Lupus Erythematosus, Systemic Clinical Trial
Official title:
An Open-Label Safety and Efficacy Study of an Anti-CD20 Antibody (Rituximab, Rituxan®) for Anti-B Cell Therapy in the Treatment of Systemic Lupus Erythematosus
The purpose of this study is to determine the safety and effectiveness of rituximab
(anti-CD20) in treating systemic lupus erythematosus (SLE).
White blood cells in the body called B cells give off substances that are active in promoting
SLE disease. Researchers have found that anti-CD20 can block production of these substances
in another disease. This study explores whether anti-CD20 will also be safe in people with
SLE and whether it may be effective in treating SLE.
B cells clearly play an essential role in the pathogenesis of SLE since they produce
autoantibodies. Clinical observations support the contention that intervening in the
production of autoantibodies by the B lymphocyte will be effective therapy. Current approved
therapy for B-cell non-Hodgkin's lymphoma includes anti-CD20. The results of anti-CD20
administration in SLE are anticipated to be similar to those in lymphoma patients. The
current proposal explores the mechanisms and applicability of B-cell depletion as a potential
treatment for SLE.
Participants receive 4 weekly infusions of study medication. Each participant is enrolled in
the study for a total of 1 year with protocol visits weekly for the first 3 months, then
every other week for the next 2 months, every month for the next 4 months, and every other
month for the remaining 5 months of the study (Weeks 0, 1, 2, 3, 4, 5, 6, 7, 9, 11, 13, 15,
19, 23, 27, 31, 39, 47, and 55). Responses to exogenous antigens are measured; assessments
for clinical response with SLE-disease activity score (SLEDEI) and systemic lupus activity
measure (SLAM) score are performed. Participants complete a health questionnaire and a health
survey and laboratory parameters are evaluated.
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