To assess the efficacy of the CD4 monoclonal antibody (MAb) cM-T412 in the treatment of early rheumatoid arthritis (RA).
Methods. Sixty patients were enrolled in a 6-week randomized, double-blind, placebo-controlled study investigating multiple dose regimens of cM-T412. Thirty patients subsequently were enrolled in a 9-month randomized, double-blind, placebo-controlled study investigating monthly single-dose adminiitrations of cM-T412.
Results. Analysis of clinical parameters revealed no changes in arthritis activity in the groups that received CD4 MAb or the placebo group, and no difference between the groups, in either in the first or the second part of the study. The number of circulating CD4+ cells decreased substantially in the patients treated with CD4 MAb.
Conclusion. CD4 MAb treatment of patients with early RA induced no therapeutic effect.
Present understanding of the pathogenesis of rheumatoid arthritis (RA) is incomplete. However, accumulating evidence has indicated that the T lymphocyte orchestrates an autoimmune process (I). Therefore, surface antigens of T cells were suggested as possible targets for a specific immunotherapy .
Monoclonal antibodies (MAb) against the CD4 molecule were shown to modulate the function of CD4+ T cells (2). Following the successful use of CD4 MAb in