Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Ardea Biosciences, Inc.
Age
18–85
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Meets the diagnosis of gout according to the American Rheumatism Association (ARA) Criteria for the Classification of Acute Arthritis of Primary Gout.
Not on a urate lowering therapy (ULT) must have an sUA level ≥ 8.0 mg/dL at screening.
If on concomitant ULT must have an sUA level ≥ 6.5 mg/dL at screening.
Must have had at least 2 gout flares in the past year.
You may not be if
Consumption of more than 14 drinks of alcohol per week (eg, 1 drink = 5 oz \[150 mL\] of wine, 12 oz \[360 mL\] of beer, or 1.5 oz \[45 mL\] of hard liquor).
History or suspicion of drug abuse.
History of autoimmune disease requiring systemic treatment.
Known or suspected human immunodeficiency virus (HIV), hepatitis C antibody (HCV), or hepatitis B antibody (HBsAg) infection.
History of malignancy within the previous 5 years (with the exception of nonmelanoma skin cancer that has been treated with no evidence of recurrence, treated cervical dysplasia or treated in situ Grade 1 cervical cancer).
Myocardial infarction, unstable angina, New York Heart Association (NYHA) class III or IV heart failure, or stroke within the last 12 months.
Uncontrolled hypertension (systolic pressure above 160 mm Hg or diastolic pressure above 95 mm Hg).
Estimated creatinine clearance \< 30 mL/min by Cockcroft-Gault formula.
Kidney or other organ transplant.
Active peptic ulcer disease requiring treatment.
History of xanthinuria, active liver disease, or hepatic dysfunction.
If unable to take gout flare prophylaxis of either colchicine or nonsteroidal anti-inflammatory drugs (NSAIDs) due to contraindication (e.g. toxicity, renal function, use of contraindicated medications).
