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

Last updated: October 28, 2011
Sponsor: Savient Pharmaceuticals
Overall Status: Completed

Phase

3

Condition

Bone Diseases

Joint Injuries

Arthritis And Arthritic Pain (Pediatric)

Treatment

N/A

Clinical Study ID

NCT01356498
C0407
  • Ages > 18
  • All Genders

Study 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

Inclusion Criteria:

  • Completed treatment in one of two double-blind, placebo controlled studies ofPEG-uricase in subjects with hyperuricemia and symptomatic gout

Exclusion

Exclusion Criteria:

  • unstable angina

  • uncontrolled arrhythmia

  • uncontrolled hypertension

  • end stage renal disease requiring dialysis

  • anemia

Study Design

Total Participants: 151
Study Start date:
December 01, 2006
Estimated Completion Date:
January 31, 2010

Connect with a study center

  • Kaiser Permanente Medical Center, Clinical Trials Unit

    San Francisco, California 94118
    United States

    Site Not Available

  • Pacific Arthritis Center Medical Group

    Santa Maria, California 93454
    United States

    Site Not Available

  • Agilence Arthritis & Osteoporosis Medical Center

    Whittier, California 90606
    United States

    Site Not Available

  • Veterans Affairs Medical Center

    Washington, District of Columbia 20422
    United States

    Site Not Available

  • Arthritis & Rheumatic Disease Specialties

    Aventura, Florida 33180
    United States

    Site Not Available

  • Ocala Rheumatology Research Center

    Ocala, Florida 34474
    United States

    Site Not Available

  • St. Petersburg Arthritis Center

    St. Petersburg, Florida 33703
    United States

    Site Not Available

  • The University of Chicago

    Chicago, Illinois 60637
    United States

    Site Not Available

  • Graves Gilbert Clinic

    Bowling Green, Kentucky 42101
    United States

    Site Not Available

  • Peter A. Holt, M.D.

    Baltimore, Maryland 21239
    United States

    Site Not Available

  • Center for Rheumatology and Bone Research

    Wheaton, Maryland 20902
    United States

    Site Not Available

  • Justus J. Fiechtner, MD, PC

    Lansing, Michigan 48910
    United States

    Site Not Available

  • CentraCare Clinic

    St. Cloud, Minnesota 56377
    United States

    Site Not Available

  • Rheumatology Associates of North Jersey

    Teaneck, New Jersey 07666
    United States

    Site Not Available

  • Duke University Medical Center

    Durham, North Carolina 27302
    United States

    Site Not Available

  • New Horizons Clinical Research

    Cincinnati, Ohio 45242
    United States

    Site Not Available

  • The Ohio State University

    Columbus, Ohio 43210
    United States

    Site Not Available

  • STAT Research, Inc.

    Dayton, Ohio 45402
    United States

    Site Not Available

  • David R. Mandel, MD, Inc.

    Mayfield Village, Ohio 44143
    United States

    Site Not Available

  • Altoona Center for Clinical Research

    Duncansville, Pennsylvania 16635
    United States

    Site Not Available

  • Mid Atlantic Research Assoc.

    Philadelphia, Pennsylvania 19154
    United States

    Site Not Available

  • Arthritis Northwest, PLLC

    Spokane, Washington 99204
    United States

    Site Not Available

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.