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natalizumab · STRIVE

Observational Study of Tysabri in Early Relapsing-Remitting Multiple Sclerosis in Anti-JC Virus Antibody Negative Participants

Ensayo de BIOGEN INC. en Esclerosis multiple remitente-recurrente.

Más ensayos de: Esclerosis múltiple remitente-recurrente.

Fase

no aplica

Estado

Completado

Participantes

231

previstos

Centros

44

Fin del objetivo primario

nov 2018

fecha real

Qué significa cada fase y cada estado.

Estudio observacional. Comenzó en feb 2012.

Qué mide

Proportion of Participants who are overall disease activity-free at Months 12 and 24 (Baseline and Months 12 and 24) (del registro, en inglés)

Cómo lo describe el promotor

En el documentoEn inglés, del registroThe primary objective of the study is to determine which baseline and yearly response factors (clinical and para clinical) predict overall disease-free status at Month 12 and Month 24, and clinical disease-free status in subsequent Months 36 and 48. The secondary objectives are: To identify prognostic factors at Baseline that predict overall disease-free status at Month 12, and to assess if yearly overall disease-free response factors predict overall disease-free status at Month 24; To evaluate clinical disease-free status (relapse, Expanded Disability Status Scale \[EDSS\]) at each analysis time point of Months 12, 24, 36, and 48; To identify prognostic factors at Baseline that predict clinical disease-free status at Month 12, and to assess yearly clinical disease-free response factors that predict clinical disease-free status (relapse, EDSS) in subsequent years at Months 24, 36, and 48; To evaluate the impact of Tysabri at each analysis time point of Months 12, 24, 36, and 48 on the following: annualized relapse rate (ARR), sustained EDSS progression and improvement (24-week sustained); To evaluate the impact of Tysabri at each analysis time point of Months 12, 24, 36, and 48 on the following: magnetic resonance image (MRI) measures: T2, T1, T1 with Gadolinium (Gd), brain atrophy; To evaluate the impact of Tysabri at Month 24 and Month 48 on the following: optical coherence tomography (OCT), Low and High Contrast Visual Acuity Assessment; To evaluate the impact of Tysabri at each analysis time point of Months 12, 24, 36, and 48 on the following: cognitive impairment (Symbol Digit Modalities Test \[SDMT\]), capacity for work (Work Productivity and Activity Impairment Questionnaire \[WPAI\]), quality of life (QoL) (Multiple Sclerosis Impact Scale \[MSIS-29\])

Más ensayos de BIIB

Todos los de BIIB, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT01485003), actualizada en feb 2019.