Fingolimod Versus Dimethyl-fumarate in Multiple Sclerosis
Status:
Terminated
Trial end date:
2019-10-30
Target enrollment:
Participant gender:
Summary
This will be a 1:1 randomized open label trial. European and outside Europe centres will be
involved. Aim of the project is to conduct a head-to-head comparison of effectiveness of two
approved disease modifying treatments (DMTs) in patients with relapsing remitting multiple
sclerosis (RRMS). 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 (fingolimod/FTY
versus dimethyl-fumarate/DMF) on disease activity, disability progression, quality of life,
functioning and symptoms. It will be a randomized trial taking place in clinical care setting
and comparing existing therapies, any of which may constitute standard care for naive
patients or sub optimal responders to first-line drugs. Post hoc analysis will also identify
the better treatment strategy on the different patient subgroups. Patient overall disease
experience will be considered for the first time as the most important outcome. In fact, in
addition to classical "no evidence of disease activity" (NEDA), a new composite NEDA taking
account also of patient point of view and quality of life, will be proposed. Finally,the
specific effectiveness profile of the two DMTs will be addressed, by exploring comparative
benefits on different outcomes (disease activity, disability progression, brain atrophy,
quality of life, fatigue, psychiatric and cognitive symptoms, medication satisfaction).
Phase:
Phase 4
Details
Lead Sponsor:
Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
Collaborators:
Patient-Centered Outcomes Research Institute Universita degli Studi di Genova