Clinical trial: A Proof-of-Concept Study of AC-201 to Prevent Gout Flares (NCT01712204)

Eligibility criteria:
Inclusion Criteria:

          -  Male or female age 20 to 80 years, inclusive

          -  Meets at least 6 of the 12 American College of Rheumatology preliminary criteria
             (1977) for the classification of acute arthritis of primary gout, OR have proven
             tophus or documented monosodium urate (MSU) crystals in the joint fluid

          -  Serum uric acid ≥7.5 mg/dL at screening

          -  Experienced ≥2 gouty arthritis flares within one year prior to screening

        Exclusion Criteria:

          -  Occurrence of a gouty arthritis flare ongoing at screening or during the screening
             period through baseline

          -  Use of allopurinol, febuxostat, benzbromarone, probenecid, or sulfinpyrazone within 4
             weeks prior to screening

          -  Use of colchicine, glucocorticoids, NSAIDs, or COX-2 inhibitors within 1 week prior to
             screening

          -  Other (non-gout) chronic arthritis, acute inflammatory arthritis, autoimmune diseases
             with arthritis, or any condition requiring chronic daily use of pain medication

          -  History of allergy to any components of study medication, including diacerein

          -  Allergy, contraindication, or intolerance to febuxostat

          -  Contraindication or allergy to NSAIDs

          -  Severe renal impairment

          -  Any prior use of biologic anti-inflammatory therapy, such as IL-1 modulators, tumor
             necrosis factor inhibitors, IL-6 inhibitors, or T-cell costimulation modulator
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 20 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? Contradiction