Actively Recruiting
Study of Efficacy and Adherence to Subcutaneous vs. Intravenous Vedolizumab in Patients With Inflammatory Bowel Disease Using a Novel Remote MONITORing Intervention
Led by Mercy Medical Center · Updated on 2025-05-08
200
Participants Needed
6
Research Sites
73 weeks
Total Duration
On this page
Sponsors
M
Mercy Medical Center
Lead Sponsor
T
Takeda
Collaborating Sponsor
AI-Summary
What this Trial Is About
The goal of this observational study is to assess the feasibility and effectiveness of a remote monitoring digital health system on adherence, clinical outcomes, and healthcare utilization in patients with inflammatory bowel disease (Crohn's disease, ulcerative colitis, and inflammatory bowel disease type undetermined) initiating therapy with vedolizumab (Entvyio). The main questions it aims to answer are: 1. Assess and compare adherence to intravenous (IV) and subcutaneous vedolizumab maintenance therapy in patients with IBD using a novel remote monitoring system. 2. Assess symptom response to vedolizumab post induction (week 6-8) and during maintenance therapy (week 22) using a novel remote monitoring system. 3. Assess time to response to vedolizumab during induction (weeks 0-6) using a novel remote monitoring system. Researchers will compare medication adherence between participants using IV and subcutaneous vedolizumab maintenance therapy to see if adherence is lower with self-administration. Participants will be asked to register adherence to medication using the novel remote monitoring system each time they take a dose of vedolizumab and to respond to two questions about bowel symptoms weekly for the first 6 weeks after starting vedolizumab then monthly thereafter for 6 months. Additionally, participants will be asked to enter information regarding demographics and social determinants of health at baseline and other variables listed below at baseline and at weeks 2, 6, 14, and 22 post baseline unless otherwise denoted: * MARS-5 * Healthcare utilization (22 weeks only) * Harvey Bradshaw Index (Crohn's disease only) * Simple clinical colitis activity index (Ulcerative colitis only) * PROMIS Global Health Scale * PROMIS Anxiety * PROMIS Depression * PROMIS Sleep Disturbance * PROMIS Pain Interference * PROMIS Physical Function * IBD Self-Efficacy * Attitudinal Survey (22 weeks only)
CONDITIONS
Official Title
Study of Efficacy and Adherence to Subcutaneous vs. Intravenous Vedolizumab in Patients With Inflammatory Bowel Disease Using a Novel Remote MONITORing Intervention
Who Can Participate
Eligibility Criteria
You may qualify if you...
- At least 18 years of age or older
- Have documented inflammatory bowel disease based on clinical symptoms and diagnostic tests
- Initiating treatment with vedolizumab
- Have access to a compatible smartphone with reliable data or Wi-Fi
- Ability to understand the protocol and provide informed consent in English or Spanish
You will not qualify if you...
- Inability to speak and read English or Spanish
- Unable to comply with study protocol or access the internet or a smart device
- Unable to access vedolizumab due to insurance restrictions
- Unable to follow up at study sites due to insurance or distance barriers
- Presence of an ileostomy, colostomy, ileoanal pouch anastomosis, or ileorectal anastomosis
- Imminent surgery within the next 60 days
- History of short bowel syndrome
- Uncontrolled medical or psychiatric conditions including degenerative neurologic disease, unstable angina, peripheral vascular disease, recent malignancy (except certain skin cancers), poorly controlled psychiatric disorders, or serious active infections requiring antibiotics (except perianal Crohn's disease on antibiotics)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 6 locations
1
Tulane University
New Orleans, Louisiana, United States, 70112
Not Yet Recruiting
2
Capital Digestive Care
Chevy Chase, Maryland, United States, 20815
Not Yet Recruiting
3
New York University
New York, New York, United States, 10016
Actively Recruiting
4
University of North Carolina
Chapel Hill, North Carolina, United States, 27599
Actively Recruiting
5
University of Cincinnati
Cincinnati, Ohio, United States, 45219
Not Yet Recruiting
6
Vanderbilt University
Nashville, Tennessee, United States, 37232
Not Yet Recruiting
Research Team
L
Liyah Courageux, MS
CONTACT
M
Makena Trout, BS
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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