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

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ClinicalTrials.gov Identifier: NCT01356498
Recruitment Status : Completed
First Posted : May 19, 2011
Results First Posted : December 2, 2011
Last Update Posted : December 2, 2011
Sponsor:
Information provided by (Responsible Party):
Savient Pharmaceuticals

Study Description
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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.

Condition or disease Intervention/treatment Phase
Gout Biological: pegloticase Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 151 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Multicenter, Open Label Extension Study of 8 mg PEG-uricase in Subjects Who Completed Protocols C0405 or C0406 for Symptomatic Gout
Study Start Date : December 2006
Actual Primary Completion Date : January 2010
Actual Study Completion Date : January 2010

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Gout
MedlinePlus related topics: Gout
Drug Information available for: Pegloticase

Arms and Interventions
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Arm Intervention/treatment
Experimental: 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
 Biological: pegloticase
8 mg intravenous infusion
Experimental: 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
 Biological: pegloticase
8 mg intravenous infusion
Experimental: 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
 Biological: pegloticase
8 mg intravenous infusion


Outcome Measures
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Primary Outcome Measures :
  1. Uric Acid (mg/dL) [ Time Frame: Week 13, Week 25, Week 53, Week 101 ]
    Uric acid measured at 3 month-intervals


Secondary Outcome Measures :
  1. Tophus Response [ Time Frame: 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.

  2. Patient Reported Outcome: SF-36 Physical Component Summary Score [ Time Frame: 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.


  3. Gout Flare Frequency [ Time Frame: 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

  4. Gout Flare Incidence [ Time Frame: 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.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01356498


Locations
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Sponsors and Collaborators
Savient Pharmaceuticals
Investigators
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Study Director: Medical Director, M.D. Savient Pharmaceuticals, Inc.
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Savient Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01356498    
Other Study ID Numbers: C0407
First Posted: May 19, 2011    Key Record Dates
Results First Posted: December 2, 2011
Last Update Posted: December 2, 2011
Last Verified: October 2011
Keywords provided by Savient Pharmaceuticals:
gout
chronic gout
Additional relevant MeSH terms:
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Gout
Arthritis
Joint Diseases
Musculoskeletal Diseases
Crystal Arthropathies
 Rheumatic Diseases
Purine-Pyrimidine Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Metabolic Diseases