REbif FLEXible Dosing in Early Multiple Sclerosis (MS)
Status:
Completed
Trial end date:
2011-07-01
Target enrollment:
Participant gender:
Summary
The study is a 24 months randomized, double-blind, Placebo-controlled, multi-center clinical
trial with an optional 12 months open label extension.
The primary objective of the study is to evaluate the effect of fetal bovine serum
[FBS]-free/human serum albumin [HSA]-free formulation of Interferon [IFN] beta-1a (RNF) 44
microgram (three times weekly and once weekly) versus placebo on the time to conversion to
McDonald multiple sclerosis (MS) criteria (2005) in subjects with a first clinical
demyelinating event at high risk of converting to MS.
The main secondary objective of study is to evaluate the effect of RNF 44 microgram (three
times weekly and once weekly) versus placebo on the "Time to conversion to clinically
definite MS (CDMS)" in subjects with a first clinical demyelinating event at high risk of
converting to MS.
At the end of 24 month double-blind core REFLEX trial, subjects who will not convert to CDMS
and decide to receive open-label (OL) treatment will be enrolled into an open-label, 12 month
extension period to evaluate the effect of RNF 44 mcg three times weekly treatment on the
time to conversion to McDonald MS and time to conversion to CDMS.