A Multi-Center, Open label, Repeated Dose Range Finding Study to Evaluate the Safety, Tolerability, Immunogenicity, Pharmacokinetics and Efficacy of an Anti-IL-1beta Monoclonal Antibody (ACZ885) Given Subcutaneously in Pediatric Subjects with Active Systemic Juvenile Idiopathic Arthritis (SJIA).

Trial Profile

A Multi-Center, Open label, Repeated Dose Range Finding Study to Evaluate the Safety, Tolerability, Immunogenicity, Pharmacokinetics and Efficacy of an Anti-IL-1beta Monoclonal Antibody (ACZ885) Given Subcutaneously in Pediatric Subjects with Active Systemic Juvenile Idiopathic Arthritis (SJIA).

Completed
Phase of Trial: Phase I/II

Latest Information Update: 17 Jun 2017

At a glance

  • Drugs Canakinumab (Primary)
  • Indications Juvenile rheumatoid arthritis
  • Focus Adverse reactions; Biomarker; Pharmacodynamics; Pharmacokinetics; Therapeutic Use
  • 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
    • 21 Jun 2012 Additional locations (France, United Kingdom) added and official title amended as reported by European Clinical Trials Database record.
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