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NCT02404350 · ClinicalTrials.gov registry record · Phase 3
Study to Demonstrate the Efficacy (Including Inhibition of Structural Damage), Safety and Tolerability up to 2 Years of Secukinumab in Active Psoriatic Arthritis
A Phase 3 study, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 997
- Enrollment target
NCT02404350 is a Phase 3 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 997 participants.
The verdict
NCT02404350, a Phase 3 study, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 997 participants
- Enrollment target
Study Summary
The purpose of this study was to demonstrate efficacy including effect on inhibition of progression of structural damage, safety and tolerability up to 2 years with primary focus at Week 16 (week 24 for structural damage), to support the use of secukinumab pre-filled syringe (PFS) by subcutaneous (s.c.) self-administration with or without loading regimen in subjects with active Psoriatic Arthritis (PsA) despite current or previous NSAID, DMARD therapy and/or previous anti-TNFα therapy. Long term efficacy up to 2 years was based on signs and symptoms of joint/bone structure preservation (X-ray) and improvement in physical function measured by Health Assessment Questionnaire - Disability Index (HAQ-DI©), as well as skin and nail improvement for psoriasis signs.
Interventions
- BIOLOGICAL Secukinumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 997 participants |
| Start Date | 2015-08-31 |
| Est. Completion | 2019-01-24 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02404350
The ClinicalTrials.gov registry entry for NCT02404350 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 997 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 1 intervention - of which Secukinumab is the first listed.
NCT02404350 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02404350 about?
NCT02404350 is a clinical study titled "Study to Demonstrate the Efficacy (Including Inhibition of Structural Damage), Safety and Tolerability up to 2 Years of Secukinumab in Active Psoriatic Arthritis". The purpose of this study was to demonstrate efficacy including effect on inhibition of progression of structural damage, safety and tolerability up to 2 years with primary focus at Week 16 (week 24 for structural damage), to support the use of secukinumab pre-filled syringe (PFS) by subcutaneous (s...
What is the current status of trial NCT02404350?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 997 participants. The study started on 2015-08-31. Estimated completion is 2019-01-24.
What interventions are being tested in trial NCT02404350?
The interventions under investigation include: Secukinumab (BIOLOGICAL).
Who is sponsoring clinical trial NCT02404350?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
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