RecruitingPhase 4interventionalRules rewrite

Phase 4: testing TNFa Antagonist - Infliximab for Crohn Disease

Q: Is NCT05928039 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

Q: What phase is NCT05928039?

Phase 4. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Q: Can PlainTrials tell me if I qualify for NCT05928039?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

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.

Official registry: https://clinicaltrials.gov/study/NCT05928039 · University of Calgary · enrollment listed as 210

What this phase means

Phase 4: the treatment is already approved. This study asks new questions — longer-term effects, other diseases, or how it compares in everyday care.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are TNFa Antagonist - Infliximab, TNFa Antagonist - Adalimumab, or Anti-IL12/23 or anti-IL23 - Ustekinumab. The registry lists allocation as randomized. 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.

They plan to enroll about 210 people at 23 sites. Taking part typically means an infusion or injection of a biologic plus check-ins.

Official title (unrewritten)

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, TNFa Antagonist - Adalimumab, Anti-IL12/23 or anti-IL23 - Ustekinumab, Anti-IL12/23 or anti-IL23 - Risankizumab, Anti-integrin - Vedolizumab IV, Anti-integrin - Vedolizumab IV and SC

Primary outcome (registry wording): Corticosteroid-free endoscopic remission

Who it is for (from inclusion criteria)

Ages 18 Years to any
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
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

Who the registry excludes

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

Public study contact (from the registry)

Harsha Ashton

226-919-6959

harsha.ashton@alimentiv.com

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

23 listed

University of Calgary — Calgary, Alberta, Canada (recruiting)
University of Alberta IBD Clinic — Edmonton, Alberta, Canada (recruiting)
GI Research Institute (G.I.R.I) — Vancouver, British Columbia, Canada (recruiting)
West Coast Gastroenterology — Vancouver, British Columbia, Canada (recruiting)
Nova Scotia Health Victoria — Halifax, Nova Scotia, Canada (recruiting)
GNRR Digestive Clinics and Research Center Inc. — Brampton, Ontario, Canada (not_yet_recruiting)
GNRR Digestive Clinics and Research Center Inc — Brampton, Ontario, Canada (recruiting)
Rajbir Rai Medical Corporation — Brantford, Ontario, Canada (recruiting)
McMaster University — Hamilton, Ontario, Canada (recruiting)
London Digestive Disease Institute — London, Ontario, Canada (not_yet_recruiting)
London Health Sciences Centre — London, Ontario, Canada (recruiting)
West GTA Research Inc. — Mississauga, Ontario, Canada (recruiting)

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FAQ about this NCT record

Is NCT05928039 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT05928039?

Phase 4. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT05928039?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary