Randomized, Multicenter, Double-Blind, Placebo-Controlled Efficacy and Safety Study of 8 mg PEG-Uricase in Two Dose Regimens in Hyperuricemic Subjects With Symptomatic Gout

Trial Profile

Randomized, Multicenter, Double-Blind, Placebo-Controlled Efficacy and Safety Study of 8 mg PEG-Uricase in Two Dose Regimens in Hyperuricemic Subjects With Symptomatic Gout

Completed
Phase of Trial: Phase III

Latest Information Update: 17 Jun 2017

At a glance

  • Drugs Pegloticase (Primary)
  • Indications Gout
  • Focus Biomarker; Registrational; Therapeutic Use
  • Acronyms GOUT-2
  • Sponsors Savient Pharmaceuticals
  • Most Recent Events

    • 17 Jun 2017 Results assessing preliminary criteria to discern a complete response in patients from two randomised clinical trials (GOUT-1 and GOUT-2), presented at the 18th Annual Congress of the European League Against Rheumatism
    • 17 Jun 2017 Results assessing clinical characteristics and response to pegloticase therapy in patients from two pivotal, randomised trials (GOUT-1 and GOUT-2; n=85), presented at the 18th Annual Congress of the European League Against Rheumatism
    • 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
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