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SARILUMAB · SariPRO
Effect of Sarilumab on Patient-reported Outcomes in Patients With Active Rheumatoid Arthritis
Ensayo de Sanofi en Artritis reumatoide.
Más ensayos de: Artritis reumatoide.
- Fase
- Fase 4
- Estado
- Completado
- Participantes
- 84
- Centros
- 33
- Fin del objetivo primario
- jul 2019
previstos
fecha real
Qué significa cada fase y cada estado.
Estudio de intervención, de un solo grupo, abierto. Comenzó en mar 2018.
Qué mide
Change From Baseline in Rheumatoid Arthritis Impact of Disease Total Score at Week 24 (del registro, en inglés) (inicio y semana 24)
Cómo lo describe el promotor
En el documentoEn inglés, del registroPrimary Objective: To assess the effect of sarilumab in combination with conventional synthetic Disease-Modifying Anti-Rheumatic Drug (csDMARD) and/or monotherapy on participant-reported impact of disease, using the rheumatoid arthritis impact of disease (RAID) questionnaire, in participants with moderately to severely active rheumatoid arthritis (RA) and inadequate response or intolerance to current csDMARD or tumor necrosis factor (TNF) inhibitors. Secondary Objectives: * To assess the change of the RAID score from baseline (to Week 4, Week 12, and Week 24) in participants with moderately to severely active RA and inadequate response or intolerance to current csDMARD or TNF inhibitors, treated with sarilumab in combination with csDMARD and/or monotherapy. * To assess the effect of sarilumab in combination with csDMARD and/or monotherapy on other participant-reported outcomes (global assessment of disease activity, disability, morning stiffness, fatigue, anxiety/depression, mood disorders, and physical activities) in participants with moderately to severely active RA and inadequate response or intolerance to current csDMARD or TNF inhibitors. * To assess the efficacy of sarilumab in combination with csDMARD and/or monotherapy using disease activity score-28 for RA with erythrocyte sedimentation rate (DAS28-ESR) and clinical disease activity index in participants with moderately to severely active RA and inadequate response or intolerance to current csDMARD or TNF inhibitors. * To assess the safety of sarilumab in combination with csDMARD and/or monotherapy in participants with moderately to severely active RA and inadequate response or intolerance to current csDMARD or TNF inhibitors.
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Todos los de SNY, en su ficha.
Ficha completa en ClinicalTrials.gov (NCT03449758), actualizada en mar 2022.