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Methods We randomly assigned 1171 patients who, despite interferon beta-1a therapy, had had at least one relapse during the 12-month period before randomization to receive continued interferon beta-1a in combination with 300 mg of natalizumab (589 patients) or placebo (582 patients) intravenously every 4 weeks for up to 116 weeks. The primary end points were the rate of clinical relapse at 1 year and the cumulative probability of disability progression sustained for 12 weeks, as measured by the Expanded Disability Status Scale, at 2 years. Results Combination therapy resulted in a 24 percent reduction in the relative risk of sustained disability progression (hazard ratio, 0.76; 95 percent confidence interval, 0.61 to 0.96; P=0.02). Kaplan–Meier estimates of the cumulative probability of progression at two years were 23 percent with combination therapy and 29 percent with interferon beta-1a alone. Combination therapy was associated with a lower annualized rate of relapse over a two-year period than was interferon beta-1a alone (0.34 vs. The adhesion molecule α 4β 1 integrin is a key initiator of the inflammatory cascade involved in the pathogenesis of multiple sclerosis. Natalizumab (Tysabri, Biogen Idec and Elan Pharmaceuticals) is the first α 4 integrin antagonist in a new class of selective adhesion-molecule inhibitors for the treatment of multiple sclerosis. Natalizumab binds to α 4 integrin on the surface of leukocytes, inhibiting their migration into the brain and thereby reducing inflammation. Current disease-modifying therapies for relapsing–remitting multiple sclerosis (interferon beta and glatiramer acetate) are only partially effective, and most patients with multiple sclerosis have breakthrough disease activity despite therapy with these agents. Hence, there is a need for additional treatment options in multiple sclerosis. Natalizumab is an attractive therapy to add to current disease-modifying therapies in patients with breakthrough disease because preliminary efficacy and safety data have been favorable and because the mechanism of action of natalizumab may complement those of other disease-modifying therapies. The Safety and Efficacy of Natalizumab in Combination with Interferon Beta-1a in Patients with Relapsing Remitting Multiple Sclerosis (SENTINEL) study was a two-year, phase 3 clinical trial designed to determine whether natalizumab, when added to interferon beta-1a, has efficacy in addition to that associated with interferon beta-1a alone. The trial was also designed to confirm the safety of natalizumab when added to interferon beta-1a. Patients One hundred twenty-four clinical centers in Europe and the United States enrolled 1196 patients beginning on January 14, 2002. All patients gave written informed consent. The study protocol was developed by the investigator advisory committee and the sponsors and was approved by central and local ethics committees, and the study was overseen by an independent safety-monitoring committee. Data were collected by the investigators and an independent organization (PPD International) and were held and analyzed by Biogen Idec and Elan Pharmaceuticals. Youtube downloader extension for google chrome windows 7. During the study, the investigator advisory committee and representatives of Biogen Idec met at least monthly to review and manage the study. The manuscript was written by Drs. Rudick and Panzara, with input from each of the other authors; all the authors vouch for the veracity and completeness of the data and analyses. Eligible patients were 18 to 55 years of age; had a diagnosis of relapsing–remitting multiple sclerosis, a score on the Expanded Disability Status Scale (EDSS) (possible scores range from 0 to 10, with higher scores indicating more severe disease) between 0 and 5.0, and a magnetic resonance imaging (MRI) scan revealing lesions consistent with a diagnosis of multiple sclerosis; had received treatment with interferon beta-1a for at least 12 months before randomization; and had had at least one relapse during the 12-month period before randomization. Patients were ineligible if they had primary progressive, secondary progressive, or progressive relapsing multiple sclerosis; if they had had a relapse within 50 days before randomization; or if they had been treated with an approved disease-modifying therapy other than interferon beta-1a intramuscularly once weekly within the 12-month period before randomization. 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