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

Completed · Phase 3

Conditions studied: Chronic Gout Refractory to Conventional Therapy

In brief

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.

Key facts

Study ID

NCT00675103

Run by

Savient Pharmaceuticals

People needed

7

Starts

2008-05-01

Expected to finish

2009-04-01

Last updated by the study team

2011-06-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

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