A Study of Persons With Gout Who Do Not Respond to or Are Allergic to Conventional Therapy

May 31, 2013 updated by: Savient Pharmaceuticals

A Phase II Study of Multiple Doses of Intravenous Puricase in Subjects With Hyperuricemia and Refractory Gout

This is a randomized, open-label, multicenter, parallel-groups study of multiple intravenous doses of Puricase, administered intravenously, in 40 patients with symptomatic gout. Subjects must wash out of any uric acid-lowering agents for one week before being dosed, and must refrain from using such agents throughout the study.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

40

Phase

  • Phase 2

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
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • Spain REhabilitation Center
    • California
      • La Jolla, California, United States, 92037
        • University of California, San Diego
    • Illinois
      • Chicago, Illinois, United States, 60637
        • University of Chicago Dept of Medicine
    • Kentucky
      • Bowling Green, Kentucky, United States, 42101
        • Graves Gilbert Clinic
    • Maryland
      • Wheaton, Maryland, United States, 20902
        • Center for Rheumatology and Bone Research
    • New York
      • Manhasset, New York, United States, 11030
        • North Shore University Hospital Division of Rheumatology
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke University Medical Center
    • Oregon
      • Portland, Oregon, United States, 97239
        • Oregon Health & Science University Arthritis & Rheumatic Diseases
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15219
        • Pride Clinical research Associates

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 to 90 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

Subjects to be included in the study are:

  • Outpatients of either gender, age 18 or older
  • Diagnosed with symptomatic gout refractory to conventional therapy or unable to tolerate conventional therapy (for example: having one or more tophi and/or having experienced a gout flare within the previous 6 months and/or having chronic, gouty arthritis)
  • Hyperuricemic: screening serum uric acid must be >=8 mg/dL.
  • The patient must be willing and able to give informed consent and adhere to visit/protocol schedules (Consent must be given before any study procedures are performed)
  • Women of childbearing potential must have a negative serum pregnancy test and must use an approved birth control method during their participation in the protocol. Such methods include oral, injectable, or implantable contraceptives; IUDs and barrier contraceptives in combination with spermicide

Exclusion Criteria:

Subjects to be excluded are those for whom any of the following apply:

  • Unstable coronary artery disease or uncontrolled hypertension
  • History of end stage renal disease requiring dialysis
  • History of liver disease, as defined by baseline serum transaminase elevation >3X the upper limit of normal in the absence of any other known cause
  • Organ transplant recipient requiring immunosuppressive therapy
  • Concurrent use of prednisone at a dose >10 mg qd (or equivalent) at or within one week before dosing
  • Concurrent use of uric acid-lowering agents
  • Prior treatment with Puricase® or other recombinant uricase
  • An acute gout flare within one week prior to first treatment with Puricase® (exclusive of chronic synovitis/arthritis) requiring use of medication which violates the protocol
  • glucose-6-phosphate dehydrogenase deficiency
  • A history of anaphylactic reaction to a recombinant protein or porcine derivatives
  • Lactation
  • Has taken an investigational drug within 4 weeks prior to study drug administration or plans to take an investigational agent during the study
  • Known allergy to urate oxidase or PEGylated products
  • Has any other medical or psychological condition which, in the opinion of the investigator, might create undue risk to the patient or interfere with the patient's ability to comply with the protocol requirements

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: RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Collaborators and Investigators

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

Sponsor

Savient Pharmaceuticals

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

March 1, 2004

Study Completion

February 1, 2005

Study Registration Dates

First Submitted

March 24, 2004

First Submitted That Met QC Criteria

March 24, 2004

First Posted (ESTIMATE)

March 25, 2004

Study Record Updates

Last Update Posted (ESTIMATE)

June 3, 2013

Last Update Submitted That Met QC Criteria

May 31, 2013

Last Verified

May 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C0403

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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