Open-Label Extension Study for Patients Who Completed a Phase 3 Double-blind Study of PEG-uricase for Symptomatic Gout

Savient Pharmaceuticals

Status and phase: Completed; Phase 3

Conditions: Gout

Treatments: Biological: pegloticase

Study type: Interventional

Funder types: Industry

Identifiers

NCT01356498

C0407

Details and patient eligibility

About

This is an open-label extension phase of two double-blind, placebo-controled Phase 3 protocols evaluating PEG-uricase in the treatment of hyperuricemic subjects with symptomatic gout. The purpose of this study is to provide a continuation of treatment to subjects completing the double-blind studies and obtain long-term safety and efficacy data.

Enrollment: 151 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Completed treatment in one of two double-blind, placebo controlled studies of PEG-uricase in subjects with hyperuricemia and symptomatic gout

Exclusion criteria

• unstable angina
• uncontrolled arrhythmia
• uncontrolled hypertension
• end stage renal disease requiring dialysis
• anemia

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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151 participants in 3 patient groups

q2 RCT

Experimental group

Description:

Pegloticase every 2 wk arm of Randomized Controlled Trial(RCT), continued to receive pegloticase every 2 weeks (q2 wk) or every 4 weeks (q4 wk) in Open Label Extention (OLE) study

Treatment:

Biological: pegloticase

q4 RCT

Experimental group

Description:

Pegloticase every 4 wk arm of Randomized Controlled Trial (RCT), continued to receive pegloticase every 2 weeks (q2 wk) or every 4 weeks (q4 wk) in Open Label Extention (OLE) study

Treatment:

Biological: pegloticase

Placebo in RCT

Experimental group

Description:

Placebo arm in Randomized Controlled Trial (RCT), received pegloticase every 2 weeks (q2 wk) or every 4 weeks (q4 wk) in OLE

Treatment:

Biological: pegloticase