Calendario›SNY›Teriflunomide · TOPIC
Teriflunomide · TOPIC
Phase III Study With Teriflunomide Versus Placebo in Patients With First Clinical Symptom of Multiple Sclerosis
Ensayo de Sanofi en Esclerosis multiple.
Más ensayos de: Esclerosis múltiple.
- Fase
- Fase 3
- Estado
- Completado
- Participantes
- 618
- Centros
- 131
- Fin del objetivo primario
- dic 2012
previstos
fecha real
Qué significa cada fase y cada estado.
Estudio de intervención, aleatorizado, doble ciego. Comenzó en feb 2008.
Qué mide
Core Treatment Period: Time to Conversion to Clinically Definite Multiple Sclerosis (CDMS) (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 (HMR1726) (14 milligram per day \[mg/day\] and 7 mg/day), in comparison to placebo, for reducing conversion of participants presenting with their first clinical episode consistent with multiple sclerosis (MS) to clinically definite multiple sclerosis (CDMS). The secondary objectives were: * To demonstrate the effect of teriflunomide, in comparison to placebo, on: * Reducing conversion to definite multiple sclerosis (DMS) * Reducing annualized relapse rate (ARR) * Reducing disease activity/progression as measured by Magnetic Resonance Imaging (MRI) * Reducing accumulation of disability for at least 12 weeks as measured by the Expanded Disability Status Scale (EDSS) * Proportion of disability-free participants as assessed by the EDSS * Reducing participant-reported fatigue * To evaluate the safety and tolerability of teriflunomide * To evaluate the pharmacokinetics (PK) of teriflunomide * Optional pharmacogenomic testing aimed 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
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Todos los de SNY, en su ficha.
Ficha completa en ClinicalTrials.gov (NCT00622700), actualizada en ene 2017.