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NCT01989468 · ClinicalTrials.gov registry record · Phase 3
24 Week Efficacy and 3-year Safety and Efficacy of Secukinumab in Active Psoriatic Arthritis
A Phase 3 study, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 414
- Enrollment target
NCT01989468: Completed Phase 3 study, sponsored by Novartis Pharmaceuticals.
NCT01989468 is a Phase 3 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 414 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (46% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01989468, a Phase 3 study, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 414 participants
- Enrollment target
Study Summary
The purpose of this study is to provide 24 - 52 week efficacy, safety and tolerability data, and up to 3-year efficacy, safety and tolerability data in subjects with active Psoriatic Arthritis despite current or previous nonsteroidal anti-inflammatory drug (NSAID), disease-modifying antirheumatic drug (DMARD) therapy and/or previous anti-tumor necrosis factor alpha (TNFα) therapy.
Primary Outcome
A patient will be considered as improved according the ACR20 criteria if she/he has at least 20% decrease in the swollen and tender joint count, and at least 20% improvements in 3 of the following 5 criteria: physical disability on the Health Assessment Questionnaire; pain score on a visual analog scale; patient global assessment; physician global assessment; and acute phase reactant \[either erythrocyte sedimentation rate (ESR) or high sensitivity C-reactive protein (hsCRP)\]
Interventions
- BIOLOGICAL Placebo
- BIOLOGICAL Secukinumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 414 participants |
| Start Date | 2014-04-10 |
| Est. Completion | 2018-03-28 |
| Phase | Phase 3 |
What the finished NCT01989468 record still lists
NCT01989468 is an interventional study that assigns participants to a tested intervention. The registered 414 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 (46% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01989468 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01989468 about?
NCT01989468 is a clinical study titled "24 Week Efficacy and 3-year Safety and Efficacy of Secukinumab in Active Psoriatic Arthritis". The purpose of this study is to provide 24 - 52 week efficacy, safety and tolerability data, and up to 3-year efficacy, safety and tolerability data in subjects with active Psoriatic Arthritis despite current or previous nonsteroidal anti-inflammatory drug (NSAID), disease-modifying antirheumatic dr...
What is the current status of trial NCT01989468?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 414 participants. The study started on 2014-04-10. Estimated completion is 2018-03-28.
What interventions are being tested in trial NCT01989468?
The interventions under investigation include: Placebo (BIOLOGICAL), Secukinumab (BIOLOGICAL).
Who is sponsoring clinical trial NCT01989468?
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 NCT01989468's enrollment target sits among peer trials
414 905th of 2000 higher than 1,096 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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