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

October 28, 2011 updated by: Savient Pharmaceuticals

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

151

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94118
        • Kaiser Permanente Medical Center, Clinical Trials Unit
      • Santa Maria, California, United States, 93454
        • Pacific Arthritis Center Medical Group
      • Whittier, California, United States, 90606
        • Agilence Arthritis & Osteoporosis Medical Center
    • District of Columbia
      • Washington, District of Columbia, United States, 20422
        • Veterans Affairs Medical Center
    • Florida
      • Aventura, Florida, United States, 33180
        • Arthritis & Rheumatic Disease Specialties
      • Ocala, Florida, United States, 34474
        • Ocala Rheumatology Research Center
      • St. Petersburg, Florida, United States, 33703
        • St. Petersburg Arthritis Center
    • Illinois
      • Chicago, Illinois, United States, 60637
        • The University of Chicago
    • Kentucky
      • Bowling Green, Kentucky, United States, 42101
        • Graves Gilbert Clinic
    • Maryland
      • Baltimore, Maryland, United States, 21239
        • Peter A. Holt, M.D.
      • Wheaton, Maryland, United States, 20902
        • Center for Rheumatology and Bone Research
    • Michigan
      • Lansing, Michigan, United States, 48910
        • Justus J. Fiechtner, MD, PC
    • Minnesota
      • St. Cloud, Minnesota, United States, 56377
        • CentraCare Clinic
    • New Jersey
      • Teaneck, New Jersey, United States, 07666
        • Rheumatology Associates of North Jersey
    • North Carolina
      • Durham, North Carolina, United States, 27302
        • Duke University Medical Center
    • Ohio
      • Cincinnati, Ohio, United States, 45242
        • New Horizons Clinical Research
      • Columbus, Ohio, United States, 43210
        • The Ohio State University
      • Dayton, Ohio, United States, 45402
        • STAT Research, Inc.
      • Mayfield Village, Ohio, United States, 44143
        • David R. Mandel, MD, Inc.
    • Pennsylvania
      • Duncansville, Pennsylvania, United States, 16635
        • Altoona Center for Clinical Research
      • Philadelphia, Pennsylvania, United States, 19154
        • Mid Atlantic Research Assoc.
    • Washington
      • Spokane, Washington, United States, 99204
        • Arthritis Northwest, PLLC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Uric Acid (mg/dL)
Time Frame: Week 13, Week 25, Week 53, Week 101
Uric acid measured at 3 month-intervals
Week 13, Week 25, Week 53, Week 101

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Up to 2 years
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.
RCT Week 25; OLE Week 25; OLE Week 53, OLE Week 77, OLE Week 101
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
Up to 2 years
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.
Assessed in 3-month intervals up to 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Savient Pharmaceuticals

Investigators

  • Study Director: Medical Director, M.D., Savient Pharmaceuticals, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2006

Primary Completion (Actual)

January 1, 2010

Study Completion (Actual)

January 1, 2010

Study Registration Dates

First Submitted

October 27, 2008

First Submitted That Met QC Criteria

May 18, 2011

First Posted (Estimate)

May 19, 2011

Study Record Updates

Last Update Posted (Estimate)

December 2, 2011

Last Update Submitted That Met QC Criteria

October 28, 2011

Last Verified

October 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C0407

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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