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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 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.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02497469
The ClinicalTrials.gov registry entry for NCT02497469 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 771 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 378-participant average among 28 other Colitis, Ulcerative trials with a reported enrollment target (104% higher). The listed sponsor is Takeda, which has 408 total studies on file at ClinicalTrials.gov.
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 reports 20 study locations spanning 7 distinct geographic areas - top geographies include 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.
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Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.