Phase 3
N=341
16-week Efficacy and 2-year Safety, Tolerability and Efficacy of Secukinumab in Participants With Active Psoriatic Arthritis
Arthritis, Psoriatic
Bottom Line
View on ClinicalTrials.gov: NCT02294227 ↗Enrolled (actual)
341
Serious AEs
13.4%
Results posted
Jul 2019
Primary outcome: Primary: Number of Participants With American College of Rheumatology 20 (ACR20) Response — 47; 45; 21 Participants — p=0.0002
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Secukinumab (Biological); Placebo (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Novartis Pharmaceuticals
- Primary completion
- Feb 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With American College of Rheumatology 20 (ACR20) Response |
33; 26; 22 | — |
| SECONDARY Disease Activity Score (DAS-C28-CRP) Score Change From Baseline Using MMRM at Week 16 |
-0.98; -0.84; -0.21 | — |
| SECONDARY Psoriatic Area and Severity Index 75 (PASI75) |
29; 27; 5 | — |
| SECONDARY Short Form Health Survey Physical Component Score (SF-36-PCS) |
3.42; 3.44; 0.63 | — |
| SECONDARY Number of Participants With American College of Rheumatology 50 (ACR50) |
26; 19; 7 | — |
| SECONDARY Number of Participants With American College of Rheumatology 20 (ACR20) Response |
33; 26; 22 | — |
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
Eligibility Criteria
Inclusion Criteria
- Diagnosis of Psoriatic Arthritis (PsA) classified by ClASsification criteria for Psoriatic ARthritis (CASPAR) criteria.
- Rheumatoid factor and anti-cyclic citrullinated peptide (CCP) antibodies negative.
- Diagnosis of active plaque psoriasis or nail changes consistent with psoriasis.
- Inadequate control of symptoms with NSAID.
- Other protocol-defined inclusion criteria do apply.
Exclusion Criteria
- Chest X-ray or chest magnetic resonance imaging (MRI) with evidence of ongoing infectious or malignant process.
- Subjects taking high potency opioid analgesics.
- Previous exposure to secukinumab or other biologic drug directly targeting interleukin-17 (IL-17) or IL-17 receptor.
- Ongoing use of prohibited psoriasis treatments / medications.
- Subjects who have ever received biologic immunomodulating agents except for those targeting TNFα.
- Previous treatment with any cell-depleting therapies.
Data sourced from ClinicalTrials.gov (NCT02294227). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.