TRIAL OF LJP 394 IN SYSTEMIC LUPUS ERYTHEMATOSUS

$0M01FY2000RRNIH

Medical University Of South Carolina, Charleston SC

Investigators

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Abstract

The primary objective of this trial is to determine doses of LJP 394 on the anti-dsDNA antibody concentration. The total duration of the trial is approximately 16 weeks (4 week screening period, 12 week dosing period). Parameters to be evaluated during the 16-week trial include: changes in anti-dsDNA antibody concentrations as measured by Farr and Elisa methodologies, changes in complement (C3,C4), results of the SLEDAI assessment of clinical studies and the MOS SF-36tm and changes in renal function parameters. The safety profile of LJP 394 will be assessed during the 16 week trial. Safety parameters will include: the incidence of adverse experiences and changes in the results of laboratory parameters (chemistry, hematology, coagulation and urinalysis), physical examinations, vital signs and SLEDAI assessments.

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