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VOICE-Early Response to Vedolizumab and IL-23 Antagonists in Participants With Crohn's Disease: A Prospective Observational Study
Sponsor: Alimentiv Inc.
Summary
The primary aim of this study is to explore the time course of response to Vedolizumab in participants with CD as measured by the Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference-short form (SF), as well as other PROMIS domain SFs (fatigue, anxiety, depression, sleep disturbance, physical function, and ability to participate in social roles and activities); other PRO measures will also be assessed.
Official title: VOICE-Characterization of Early Response to Vedolizumab and IL-23 Antagonists in Participants With Crohn's Disease Using Patient-Reported Outcome Measures: A Prospective Observational Study
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
300
Start Date
2024-03-20
Completion Date
2026-12
Last Updated
2026-02-13
Healthy Volunteers
No
Conditions
Interventions
Vedolizumab (VDZ)
Participants will receive VDZ as part of routine care.
Ustekinumab (UST)
Participants will receive UST as part of routine care.
Risankizumab (RISA)
Participants will receive RISA as part of routine care.
Guselkumab (GUS)
Participants will receive GUS as part of routine care.
Mirikizumab (MIR)
Participants will receive MIR as part of routine care.
Locations (25)
GI Alliance - Sun City
Sun City, Arizona, United States
Digestive and Liver Center of Florida
Kissimmee, Florida, United States
Northwestern University
Evanston, Illinois, United States
University of Iowa
Iowa City, Iowa, United States
University Medical Center New Orleans
New Orleans, Louisiana, United States
Brigham and Women's Hospital
Chestnut Hill, Massachusetts, United States
University of North Carolina
Chapel Hill, North Carolina, United States
Cleveland Clinic Foundation
Cleveland, Ohio, United States
OR Clinic - East - GI
Portland, Oregon, United States
GI Alliance Research Fort Worth
Fort Worth, Texas, United States
GI Alliance Research Mansfield
Mansfield, Texas, United States
GI Alliance - Bellevue - Washington Gastroenterology
Bellevue, Washington, United States
University of Alberta
Edmonton, Alberta, Canada
University of British Columbia
Vancouver, British Columbia, Canada
GNRR Digestive Clinics and Research Center
Brampton, Ontario, Canada
London Health Sciences Centre
London, Ontario, Canada
Alimentiv
London, Ontario, Canada
West GTA Research Inc.
Mississauga, Ontario, Canada
Rajbir Rai Medicine Professional Corporation
Oakville, Ontario, Canada
ABP Research Services Corp.
Oakville, Ontario, Canada
The Ottawa Hospital
Ottawa, Ontario, Canada
Scarborough Center for Inflammatory Bowel Disease
Scarborough Village, Ontario, Canada
Toronto Immune & Digestive Health Institute Inc.
Toronto, Ontario, Canada
McMaster University Medical Center
Hamilton, Ontatrio, Canada
Montreal General Hospital
Montreal, Quebec, Canada