Anakinra (Kineret®) in Combination With Disease Modifying Anti-Rheumatic Drugs (DMARDS) in Subjects With Active Rheumatoid Arthritis (RA)

Inclusion Criteria: - Subjects diagnosed with RA as determined by American College ofRheumatology (ACR) criteria with a disease duration of at least 24 weeks prior toenrollment - Active RA at screening as defined by EITHER: (1) At least 6 swollen joints (using a 66 joint count) and at least 6 tender joints (using a 68 joint count) OR (2) 4non-hand joints and at least 1 of the following: *Morning stiffness of at least 45 minutes; *CRP greater than 1.5 mg/dL (15.0 mg/L); *ESR greater than 28 mm/h; *DAS28 greater than 3.2

• Subjects must have failed an adequate trial of at least 3 disease-modifying antirheumaticdrugs (DMARDS) alone or in combination (one of which must be MTX) and have been on the sametreatment and doses for 4 weeks prior to enrollment (i.e., an adequate trial is defined as 12 weeks unless limited by toxicity or intolerance) - Subjects' doses of nonsteroidalantiinflammatory drugs (NSAIDs) and oral corticosteroids (less than or equal to 10 mg/dayof prednisone or equivalent) must have been kept stable for 4 weeks prior to enrollment. Doses of 10 mg/day prednisone or equivalent should not be exceeded during the study

Exclusion Criteria: - ACR functional class IV or ARA anatomical stage IV - Subjects thatare scheduled for surgery or being evaluated for surgery for hands, wrist and feet -Felty's syndrome - Any poorly controlled, clinically significant systemic disease (e.g.,chronic obstructive pulmonary disease, congestive heart failure, stroke, chronic renalfailure, liver disease) - Poorly controlled diabetes mellitus (e.g., diabetics with HbA1Cgreater than 8%, peripheral neuropathy, renal/retinal involvement, or vascular disorders) -Malignancy, other than basal cell carcinoma of the skin or in situ carcinoma of the cervixwithin the past 5 years - Abnormal chest x-ray that is clinically significant orbronchiectasis - Within 12 weeks before date of enrollment any of the followingoccurrences: presence of serious infection (e.g., requiring hospitalization and/or IVantibiotics), frequent, acute, or chronic infections - History of chronic infection -Recent history (within 24 weeks of enrollment) of drug or alcohol abuse - Known to bepositive for hepatitis B surface antigen, hepatitis C virus, or human immunodeficiencyvirus - Presence of any condition that may compromise the ability of the subject to giveinformed consent - Planned events (e.g., planned hospitalizations, vacations, etc.) thatwould interfere with the collection of the required assessments and/or may prevent thesubject from completing the study according to protocol - White cell count less than orequal to 3.5 x 10^9/L, a neutrophil count of less than or equal to 2.5 x 10^9/L, orplatelet count of less than or equal to 125 x 10^9/L at screening - Hemoglobin less than orequal to 8.0 g/dL at screening - Elevated AST or ALT greater than or equal to 1.5 x theupper limit of normal at screening - Elevated serum creatinine greater than or equal to 1.5x the upper limit of normal at screening - Received intra-articular or systemiccorticosteroid injections within 4 weeks before enrollment - Subjects who have receivedprevious treatment with anti-IL-1ra or anti-TNF therapies (e.g., anakinra, etanercept orinfliximab) within 4 weeks prior to enrollment - Subjects who are pregnant orbreast-feeding, or plan to become pregnant during the course of the study - Subject (man orwoman) is of child bearing potential and not using adequate contraceptive precautions -Known allergy to E. coli derived products - Receiving or has received any investigationaldrug within the previous 30 days or within 5 half-lives of any investigational drug,whichever is greater (or is currently using an investigational device)