A 12-month double-blind, randomized, multicenter, active controlled, p
A 12-month double-blind, randomized, multicenter, active controlled, parallel-group study comparing the efficacy and safety of 0.5 mg and 1.25 mg fingolimod (FTY720) administered orally once daily versus interferon β-1a (Avonex®) administered i.m. once weekly in patients with relapsing-remitting multiple sclerosis with optional Extension Phase
What it found
We found no results in the registry or in papers.
What was tested
Treatment tested
Compared with
- Interferon beta-1a
Interferon alpha/beta receptor agonist
What it measured
Main measures
The primary endpoint will be the annualized relapse rate (ARR), which is defined as the number of relapses in a year.
Relapses
Who could take part
Relapsing MS
Show the full criteria
Inclusion criteria
Inclusion: General Exclusion: Patients who meet any of the following exclusion criteria during the Pre-Randomization Phase will not be eligible for enrollment in the study:
Exclusion criteria
Not separately supplied in the registry.
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
The primary objective is to compare fingolimod 1.25 mg and 0.5 mg with interferon β-1a and to demonstrate that at least 1.25 mg fingolimod is superior to interferon β-1a in terms of annualized relapse rate for patients with RRMS treated for up to 12 months.
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History
Started
May 2006