SAR153191

Long Term Evaluation of Sarilumab in Rheumatoid Arthritis Patients (SARIL-RA-EXTEND)

Ensayo de Sanofi en Artritis reumatoide.

Fase: Fase 3
Estado: Completado
Participantes: 2.023
Centros: 335
Fin del objetivo primario: dic 2020

Qué significa cada fase y cada estado.

Estudio de intervención, no aleatorizado, abierto. Comenzó en jun 2010.

Qué mide

Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) (From first dose (i.e., Day 1 of study LTS11210) up to 60 days after last dose (maximum duration: up to 523 weeks)) (del registro, en inglés)

Cómo lo describe el promotor

En el documentoEn inglés, del registroMain Study: Primary Objective: Assess the long term safety of sarilumab in participants with rheumatoid arthritis (RA). Secondary Objective: Assess the long term efficacy of sarilumab in participants with RA. Sub-Study: This phase 3, open label sub-study was aimed to assess the usability of PFS-S when used by participants with moderate or severe RA, or their professional or non-professional healthcare providers in an unsupervised real-world situation. To mimic the real-world practice, the sub-study was incorporated into the LTS11210 study without additional visits compared to the scheduled visits in the main study. The duration of this sub-study was 12 weeks.

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Todos los de SNY, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT01146652), actualizada en mar 2022.