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NCT02764762 · ClinicalTrials.gov registry record · Phase 4
Triple Combination Therapy in High Risk Crohn's Disease (CD)
A Phase 4 study of Crohn Disease, sponsored by Takeda.
- Completed
- Registry status
- Phase 4
- Development phase
- 55
- Enrollment target
- 20
- Study locations
NCT02764762 is a Phase 4 study of Crohn Disease that has completed, run by Takeda. The registered enrollment target is 55 participants, below the 205-participant average among 71 other Crohn Disease trials with a reported enrollment target (73% lower). The trial reports 20 study locations across 15 states.
The verdict
NCT02764762, a Phase 4 study of Crohn Disease, has completed, sponsored by Takeda.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 55 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to determine the effect of triple combination therapy with an anti-integrin (vedolizumab intravenous \[IV\]), a tumor necrosis factor (TNF) antagonist (adalimumab subcutaneously \[SC\]), and an immunomodulator (oral methotrexate) on endoscopic remission in participants with newly-diagnosed CD stratified at higher risk for complications.
Conditions Studied
Interventions
- DRUG Adalimumab
- DRUG Vedolizumab
- DRUG Methotrexate
Study Locations (20)
Kansas
- University of Kansas Medical Center - Kansas City
- Cotton O'Neil Clinical Research - Topeka
Louisiana
- Texas Digestive Disease Consultants Baton Rouge - Baton Rouge
- Louisana Research Center, LLC - Shreveport
Michigan
- Center for Digestive Health - Troy
- Huron Gastroenterology Associates - Ypsilanti
North Carolina
- Digestive Health Partners, PS - Asheville
- Carolinas HealthCare System Digestive Health - Charlotte
Oklahoma
- Digestive Disease Specialists, Inc. - Oklahoma City
- Options Health Research, LLC - Tulsa
Alabama
- Digestive Health Specialists of the Southeast - Dothan
Florida
- Gastro Florida - Clearwater
Georgia
- Atlanta Gastroenterology Associates - Atlanta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 55 participants |
| Start Date | 2017-04-18 |
| Est. Completion | 2022-07-05 |
| Phase | Phase 4 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02764762
The ClinicalTrials.gov registry entry for NCT02764762 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 55 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 205-participant average among 71 other Crohn 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 Disease appearing as the primary indexed condition, and to 3 interventions - of which Adalimumab is the first listed.
NCT02764762 reports 20 study locations spanning 15 distinct geographic areas - top geographies include Kansas, Louisiana, Michigan.
Frequently Asked Questions
What is clinical trial NCT02764762 about?
NCT02764762 is a clinical study titled "Triple Combination Therapy in High Risk Crohn's Disease (CD)". The purpose of this study is to determine the effect of triple combination therapy with an anti-integrin (vedolizumab intravenous \[IV\]), a tumor necrosis factor (TNF) antagonist (adalimumab subcutaneously \[SC\]), and an immunomodulator (oral methotrexate) on endoscopic remission in participants w...
What is the current status of trial NCT02764762?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 55 participants. The study started on 2017-04-18. Estimated completion is 2022-07-05.
What conditions does trial NCT02764762 study?
This clinical trial studies the following conditions: Crohn Disease.
What interventions are being tested in trial NCT02764762?
The interventions under investigation include: Adalimumab (DRUG), Vedolizumab (DRUG), Methotrexate (DRUG).
Who is sponsoring clinical trial NCT02764762?
This trial is sponsored by Takeda, which has 408 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02764762 being conducted?
This trial has 20 study locations across Alabama, Florida, Georgia, Idaho, Illinois. 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.