- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica 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)
Panoramica dello studio
Stato
Condizioni
Tipo di studio
Iscrizione (Anticipato)
Contatti e Sedi
Luoghi di studio
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Alabama
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Birmingham, Alabama, Stati Uniti, 35294
- University of Alabama - Birmingham
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Cullman, Alabama, Stati Uniti, 35058
- Physicians Resource Network
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Arizona
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Phoenix, Arizona, Stati Uniti, 85013
- Barrow Neurological Institute
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California
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Irvine, California, Stati Uniti, 92697
- University of California - Irvine
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San Francisco, California, Stati Uniti, 94117
- University of California San Francisco - MS Center
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Florida
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Tampa, Florida, Stati Uniti, 33609
- Tampa Neurology
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Illinois
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Chicago, Illinois, Stati Uniti, 60611
- Northwestern University
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Chicago, Illinois, Stati Uniti, 60637
- University of Chicago
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Peoria, Illinois, Stati Uniti, 61637
- OSF Saint Francis Medical Center, Illinois Neurological Institute
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Indiana
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Fort Wayne, Indiana, Stati Uniti, 46805
- Fort Wayne Neurological Center
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Iowa
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Des Moines, Iowa, Stati Uniti, 50314
- Mercy Ruan Neurology Clinic
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Kentucky
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Louisville, Kentucky, Stati Uniti, 40202
- Kentucky Neuroscience Research / University Neurologists, P.S.C
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Louisiana
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Shreveport, Louisiana, Stati Uniti, 71130
- Louisiana State University Health Sciences Center
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Michigan
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Ann Arbor, Michigan, Stati Uniti, 48109
- University of Michigan
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Missouri
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St. Louis, Missouri, Stati Uniti, 63110
- Washington University
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St. Louis, Missouri, Stati Uniti, 63110
- BJC Medical Group
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New York
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White Plains, New York, Stati Uniti, 10601
- Family Health Center
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Ohio
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Columbus, Ohio, Stati Uniti, 43221
- The Multiple Sclerosis Center at the Ohio State University
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Pennsylvania
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Pittsburgh, Pennsylvania, Stati Uniti, 15213
- University of Pittsburgh
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Rhode Island
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Providence, Rhode Island, Stati Uniti, 02905
- Brown University / Rhode Island Hospital
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Tennessee
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Knoxville, Tennessee, Stati Uniti, 37922
- The Baptist Hospital of East Tennessee
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Nashville, Tennessee, Stati Uniti, 37212
- Vanderbilt University
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Nashville, Tennessee, Stati Uniti, 37205
- The Advanced Neurosciences Institute
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Texas
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Houston, Texas, Stati Uniti, 77030
- Baylor College of Medicine - The Methodist College Multiple Sclerosis Center
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Houston, Texas, Stati Uniti, 77030
- The University of Texas Houston
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Virginia
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Fairfax, Virginia, Stati Uniti, 22031
- Neurology Center of Fairfax, Ltd.
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Washington
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Seattle, Washington, Stati Uniti, 98195
- University of Washington
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Tacoma, Washington, Stati Uniti, 95405
- Neurology Associates of Tacoma
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Metodo di campionamento
Popolazione di studio
Descrizione
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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
Coorti e interventi
Gruppo / Coorte |
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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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Collaboratori e investigatori
Sponsor
Investigatori
- Direttore dello studio: Thorsten Eickenhorst, MD, Biogen
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 008-05-AVX
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .