Recruiting

Vedolizumab vs. Vedolizumab

Sponsor:

Mercy Medical Center

Code:

NCT06750731

Conditions

Inflammatory Bowel Disease (IBD)

Crohn's Disease

Ulcerative Colitis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Tappt

Study Details

Brief summary:

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)

Conditions

Inflammatory Bowel Disease (IBD)

Crohn's Disease

Ulcerative Colitis

Study ID

NCT06750731

Start date

May 5, 2025

Status verified date

May, 2025

Completion date

Sep 30, 2026

Anticipated

Primary completion date

Sep 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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)

Study Design

Enrollment

200 participants

Anticipated

Interventions and Outcome Measures

Arms

Participants with IBD receiving vedolizumab

Interventions

Tappt

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 injections. At the time of a vedolizumab dose, participants will scan the smart label by tapping it with their mobile device to verify that they are taking the medication. Each day that vedolizumab is due, patients will receive a reminder through SMS message. If participants fail to scan the label at a given time (as expected by their specific medication regimen), they will receive an end of day text message reminder. Participants will also complete a patient reported outcome assessment at baseline, weekly for 6 weeks, and then monthly for the entire 22 weeks of the study triggered by the system.

Primary outcome measure

  • Medication Adherence [ Time Frame: From enrollment to the end of the study (22 weeks). ]
  • Self Reported Medication Adherence [ Time Frame: From enrollment to the end of the study (22 weeks). ]

Central Contacts and Locations

Central contacts

Liyah Courageux, MS

4103329356lcourage@mdmercy.com

Makena Trout, BS

4103329356mtrout@mdmercy.com

Locations

New York University

Recruiting

New York, New York, United States, 10016

Contacts

Nathasha Melukkaran

646-754-3417Nathasha.Melukkaran@nyulangone.org

Principal Investigator:

Jordan Axelrad

University of North Carolina

Recruiting

Chapel Hill, North Carolina, United States, 27599

Contacts

Emily English

919-843-8105emily_english@med.unc.edu

Principal Investigator:

Millie Long, MD

More Information

Sponsor

Mercy Medical Center

Last update posted

May 8, 2025

Last verified

May, 2025

Keywords

  • inflammatory bowel disease
  • ulcerative colitis
  • Crohn's disease
  • remote monitoring
  • vedolizumab
  • Entvyio
  • adherence

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-26. This information was provided to ClinicalTrials.gov by Mercy Medical Center on 2025-05-08. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.