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

Inclusion Criteria

• Diagnosis of psoriatic arthritis (Moll and Wright Criteria), including symmetrical or asymmetrical peripheral joint involvement for at least 6 months
• Active psoriatic arthritis at the time of screening and baseline as defined by: 3 or more swollen joints AND 3 or more tender joints
• Negative rheumatoid factor (RF)
• If using methotrexate, be on methotrexate for at least 168 days (24 weeks) and be on a stable dose for at least 56 days prior to screening and throughout the study
• If using oral corticosteroids, be on a stable dose of prednisone ≤ 10 mg/day or equivalent for at least 28 days prior to screening and throughout the study
• If using nonsteroidal anti-inflammatory drug (NSAID) therapy, be on a stable dose for at least 14 days prior to screening and throughout the study
• Must meet the following laboratory criteria:
• Hemoglobin ≥ 9 g/dL
• Hematocrit ≥ 27%
• White blood cell (WBC) count ≥ 3000/μL (≥ 3.0 X 10^9/L) and 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