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NCT02497469 · ClinicalTrials.gov registry record · Phase 3
An Efficacy and Safety Study of Vedolizumab Intravenous (IV) Compared to Adalimumab Subcutaneous (SC) in Participants With Ulcerative Colitis
A Phase 3 study of Colitis, Ulcerative, sponsored by Takeda.
- Completed
- Registry status
- Phase 3
- Development phase
- 771
- Enrollment target
- 20
- Study locations
NCT02497469: Completed Phase 3 study of Colitis, Ulcerative, sponsored by Takeda.
NCT02497469 is a Phase 3 study of Colitis, Ulcerative that has completed, run by Takeda. The registered enrollment target is 771 participants, above the 378-participant average among 28 other Colitis, Ulcerative trials with a reported enrollment target (104% higher). The trial reports 20 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02497469, a Phase 3 study of Colitis, Ulcerative, has completed, sponsored by Takeda.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 771 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to evaluate the efficacy and safety of vedolizumab intravenous (IV) treatment compared to adalimumab subcutaneous (SC) treatment over a 52-week treatment period.
Primary Outcome
Clinical remission was defined as a complete Mayo score of ≤2 points and no individual subscore \>1 point. The Mayo score was a standard assessment tool to measure ulcerative colitis disease activity in clinical trials. The index consisted of 4 subscores: rectal bleeding, stool frequency, findings on endoscopy, and physician's global assessment. Each subscore was scored on a scale from 0 to 3 and the complete Mayo score ranges from 0 to 12 (higher scores indicate greater disease activity).
Conditions Studied
Interventions
- DRUG Adalimumab
- DRUG Vedolizumab
- DRUG Adalimumab placebo
- DRUG Vedolizumab placebo
Study Locations (20)
Florida
- Innovative Medical Research of South Florida, Inc. - Aventura
- Advanced Clinical Research of Miami - Doral
- Wellness Clinical Research - Hialeah Gardens
- Nature Coast Clinical Research, LLC - Inverness
- Florida Center for Gastroenterology - Largo
- Gastro Health - Miami
- Medical Professional Clinical Research - Miami
- Tellus Clinical Research, Inc. - Miami
- South Florida Research Phase I-IV - Miami Springs
- Gastroenterology Group of Naples - Naples
- Internal Medicine Specialists - Orlando
- BRCR Medical Center, Inc. - Plantation
California
- WCCT Global (PH 1 Unit) - Costa Mesa
- California Medical Research Associates Inc. - Northridge
- Sutter Institute for Medical Research - Sacramento
Alabama
- IMC - Diagnostic and Medical Clinic - Mobile
Arizona
- Arizona Arthritis & Rheumatology Research, PLLC - Phoenix
Arkansas
- Arkansas Primary Care Clinic, PA - Little Rock
Colorado
- Rocky Mountain Gastroenterology - Lakewood
Connecticut
- Medical Research Center of Connecticut, LLC - Hamden
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 771 participants |
| Start Date | 2015-06-29 |
| Est. Completion | 2019-01-18 |
| Phase | Phase 3 |
What the finished NCT02497469 record still lists
NCT02497469 is an interventional study that assigns participants to a tested intervention. The registered 771 participants enrollment target is mid-sized for trials with a published cap, above the 378-participant average among 28 other Colitis, Ulcerative trials with a reported enrollment target (104% higher).
The record links to 1 condition, with Colitis, Ulcerative appearing as the primary indexed condition, and to 4 interventions - of which Adalimumab is the first listed.
NCT02497469 names 20 study sites across 7 states, led by Florida, California, Alabama.
Frequently Asked Questions
What is clinical trial NCT02497469 about?
NCT02497469 is a clinical study titled "An Efficacy and Safety Study of Vedolizumab Intravenous (IV) Compared to Adalimumab Subcutaneous (SC) in Participants With Ulcerative Colitis". The purpose of this study is to evaluate the efficacy and safety of vedolizumab intravenous (IV) treatment compared to adalimumab subcutaneous (SC) treatment over a 52-week treatment period.
What is the current status of trial NCT02497469?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 771 participants. The study started on 2015-06-29. Estimated completion is 2019-01-18.
What conditions does trial NCT02497469 study?
This clinical trial studies the following conditions: Colitis, Ulcerative.
What interventions are being tested in trial NCT02497469?
The interventions under investigation include: Adalimumab (DRUG), Vedolizumab (DRUG), Adalimumab placebo (DRUG), Vedolizumab placebo (DRUG).
Who is sponsoring clinical trial NCT02497469?
This trial is sponsored by Takeda, which has 408 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02497469 being conducted?
This trial has 20 study locations across Alabama, Arizona, Arkansas, California, Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT02497469's enrollment target sits among peer trials
771 6th of 28 higher than 23 of 28 other Colitis, Ulcerative trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Colitis, Ulcerative trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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