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

Purpose

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.

Condition	Intervention	Phase
Gout	Biological: pegloticase	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Multicenter, Open Label Extension Study of 8 mg PEG-uricase in Subjects Who Completed Protocols C0405 or C0406 for Symptomatic Gout

Resource links provided by NLM:

MedlinePlus related topics: Gout

Drug Information available for: Pegloticase

U.S. FDA Resources

Further study details as provided by Savient Pharmaceuticals:

Primary Outcome Measures:

Uric Acid (mg/dL) [ Time Frame: Week 13, Week 25, Week 53, Week 101 ] [ Designated as safety issue: No ]
Uric acid measured at 3 month-intervals

Secondary Outcome Measures:

Tophus Response [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]
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.
Patient Reported Outcome: SF-36 Physical Component Summary Score [ Time Frame: RCT Week 25; OLE Week 25; OLE Week 53, OLE Week 77, OLE Week 101 ] [ Designated as safety issue: No ]
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.
Gout Flare Frequency [ Time Frame: Up to 2 years ] [ Designated as safety issue: Yes ]
The the mean number of flares per subject (flare frequency)was assessed over 3-month periods for up to 2 years of treatment
Gout Flare Incidence [ Time Frame: Assessed in 3-month intervals up to 2 years ] [ Designated as safety issue: Yes ]
Percentage of participants remaining in the study during the specified interval who experienced a gout flare during this interval.

Enrollment:	151
Study Start Date:	December 2006
Study Completion Date:	January 2010
Primary Completion Date:	January 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: q2 RCT Pegloticase every 2 wk arm of Randomized Controlled Trial(RCT), continued to receive pegloticase every 2 weeks (q2 wk) or every 4 weeks (q4 wk) in Open Label Extention (OLE) study	Biological: pegloticase 8 mg intravenous infusion
Experimental: q4 RCT Pegloticase every 4 wk arm of Randomized Controlled Trial (RCT), continued to receive pegloticase every 2 weeks (q2 wk) or every 4 weeks (q4 wk) in Open Label Extention (OLE) study	Biological: pegloticase 8 mg intravenous infusion
Experimental: Placebo in RCT Placebo arm in Randomized Controlled Trial (RCT), received pegloticase every 2 weeks (q2 wk) or every 4 weeks (q4 wk) in OLE	Biological: pegloticase 8 mg intravenous infusion

Eligibility

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

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01356498

Locations

United States, California
Kaiser Permanente Medical Center, Clinical Trials Unit
San Francisco, California, United States, 94118
Pacific Arthritis Center Medical Group
Santa Maria, California, United States, 93454
Agilence Arthritis & Osteoporosis Medical Center
Whittier, California, United States, 90606
United States, District of Columbia
Veterans Affairs Medical Center
Washington, District of Columbia, United States, 20422
United States, Florida
Arthritis & Rheumatic Disease Specialties
Aventura, Florida, United States, 33180
Ocala Rheumatology Research Center
Ocala, Florida, United States, 34474
St. Petersburg Arthritis Center
St. Petersburg, Florida, United States, 33703
United States, Illinois
The University of Chicago
Chicago, Illinois, United States, 60637
United States, Kentucky
Graves Gilbert Clinic
Bowling Green, Kentucky, United States, 42101
United States, Maryland
Peter A. Holt, M.D.
Baltimore, Maryland, United States, 21239
Center for Rheumatology and Bone Research
Wheaton, Maryland, United States, 20902
United States, Michigan
Justus J. Fiechtner, MD, PC
Lansing, Michigan, United States, 48910
United States, Minnesota
CentraCare Clinic
St. Cloud, Minnesota, United States, 56377
United States, New Jersey
Rheumatology Associates of North Jersey
Teaneck, New Jersey, United States, 07666
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27302
United States, Ohio
New Horizons Clinical Research
Cincinnati, Ohio, United States, 45242
The Ohio State University
Columbus, Ohio, United States, 43210
STAT Research, Inc.
Dayton, Ohio, United States, 45402
David R. Mandel, MD, Inc.
Mayfield Village, Ohio, United States, 44143
United States, Pennsylvania
Altoona Center for Clinical Research
Duncansville, Pennsylvania, United States, 16635
Mid Atlantic Research Assoc.
Philadelphia, Pennsylvania, United States, 19154
United States, Washington
Arthritis Northwest, PLLC
Spokane, Washington, United States, 99204

Sponsors and Collaborators

Savient Pharmaceuticals

Investigators

Study Director:

Medical Director, M.D.

Savient Pharmaceuticals, Inc.

More Information

No publications provided

Responsible Party:	Savient Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT01356498 History of Changes
Other Study ID Numbers:	C0407
Study First Received:	October 27, 2008
Results First Received:	August 5, 2011
Last Updated:	October 28, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by Savient Pharmaceuticals:

gout
chronic gout

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 May 19, 2013