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



Status:Completed
Conditions:Lupus
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:18 - Any
Updated:10/5/2018
Start Date:July 2011
End Date:February 2016

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A Phase 3, Multicenter, Open-label, Extension Study to Assess the Safety and Tolerability of Epratuzumab Treatment in Systemic Lupus Erythematosus Subjects

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

Treatment period was extended by 2 years to a total of 4 years and an amendment was prepared
accordingly.

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
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