Clinical trial: A Study of the Efficacy of Canakinumab in Prevention of Acute Flares in Chronic Gout Patients Initiating Allopurinol Therapy (Core Study) and a Long-term Study of the Efficacy and Safety of Canakinumab in Patients With Gout (Extension Study) (NCT00819585)

Eligibility criteria:
Core study

        Inclusion Criteria:

          -  Signed written informed consent before any study procedure is performed.

          -  History of at least 2 gout flares in the year prior to Screening (Visit 1, based on
             patient history), thus, candidates for initiating uric acid lowering therapy.

          -  Confirmed diagnosis of gout meeting the American College of Rheumatology (ACR) 1977
             preliminary criteria for the classification of arthritis of primary gout.

          -  Body Mass Index (BMI) ≤ 40 kg/m^2.

          -  Willingness to initiate allopurinol therapy as urate lowering agent for their gout
             therapy or having initiated allopurinol therapy within ≤ 1 month before Screening
             (Visit 1) or willing to re-initiate allopurinol therapy if this was stopped > 2 months
             before Screening (Visit 1) for reasons different to toxicity/ intolerance or lack of
             efficacy.

        Exclusion Criteria:

          -  Acute gout flare within 2 weeks of Screening (Visit 1) and during the Screening
             period.

          -  History of allergy or contraindication to colchicine or allopurinol.

          -  History of intolerance to allopurinol or to oral colchicine in appropriate dose for
             prophylactic use.

          -  History of bone marrow suppression.

          -  Absolute or relative contraindication to both naproxen and oral prednisolone/
             prednisone.

        Extension study

        Inclusion criteria:

          -  Patients who completed the core study. A patient is defined as completing the core
             study if he/she completed the study up to and including the last visit (Visit 9).

          -  Patients who have signed a written informed consent before any trial procedure is
             performed.

        Exclusion Criteria:

          -  Patients for whom continuation in the extension study is not considered appropriate by
             the treating physician.

          -  Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a
             female after conception and until the termination of gestation, confirmed by a
             positive pregnancy test (serum or urine).

        Other protocol-defined inclusion/exclusion criteria applied to 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.
Subject must be at most 80 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? 0