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Sarilumab · ALIGN
Dose Ranging Study to Evaluate the Efficacy and Safety of SAR153191 (REGN88) in Patients With Ankylosing Spondylitis
Ensayo de Sanofi en Ankylosing Spondylitis (del registro, en inglés).
- Fase
- Fase 2
- Estado
- Completado
- Participantes
- 301
- Centros
- 80
- Fin del objetivo primario
- jun 2011
previstos
fecha real
Qué significa cada fase y cada estado.
Estudio de intervención, aleatorizado, triple ciego. Comenzó en feb 2010.
Qué mide
Percentage of Participants Who Achieved 20% Response According to the Assessment in Ankylosing Spondylitis (AS) Working Group Criteria for Response (ASAS20) at Week 12 (Baseline to Week 12 (Last Observation Carried Forward [LOCF])) (del registro, en inglés)
Cómo lo describe el promotor
En el documentoEn inglés, del registroPrimary objective: \- to evaluate the efficacy of Sarilumab in participants with Ankylosing Spondylitis (AS) using the assessment in AS working group criteria (ASAS) 20% response criteria (ASAS20) Secondary objectives: * to demonstrate that Sarilumab was effective on: * assessment of higher level of response \[ASAS 40% response criteria (ASAS40)\] * partial remission * disease activity * range of motion * Magnetic Resonance Imaging (MRI) of the spine * to assess the safety and tolerability of Sarilumab in participants with AS as well as the pharmacokinetic profile of Sarilumab in participants with AS
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Todos los de SNY, en su ficha.
Ficha completa en ClinicalTrials.gov (NCT01061723), actualizada en jul 2017.