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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00080210
Recruitment Status : Completed
First Posted : March 25, 2004
Last Update Posted : June 3, 2013
Information provided by:
Savient Pharmaceuticals

Brief 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.

Condition or disease Intervention/treatment Phase
Gout Drug: Puricase Phase 2

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Study Type : Interventional  (Clinical Trial)
Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study of Multiple Doses of Intravenous Puricase in Subjects With Hyperuricemia and Refractory Gout
Study Start Date : March 2004
Study Completion Date : February 2005

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Gout
MedlinePlus related topics: Gout
Drug Information available for: Pegloticase

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00080210

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United States, Alabama
Spain Rehabilitation Center
Birmingham, Alabama, United States, 35294
United States, California
University of California, San Diego
La Jolla, California, United States, 92037
United States, Illinois
University of Chicago Dept of Medicine
Chicago, Illinois, United States, 60637
United States, Kentucky
Graves Gilbert Clinic
Bowling Green, Kentucky, United States, 42101
United States, Maryland
Center for Rheumatology and Bone Research
Wheaton, Maryland, United States, 20902
United States, New York
North Shore University Hospital Division of Rheumatology
Manhasset, New York, United States, 11030
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
United States, Oregon
Oregon Health & Science University Arthritis & Rheumatic Diseases
Portland, Oregon, United States, 97239
United States, Pennsylvania
Pride Clinical research Associates
Pittsburgh, Pennsylvania, United States, 15219
Sponsors and Collaborators
Savient Pharmaceuticals
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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ClinicalTrials.gov Identifier: NCT00080210    
Other Study ID Numbers: C0403
First Posted: March 25, 2004    Key Record Dates
Last Update Posted: June 3, 2013
Last Verified: May 2013
Keywords provided by Savient Pharmaceuticals:
elevated uric acid
Elevated serum uric acid level
Symptomatic gout
Additional relevant MeSH terms:
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Joint Diseases
Musculoskeletal Diseases
Crystal Arthropathies
Rheumatic Diseases
Purine-Pyrimidine Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Metabolic Diseases