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NCT02611817 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety of Vedolizumab Subcutaneous (SC) as Maintenance Therapy in Crohn's Disease (CD)
A Phase 3 study of Crohn's Disease, sponsored by Takeda.
- Completed
- Registry status
- Phase 3
- Development phase
- 644
- Enrollment target
- 20
- Study locations
NCT02611817 is a Phase 3 study of Crohn's Disease that has completed, run by Takeda. The registered enrollment target is 644 participants, below the 2,408-participant average among 104 other Crohn's Disease trials with a reported enrollment target (73% lower). The trial reports 20 study locations across 11 states.
The verdict
NCT02611817, a Phase 3 study of Crohn's Disease, has completed, sponsored by Takeda.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 644 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to assess the effect of vedolizumab subcutaneous (vedolizumab SC) as maintenance treatment in participants with moderately to severely active CD who achieved clinical response following administration of vedolizumab intravenous (vedolizumab IV) induction therapy.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Vedolizumab SC 108 mg
- DRUG Vedolizumab IV 300 mg
Study Locations (20)
Florida
- Nature Coast Clinical Research, LLC - Inverness
- L & L Research Choices, Inc. - Miami
- Gastroenterology Group of Naples - Naples
- Shafran Gastroenterology Center - Winter Park
Georgia
- Atlanta Gastroenterology Associates - Atlanta
- Gastroenterology Associates of Central Georgia - Macon
- Atlanta Gastroenterology Specialists, PC - Suwanee
Connecticut
- Medical Research Center of Connecticut, LLC - Hamden
- Middlesex Gastroenterology Associates - Middletown
Illinois
- Rush University Medical Center - Chicago
- Carle Foundation Hospital - Urbana
Louisiana
- Gastroenterology Associates, LLC - Baton Rouge
- Louisiana Research Center, LLC - Shreveport
Michigan
- Clinical Research Institute of Michigan, LLC - Chesterfield
- Gastroenterology Associates of Western Michigan, P.L.C. - Wyoming
Arizona
- Arizona Arthritis & Rheumatology Research, PLLC - Phoenix
Idaho
- Grand Teton Research Group, PLL - Idaho Falls
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 644 participants |
| Start Date | 2016-01-04 |
| Est. Completion | 2019-08-06 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02611817
The ClinicalTrials.gov registry entry for NCT02611817 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 644 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,408-participant average among 104 other Crohn's Disease trials with a reported enrollment target (73% lower). The listed sponsor is Takeda, which has 408 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Crohn's Disease appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.
NCT02611817 reports 20 study locations spanning 11 distinct geographic areas - top geographies include Florida, Georgia, Connecticut.
Frequently Asked Questions
What is clinical trial NCT02611817 about?
NCT02611817 is a clinical study titled "Efficacy and Safety of Vedolizumab Subcutaneous (SC) as Maintenance Therapy in Crohn's Disease (CD)". The purpose of this study is to assess the effect of vedolizumab subcutaneous (vedolizumab SC) as maintenance treatment in participants with moderately to severely active CD who achieved clinical response following administration of vedolizumab intravenous (vedolizumab IV) induction therapy.
What is the current status of trial NCT02611817?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 644 participants. The study started on 2016-01-04. Estimated completion is 2019-08-06.
What conditions does trial NCT02611817 study?
This clinical trial studies the following conditions: Crohn's Disease.
What interventions are being tested in trial NCT02611817?
The interventions under investigation include: Placebo (DRUG), Vedolizumab SC 108 mg (DRUG), Vedolizumab IV 300 mg (DRUG).
Who is sponsoring clinical trial NCT02611817?
This trial is sponsored by Takeda, which has 408 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02611817 being conducted?
This trial has 20 study locations across Arizona, Connecticut, Florida, Georgia, Idaho. 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.