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
Recruiting
Apply to this trial

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

Start date
Mar 20, 2024
Status verified
Feb 2026
Primary completion
Jun 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 ]

Central Contacts

Locations (12)

FacilityCityStateZIPSite coordinators
GI Alliance - Sun CitySun CityArizona85351
Dr. Trivedi (PRINCIPAL_INVESTIGATOR)
Digestive and Liver Center of FloridaKissimmeeFlorida34741-
Northwestern UniversityEvanstonIllinois60611
Dr. Dulai (PRINCIPAL_INVESTIGATOR)
University of IowaIowa CityIowa52242
Dr. Ashat (PRINCIPAL_INVESTIGATOR)
University Medical Center New OrleansNew OrleansLouisiana70112
Dr. Loganantharaj
[email protected]
Dr. Loganantharaj (PRINCIPAL_INVESTIGATOR)
Brigham and Women's HospitalChestnut HillMassachusetts02467
Alexander Carlin
[email protected]
Rahul Dalal, Dr (PRINCIPAL_INVESTIGATOR)
University of North CarolinaChapel HillNorth Carolina27599
Dr. Long (PRINCIPAL_INVESTIGATOR)
Cleveland Clinic FoundationClevelandOhio44195
Jason Soltis
[email protected]
Florian Rieder, Dr (PRINCIPAL_INVESTIGATOR)
OR Clinic - East - GIPortlandOregon97220
Dr. Kiyasu (PRINCIPAL_INVESTIGATOR)
GI Alliance Research Fort WorthFort WorthTexas76104
Dr. Gutta (PRINCIPAL_INVESTIGATOR)
GI Alliance Research MansfieldMansfieldTexas76063
Dr. Odunsi-Shiyanbade
[email protected]
Dr. Odunsi-Shiyanbade (PRINCIPAL_INVESTIGATOR)
GI Alliance - Bellevue - Washington GastroenterologyBellevueWashington98004
Dr. Procaccini
[email protected]
Dr. Procaccini (PRINCIPAL_INVESTIGATOR)

Find similar trials in Sun City, AZ

By condition
Crohn's disease
By specialty
GastroenterologyInflammatory bowel diseaseAutoimmune disease
By research site
GI Alliance - Sun City· Sun City, AZDigestive and Liver Center of Florida· Kissimmee, FLNorthwestern University· Evanston, ILUniversity of Iowa· Iowa City, IAUniversity Medical Center New Orleans· New Orleans, LABrigham and Women's Hospital· Chestnut Hill, MA

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