Specifically, the Teracles study will evaluate whether once daily oral Teriflunomide 14 or 7mg, in patients treated for at least 6 months on a stable dose of IFN ß prior to randomisation, can reduce the annualised relapse rate (primary endpoint) compared to IFN ß plus oral placebo tablets.
The secondary endpoints of the study are to document the disease activity measured by MRI, the time to disability progression and overall safety.
The Phase II study resultsdemonstrated that Teriflunomide in adjunct with IFN ß improved disease control (evaluated by MRI activity) beyond IFN ß plus oral placebo at one year, with a trend towards fewer clinical relapses and with a consistent safety profile with the data from a Phase II monotherapy study.
Sanofi-aventis Research & Development executive vice president Marc Cluzel said that initiation of the Teracles study is a tremendous milestone as it is the first ever Phase III study of an oral drug in adjunct therapy to be launched in multiple sclerosis.
"We are confident that teriflunomide is an excellent candidate for assessing innovative adjunct therapy in multiple sclerosis considering the positive effect observed when it was used in adjunct with interferon beta in the Phase II study," Cluzel said.