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NCT02065570 · ClinicalTrials.gov registry record · Phase 3
Study to Evaluate Efficacy and Safety of Two Drug Regimens in Subjects With Moderate to Severe Crohn's Disease
A Phase 3 study of Crohn's Disease, sponsored by AbbVie.
- Completed
- Registry status
- Phase 3
- Development phase
- 514
- Enrollment target
- 20
- Study locations
NCT02065570: Completed Phase 3 study of Crohn's Disease, sponsored by AbbVie.
NCT02065570 is a Phase 3 study of Crohn's Disease that has completed, run by AbbVie. The registered enrollment target is 514 participants, below the 2,390-participant average among 105 other Crohn's Disease trials with a reported enrollment target (78% lower). The trial reports 20 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02065570, a Phase 3 study of Crohn's Disease, has completed, sponsored by AbbVie.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 514 participants
- Enrollment target
- 20
- Study locations
Study Summary
This study will evaluate higher versus standard adalimumab dosing regimens for induction and maintenance therapy in subjects with moderately to severely active Crohn's Disease and evidence of mucosal ulceration.
Primary Outcome
Crohn's Disease Activity Index (CDAI) is used to assess the symptoms of participants with Crohn's Disease. Scores generally range from 0 to 600, where clinical remission of Crohn's disease is defined as CDAI \< 150, and very severe disease is defined as CDAI \> 450.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Adalimumab
Study Locations (20)
Florida
- Gastroenterology Group Naples /ID# 122493 - Naples
- Internal Med Specialists /ID# 137737 - Orlando
- Shafran Gastroenterology Ctr /ID# 119057 - Winter Park
Georgia
- Winship Cancer Institute of Emory University /ID# 136851 - Atlanta
- Atlanta Gastro Assoc /ID# 119065 - Atlanta
- Gastroenterology Associates of Central Georgia, LLC /ID# 119056 - Macon
Illinois
- Northwestern University Feinberg School of Medicine /ID# 119043 - Chicago
- University of Chicago DCAM /ID# 119077 - Chicago
- Carle Foundation Hospital Digestive Health Research Center /ID# 136008 - Urbana
Alabama
- Birmingham Gastroenterology Associates O.C /ID# 137282 - Birmingham
- Digestive Health Specialists of the Southeast /ID# 122483 - Dothan
California
- Moore UC San Diego Cancer Center /ID# 119053 - La Jolla
- Axis Clinical Trials /ID# 130390 - Los Angeles
Maryland
- Investigative Clinical Research /ID# 119033 - Annapolis
- MGG Group Co, Inc.Chevy Chase Clinical Research /ID# 119042 - Chevy Chase
Colorado
- Rocky Mountain Gastroenterology /ID# 119038 - Wheat Ridge
Connecticut
- Medical Research Ctr CT /ID# 119037 - Hamden
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 514 participants |
| Start Date | 2014-05-01 |
| Est. Completion | 2020-01-30 |
| Phase | Phase 3 |
What the finished NCT02065570 record still lists
NCT02065570 is an interventional study that assigns participants to a tested intervention. The registered 514 participants enrollment target is mid-sized for trials with a published cap, below the 2,390-participant average among 105 other Crohn's Disease trials with a reported enrollment target (78% lower).
The record links to 1 condition, with Crohn's Disease appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT02065570 names 20 study sites across 11 states, led by Florida, Georgia, Illinois.
Frequently Asked Questions
What is clinical trial NCT02065570 about?
NCT02065570 is a clinical study titled "Study to Evaluate Efficacy and Safety of Two Drug Regimens in Subjects With Moderate to Severe Crohn's Disease". This study will evaluate higher versus standard adalimumab dosing regimens for induction and maintenance therapy in subjects with moderately to severely active Crohn's Disease and evidence of mucosal ulceration.
What is the current status of trial NCT02065570?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 514 participants. The study started on 2014-05-01. Estimated completion is 2020-01-30.
What conditions does trial NCT02065570 study?
This clinical trial studies the following conditions: Crohn's Disease.
What interventions are being tested in trial NCT02065570?
The interventions under investigation include: Placebo (DRUG), Adalimumab (DRUG).
Who is sponsoring clinical trial NCT02065570?
This trial is sponsored by AbbVie, which has 526 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02065570 being conducted?
This trial has 20 study locations across Alabama, California, Colorado, Connecticut, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Crohn's Disease
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02065570's enrollment target sits among peer trials
514 25th of 105 higher than 81 of 105 other Crohn's Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Crohn's 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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