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news.Biogen Idec and Elan Corporation have enrolled first patient in a global Phase IIIb, randomised, rater-blinded, active-controlled study designed to evaluate switching to Tysabri (natalizumab) from Copaxone (glatiramer acetate) or Rebif (interferon beta-1a) in patients with relapsing remitting multiple sclerosis (RRMS).
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The study, called Surpass, is expected to enroll 1,800 patients in 27 countries and provide direct comparative data of different treatment options for RRMS patients who experience breakthrough disease activity.
The Surpass study, a large, well-controlled comparative trial of MS treatments, is expected to evaluate switching to Tysabri versus staying on or switching between Copaxone and Rebif and determine whether early use of Tysabri in the treatment algorithm ultimately leads to better outcomes.
The primary endpoint of the study is the annualised relapse rate. Secondary endpoints include the change from baseline to 48 weeks in T2 lesion volume and the proportion of subjects who remain free of disease activity – defined as no clinical relapses, no new Gd+ lesions, no new or newly-enlarging T2 lesions, and no sustained progression on EDSS. Additional study objectives will evaluate the safety and tolerability of switching to Tysabri.
Alfred Sandrock, senior vice president of neurology research and development at Biogen Idec, said: “Tysabri is a compelling treatment option that is bringing hope to many MS patients. By evaluating Tysabri against other MS treatments, our goal is to provide the data needed to make better treatment decisions and improve patients’ lives.”