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 .
