Clinical trial: Safety and Efficacy Study of PEG-uricase in the Treatment of Hyperuricemic Patients With Symptomatic Gout (NCT00325195)

Eligibility criteria:
Inclusion Criteria:

          1. Outpatients of either gender, age 18 or older ( no upper age limit).

          2. Patient is hyperuricemic: screening serum uric acid must be ≥8 mg/dL.

          3. 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).

          4. 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.

          5. 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).

          6. 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.)

        Exclusion Criteria:

          1. The patient has unstable angina.

          2. The patient has uncontrolled arrhythmia.

          3. The patient has non-compensated congestive heart failure.

          4. The patient has uncontrolled hypertension (above 150/95).

          5. The patient has a history of end stage renal disease requiring dialysis.

          6. The patient has hemoglobin < 8 g/dL (males) or < 7 g/dL (females).

          7. The patient is an organ transplant recipient

          8. The patient has had prior treatment with PEG-uricase, or other recombinant uricase, or
             any concomitant therapy with a PEG-conjugated drug.

          9. 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).

         10. The patient has glucose-6-phosphate dehydrogenase (G6PD) deficiency.

         11. The patient has a history of anaphylactic reaction to a recombinant protein or porcine
             product, or hypersensitivity to PEG.

         12. The patient is pregnant or breast feeding.

         13. 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.

         14. The patient has a known allergy to urate oxidase or PEGylated products.

         15. 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.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.


Patient description (medical language): A 39-year-old man comes to the emergency department with an acute onset of severe left toe pain.  The toe is red and exhibits swelling. The patient is not febrile, and does not remember any recent trauma. Medical history is not significant except for the similar attacks and the diagnosis of gouty arthritis. His medication history includes Allopurinol to prevent gouty attacks. His father has the same medical condition. However, his older brother who is 41 years old is healthy with no history of gouty arthritis. Physical examination shows a swollen, tender first metatarsophalangeal joint.  Aspiration of the joint showed high leukocyte count, negative Gram stain, and numerous needle-shaped crystals, which is compatible with gouty arthritis.

Patient description (patient's own words): I'm a 39-year-old man and got admitted to the ER after an unbearable pain in my left toe. My toe was red and terribly swollen. I was still standing on my feet, not febrile and I don't remember hitting my head or anything. I don't have any special medical history, but I had been diagnosed with gout before. I take Lopurin to prevent my gouty attacks. My dad had the same problem, but my 41-year-old brother is healthy and does not have gouty attacks. The doctor did a physical exam and found that the joints between my toes and the rest of my foot were swollen and tender. The doctor renewed his diagnosis of gouty arthritis.

Does the patient match the trial criteria? Contradiction