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NCT01770379 · ClinicalTrials.gov registry record · Phase 3
Secukinumab Efficacy and Safety Study in Patients With Rheumatoid Arthritis and Inadequate Response to Anti-TNFα Agents.
A Phase 3 study, sponsored by Novartis Pharmaceuticals.
- Terminated
- Registry status
- Phase 3
- Development phase
- 242
- Enrollment target
NCT01770379: Clinical Trial Phase 3 study, sponsored by Novartis Pharmaceuticals.
NCT01770379 is a Phase 3 study that was terminated before completion, run by Novartis Pharmaceuticals. The registered enrollment target is 242 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (69% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01770379, a Phase 3 study, was terminated before completion, sponsored by Novartis Pharmaceuticals.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 242 participants
- Enrollment target
Study Summary
This study will provide efficacy and safety data of the secukinumab pre-filled syringe (PFS) for subcutaneous self-administration in patients with active rheumatoid arthritis who are intolerant to or have had an inadequate response to anti-TNF-α agents.
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
Interventions
- BIOLOGICAL Placebo
- BIOLOGICAL Secukinumab (AIN457)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 242 participants |
| Start Date | 2012-10 |
| Est. Completion | 2015-05 |
| Phase | Phase 3 |
Why NCT01770379 stopped before completion
NCT01770379 is an interventional study that assigns participants to a tested intervention. The registered 242 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (69% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01770379 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01770379 about?
NCT01770379 is a clinical study titled "Secukinumab Efficacy and Safety Study in Patients With Rheumatoid Arthritis and Inadequate Response to Anti-TNFα Agents.". This study will provide efficacy and safety data of the secukinumab pre-filled syringe (PFS) for subcutaneous self-administration in patients with active rheumatoid arthritis who are intolerant to or have had an inadequate response to anti-TNF-α agents.
What is the current status of trial NCT01770379?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 242 participants. The study started on 2012-10. Estimated completion is 2015-05.
What interventions are being tested in trial NCT01770379?
The interventions under investigation include: Placebo (BIOLOGICAL), Secukinumab (AIN457) (BIOLOGICAL).
Who is sponsoring clinical trial NCT01770379?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01770379's enrollment target sits among peer trials
242 1270th of 2000 higher than 729 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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