A Randomized, Double-Blind, Placebo Controlled, Withdrawal Study of Flare Prevention of Canakinumab (ACZ885) in Patients With Systemic Juvenile Idiopathic Arthritis (SJIA) and Active Systemic Manifestations.

Trial Profile

A Randomized, Double-Blind, Placebo Controlled, Withdrawal Study of Flare Prevention of Canakinumab (ACZ885) in Patients With Systemic Juvenile Idiopathic Arthritis (SJIA) and Active Systemic Manifestations.

Completed
Phase of Trial: Phase III

Latest Information Update: 17 Jun 2017

At a glance

  • Drugs Canakinumab (Primary)
  • Indications Juvenile rheumatoid arthritis
  • Focus Biomarker; Pharmacogenomic; Registrational; Therapeutic Use
  • Acronyms Beta-SPECIFIC-2
  • Sponsors Novartis
  • Most Recent Events

    • 17 Jun 2017 Results of pooled analysis (NCT00426218, NCT00886769, NCT00889863, NCT00891046) presented at the 18th Annual Congress of the European League Against Rheumatism
    • 27 Apr 2016 Results assessing pharmacokinetics and pharmacodynamics in paediatric patients from four trials published in the Journal of Clinical Pharmacology
    • 17 Dec 2013 Health Canada approved canakinumab for systemic juvenile idiopathic arthritis based on data from this trial, according to a Novartis Pharmaceuticals Canada media release.
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