Calendario›SNY›Sarilumab SAR153191
Sarilumab SAR153191
Evaluation of the Efficacy and Safety of Sarilumab in Patients With Polymyalgia Rheumatica
Ensayo de Sanofi en Polymyalgia Rheumatica (del registro, en inglés).
- Fase
- Fase 3
- Estado
- Interrumpido
- Participantes
- 118
- Centros
- 84
- Fin del objetivo primario
- may 2021
previstos
fecha real
Qué significa cada fase y cada estado.
Estudio de intervención, aleatorizado, cuádruple ciego. Comenzó en oct 2018.
Este ensayo se detuvo. Motivo declarado por el promotor (del registro, en inglés): «Protracted recruitment timeline exacerbated by COVID-19 pandemic».
Qué mide
Percentage of Participants Achieving Sustained Remission at Week 52 (del registro, en inglés) (en la semana 52)
Cómo lo describe el promotor
En el documentoEn inglés, del registroPrimary Objective: To evaluate the efficacy of KEVZARA (sarilumab) in participants with polymyalgia rheumatica (PMR) as assessed by the proportion of participants with sustained remission for sarilumab with a shorter corticosteroid (CS) tapering regimen as compared to placebo with a longer CS tapering regimen. Secondary Objectives: * To demonstrate the efficacy of sarilumab in participants with PMR compared to placebo, in combination with a CS taper with regards to: * Clinical responses (such as components of sustained remission, disease remission rates, time to first disease flare) over time. * Cumulative CS (including prednisone) exposure. * To assess the safety (including immunogenicity) and tolerability of sarilumab in participants with PMR. * To measure sarilumab serum concentrations in participants with PMR. * To assess the effect of sarilumab in reducing glucocorticoid toxicity as measured by the composite glucocorticoid toxicity index (GTI) questionnaire.
Más ensayos de SNY
| Ensayo | Fase | Estado | Lectura de resultados |
|---|---|---|---|
| Avalglucosidase alfa · Mini-COMET | Fase 2 | En marcha, sin reclutar | sep 2019 (real) |
| Yellow fever vaccine | Fase 2 | En marcha, sin reclutar | may 2022 (real) |
| Yellow fever vaccine · VYF02 | Fase 2 | En marcha, sin reclutar | jun 2022 (real) |
| SAR441344 IV | Fase 2 | En marcha, sin reclutar | sep 2022 (real) |
| Meningococcal Polysaccharide | Fase 3 | En marcha, sin reclutar | mar 2023 (real) |
| Isatuximab IV · IRAKLIA | Fase 3 | En marcha, sin reclutar | nov 2024 (real) |
Todos los de SNY, en su ficha.
Ficha completa en ClinicalTrials.gov (NCT03600818), actualizada en may 2022.