VOICE-Early Response to Vedolizumab and IL-23 Antagonists in Participants With Crohn's Disease: A Prospective Observational Study
VOICE
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
1 other identifier
observational
300
2 countries
25
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2024
Typical duration for all trials
25 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 24, 2024
CompletedFirst Posted
Study publicly available on registry
February 8, 2024
CompletedStudy Start
First participant enrolled
March 20, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2026
February 13, 2026
February 1, 2026
2.2 years
January 24, 2024
February 11, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To assess time of onset of biologic therapy in pain interference
Time to meaningful clinical improvement in pain interference, defined as a ≥ 2-point decrease in the PROMIS Pain Interference-SF T-score
Baseline to Week 14
Secondary Outcomes (24)
To assess time of onset of biologic therapy in multiple QOL and functioning domains
Baseline to Weeks 14, 30, and 52
To assess the efficacy of therapy in inducing a meaningful clinical improvement in pain interference through Week 52 through a reduction in PROMIS - Pain Interference - Short Form Scores.
Baseline to Weeks 14, 30, and 52
To assess the efficacy of therapy in inducing a meaningful clinical improvement in fatigue through Week 52 through a reduction in PROMIS - Fatigue - Short Form Scores.
Baseline to Weeks 14, 30, and 52
To assess the efficacy of therapy in inducing a meaningful clinical improvement in anxiety through Week 52 through a reduction in PROMIS - Emotional Distress - Anxiety - Short Form Scores.
Baseline to Weeks 14, 30, and 52
To assess the efficacy of therapy in inducing a meaningful clinical improvement in depression through Week 52 through a reduction in PROMIS Emotional Distress - Depression - Short Form.
Baseline to Weeks 14, 30, and 52
- +19 more secondary outcomes
Study Arms (2)
Vedolizumab
Group one will include participants who will be starting Vedolizumab as part of routine care. Dose, frequency and duration are not mandated as part of the study and are determined by the health care provider.
IL-23 Antagonists
Group two will include participants who will be starting an IL-23 antagonist as part of routine care. Dose, frequency and duration are not mandated as part of the study and are determined by the health care provider.
Interventions
Participants will receive VDZ as part of routine care.
Participants will receive UST as part of routine care.
Participants will receive RISA as part of routine care.
Participants will receive GUS as part of routine care.
Participants will receive MIR as part of routine care.
Eligibility Criteria
This study will be conducted in US and Canadian participants with CD prescribed VDZ or IL-23 antagonists for the first time. Approximately 300 participants with CD who are initiating first-time treatment with VDZ or UIL-23 antagonists will be enrolled in this study.
You may qualify if:
- Participant is an adult 18 years of age or older with confirmed CD, as per standard clinical criteria which may include symptoms, endoscopy, histopathology, and imaging.
- Participant has active CD and has been prescribed as standard of care (SOC) and is planned to start VDZ or IL-23 antagonist therapy (UST, RISA, or GUS or MIR \[if approved for the treatment of CD during the recruitment period for this study\]) for the first time in accordance with the product label, as determined by the treating physician.
- Participant has a baseline PROMIS Pain Interference-SF score ≥ 15 (corresponding T-score ≥ 55) (PROMIS Pain Interference-SF 8a \[V1.1\]).
- a. Score is calculated by adding score (1 to 5) for each of the 8 subcomponents.
- Participant has completed all SOC biologic work-up assessments (this may include assessment of tuberculosis, chronic infections, Clostridioides difficile infection and vaccination status per local practice).
- Ability of participant to participate fully in all aspects of this observational study. Full comprehension of consent language and informed consent must be obtained from the participant and documented.
You may not qualify if:
- Participant has CD-related surgery planned or anticipated during the study.
- Participant has an active infection at baseline requiring intravenous systemic antibiotics.
- Note: The treating physician must have completed all appropriate baseline screening tests as per the product label.
- Participant has evidence of C. difficile toxin or is prescribed treatment for C. difficile infection, or other intestinal bacterial pathogen, ≤ 2 weeks prior to Screening.
- Participant has chronic non-inflammatory bowel disease pain.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Alimentiv Inc.lead
- Takedacollaborator
Study Sites (25)
GI Alliance - Sun City
Sun City, Arizona, 85351, United States
Digestive and Liver Center of Florida
Kissimmee, Florida, 34741, United States
Northwestern University
Evanston, Illinois, 60611, United States
University of Iowa
Iowa City, Iowa, 52242, United States
University Medical Center New Orleans
New Orleans, Louisiana, 70112, United States
Brigham and Women's Hospital
Chestnut Hill, Massachusetts, 02467, United States
University of North Carolina
Chapel Hill, North Carolina, 27599, United States
Cleveland Clinic Foundation
Cleveland, Ohio, 44195, United States
OR Clinic - East - GI
Portland, Oregon, 97220, United States
GI Alliance Research Fort Worth
Fort Worth, Texas, 76104, United States
GI Alliance Research Mansfield
Mansfield, Texas, 76063, United States
GI Alliance - Bellevue - Washington Gastroenterology
Bellevue, Washington, 98004, United States
University of Alberta
Edmonton, Alberta, T6G2X8, Canada
University of British Columbia
Vancouver, British Columbia, V6Z2K5, Canada
GNRR Digestive Clinics and Research Center
Brampton, Ontario, L6S0E2, Canada
London Health Sciences Centre
London, Ontario, N6A5A5, Canada
Alimentiv
London, Ontario, N6Z5B6, Canada
West GTA Research Inc.
Mississauga, Ontario, L5M7N4, Canada
Rajbir Rai Medicine Professional Corporation
Oakville, Ontario, L6L4P7, Canada
ABP Research Services Corp.
Oakville, Ontario, L6L5L7, Canada
The Ottawa Hospital
Ottawa, Ontario, K1H8L6, Canada
Scarborough Center for Inflammatory Bowel Disease
Scarborough Village, Ontario, M1B3V4, Canada
Toronto Immune & Digestive Health Institute Inc.
Toronto, Ontario, M6A3B4, Canada
McMaster University Medical Center
Hamilton, Ontatrio, L8N 3Z5, Canada
Montreal General Hospital
Montreal, Quebec, H3G1A4, Canada
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 24, 2024
First Posted
February 8, 2024
Study Start
March 20, 2024
Primary Completion (Estimated)
June 1, 2026
Study Completion (Estimated)
December 1, 2026
Last Updated
February 13, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will not share