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 1, 2006

Last verified: May 2006

History of Changes

Tracking Information
First Received Date ^ICMJE	March 24, 2004
Last Updated Date	May 1, 2006
Start Date ^ICMJE	March 2004
Primary Completion Date
Current Primary Outcome Measures ^ICMJE
Original Primary Outcome Measures ^ICMJE
Change History	Complete list of historical versions of study NCT00080210 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE
Current Other Outcome Measures ^ICMJE
Original Other Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	A Study of Persons With Gout Who Do Not Respond to or Are Allergic to Conventional Therapy
Official Title ^ICMJE	A Phase II Study of Multiple Doses of Intravenous Puricase in Subjects With Hyperuricemia and Refractory Gout
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.
Detailed Description
Study Type ^ICMJE	Interventional
Study Phase	Phase 2
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Gout
Intervention ^ICMJE	Drug: Puricase
Study Arm (s)
Publications *	Sundy JS, Becker MA, Baraf HS, Barkhuizen A, Moreland LW, Huang W, Waltrip RW 2nd, Maroli AN, Horowitz Z; Pegloticase Phase 2 Study Investigators. Reduction of plasma urate levels following treatment with multiple doses of pegloticase (polyethylene glycol-conjugated uricase) in patients with treatment-failure gout: results of a phase II randomized study. Arthritis Rheum. 2008 Sep;58(9):2882-91.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	40
Completion Date	February 2005
Primary Completion Date
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years to 90 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT00080210
Other Study ID Numbers ^ICMJE	C0403
Has Data Monitoring Committee
Responsible Party
Study Sponsor ^ICMJE	Savient Pharmaceuticals
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	Savient Pharmaceuticals
Verification Date	May 2006
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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