What side effects are associated with this type of intervention?

Common treatments for Crohn's Disease include biologic agents such as Vedolizumab (an integrin antagonist), infliximab, and adalimumab (both anti-TNF agents). Vedolizumab is generally well-tolerated but may cause headaches, nasopharyngitis, and arthralgia. Infliximab and adalimumab can lead to increased risk of infections, infusion reactions, and potential development of antibodies against the drug, which may reduce efficacy. Other side effects include injection site reactions, liver enzyme abnormalities, and rare cases of lupus-like syndrome.

What prior FDA approvals exist?

The FDA has approved several biologic therapies for the treatment of Crohn's Disease. Anti-TNF agents such as Infliximab (Remicade), Adalimumab (Humira), and Certolizumab pegol (Cimzia) have been approved and shown efficacy in inducing and maintaining remission in moderate to severe Crohn's Disease. Vedolizumab (Entyvio), an integrin antagonist, is specifically approved for patients with moderate to severe Crohn's Disease who have not responded adequately to other therapies. Ustekinumab (Stelara), an IL-12 and IL-23 antagonist, is another biologic approved for similar indications. These treatments offer targeted approaches to managing Crohn's Disease by modulating the immune response.

What other types of research exist?

Promising novel alternatives to Vedolizumab for Crohn's Disease patients include Ustekinumab (an IL-12/23 inhibitor) and Tofacitinib (a JAK inhibitor). Both have shown efficacy in clinical trials and are approved for use in Crohn's Disease. Additionally, Risankizumab (an IL-23 inhibitor) is emerging as a potential option with ongoing studies demonstrating positive outcomes.

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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 below

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My Crohn's disease affects only my small bowel or ileocecal area, confirmed by an MRE.

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I am currently taking Vedolizumab, with or without thiopurines or methotrexate.

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am under 18 years old.

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I have Crohn's disease affecting the area around my anus.

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My colon cancer affects parts other than the ascending colon and cecum.

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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 16±2 weeks for reporting.

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 • NCT03029143

11%

Colitis ulcerative

11%

Headache

11%

Diarrhoea

Abdominal pain upper

Cough

Upper respiratory tract infection

Vomiting

Sinus congestion

Fatigue

Abdominal pain lower

C-reactive protein increased

100%

80%

60%

40%

20%

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.

0 / 7Eligibility criteria met

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.