Clinical Disease Activity With Long Term Natalizumab Treatment
3 de enero de 2019 actualizado por: Biogen
MRI and Clinical Disease Activity in Patients Treated Long Term With Natalizumab
The primary objective of the study is to retrospectively investigate the proportion of participants free of new or enlarging fluid-attenuated inversion recovery (FLAIR) lesions over time in approximately 300 Relapsing-Remitting Multiple Sclerosis (RRMS) participants with regular MRI follow-up, who have received natalizumab ≥24 month from two different observational cohorts: 1) approximately 230 participants from the Czech Republic; and 2) approximately 70 participants from Belgium.
The secondary objectives of this study are as follows: Brain volume change by various measures; Changes in the number and volume of magnetic resonance imaging (MRI) lesions; No evidence of disease activity (NEDA) with and without brain volume change.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
Natalizumab will not be provided to participants by Biogen as a part of this study.
Participants will remain on natalizumab therapy as prescribed by their physician.
Tipo de estudio
De observación
Inscripción (Actual)
277
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años a 65 años (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Método de muestreo
Muestra de probabilidad
Población de estudio
Participants who have been receiving treatment with natalizumab for ≥24 months.
Descripción
Key Inclusion Criteria:
- Diagnosis of RRMS.
- Continuous treatment with natalizumab of ≥24 months. In case of a treatment interruption from natalizumab ≥60 days after a total treatment period of ≥24 months, only the treatment prior to the interruption will be analyzed. Any data after this treatment interruption (even if the patient restarts natalizumab) will not be analyzed/collected.
- ≥1 MRI scan of sufficient quality for reliable measurement.
- Baseline MRI scan ≤6 month prior to natalizumab treatment acquired.
- ≥1 MRI scan of sufficient quality for reliable measurement taken while on natalizumab treatment for ≥6 months.
- EDSS ≤ 6.5.
Key Exclusion Criteria:
- Anti-natalizumab antibody detection.
- Prior treatment with alemtuzumab.
- Prior treatment with mitoxantrone within 12 months of the first infusion of natalizumab.
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
|---|---|
|
Czech Republic
Approximately 230 participants with RRMS receiving commercial natalizumab in Czech Republic
|
Participants with RRMS receiving commercial natalizumab in Belgium and Czech Republic
Otros nombres:
|
|
Belgium
Approximately 70 participants with RRMS receiving commercial natalizumab in Belgium
|
Participants with RRMS receiving commercial natalizumab in Belgium and Czech Republic
Otros nombres:
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change over time in the number of participants free of new or enlarging FLAIR lesions
Periodo de tiempo: Treatment years 3 and 4
|
Lesions that are ≥5 mm per scan (slice thickness 3 mm) as assessed by semiautomatic lesion count (by the Icometrix algorithm).
|
Treatment years 3 and 4
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Annualized brain volume change rate as assessed by % change in brain parenchymal fraction [BPF]
Periodo de tiempo: Post long term treatment with natalizumab (>2 years) through Year 4
|
Post long term treatment with natalizumab (>2 years) through Year 4
|
|
|
Annualized brain volume change rate as assessed by percent brain volume change [PBVC]
Periodo de tiempo: Post long term treatment with natalizumab (>2 years) through Year 4
|
Post long term treatment with natalizumab (>2 years) through Year 4
|
|
|
Annualized brain volume change rate as assessed by white matter [WM] and gray matter [GM] atrophy)
Periodo de tiempo: Post long term treatment with natalizumab (>2 years) through Year 4
|
Post long term treatment with natalizumab (>2 years) through Year 4
|
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|
Cumulative number of new ≥6-month confirmed T1-hypointense lesions
Periodo de tiempo: Post long term treatment with natalizumab (>2 years) through Year 4
|
Post long term treatment with natalizumab (>2 years) through Year 4
|
|
|
Annualized T1-hypointense and FLAIR lesion volume change
Periodo de tiempo: Post long term treatment with natalizumab (>2 years) through Year 4
|
Post long term treatment with natalizumab (>2 years) through Year 4
|
|
|
Cumulative percent change in T1-hypointense and FLAIR lesion volume
Periodo de tiempo: Post long term treatment with natalizumab (>2 years) through Year 4
|
Post long term treatment with natalizumab (>2 years) through Year 4
|
|
|
Cumulative number of ≥6-month-confirmed T1-hypointense lesions arising from new on- treatment Gadolinium (Gd+)-enhancing lesions
Periodo de tiempo: Post long term treatment with natalizumab (>2 years) through Year 4
|
No relapse and no ≥6-month confirmed Expanded Disability Status Scale (EDSS) progression and no new or enlarging FLAIR lesions and no new Gd+-enhancing lesions
|
Post long term treatment with natalizumab (>2 years) through Year 4
|
|
Number of total participants and 4-year completers with NEDA as measured by clinical measures
Periodo de tiempo: Post long term treatment with natalizumab (>2 years) through Year 4
|
No relapse and no ≥6-month confirmed EDSS progression and no new or enlarging FLAIR lesions and no new Gd+-enhancing lesions, brain volume change rate as assessed by PBVC
|
Post long term treatment with natalizumab (>2 years) through Year 4
|
|
Number of total participants and 4-year completers with NEDA as measured by radiological measures
Periodo de tiempo: Post long term treatment with natalizumab (>2 years) through Year 4
|
No new or enlarging FLAIR lesions and no new Gd+-enhancing lesions
|
Post long term treatment with natalizumab (>2 years) through Year 4
|
|
Number of participants with brain volume loss ≤0.2% and ≤0.4%
Periodo de tiempo: Post long term treatment with natalizumab (>2 years) through Year 4
|
Post long term treatment with natalizumab (>2 years) through Year 4
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
31 de diciembre de 2015
Finalización primaria (Actual)
18 de agosto de 2016
Finalización del estudio (Actual)
18 de agosto de 2016
Fechas de registro del estudio
Enviado por primera vez
3 de diciembre de 2015
Primero enviado que cumplió con los criterios de control de calidad
4 de febrero de 2016
Publicado por primera vez (Estimar)
9 de febrero de 2016
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
4 de enero de 2019
Última actualización enviada que cumplió con los criterios de control de calidad
3 de enero de 2019
Última verificación
1 de diciembre de 2018
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Enfermedades del Sistema Nervioso
- Enfermedades del sistema inmunológico
- Enfermedades Autoinmunes Desmielinizantes, SNC
- Enfermedades Autoinmunes del Sistema Nervioso
- Enfermedades desmielinizantes
- Enfermedades autoinmunes
- Esclerosis múltiple
- Esclerosis Múltiple Recurrente-Remitente
- Efectos fisiológicos de las drogas
- Factores inmunológicos
- Natalizumab
Otros números de identificación del estudio
- BEL-TYS-14-10727
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