VOICE-Early Response to Vedolizumab and IL-23 Antagonists in Participants With Crohn's Disease: A Prospective Observational Study

Part of paid clinical trials in Sun City, Arizona.

Sponsor
Alimentiv Inc.
Study ID
NCT06249555
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Vedolizumab (VDZ) — DRUG
    Participants will receive VDZ as part of routine care.
  • Ustekinumab (UST) — DRUG
    Participants will receive UST as part of routine care.
  • Risankizumab (RISA) — DRUG
    Participants will receive RISA as part of routine care.
  • Guselkumab (GUS) — DRUG
    Participants will receive GUS as part of routine care.
  • Mirikizumab (MIR) — DRUG
    Participants will receive MIR as part of routine care.

Study Details

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.

Key Dates

First listed
Feb 8, 2024
Start date
Mar 20, 2024
Status verified
Aug 2026
Primary completion
Sep 30, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
300 participants (estimated)

Arms

  • Arm: 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.
  • Arm: 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.

Primary Outcome Measure

To assess time of onset of biologic therapy in pain interference [ Time Frame: Baseline to Week 14 ]

Locations (11)

FacilityCityStateZIPSite coordinators
GI Alliance - Sun CitySun CityArizona85351-
Northwestern UniversityEvanstonIllinois60611-
University of IowaIowa CityIowa52242-
University Medical Center New OrleansNew OrleansLouisiana70112-
Brigham and Women's HospitalChestnut HillMassachusetts02467-
University of North CarolinaChapel HillNorth Carolina27599-
Cleveland Clinic FoundationClevelandOhio44195-
OR Clinic - East - GIPortlandOregon97220-
GI Alliance Research Fort WorthFort WorthTexas76104-
GI Alliance Research MansfieldMansfieldTexas76063-
GI Alliance - Bellevue - Washington GastroenterologyBellevueWashington98004-

Find similar trials in Sun City, AZ

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By condition
Crohn's disease
By specialty
GastroenterologyInflammatory bowel diseaseAutoimmune disease
By research site
GI Alliance - Sun City· Sun City, AZNorthwestern University· Evanston, ILUniversity of Iowa· Iowa City, IAUniversity Medical Center New Orleans· New Orleans, LABrigham and Women's Hospital· Chestnut Hill, MAUniversity of North Carolina· Chapel Hill, NC

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