Multicenter, Open Label Extension Study of 8 mg PEG-uricase in Subjects Who Completed Protocols C0405 or C0406 for Symptomatic Gout

Trial Profile

Multicenter, Open Label Extension Study of 8 mg PEG-uricase in Subjects Who Completed Protocols C0405 or C0406 for Symptomatic Gout

Completed
Phase of Trial: Phase III

Latest Information Update: 17 Jun 2017

At a glance

  • Drugs Pegloticase (Primary)
  • Indications Gout; Hyperuricaemia
  • Focus Registrational; Therapeutic Use
  • Sponsors Savient Pharmaceuticals
  • Most Recent Events

    • 17 Jun 2017 Results (n=14) of analysis assessing the effect of a 28 day gap between doses of pegloticase on subsequent urate lowering response and frequency of infusion reactions using patient data from NCT01356498, NCT00325195 and NCT00325195 trials, presented at the 18th Annual Congress of the European League Against Rheumatism
    • 30 Oct 2013 Tophus response rates, assessed as a function of tophus size, presented at the 77th American College of Rheumatology and the 48th Annual Meeting of the Association of Rheumatology and Health Professionals.
    • 08 Jan 2013 Results from this trial were used in support of regulatory filings for the approval of pegloticase as a treatment for tophaceous gout according to a Savient Pharmaceuticals media release.
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