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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

October 27, 2008
May 19, 2011
August 5, 2011
December 2, 2011
December 2, 2011
December 2006
January 2010   (Final data collection date for primary outcome measure)
Uric Acid (mg/dL) [ Time Frame: Week 13, Week 25, Week 53, Week 101 ]
Uric acid measured at 3 month-intervals
Uric Acid (mg/dL) [ Time Frame: Up to 2 years ]
Uric acid measured at 3 month-intervals
Complete list of historical versions of study NCT01356498 on ClinicalTrials.gov Archive Site
  • 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.
  • 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.

  • 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
  • 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.
  • 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
  • Patient Reported Outcome: SF-36 Physical Component Summary Score [ Time Frame: up to 2 years ]
    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 limitations in the dimensions related to physical function and pain.
  • Gout Flare Incidence and Frequency [ Time Frame: Up to 2 years ]
    The number of subjects reporting flares (flare frequency) and the mean number of flares per subject (flare frequency)were assessed over 3-month periods for up to 2 years of treatment
Not Provided
Not Provided
 
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
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.
Not Provided
Interventional
Phase 3
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Gout
Biological: pegloticase
8 mg intravenous infusion
  • 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
    Intervention: Biological: pegloticase
  • 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
    Intervention: Biological: pegloticase
  • 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
    Intervention: Biological: pegloticase
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
151
Same as current
January 2010
January 2010   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01356498
C0407
No
Not Provided
Not Provided
Savient Pharmaceuticals
Savient Pharmaceuticals
Not Provided
Study Director: Medical Director, M.D. Savient Pharmaceuticals, Inc.
Savient Pharmaceuticals
October 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP