Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
UCB Pharma
Treatment period was extended by 2 years to a total of 4 years and an amendment was prepared accordingly.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
