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NCT01752634 · ClinicalTrials.gov registry record · Phase 3
Efficacy at 24 Weeks With Long Term Safety, Tolerability and Efficacy up to 5 Years of Secukinumab in Patients of Active Psoriatic Arthritis
A Phase 3 study, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 397
- Enrollment target
NCT01752634: Completed Phase 3 study, sponsored by Novartis Pharmaceuticals.
NCT01752634 is a Phase 3 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 397 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (49% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01752634, a Phase 3 study, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 397 participants
- Enrollment target
Study Summary
This study was to provide 24 - 52 week efficacy, safety and tolerability data to support the registration of the secukinumab (AIN457) prefilled syringe (PFS) for subcutaneous self administration in subjects with active PsA despite current or previous NSAID, DMARD and/or anti-TNFα therapy. An additional 4 years of long-term efficacy and safety data were collected during the post Week 52 period of the study.
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
- DRUG Placebo
- DRUG Secukinumab (AIN457)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 397 participants |
| Start Date | 2013-04-14 |
| Est. Completion | 2019-01-09 |
| Phase | Phase 3 |
What the finished NCT01752634 record still lists
NCT01752634 is an interventional study that assigns participants to a tested intervention. The registered 397 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 (49% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01752634 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01752634 about?
NCT01752634 is a clinical study titled "Efficacy at 24 Weeks With Long Term Safety, Tolerability and Efficacy up to 5 Years of Secukinumab in Patients of Active Psoriatic Arthritis". This study was to provide 24 - 52 week efficacy, safety and tolerability data to support the registration of the secukinumab (AIN457) prefilled syringe (PFS) for subcutaneous self administration in subjects with active PsA despite current or previous NSAID, DMARD and/or anti-TNFα therapy. An additio...
What is the current status of trial NCT01752634?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 397 participants. The study started on 2013-04-14. Estimated completion is 2019-01-09.
What interventions are being tested in trial NCT01752634?
The interventions under investigation include: Placebo (DRUG), Secukinumab (AIN457) (DRUG).
Who is sponsoring clinical trial NCT01752634?
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 NCT01752634's enrollment target sits among peer trials
397 964th of 2000 higher than 1,037 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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