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

Phase 3

Completed

• Conditions: Gout
• Interventions: Biological: pegloticase

• Registration Number: NCT01356498
• Lead Sponsor: Savient Pharmaceuticals

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-12
• Study First Submitted: 2008-10-27
• Primary Completion: 2010-01
• Study Completion: 2010-01
• Study First Submitted QC: 2011-05-18
• Study First Posted: 2011-05-19
• Results First Submitted: 2011-08-05
• Status Verified: 2011-10
• Results First Submitted QC: 2011-10-28
• Last Update Submitted: 2011-10-28
• Results First Posted: 2011-12-02
• Last Update Posted: 2011-12-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 151

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
q2 RCT	pegloticase	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
q4 RCT	pegloticase	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
Placebo in RCT	pegloticase	Placebo arm in Randomized Controlled Trial (RCT), received pegloticase every 2 weeks (q2 wk) or every 4 weeks (q4 wk) in OLE

Primary Outcome Measures

Name	Time	Method
Uric Acid (mg/dL)	Week 13, Week 25, Week 53, Week 101	Uric acid measured at 3 month-intervals

Secondary Outcome Measures

Name	Time	Method
Gout Flare Incidence	Assessed in 3-month intervals up to 2 years	Percentage of participants remaining in the study during the specified interval who experienced a gout flare during this interval.
Tophus Response	Up to 2 years	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	RCT Week 25; OLE Week 25; OLE Week 53, OLE Week 77, OLE Week 101	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	Up to 2 years	The the mean number of flares per subject (flare frequency)was assessed over 3-month periods for up to 2 years of treatment

Trial Locations

Locations (22)

Pacific Arthritis Center Medical Group; 🇺🇸 Santa Maria, California, United States

Veterans Affairs Medical Center; 🇺🇸 Washington, District of Columbia, United States

Graves Gilbert Clinic; 🇺🇸 Bowling Green, Kentucky, United States

Ocala Rheumatology Research Center; 🇺🇸 Ocala, Florida, United States

CentraCare Clinic; 🇺🇸 St. Cloud, Minnesota, United States

David R. Mandel, MD, Inc.; 🇺🇸 Mayfield Village, Ohio, United States

Center for Rheumatology and Bone Research; 🇺🇸 Wheaton, Maryland, United States

Altoona Center for Clinical Research; 🇺🇸 Duncansville, Pennsylvania, United States

Rheumatology Associates of North Jersey; 🇺🇸 Teaneck, New Jersey, United States

STAT Research, Inc.; 🇺🇸 Dayton, Ohio, United States

Arthritis Northwest, PLLC; 🇺🇸 Spokane, Washington, United States

Arthritis & Rheumatic Disease Specialties; 🇺🇸 Aventura, Florida, United States

New Horizons Clinical Research; 🇺🇸 Cincinnati, Ohio, United States

Kaiser Permanente Medical Center, Clinical Trials Unit; 🇺🇸 San Francisco, California, United States

St. Petersburg Arthritis Center; 🇺🇸 St. Petersburg, Florida, United States

The University of Chicago; 🇺🇸 Chicago, Illinois, United States

Peter A. Holt, M.D.; 🇺🇸 Baltimore, Maryland, United States

The Ohio State University; 🇺🇸 Columbus, Ohio, United States

Mid Atlantic Research Assoc.; 🇺🇸 Philadelphia, Pennsylvania, United States

Justus J. Fiechtner, MD, PC; 🇺🇸 Lansing, Michigan, United States

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States

Agilence Arthritis & Osteoporosis Medical Center; 🇺🇸 Whittier, California, United States