Determination of the Optimal Treatment Target in Ulcerative Colitis (NCT04259138)
VERDICT: In actiVE Ulcerative Colitis, a RanDomIzed Controlled Trial for Determination of the Optimal Treatment Target
π©Ί Plain-English Summary (8th-Grade Level)
Disease activity and response to therapy in ulcerative colitis (UC) can be assessed by a range of endpoints including symptoms, endoscopic mucosal activity, histological disease activity, and biomarkers. This study aims to determine the optimal treatment target, which is a research priority for the management of UC both to inform clinical practice and to help inform regulatory endpoints and targets for drug development. Participants with active UC will be randomized in a 5:4:1 (initially 2:3:5) ratio to 1 of 3 groups, each with a different treatment target. Treatment targets will be defined as: * Group 1: corticosteroid-free symptomatic remission * Group 2: corticosteroid-free endoscopic + symptomatic remission * Group 3: corticosteroid-free histological + endoscopic + symptomatic remission An interim analysis was performed to assess the proportion of subjects that reached their assigned treatment target after 50 subjects in each group had reached the first 32-week assessment. The interim analysis and projections made based on target achievement rates for all subjects included in the interim analysis resulted in a recommendation to adjust the randomization ratio from 2:3:5 to 5:4:1 for Groups 1, 2 and 3 respectively as of May 5th, 2023. This change was necessary in order to complete the study with approximately 100 subjects achieving treatment target within each group.
Who can join: Review the eligibility criteria below.
Location: St. Joseph Mercy Hospital/Huron Gastroenterology Associates β Ypsilanti, Michigan
Age range: 18 Years
π§ͺ Interventions in This Study
π "Do I Qualify?" β 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria β
π All Participating Trial Locations (58 Sites)
Showing the first 25 of 58 sites.
- St. Joseph Mercy Hospital/Huron Gastroenterology Associates β Ypsilanti, Michigan
- Icahn School of Medicine at Mt Sinai Hospital β New York, New York
- New York-Presbyterian/Weill Cornell Medical Center β New York, New York
- Digestive Health Partners - Asheville Gastroenterology Associate β Asheville, North Carolina
- Atrium Health (Carolinas HealthCare) β Charlotte, North Carolina
- Gomel Regional Clinical Hospital β Homyel, Homiel
- Vitebsk Regional Clinical Hospital β Vitebsk, Vitebsk Oblast
- Imelda Ziekenhuis Bonheiden β Bonheiden, Antwerp
- University Hospital Ghent β Ghent, East Flanders
- UZ Leuven - University Hospital Gasthuisberg β Leuven, Flemish Brabant
- University of Calgary β Calgary, Alberta
- GIRI (GI Research Institute) β Vancouver, British Columbia
- Barrie GI Associates Inc. β Barrie, Ontario
- McMaster University Medical Centre β Hamilton, Ontario
- London Health Sciences Centre - University Campus β London, Ontario
- LHSC - Victoria Hospital β London, Ontario
- ABP Research Services Corp. β Oakville, Ontario
- Taunton Surgical Centre β Oshawa, Ontario
- Toronto Immune and Digestive Health Institute (TIDHI) β Toronto, Ontario
- McGill University Health Centre (MUHC) Montreal General Hospital β Montreal, Quebec
- CH Saint Etienne Hopital Nord β Saint-Priest-en-Jarez, Auvergne-RhΓ΄ne-Alpes
- CHU BesanΓ§on - HΓ΄pital Jean Minjoz β BesanΓ§on, Bourgogne-Franche-ComtΓ©
- CHRU De Nancy - Hopital de Brabois β VandΕuvre-lΓ¨s-Nancy, Grand Est
- CHRU de Lille - Hopital Claude Huriez β Lille, Hauts-de-France
- CHU de Bordeaux - Hopital Haut Leveque - Groupe Hospitalier Sud β Pessac, New Aquitaine
π° 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 Β§ 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 Colitis, Ulcerative
- A Study of Guselkumab in Pediatric Participants With Moderately to Severely Active Ulcerative Colitis β Oakland, California
- A Study of Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Ulcerative Colitis β Arcadia, California
- A Study of Guselkumab Therapy in Participants With Moderately to Severely Active Ulcerative Colitis β Litchfield Park, Arizona
- A Study to Learn About the Effectiveness of Etrasimod in People With Ulcerative Colitis β Kelowna, British Columbia
- A Study to Assess the Efficacy and Safety of Golimumab in Pediatric Participants With Moderately to Severely Active Ulcerative Colitis β San Francisco, California
Explore by condition: All Colitis, Ulcerative clinical trials
π‘ 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.