Study of Epratuzumab in Systemic Lupus Erythematosus

A Phase III, Randomized, Double-Blind. Placebo-Controlled, Multi-Center Study of Systemic Lupus Erythematosus With Acute Severe SLE Flares Excluding Renal or Neurological Systems

The purpose of the study is to evaluate the safety & efficacy of Epratuzumab with standard treatments for patients with SLE.

Inclusion Criteria:

• Has SLE by ACR revised criteria (meets <4 criteria);
• Has SLE with at least one elevated lupus antibody;
• Has new onset of severe lupus disease flare in at least one body or organ system, excluding renal or neurologic

Exclusion Criteria:

• Active severe CNS or Renal disease defined by BILAG as Level A
• Allergy to murine or human antibodies
• Antiphospholid antibodies AND a history of thrombocytopenic events