Characterization of CD Responders to Vedolizumab

NCT04909359 | Completed

• 2 other identifiers: 20150750VEDO-IISR-2014-100892
• Study Type: observational
• Target: 51
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to characterize which patients with Crohn's disease are likely to respond to standard of care to vedolizumab therapy.

Conditions

Crohn Disease; Ulcerative Colitis

Keywords

Inflammatory Bowel Disease (IBD); IBD; CD; UC; Vedolizumab; VDZ; Biomarkers; Response

Outcome Measures

Primary Outcomes (1)

• T cell concentration

  Evaluated from peripheral blood samples and lamina propria biopsies

  up to 22 weeks

Secondary Outcomes (2)

• Effector memory T cells concentration

  up to 22 weeks

• T regulatory cells concentration

  up to 22 weeks

Study Arms (2)

Crohn's disease (CD)

People with CD recently receiving vedolizumab as standard of care will be followed up to 5 years.

Ulcerative colitis (UC)

People with UC recently receiving vedolizumab as standard of care will be followed up to 5 years.

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants being seen at the University of Miami IBD clinics with a diagnosis of CD or UC and about to initiate standard of care treatment with vedolizumab.

You may qualify if:

• Male or Female ≥18 and ≤70 years old.
• Patients must be appropriate for baseline colonoscopy prior to induction therapy with vedolizumab.
• Patients must have active inflammatory disease as seen by colonoscopy. 3A-Adult patients with moderately to severely active UC who have:
• had an inadequate response with, lost response to, or were;
• intolerant to a tumor necrosis factor (TNF) blocker or;
• immunomodulator; or had an inadequate response with, were;
• intolerant to, or demonstrated dependence on corticosteroids:
• inducing and maintaining clinical response
• inducing and maintaining clinical remission
• improving endoscopic appearance of the mucosa
• achieving corticosteroid-free remission 3B-Adult patients with moderately to severely active CD who have
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• had an inadequate response with, lost response to, or were
• intolerant to a TNF blocker or immunomodulator; or had an
• inadequate response with, were intolerant to, or demonstrated

You may not qualify if:

• Patients that will not undergo colonoscopy at baseline prior to treatment with vedolizumab.
• Patients who do not have endoscopic or biochemical (CRP, calprotectin) evidence of inflammation.
• Patients that have been on natalizumab within 12 weeks of beginning vedolizumab.
• Previous treatment with cyclosporine, thalidomide, or investigational drugs within 30 days of enrollment, prior treatment with vedolizumab
• Toxic megacolon
• Abdominal abscess
• Symptomatic colonic stricture
• Stoma
• Increased risk of infection (eg, active or latent tuberculosis, immunodeficiency) Other clinically meaningful laboratory abnormalities: pregnancy or lactation, an unstable or uncontrolled medical disorder, colonic dysplasia or adenomas, and malignant neoplasms.

Sponsors & Collaborators

• University of Miami: lead
• Takeda: collaborator

Study Sites (1)

University of Miami

Miami, Florida, 33136, United States

Location

MeSH Terms

Conditions

Crohn Disease; Colitis, Ulcerative; Inflammatory Bowel Diseases

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Colitis; Colonic Diseases

Study Officials

• Maria T Abreu, MD

  University of Miami

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: May 26, 2021
• First Posted: June 1, 2021
• Study Start: August 25, 2015
• Primary Completion: May 15, 2018
• Study Completion: May 18, 2020
• Last Updated: June 1, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)