Autoimmune Diseases Clinical Trial
Official title:
Influence of Plasma Exchange Therapy on the Pharmacokinetics of Rituximab in Patients Treated for Autoimmune Disorders.
Rituximab (a monoclonal antibody raised against CD20) is used to treat various immune
disorders. In some cases such as treatment of humoral acute rejection of renal transplant,
thrombotic thrombocytopenic purpura, vasculitis or cryoglobulinemia, rituximab is often
associated with plasma exchange. The pharmacokinetic of the rituximab can be affected by
plasma exchange but the knowledge is poor in this matter.
The aim of the study is to explore the influence of plasma exchange on the pharmacokinetic
of rituximab.
The results of this study should conclude if plasma exchange leads to a significant decrease
of plasma concentration of rituximab or not, and if the decreased of the concentration is
associated with a decrease in efficacy.
Twenty patients will be enrolled: ten patients treated by rituximab and ten patients treated
by rituximab and plasma exchange. The plasma concentration of rituximab and the efficacy of
the treatment will be compared between the two groups of patients.
The enrollment in the study will not change the treatment of patients except for blood
sampling.
Each patient will undergo fifteen blood samples between the start of infusion of rituximab
and three months after the start of infusion. For the patients who will undergo plasma
exchange, three additional blood samples will be performed at each plasma exchange (at the
start, at the end and one day after the plasma exchange) and a sample of the plasma
exchanged will be keep.
The plasma concentration of rituximab will be determined by ELISA method (Enzyme Linked
ImmunoSorbent Assay) The pharmacokinetic analyse will consist in the determination of the
Area Under the Concentration Curve (AUC) by a non compartmental approach.
The AUC levels will be compared (using the t Student test) between the two populations of
patients (patients treated by rituximab, versus patients treated by rituximab and plasma
exchange) The efficacy of the treatment will be evaluated by the CD19+ B Cell count.
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