Open Label Study to Assess Efficacy and Safety of the Fully Human Anti-TNF-Alpha Monoclonal Antibody Adalimumab (PROWD)

Inclusion Criteria:

• Males and females >= 18 years of age
• ACR criteria for RA diagnosis for at least 6 months
• Active RA defined as a DAS 28 >3.2 at study entry
• Unsatisfactory response, loss of response or intolerance to prior infliximab treatment
• A negative pregnancy test for females of childbearing potential

Exclusion Criteria:

• Patient who had previous treatment with cyclophosphamide and chlorambucil
• Treatment within the last 8 weeks with infliximab
• Prior treatment with more than one DMARD or DMARD combination following infliximab treatment
• Prior treatment with biologics (Investigational or Commercial) RA therapies other than infliximab
• History of cancer, other than successfully treated squamous cell or basal cell carcinoma or lymphoproliferative disease
• Prior treatment with total lymphoid irradiation