Clinical trial NCT00080210: A Study of Persons With Gout Who Do Not Respond to or Are Allergic to Conventional Therapy
Official title: A Phase II Study of Multiple Doses of Intravenous Puricase in Subjects With Hyperuricemia and Refractory Gout
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Gout
Keywords: elevated uric acid
Elevated serum uric acid level
Symptomatic gout
Lead sponsor: Savient Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2004-03-25
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Spain Rehabilitation Center
state: Alabama
city: La Jolla
country: United States
facility: University of California, San Diego
state: California
city: Chicago
country: United States
facility: University of Chicago Dept of Medicine
state: Illinois
city: Bowling Green
country: United States
facility: Graves Gilbert Clinic
state: Kentucky
city: Wheaton
country: United States
facility: Center for Rheumatology and Bone Research
state: Maryland
city: Manhasset
country: United States
facility: North Shore University Hospital Division of Rheumatology
state: New York
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Portland
country: United States
facility: Oregon Health & Science University Arthritis & Rheumatic Diseases
state: Oregon
city: Pittsburgh
country: United States
facility: Pride Clinical research Associates
state: Pennsylvania
Study officials:
References:
citation: 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. doi: 10.1002/art.23810.