Study of Efficacy and Adherence to Subcutaneous vs. Intravenous Vedolizumab in Patients With Inflammatory Bowel Disease Using a Novel Remote MONITORing Intervention

Launched by MERCY MEDICAL CENTER · Dec 18, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at how well patients with inflammatory bowel disease (IBD) respond to a medication called vedolizumab, which can be given either through an IV (intravenous) line or as a self-injected shot under the skin (subcutaneous). The researchers want to see if using a new remote monitoring system helps patients stick to their medication schedule and how it affects their symptoms over time. Participants will track their medication adherence and report their bowel symptoms regularly for the first six weeks and monthly thereafter for up to six months. The study will also evaluate how quickly patients respond to the treatment.

To be eligible for this study, you need to be at least 18 years old and have a confirmed diagnosis of IBD, such as Crohn's disease or ulcerative colitis. You should be starting treatment with vedolizumab and have access to a smartphone that can connect to the internet. If you join the study, you will provide information about your health and symptoms, and you will be asked to use the monitoring system to help keep track of your medication use. The study is not yet recruiting participants, but it aims to gather important data on the effectiveness of different ways to administer this medication for better health outcomes in patients with IBD.

Gender

ALL

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)