Clinical Trial: Study of Power Doppler Ultrasound (PDUS) to Measure Response of Secukinumab Treatment in Patients With Active Psoriatic Arthritis (PsA)

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: 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 Arth

Brief Summary: This study is 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 will be assessed using the OMERACT enthesitis score.

Detailed Summary:

This is 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 is 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) is to allow patients who respond to secukinumab to extend study treatment up to Week 52 or until commercial drug becomes available, whichever occurs sooner.


Sponsor: Novartis Pharmaceuticals

Current Primary Outcome: Difference between secukinumab and placebo in terms of joint synovitis as measured by the PDUS Global OMERACT-EULAR Synovitis Score (GLOESS) [ Time Frame: 12 weeks ]

The primary objective of this study is to demonstrate that there is a difference between secukinumab and placebo in terms of joint synovitis response over 12 weeks as measured by the PDUS Global OMERACT-EULAR Synovitis Score (GLOESS) of the affected joints in PsA patients with an inadequate response (IR) to non biologic DMARDs.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • American College of Rheumatology (ACR)-20 [ Time Frame: Baseline to Week 12 ]
    To demonstrate that the efficacy of secukinumab at Week 12 is superior to placebo based on the proportion of patients achieving an ACR 20 response
  • ACR-50 [ Time Frame: Baseline to Week 12 ]
    To demonstrate that the efficacy of secukinumab at Week 12 is superior to placebo based on the proportion of patients achieving an ACR 50 response.
  • Spondyloarthritis Research Consortium of Canada(SPARCC) [ Time Frame: Baseline to Week 12 ]
    To demonstrate that the clinical response of secukinumab at Week 12 is superior to placebo based on the change in SPARCC enthesitis index from Baseline to Week 12


Original Secondary Outcome: Same as current

Information By: Novartis

Dates:
Date Received: January 13, 2016
Date Started: August 22, 2016
Date Completion: September 3, 2019
Last Updated: May 1, 2017
Last Verified: May 2017