Clinical trial: Safety and Efficacy of Canakinumab Prefilled Syringes in Frequently Flaring Acute Gouty Arthritis Patients (NCT01356602)

Eligibility criteria:
Inclusion criteria:

          -  3 or more gout flares within last year

          -  Contraindication, intolerance or lack of efficacy for NSAIDs and/or colchicine

          -  Body mass index of less than or equal to 45 kg/m2

        Exclusion criteria:

          -  Use of the following therapies (within varying protocol defined timeframes):
             corticosteroids, narcotics, topical ice/cold packs, chronic opiate treatment, NSAIDs
             (such as aspirin), colchicine.

          -  Hemodialysis

          -  Live vaccine within 3 months before first dose

          -  Donation or loss of 400 mL or more within 3 months before first dose

          -  Gout brought on by other factors such as chemotherapy, lead, transplant, etc.

          -  Presence of other acute inflammatory arthritis such as Rheumatoid Arthritis

          -  Any conditions or significant medical problems that puts the patient at an
             unacceptable immunological risk to receive this type of therapy such as HIV,
             Hepatitis, Tuberculosis and other infections/conditions

          -  Significant cardiovascular conditions such as uncontrolled hypertension

          -  Significant medical diseases such as uncontrolled diabetes, thyroid disease

          -  History of malignancy of any organ system within the past 5 years

          -  Women who are pregnant or nursing

          -  Other protocol-defined inclusion/exclusion criteria may apply
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 85 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