Phase I trial of autologous dendritic cells
 Ranjeny Thomas
The primary aims are to demonstrate in a phase I clinical trial of Rheumavax administered to patients with rheumatoid arthritis taking disease-modifying drugs for their disease, (1) safety and (2) capacity to suppress the immune response to citrullinated autoantigen
Safety as evaluated by clinical assessment and laboratory test monitoring in the DC groups compared with the control group, as measured by hematological, biochemical and lipid profile, autoantibodies, and measures of inflammation carried out at intervals, over 6 months.
Tolerance induction in the DC groups, compared with a control group, as measured by peripheral blood T cell proliferative and T cell cytokine responses to citrullinated-peptides, control peptides and tetanus toxoid antigen for up to 6 months after delivery of Rheumavax. Antigen-specificity of suppression will be determined by changes in the T cell proliferative and cytokine responses to citrullinated-peptide restimulation in vitro as compared to the response to tetanus toxoid and control peptides.
The secondary aim is efficacy, to determine whether Rheumavax administered to patients with rheumatoid arthritis influences RA disease activity, as measured by the health assessment questionnaire, disease activity and American College of Rheumatology scores, and hand radiographs.
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