Clinical trial NCT01356498: Open-Label Extension Study for Patients Who Completed a Phase 3 Double-blind Study of PEG-uricase for Symptomatic Gout
Official title: Multicenter, Open Label Extension Study of 8 mg PEG-uricase in Subjects Who Completed Protocols C0405 or C0406 for Symptomatic Gout
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Gout
Keywords: gout
chronic gout
Lead sponsor: Savient Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2011-05-19
Enrollment: 151
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Uric Acid (mg/dL)
timeFrame: Week 13, Week 25, Week 53, Week 101
Secondary outcomes:
measure: Tophus Response
timeFrame: Up to 2 years
measure: Patient Reported Outcome: SF-36 Physical Component Summary Score
timeFrame: RCT Week 25; OLE Week 25; OLE Week 53, OLE Week 77, OLE Week 101
measure: Gout Flare Frequency
timeFrame: Up to 2 years
measure: Gout Flare Incidence
timeFrame: Assessed in 3-month intervals up to 2 years
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: Kaiser Permanente Medical Center, Clinical Trials Unit
state: California
city: Santa Maria
country: United States
facility: Pacific Arthritis Center Medical Group
state: California
city: Whittier
country: United States
facility: Agilence Arthritis & Osteoporosis Medical Center
state: California
city: Washington
country: United States
facility: Veterans Affairs Medical Center
state: District of Columbia
city: Aventura
country: United States
facility: Arthritis & Rheumatic Disease Specialties
state: Florida
city: Ocala
country: United States
facility: Ocala Rheumatology Research Center
state: Florida
city: St. Petersburg
country: United States
facility: St. Petersburg Arthritis Center
state: Florida
city: Chicago
country: United States
facility: The University of Chicago
state: Illinois
city: Bowling Green
country: United States
facility: Graves Gilbert Clinic
state: Kentucky
city: Baltimore
country: United States
facility: Peter A. Holt, M.D.
state: Maryland
city: Wheaton
country: United States
facility: Center for Rheumatology and Bone Research
state: Maryland
city: Lansing
country: United States
facility: Justus J. Fiechtner, MD, PC
state: Michigan
city: St. Cloud
country: United States
facility: CentraCare Clinic
state: Minnesota
city: Teaneck
country: United States
facility: Rheumatology Associates of North Jersey
state: New Jersey
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Cincinnati
country: United States
facility: New Horizons Clinical Research
state: Ohio
city: Columbus
country: United States
facility: The Ohio State University
state: Ohio
city: Dayton
country: United States
facility: STAT Research, Inc.
state: Ohio
city: Mayfield Village
country: United States
facility: David R. Mandel, MD, Inc.
state: Ohio
city: Duncansville
country: United States
facility: Altoona Center for Clinical Research
state: Pennsylvania
city: Philadelphia
country: United States
facility: Mid Atlantic Research Assoc.
state: Pennsylvania
city: Spokane
country: United States
facility: Arthritis Northwest, PLLC
state: Washington
Study officials:
affiliation: Savient Pharmaceuticals, Inc.
name: Medical Director, M.D.
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.