Open-Label Extension Study for Patients Who Completed a Phase 3 Double-blind Study of PEG-uricase for Symptomatic Gout
NCT ID: NCT01356498
Last Updated: 2011-12-02
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
PHASE3
151 participants
INTERVENTIONAL
2006-12-31
2010-01-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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
pegloticase
8 mg intravenous infusion
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
pegloticase
8 mg intravenous infusion
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
pegloticase
8 mg intravenous infusion
Interventions
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pegloticase
8 mg intravenous infusion
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* uncontrolled arrhythmia
* uncontrolled hypertension
* end stage renal disease requiring dialysis
* anemia
18 Years
ALL
No
Sponsors
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Savient Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director, M.D.
Role: STUDY_DIRECTOR
Savient Pharmaceuticals, Inc.
Locations
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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
Countries
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References
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Pillinger MH, Fields TR, Yeo AE, Lipsky PE. Dissociation Between Clinical Benefit and Persistent Urate Lowering in Patients with Chronic Refractory Gout Treated with Pegloticase. J Rheumatol. 2020 Apr;47(4):605-612. doi: 10.3899/jrheum.190161. Epub 2019 Jun 15.
Lipsky PE, Calabrese LH, Kavanaugh A, Sundy JS, Wright D, Wolfson M, Becker MA. Pegloticase immunogenicity: the relationship between efficacy and antibody development in patients treated for refractory chronic gout. Arthritis Res Ther. 2014 Mar 4;16(2):R60. doi: 10.1186/ar4497.
Baraf HS, Becker MA, Gutierrez-Urena SR, Treadwell EL, Vazquez-Mellado J, Rehrig CD, Ottery FD, Sundy JS, Yood RA. Tophus burden reduction with pegloticase: results from phase 3 randomized trials and open-label extension in patients with chronic gout refractory to conventional therapy. Arthritis Res Ther. 2013 Sep 26;15(5):R137. doi: 10.1186/ar4318.
Other Identifiers
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C0407
Identifier Type: -
Identifier Source: org_study_id