Safety and Efficacy of Adalimumab Versus Ustekinumab for One Year
Public ClinicalTrials.gov record NCT03464136. 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
A Phase 3b, Multicenter, Randomized, Blinded, Active-Controlled Study to Compare the Efficacy and Safety of Ustekinumab to That of Adalimumab in the Treatment of Biologic Naïve Subjects With Moderately-to-Severely Active Crohn's Disease
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The purpose of this study is to compare the efficacy of treatment with ustekinumab or adalimumab in biologic naive participants with moderately-to-severely active Crohn's disease (CD) who have previously failed or were intolerant to conventional therapy (corticosteroids and/or immunomodulators, such as azathioprine, 6-mercaptopurine, or methotrexate), as measured by clinical remission at one year.
Study identification
- NCT ID
- NCT03464136
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 386 participants
Conditions and interventions
Conditions
Interventions
- Placebo for Ustekinumab Biological
- Placebo for Adalimumab Biological
- Ustekinumab (6 mg/kg) Biological
- Ustekinumab (90 mg) Biological
- Adalimumab (40 mg) Biological
Biological
Eligibility (public fields only)
- Age range
- 18 Years and older
- 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
- Mar 29, 2018 (Actual)
- Primary completion
- Dec 15, 2020 (Actual)
- Completion
- May 21, 2021 (Actual)
- Last update posted
- Apr 29, 2025
2018 – 2021
United States locations
- U.S. sites
- 67
- U.S. states
- 26
- U.S. cities
- 63
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Alabama Medical Group | Mobile | Alabama | 36608 | — |
| Precision Research Institute | San Diego | California | 92114 | — |
| Peak Gastroenterology Associates | Colorado Springs | Colorado | 80907 | — |
| Gastro Associates of Fairfield County PC | Bridgeport | Connecticut | 06606 | — |
| Western Connecticut Health Network/Danbury Hospital | Danbury | Connecticut | 06810 | — |
| Medstar Washington Hospital Center | Washington D.C. | District of Columbia | 20010 | — |
| Gastro Florida | Clearwater | Florida | 33756 | — |
| Florida Research Network, LLC | Gainesville | Florida | 32605 | — |
| Florida Center For Gastroenterology | Largo | Florida | 33777 | — |
| Center for Advanced Gastroenterology | Maitland | Florida | 32751 | — |
| Gastroenterology Group Of Naples | Naples | Florida | 34102 | — |
| Advanced Medical Research Center | Port Orange | Florida | 32127 | — |
| Apex Clinical Research | Tampa | Florida | 33612 | — |
| Cleveland Clinic Florida | Weston | Florida | 33331 | — |
| Atlanta Gastroenterology Specialists, PC | Suwanee | Georgia | 30024 | — |
| Grand Teton Research Group, PLLC | Idaho Falls | Idaho | 83404 | — |
| Health Science Research Center | Pratt | Kansas | 67124 | — |
| Tri-State Gastroenterology Assoc | Crestview Hills | Kentucky | 41017 | — |
| Gastroenterology Associates Of Hazard | Hazard | Kentucky | 41701 | — |
| University of Louisville | Louisville | Kentucky | 40202 | — |
| Texas Digestive Disease Consultants | Baton Rouge | Louisiana | 70809 | — |
| CroNOLA, LLC | Houma | Louisiana | 70360 | — |
| Louisiana Research Center, LLC | Shreveport | Louisiana | 71105 | — |
| Chevy Chase Clinical Research | Chevy Chase | Maryland | 20815 | — |
| Clinical Research Institute of Michigan, LLC | Chesterfield | Michigan | 48047 | — |
| Huron Gastroenterology Associates Center for Digestive Care | Ypsilanti | Michigan | 48197 | — |
| Mayo Clinic | Rochester | Minnesota | 55905 | — |
| Saint Louis University Hospital | St Louis | Missouri | 63104 | — |
| Mercy Clinic East Community | St Louis | Missouri | 63141 | — |
| Saratoga Schenectady Gastroenterology Associates | Burnt Hills | New York | 12027 | — |
| NYU Langone Long Island Clinical Research Associates | Great Neck | New York | 11021 | — |
| Weill Cornell Medical College | New York | New York | 10021 | — |
| Mount Sinai School of Medicine | New York | New York | 10029 | — |
| Columbia University Medical Center | New York | New York | 10032 | — |
| Premier Medical Group Of The Hudson Valley, Pc | Poughkeepsie | New York | 12601 | — |
| University of Rochester Medical Center | Rochester | New York | 14642 | — |
| Digestive Health Partners | Asheville | North Carolina | 28801 | — |
| University of North Carolina at Chapel Hill | Chapel Hill | North Carolina | 27599 | — |
| Duke University Hospital Medical Center | Raleigh | North Carolina | 27609 | — |
| Wilmington Gastroenterology Associates | Wilmington | North Carolina | 28403 | — |
| Fargo Gastroenterology Clinic, PC | Fargo | North Dakota | 58103 | — |
| Northshore Gastroenterology Research, LLC | Beachwood | Ohio | 44122 | — |
| TriHealth Digestive Institute | Cincinnati | Ohio | 45242 | — |
| University Hospitals Case Medical Center | Cleveland | Ohio | 44106 | — |
| Ohio State University Hospital | Columbus | Ohio | 43210 | — |
| Dayton Gastroenterology, Inc | Dayton | Ohio | 45440 | — |
| Great Lakes Gastroenterology Research, LLC | Mentor | Ohio | 44060 | — |
| Digestive Disease Specialists Inc | Oklahoma City | Oklahoma | 73112 | — |
| Penn State Milton S. Hershey Medical Center | Hershey | Pennsylvania | 17033 | — |
| Allegheny-Singer Research Institute | Pittsburgh | Pennsylvania | 15212-4756 | — |
| Gastroenterology Associates P.A. | Greenville | South Carolina | 29615 | — |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37212 | — |
| Aztec Clinical Research, Inc. | Channelview | Texas | 77530 | — |
| DHAT Research Institute | Garland | Texas | 75044 | — |
| Baylor College of Medicine | Houston | Texas | 77030 | — |
| University of Texas at Houston Medical School | Houston | Texas | 77030 | — |
| Gastroenterology Research of America, LLC | San Antonio | Texas | 78229 | — |
| Texas Digestive Disease Consultants | Southlake | Texas | 76092 | — |
| Tyler Research Institute, LLC | Tyler | Texas | 75701 | — |
| Gastroenterology Associates of Tidewater | Chesapeake | Virginia | 23320 | — |
| Verity Research, Inc | Fairfax | Virginia | 22031 | — |
| Gastroenterology Associates of Central Virginia | Lynchburg | Virginia | 24502 | — |
| Digestive And Liver Disease Specialists | Norfolk | Virginia | 23502 | — |
| McGuire VAMC | Richmond | Virginia | 23229 | — |
| Virginia Gastroenterology Institute | Suffolk | Virginia | 23434 | — |
| Washington Gastroenterology, PLLC | Bellevue | Washington | 98004 | — |
| Washington Gastroenterology, PLLC | 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 115 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03464136, 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 Apr 29, 2025 · Synced Oct 23, 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 NCT03464136 live on ClinicalTrials.gov.