Study of Epratuzumab Versus Placebo in Subjects With Moderate to Severe General Systemic Lupus Erythematosus (SLE) (EMBODY 2)

The primary objective of the study is to confirm the clinical efficacy of epratuzumab in the treatment of subjects with Systemic Lupus Erythematosus (SLE).

April 18, 2014
Rheumatology - Systemic Lupus Erythematosis (SLE)
Philip J. Mease, MD

Inclusion Criteria:

  • Positive antinuclear antibodies (ANA) at Screening (Visit 1)
  • Current clinical diagnosis of Systemic Lupus Erythematosus (SLE) by American College of Rheumatology (ACR) criteria such that at least 4 of the 11 criteria are met
  • Active moderate to severe SLE activity as demonstrated by the British Isles Lupus Assessment Group Index (BILAG)
  • Active moderate to severe SLE disease as demonstrated by SLE disease activity index (SLEDAI) total score
  • Sephren Barrow