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NCT02294227 · ClinicalTrials.gov registry record · Phase 3
16-week Efficacy and 2-year Safety, Tolerability and Efficacy of Secukinumab in Participants With Active Psoriatic Arthritis
A Phase 3 study of Arthritis, Psoriatic, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 341
- Enrollment target
- 20
- Study locations
NCT02294227: Completed Phase 3 study of Arthritis, Psoriatic, sponsored by Novartis Pharmaceuticals.
NCT02294227 is a Phase 3 study of Arthritis, Psoriatic that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 341 participants, below the 555-participant average among 16 other Arthritis, Psoriatic trials with a reported enrollment target (39% lower). The trial reports 20 study locations across 17 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02294227, a Phase 3 study of Arthritis, Psoriatic, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 341 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study was to provide 16-week efficacy, safety and tolerability data versus placebo to support the use of secukinumab 150 mg by subcutaneous (s.c.) self-administration with or without a loading regimen and maintenance dosing using pre-filled syringe (PFS) and to assess efficacy, safety and tolerability up to 2 years in subjects with active PsA despite current or previous NSAID or DMARD therapy
Primary Outcome
The ACR20 response is defined by at least 20% decrease in the swollen and tender joint count, and at least 20% improvement in 3 of the following 5 criteria: Health Assessment Questionnaire - Disability Index, pain score on a visual analog scale, patient global assessment of disease activity, physician global assessment of disease activity and acute phase reactant \[either erythrocyte sedimentation rate (ESR) or high sensitivity C-reactive protein (hsCRP)\]. ACR20 is used to assess the efficacy
Conditions Studied
Interventions
- OTHER Placebo
- BIOLOGICAL Secukinumab
Study Locations (20)
Florida
- Novartis Investigative Site - Palm Harbor
- Novartis Investigative Site - Sarasota
South Carolina
- Novartis Investigative Site - Charleston
- Novartis Investigative Site - Greenville
Washington
- Novartis Investigative Site - Seattle
- Novartis Investigative Site - Seattle
Arizona
- Novartis Investigative Site - Mesa
California
- Novartis Investigative Site - Upland
Colorado
- Novartis Investigative Site - Denver
Illinois
- Novartis Investigative Site - Peoria
Louisiana
- Novartis Investigative Site - Shreveport
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 341 participants |
| Start Date | 2015-05-29 |
| Est. Completion | 2017-12-19 |
| Phase | Phase 3 |
What the finished NCT02294227 record still lists
NCT02294227 is an interventional study that assigns participants to a tested intervention. The registered 341 participants enrollment target is mid-sized for trials with a published cap, below the 555-participant average among 16 other Arthritis, Psoriatic trials with a reported enrollment target (39% lower).
The record links to 1 condition, with Arthritis, Psoriatic appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT02294227 names 20 study sites across 17 states, led by Florida, South Carolina, Washington.
Frequently Asked Questions
What is clinical trial NCT02294227 about?
NCT02294227 is a clinical study titled "16-week Efficacy and 2-year Safety, Tolerability and Efficacy of Secukinumab in Participants With Active Psoriatic Arthritis". The purpose of this study was to provide 16-week efficacy, safety and tolerability data versus placebo to support the use of secukinumab 150 mg by subcutaneous (s.c.) self-administration with or without a loading regimen and maintenance dosing using pre-filled syringe (PFS) and to assess efficacy, s...
What is the current status of trial NCT02294227?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 341 participants. The study started on 2015-05-29. Estimated completion is 2017-12-19.
What conditions does trial NCT02294227 study?
This clinical trial studies the following conditions: Arthritis, Psoriatic.
What interventions are being tested in trial NCT02294227?
The interventions under investigation include: Placebo (OTHER), Secukinumab (BIOLOGICAL).
Who is sponsoring clinical trial NCT02294227?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02294227 being conducted?
This trial has 20 study locations across Arizona, California, Colorado, Florida, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT02294227's enrollment target sits among peer trials
341 10th of 16 higher than 7 of 16 other Arthritis, Psoriatic trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Arthritis, Psoriatic 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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