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: 08 Nov 2017

At a glance

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

    • 08 Nov 2017 Results assessing the criteria for a complete response in individuals from two randomised trials (GOUT-1 and GOUT-2), presented at the 81st American College of Rheumatology and the 52nd Association of Rheumatology Health Professionals Annual Scientific Meeting
    • 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
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