Crohn'sUCRecruiting
Study of Efficacy and Adherence to Subcutaneous vs. Intravenous Vedolizumab in Patients With Inflammatory Bowel Disease Using a Novel Remote MONITORing Intervention
Observational · No treatment assigned · 6 sites · Mercy Medical Center
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
Condition(s) listed: Inflammatory Bowel Disease (IBD), Crohn's Disease and Ulcerative Colitis. This is an observational study: researchers collect information (for example questionnaires, samples, or scans) but the study does not assign a treatment.
Who can join
- Ages 18 and older
- Any sex
Some of the main requirements, copied from the record:
- 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
There are also 14 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 200 participants are expected to take part.
- The study has 1 group.
- Start date: 2025-05-05.
- Main results expected around 2027-09-30 (estimate from the record).
- 6 study sites listed (2 marked recruiting) in United States.
Groups in this study
- Participants with IBD receiving vedolizumab
Main thing being measured
- Medication Adherence (From enrollment to the end of the study (22 weeks).)
- Self Reported Medication Adherence (From enrollment to the end of the study (22 weeks).)
In the researchers’ words
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…
Words you might see
- Endoscopy: a camera exam inside the digestive tract.
- Induction: the first phase of treatment, aimed at getting the disease under control.
- Maintenance: longer-term treatment aimed at keeping the disease under control.
- Biopsy / histology: a small tissue sample examined under a microscope.
General definitions, not specific to this trial.
This summary was written automatically from the official record using fixed templates (no AI), so it only says what the record says, and may leave things out.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Recruiting |
|---|---|
| Phase | Observational |
| Study type | Observational |
| Conditions | Inflammatory Bowel Disease (IBD); Crohn's Disease; Ulcerative Colitis |
| Lead sponsor | Mercy Medical Center |
| Collaborators | Takeda |
| Enrollment | 200 (estimated) |
| Start date | 2025-05-05 |
| Primary completion (est.) | 2027-09-30 |
| First posted | 2024-12-27 |
| Last updated | 2026-10-09 |
| Official title | 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) |
| ClinicalTrials.gov ID | NCT06750731 |
Interventions
- Tappt (Device)
Tappt is a web-based system designed to record participants medication taking behavior and bowel symptoms. Participants will be assigned smart labels for their specific vedolizumab regimen, which will be used by participants to record their vedolizumab use. Participants will be shipped smart labels to be affixed to an IV "card" for the first three infusions and for subsequent infusions or injectio…
Full eligibility criteria (from the record)
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)
Locations (6)
| Site | City | Country | Site status |
|---|---|---|---|
| Tulane University | New Orleans, Louisiana | United States | Not yet recruiting |
| Capital Digestive Care | Chevy Chase, Maryland | United States | Not yet recruiting |
| NYU Langone Health | 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 |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.