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TNF-alpha Inhibitor
Biologic Therapies for Crohn's Disease
Phase 4
Recruiting
Research Sponsored by University of Calgary
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
Drug Has Already Been Approved
No Placebo-Only Group
Pivotal Trial
Summary
This trial compares three approved treatments for Crohn's Disease to determine which best heals ulcers in the small bowel, reducing need for corticosteroids.
Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Potential side effects include immune system suppression leading to increased infection risk; allergic reactions; infusion-related reactions such as fever and chills; possible liver issues; and other drug-specific side effects that vary from person to person.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Corticosteroid-free endoscopic remission
Secondary study objectives
Biomarker remission
CD-related complications
Corticosteroid-free clinical remission
+4 moreAwards & Highlights
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
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
Find a Location
Who is running the clinical trial?
Alimentiv Inc.OTHER
14 Previous Clinical Trials
2,957 Total Patients Enrolled
University of CalgaryLead Sponsor
809 Previous Clinical Trials
886,086 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am not currently on treatment for any serious infections.I had a colonoscopy showing a large ulcer in my ileum within the last 3 months.I have an active hepatitis B, hepatitis C, or HIV infection.I have been treated with specific immune system targeting drugs.My health burden index is 5 or higher.I haven't had cancer in the last 5 years, except for certain skin cancers or cervical cancer that were fully treated.I am willing to stop taking certain medications if they are not allowed in the trial.I have never received biologic treatments for Crohn's disease.I am willing and able to follow all the study's requirements.I am an adult over 18 and not pregnant or breastfeeding.I currently have an active COVID-19 infection.I don't have any serious health issues that could stop me from fully participating in the study.I am capable of becoming pregnant and have a negative pregnancy test.I am not allergic or intolerant to the medications in this study.I have Crohn's disease complications needing urgent surgery.I have or had severe colon issues, including abnormal growths.I had surgery on my intestines less than 3 months ago.I tested positive for tuberculosis.I am a candidate for biologic treatment for my moderate-to-severe Crohn's disease.
Research Study Groups:
This trial has the following groups:- Group 1: TNFα antagonist
- Group 2: Anti-IL12/23 or anti-IL23
- Group 3: Anti-integrin
Awards:
This trial has 3 awards, including:- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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