RecruitingNCT06249555

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

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

Sponsor

Alimentiv Inc.

Enrollment

300 participants

Start Date

Mar 20, 2024

Study Type

OBSERVATIONAL

Conditions

Crohn's Disease

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This observational study follows people with Crohn's disease (a type of inflammatory bowel disease) who are starting treatment with vedolizumab or an IL-23 blocker (such as ustekinumab or risankizumab) for the first time. Researchers want to understand how quickly and well these drugs reduce pain and symptoms in real-world patients. **You may be eligible if...** - You are 18 or older - You have confirmed Crohn's disease - Your doctor has prescribed vedolizumab or an IL-23 inhibitor as part of your standard care - You have significant pain at the start of the study (as measured by a standard pain questionnaire) - You have completed all required pre-treatment testing **You may NOT be eligible if...** - You have previously used vedolizumab or IL-23 inhibitors - Your pain level does not meet the minimum threshold - You have not yet started the prescribed medication Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGVedolizumab (VDZ)

Participants will receive VDZ as part of routine care.

DRUGUstekinumab (UST)

Participants will receive UST as part of routine care.

DRUGRisankizumab (RISA)

Participants will receive RISA as part of routine care.

DRUGGuselkumab (GUS)

Participants will receive GUS as part of routine care.

DRUGMirikizumab (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

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

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NCT06249555

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