Sanofi-Aventis has initiated a Phase III Study of teriflunomide, a novel oral disease modifier for the treatment of relapsing multiple sclerosis (RMS).
The multinational Phase III study is designed to evaluate the safety and efficacy of 7mg and 14mg doses of once daily teriflunomide versus a placebo in patients with RMS treated with interferon beta (IFN beta).
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The study will evaluate if once daily teriflunomide (7mg or 14mg) in patients treated with IFN beta can reduce annualised relapse rate compared to IFN beta plus oral placebo tablets.
The major secondary endpoints of the study are to document the disease activity using MRI, the time to disability progression and overall safety.
The study will be conducted at 240 study sites across 28 countries and will enrol 1455 patients with RMS.
Multiple sclerosis is a chronic, unpredictable and progressively disabling disease which is caused due to damage to myelin.
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