VECTORS Study for Moderately to Severely Active Crohn's Disease
This study, called VECTORS, is looking at a new way to treat moderately to severely active Crohn's disease (a type of inflammatory bowel disease). It's testing if using intestinal ultrasound (IUS), a patient-friendly scan, to guide treatment with vedolizumab (an IV medication) is better than just relying on symptoms and other markers. All participants will receive vedolizumab. The study aims to see if this approach leads to more people achieving corticosteroid-free endoscopic remission (meaning their gut lining heals without needing steroids) after 48 weeks. You may be able to join if you are 18 to 80 years old and have moderately to severely active Crohn's disease.
- Study design
- This interventional study plans to enroll 304 participants. It compares two different treatment approaches using vedolizumab.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for at least 48 weeks to measure the primary outcome.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
VECTORS - A Study to Evaluate Transmural Healing as a Treatment Target in Crohn's Disease
At a glance
Conditions
Where it's being run
69 sites across 52 statesStudy leadership
- Vipul Jairath, MD · PRINCIPAL_INVESTIGATOR · Alimentiv Inc.
Who to contact
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What this trial measures
- Percentage of participants with Corticosteroid-free Endoscopic remission in group 1 and group 2 at week 48week 48
Corticosteroid-free is defined as not using corticosteroids at the time of the assessment. Endoscopic remission is defined by a total Simple Endoscopic Score for CD (SES-CD) ≤4 and at least a 2-point reduction versus baseline with no subscore greater than 1 in any individual variable. The SES-CD scores 4 endoscopic items (ulcer size, proportion of ulcerated surface, proportion of the surface area affected by any disease lesion, and stenosis) from 0 to 3, with higher scores representing more severe endoscopic disease activity. Each variable is scored for the 5 intestinal segments (ileum, right colon, transverse colon, left colon, and rectum) and summed to provide the total variable score. The sum of each variable score ranges from 0 to 15, except for stenosis (ranges from 0 to 11), because 3 represents a stenosis through which a colonoscope cannot be passed and therefore, can only be observed once. Total SES-CD score is then calculated by summing the item scores (range, 0-56 points).