Actively Recruiting
VOICE-Early Response to Vedolizumab and IL-23 Antagonists in Participants With Crohn's Disease: A Prospective Observational Study
Led by Alimentiv Inc. · Updated on 2026-02-13
300
Participants Needed
25
Research Sites
140 weeks
Total Duration
On this page
Sponsors
A
Alimentiv Inc.
Lead Sponsor
T
Takeda
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
VOICE-Early Response to Vedolizumab and IL-23 Antagonists in Participants With Crohn's Disease: A Prospective Observational Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult 18 years or older with confirmed Crohn's disease by standard clinical criteria
- Active Crohn's disease and starting Vedolizumab or an IL-23 antagonist (Ustekinumab, Risankizumab, Guselkumab, or Mirikizumab if approved) for the first time as part of standard care
- Baseline PROMIS Pain Interference short form score of 15 or higher (T-score 55 or higher)
- Completed all standard biologic work-up assessments including infection and vaccination status
- Able to fully participate in all study aspects and provide informed consent
You will not qualify if you...
- Planned or expected Crohn's disease-related surgery during the study
- Previous use of advanced therapies for Crohn's disease other than anti-TNF drugs, or failure/intolerance to two or more anti-TNF therapies in the past 3 years
- Active infection at baseline requiring intravenous antibiotics
- Evidence or recent treatment (within 2 weeks) for C. difficile or other intestinal bacterial infections
- Chronic pain not related to inflammatory bowel disease
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 25 locations
1
GI Alliance - Sun City
Sun City, Arizona, United States, 85351
Actively Recruiting
2
Digestive and Liver Center of Florida
Kissimmee, Florida, United States, 34741
Withdrawn
3
Northwestern University
Evanston, Illinois, United States, 60611
Actively Recruiting
4
University of Iowa
Iowa City, Iowa, United States, 52242
Actively Recruiting
5
University Medical Center New Orleans
New Orleans, Louisiana, United States, 70112
Actively Recruiting
6
Brigham and Women's Hospital
Chestnut Hill, Massachusetts, United States, 02467
Actively Recruiting
7
University of North Carolina
Chapel Hill, North Carolina, United States, 27599
Actively Recruiting
8
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
Actively Recruiting
9
OR Clinic - East - GI
Portland, Oregon, United States, 97220
Actively Recruiting
10
GI Alliance Research Fort Worth
Fort Worth, Texas, United States, 76104
Actively Recruiting
11
GI Alliance Research Mansfield
Mansfield, Texas, United States, 76063
Actively Recruiting
12
GI Alliance - Bellevue - Washington Gastroenterology
Bellevue, Washington, United States, 98004
Actively Recruiting
13
University of Alberta
Edmonton, Alberta, Canada, T6G2X8
Actively Recruiting
14
University of British Columbia
Vancouver, British Columbia, Canada, V6Z2K5
Actively Recruiting
15
GNRR Digestive Clinics and Research Center
Brampton, Ontario, Canada, L6S0E2
Actively Recruiting
16
London Health Sciences Centre
London, Ontario, Canada, N6A5A5
Actively Recruiting
17
Alimentiv
London, Ontario, Canada, N6Z5B6
Actively Recruiting
18
West GTA Research Inc.
Mississauga, Ontario, Canada, L5M7N4
Actively Recruiting
19
Rajbir Rai Medicine Professional Corporation
Oakville, Ontario, Canada, L6L4P7
Actively Recruiting
20
ABP Research Services Corp.
Oakville, Ontario, Canada, L6L5L7
Actively Recruiting
21
The Ottawa Hospital
Ottawa, Ontario, Canada, K1H8L6
Actively Recruiting
22
Scarborough Center for Inflammatory Bowel Disease
Scarborough Village, Ontario, Canada, M1B3V4
Actively Recruiting
23
Toronto Immune & Digestive Health Institute Inc.
Toronto, Ontario, Canada, M6A3B4
Actively Recruiting
24
McMaster University Medical Center
Hamilton, Ontatrio, Canada, L8N 3Z5
Actively Recruiting
25
Montreal General Hospital
Montreal, Quebec, Canada, H3G1A4
Actively Recruiting
Research Team
S
Susan Archer
CONTACT
B
Becky Petrie
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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