Clinical trial: A Study of Persons With Gout Who Do Not Respond to or Are Allergic to Conventional Therapy (NCT00080210)

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
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.
Subject must be at most 90 Years

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