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Global Study to Compare Natalizumab, Glatiramer Acetate, and Interferon Beta-1a in Relapsing-Remitting MS CAMBRIDGE, Mass -- March 26, 2010 -- The first patient was enrolled yesterday in a global phase 3b, randomised, rater-blinded, active-controlled study designed to evaluate switching to natalizumab (Tysabri) from glatiramer acetate (Copaxone) or interferon beta-1a (Rebif) in patients with relapsing-remitting multiple sclerosis (RRMS). The SURPASS study is expected to enrol 1,800 patients in 27 countries and provide direct comparative data of different treatment options for RRMS patients who experience breakthrough disease activity. “Despite being on therapy, many MS patients still experience disease progression, resulting in loss of physical abilities and permanent damage to the central nervous system,” said SURPASS trial advisory committee member Richard Rudick, MD, Mellen Center for Multiple Sclerosis Treatment and Research at the Cleveland Clinic, Cleveland, Ohio. “Currently, there are limited data to inform decisions about how to switch in patients who have disease activity while on therapy. The goal of the SURPASS study is to provide those data so physicians can improve treatment decisions and outcomes for their MS patients.” A significant number of MS patients continue to experience clinical relapses and disease progression despite treatment with disease-modifying therapies such as glatiramer acetate and interferon beta-1a. The SURPASS study, a large, well-controlled comparative trial of MS treatments, will evaluate switching to natalizumab versus staying on or switching between glatiramer acetate and interferon beta-1a and determine whether early use of natalizumab in the treatment algorithm ultimately leads to better outcomes. “[Natalizumab] … is bringing hope to many MS patients,” said Alfred Sandrock, MD, MPH, Neurology Research and Development, Biogen Idec, Cambridge, Massachusetts. “By evaluating [natalizumab] against other MS treatments, our goal is to provide the data needed to make better treatment decisions and improve patients’ lives.” SURPASS will enrol patients with RRMS, ages 18 to 60 years, with a baseline Expanded Disability Status Scale (EDSS) score from 0.0 to 5.5. Patients must have been treated with a stable regimen of either glatiramer acetate or interferon beta-1a as their principal first therapy for MS for 6 to 18 months prior to randomisation. Patients must also have had disease activity within 12 months prior to screening defined as 1 or more clinical relapses or 2 or more new MRI lesions (Gd+ and/or T2 hyperintense lesions). 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 natalizumab. Participants will be randomized in a 2:1:1 ratio to 1 of the following groups: · Group 1: 900 patients will receive natalizumab 300 mg intravenous (IV) every 4 weeks · Group 2: 450 patients will receive interferon beta-1a 44 mcg subcutaneous (SC) 3 times per week · Group 3: 450 patients will receive glatiramer acetate 20 mg SC once daily. SOURCE: Biogen Idec and Elan Corporation, plc E-mail this page to a friend or colleague! To print, use this version