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RECRUITING
NCT06249555

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

Sponsor: Alimentiv Inc.

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

300

Start Date

2024-03-20

Completion Date

2026-12

Last Updated

2026-02-13

Healthy Volunteers

No

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.

Locations (25)

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

Brigham and Women's Hospital

Chestnut Hill, Massachusetts, United States

University of North Carolina

Chapel Hill, North Carolina, United States

Cleveland Clinic Foundation

Cleveland, Ohio, 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