Re-Exposure Study of Pegloticase Intravenous (i.v.) in Symptomatic Gout Patients - Full Text View

Sponsored by:	Savient Pharmaceuticals
Information provided by:	Savient Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00675103

Purpose

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.

Condition	Intervention	Phase
Treatment Failure Gout	Drug: pegloticase 8 mg i.v.	Phase III

MedlinePlus related topics: Gout

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
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.

Further study details as provided by Savient Pharmaceuticals:

Primary Outcome Measures:

evaluate the safety profile of pegloticase in this patient population [ Time Frame: 24 weeks of treatment ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

clinical effect on quality of life, functional improvement,swollen and tender joints, and tophus burden [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	18
Study Start Date:	May 2008
Estimated Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
pegloticase: Experimental	Drug: pegloticase 8 mg i.v. pegloticase 8 mg i.v. every 2 weeks for 24 weeks

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00675103

Locations

United States, Illinois
University of Chicago- Dept. Biological Services
Chicago, Illinois, United States, 60637
United States, Maryland
The Center for Rheumatology and Bone Research
Wheaton, Maryland, United States, 20902
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
United States, Oregon
Portland Rheumatology Clinic, L.L.C.
Lake Oswego, Oregon, United States, 97035

Sponsors and Collaborators

Savient Pharmaceuticals

More Information

Responsible Party:	Savient Pharmaceuticals ( Royce W. Waltrip II, MD, Senior Director, Clinical Research )
Study ID Numbers:	C0409
Study First Received:	May 6, 2008
Last Updated:	October 27, 2008
ClinicalTrials.gov Identifier:	NCT00675103
Health Authority:	United States: Food and Drug Administration

Keywords provided by Savient Pharmaceuticals:

Gout
Gouty Arthritis
Anti-Gout preparations

Study placed in the following topic categories:

Metabolism, Inborn Errors
Arthritis, Gouty
Metabolic Diseases
Genetic Diseases, Inborn
Musculoskeletal Diseases
Joint Diseases

Arthritis
Rheumatic Diseases
Metabolic disorder
Purine-Pyrimidine Metabolism, Inborn Errors
Gout

ClinicalTrials.gov processed this record on January 16, 2009