NCT06750731 Study of Efficacy and Adherence to Subcutaneous vs. Intravenous Vedolizumab in Patients With Inflammatory Bowel Disease Using a Novel Remote MONITORing Intervention
| NCT ID | NCT06750731 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Mercy Medical Center |
| Condition | Inflammatory Bowel Disease (IBD) |
| Study Type | OBSERVATIONAL |
| Enrollment | 200 participants |
| Start Date | 2025-05-05 |
| Primary Completion | 2026-09-30 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 200 participants in total. It began in 2025-05-05 with a primary completion date of 2026-09-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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)
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)
Contact & Investigator
Raymond K Cross, MD, MS
PRINCIPAL INVESTIGATOR
Mercy Medical Center
Frequently Asked Questions
Who can join the NCT06750731 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Inflammatory Bowel Disease (IBD). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06750731 currently recruiting?
Yes, NCT06750731 is actively recruiting participants. Contact the research team at lcourage@mdmercy.com for enrollment information.
Where is the NCT06750731 trial being conducted?
This trial is being conducted at New Orleans, United States, Chevy Chase, United States, New York, United States, Chapel Hill, United States and 2 additional locations.
Who is sponsoring the NCT06750731 clinical trial?
NCT06750731 is sponsored by Mercy Medical Center. The principal investigator is Raymond K Cross, MD, MS at Mercy Medical Center. The trial plans to enroll 200 participants.