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

This study has been completed.
Sponsor:
Information provided by:
Savient Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00080210
First received: March 24, 2004
Last updated: May 31, 2013
Last verified: May 2013
  Purpose

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 Intervention Phase
Gout
Drug: Puricase
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Study of Multiple Doses of Intravenous Puricase in Subjects With Hyperuricemia and Refractory Gout

Resource links provided by NLM:


Further study details as provided by Savient Pharmaceuticals:

Estimated Enrollment: 40
Study Start Date: March 2004
Estimated Study Completion Date: February 2005
  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00080210

Locations
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
  More Information

No publications provided by Savient Pharmaceuticals

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00080210     History of Changes
Other Study ID Numbers: C0403
Study First Received: March 24, 2004
Last Updated: May 31, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Savient Pharmaceuticals:
elevated uric acid
Elevated serum uric acid level
Symptomatic gout

Additional relevant MeSH terms:
Gout
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Purine-Pyrimidine Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Metabolic Diseases

ClinicalTrials.gov processed this record on August 20, 2014