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

Gout Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00080210
• Other study ID #: C0403
• Status: Completed
• Phase: Phase 2
• First received: March 24, 2004
• Last updated: May 31, 2013
• Start date: March 2004
• Est. completion date: February 2005

Study information

• Verified date: May 2013
• Source: Savient Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: February 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gout

Intervention

Drug:
• Puricase

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Savient Pharmaceuticals

Country where clinical trial is conducted

United States,