VOICE-Early Response to Vedolizumab and IL-23 Antagonists in Participants With Crohn's Disease: A Prospective Observational Study
NCT06249555 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 300
Last updated 2026-02-13
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.
Conditions
Interventions
- DRUG
-
Vedolizumab (VDZ)
Participants will receive VDZ as part of routine care.
- DRUG
-
Ustekinumab (UST)
Participants will receive UST as part of routine care.
- DRUG
-
Risankizumab (RISA)
Participants will receive RISA as part of routine care.
- DRUG
-
Guselkumab (GUS)
Participants will receive GUS as part of routine care.
- DRUG
-
Mirikizumab (MIR)
Participants will receive MIR as part of routine care.
Sponsors & Collaborators
- collaborator INDUSTRY
-
Alimentiv Inc.
lead OTHER
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-03-20
- Primary Completion
- 2026-06-30
- Completion
- 2026-12-31
Countries
- United States
- Canada
Study Locations
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