Calendario›BIIB›Dimethyl Fumarate · TEC-ADHERE
Dimethyl Fumarate · TEC-ADHERE
Dimethyl Fumarate (DMF, Tecfidera®) Persistence in RR-MS Patients Included in the French Patient Support Program OroSEP
Ensayo de BIOGEN INC. en Esclerosis multiple remitente-recurrente.
Más ensayos de: Esclerosis múltiple remitente-recurrente.
- Fase
- no aplica
- Estado
- Completado
- Participantes
- 353
- Centros
- 63
- Fin del objetivo primario
- sep 2022
previstos
fecha real
Qué significa cada fase y cada estado.
Estudio observacional. Comenzó en ago 2019.
Qué mide
Porcentaje de participantes con persistencia del fumarato de dimetilo (DMF) oral a los 6 meses (6 meses)
Cómo lo describe el promotor
En el documentoEn inglés, del registroThe primary objective is to compare oral dimethyl fumarate (DMF) persistence at six months in relapsing-remitting multiple sclerosis (RR-MS) participants initiating DMF with and without OroSEP patient support program (PSP), respectively. The secondary objectives are: to compare oral DMF persistence at one month and three months in RR-MS participants initiating DMF with and without OroSEP PSP, respectively; To compare oral DMF adherence at six months in RR-MS participants initiating DMF with and without OroSEP PSP; To compare at three months and six months the reason of oral DMF discontinuation, in the two groups; To describe the percentage of participants with treatment-related adverse events globally and by class of adverse events, in the two groups of participants; To assess the evolution of participants' anxiety globally and to compare it at inclusion and at six months in participants with and without OroSEP PSP, respectively; To describe participants' satisfaction regarding oral DMF initiation and follow-up globally at six months and to compare it in patients with and without OroSEP PSP, respectively; For OroSEP PSP group: To assess participants' satisfaction regarding their participation in OroSEP PSP at six months; To assess neurologists' satisfaction regarding their participation in OroSEP PSP, after the last participant last visit of center.
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| Litifilimab · TOPAZ-2 | Fase 3 | En marcha, sin reclutar | sep 2026 (prevista, ya pasada: sin actualizar en el registro) |
| Litifilimab · TOPAZ-1 | Fase 3 | En marcha, sin reclutar | sep 2026 (prevista, ya pasada: sin actualizar en el registro) |
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| Natalizumab | no aplica | En marcha, sin reclutar | oct 2026 (prevista) |
Todos los de BIIB, en su ficha.
Ficha completa en ClinicalTrials.gov (NCT04221191), actualizada en jul 2023.