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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: Completed Phase 3 study of Rheumatoid Arthritis, sponsored by Novartis Pharmaceuticals.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
ACR20 response was defined as having a positive clinical response to treatment (individual improvement) in disease activity if the participant had at least 20% improvement in tender 68-joint count, swollen 66-joint count and at least 3 of the following 5 measures: patient's assessment of RA pain, patient's global assessment of disease activity, physician's global assessment of disease activity, subject self-assessed disability (Health Assessment Questionnaire \[HAQ-DI\] score), and/or acute phas
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 |
What the finished NCT01377012 record still lists
NCT01377012 is an interventional study that assigns participants to a tested intervention. The registered 637 participants enrollment target is mid-sized for trials with a published cap, below the 4,687-participant average among 197 other Rheumatoid Arthritis trials with a reported enrollment target (86% lower).
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 names 20 study sites across 7 states, led by 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.
Learn More About Clinical Trials
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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 NCT01377012's enrollment target sits among peer trials
637 34th of 197 higher than 164 of 197 other Rheumatoid Arthritis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Rheumatoid Arthritis 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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