18 and older, any sex, with Psoriatic Arthritis. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Difference Between Secukinumab and Placebo in Terms of Joint Synovitis as Measured by the Power Doppler Ultrasonography (PDUS) Global OMERACT-EULAR Synovitis Score (GLOESS)Primary· 12 weeks
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.
Group
Value
95% CI
Group 1 - Secukinumab (150 mg + 300 mg)
-9.05
± 0.94
Group 2 - Placebo/Secukinumab
-5.86
± 0.93
Proportion of Participants With American College of Rheumatology (ACR)-20 ResponseSecondary· Week 12
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
Group
Value
95% CI
Group 1 - Secukinumab (150 mg + 300 mg)
56
Group 2 - Placebo/Secukinumab
26
Proportion of Participants With American College of Rheumatology (ACR)-50 ResponseSecondary· Week 12
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.
Group
Value
95% CI
Group 1 - Secukinumab (150 mg + 300 mg)
38
Group 2 - Placebo/Secukinumab
7
Spondyloarthritis Research Consortium of Canada (SPARCC)Secondary· Baseline to Week 12
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.
Group
Value
95% CI
Group 1 - Secukinumab (150 mg + 300 mg)
-2.23
± 0.29
Group 2 - Placebo/Secukinumab
-1.57
± 0.29
Adverse events — posted to ClinicalTrials.gov
Time frame: AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for 12 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks.
Reporting threshold: 2%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Treatment Group 1 - Secukinumab (150+300 mg)
Serious: 9/161 (6%)
Deaths: 1/161
Treatnent Group 2 - Placebo/Secukinumab
Serious: 2/83 (2%)
Deaths: 0/83
Serious adverse events (13 terms)
Reaction
System
Treatment Group 1 - Secuki…
Treatnent Group 2 - Placeb…
Acute myocardial infarction
Cardiac disorders
—
—
Atrial fibrillation
Cardiac disorders
—
—
Coronary artery stenosis
Cardiac disorders
—
—
Diarrhoea
Gastrointestinal disorders
—
—
COVID-19
Infections and infestations
—
—
Femur fracture
Injury, poisoning and procedural complications
—
—
Incisional hernia
Injury, poisoning and procedural complications
—
—
Malnutrition
Metabolism and nutrition disorders
—
—
Invasive ductal breast carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
—
—
Ovarian cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
—
—
Prostate cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
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.
Publications & conference data
5 peer-reviewed publications reference this trial (live from Europe PMC):
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Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Novartis Pharmaceuticals
Last refreshed: 7 December 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02662985.