Triple Combination Therapy in High Risk Crohn's Disease (CD)
Public ClinicalTrials.gov record NCT02764762. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
An Open-Label, Phase 4 Study to Evaluate the Efficacy and Safety of Triple Combination Therapy With Vedolizumab IV, Adalimumab SC, and Oral Methotrexate in Early Treatment of Subjects With Crohn's Disease Stratified at Higher Risk for Developing Complications
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT02764762
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 4
- Enrollment
- 55 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 65 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Apr 18, 2017 (Actual)
- Primary completion
- Sep 22, 2020 (Actual)
- Completion
- Jul 5, 2022 (Actual)
- Last update posted
- Jul 14, 2023
2017 – 2022
United States locations
- U.S. sites
- 27
- U.S. states
- 18
- U.S. cities
- 27
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Digestive Health Specialists of the Southeast | Dothan | Alabama | 36305 | — |
| Gastro Florida | Clearwater | Florida | 33761 | — |
| Atlanta Gastroenterology Associates | Atlanta | Georgia | 30342-5000 | — |
| Grand Teton Research Group, PLLC | Idaho Falls | Idaho | 83404 | — |
| Northshore University HealthSystem | Evanston | Illinois | 60201 | — |
| University of Kansas Medical Center | Kansas City | Kansas | 66160 | — |
| Cotton O'Neil Clinical Research | Topeka | Kansas | 66606 | — |
| Texas Digestive Disease Consultants Baton Rouge | Baton Rouge | Louisiana | 70809 | — |
| Louisana Research Center, LLC | Shreveport | Louisiana | 71105 | — |
| Center for Digestive Health | Troy | Michigan | 48098 | — |
| Huron Gastroenterology Associates | Ypsilanti | Michigan | 48197 | — |
| Minnesota Gastroenterology, PA - Plymouth | Plymouth | Minnesota | 55446 | — |
| University of Mississippi Medical Center | Jackson | Mississippi | 39216 | — |
| Las Vegas Medical Research | Las Vegas | Nevada | 89113 | — |
| Icahn School of Medicine at Mt. Sinai | New York | New York | 10029 | — |
| Digestive Health Partners, PS | Asheville | North Carolina | 28801 | — |
| Carolinas HealthCare System Digestive Health | Charlotte | North Carolina | 28204 | — |
| The Ohio State University Wexner Medical Center | Columbus | Ohio | 43210 | — |
| Digestive Disease Specialists, Inc. | Oklahoma City | Oklahoma | 73112 | — |
| Options Health Research, LLC | Tulsa | Oklahoma | 74104 | — |
| Baylor College of Medicine | Houston | Texas | 77030 | — |
| Pinnacle Clinical Research | San Antonio | Texas | 78229 | — |
| Texas Digestive Disease Consultants Southlake | Southlake | Texas | 76092 | — |
| Tyler Research Institute, LLC | Tyler | Texas | 75701 | — |
| Texas Digestive Disease Consultants, Webster | Webster | Texas | 77598 | — |
| University of Utah Health Sciences Center | Salt Lake City | Utah | 84132 | — |
| Digestive Health Specialists | Tacoma | Washington | 98405 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 5 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02764762, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jul 14, 2023 · Synced Oct 26, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT02764762 live on ClinicalTrials.gov.