๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2026-08-20

VOICE-Early Response to Vedolizumab and IL-23 Antagonists in Participants With Crohn's Disease: A Prospective Observational Study (NCT06249555)

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

๐Ÿ”ต Active, Not Recruiting Interventional Protocol ๐Ÿ“Š Observational Clinical Research Sponsor: Alimentiv Inc.

๐Ÿฉบ Plain-English Summary (8th-Grade Level)

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.

Who can join: Review the eligibility criteria below.

Location: GI Alliance - Sun City โ€” Sun City, Arizona

Age range: 18 Years

๐Ÿ“‹ "Do I Qualify?" โ€” 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria โ†—

๐Ÿ“ All Participating Trial Locations (24 Sites)

  • GI Alliance - Sun City โ€” Sun City, Arizona
  • Northwestern University โ€” Evanston, Illinois
  • University of Iowa โ€” Iowa City, Iowa
  • University Medical Center New Orleans โ€” New Orleans, Louisiana
  • Brigham and Women's Hospital โ€” Chestnut Hill, Massachusetts
  • University of North Carolina โ€” Chapel Hill, North Carolina
  • Cleveland Clinic Foundation โ€” Cleveland, Ohio
  • OR Clinic - East - GI โ€” Portland, Oregon
  • GI Alliance Research Fort Worth โ€” Fort Worth, Texas
  • GI Alliance Research Mansfield โ€” Mansfield, Texas
  • GI Alliance - Bellevue - Washington Gastroenterology โ€” Bellevue, Washington
  • University of Alberta โ€” Edmonton, Alberta
  • University of British Columbia โ€” Vancouver, British Columbia
  • GNRR Digestive Clinics and Research Center โ€” Brampton, Ontario
  • London Health Sciences Centre โ€” London, Ontario
  • Alimentiv โ€” London, Ontario
  • West GTA Research Inc. โ€” Mississauga, Ontario
  • Rajbir Rai Medicine Professional Corporation โ€” Oakville, Ontario
  • ABP Research Services Corp. โ€” Oakville, Ontario
  • The Ottawa Hospital โ€” Ottawa, Ontario
  • Scarborough Center for Inflammatory Bowel Disease โ€” Scarborough Village, Ontario
  • Toronto Immune & Digestive Health Institute Inc. โ€” Toronto, Ontario
  • McMaster University Medical Center โ€” Hamilton, Ontatrio
  • Montreal General Hospital โ€” Montreal, Quebec

๐Ÿ’ฐ Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

Explore by condition: All Crohn's Disease clinical trials

๐Ÿ’ก How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Review the official NIH record below to find the coordinating site.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
๐Ÿ›๏ธ View Official NIH Record โ†—