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NCT01377012 · ClinicalTrials.gov registry record · Phase 3
Efficacy at 24 Weeks and Safety, Tolerability and Long Term Efficacy up to 2 Years of Secukinumab (AIN457) in Patients With Active Rheumatoid Arthritis and an Inadequate Response to Anti-TNFα Agents
A Phase 3 study of Rheumatoid Arthritis, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 637
- Enrollment target
- 20
- Study locations
NCT01377012 is a Phase 3 study of Rheumatoid Arthritis that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 637 participants, below the 4,687-participant average among 197 other Rheumatoid Arthritis trials with a reported enrollment target (86% lower). The trial reports 20 study locations across 7 states.
The verdict
NCT01377012, a Phase 3 study of Rheumatoid Arthritis, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 637 participants
- Enrollment target
- 20
- Study locations
Study Summary
The core and extension studies assessed the safety and efficacy of secukinumab when added to a background therapy in patients with active rheumatoid arthritis who are intolerant to or have had an inadequate response to anti-TNF-α agents. Patients received either secukinumab, placebo. The core study was completed. However, the extension study was terminated early (unrelated to safety) due to the results of study AIN457F2309, which indicated the efficacy of AIN457 was not comparable to the currently available RA treatment, abatacept, thus leading to closing of the AIN457 RA program.
Conditions Studied
Interventions
- BIOLOGICAL Placebo
- BIOLOGICAL Secukinumab (AIN457)
Study Locations (20)
Florida
- Novartis Investigative Site - Hialeah
- Novartis Investigative Site - Largo
- Novartis Investigative Site - Miami
- Novartis Investigative Site - Orlando
- Novartis Investigative Site - Palm Harbor
- Novartis Investigative Site - South Miami
- Novartis Investigative Site - Tamarac
- Novartis Investigative Site - Tampa
- Novartis Investigative Site - Tampa
California
- Novartis Investigative Site - Santa Monica
- Novartis Investigative Site - Stanford
- Novartis Investigative Site - Torrance
- Novartis Investigative Site - Upland
Arizona
- Novartis Investigative Site - Mesa
- Novartis Investigative Site - Paradise Valley
- Novartis Investigative Site - Peoria
Arkansas
- Novartis Investigative Site - Little Rock
Georgia
- Novartis Investigative Site - Canton
Kentucky
- Novartis Investigative Site - Bowling Green
Maryland
- Novartis Investigative Site - Wheaton
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 637 participants |
| Start Date | 2011-08-30 |
| Est. Completion | 2015-09-09 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01377012
The ClinicalTrials.gov registry entry for NCT01377012 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 637 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 4,687-participant average among 197 other Rheumatoid Arthritis trials with a reported enrollment target (86% lower). The listed sponsor is Novartis Pharmaceuticals, which has 1,375 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Rheumatoid Arthritis appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT01377012 reports 20 study locations spanning 7 distinct geographic areas - top geographies include Florida, California, Arizona.
Frequently Asked Questions
What is clinical trial NCT01377012 about?
NCT01377012 is a clinical study titled "Efficacy at 24 Weeks and Safety, Tolerability and Long Term Efficacy up to 2 Years of Secukinumab (AIN457) in Patients With Active Rheumatoid Arthritis and an Inadequate Response to Anti-TNFα Agents". The core and extension studies assessed the safety and efficacy of secukinumab when added to a background therapy in patients with active rheumatoid arthritis who are intolerant to or have had an inadequate response to anti-TNF-α agents. Patients received either secukinumab, placebo. The core study ...
What is the current status of trial NCT01377012?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 637 participants. The study started on 2011-08-30. Estimated completion is 2015-09-09.
What conditions does trial NCT01377012 study?
This clinical trial studies the following conditions: Rheumatoid Arthritis.
What interventions are being tested in trial NCT01377012?
The interventions under investigation include: Placebo (BIOLOGICAL), Secukinumab (AIN457) (BIOLOGICAL).
Who is sponsoring clinical trial NCT01377012?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01377012 being conducted?
This trial has 20 study locations across Arizona, Arkansas, California, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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