A Study of Retreatment With Rituximab in Patients With Rheumatoid Arthritis Receiving Background Methotrexate

Exclusion Criteria

• •Rheumatic autoimmune disease other than RA or significant systemic involvement secondary to RA; Secondary Sjogren's syndrome with RA is permitted.
• •History of or current inflammatory joint disease other than RA or other systemic rheumatic disorder (e.g., systemic lupus erythematosus, inflammatory bowel disease, scleroderma, inflammatory myopathy, or overlap syndrome)
• •History of deep space/tissue infection within 52 weeks prior to Day 1
• •Diagnosis of juvenile idiopathic arthritis (JIA), juvenile rheumatoid arthritis (JRA), and/or RA before age 16
• •Functional Class IV, as defined by the ACR Classification of Functional Status in Rheumatoid Arthritis
• •Any surgical procedure, including bone/joint surgery/synovectomy (including joint fusion or replacement), within 12 weeks prior to Day 1 or planned within 48 weeks after Day 1
• •Known hypersensitivity to any component of a humanized or murine monoclonal antibody
• •Receipt of any vaccination within 4 weeks prior to Day 1
• •Significant cardiac or pulmonary disease, including obstructive pulmonary disease
• •Evidence of significant uncontrolled concomitant disease, such as, but not limited to nervous system, renal, hepatic, endocrine, or gastrointestinal disorders
• •Known active bacterial, viral, fungal, mycobacterial, or other infection (including tuberculosis or atypical mycobacterial disease but excluding fungal infections of the nail beds) or any major episode of infection requiring hospitalization or treatment with IV antibiotics within 4 weeks of Day 1 or oral antibiotics within 2 weeks of Day 1
• •History of serious recurrent or chronic infection (a chest X-ray will be performed at screening if one has not been performed within 12 weeks of screening that showed no clinically significant abnormality)
• •History of or currently active primary or secondary immunodeficiency, including HIV infection
• •History of cancer, including solid tumors and hematologic malignancies (except basal cell or squamous cell carcinoma of the skin that has been excised and cured)
• •History of significant cytopenias or other bone marrow disorders
• •History of alcohol, drug, or chemical abuse within 24 weeks prior to Day 1
• •Pregnancy or lactation
• •Neuropathies and neurovasculopathies that might interfere with pain evaluation
• •Poor peripheral venous access
• •Intolerance or contraindications to oral or IV corticosteroids
• •Positive hepatitis B surface antigen or hepatitis C antibody serology
• •For women of childbearing potential (including those who have had a tubal ligation), a positive serum pregnancy test at screening
• •Current use of any DMARD other than MTX
• •Concurrent treatment with any biologic agent
• •Treatment with any investigational agent within 4 weeks prior to Day 1 or five half-lives of the investigational drug (whichever is longer)
• •Any previous treatment with rituximab or other cell-depleting therapies, including CAMPATH, anti-CD4, anti-CD5, anti-CD3, anti-CD19, anti-CD11a, anti-CD22, anti-BLys/ BAFF, and other anti-CD20 agents
• •Previous treatment with a co-stimulation blocking agent, including abatacept
• •Previous treatment with an anti-\<alpha\> 4 integrin agent, including natalizumab
• •Previous treatment within 6 months of screening with IV \& globulin or the Prosorba(R) Column
• •Intra-articular or parenteral corticosteroids within 4 weeks prior to Day 1