Calendario›SNY›Sarilumab SAR153191
Sarilumab SAR153191
Evaluation of Efficacy and Safety of Sarilumab in Patients With GCA
Ensayo de Sanofi en Giant Cell Arteritis (del registro, en inglés).
- Fase
- Fase 3
- Estado
- Interrumpido
- Participantes
- 83
- Centros
- 61
- Fin del objetivo primario
- nov 2020
previstos
fecha real
Qué significa cada fase y cada estado.
Estudio de intervención, aleatorizado, cuádruple ciego. Comenzó en nov 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 Who Achieved Sustained Disease 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 sarilumab in participants with giant cell arteritis (GCA) as assessed by the proportion of participants with sustained remission for sarilumab compared to placebo, in combination with a corticosteroid (CS) tapering course. Secondary Objective: * To demonstrate the efficacy of sarilumab in participants with GCA compared to placebo, in combination with CS taper with regards to: * Clinical responses (such as responses based on 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 GCA. * To measure sarilumab serum concentrations in participants with GCA. * To assess the effect of sarilumab on sparing glucocorticoid toxicity as measured by glucocorticoid toxicity index (GTI).
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 (NCT03600805), actualizada en mar 2022.