Open-Label Extension Study for Patients Who Completed a Phase 3 Double-blind Study of PEG-uricase for Symptomatic Gout

Gout Clinical Trial

Official title:

Multicenter, Open Label Extension Study of 8 mg PEG-uricase in Subjects Who Completed Protocols C0405 or C0406 for Symptomatic Gout

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01356498
• Other study ID #: C0407
• Status: Completed
• Phase: Phase 3
• First received: October 27, 2008
• Last updated: October 28, 2011
• Start date: December 2006
• Est. completion date: January 2010

Study information

• Verified date: October 2011
• Source: Savient Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This is an open-label extension phase of two double-blind, placebo-controled Phase 3 protocols evaluating PEG-uricase in the treatment of hyperuricemic subjects with symptomatic gout. The purpose of this study is to provide a continuation of treatment to subjects completing the double-blind studies and obtain long-term safety and efficacy data.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 151
• Est. completion date: January 2010
• Est. primary completion date: January 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Completed treatment in one of two double-blind, placebo controlled studies of PEG-uricase in subjects with hyperuricemia and symptomatic gout

Exclusion Criteria:

• unstable angina

• uncontrolled arrhythmia

• uncontrolled hypertension

• end stage renal disease requiring dialysis

• anemia

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gout

Intervention

Biological:
• pegloticase
8 mg intravenous infusion

Locations

Country	Name	City	State
United States	Arthritis & Rheumatic Disease Specialties	Aventura	Florida
United States	Peter A. Holt, M.D.	Baltimore	Maryland
United States	Graves Gilbert Clinic	Bowling Green	Kentucky
United States	The University of Chicago	Chicago	Illinois
United States	New Horizons Clinical Research	Cincinnati	Ohio
United States	The Ohio State University	Columbus	Ohio
United States	STAT Research, Inc.	Dayton	Ohio
United States	Altoona Center for Clinical Research	Duncansville	Pennsylvania
United States	Duke University Medical Center	Durham	North Carolina
United States	Justus J. Fiechtner, MD, PC	Lansing	Michigan
United States	David R. Mandel, MD, Inc.	Mayfield Village	Ohio
United States	Ocala Rheumatology Research Center	Ocala	Florida
United States	Mid Atlantic Research Assoc.	Philadelphia	Pennsylvania
United States	Kaiser Permanente Medical Center, Clinical Trials Unit	San Francisco	California
United States	Pacific Arthritis Center Medical Group	Santa Maria	California
United States	Arthritis Northwest, PLLC	Spokane	Washington
United States	CentraCare Clinic	St. Cloud	Minnesota
United States	St. Petersburg Arthritis Center	St. Petersburg	Florida
United States	Rheumatology Associates of North Jersey	Teaneck	New Jersey
United States	Veterans Affairs Medical Center	Washington	District of Columbia
United States	Center for Rheumatology and Bone Research	Wheaton	Maryland
United States	Agilence Arthritis & Osteoporosis Medical Center	Whittier	California

Sponsors (1)

Lead Sponsor	Collaborator
Savient Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Uric Acid (mg/dL)	Uric acid measured at 3 month-intervals	Week 13, Week 25, Week 53, Week 101	No
Secondary	Tophus Response	Target tophi evaluated during the randomized, controlled study were followed for response at 3, 6, 12, 18 and 24 months in this open-label extention study. Results from each participant's final assessment on drug are reported (as last observation carried forward). Complete response=complete disappearance of at least one tophus with no new or worsening tophus. Partial Response=a 50% or more decrease in at least one tophus with no new or worsening tophus.	Up to 2 years	No
Secondary	Patient Reported Outcome: SF-36 Physical Component Summary Score	SF-36 is the Medical Outcomes Survey Short Form-36, a 36-item self-reported questionnaire which assesses health-related limitations in 8 dimensions. The Physical Component Summary Score (PCS) is a composite summary score derived from the dimensions related to physical functioning outcomes: Physical Function, Role Physical, General Health and Bodily Pain (each with a 0 to 100 scale where 0=worst, 100=best).; The Summary Score is constructed as a T-score with a mean of 50 and standard deviation of 10, where higher scores indicate a better health status.	RCT Week 25; OLE Week 25; OLE Week 53, OLE Week 77, OLE Week 101	No
Secondary	Gout Flare Frequency	The the mean number of flares per subject (flare frequency)was assessed over 3-month periods for up to 2 years of treatment	Up to 2 years	Yes
Secondary	Gout Flare Incidence	Percentage of participants remaining in the study during the specified interval who experienced a gout flare during this interval.	Assessed in 3-month intervals up to 2 years	Yes