Calendario›SNY›Sarilumab

Sarilumab

To Evaluate The Effect Of SAR153191 (REGN88) Added To Other RA Drugs In Patients With RA Who Are Not Responding To Or Intolerant Of Anti-TNF Therapy (SARIL-RA-TARGET)

Ensayo de Sanofi en Artritis reumatoide.

Más ensayos de: Artritis reumatoide.

Fase

Fase 3

Estado

Completado

Participantes

546

previstos

Centros

196

Fin del objetivo primario

mar 2015

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, aleatorizado, cuádruple ciego. Comenzó en oct 2012.

Qué mide

Percentage of Participants Who Achieved at Least 20% Improvement in the American College of Rheumatology (ACR20) Criteria at Week 24 (del registro, en inglés) (semana 24)

Cómo lo describe el promotor

En el documentoEn inglés, del registroPrimary Objective: To demonstrate that sarilumab added to disease modifying anti-rheumatic drugs (DMARDs) were effective for: * reduction of signs and symptoms at Week 24 and * improvement of physical function at Week 12 in participants with active rheumatoid arthritis (RA) who were inadequate responders or intolerant to tumor necrosis factor alpha (TNF-α) antagonists. Secondary Objectives: The secondary objectives were to investigate the effects of SAR153191 (REGN88) when added to DMARD therapy, in participants with active RA who were inadequate responders or intolerant to TNF-α antagonists, for: * Reduction of signs and symptoms at Week 12; * Improvement in physical function at Week 24; * Improvement in disease activity score as measured by other American College of Rheumatology (ACR) derived components at Weeks 12 and 24; * Improvement in quality of life as measured by participant reported outcomes (PROs) at intermediate visits and Week 24. To assess the exposure of sarilumab added to DMARD therapy in this population. To assess the safety of sarilumab in this population.

Más ensayos de SNY

Todos los de SNY, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT01709578), actualizada en jul 2017.