VOICE-Early Response to Vedolizumab and IL-23 Antagonists in Participants With Crohn's Disease: A Prospective Observational Study
NCT ID: NCT06249555
Last Updated: 2026-01-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
300 participants
OBSERVATIONAL
2024-03-20
2026-12-31
Brief Summary
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Detailed Description
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Rapidity of symptom resolution, which is commonly used as a surrogate for speed of onset, is a priority for patients and clinicians. It is therefore important to better understand the kinetics of symptom improvement captured using patient-reported outcomes (PROs) in patients initiating VDZ for treatment of CD.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
Vedolizumab (VDZ)
Participants will receive VDZ as part of routine care.
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.
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.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. 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.
3. 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.
4. 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).
5. 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.
Exclusion Criteria
2. Participant has prior exposure to an advanced therapy for the treatment of CD (biologic or small molecule) other than an anti-TNF (i.e., anti-integrin, anti-IL, Janus kinase inhibitors, or sphingosine-1-phosphate receptor 1). Prior failure or intolerance to 2 or more anti-TNF (i.e., infliximab, adalimumab, or certolizumab pegol) therapies in the past 3 years is also cause for exclusion.
3. 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.
4. 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.
5. Participant has chronic non-inflammatory bowel disease pain.
18 Years
ALL
No
Sponsors
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Takeda
INDUSTRY
Alimentiv Inc.
OTHER
Responsible Party
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Locations
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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
University of North Carolina
Chapel Hill, North Carolina, 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
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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TAK01796
Identifier Type: -
Identifier Source: org_study_id
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