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

Study Overview
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Brief Summary
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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.

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

Conditions
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Gout

Intervention / Treatment
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* Drug: Puricase


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Puricase|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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elevated uric acid, Elevated serum uric acid level, Symptomatic gout