Comparing subcutaneous and intravenous vedolizumab for inflammatory bowel disease with remote monitoring

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to evaluate the effectiveness of a remote monitoring digital health system on medication adherence and clinical outcomes in patients with inflammatory bowel disease (IBD) starting treatment with vedolizumab. Participants will be monitored for adherence to either intravenous or subcutaneous vedolizumab over a 22-week period, with symptom assessments conducted weekly for the first six weeks and monthly thereafter. The study will also collect data on healthcare utilization and quality of life, utilizing a web-based system for tracking medication adherence and symptoms.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. At least 18 years of age or older
2. Have documented IBD based on usual diagnostic criteria including clinical symptoms and findings from endoscopy, radiology studies, and histology
3. Initiating treatment with vedolizumab
4. Have access to a mobile smartphone (iPhone 7 or later; Android release date 2012 or later) with reliable data and/or Wi-Fi access
5. Ability to understand the protocol and provide informed consent in English or Spanish

Exclusion Criteria:

1. Inability to speak and read English or Spanish
2. Unable to comply with the study protocol including inability to access the internet and/or inadequate access to a smart device
3. Unable to access vedolizumab due to insurance restrictions
4. Unable to follow up at respective sites due to insurance restrictions or other barriers (i.e., distance from patient's home to study site)
5. Presence of an ileostomy, colostomy, ileoanal pouch anastomosis, or ileorectal anastomosis
6. Imminent surgery (within the next 60 days)
7. History of short bowel syndrome
8. Uncontrolled medical or psychiatric disease at the opinion of the investigator

   1. Degenerative neurologic condition
   2. Unstable angina
   3. Symptomatic peripheral vascular disease
   4. Malignancy within the last 2 years (excluding squamous or basal cell cancers of the skin)
   5. Poorly controlled depression, mania, and schizophrenia
   6. Serious active infection requiring antimicrobial therapy (excluding CD patients with perianal CD on antibiotics)

Where it's running

• NYU Langone Health
  New York, New York, United States Recruiting
• University of North Carolina
  Chapel Hill, North Carolina, United States Recruiting
• Tulane University
  New Orleans, Louisiana, United States Not yet recruiting
• Capital Digestive Care
  Chevy Chase, Maryland, United States Not yet recruiting
• University of Cincinnati
  Cincinnati, Ohio, United States Not yet recruiting
• Vanderbilt University
  Nashville, Tennessee, United States Not yet recruiting

Study contacts

• Principal investigator: Raymond K Cross, MD, MS — Mercy Medical Center
• Study coordinator: Liyah Courageux, MS
• Email: lcourage@mdmercy.com
• Phone: 4103329356

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.