Recombinant human interferon beta in the treatment of relapsing-remitting and secondary progressive multiple...

Two multicenter, randomized, double-blind, placebo-controlled phase III studies to evaluate the safety and efficacy of 6 and 12 MIU of recombinant human interferon beta (r-hIFN-beta) (Rebif) given subcutaneously three times per week, in patients with MS, are described. In one study, patients with relapsing-remitting multiple sclerosis are treated for 24 months; the primary efficacy end point is the number of exacerbations. In the other study patients with secondary progressive multiple sclerosis are treated for 36 months; the primary efficacy end point is time to sustained progression in disability as determined by the Expanded Disability Status Scale (EDSS). Both studies are conducted in centers in Europe, Australia and Canada.