Prospective, Open-label Tolerability and Safety Monitoring Study of Novantrone in a Selected Cohort of Multiple Sclerosis Patients (RENEW)
21 de octubre de 2013 actualizado por: EMD Serono
The overall objective of this study is to collect data relevant to the tolerability of Novantrone® therapy in patients with multiple sclerosis (MS) using dosing and monitoring recommendations specified in the package insert.
Descripción general del estudio
Estado
Terminado
Condiciones
Descripción detallada
This phase IV, multicenter, prospective, open-label tolerability and safety monitoring study will enroll a select cohort of 500 multiple sclerosis patients receiving commercially available Novantrone®. The patients will be assessed every 3 months during treatment followed by annual assessment for a total of five (5) years.
The select cohort of MS patients enrolled will have secondary (chronic) progressive, progressive relapsing, or worsening relapsing-remitting disease (i.e., patients whose neurological status is significantly abnormal between relapses).
The overall objective of this study is to collect data relevant to the tolerability of Novantrone® therapy in patients with multiple sclerosis (MS) using dosing and monitoring recommendations specified in the package insert.
Tipo de estudio
De observación
Inscripción (Actual)
509
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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Kentucky
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Lexington, Kentucky, Estados Unidos, 40504-3276
- Registrat Inc
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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 65 años (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Método de muestreo
Muestra no probabilística
Población de estudio
Male and female patients with a clinically definite or laboratory supported diagnosis of MS and having secondary (chronic) progressive, progressive relapsing, or worsening relapsing-remitting disease (i.e., patients whose neurologic status is significantly abnormal between relapses).
Patients with primary progressive disease will not be included in this study.
Descripción
Inclusion Criteria:
- To be eligible for inclusion into this study, the subjects must fulfill all of the following criteria:
- Platelet count >100,000 cells/µL
- Granulocyte count > 2000 cells/µL
- Age 18-65 years
- Negative pregnancy test for female patients who are biologically capable of becoming pregnant, even if they are taking birth control
- For patients of reproductive age, agreement to practice effective contraception throughout the study and for 6 months following the last administration of Novantrone®
- Signed Inform Consent.
Exclusion Criteria:
- To be eligible for inclusion in this study the subjects must not meet any of the following criteria:
- Presence of cardiac risk factors:
- History of congestive heart failure
- LVEF < 50% determined by echocardiography or MUGA
- Previous treatment with Novantrone®, other anthracenediones, or anthracyclines
- Prior mediastinal radiotherapy or total lymphoidal irradiation
- AST, ALT, bilirubin > 2x upper limits of normal
- Severe untreated infection (including current urinary tract infection)
- Nursing or pregnant women)
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
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Congestive Heart Failure (Treatment Phase)
Periodo de tiempo: up to 36 months
|
Number of patients experiencing congestive heart failure during the treatment phase of the trial
|
up to 36 months
|
|
Congestive Heart Failure (Annual Follow-Up Phase)
Periodo de tiempo: up to 5 years
|
Number of patients experiencing congestive heart failure during the annual follow-up phase of the trial
|
up to 5 years
|
|
Left Ventricular Ejection Fraction (Treatment Phase)
Periodo de tiempo: up to 36 months
|
Number of patients with left ventricular ejection fraction test results that decreased below 50% during the treatment phase of the trial
|
up to 36 months
|
|
Left Ventricular Ejection Fraction (Annual Follow-Up Phase)
Periodo de tiempo: up to 5 years
|
Number of patients with left ventricular ejection fraction test results that decreased below 50% during the annual follow-up phase of the trial
|
up to 5 years
|
|
Serious Infections (Treatment Phase)
Periodo de tiempo: up to 36 months
|
Number of serious infections during the treatment phase of the trial
|
up to 36 months
|
|
Serious Infections (Annual Follow-Up Phase)
Periodo de tiempo: up to 5 years
|
Number of serious infections during the annual follow-up phase of the trial
|
up to 5 years
|
|
IV Antibiotics (Individual Drugs Unspecified) Utilized Due to Serious Infection (Treatment Phase)
Periodo de tiempo: up to 36 months
|
Number of subjects in whom IV antibiotics were utilized due to serious infection during the treatment phase
|
up to 36 months
|
|
IV Antibiotics (Individual Drugs Unspecified) Utilized Due To Serious Infection (Annual Follow-Up Phase)
Periodo de tiempo: up to 5 years
|
Number of subjects in whom IV antibiotics were utilized due to serious infection during the annual follow-up phase
|
up to 5 years
|
|
Severe Neutropenia (Treatment Phase)
Periodo de tiempo: up to 36 months
|
Number of infections associated with severe neutropenia at onset during the treatment phase
|
up to 36 months
|
|
Severe Neutropenia (Annual Follow-Up Phase)
Periodo de tiempo: up to 5 years
|
Number of infections associated with severe neutropenia at onset during the annual follow-up phase
|
up to 5 years
|
|
Clinical Relapses (Treatment Phase)
Periodo de tiempo: up to 36 months
|
Number of clinical relapses reported during the treatment phase of the trial
|
up to 36 months
|
|
Clinical Relapses (Annual Follow-Up Phase)
Periodo de tiempo: up to 5 years
|
Number of clinical relapses reported during the annual follow-up phase of the trial
|
up to 5 years
|
|
Symptomatic CHF, Left Ventricular Ejection Fraction - Prior to Each Dose • Serious Infections, IV Antibiotics, or Assoc w/ Severe Neutropenia-evaluated. Novantrone Admin - Per PI • SAE, Clinical Relapses
Periodo de tiempo: up to 5 years
|
Outcomes are presented separately above apart from adverse events which are presented in the adverse event section
|
up to 5 years
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Director de estudio: Randy Bennett, EMD Serono
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
1 de octubre de 2000
Finalización primaria (Actual)
1 de enero de 2008
Finalización del estudio (Actual)
1 de septiembre de 2008
Fechas de registro del estudio
Enviado por primera vez
5 de diciembre de 2005
Primero enviado que cumplió con los criterios de control de calidad
5 de diciembre de 2005
Publicado por primera vez (Estimar)
6 de diciembre de 2005
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
14 de noviembre de 2013
Última actualización enviada que cumplió con los criterios de control de calidad
21 de octubre de 2013
Última verificación
1 de octubre de 2013
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 24293
- 19-297
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. .