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Monoclonal Antibodies
Vedolizumab for Crohn's Disease
Phase 4
Waitlist Available
Led By Parakkal Deepak, MBBS, MS
Research Sponsored by Washington University School of Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Moderate to severe disease activity small bowel CD (small bowel only or ileocecal only) visible on MRE
Initiated on Vedolizumab with/without thiopurines or methotrexate
Must not have
Age <18
Perianal CD
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 16±2 weeks
Awards & highlights
Pivotal Trial
Drug Has Already Been Approved
No Placebo-Only Group
All Individual Drugs Already Approved
Summary
This trial aims to guide doctors on using vedolizumab for patients with small bowel Crohn's Disease. Vedolizumab helps reduce intestinal inflammation by blocking specific cells. The study will also explore new ways to predict and monitor long-term treatment success. Vedolizumab has been a standard treatment for inflammatory bowel diseases like Crohn's disease and ulcerative colitis.
Who is the study for?
This trial is for adults over 18 with moderate to severe Crohn's Disease affecting only the small bowel or ileocecal area, who are starting treatment with Vedolizumab, possibly alongside thiopurines or methotrexate. It excludes those unable to consent, pregnant individuals, patients with colonic involvement beyond the ascending colon and cecum, contraindications for MRE like chronic kidney disease or incompatible medical devices, and anyone planning surgery before follow-up MRE.
What is being tested?
The study aims to evaluate how well Vedolizumab works in treating small bowel Crohn's Disease using MR enterography as a measure of response. It also seeks to develop predictive models based on clinical data and imaging/endoscopic findings that could forecast long-term remission. Additionally, it will explore potential new biomarkers in blood that correlate with radiological responses.
What are the potential side effects?
While not explicitly listed here, common side effects of Vedolizumab may include headache, joint pain, nausea or fever; more serious risks involve allergic reactions during infusion and increased risk of infection due to its immune system effects.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My Crohn's disease affects only my small bowel or ileocecal area, confirmed by an MRE.
Select...
I am currently taking Vedolizumab, with or without thiopurines or methotrexate.
Select...
I am 18 years old or older.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am under 18 years old.
Select...
I have Crohn's disease affecting the area around my anus.
Select...
My colon cancer affects parts other than the ascending colon and cecum.
Select...
I do not have kidney issues or implants that prevent me from having an MRE.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 16±2 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~16±2 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Radiological response
Side effects data
From 2020 Phase 4 trial • 278 Patients • NCT0302914311%
Colitis ulcerative
11%
Headache
11%
Diarrhoea
7%
Abdominal pain upper
7%
Cough
7%
Upper respiratory tract infection
7%
Vomiting
7%
Sinus congestion
4%
Fatigue
4%
Abdominal pain lower
4%
C-reactive protein increased
100%
80%
60%
40%
20%
0%
Study treatment Arm
RTP: VDZ Dose Optimization: Regimen A
RTP: Standard Treatment Arm
RTP: VDZ Dose Optimization: Regimen B
Lead-in Failure Follow-up Period
Lead-in Period
Awards & Highlights
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
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.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Vedolizumab 300 MG Injection [Entyvio]Experimental Treatment1 Intervention
Vedolizumab will be initiated at 300 mg intravenous (IV) dosing at 0, 2 and 6 weeks followed by the 1st maintenance with 300 mg IV at week 14. Patients who have not achieved clinical response at week 14 will be eligible to undergo dose escalation to 4 weekly dosing of vedolizumab depending on the judgement of the treating gastroenterologist.
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for Crohn's Disease include biologic agents such as anti-TNF agents (e.g., infliximab, adalimumab), integrin antagonists (e.g., vedolizumab), and interleukin inhibitors (e.g., ustekinumab). Anti-TNF agents work by blocking tumor necrosis factor-alpha, a cytokine involved in systemic inflammation.
Integrin antagonists like vedolizumab inhibit the migration of white blood cells to the gut, reducing inflammation specifically in the gastrointestinal tract. Interleukin inhibitors target specific interleukins involved in the inflammatory process.
These mechanisms are crucial for Crohn's Disease patients as they help to control inflammation, reduce symptoms, and maintain remission, thereby improving quality of life and preventing complications.
Find a Location
Who is running the clinical trial?
Washington University School of MedicineLead Sponsor
1,985 Previous Clinical Trials
2,291,920 Total Patients Enrolled
Parakkal Deepak, MBBS, MSPrincipal InvestigatorWashington University School of Medicine
1 Previous Clinical Trials
200 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am under 18 years old.I am currently taking Vedolizumab, with or without thiopurines or methotrexate.I am scheduled for surgery before my first follow-up MRE.I have Crohn's disease affecting the area around my anus.My colon cancer affects parts other than the ascending colon and cecum.My inpatient scan was an MRE with good contrast and showed my small bowel clearly.I do not have kidney issues or implants that prevent me from having an MRE.My Crohn's disease affects only my small bowel or ileocecal area, confirmed by an MRE.I am 18 years old or older.
Research Study Groups:
This trial has the following groups:- Group 1: Vedolizumab 300 MG Injection [Entyvio]
Awards:
This trial has 4 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- 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.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
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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