Clinical Trial: Secukinumab Safety and Efficacy in JPsA and ERA

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: A Three-part Randomized, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of Secukinumab Treatment in Juvenile Idiopathic Arthritis Subtypes of Psoriatic and Enthesitis-re

Brief Summary: This is a double-blind, placebo-controlled, event-driven randomized withdrawal study to investigate the efficacy and safety of secukinumab treatment in the Juvenile Idiopathic Arthritis (JIA) categories of Juvenile Psoriatic Arthritis (JPsA) and Enthesitis-related Arthritis (ERA). The study is divided into 3 parts (plus a post-treatment follow-up period) consisting of open-label, single-arm active treatment in Treatment Periods 1 and 3 and a randomized, double-blind, placebo controlled, event-driven withdrawal design in Treatment Period 2.

Detailed Summary:
Sponsor: Novartis Pharmaceuticals

Current Primary Outcome: Time to flare in Treatment Period 2 [ Time Frame: From Week 12 until max Week 104 ]

Patients will be randomised 1:1 secukinumab:Placebo at beginning of event-driven Treatment Period 2 at Week 12.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Change from baseline for Juvenile idiopathic arthritis (JIA) American college of rheumatology (ACR) 30/50/70/90/100 response [ Time Frame: 12 weeks ]
  • Change from baseline for JIA ACR core components [ Time Frame: 12 weeks ]
  • Change from baseline Juvenile Arthritis Disease Activity Score (JADAS) score [ Time Frame: 12 weeks ]
  • Change from baseline in total enthesitis count [ Time Frame: 12 weeks ]
  • Change from baseline in total dactylitis count [ Time Frame: 12 weeks ]
  • Percentage of participants with JIA ACR 30/50/70/90/100 and inactive disease [ Time Frame: From week 12 to up to week 104 ]
    To evaluate the effect of withdrawal of secukinumab treatment
  • Secukinumab serum concentration [ Time Frame: 104 weeks ]
    Will assess secukinumab serum concentrations over time
  • Number of participants with reported Adverse Events [ Time Frame: 104 weeks ]
  • Percentage of participants with anti-secukinumab anitbodies [ Time Frame: 104 weeks ]
    Will be assessed by immunogenicity techniques from blood samples drawn during the study.
  • Change from baseline for inactive disease status [ Time Frame: 12 weeks ]


Original Secondary Outcome: Same as current

Information By: Novartis

Dates:
Date Received: November 2, 2016
Date Started: June 6, 2017
Date Completion: December 30, 2020
Last Updated: May 3, 2017
Last Verified: May 2017