CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 166 enrolled
Drug / intervention
AIN457 (secukinumab) +1 moredrug
Likely dose
AIN457 (secukinumab) 150 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02662985
NCT02662985Phase 3Completed
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A 52-week, Multicenter Study to Assess the Time Course of Response to Secukinumab on Joint Inflammation Using Power Doppler Ultrasonography in Patients With Active Psoriatic Arthritis

Novartis Pharmaceuticals·interventional·Posted Jan 26, 2016·Updated Dec 7, 2021

In Brief

A Phase 3 clinical trial evaluating AIN457 (secukinumab) and Placebo for Psoriatic Arthritis. Completed, enrolled 166 participants across 33 sites in 17 countries.

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPsoriatic Arthritis
CountriesArgentina, Austria, Belgium, Canada, Colombia, Czechia, France, Germany, Hungary, Ireland, Italy, Mexico, Netherlands, Norway, Spain, United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
20162017201820192020202120222023202420252026
First PostedJan 26, 2016
Enrollment StartAug 22, 2016
Primary CompletionNov 10, 2020
TodayJul 2, 2026
Enrollment to primary: 4.2 yearsPosted 10.4 years ago

Interventions

AIN457 (secukinumab)drug

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.

Placebodrug

Secukinumab placebo was provided in a 1 mL PFS for s.c. injection.