Clinical trial: Efficacy, Safety And Tolerability Of PF-06743649 In Gout Subjects. (NCT02187029)

Eligibility criteria:
Inclusion Criteria:

          -  Subject meets the diagnosis of gout as per the American Rheumatism Association
             Criteria for the Classification of acute Arthritis of Primary Gout.

          -  Subjects taking urate lowering therapy at the time of screening must be willing to
             discontinue their prior urate lowering therapy from the time of Screening Visit 1
             until completion of the study period Day 16.

          -  Subjects taking urate lowering therapy at the time of screening must have a serum
             urate level of >= 8.0 mg/dL at time of the second screening visit.

          -  Subjects NOT taking urate lowering therapy at the time of screening must have a serum
             urate level of >= 8.0 mg/dL at both screening visits 1 and 2.

        Exclusion Criteria:

          -  Positive medical history or current evidence of medical or psychiatric
             condition/disease, or ECG or laboratory abnormality that may increase the risk
             associated with study participation or investigational product administration or may
             interfere with the interpretation of study results and, in the judgment of the
             Investigator, would make the subject inappropriate for entry into this study.

          -  Chronic kidney disease classified as moderate or severe (Clinical Practice Guideline,
             National Kidney Foundation)12; with GFR < 60 mL/min/1.73m2 calculated by the
             Cockcroft-Gault equation.

          -  Subjects with current tophaceous gout.

          -  Gout flare that has not resolved for at least 2 weeks prior to randomization.
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 60 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