Safety and Efficacy Study of PEG-uricase in the Treatment of Hyperuricemic Patients With Symptomatic Gout

Completed · Phase 3 · Has a placebo group

Conditions studied: Gout

In brief

These are two replicate studies to evaluate the safety and efficacy of PEG (polyethylene glycol)-uricase in controlling the uric acid level in symptomatic gout patients with high uric acid levels who are unable to take standard gout therapies, or for whom those therapies have been unsuccessful in controlling their uric acid level.

Key facts

Study ID

NCT00325195

Run by

Savient Pharmaceuticals

People needed

225

Starts

2006-05-01

Expected to finish

2007-12-01

Last updated by the study team

2011-02-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Outpatients of either gender, age 18 or older ( no upper age limit).
• Patient is hyperuricemic: screening serum uric acid must be ≥8 mg/dL.
• Patient has symptomatic gout (presence of at least 3 gout flares in the 18 months prior to entry, or at least one gout tophus, or gouty arthritis).
• Conventional therapy is contraindicated or has been ineffective in this patient, i.e., patient has a history (either by medical record or patient interview) of hypersensitivity or of failure to normalize SUA with at least 3 months treatment with allopurinol at the maximum labeled dose (800 mg/dL in the U.S.), or at a medically appropriate lower dose based on dose-limiting toxicity or dose-limiting co-morbidity.
• Patient is willing and able to give informed consent and adhere to visit/protocol schedules (informed consent must be given before the first study procedure is performed, including washout).
• If the patient is a woman of childbearing potential, she must have had a negative screening serum pregnancy test and must use a medically approved form of birth control during her participation in the protocol. Such methods include oral, injectable or implantable contraceptives; IUDs and barrier contraceptives in combination with spermicide. (If male or surgically sterile, check N/A.)

You may not qualify if…

• The patient has unstable angina.
• The patient has uncontrolled arrhythmia.
• The patient has non-compensated congestive heart failure.
• The patient has uncontrolled hypertension (above 150/95).
• The patient has a history of end stage renal disease requiring dialysis.
• The patient has hemoglobin < 8 g/dL (males) or < 7 g/dL (females).
• The patient is an organ transplant recipient
• The patient has had prior treatment with PEG-uricase, or other recombinant uricase, or any concomitant therapy with a PEG-conjugated drug.
• The patient has had a gout flare at screening that is resolved for less than one week prior to first treatment with study drug (exclusive of chronic synovitis/ arthritis).
• The patient has glucose-6-phosphate dehydrogenase (G6PD) deficiency.
• The patient has a history of anaphylactic reaction to a recombinant protein or porcine product, or hypersensitivity to PEG.
• The patient is pregnant or breast feeding.
• The patient has taken an investigational drug within 4 weeks prior to study drug administration or plans to take an investigational agent during the study.
• The patient has a known allergy to urate oxidase or PEGylated products.
• The patient has any other medical or psychological condition which, in the opinion of the investigator, might create undue risk to the subject or interfere with the subject's ability to comply with the protocol requirements, or to complete the study.

Where it is running

• University of Arizona Arthritis Center — Tucson, Arizona, United States
• NEA Clinic — Jonesboro, Arkansas, United States
• UCSD Rheumatology Division — La Jolla, California, United States
• Kaiser Permanente Medical Center, Clinical Trials Unit — San Francisco, California, United States
• Pacific Arthritis Center Medical Group — Santa Maria, California, United States
• E. Robert Harris Medical Corporation — Whittier, California, United States
• Agilence Arthritis & Osteoporosis Medical Center — Whittier, California, United States
• Arthritis Associates & Osteoporosis Center of Colorado Springs — Colorado Springs, Colorado, United States
• Veterans Affairs Medical Center — Washington D.C., District of Columbia, United States
• Arthritis & Rheumatic Disease Specialties — Aventura, Florida, United States
• Malcom Randall VA Medical Center — Gainesville, Florida, United States
• Horizon Institute for Clinical Research — Hollywood, Florida, United States
• Ocala Rheumatology Research Center — Ocala, Florida, United States
• Arthritis & Osteoporosis Treatment Center, PA — Orange Park, Florida, United States
• St. Petersburg Arthritis Center — St. Petersburg, Florida, United States
• Idaho Arthritis & Osteoporosis Center — Boise, Idaho, United States
• Institute of Arthritis Research — Idaho Falls, Idaho, United States
• The University of Chicago — Chicago, Illinois, United States
• Graves Gilbert Clinic — Bowling Green, Kentucky, United States
• Peter A. Holt, M.D. — Baltimore, Maryland, United States
• Malamet & Klein, MD, PA — Hagerstown, Maryland, United States
• The Center for Rheumatology and Bone Research — Wheaton, Maryland, United States
• Fallon Clinic, Inc — Worcester, Massachusetts, United States
• Michigan Arthritis Research Center — Brighton, Michigan, United States
• UAB Arthritis Clinical Intervention Program — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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