Open-Label Extension Study for Patients Who Completed a Phase 3 Double-blind Study of PEG-uricase for Symptomatic Gout
Completed · Phase 3 · Has a placebo group
Conditions studied: Gout
In brief
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.
Key facts
- Study ID
- NCT01356498
- Run by
- Savient Pharmaceuticals
- People needed
- 151
- Starts
- 2006-12-01
- Expected to finish
- 2010-01-01
- Last updated by the study team
- 2011-12-02
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Completed treatment in one of two double-blind, placebo controlled studies of PEG-uricase in subjects with hyperuricemia and symptomatic gout
You may not qualify if…
- unstable angina
- uncontrolled arrhythmia
- uncontrolled hypertension
- end stage renal disease requiring dialysis
- anemia
Where it is running
- Kaiser Permanente Medical Center, Clinical Trials Unit — San Francisco, California, United States
- Pacific Arthritis Center Medical Group — Santa Maria, California, United States
- Agilence Arthritis & Osteoporosis Medical Center — Whittier, California, United States
- Veterans Affairs Medical Center — Washington D.C., District of Columbia, United States
- Arthritis & Rheumatic Disease Specialties — Aventura, Florida, United States
- Ocala Rheumatology Research Center — Ocala, Florida, United States
- St. Petersburg Arthritis Center — St. Petersburg, Florida, United States
- The University of Chicago — Chicago, Illinois, United States
- Graves Gilbert Clinic — Bowling Green, Kentucky, United States
- Peter A. Holt, M.D. — Baltimore, Maryland, United States
- Center for Rheumatology and Bone Research — Wheaton, Maryland, United States
- Justus J. Fiechtner, MD, PC — Lansing, Michigan, United States
- CentraCare Clinic — Saint Cloud, Minnesota, United States
- Rheumatology Associates of North Jersey — Teaneck, New Jersey, United States
- Duke University Medical Center — Durham, North Carolina, 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
- David R. Mandel, MD, Inc. — Mayfield Village, Ohio, United States
- Altoona Center for Clinical Research — Duncansville, Pennsylvania, United States
- Mid Atlantic Research Assoc. — Philadelphia, Pennsylvania, United States
- Arthritis Northwest, PLLC — Spokane, Washington, United States
Full record on ClinicalTrials.gov
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