Longitudinal Pharmacokinetic, Pharmacodynamic, Immunological, and Biochemical
4 de enero de 2012 actualizado por: John F. Foley, MD
Longitudinal Pharmacokinetic, Pharmacodynamic, Immunological, and Biochemical Sample Collection With MRI and Relapse Analysis of a Tysabri Patient Cohort
This is an open-label study of patients with relapsing forms of Multiple Sclerosis designed to assess the longitudinal pharmacokinetic, pharmacodynamic, immunological, and biochemical sample collection with MRI and relapse analysis of a Tysabri patient cohort.
The study hopes to identify secondary and tertiary risk stratification markers that would aid in the clinical management of patients who are JC antibody positive.
Descripción general del estudio
Estado
Terminado
Condiciones
Descripción detallada
Progressive multifocal leukoencephalopathy (PML) has been related to the utilization of Tysabri as a therapeutic agent in the treatment of multiple sclerosis.
The etiologic agent is the human polyomavirus JC.
PML can result from lytic infection of glial cells via a mutant JC virus in multiple sclerosis patients being actively treated with Tysabri.
The mutated JC virus is a neurotrophic virus that infects only humans.
"The regulatory region sequence of the JC virus is hypervariable and contains determinants for neurotropism and neurovirulence."
(Jensen and Major, 2001).
In patients initially infected for the most part in childhood the virus tends to remain quiescent in kidneys, bone marrow and lymphoid tissue.
The true incidence of JC virus seroprevalance is currently being assessed via two Biogen Idec clinical trials (STRATIFY 1 101JC401 and STRATIFY 2 101JC402).
Application has been made to the FDA regarding a label change for Tysabri which will incorporate the use of the JC antibody assay.
Upon FDA approval of the label change, the JC assay will serve as a primary risk stratification tool in the clinical use of Tysabri.
Secondary and tertiary risk stratification markers would greatly aid in the clinical management of patients who are JC antibody positive.
Tipo de estudio
De observación
Inscripción (Actual)
229
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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Utah
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Salt Lake City, Utah, Estados Unidos, 84103
- Rocky Mountain Multiple Sclerosis Clinic
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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 80 años (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Método de muestreo
Muestra no probabilística
Población de estudio
Patients with relapsing forms of MS. Conducted at one site in the US. Subjects currently enrolled in TOUCH Prescribing Program, and participated in Foley 001-001-TY eligible.
Subset of approx. 40 patients to participate in Part B. 11 high risk bivalent patients 11 low risk monovalent patients 9 patients who participated in 2009 PK/PD study (Biogen Idec, 101MS406) 9 patients with infusion cycle of 38 days plus or minus 2 days
Part C "Intracellular energetic in Tysabri therapy":
Patients whose iATP fell into the bottom 20th percentile will be asked to participate in a sub-study that includes Part A with the addition of collecting iATP. This number is approximately 50 participants.
Part D patients from 001-001-TY with low or normal IgG4 levels will be asked to participate in sub-study for an additional IgG4 assay collected at 3-5 days post-infusion. This number is approximately 30 participants.
Descripción
Inclusion Criteria:
- Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information (PHI) in accordance with national and local subject privacy regulations.
- Aged 18 to 80 years old, inclusive, at the time of informed consent.
- Must be a patient with a relapsing form of Multiple Sclerosis enrolled in the TOUCH Prescribing Program who is not expected to discontinue Tysabri® therapy prior to completion of the requirements of this study.
- Must have participated in IIT I (Foley, IIT 1 001-001-TY) in March, April, or May of 2010.
- Must have a magnetic resonance imaging (MRI) brain scan, performed prior to the initiation of treatment with natalizumab, on file.
- Must weigh between 38 and 180 kg, inclusive.
- Up to 40 patients will be asked to also participate in Part B, the PK/PD subset,
- Approximately fifty patients will be asked to also participate in the sub-study Part C. These patients will have been in the bottom 20th percentile for iATP in Foley IIT 1 001-001-TY.
Exclusion Criteria:
- If subject answers 'Yes" to any question on the PML questionnaire that is not resolved prior to infusion as per standard operating procedure for natalizumab infusion.
- If subject consumes alcohol within 24 hours of blood specimen collection.
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 |
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Tysabri (natalizumab) infusing
Patients with relapsing forms of MS who participated in 001-001-TY and are currently still infusing with Tysabri (natalizumab).
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Duration Effect of natalizumab
Periodo de tiempo: 18 months
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Primary: To further understand the duration effect of natalizumab at the biochemical, cellular, and pharmacokinetic levels in natalizumab patients; identify biomarkers which could aid in patient risk modification for (PML).
Assess the stability of natalizumab concentration via pharmacokinetic measurement in ug/ml.
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18 months
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Stability of cell trafficking inhibition
Periodo de tiempo: 18 months
|
Secondary endpoint: Assess the stability of cell trafficking inhibition produced through steady state Natalizumab administration through an infusion cycle.
Cell trafficking is measured via sVCAM, measurement units ng/mL.
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18 months
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: John F Foley, MD, Rocky Mountain MS Research Group, LLC
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 abril de 2011
Finalización primaria (Actual)
1 de agosto de 2011
Finalización del estudio (Actual)
1 de agosto de 2011
Fechas de registro del estudio
Enviado por primera vez
31 de marzo de 2011
Primero enviado que cumplió con los criterios de control de calidad
5 de abril de 2011
Publicado por primera vez (Estimar)
7 de abril de 2011
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
6 de enero de 2012
Última actualización enviada que cumplió con los criterios de control de calidad
4 de enero de 2012
Última verificación
1 de enero de 2012
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 001-002-TY
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. .