This study was designed to leverage the sensitivity of ultrasonography available in clinical practice setting to better describe the time course of response to secukinumab (150 mg and 300 mg) on joint synovitis and enthesitis in PsA patients with an inadequate response to non-biologic DMARDs. PDUS changes in joint synovitis will be assessed using the global Outcome Measures in Rheumatology (OMERACT)-European League against Rheumatism (EULAR) synovitis score (GLOESS) and changes in joint enthesitis were assessed using the OMERACT enthesitis score.
This was a 52-week, multicenter, international study consisting of a 2 to 4-week Screening period, a 12-week randomized, placebo-controlled double-blind treatment period (Period 1), a 12-week open-label treatment period (Period 2) and a 6-month open-label extension period (Period 3). Treatment Period 1 is a 12-week placebo-controlled, randomized period primarily designed to demonstrate the early and optimal efficacy of secukinumab vs placebo on joint synovitis using PDUS via the GLOESS and global entheseal score after 12 weeks of treatment. The main aim of Period 2 was to assess the maintenance or increased magnitude of treatment response on joint synovitis for patients from the original secukinumab groups and to assess the time course of response with secukinumab on joint synovitis in the original placebo group switched to secukinumab from Week 12. The main aim of Period 3 (extension period) was to allow patients who respond to secukinumab to extend study treatment up to Week 52 or until commercial drug becomes available, whichever occurs sooner.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
166
Is a recombinant monoclonal antibody which neutralizes the activity of IL-17A, and has been shown to be effective in treating patients with moderate-to-severe plaque psoriasis. Secukinumab 150 mg provided in 1 mL pre filled syringes (PFS) for s.c. injection. The 300 mg dose was administered as 2 × PFS injections.
Secukinumab placebo was provided in a 1 mL PFS for s.c. injection.
Novartis Investigative Site
Beverly Hills, California, United States
Novartis Investigative Site
Los Angeles, California, United States
Novartis Investigative Site
Wheaton, Maryland, United States
Novartis Investigative Site
Salt Lake City, Utah, United States
Novartis Investigative Site
CABA, Buenos Aires, Argentina
Difference Between Secukinumab and Placebo in Terms of Joint Synovitis as Measured by the Power Doppler Ultrasonography (PDUS) Global OMERACT-EULAR Synovitis Score (GLOESS)
Mixed model repeated measures (MMRM) analysis of change in Global OMERACT-EULAR Synovitis Score (GLOESS) score at Week 12 (observed data) to compare treatments The range for the GLOESS score is 0 to 144. GLOESS is the ultrasound scoring system measured for 24 pairs of joints. The scoring is from 0 to 3 for each joint; so the minimum score can be 0 and maximum can be 144.
Time frame: 12 weeks
Proportion of Participants With American College of Rheumatology (ACR)-20 Response
ACR 20 responder has ≥ 20% improvement in TJC and SJC and \>20% improvement in 3 of the following 5 domains: patient's assessment of disease activity, physician's assessment of disease activity, patient's
Time frame: Week 12
Proportion of Participants With American College of Rheumatology (ACR)-50 Response
ACR 50 responder has ≥ 50% improvement in TJC and SJC and \>25% improvement in 3 of the following 5 domains: patient's assessment of disease activity, physician's assessment of disease activity, patient's assessment of PsA pain, HAQ-DI, or hsCRP.
Time frame: Week 12
Spondyloarthritis Research Consortium of Canada (SPARCC)
Repeated measures mixed effect (MMRM) analysis of SPARCC total score change from baseline to Week 12 between the 2 treatment groups. SPARCC index ranges from 0 to 16.
Time frame: Baseline to Week 12
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Novartis Investigative Site
Ciudad Autonoma de Bs As, Argentina
Novartis Investigative Site
San Miguel de Tucumán, Argentina
Novartis Investigative Site
Vienna, Austria
Novartis Investigative Site
Brussels, Belgium
Novartis Investigative Site
Ghent, Belgium
...and 23 more locations