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New treatment option for Crohn Disease
Official title PATHFINDER: Evaluating the Optimal First-Line Treatment Strategy for Moderate-to-Severely Active Ileal-dominant Crohn's Disease
ClinicalTrials.gov ID: NCT05928039
What this study is testing
What is TNFa Antagonist - Infliximab?
TNFa Antagonist - Infliximab is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for crohn disease.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Male or nonpregnant, nonlactating females, 18 years of age or older. Females of childbearing potential must have a negative serum or urine pregnancy...
- 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...
- HBI ≥5
- Biologic-treatment naïve for CD-related therapies
You likely can't join if
- 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...
- 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...
- Known active hepatitis B, hepatitis C, or human immunodeficiency virus infection
See the full eligibility criteria
- 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...
- 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
- 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
- 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
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Calgary, Alberta, Canada
- Edmonton, Alberta, Canada
- Vancouver, British Columbia, Canada
- Halifax, Nova Scotia, Canada
- Brampton, Ontario, Canada
- Brantford, Ontario, Canada
- Hamilton, Ontario, Canada
- London, Ontario, Canada
- Mississauga, Ontario, Canada
- Oakville, Ontario, Canada
- Oshawa, Ontario, Canada
- Ottawa, Ontario, Canada
- Thunder Bay, Ontario, Canada
- Toronto, Ontario, Canada
- Montreal, Quebec, Canada
- Sherbrooke, Quebec, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Calgary, Alberta, Canada; Edmonton, Alberta, Canada; Vancouver, British Columbia, Canada; Halifax, Nova Scotia, Canada; Brampton, Ontario, Canada; Brantford, Ontario, Canada and 10 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.