Open Label Extension Study of Epratuzumab in Subjects With Systemic Lupus Erythematosus (EMBODY4)

• Number of subjects prematurely discontinuing due to a treatment-emergent adverse event (TEAE) during the treatment period (maximum 96 weeks) [ Time Frame: During the treatment period (through Week 96) ] [ Designated as safety issue: No ]
  A TEAE i s any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment.
• Number of subjects reporting at least 1 serious adverse event (SAE) during the treatment period (maximum 96 weeks) [ Time Frame: During the treatment period (through Week 96) ] [ Designated as safety issue: No ]

  A SAE is a treatment-emergent adverse event (TEAE) that the investigator classifies as serious. This includes:

  • Death
  • Life-threatening
  • Significant or persistent disability/incapacity
  • Congenital anomaly/birth defect (including that occurring in a fetus)
  • Important medical event that, based upon appropriate medical judgment, may jeopardize the patient or subject and may require medical or surgical intervention to prevent 1 of the other outcomes listed in the definition of serious
  • Initial inpatient hospitalization or prolongation of hospitalization

• Number of subjects prematurely discontinuing due to a treatment emergent adverse event (TEAE) during the treatment period (maximum 96 weeks) [ Time Frame: During the treatment period (through Week 96) ] [ Designated as safety issue: No ]
• Number of subjects reporting at least 1 serious adverse event (SAE) during the treatment period (maximum 96 weeks) [ Time Frame: During the treatment period (through Week 96) ] [ Designated as safety issue: No ]

• The percent of subjects meeting treatment response criteria according to a combined response index [ Time Frame: Week 48 ] [ Designated as safety issue: No ]
  Combined response index is a response variable (yes/no) incorporating the following criteria for achievement of responder status (ie, all criteria must be met to achieve responder status): (1) British Isles Lupus Activity Group (BILAG) improvement, (2) No worsening in Systemic Lupus Erythematosus Activity Index (SLEDAI), (3) No worsening in Physician's Global Assessment of Disease, and (4) No disallowed changes in concomitant medications, with disallowed changes including mainly increases in corticosteroids, immunosuppressants, and antimalarials.
• The percent of subjects meeting treatment response criteria according to a combined response index [ Time Frame: Week 96 ] [ Designated as safety issue: No ]
  Combined response index is a response variable (yes/no) incorporating the following criteria for achievement of responder status (ie, all criteria must be met to achieve responder status): (1) British Isles Lupus Activity Group (BILAG) improvement, (2) No worsening in Systemic Lupus Erythematosus Activity Index (SLEDAI), (3) No worsening in Physician's Global Assessment of Disease, and (4) No disallowed changes in concomitant medications, with disallowed changes including mainly increases in corticosteroids, immunosuppressants, and antimalarials.

The primary objective of the study is assess the safety and tolerability of long-term epratuzumab treatment in subjects with Systemic Lupus Erythematosus (SLE)

Study design was modified and an amendment was prepared accordingly.

• Drug: Epratuzumab
  600 mg infusions delivered weekly for a total of 4 consecutive weeks (cumulative dose 2400 mg) over eight 12-week treatment cycles
• Drug: Epratuzumab
  1200 mg infusions delivered every other week for a total of 4 weeks (cumulative dose 2400 mg) over eight 12 week treatment cycles

• Experimental: Epratuzumab 600 mg per week
  600 mg infusions delivered weekly for a total of 4 consecutive weeks (cumulative dose 2400 mg) over eight 12 week treatment cycles
  Intervention: Drug: Epratuzumab
• Experimental: Epratuzumab 1200 mg every other week
  1200 mg infusions delivered every other week for a total of 4 weeks (cumulative dose 2400 mg) over eight 12 week treatment cycles
  Intervention: Drug: Epratuzumab

Inclusion Criteria:

• Subject has completed the double-blind study SL0009 (NCT01262365) or SL0010 (NCT01261793) or terminated prematurely at Week 16 or later in SL0009 or SL0010 due to lack of efficacy and would, in the opinion of the investigator, continue to benefit from continued epratuzumab treatment
• Subject has completed open-label study SL0006 (NCT00383513) or SL0008 (NCT00660881), and would, in the opinion of the investigator, continue to benefit from continued epratuzumab treatment
• Women of childbearing potential must agree to use an acceptable method of birth control

Exclusion Criteria:

• Subjects with active, severe, neuropsychiatric SLE, defined as any neuropsychiatric element scoring British Isles Lupus Assessment Group Index (BILAG) level A disease
• Subjects with active, severe SLE disease activity which involves the renal system
• Subjects with concurrent relevant medical conditions like defined chronic infections or high risk of new significant infections
• Substance abuse or dependence
• History of malignant cancer
• Subjects with any other condition which, in the investigator's judgment, would make the subject unsuitable for inclusion