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
๐ฉบ 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
๐งช Interventions in This Study
๐ "Do I Qualify?" โ 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria โ
๐ 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
๐ฐ 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.
More studies in Crohn's Disease
- A Non-Interventional Clinical Study to Evaluate Long-Term Safety and Effectiveness of HUMIRA (Adalimumab) in Pediatric Patients With Moderately to Severely Active Crohn's Disease (CD) โ Birmingham, Alabama
- A Study of Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Crohn's Disease โ Birmingham, Alabama
- A Study to Assess Adverse Events and Change in Disease Activity of Risankizumab Subcutaneous Induction Treatment for Moderately to Severely Active Crohn's Disease. โ Sun City, Arizona
- Study to Assess Speed of Onset and Durability of Effectiveness of Upadacitinib in Adult Participants With Moderate to Severe Crohn's Disease (CD) in Real World Clinical Practice. โ Blacktown, New South Wales
- Transmural Healing and Disease-Modifying Effect of Guselkumab in Crohn's Disease Patients โ San Francisco, California
- Dietary Therapy and Gut Microbiome in Crohn's Disease and Ulcerative Colitis โ Boston, Massachusetts
Explore by condition: All Crohn's Disease clinical trials
๐ก How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.