Clinical trial: Effects of Allopurinol on Inflammation and Ultrasonographic Changes in People With Elevated Uric Acid But no Symptoms (NCT04012294)

Eligibility criteria:
Inclusion Criteria:

          -  Individuals with two urate determinations >7 mg/dL in the last year and no clinical
             sign, past or present, suggestive of joint inflammation (acute gout attack),
             urolithiasis or uric acid nephropathy

          -  Over 18 years of age

          -  Residents of Mexico City or its metropolitan area

          -  Individuals with a signed informed consent form for the participation in the clinical
             trial

        Exclusion Criteria:

          -  Individuals with joint inflammation suggestive of gout during the clinical evaluation

          -  Patients without elemental ultrasonographic lesions (double contour sign, aggregates,
             tophi) on the first metatarsophalangeal joint, knee, ankle or the tendons of the
             quadriceps, patella, and calcaneus when evaluated by MSUS

          -  Patients taking thiazides

          -  Patients with history of stroke or coronary artery disease in the last year

          -  Patients with osteoarthritis be it by clinical presentation or imaging

          -  Pregnant women

          -  Neoplasms

          -  Known Hepatitis B Virus (HBV), Hepatitis C Virus (HCV) , Human immunodeficiency Virus
             (HIV) infection, or any other know active infections

          -  Autoimmune or autoinflammatory disease

          -  Allopurinol hypersensitivity or allergy

          -  Deteriorated kidney function (Glomerular Filtration Rate (GFR) <50 mL/min/1.73m^2)

          -  Patients taking azathioprine

          -  Functional New York Heart Association (NYHA) score of II or more
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
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