Novel data to inform decision-makers will conduct a head-to-head comparison of effectiveness of two approved disease-modifying therapies (DMTs).
The term effectiveness refers to efficacy in a real life setting: this is intended to be in fact the first pragmatic multi-centre randomised controlled trial to directly assess the effectiveness of the new oral agents approved for MS. Relapsing–remitting MS (RRMS), the type of MS that is the first diagnosis in 80–85% of patients, is characterized by episodes of neurological dysfunction, known as relapses, followed by periods of remission. DMTs form the mainstay of treatment for RRMS.
They aim to reduce the frequency and severity of relapses, extend the time intervals between relapses and slow progression to permanent disability. Primary outcome of the project will be to assess the superiority of one treatment in preserving the status of “no evidence of disease activity” (NEDA).
Consortium: 17 main coordinating centers and several MS patients associations and recruiting centers from 6 countries
Coordinator of the project: Fondazione IRCSS Istituto Neurologico Carlo Besta
Funding programme: PCORI - Patient-Centered Outcomes Research Institute
Project start: 1 November 2016
End date for the project: 1 July 2021
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