Phase II Study of Apremilast (CC-10004) in Adults With in Psoriatic Arthritis

Exclusion Criteria

• •History of any clinically significant cardiac, endocrinologic, pulmonary, neurologic, psychiatric, hepatic, renal, hematologic, immunologic, or other major diseases
• •Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study
• •Pregnant or lactating female
• •History of active Mycobacterium tuberculosis infection (any subspecies) within 3 years prior to the screening visit. Infections that occurred \> 3 years prior to entry must have been effectively treated.
• •History of incompletely treated latent Mycobacterium tuberculosis infection (as indicated by a positive Purified Protein Derivative \[PPD\] skin test or in vitro test \[T SPOT®.TB, QuantiFERON Gold®\])
• •Clinically significant abnormality on the chest x-ray (CXR) at screening
• •Current erythrodermic, guttate, or pustular forms of psoriasis
• •History of infected joint prosthesis within the past 5 years
• •Systemic therapy for psoriasis and/or psoriatic arthritis (except for methotrexate, ≤ 10 mg/day prednisone or equivalent, and NSAIDs) including, but not limited to, sulfasalazine, leflunomide, chloroquine, hydroxychloroquine, gold compounds, parenteral corticosteroids (including intra-articular), penicillamine, cyclosporine, oral retinoids, mycophenolate mofetil, thioguanine, hydroxyurea, sirolimus, tacrolimus, azathioprine, and fumaric acid esters within 28 days of randomization and throughout the study
• •Topical therapy for the treatment of psoriasis including, but not limited to topical steroids, topical vitamin A or D analog preparations, tacrolimus, pimecrolimus, or anthralin within 14 days of randomization (Note: Topical background therapy for treatment of psoriasis is allowed, except within 24 hours of a study visit, as follows: mild or moderate potency corticosteroids for treatment of the palms, face, scalp, axillae, plantar surfaces, and groin in accordance with the manufacturer's suggested usage. Nonmedicated emollients \[eg, Eucerin®\] and tar shampoo are also allowed.)
• •Phototherapy (ultraviolet light A \[UVA\], narrow-band ultraviolet light B \[NB-UVB\], psoralens and long-wave ultraviolet radiation \[PUVA\]) within 28 days prior to randomization
• •Etanercept use within 56 days prior to randomization
• •Adalimumab, efalizumab, or infliximab use within 84 days prior to randomization
• •Alefacept use within 168 days (24 weeks) prior to randomization
• •Use of intra-articular corticosteroids within 28 days prior to randomization
• •Use of any investigational medication within 28 days prior to randomization or 5 half-lives if known (whichever is longer)
• •Any clinically significant abnormality on 12-lead electrocardiogram (ECG) at screening
• •High-risk factor(s) for, or a history of, human immunodeficiency virus (HIV), hepatitis B, or hepatitis C virus infection
• •History of malignancy within previous 5 years (except for treated basal-cell skin carcinoma(s) and/or fewer than 3 treated squamous-cell skin carcinomas)
• •Evidence of skin conditions at the time of screening visit that would interfere with evaluations of the effect of study medication on psoriasis