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Sarilumab · RA-MOBILITY

Evaluation of Sarilumab (SAR153191/REGN88) on Top of Methotrexate in Rheumatoid Arthritis Patients

Ensayo de Sanofi en Artritis reumatoide.

Más ensayos de: Artritis reumatoide.

Fase

Fase 2/3

Estado

Completado

Participantes

1.675

previstos

Centros

262

Fin del objetivo primario

oct 2013

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, aleatorizado, triple ciego. Comenzó en mar 2010.

Qué mide

Part A: Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Week 12 (del registro, en inglés) (del inicio a la semana 12)

Cómo lo describe el promotor

En el documentoEn inglés, del registroPrimary Objectives: Part A (dose ranging study): To demonstrate that sarilumab (SAR153191/REGN88) on top of MTX was effective on reduction of signs and symptoms of rheumatoid arthritis at 12 weeks. Part B (pivotal study): To demonstrate that sarilumab added to MTX was effective in: * reduction of signs and symptoms of rheumatoid arthritis at 24 weeks * inhibition of progression of structural damage at 52 weeks * improvement in physical function at 16 weeks Secondary Objectives: Part B: To demonstrate that sarilumab added to MTX was effective in induction of a major clinical response at 52 weeks To assess the safety of sarilumab added to MTX To document the pharmacokinetic profile of sarilumab added to MTX in participants with active rheumatoid arthritis who were inadequate responders to MTX therapy.

Más ensayos de SNY

Todos los de SNY, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT01061736), actualizada en jun 2017.