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Teriflunomide · TERACLES
Efficacy and Safety of Teriflunomide in Patients With Relapsing Multiple Sclerosis and Treated With Interferon-beta
Ensayo de Sanofi en Multiple Sclerosis Relapse (del registro, en inglés).
- Fase
- Fase 3
- Estado
- Interrumpido
- Participantes
- 534
- Centros
- 185
- Fin del objetivo primario
- abr 2013
Qué significa cada fase y cada estado.
Estudio de intervención, aleatorizado, triple ciego. Comenzó en ene 2011.
Este ensayo se detuvo. Motivo declarado por el promotor (del registro, en inglés): «Sponsor decision to prematurely stop the study, not linked to any safety concern.».
Qué mide
Annualized Relapse Rate (ARR) (Poisson Regression Estimates) (Up to a maximum of 108 weeks depending on time of enrollment) (del registro, en inglés)
Cómo lo describe el promotor
En el documentoEn inglés, del registroThe primary objective was to demonstrate the effect of teriflunomide, in comparison to placebo, on frequency of Multiple Sclerosis (MS) relapses in patients with relapsing forms of MS who are treated with Interferon-beta (IFN-beta). The secondary objectives were: * Assess the effect of teriflunomide, in comparison to placebo, when added to IFN-beta on: * Disease activity as measured by brain Magnetic Resonance Imaging (MRI) * Disability progression * Burden of disease and disease progression as measured by brain MRI * Evaluate the safety and tolerability of teriflunomide when added to IFN-beta therapy * Assess the pharmacokinetics of teriflunomide in use in addition to baseline IFN-beta therapy * Assess associations between variations in genes and clinical outcomes (safety and efficacy) * Assess other measures of efficacy of teriflunomide such as fatigue and health-related quality of life * Assess measures of health economics (hospitalization due to relapse, including the length of stay and any admission to intensive care unit)
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Ficha completa en ClinicalTrials.gov (NCT01252355), actualizada en may 2014.