Apremilast Therapy for Acute Gouty Arthritis

WITHDRAWN

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)