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Interferon β-1a · TENERE

A Study Comparing the Effectiveness and Safety of Teriflunomide and Interferon Beta-1a in Patients With Relapsing Multiple Sclerosis

Ensayo de Sanofi en Esclerosis multiple.

Más ensayos de: Esclerosis múltiple.

Fase

Fase 3

Estado

Completado

Participantes

324

previstos

Centros

54

Fin del objetivo primario

sep 2011

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, aleatorizado, simple ciego. Comenzó en abr 2009.

Qué mide

Core Treatment Period: Overview of Failures (Core treatment period between 48 and 118 weeks depending on when the participant was enrolled) (del registro, en inglés)

Cómo lo describe el promotor

En el documentoEn inglés, del registroPrimary objective was to assess the effectiveness evaluated by the time to failure of two doses of teriflunomide in comparison to interferon beta-1a in participants with relapsing Multiple Sclerosis \[MS\]. Secondary objectives were: * To assess the effect of the two doses in comparison to interferon beta-1a on: * Frequency of relapses, * Fatigue, * Participant's satisfaction with treatment. * To evaluate the safety and tolerability of the two doses in comparison to interferon beta-1a. The study consisted of a core treatment period with a common end date defined as 48 weeks after randomization of the last participant, followed by an optional long-term extension treatment period until teriflunomide is commercially available in accordance with local regulations.

Más ensayos de SNY

Todos los de SNY, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT00883337), actualizada en may 2016.