 targeted treatment. All interventions will be offered according to standard of care.

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
Crohn Disease
Being tested
TNFa Antagonist - Infliximab, TNFa Antagonist - Adalimumab, Anti-IL12/23 or anti-IL23 - Ustekinumab, Anti-IL12/23 or anti-IL23 - Risankizumab, Anti-integrin - Vedolizumab IV
Medical subject headings
Crohn Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TNFa Antagonist - InfliximabBiological

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

  • TNFa Antagonist - AdalimumabBiological

    • 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 - UstekinumabBiological

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

  • Anti-IL12/23 or anti-IL23 - RisankizumabBiological

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

  • Anti-integrin - Vedolizumab IVBiological

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

  • Anti-integrin - Vedolizumab IV and SCBiological

    • Vedolizumab 300 mg IV at weeks 0 and 2, then 108 mg SC every 2 weeks
Study groups in NCT05928039
Study groupRoleWhat they receive
TNFα antagonistActive comparatorParticipants 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
Receives: Biological: TNFa Antagonist - Infliximab; Biological: TNFa Antagonist - Adalimumab
Anti-IL12/23 or anti-IL23Active comparatorParticipants 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
Receives: Biological: Anti-IL12/23 or anti-IL23 - Ustekinumab; Biological: Anti-IL12/23 or anti-IL23 - Risankizumab
Anti-integrinActive comparatorParticipants 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
Receives: Biological: Anti-integrin - Vedolizumab IV; Biological: Anti-integrin - Vedolizumab IV and SC

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Corticosteroid-free endoscopic remission

    SES-CD ≤4, ileal segment SES-CD ≤2, and no ulcers in any segment >5 mm, off corticosteroids for ≥ 16 weeks

    Measured: 1 year

Secondary outcomes (7)

  1. CD-related complications

    Composite of disease flare, obstruction, new fistula/abscess, CD-related hospitalization, CD-related surgery

    Measured: 1 year

  2. Time to first Crohn's disease-related complication.

    Composite of disease flare, obstruction, new fistula/abscess, CD-related hospitalization, CD-related surgery

    Measured: From date of randomization until the date of first documented Crohn's disease-related complication or date of death from any cause, whichever came first, assessed up to 12 months

  3. Biomarker remission

    C-reactive protein (CRP) <5 mg/L and fecal calprotectin <250 µg/g, assessed in participants with elevated biomarkers at baseline

    Measured: Months 4, 8, and 12

  4. Corticosteroid-free clinical remission

    Harvey Bradshaw Index [HBI] ≤4 without exposure to systemic corticosteroids for ≥16 weeks prior to assessment

    Measured: Months 4, 8, and 12

  5. Treatment persistence

    Duration of time from first biologic dose to discontinuation, the proportion of participants requiring a class switch, and the proportion of participants requiring dose optimization of biologic treatment or addition of rescue immunomodulators

    Measured: 1 year

  6. Health-related quality of life after first-line biologic treatment

    Quality of life at 1-year measured using EuroQol 5D (range 0 [worst imaginable health state] to 100 [best imaginable health state])

    Measured: 1 year

  7. Safety of first-line biologic treatment

    Unexpected AEs, severe AEs, drug and procedure-related AEs, any serious AEs (SAEs), any AEs leading to biologic discontinuation

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Jul 2023
  2. Study start25 Oct 2023
  3. Primary completion30 Jul 2027 (estimated)
  4. Study completion31 Dec 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
This trial is a prospective, randomized, open-label, blinded-endpoint (PROBE) trial. The primary endpoint will be evaluated by a blinded, external central reviewer.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
210 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05928039
Sponsor's protocol ID
REB22-1641/RCT-01741
Acronym
PATHFINDER
Status last verified
Oct 2026
First submitted
13 Jun 2023
Last updated
26 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: De-identified patient information may be shared at the discretion the the trial steering committee and upon written request.

Publications

  • 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.

    PubMed 40357993

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing TNFa Antagonist - Infliximab, TNFa Antagonist - Adalimumab and Anti-IL12/23 or anti-IL23 - Ustekinumab in people with Crohn Disease, run by University of Calgary at 23 sites in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 23 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Harsha Ashton (226-919-6959, harsha.ashton@alimentiv.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Corticosteroid-free endoscopic remission (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05928039, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2026.

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