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Study which compares the effectiveness and safety of a not yet approved drug called ONO-4641 versus an approved drug called interferon beta 1a (active comparator) in patients with multiple sclerosis. ...

Update Il y a 4 ans
Reference: EUCTR2013-002351-15

Study which compares the effectiveness and safety of a not yet approved drug called ONO-4641 versus an approved drug called interferon beta 1a (active comparator) in patients with multiple sclerosis. The study is double-blind (that is when neither the patient nor the investigator know which of the 2 drugs the patient is receiving). Patients will be randomly assigned (like the flip of a coin) to receive the study drug (two different doses) or the comparator

Woman and Man

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Extract

The primary objective of this trial is to demonstrate the effect of ONO 4641 versus interferon (IFN) ? 1a (Avonex) 30 µg on the proportion of subjects, with relapsing-remitting multiple sclerosis (RRMS), who remain qualifying relapse?free during their participation in the trial when the last evaluable subject completes 1 year. El objetivo principal de este ensayo es demostrar el efecto de ONO-4641 en comparación con interferón (IFN)-?-1a (Avonex) 30 µg sobre la proporción de pacientes con esclerosis múltiple recurrente remitente (EMRR), que continúen sin presentar recaídas aptas durante su participación en el ensayo cuando el último paciente evaluable complete 1 año

Inclusion criteria

  • Relapsing-Remitting Multiple Sclerosis,Esclerosis Múltiple Remitente-Recidivante

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