- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT02881567
Efficacy and Safety of Daclizumab in Participants With RRMS Switching From Natalizumab (SUSTAIN)
25 de septiembre de 2019 actualizado por: Biogen
A Phase 3b, 12-month, Open-label, Multicenter Study to Evaluate the Efficacy and Safety of BIIB019, Daclizumab, in Subjects With Relapsing-Remitting Multiple Sclerosis (RRMS) Switching From Natalizumab (SUSTAIN)
The primary objective of the study is to evaluate the effects of treatment with daclizumab on the proportion of participants relapse-free at 6 months in Relapsing-Remitting Multiple Sclerosis (RRMS) participants, who switched from treatment with natalizumab to daclizumab due to safety concerns.
The secondary objectives of this study in this study population are to evaluate the effects of daclizumab on the following: 1) Multiple Sclerosis (MS) relapse activity including the annualized relapse rate (ARR) and the proportion of participants experiencing relapses requiring hospitalization and/or steroid treatment; 2) MS-related outcomes measured using magnetic resonance imaging (MRI); 3) Safety and tolerability in participants previously treated with natalizumab.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Actual)
41
Fase
- Fase 3
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.
Ubicaciones de estudio
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Hamburg, Alemania, 20249
- Research Site
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Bayern
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Muenchen, Bayern, Alemania, 81675
- Research Site
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Brandenburg
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Potsdam, Brandenburg, Alemania, 14471
- Research Site
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Sachsen
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Dresden, Sachsen, Alemania, 01307
- Research Site
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Alberta
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Edmonton, Alberta, Canadá, T6G 2G3
- Research Site
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Florida
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Tampa, Florida, Estados Unidos, 33612
- Research Site
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Iowa
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Des Moines, Iowa, Estados Unidos, 50314
- Research Site
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Wisconsin
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Milwaukee, Wisconsin, Estados Unidos, 53501
- Research Site
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Napoli, Italia, 80131
- Research Site
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Isernia
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Pozzilli, Isernia, Italia, 86077
- Research Site
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Guaynabo, Puerto Rico, 00968
- Research Site
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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 55 años (Adulto)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Key Inclusion Criteria
- Must have documented diagnosis of RRMS (McDonald 2010 Criteria) at screening [Polman 2011].
- Must have been treated with natalizumab for at least the 12 months prior to screening and have not missed 2 or more consecutive scheduled doses.
- Must be naïve to daclizumab and other forms of daclizumab such as Zenapax® prior to enrollment.
- Must have a confirmed Expanded Disability Status Scale (EDSS) score of 0 to 5.5, inclusive, at screening.
- Female participants of childbearing potential must practice effective contraception from Day -1 and be willing and able to continue contraception for duration of the study.
Key Exclusion Criteria
- Current participation in another investigational study.
- Diagnosis of primary progressive, secondary progressive, or progressive relapsing MS (as defined by Lublin and Reingold) [Lublin 2014].
- Females breastfeeding, pregnant, or planning to become pregnant; or women who have a positive pregnancy test result during screening.
- History of drug or alcohol abuse (as defined by the Investigator) within 1 year prior to screening.
- History of severe hypersensitivity (e.g., anaphylaxis or anaphylactoid reactions) to the active ingredient or any of the excipients.
- History of severe opportunistic infections (including progressive multifocal leukoencephalopathy (PML)) or any clinically significant, cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic (other than MS), dermatologic, psychiatric, and renal, or other major disease, as determined by the Investigator.
- Discontinued natalizumab due to suspicion of PML.
- Known active malignancies (participants with cutaneous basal cell carcinoma that has been completely excised prior to study entry remain eligible).
- The participant is using another MS therapy concomitantly.
- Known history of human immunodeficiency virus (HIV).
- Positive test result for Hepatitis C virus (test for hepatitis C virus antibody [HCV Ab]) or hepatitis B virus (test for hepatitis B surface antigen [HBsAg] and/or hepatitis B core antibody [HBcAb]).
- The participant has been treated with immunosuppressive or immunomodulating treatments including mitoxantrone, azathioprine, methotrexate, cyclophosphamide, or mycophenolate mofetil.
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
- Propósito principal: Tratamiento
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: Daclizumab
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High yield formulation
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Percentage of Participants Relapse-free at Month 6
Periodo de tiempo: Month 6
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Relapses were defined as new or recurrent neurological symptoms not associated with fever or infection, lasting at least 24 hours, and accompanied by new objective neurological findings upon examination by the Examining Neurologist.
The Kaplan-Meier estimate of the percentage of participants relapse-free at Month 6 is reported.
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Month 6
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Percentage of Participants Relapse-free at Month 12
Periodo de tiempo: Month 12
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Relapses were defined as new or recurrent neurological symptoms not associated with fever or infection, lasting at least 24 hours, and accompanied by new objective neurological findings upon examination by the Examining Neurologist.
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Month 12
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Percentage of Participants Experiencing Relapse Requiring Hospitalization and/or Steroid Treatment at Month 12
Periodo de tiempo: Month 12
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Relapses were defined as new or recurrent neurological symptoms not associated with fever or infection, lasting at least 24 hours, and accompanied by new objective neurological findings upon examination by the Examining Neurologist.
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Month 12
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Annualized Relapse Rate (ARR) at Month 12
Periodo de tiempo: Month 12
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Relapses were defined as new or recurrent neurological symptoms not associated with fever or infection, lasting at least 24 hours, and accompanied by new objective neurological findings upon examination by the Examining Neurologist.
The ARR was calculated by tabulating the total number of relapses experienced in the group divided by the number of days up to the end of Month 12, and the ratio then multiplied by 365.
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Month 12
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Number of Participants With New Gadolinium-Enhanced (Gd+) and T1 Hypointense Lesions at Months 6 and 12
Periodo de tiempo: Months 6 and 12
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New Gadolinium-Enhanced (Gd+) and T1 Hypointense Lesions were assessed using magnetic resonance imaging (MRI).
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Months 6 and 12
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Number of Participants With New and Newly Enlarged T2 Hypointense Lesions at Months 6 and 12
Periodo de tiempo: Months 6 and 12
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New and newly enlarged T2 Hypointense Lesions were measured by MRI.
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Months 6 and 12
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Permanent Discontinuation Rate of Daclizumab at Month 12
Periodo de tiempo: Month 12
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Permanent Discontinuation Rate was calculated as the ratio of number of participants who had permanently discontinued daclizumab prior to Month 12 over the total number of participants who received at least 1 dose of daclizumab in the study.
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Month 12
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Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Periodo de tiempo: First dose of study drug to within 30 days of last dose (up to 11 months)
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An AE can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
An SAE is any untoward medical occurrence that at any dose results in death or in the view of the Investigator, places the participant at immediate risk of death or requires inpatient hospitalization or prolongation of existing hospitalization or results in persistent or significant disability or results in a birth defect.
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First dose of study drug to within 30 days of last dose (up to 11 months)
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Number of Participants With Clinically Relevant Shifts in Laboratory Assessments
Periodo de tiempo: First dose of study drug to within 30 days of last dose (up to 11 months)
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Clinical Laboratory assessments were tests of Chemistry and Hematology.
The investigator determined if any of the laboratory results were clinically relevant shifts from Baseline.
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First dose of study drug to within 30 days of last dose (up to 11 months)
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
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)
18 de abril de 2017
Finalización primaria (Actual)
12 de septiembre de 2018
Finalización del estudio (Actual)
12 de septiembre de 2018
Fechas de registro del estudio
Enviado por primera vez
24 de agosto de 2016
Primero enviado que cumplió con los criterios de control de calidad
26 de agosto de 2016
Publicado por primera vez (Estimar)
29 de agosto de 2016
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
27 de septiembre de 2019
Última actualización enviada que cumplió con los criterios de control de calidad
25 de septiembre de 2019
Última verificación
1 de septiembre de 2019
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Procesos Patológicos
- Enfermedades del Sistema Nervioso
- Enfermedades del sistema inmunológico
- Enfermedades Autoinmunes Desmielinizantes, SNC
- Enfermedades Autoinmunes del Sistema Nervioso
- Enfermedades desmielinizantes
- Enfermedades autoinmunes
- Esclerosis múltiple
- Esclerosis
- Esclerosis Múltiple Recurrente-Remitente
- Efectos fisiológicos de las drogas
- Agentes inmunosupresores
- Factores inmunológicos
- Daclizumab
Otros números de identificación del estudio
- 205MS305
- 2016-002820-10 (Número EudraCT)
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Sí
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
producto fabricado y exportado desde los EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
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