Determining the Responses and Impact of Rituximab-instigated Cell Depletion on T Cells in People With SLE

Exclusion Criteria

• •Severe thrombocytopenia
• •Active, moderate, or severe proliferative glomerulonephritis
• •Active CNS manifestations due to lupus other than migraines, mild cognitive dysfunction, or mood disorders. More information about this criterion can be found in the protocol.
• •Poorly controlled anti-phospholipid syndrom
• •Significant organ dysfunction
• •Conditions, other than SLE, that are likely to require prolonged systemic steroids
• •Chronic infections. More information about this criterion can be found in the protocol.
• •Hepatitis B infection
• •Hepatitis C infection
• •Deep space infection within two years of study entry
• •Severe bacterial infection within three months of study entry
• •More than one severe bacterial infection within two years of study entry
• •Positive purified protein derivative tuberculin skin test
• •History of cancer, not including basal cell carcinomas and carcinoma in situ of the cervix with documentation of successful treatment
• •Alcohol or drug abuse
• •Surgery within three months of study entry
• •Immunization with a live vaccine within two months of study entry
• •Any immunization within one month of study entry
• •Received cyclophosphamide or calcineurin inhibitors within six months of study entry
• •Received anti-TNF alpha antibody within 3 months of study entry
• •Received etanercept within one month of study entry
• •Received anti-CD20 antibodies or other lymphocyte depleting antibodies
• •Received Immunoglobin G infusion protein or monoclonal antibody
• •Treatment with FDA non-approved agents within six months of study entry
• •Transaminases greater than two times the upper limit of normal
• •Pregnant or breastfeeding