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NCT01350804 · ClinicalTrials.gov registry record · Phase 3
Efficacy at 24 Weeks and Safety, Tolerability and Long Term Efficacy of Secukinumab (AIN457) in Patients With Active Rheumatoid Arthritis (RA) and an Inadequate Response to Anti-Tumor Necrosis Factor α (Anti-TNFα) Agents (CAIN457F2309 and CAIN457F2309E1)
A Phase 3 study, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 551
- Enrollment target
NCT01350804 is a Phase 3 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 551 participants.
The verdict
NCT01350804, a Phase 3 study, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 551 participants
- Enrollment target
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 or abatacept (active comparator). The core study was completed. However, the extension study was prematurely terminated after the primary endpoint analysis of the core study at week 24 had demonstrated numerically higher efficacy for the active comparator abatacept compared to secukinumab.
Interventions
- BIOLOGICAL Placebo
- BIOLOGICAL Abatacept
- BIOLOGICAL AIN457
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 551 participants |
| Start Date | 2011-09 |
| Est. Completion | 2015-02 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01350804
The ClinicalTrials.gov registry entry for NCT01350804 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 551 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Novartis Pharmaceuticals, which has 1,375 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT01350804 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01350804 about?
NCT01350804 is a clinical study titled "Efficacy at 24 Weeks and Safety, Tolerability and Long Term Efficacy of Secukinumab (AIN457) in Patients With Active Rheumatoid Arthritis (RA) and an Inadequate Response to Anti-Tumor Necrosis Factor α (Anti-TNFα) Agents (CAIN457F2309 and CAIN457F2309E1)". 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 or abatacept (ac...
What is the current status of trial NCT01350804?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 551 participants. The study started on 2011-09. Estimated completion is 2015-02.
What interventions are being tested in trial NCT01350804?
The interventions under investigation include: Placebo (BIOLOGICAL), Abatacept (BIOLOGICAL), AIN457 (BIOLOGICAL).
Who is sponsoring clinical trial NCT01350804?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
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