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Primary:
To assess the effectiveness of 2 doses of teriflunomide in
comparison to interferon-beta 1a, evaluated by the time to failure,
with failure being defined as either relapse or permanent study
treatment discontinuation for any cause whichever comes first.
Secondary:
To assess the effect of 2 doses of teriflunomide in comparison to
interferon-beta 1a, on:
• Frequency of relapses
• Fatigue.
• Patient’s satisfaction with treatment
To evaluate the safety and tolerability of 2 doses of teriflunomide in
comparison to interferon-beta 1a.
An optional Pharmacogenomic Teriflunomide Substudy aims at
assessing the association between the main enzyme systems of
teriflunomide metabolism and hepatic safety, and other potential
associations between gene variations and clinical outcomes.
Multi-center, multinational, randomized, parallel-group study.
Study Design:
Conditions of administration of oral teriflunomide versus subcutaneous
interferon-beta-1a will be open-label. The two doses of
teriflunomide will be administered in double-blind fashion. A
physician rater blind to all treatments will be used for rating clinical
scales. The treatment duration is 48 weeks for the last patient
recruited. The treatment period will have a fixed end for all patients
who have not been prematurely discontinued: it will last until all
these patients (not prematurely discontinued) have been treated for
a minimum of 48 weeks.