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

Phase 3

Completed

• Conditions: Chronic Gout Refractory to Conventional Therapy
• Interventions: Drug: pegloticase 8 mg i.v.

• Registration Number: NCT00675103
• Lead Sponsor: Savient Pharmaceuticals

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 Description

Not available

Study Timeline

• Study Start: 2008-05
• Study First Submitted: 2008-05-06
• Study First Submitted QC: 2008-05-07
• Study First Posted: 2008-05-08
• Primary Completion: 2009-01
• Study Completion: 2009-04
• Status Verified: 2011-06
• Results First Submitted: 2011-06-07
• Results First Submitted QC: 2011-06-07
• Last Update Submitted: 2011-06-07
• Results First Posted: 2011-06-28
• Last Update Posted: 2011-06-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 7

Inclusion Criteria

• Previous treatment in studies of pegloticase i.v.
• Last exposure to pegloticase i.v. greater than one year prior to study entry
• Symptomatic gout
• Documented hyperuricemic (SUA ≥ 7 mg/dL)

Exclusion Criteria

• Prior exposure to Elitek® (rasburicase)
• Unstable angina
• Uncontrolled arrhythmia or hypertension
• Non-compensated congestive heart failure
• End stage renal disease requiring dialysis
• Concomitant use of SUA lowering agents and use of other investigational drugs

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
pegloticase	pegloticase 8 mg i.v.	-

Primary Outcome Measures

Name	Time	Method
Adverse Event Profile	6 months	Number of participants reporting events

Secondary Outcome Measures

Name	Time	Method
Mean Plasma Uric Acid	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.

Trial Locations

Locations (4)

University of Chicago- Dept. Biological Services; 🇺🇸 Chicago, Illinois, United States

The Center for Rheumatology and Bone Research; 🇺🇸 Wheaton, Maryland, United States

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States

Portland Rheumatology Clinic, L.L.C.; 🇺🇸 Lake Oswego, Oregon, United States