Clinical trial: Apremilast Therapy for Acute Gouty Arthritis (NCT00997581)

Eligibility criteria:
Inclusion Criteria:

          -  Must understand and voluntarily sign the informed consent

          -  Must have the diagnosis of gout proven by identification of urate crystals from body
             fluids

          -  Must be male age >18 years at the time of consent

          -  Must be able to adhere to the study visit schedule and other protocol requirements

          -  Must meet the following laboratory criteria:

               -  Hemoglobin > 9.0 g/dL

               -  White blood cell (WBC) count > 3000/μL and < 14,000/μL

               -  Platelet count >100,000/μL

               -  Serum creatinine < 2.0mg/dL

               -  Total bilirubin < 2.0 mg/dL

               -  Aspartate transaminase (AST) and alanine transaminase (ALT) <1.5 X upper limit of
                  normal

          -  Males, including those who have had a vasectomy, must agree to use barrier
             contraception (latex condom) when engaging in sexual activity with a female of
             child-bearing potential (FCBP) while on study medications and for 84 days after taking
             the last does of the medication

        Exclusion Criteria:

          -  Inability to provide voluntary consent

          -  Any condition, including the presence of laboratory abnormalities, which places the
             subject at unacceptable risk if he were to participate in the study or confounds the
             ability to interpret the data from the study

          -  Females

          -  Systemic fungal infection

          -  History of recurrent bacterial infection (at least 3 major infections resulting in
             hospitalization and/or requiring intravenous antibiotic treatment in the past 2 years

          -  An active infection at presentation

          -  Use of any investigational medication within 4 weeks prior to start of study or 5
             pharmacokinetic/pharmacodynamic half-lives, whichever is longer

          -  Any use of corticosteroids, cyclosporine, methotrexate, cyclophosphamide,
             azathioprine, mycophenolate within 4 weeks prior to start of study

          -  Any clinically significant abnormality on 12-lead ECG screening

          -  Malignancy or history of malignancy (except for treated and cured basal-cell skin
             carcinomas > 3 years prior to screening)
Male
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? 1