Clinical trial: CSP594 Comparative Effectiveness in Gout: Allopurinol vs. Febuxostat (NCT02579096)

Eligibility criteria:
Inclusion Criteria:

          -  Age 18 years

          -  History of gout - crystal proven or historical as defined by ACR criteria listed above

          -  Serum urate level 6.8 mg/dl

        Exclusion Criteria:

          -  Stage 4 or 5 Chronic Kidney Disease (CKD) - defined as eGFR of <30 ml/min

          -  Women less than 50 years of age

          -  Patients with a history of prior solid organ / hematopoietic transplantation

          -  Previous allergy or intolerance to allopurinol or febuxostat

          -  Patients who are not candidates for any of the recommended prophylactic medications
             (colchicine, naprosyn or glucocorticoids)

          -  Patients who in the opinion of the investigator have a high genetic risk for
             allopurinol hypersensitivity syndrome (AHS*) unless they have been found to be
             negative for HLA B5801.

          -  Previous history of failure to reach target uric acid levels despite therapy with
             allopurinol at dose > 300 mg/day

          -  Prior febuxostat use

          -  Patients with malignancies that are currently active with exception of non-melanoma
             skin cancer

          -  Patients with serum uric acid levels >15 mg/dl

          -  Patients with myelodysplasia and hemoglobin of < 8.5 g/dL

          -  Patients with chronic liver disease with more than one of the following:

               -  INR 1.7, not on Warfarin therapy

               -  Bilirubin 2 mg/dL

               -  Serum albumin <3.5 g/dL

               -  Ascites

               -  Encephalopathy

          -  Current use of azathioprine, mercaptopurine, didanosine, cyclophosphamide, or
             probenecid

          -  Patient who are unable to give informed consent

          -  Enrollment in another randomized interventional clinical trial

          -  Any severe medical condition that, in the enrollee's opinion, is likely to compromise
             the participant's ability to complete the trial
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.


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