- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00288990
A Serologic Study to Correlate Beta-IFN NAb Titers to Beta-IFN Induced Biomarker Response in Patients With Multiple Sclerosis
Impact of Neutralizing Antibodies on Interferon Responsive Genes Highlights Biomarker Response.
Study Title: A Serologic Study to Correlate b-IFN NAb titers to b-IFN Induced Biomarker Response in Patients with Multiple Sclerosis
Objectives: Subjects currently on any of the three b-IFN preparations (Avonex (Interferon b-1a 30 mcg IM Q 7 days), Rebif (Interferon b-1a 22 or 44mcg SC TIW), or Betaseron (Interferon b-1b 250mcg SC QOD)) will be enrolled to one of 3 groups:
Group 1: Approximately 200 subjects will be enrolled who are NAb+ (titer ³ 20NU/ml) Group 2: Approximately 50 subjects will be enrolled who are BAb- (titer <8U) and NAb- (titer <20 NU/ml) Group 3: Approximately 50 subjects will be enrolled who are BAb+ (titer ³8U) and NAb- (titer <20 NU/ml)
The primary objective of this study is to compare baseline b-IFN induced MxA mRNA response in neutralizing antibody positive (NAb+, titers ³ 20NU/ml, Group 1) vs. antibody negative (NAb-, titers < 20NU/ml, BAb-, titers <8U, Group 2) patients.
Secondary objectives are:
- To compare b-IFN induced MxA mRNA response in neutralizing antibody positive (NAb+, titers ³ 20NU/ml, Group 1) vs. antibody negative (NAb-, titers < 20NU/ml, BAb-, titers <8U, Group 2) patients at the month 6 visit.
- To compare b-IFN induced biomarker response (viperin, IFIT1) in neutralizing antibody positive (NAb+, titers ³ 20NU/ml, Group 1) vs. antibody negative (NAb-, titers < 20NU/ml, BAb-, titers <8U, Group 2) patients (data compared at baseline and month 6 visits)
- To compare b-IFN induced biomarker response (MxA, viperin, IFIT1) in neutralizing antibody positive (NAb+, titers ³ 20NU/ml, Group 1) vs. BAb+ (titers ³8U)/NAb- (titers <20 NU/ml, Group 3) patients at baseline and month 6 visits.
- To correlate NAb titer levels with b-IFN induced biomarker response (data taken from baseline and month 6 visits from Group 1).
- To compare b-IFN induced biomarker response (MxA, viperin, IFIT1) in BAb-/NAb- patients (Group 2) vs. BAb +/NAb- patients (Group 3) in order to determine if BAbs affect b-IFN induced biomarker response (data compared at baseline and month 6 visits).
Tertiary objectives are:
1. To explore patient characteristics that may predict NAb positivity.
Design: This is a multi-center, open-label study of approximately 300 (200 NAb+ and 100 NAb- (50 BAb+ and 50 BAb-)) MS patients that will compare b-IFN induced biomarker response following b-IFN injection in neutralizing antibody positive vs. antibody negative patients.
Study Population: Approximately 300 subjects (200 in Group 1, 50 in Group 2, and 50 in Group 3) will be recruited for the study.
Inclusion Criteria: To be eligible for entry into this study, candidates must meet all of the following eligibility criteria at the time of randomization:
- Patients (male or female) diagnosed with relapsing forms of MS.
- Currently being treated with the same b-IFN (in accordance with FDA approved dosing and schedules) for 12 to 48 months inclusive.
- All levels of disability
- Age 18-65 years inclusive
- Subjects must be willing to be followed for the 6-month study period.
Exclusion Criteria: Candidates will be excluded from study entry if any of the following exclusion criteria exist at the time of study initiation.
- Patients with prior b-IFN NAb test (whether positive or negative).
- Patients who are currently being treated or have been treated within 6 months prior to screening with combination therapy (b-IFN plus any other immunosuppressant/immunomodulatory) other than IV steroids (either pulse or for a relapse).
- Unwillingness or inability to comply with the requirements of this protocol including the presence of any condition (physical, mental, or social) that is likely to affect the subject's ability to comply with the study protocol.
- Any other reasons that, in the opinion of the Investigator, the subject is determined to be unsuitable for enrollment into this study.
Treatment Groups: This is a multi-center, open-label study of approximately 300 (200 NAb+ patients and 100 NAb- patients (50 BAb+ and 50 BAb-)) relapsing MS patients that will compare b-IFN induced biomarker response following b-IFN injection in neutralizing antibody positive vs. antibody negative patients.
Subjects currently on any of the three b-IFN preparations (Avonex (Interferon b-1a 30 mcg IM Q 7 days), Rebif (Interferon b-1a 22 or 44mcg SC TIW), or Betaseron (Interferon b-1b 250mcg SC QOD)) will be enrolled to one of 3 groups:
Group 1: Approximately 200 subjects will be enrolled who are NAb+ (titer ³ 20NU/ml)
Group 2: Approximately 50 subjects will be enrolled who are BAb- (titer <8U) and NAb- (titer <20 NU/ml)
Group 3: Approximately 50 subjects will be enrolled who are BAb+ (titer ³8U) and NAb- (titer <20 NU/ml)
Descripción general del estudio
Estado
Condiciones
Tipo de estudio
Inscripción (Anticipado)
Contactos y Ubicaciones
Ubicaciones de estudio
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Alabama
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Birmingham, Alabama, Estados Unidos, 35294
- University of Alabama - Birmingham
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Cullman, Alabama, Estados Unidos, 35058
- Physicians Resource Network
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Arizona
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Phoenix, Arizona, Estados Unidos, 85013
- Barrow Neurological Institute
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California
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Irvine, California, Estados Unidos, 92697
- University of California - Irvine
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San Francisco, California, Estados Unidos, 94117
- University of California San Francisco - MS Center
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Florida
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Tampa, Florida, Estados Unidos, 33609
- Tampa Neurology
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Illinois
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Chicago, Illinois, Estados Unidos, 60611
- Northwestern University
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Chicago, Illinois, Estados Unidos, 60637
- University of Chicago
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Peoria, Illinois, Estados Unidos, 61637
- OSF Saint Francis Medical Center, Illinois Neurological Institute
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Indiana
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Fort Wayne, Indiana, Estados Unidos, 46805
- Fort Wayne Neurological Center
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Iowa
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Des Moines, Iowa, Estados Unidos, 50314
- Mercy Ruan Neurology Clinic
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Kentucky
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Louisville, Kentucky, Estados Unidos, 40202
- Kentucky Neuroscience Research / University Neurologists, P.S.C
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Louisiana
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Shreveport, Louisiana, Estados Unidos, 71130
- Louisiana State University Health Sciences Center
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Michigan
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Ann Arbor, Michigan, Estados Unidos, 48109
- University of Michigan
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Missouri
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St. Louis, Missouri, Estados Unidos, 63110
- Washington University
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St. Louis, Missouri, Estados Unidos, 63110
- BJC Medical Group
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New York
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White Plains, New York, Estados Unidos, 10601
- Family Health Center
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Ohio
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Columbus, Ohio, Estados Unidos, 43221
- The Multiple Sclerosis Center at the Ohio State University
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Pennsylvania
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Pittsburgh, Pennsylvania, Estados Unidos, 15213
- University of Pittsburgh
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Rhode Island
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Providence, Rhode Island, Estados Unidos, 02905
- Brown University / Rhode Island Hospital
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Tennessee
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Knoxville, Tennessee, Estados Unidos, 37922
- The Baptist Hospital of East Tennessee
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Nashville, Tennessee, Estados Unidos, 37212
- Vanderbilt University
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Nashville, Tennessee, Estados Unidos, 37205
- The Advanced Neurosciences Institute
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Texas
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Houston, Texas, Estados Unidos, 77030
- Baylor College of Medicine - The Methodist College Multiple Sclerosis Center
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Houston, Texas, Estados Unidos, 77030
- The University of Texas Houston
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Virginia
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Fairfax, Virginia, Estados Unidos, 22031
- Neurology Center of Fairfax, Ltd.
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Washington
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Seattle, Washington, Estados Unidos, 98195
- University of Washington
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Tacoma, Washington, Estados Unidos, 95405
- Neurology Associates of Tacoma
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Descripción
Inclusion Criteria:
- Patients (male or female) diagnosed with relapsing forms of MS.
- Currently being treated with the same b-IFN (in accordance with FDA approved dosing and schedules) for 12 to 48 months inclusive.
- All levels of disability
- Age 18-65 years inclusive
- Subjects must be willing to be followed for the 6-month study period.
Exclusion Criteria:
- Patients with prior b-IFN NAb test (whether positive or negative).
- Patients who are currently being treated or have been treated within 6 months prior to screening with combination therapy (b-IFN plus any other immunosuppressant/immunomodulatory) other than IV steroids (either pulse or for a relapse).
- Unwillingness or inability to comply with the requirements of this protocol including the presence of any condition (physical, mental, or social) that is likely to affect the subject's ability to comply with the study protocol.
- Any other reasons that, in the opinion of the Investigator, the subject is determined to be unsuitable for enrollment into this study.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
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1
subjects who are NAb positive
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2
Subjects who are antibody negative
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3
subjects who are BAb positive
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Director de estudio: Thorsten Eickenhorst, MD, Biogen
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 008-05-AVX
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. .