NCT06750731Recruiting
Study of Efficacy and Adherence to Subcutaneous vs. Intravenous Vedolizumab in Patients With Inflammatory Bowel Disease Using a Novel Remote MONITORing Intervention
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)
Source: ClinicalTrials.gov · Last updated 9 Oct 2026
Brief summary (registry, in English)
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)
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 200 (estimated)
- First submitted
- 2 Dec 2024
- Start date
- 5 May 2025
- Primary completion date
- 30 Sept 2027
- Lead sponsor
- Mercy Medical Center
- Diseases
- Crohn's disease, Ulcerative colitis
- NCT number
- NCT06750731
What you commit to
- Study type: Observational
- Planned participants: 200
- From 5 May 2025 to the primary completion date, 30 Sept 2027
- 6 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Imminent surgery (within the next 60 days)
Other illness
- History of short bowel syndrome
- Uncontrolled medical or psychiatric disease at the opinion of the investigator
- Degenerative neurologic condition
- Unstable angina
- Symptomatic peripheral vascular disease
- Malignancy within the last 2 years (excluding squamous or basal cell cancers of the skin)
- Poorly controlled depression, mania, and schizophrenia
- Serious active infection requiring antimicrobial therapy (excluding CD patients with perianal CD on antibiotics)
Other
- Inability to speak and read English or Spanish
- Unable to comply with the study protocol including inability to access the internet and/or inadequate access to a smart device
- Unable to access vedolizumab due to insurance restrictions
- Unable to follow up at respective sites due to insurance restrictions or other barriers (i.e., distance from patient's home to study site)
- Presence of an ileostomy, colostomy, ileoanal pouch anastomosis, or ileorectal anastomosis
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (6)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of North Carolina Coordinator of this site? Confirm its status | Chapel Hill | United States | Recruiting |
| Capital Digestive Care Coordinator of this site? Confirm its status | Chevy Chase | United States | Not yet recruiting |
| University of Cincinnati Coordinator of this site? Confirm its status | Cincinnati | United States | Not yet recruiting |
| Vanderbilt University Coordinator of this site? Confirm its status | Nashville | United States | Not yet recruiting |
| Tulane University Coordinator of this site? Confirm its status | New Orleans | United States | Not yet recruiting |
| NYU Langone Health Coordinator of this site? Confirm its status | New York | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.