Re-exposure Study of Pegloticase Intravenous (i.v.) in Symptomatic Gout Patients

Chronic Gout Refractory to Conventional Therapy Clinical Trial

Official title: Multicenter, Open-Label, 24 Week Regimen of 8 mg Pegloticase i.v. in Symptomatic Gout Subjects Who Participated in Previous Studies of Pegloticase i.v.

Status Completed

Clinical Trial Summary

The purpose of the study is to evaluate the safety and clinical effect of re-exposure to a 24 week course of treatment of pegloticase i.v. in subjects whose last exposure to pegloticase i.v. was at least one year before study entry.

This study is limited to four study centers in the US.

Clinical Trial Description

n/a

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Gout Refractory to Conventional Therapy
• Gout

• NCT number: NCT00675103
• Study type: Interventional
• Source: Savient Pharmaceuticals
• Status: Completed
• Phase: Phase 3
• Start date: May 2008
• Completion date: April 2009