Study of Epratuzumab Versus Placebo in Subjects With Moderate to Severe General Systemic Lupus Erythematosus

Exclusion Criteria

• •Subjects who are breastfeeding, pregnant, or plan to become pregnant
• •Subjects with active, severe SLE disease activity which involves the renal system
• •Subjects with active, severe, neuropsychiatric SLE, defined as any neuropsychiatric element scoring BILAG level A disease.
• •Subjects with the evidence of an immunosuppressive state
• •Subjects who, in the opinion of the investigator, are at a particularly high risk of significant infection
• •History of malignant cancer, except the following treated cancers: cervical carcinoma in situ, basal cell carcinoma, or dermatological squamous cell carcinoma.
• •Subjects receiving any live vaccination within the 8 weeks prior to screening (Visit 1).
• •Subjects with history of infections, including but not limited to concurrent acute or chronic viral hepatitis B or C
• •Subjects with substance abuse or dependence or other relevant concurrent medical condition
• •Subjects with history of thromboembolic events within 1 year of screening Visit.
• •Subjects with significant hematologic abnormalities
• •Subject has received treatment with other anti- B cell antibodies within 12 months prior to screening (visit 1)
• •Subject use of oral anticoagulant (not including) nonsteroidal anti-inflammatory drugs (NSAIDs) within 12 weeks prior to screening (Visit 1)
• •Subject has previously participated in this study or has previously received epratuzumab treatment.