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NCT03464136 · ClinicalTrials.gov registry record · Phase 3
Safety and Efficacy of Adalimumab Versus Ustekinumab for One Year
A Phase 3 study of Crohn Disease, sponsored by Janssen Scientific Affairs.
- Completed
- Registry status
- Phase 3
- Development phase
- 386
- Enrollment target
- 20
- Study locations
NCT03464136 is a Phase 3 study of Crohn Disease that has completed, run by Janssen Scientific Affairs. The registered enrollment target is 386 participants, above the 200-participant average among 71 other Crohn Disease trials with a reported enrollment target (93% higher). The trial reports 20 study locations across 10 states.
The verdict
NCT03464136, a Phase 3 study of Crohn Disease, has completed, sponsored by Janssen Scientific Affairs.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 386 participants
- Enrollment target
- 20
- Study locations
Study Summary
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.
Conditions Studied
Interventions
- BIOLOGICAL Placebo for Ustekinumab
- BIOLOGICAL Placebo for Adalimumab
- BIOLOGICAL Ustekinumab (6 mg/kg)
- BIOLOGICAL Ustekinumab (90 mg)
- BIOLOGICAL Adalimumab (40 mg)
Study Locations (20)
Florida
- Gastro Florida - Clearwater
- Florida Research Network, LLC - Gainesville
- Florida Center For Gastroenterology - Largo
- Center for Advanced Gastroenterology - Maitland
- Gastroenterology Group Of Naples - Naples
- Advanced Medical Research Center - Port Orange
- Apex Clinical Research - Tampa
- Cleveland Clinic Florida - Weston
Kentucky
- Tri-State Gastroenterology Assoc - Crestview Hills
- Gastroenterology Associates Of Hazard - Hazard
- University of Louisville - Louisville
Connecticut
- Gastro Associates of Fairfield County PC - Bridgeport
- Western Connecticut Health Network/Danbury Hospital - Danbury
Alabama
- Alabama Medical Group - Mobile
California
- Precision Research Institute - San Diego
Colorado
- Peak Gastroenterology Associates - Colorado Springs
District of Columbia
- Medstar Washington Hospital Center - Washington D.C.
Georgia
- Atlanta Gastroenterology Specialists, PC - Suwanee
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 386 participants |
| Start Date | 2018-03-29 |
| Est. Completion | 2021-05-21 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03464136
The ClinicalTrials.gov registry entry for NCT03464136 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 386 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 200-participant average among 71 other Crohn Disease trials with a reported enrollment target (93% higher). The listed sponsor is Janssen Scientific Affairs, which has 37 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Crohn Disease appearing as the primary indexed condition, and to 5 interventions - of which Placebo for Ustekinumab is the first listed.
NCT03464136 reports 20 study locations spanning 10 distinct geographic areas - top geographies include Florida, Kentucky, Connecticut.
Frequently Asked Questions
What is clinical trial NCT03464136 about?
NCT03464136 is a clinical study titled "Safety and Efficacy of Adalimumab Versus Ustekinumab for One Year". 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...
What is the current status of trial NCT03464136?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 386 participants. The study started on 2018-03-29. Estimated completion is 2021-05-21.
What conditions does trial NCT03464136 study?
This clinical trial studies the following conditions: Crohn Disease.
What interventions are being tested in trial NCT03464136?
The interventions under investigation include: Placebo for Ustekinumab (BIOLOGICAL), Placebo for Adalimumab (BIOLOGICAL), Ustekinumab (6 mg/kg) (BIOLOGICAL), Ustekinumab (90 mg) (BIOLOGICAL), Adalimumab (40 mg) (BIOLOGICAL).
Who is sponsoring clinical trial NCT03464136?
This trial is sponsored by Janssen Scientific Affairs, which has 37 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03464136 being conducted?
This trial has 20 study locations across Alabama, California, Colorado, Connecticut, District of Columbia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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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.