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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: Completed Phase 3 study of Crohn Disease, sponsored by Janssen Scientific Affairs.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Percentage of participants with clinical remission at Week 52 were assessed. Clinical remission was defined as a Crohn's Disease Activity Index (CDAI) score of less than (\<) 150 points (in general, CDAI score ranges from 0 to approximately 600; higher score indicates higher disease activities). The CDAI score is used to quantify the symptoms of participants with Crohn's Disease. A decrease in CDAI over time indicates improvement in disease activity.
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 |
What the finished NCT03464136 record still lists
NCT03464136 is an interventional study that assigns participants to a tested intervention. The registered 386 participants enrollment target is mid-sized for trials with a published cap, above the 200-participant average among 71 other Crohn Disease trials with a reported enrollment target (93% higher).
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 names 20 study sites across 10 states, led by 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.
Learn More About Clinical Trials
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Where NCT03464136's enrollment target sits among peer trials
386 9th of 71 higher than 63 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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