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

Completed · Phase 2

Conditions studied: Gout

In brief

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.

Key facts

Study ID

NCT00080210

Run by

Savient Pharmaceuticals

People needed

40

Starts

2004-03-01

Expected to finish

2005-02-01

Last updated by the study team

2013-06-03

Who can join

Age: 18 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

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

Full record on ClinicalTrials.gov

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