Open-Label Extension Study for Patients Who Completed a Phase 3 Double-blind Study of PEG-uricase for Symptomatic Gout
Multicenter, Open Label Extension Study of 8 mg PEG-uricase in Subjects Who Completed Protocols C0405 or C0406 for Symptomatic Gout
1 other identifier
interventional
151
1 country
22
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Dec 2006
Typical duration for phase_3
22 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2006
CompletedFirst Submitted
Initial submission to the registry
October 27, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2010
CompletedFirst Posted
Study publicly available on registry
May 19, 2011
CompletedResults Posted
Study results publicly available
December 2, 2011
CompletedDecember 2, 2011
October 1, 2011
3.1 years
October 27, 2008
August 5, 2011
October 28, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Uric Acid (mg/dL)
Uric acid measured at 3 month-intervals
Week 13, Week 25, Week 53, Week 101
Secondary Outcomes (4)
Tophus Response
Up to 2 years
Patient Reported Outcome: SF-36 Physical Component Summary Score
RCT Week 25; OLE Week 25; OLE Week 53, OLE Week 77, OLE Week 101
Gout Flare Frequency
Up to 2 years
Gout Flare Incidence
Assessed in 3-month intervals up to 2 years
Study Arms (3)
q2 RCT
EXPERIMENTALPegloticase 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
EXPERIMENTALPegloticase 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
EXPERIMENTALPlacebo arm in Randomized Controlled Trial (RCT), received pegloticase every 2 weeks (q2 wk) or every 4 weeks (q4 wk) in OLE
Interventions
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (22)
Kaiser Permanente Medical Center, Clinical Trials Unit
San Francisco, California, 94118, United States
Pacific Arthritis Center Medical Group
Santa Maria, California, 93454, United States
Agilence Arthritis & Osteoporosis Medical Center
Whittier, California, 90606, United States
Veterans Affairs Medical Center
Washington D.C., District of Columbia, 20422, United States
Arthritis & Rheumatic Disease Specialties
Aventura, Florida, 33180, United States
Ocala Rheumatology Research Center
Ocala, Florida, 34474, United States
St. Petersburg Arthritis Center
St. Petersburg, Florida, 33703, United States
The University of Chicago
Chicago, Illinois, 60637, United States
Graves Gilbert Clinic
Bowling Green, Kentucky, 42101, United States
Peter A. Holt, M.D.
Baltimore, Maryland, 21239, United States
Center for Rheumatology and Bone Research
Wheaton, Maryland, 20902, United States
Justus J. Fiechtner, MD, PC
Lansing, Michigan, 48910, United States
CentraCare Clinic
Saint Cloud, Minnesota, 56377, United States
Rheumatology Associates of North Jersey
Teaneck, New Jersey, 07666, United States
Duke University Medical Center
Durham, North Carolina, 27302, United States
New Horizons Clinical Research
Cincinnati, Ohio, 45242, United States
The Ohio State University
Columbus, Ohio, 43210, United States
STAT Research, Inc.
Dayton, Ohio, 45402, United States
David R. Mandel, MD, Inc.
Mayfield Village, Ohio, 44143, United States
Altoona Center for Clinical Research
Duncansville, Pennsylvania, 16635, United States
Mid Atlantic Research Assoc.
Philadelphia, Pennsylvania, 19154, United States
Arthritis Northwest, PLLC
Spokane, Washington, 99204, United States
Related Publications (3)
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.
PMID: 31203212DERIVEDLipsky 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.
PMID: 24588936DERIVEDBaraf 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.
PMID: 24286509DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Chief Medical Officer
- Organization
- Savient Pharmaceuticals, Inc.
Study Officials
- STUDY DIRECTOR
Medical Director, M.D.
Savient Pharmaceuticals, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 27, 2008
First Posted
May 19, 2011
Study Start
December 1, 2006
Primary Completion
January 1, 2010
Study Completion
January 1, 2010
Last Updated
December 2, 2011
Results First Posted
December 2, 2011
Record last verified: 2011-10