Safety and Efficacy Study of Adalimumab in Patients With Active Psoriatic Arthritis (PsA) (STEREO)

Inclusion Criteria:

• Males and females > 18 years of age
• Active PsA with > 3 tender and > 3 swollen joints despite standard therapy
• Unsatisfactory response or intolerance to at least one prior or ongoing DMARD (study enrollment must be in accordance with current national guidelines for treatment of PsA with TNF inhibitors)
• A negative serum pregnancy test (serum HCG) for women of childbearing potential prior to the start of treatment.
• Use of a reliable method of contraception by all female patients of childbearing potential
• Able and willing to self-administer sc injections or have a suitable person to administer sc injections
• Able and willing to give written informed consent and comply with the protocol

Exclusion Criteria:

• Prior treatment with any investigational agent within 30 days or five half lives of the product, whichever is longer
• Treatment within last 2 months with infliximab or within last 3 weeks with etanercept
• Treatment within last 4 weeks with a combination of MTX and leflunomide
• Treatment within last 4 weeks with a combination of cyclosporine with any other DMARD-Subject has received UVA phototherapy (including PUVA within 2 weeks prior to screening)
• History of cancer or lymphoproliferative disease other than a successfully and completely treated squamous cell or basal cell carcinoma of the skin or cervical dysplasia
• History of or current active acute inflammatory joint disease of origin other than PsA
• Comorbidities (uncontrolled diabetes, unstable ischemic heart disease, CHF, active IBD, stroke within 3 months, chronic leg ulcer and other condition which would put subject at risk by participation in the protocol
• Positive serology for hepatitis B or C
• History of positive HIV status
• Persistent or recurrent infections or severe infections requiring hospitalization or treatment with iv antibiotics within 30 days, or oral antibiotics within 14 days prior to enrollment
• Females who are pregnant or breast-feeding
• History of clinically significant drug or alcohol abuse in the last year
• Previous diagnosis or signs of central nervous system demyelinating diseases
• History of tuberculosis, histoplasmosis or listeriosis
• Subjects with latent TB or having other risk factors for activation of latent TB who have not initiated a TB prophylaxis prior to the first adalimumab treatment .