Pharmacokinetics Study of Epratuzumab in Systemic Lupus Erythematosus (SLE)
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The goal of this study is to evaluate how epratuzumab is processed by the body (pharmacokinetics) and whether 2 dose levels of epratuzumab are safe and effective in patients with SLE.
Condition or disease
Lupus Erythematosus, Systemic
This study is planned to provide information on how the body processes epratuzumab and how epratuzumab affects the body when epratuzumab is given once weekly for 4 weeks in a row at one of 2 different dose levels. Additional information will be obtained related to the natural variability of disease activity in SLE patients.
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Layout table for eligibility information
Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Has SLE by American College of Rheumatology revised criteria (meets >/= 4 criteria)
Has had SLE for at least 6 months prior to study entry
Has at least one elevated autoantibody level at study entry
Has moderately active SLE disease at study entry in any body/organ system (Full criteria not present here due to length of considerations. The protocols should be consulted regarding the complete list of entry criteria.)
Active Severe Lupus as defined by BILAG Index Level A in any body system or organ