The purpose of this study is to evaluate the safety and efficacy of Epratuzumab with standard treatments for patients with SLE.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
54
360 mg/m2 or 720 mg/m2 delivered by slow intravenous infusion
Intravenous
Patient response variable (complete response, partial response, non-response) evaluated at 24 weeks
Proportion of patients with complete response or partial response;
Individual BILAG assessments;
Physician and patient assessment scores;
Time-to treatment failure;
Successful steroid reduction by weeks 20 and 24;
Maintenance of steroid reduction at 24 and 48 weeks;
Monitor the plasma concentration and immunogenicity profile of epratuzumab in patients with Lupus;
Assess epratuzumab on Health-related quality of life
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Birmingham, Alabama, United States
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Tucson, Arizona, United States
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Los Angeles, California, United States
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Upland, California, United States
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Colorado Springs, Colorado, United States
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Denver, Colorado, United States
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Farmington, Connecticut, United States
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Washington D.C., District of Columbia, United States
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Aventura, Florida, United States
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Chicago, Illinois, United States
...and 50 more locations