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	Treatment or Intervention	Phase
Gout	Drug: Puricase	Phase II

Further Study Details: 

Expected Total Enrollment:  40

Ages Eligible for Study:  18 Years   -   90 Years,  Genders Eligible for Study:  Both

Criteria

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

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

Study ID Numbers:  C0403
Record last reviewed:  January 2005
Last Updated:  January 27, 2005
Record first received:  March 24, 2004
ClinicalTrials.gov Identifier:  NCT00080210
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08