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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 16±2 weeks
Awards & highlights

Study Summary

This trial is exploring whether vedolizumab is an effective treatment for small bowel Crohn's disease, using MR enterography to measure response. They also hope to develop predictive models and identify biomarkers that correlate with vedolizumab's effectiveness, to help guide personalized treatment approaches.

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.Check my eligibility
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.See study design
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.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Radiological response

Side effects data

From 2020 Phase 4 trial • 278 Patients • NCT03029143
1%
Colitis ulcerative
1%
Headache
1%
C-reactive protein increased
100%
80%
60%
40%
20%
0%
Study treatment Arm
Lead-in Failure Follow-up Period
RTP: VDZ Dose Optimization: Regimen B
RTP: VDZ Dose Optimization: Regimen A
RTP: Standard Treatment Arm
Lead-in Period

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.

Find a Location

Who is running the clinical trial?

Washington University School of MedicineLead Sponsor
1,928 Previous Clinical Trials
2,297,008 Total Patients Enrolled
Parakkal Deepak, MBBS, MSPrincipal InvestigatorWashington University School of Medicine
1 Previous Clinical Trials
200 Total Patients Enrolled

Media Library

Vedolizumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT03142321 — Phase 4
Crohn's Disease Research Study Groups: Vedolizumab 300 MG Injection [Entyvio]
Crohn's Disease Clinical Trial 2023: Vedolizumab Highlights & Side Effects. Trial Name: NCT03142321 — Phase 4
Vedolizumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03142321 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the maximum capacity of participants in this experiment?

"Indeed, the available information on clinicaltrials.gov establishes that this investigation is actively enrolling patients. This trial was first announced on June 8th 2018 and has been updated as recently as August 29th 2022. The research requires 80 participants from one location."

Answered by AI

Has the FDA sanctioned the use of Vedolizumab 300 MG Injection [Entyvio]?

"We have assigned a score of 3 to the safety profile of Vedolizumab 300 MG Injection [Entyvio], as this is an approved Phase 4 trial."

Answered by AI

Is this experiment actively recruiting participants?

"Affirmative. The information found on clinicaltrials.gov implicates that this medical experiment is currently enlisting patients. It was first published on June 8th 2018, and updated most recently on August 29th 2022, with the aim of enrolling 80 individuals from a single site."

Answered by AI

Has any research like this been conducted before?

"Research into the effects of Vedolizumab 300 MG Injection [Entyvio] began in 2015. Funded by Takeda, a phase 1 trial involving 260 patients was conducted that year and eventually culminated in FDA approval. Currently, 23 distinct studies are being performed across 42 nations and 312 cities."

Answered by AI
~2 spots leftby Jun 2024