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

Savient Pharmaceuticals

Status and phase

Completed

Phase 2

Conditions

Gout

Treatments

Drug: Puricase

Study type

Interventional

Funder types

Industry

Identifiers

NCT00080210

C0403

Details and patient eligibility

About

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.

Sex

All

Ages

18 to 90 years old

Volunteers

No Healthy Volunteers

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