297 Participants Needed

Biologic Therapies for Crohn's Disease

(PATHFINDER Trial)

Recruiting at 19 trial locations
HA
CM
Overseen ByChristopher Ma, MD MPH
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human 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?

Adalimumab is effective in inducing remission in patients with active Crohn's disease who had secondary failure to infliximab therapy, and it has been shown to maintain remission in both Crohn's disease and ulcerative colitis.12345

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?

Vedolizumab is unique because it targets the α4β7 integrin, which helps control the movement of immune cells into the gut, making it effective for patients who do not respond to or cannot tolerate other treatments like anti-TNF drugs.257911

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

I had a colonoscopy showing a large ulcer in my ileum within the last 3 months.
Established CD diagnosis by conventional criteria
Written informed consent must be obtained and documented
See 5 more

Exclusion Criteria

I am not currently on treatment for any serious infections.
I have an active hepatitis B, hepatitis C, or HIV infection.
I have been treated with specific immune system targeting drugs.
See 11 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive biologic treatments (TNF antagonist, anti-integrin, or anti-IL23) according to standard of care

12 months
Visits at weeks 0, 2, 4, 6, 8, and every 8 weeks thereafter

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments for endoscopic remission and biomarker levels

4 weeks
Evaluations at months 4, 8, and 12

Extension

Participants may continue treatment based on standard care and clinical outcomes

Ongoing

Treatment Details

Interventions

  • Adalimumab
  • Infliximab
  • Risankizumab
  • Ustekinumab
  • Vedolizumab IV
  • Vedolizumab IV and SC
Trial Overview The PATHFINDER trial is testing which class of approved biologic treatments (anti-TNF alpha, anti-integrin, anti-IL-23) best induces endoscopic remission in small bowel Crohn's disease at one year without steroids. Patients will receive Vedolizumab IV/SC, Risankizumab, Ustekinumab, Infliximab or Adalimumab.
Participant Groups
3Treatment groups
Active Control
Group I: TNFα antagonistActive Control2 Interventions
Participants 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
Group II: Anti-IL12/23 or anti-IL23Active Control2 Interventions
Participants 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
Group III: Anti-integrinActive Control2 Interventions
Participants 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

Adalimumab is already approved in European Union, United States, Canada, Japan for the following indications:

🇪🇺
Approved in European Union as Humira for:
  • Rheumatoid arthritis
  • Psoriatic arthritis
  • Ankylosing spondylitis
  • Crohn's disease
  • Ulcerative colitis
  • Plaque psoriasis
  • Juvenile idiopathic arthritis
🇺🇸
Approved in United States as Humira for:
  • Rheumatoid arthritis
  • Psoriatic arthritis
  • Ankylosing spondylitis
  • Crohn's disease
  • Ulcerative colitis
  • Plaque psoriasis
  • Juvenile idiopathic arthritis
  • Hidradenitis suppurativa
🇨🇦
Approved in Canada as Humira for:
  • Rheumatoid arthritis
  • Psoriatic arthritis
  • Ankylosing spondylitis
  • Crohn's disease
  • Ulcerative colitis
  • Plaque psoriasis
  • Juvenile idiopathic arthritis
🇯🇵
Approved in Japan as Humira for:
  • 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

Trials
827
Recruited
902,000+

Alimentiv Inc.

Collaborator

Trials
15
Recruited
3,300+

Findings from Research

In a 52-week study involving 24 patients with Crohn's disease who previously lost response to infliximab, adalimumab demonstrated significant efficacy, with clinical remission rates increasing from 35% at baseline to 58% at week 52.
Adalimumab was well tolerated, with no patients experiencing intolerance and no serious toxicities reported, indicating it is a safe option for maintaining remission in these patients.
Adalimumab maintenance therapy for Crohn's disease with intolerance or lost response to infliximab: an open-label study.Peyrin-Biroulet, L., Laclotte, C., Bigard, MA.[2015]
Biologic treatments, particularly the anti-TNF monoclonal antibody infliximab, have significantly advanced the management of inflammatory bowel disease (IBD), especially for moderate-to-severe cases of Crohn's disease (CD) and ulcerative colitis (UC).
The review highlights various biologics under evaluation or approved for IBD, indicating a growing range of treatment options, although infliximab remains the only widely available biologic globally.
Advances in biologic therapy for ulcerative colitis and Crohn's disease.D'Haens, G., Daperno, M.[2019]
In a systematic review of five randomized controlled trials involving patients with moderate-to-severe Crohn's disease who were nonresponsive or intolerant to TNF-antagonist therapy, ustekinumab and vedolizumab showed no significant differences in clinical response or remission during both induction and maintenance phases.
The safety profiles of ustekinumab and vedolizumab were also comparable, with no significant differences in the risk of adverse events, indicating that both treatments are similarly safe for patients with Crohn's disease.
An indirect comparison of ustekinumab and vedolizumab in the therapy of TNF-failure Crohn's disease patients.Kawalec, P., Moćko, P.[2019]

References

Adalimumab maintenance therapy for Crohn's disease with intolerance or lost response to infliximab: an open-label study. [2015]
Advances in biologic therapy for ulcerative colitis and Crohn's disease. [2019]
An indirect comparison of ustekinumab and vedolizumab in the therapy of TNF-failure Crohn's disease patients. [2019]
Adalimumab for Crohn's disease with intolerance or lost response to infliximab: a 3-year single-centre experience. [2022]
IBD: Adalimumab for ulcerative colitis— is the glass half empty or half full? [2021]
Assessment of the real-world safety profile of vedolizumab using the United States Food and Drug Administration adverse event reporting system. [2023]
Vedolizumab as a Treatment for Crohn's Disease and Ulcerative Colitis. [2022]
Vedolizumab in the treatment of Crohn's disease. [2016]
Vedolizumab: first global approval. [2021]
Influence of Drug Exposure on Vedolizumab-Induced Endoscopic Remission in Anti-Tumour Necrosis Factor [TNF] Naïve and Anti-TNF Exposed IBD Patients. [2021]
[Biologic therapies in chronic inflammatory bowel diseases]. [2016]
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