Study of Efficacy and Adherence to Subcutaneous vs. Intravenous Vedolizumab in Patients With Inflammatory Bowel Disease Using a Novel Remote MONITORing Intervention
Recruiting now
Conditions studied: Inflammatory Bowel Disease (IBD), Crohn's Disease, Ulcerative Colitis
In brief
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)
Key facts
- Study ID
- NCT06750731
- Run by
- Mercy Medical Center
- People needed
- 200
- Starts
- 2025-05-05
- Expected to finish
- 2026-09-30
- Last updated by the study team
- 2025-05-08
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
- Imminent surgery (within the next 60 days)
- 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)
Where it is running
- New York University — New York, New York, United States (enrolling)
- University of North Carolina — Chapel Hill, North Carolina, United States (enrolling)
- Tulane University — New Orleans, Louisiana, United States
- Capital Digestive Care — Chevy Chase, Maryland, United States
- University of Cincinnati — Cincinnati, Ohio, United States
- Vanderbilt University — Nashville, Tennessee, United States
Full record on ClinicalTrials.gov
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