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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Chronic Gout Refractory to Conventional Therapy Arthritis Arthritis, Gouty Congenital, Hereditary, and Neonatal Diseases and Abnormalities Crystal Arthropathies Genetic Diseases, Inborn Gout Joint Diseases Metabolic Diseases Metabolism, Inborn Errors Musculoskeletal Diseases Nutritional and Metabolic Diseases Purine-Pyrimidine Metabolism, Inborn Errors Rheumatic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

pegloticase 8 mg i.v.

Drug

pegloticase 8 mg i.v. every 2 weeks for 24 weeks

Primary outcomes

Adverse Event Profile

Time frame: 6 months

Number of participants reporting events

Secondary outcomes

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.

Sponsors and collaborators

Lead sponsor

Savient Pharmaceuticals

Industry

Registry information

Official study 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.

Important dates

Study start: 2008
Primary completion: 2009
Study completion: 2009
First posted: May 8, 2008
Registry last updated: Jun 28, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed