Real World Study of Efficacy and Adherence to Subcutaneous vs. Intravenous Vedolizumab in Patients With Inflammatory Bowel Disease Using a Novel Remote MONITORing Intervention (MONITOR Study)

Status: Recruiting
Location: See all (6) locations...
Intervention Type: Device
Study Type: Observational
SUMMARY

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)

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• At least 18 years of age or older

• Have documented IBD based on usual diagnostic criteria including clinical symptoms and findings from endoscopy, radiology studies, and histology

• Initiating treatment with vedolizumab

• Have access to a mobile smartphone (iPhone 7 or later; Android release date 2012 or later) with reliable data and/or Wi-Fi access

• Ability to understand the protocol and provide informed consent in English or Spanish

Locations
United States
Louisiana
Tulane University
NOT_YET_RECRUITING
New Orleans
Maryland
Capital Digestive Care
NOT_YET_RECRUITING
Chevy Chase
North Carolina
University of North Carolina
RECRUITING
Chapel Hill
New York
New York University
RECRUITING
New York
Ohio
University of Cincinnati
NOT_YET_RECRUITING
Cincinnati
Tennessee
Vanderbilt University
NOT_YET_RECRUITING
Nashville
Contact Information
Primary
Liyah Courageux, MS
lcourage@mdmercy.com
4103329356
Backup
Makena Trout, BS
mtrout@mdmercy.com
4103329356
Time Frame
Start Date: 2025-05-05
Estimated Completion Date: 2026-09-30
Participants
Target number of participants: 200
Treatments
Participants with IBD receiving vedolizumab
Sponsors
Collaborators: Takeda
Leads: Mercy Medical Center

This content was sourced from clinicaltrials.gov