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NCT Number: NCT01356498

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

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Key information

Conditions

Gout Arthritis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Crystal Arthropathies Genetic Diseases, Inborn Joint Diseases Metabolic Diseases Metabolism, Inborn Errors Musculoskeletal Diseases Nutritional and Metabolic Diseases Purine-Pyrimidine Metabolism, Inborn Errors Rheumatic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Kaiser Permanente Medical Center, Clinical Trials Unit, San Francisco, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pegloticase

Biological

8 mg intravenous infusion

Primary outcomes

  1. Uric Acid (mg/dL)

    Time frame: Week 13, Week 25, Week 53, Week 101

    Uric acid measured at 3 month-intervals

Secondary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Savient Pharmaceuticals

Industry

Registry information

Official study title

Multicenter, Open Label Extension Study of 8 mg PEG-uricase in Subjects Who Completed Protocols C0405 or C0406 for Symptomatic Gout

Important dates

Study start
2006
Primary completion
2010
Study completion
2010
First posted
May 19, 2011
Registry last updated
Dec 2, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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