Ignite Creation Date:
2024-05-05 @ 4:38 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00288990
Status:
COMPLETED
Last Update Posted:
2007-12-24
First Post:
2006-02-08
Brief Title:
A Serologic Study to Correlate Beta-IFN NAb Titers to Beta-IFN Induced Biomarker Response in Patients With Multiple Sclerosis
Sponsor:
Biogen
Organization:
Biogen
Study Overview
Official Title:
Impact of Neutralizing Antibodies on Interferon Responsive Genes Highlights Biomarker Response
Status:
COMPLETED
Status Verified Date:
2007-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 20NUml Group 2 Approximately 50 subjects will be enrolled who are BAb- titer 8U and NAb- titer 20 NUml Group 3 Approximately 50 subjects will be enrolled who are BAb titer ³8U and NAb- titer 20 NUml
The primary objective of this study is to compare baseline b-IFN induced MxA mRNA response in neutralizing antibody positive NAb titers ³ 20NUml Group 1 vs antibody negative NAb- titers 20NUml BAb- titers 8U Group 2 patients
Secondary objectives are
1 To compare b-IFN induced MxA mRNA response in neutralizing antibody positive NAb titers ³ 20NUml Group 1 vs antibody negative NAb- titers 20NUml BAb- titers 8U Group 2 patients at the month 6 visit
2 To compare b-IFN induced biomarker response viperin IFIT1 in neutralizing antibody positive NAb titers ³ 20NUml Group 1 vs antibody negative NAb- titers 20NUml BAb- titers 8U Group 2 patients data compared at baseline and month 6 visits
3 To compare b-IFN induced biomarker response MxA viperin IFIT1 in neutralizing antibody positive NAb titers ³ 20NUml Group 1 vs BAb titers ³8UNAb- titers 20 NUml Group 3 patients at baseline and month 6 visits
4 To correlate NAb titer levels with b-IFN induced biomarker response data taken from baseline and month 6 visits from Group 1
5 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
1 Patients male or female diagnosed with relapsing forms of MS
2 Currently being treated with the same b-IFN in accordance with FDA approved dosing and schedules for 12 to 48 months inclusive
3 All levels of disability
4 Age 18-65 years inclusive
5 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
1 Patients with prior b-IFN NAb test whether positive or negative
2 Patients who are currently being treated or have been treated within 6 months prior to screening with combination therapy b-IFN plus any other immunosuppressantimmunomodulatory other than IV steroids either pulse or for a relapse
3 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 subjects ability to comply with the study protocol
4 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 20NUml
Group 2 Approximately 50 subjects will be enrolled who are BAb- titer 8U and NAb- titer 20 NUml
Group 3 Approximately 50 subjects will be enrolled who are BAb titer ³8U and NAb- titer 20 NUml
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 20NUml Group 2 Approximately 50 subjects will be enrolled who are BAb- titer 8U and NAb- titer 20 NUml Group 3 Approximately 50 subjects will be enrolled who are BAb titer ³8U and NAb- titer 20 NUml
The primary objective of this study is to compare baseline b-IFN induced MxA mRNA response in neutralizing antibody positive NAb titers ³ 20NUml Group 1 vs antibody negative NAb- titers 20NUml BAb- titers 8U Group 2 patients
Secondary objectives are
1 To compare b-IFN induced MxA mRNA response in neutralizing antibody positive NAb titers ³ 20NUml Group 1 vs antibody negative NAb- titers 20NUml BAb- titers 8U Group 2 patients at the month 6 visit
2 To compare b-IFN induced biomarker response viperin IFIT1 in neutralizing antibody positive NAb titers ³ 20NUml Group 1 vs antibody negative NAb- titers 20NUml BAb- titers 8U Group 2 patients data compared at baseline and month 6 visits
3 To compare b-IFN induced biomarker response MxA viperin IFIT1 in neutralizing antibody positive NAb titers ³ 20NUml Group 1 vs BAb titers ³8UNAb- titers 20 NUml Group 3 patients at baseline and month 6 visits
4 To correlate NAb titer levels with b-IFN induced biomarker response data taken from baseline and month 6 visits from Group 1
5 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
1 Patients male or female diagnosed with relapsing forms of MS
2 Currently being treated with the same b-IFN in accordance with FDA approved dosing and schedules for 12 to 48 months inclusive
3 All levels of disability
4 Age 18-65 years inclusive
5 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
1 Patients with prior b-IFN NAb test whether positive or negative
2 Patients who are currently being treated or have been treated within 6 months prior to screening with combination therapy b-IFN plus any other immunosuppressantimmunomodulatory other than IV steroids either pulse or for a relapse
3 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 subjects ability to comply with the study protocol
4 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 20NUml
Group 2 Approximately 50 subjects will be enrolled who are BAb- titer 8U and NAb- titer 20 NUml
Group 3 Approximately 50 subjects will be enrolled who are BAb titer ³8U and NAb- titer 20 NUml
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None