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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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.

Brief 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.


Detailed Summary:
Sponsor: Savient Pharmaceuticals

Current Primary Outcome: Adverse Event Profile [ Time Frame: 6 months ]

Number of participants reporting events


Original Primary Outcome: evaluate the safety profile of pegloticase in this patient population [ Time Frame: 24 weeks of treatment ]

Current Secondary Outcome: Mean Plasma Uric Acid [ Time Frame: Baseline, Week 3 and Week 7 ]

This endpoint assessed the change in mean PUA concentration from baseline after the first dose and after the third dose. Mean PUA was calculated from samples collected at 5 timepoints following each of those doses. For example, Mean PUA at Week 3 included 5 timepoints before dose 2 infusion.


Original Secondary Outcome: clinical effect on quality of life, functional improvement,swollen and tender joints, and tophus burden [ Time Frame: 24 weeks ]

Information By: Savient Pharmaceuticals

Dates:
Date Received: May 6, 2008
Date Started: May 2008
Date Completion:
Last Updated: June 7, 2011
Last Verified: June 2011