- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg 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)
Studieoversigt
Status
Betingelser
Undersøgelsestype
Tilmelding (Forventet)
Kontakter og lokationer
Studiesteder
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Alabama
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Birmingham, Alabama, Forenede Stater, 35294
- University of Alabama - Birmingham
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Cullman, Alabama, Forenede Stater, 35058
- Physicians Resource Network
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Arizona
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Phoenix, Arizona, Forenede Stater, 85013
- Barrow Neurological Institute
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California
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Irvine, California, Forenede Stater, 92697
- University of California - Irvine
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San Francisco, California, Forenede Stater, 94117
- University of California San Francisco - MS Center
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Florida
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Tampa, Florida, Forenede Stater, 33609
- Tampa Neurology
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Illinois
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Chicago, Illinois, Forenede Stater, 60611
- Northwestern University
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Chicago, Illinois, Forenede Stater, 60637
- University of Chicago
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Peoria, Illinois, Forenede Stater, 61637
- OSF Saint Francis Medical Center, Illinois Neurological Institute
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Indiana
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Fort Wayne, Indiana, Forenede Stater, 46805
- Fort Wayne Neurological Center
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Iowa
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Des Moines, Iowa, Forenede Stater, 50314
- Mercy Ruan Neurology Clinic
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Kentucky
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Louisville, Kentucky, Forenede Stater, 40202
- Kentucky Neuroscience Research / University Neurologists, P.S.C
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Louisiana
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Shreveport, Louisiana, Forenede Stater, 71130
- Louisiana State University Health Sciences Center
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Michigan
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Ann Arbor, Michigan, Forenede Stater, 48109
- University of Michigan
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Missouri
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St. Louis, Missouri, Forenede Stater, 63110
- Washington University
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St. Louis, Missouri, Forenede Stater, 63110
- BJC Medical Group
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New York
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White Plains, New York, Forenede Stater, 10601
- Family Health Center
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Ohio
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Columbus, Ohio, Forenede Stater, 43221
- The Multiple Sclerosis Center at the Ohio State University
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Pennsylvania
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Pittsburgh, Pennsylvania, Forenede Stater, 15213
- University of Pittsburgh
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Rhode Island
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Providence, Rhode Island, Forenede Stater, 02905
- Brown University / Rhode Island Hospital
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Tennessee
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Knoxville, Tennessee, Forenede Stater, 37922
- The Baptist Hospital of East Tennessee
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Nashville, Tennessee, Forenede Stater, 37212
- Vanderbilt University
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Nashville, Tennessee, Forenede Stater, 37205
- The Advanced Neurosciences Institute
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Texas
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Houston, Texas, Forenede Stater, 77030
- Baylor College of Medicine - The Methodist College Multiple Sclerosis Center
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Houston, Texas, Forenede Stater, 77030
- The University of Texas Houston
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Virginia
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Fairfax, Virginia, Forenede Stater, 22031
- Neurology Center of Fairfax, Ltd.
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Washington
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Seattle, Washington, Forenede Stater, 98195
- University of Washington
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Tacoma, Washington, Forenede Stater, 95405
- Neurology Associates of Tacoma
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
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.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
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1
subjects who are NAb positive
|
2
Subjects who are antibody negative
|
3
subjects who are BAb positive
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Studieleder: Thorsten Eickenhorst, MD, Biogen
Datoer for undersøgelser
Studer store datoer
Studiestart
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 008-05-AVX
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Kliniske forsøg med Multipel sclerose
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City of Hope Medical CenterNational Cancer Institute (NCI)Aktiv, ikke rekrutterendeKlassisk Hodgkin lymfom | Lymfocytrigt klassisk Hodgkin-lymfom | Ann Arbor Stage IB Hodgkin lymfom | Ann Arbor Stage II Hodgkin lymfom | Ann Arbor Stage IIA Hodgkin lymfom | Ann Arbor Stage IIB Hodgkin lymfom | Ann Arbor Stage I Hodgkin lymfom | Ann Arbor Stage I Mixed Cellularity Klassisk Hodgkin-lymfom og andre forholdForenede Stater