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

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)

This study is testing if a digital health system can help people with inflammatory bowel disease stick to their vedolizumab treatment, whether they receive it through an injection under the skin or through an IV, and how it affects their health over 22 weeks.

Quick facts

• Study type: Observational
• Enrollment: 200 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Mercy Medical Center (other)
• Drugs / interventions: vedolizumab, prednisone
• Locations: 6 sites (New Orleans, Louisiana and 5 other locations)
• Trial ID: NCT06750731 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older who have documented inflammatory bowel disease and are initiating treatment with vedolizumab.

Not a fit: Patients with an ostomy or those who have undergone significant bowel surgery may not benefit from this study due to the nature of symptom assessment.

Why it matters

Potential benefit: If successful, this study could enhance medication adherence and improve clinical outcomes for patients with inflammatory bowel disease.

How similar studies have performed: While this approach is innovative, similar studies have shown promise in improving adherence and outcomes through remote monitoring in other chronic conditions.

Eligibility criteria

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 this trial is running

New Orleans, Louisiana and 5 other locations

• Tulane University — New Orleans, Louisiana, United States (NOT_YET_RECRUITING)
• Capital Digestive Care — Chevy Chase, Maryland, United States (NOT_YET_RECRUITING)
• New York University — New York, New York, United States (RECRUITING)
• University of North Carolina — Chapel Hill, North Carolina, United States (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

Conditions: Inflammatory Bowel Disease, Crohn&#39, s Disease, Ulcerative Colitis, inflammatory bowel disease, ulcerative colitis, s disease, remote monitoring