A Randomized, Double-Blind, Placebo Controlled, Single-Dose Study to Assess the Initial Efficacy of Canakinumab (ACZ885) With Respect to the Adapted ACR Pediatric 30 Criteria in Patients With Systemic Juvenile Idiopathic Arthritis (SJIA) and Active Systemic Manifestations.

Trial Profile

A Randomized, Double-Blind, Placebo Controlled, Single-Dose Study to Assess the Initial Efficacy of Canakinumab (ACZ885) With Respect to the Adapted ACR Pediatric 30 Criteria in Patients With Systemic Juvenile Idiopathic Arthritis (SJIA) and Active Systemic Manifestations.

Discontinued
Phase of Trial: Phase III

Latest Information Update: 17 Jun 2017

At a glance

  • Drugs Canakinumab (Primary)
  • Indications Juvenile rheumatoid arthritis
  • Focus Pharmacogenomic; Registrational; Therapeutic Use
  • Acronyms Beta-SPECIFIC-1
  • 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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