Characterization of CD Responders to Vedolizumab

Completed

• Conditions: Crohn Disease; Ulcerative Colitis

• Registration Number: NCT04909359
• Lead Sponsor: University of Miami

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-08-25
• Primary Completion: 2018-05-15
• Study Completion: 2020-05-18
• Status Verified: 2021-05
• Study First Submitted: 2021-05-26
• Study First Submitted QC: 2021-05-26
• Last Update Submitted: 2021-05-26
• Study First Posted: 2021-06-01
• Last Update Posted: 2021-06-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 51

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
T cell concentration	up to 22 weeks	Evaluated from peripheral blood samples and lamina propria biopsies

Secondary Outcome Measures

Name	Time	Method
Effector memory T cells concentration	up to 22 weeks	Evaluated from peripheral blood samples and lamina propria biopsies
T regulatory cells concentration	up to 22 weeks	Evaluated from peripheral blood samples and lamina propria biopsies

Trial Locations

Locations (1)

University of Miami; 🇺🇸 Miami, Florida, United States