Study of Epratuzumab in Systemic Lupus Erythematosus

An Open-Label Re-treatment Trial for Patients Previously Randomized Into the SL0003 and SL0004, Randomized, Double-blind, Placebo-controlled, Multi-center Studies of Epratuzumab in Patients With Systemic Lupus Erythematosus

Epratuzumab is an investigational antibody designed to help treat Systemic Lupus Erythematosus (SLE). The purpose of the study is to obtain additional long-term information regarding the safety and efficacy of continued maintenance-cycle administrations of Epratuzumab.

Due to the logistical considerations, UCB has decided to consolidate the Phase II and Phase III open-label extension trials. Subjects completing this study will be offered the option of continuing to receive epratuzumab through participation in Phase III open-label extension study SL0012 (NCT01408576).

Inclusion Criteria:

• Must have participated in SL0003 or SL0004 and benefitted from participation in those studies

Exclusion Criteria:

• Development of toxicity to epratuzumab
• Significant protocol deviations during the SL0003 or SL0004 studies
• Evidence of significant infection