New York, NYNCT06750731Now EnrollingIRB Ready

Inflammatory Bowel Disease (IBD) Clinical Trial in New York, NY

Access cutting-edge inflammatory bowel disease (ibd) treatment through this clinical trial at a research site in New York. Study-provided care at no cost to qualified participants.

Sponsored by Mercy Medical Center

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Expert Care in New York

Access inflammatory bowel disease (ibd) specialists at no cost

IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related inflammatory bowel disease (ibd) treatment provided free

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Check if you qualify for this inflammatory bowel disease (ibd) clinical trial in New York, NY

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Why Participate?

  • No-Cost Study Care

  • Local to New York

    Convenient for NY residents

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3Visit New York site if eligible
  4. 4Begin participation

About This Inflammatory Bowel Disease (IBD) Study in New York

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)

Sponsor: Mercy Medical Center

Who Can Participate

Inclusion Criteria

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

Exclusion Criteria

Inability to speak and read English or Spanish
Unable to comply with the study protocol including inability to access the internet and/or inadequate access to a smart device
Unable to access vedolizumab due to insurance restrictions
Unable to follow up at respective sites due to insurance restrictions or other barriers (i.e., distance from patient's home to study site)
Presence of an ileostomy, colostomy, ileoanal pouch anastomosis, or ileorectal anastomosis
Imminent surgery (within the next 60 days)
History of short bowel syndrome
Uncontrolled medical or psychiatric disease at the opinion of the investigator
Degenerative neurologic condition
Unstable angina
Symptomatic peripheral vascular disease
Malignancy within the last 2 years (excluding squamous or basal cell cancers of the skin)
Poorly controlled depression, mania, and schizophrenia
Serious active infection requiring antimicrobial therapy (excluding CD patients with perianal CD on antibiotics)

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in New York?

Yes, this clinical trial (NCT06750731) has an active research site in New York, NY that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Inflammatory Bowel Disease (IBD) Treatment Options in New York, NY

If you're searching for inflammatory bowel disease (ibd) treatment options in New York, NY, this clinical trial (NCT06750731) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our New York research site is actively enrolling participants for this clinical trial. You'll receive care from experienced inflammatory bowel disease (ibd) specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all inflammatory bowel disease (ibd) clinical trials near you to find additional studies recruiting in your area.

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