Biologic Therapies for Crohn's Disease
(PATHFINDER Trial)
Trial Summary
Will I have to stop taking my current medications?
The trial protocol does not specify if you must stop taking your current medications, but it mentions that participants must not use any medications that are prohibited by the study. It's best to discuss your current medications with the trial team to see if they are allowed.
What data supports the effectiveness of the drug Adalimumab for Crohn's disease?
Is Vedolizumab safe for treating Crohn's disease?
Vedolizumab has been shown to be generally safe for treating Crohn's disease, with studies indicating a favorable safety profile and no evidence of serious conditions like PML (a rare brain infection) or reactivation of latent infections like TB (tuberculosis) or hepatitis B. However, some adverse events have been reported, and longer-term studies are needed to fully understand its safety.678910
How does the drug Vedolizumab differ from other treatments for Crohn's disease?
What is the purpose of 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.
Eligibility Criteria
This trial is for adults over 18 with moderate-to-severe ileal Crohn's Disease who haven't been treated with biologics before. They should have a documented large ileal ulcer and be experiencing active symptoms. Pregnant or breastfeeding women, those with recent surgeries, infections like TB or COVID-19, or a history of certain complications are excluded.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive biologic treatments (TNF antagonist, anti-integrin, or anti-IL23) according to standard of care
Follow-up
Participants are monitored for safety and effectiveness after treatment, including assessments for endoscopic remission and biomarker levels
Extension
Participants may continue treatment based on standard care and clinical outcomes
Treatment Details
Interventions
- Adalimumab
- Infliximab
- Risankizumab
- Ustekinumab
- Vedolizumab IV
- Vedolizumab IV and SC
Adalimumab is already approved in European Union, United States, Canada, Japan for the following indications:
- Rheumatoid arthritis
- Psoriatic arthritis
- Ankylosing spondylitis
- Crohn's disease
- Ulcerative colitis
- Plaque psoriasis
- Juvenile idiopathic arthritis
- Rheumatoid arthritis
- Psoriatic arthritis
- Ankylosing spondylitis
- Crohn's disease
- Ulcerative colitis
- Plaque psoriasis
- Juvenile idiopathic arthritis
- Hidradenitis suppurativa
- Rheumatoid arthritis
- Psoriatic arthritis
- Ankylosing spondylitis
- Crohn's disease
- Ulcerative colitis
- Plaque psoriasis
- Juvenile idiopathic arthritis
- Rheumatoid arthritis
- Psoriatic arthritis
- Ankylosing spondylitis
- Crohn's disease
- Ulcerative colitis
- Plaque psoriasis
- Juvenile idiopathic arthritis
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Calgary
Lead Sponsor
Alimentiv Inc.
Collaborator