Biogen/Elan drug to be pitted against Serono/Pfizer rival in MS
The study, named STARS, is a randomized, assessor-blinded, parallel group study that will enroll more than 1,000 multiple sclerosis (MS) patients in North and South America, Europe, Australia, Turkey and Israel. Patients who enroll in the study will be randomized to either treatment on Rebif, administered subcutaneously at 44mcg three times per week, or treatment with Tysabri, administered as a 300mg IV infusion once every four weeks. The primary endpoint will compare the effect of Tysabri to Rebif on the rate of clinical relapses. Secondary endpoints include analysis of the proportion of patients remaining relapse free, MRI brain scans, safety, tolerability and quality of life. To help ensure the objectivity of data emerging from STARS, relapses will be assessed and determined in a blinded fashion by an independent panel of experienced neurologists who are not participants in the study. "Tysabri has shown very encouraging efficacy results and a favorable safety profile after one year, both as a monotherapy and as an add-on therapy to Avonex," said Dr Ludwig Kappos, professor of neurology at Basel University, Switzerland, and member of STARS independent panel. "This head-to-head comparison with Rebif will provide important information that will further assist patients and physicians in making therapeutic choices." The companies expect to enroll the first patient in STARS in the first quarter of 2005.