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

Sponsor
Savient Pharmaceuticals (Industry)
Overall Status
Completed
CT.gov ID
NCT00080210
Collaborator
(none)
40
Enrollment
9
Locations
11.1
Duration (Months)
4.4
Patients Per Site
0.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Allocation:
Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase II Study of Multiple Doses of Intravenous Puricase in Subjects With Hyperuricemia and Refractory Gout
Study Start Date :
Mar 1, 2004
Study Completion Date :
Feb 1, 2005

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 90 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Spain Rehabilitation Center Birmingham Alabama United States 35294
    2 University of California, San Diego La Jolla California United States 92037
    3 University of Chicago Dept of Medicine Chicago Illinois United States 60637
    4 Graves Gilbert Clinic Bowling Green Kentucky United States 42101
    5 Center for Rheumatology and Bone Research Wheaton Maryland United States 20902
    6 North Shore University Hospital Division of Rheumatology Manhasset New York United States 11030
    7 Duke University Medical Center Durham North Carolina United States 27710
    8 Oregon Health & Science University Arthritis & Rheumatic Diseases Portland Oregon United States 97239
    9 Pride Clinical research Associates Pittsburgh Pennsylvania United States 15219

    Sponsors and Collaborators

    • Savient Pharmaceuticals

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00080210
    Other Study ID Numbers:
    • C0403
    First Posted:
    Mar 25, 2004
    Last Update Posted:
    Jun 3, 2013
    Last Verified:
    May 1, 2013
    Keywords provided by , ,
    elevated uric acid
    Elevated serum uric acid level
    Symptomatic gout
    Additional relevant MeSH terms:
    Gout

    Study Results

    No Results Posted as of Jun 3, 2013