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

Sponsor:	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 in the US.

Condition	Intervention	Phase
Chronic Gout Refractory to Conventional Therapy	Drug: pegloticase 8 mg i.v.	Phase III

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
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.

Resource links provided by NLM:

MedlinePlus related topics: Gout

U.S. FDA Resources

Further study details as provided by Savient Pharmaceuticals:

Primary Outcome Measures:

Adverse Event Profile [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
Number of participants reporting events

Secondary Outcome Measures:

Mean Plasma Uric Acid [ Time Frame: Baseline, Week 3 and Week 7 ] [ Designated as safety issue: No ]
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.

Enrollment:	7
Study Start Date:	May 2008
Study Completion Date:	April 2009
Primary Completion Date:	January 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: pegloticase	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

No publications provided

Responsible Party:	Chief Medical Officer, Savient Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00675103 History of Changes
Other Study ID Numbers:	C0409
Study First Received:	May 6, 2008
Results First Received:	June 7, 2011
Last Updated:	June 7, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by Savient Pharmaceuticals:

Gout
Gouty Arthritis
Anti-Gout preparations

Additional relevant MeSH terms:

Gout
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

Purine-Pyrimidine Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Metabolic Diseases

ClinicalTrials.gov processed this record on February 12, 2012