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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: Completed Phase 4 study of Crohn Disease, sponsored by Takeda.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Endoscopic remission was defined as simple endoscopic score for Crohn's Disease (SES-CD) scale score from 0-2. The SES-CD evaluated 4 endoscopic variables: ulcer size, proportion of the surface area that was ulcerated, proportion of the surface area affected, and stenosis in 5 colonic segments evaluated during ileocolonoscopy (ileum, right colon, transverse colon, left colon, and rectum). The score for each endoscopic variable was the sum of values obtained for each segment. The SES-CD total was
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 |
What the finished NCT02764762 record still lists
NCT02764762 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 55 participants, a relatively small participant target, below the 205-participant average among 71 other Crohn Disease trials with a reported enrollment target (73% lower).
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 names 20 study sites across 15 states, led by 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.
Learn More About Clinical Trials
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Where NCT02764762's enrollment target sits among peer trials
55 45th of 71 higher than 25 of 71 other Crohn Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Crohn Disease 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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