Ignite Creation Date:
2024-05-05 @ 11:38 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00099489
Status:
COMPLETED
Last Update Posted:
2010-03-05
First Post:
2004-12-15
Brief Title:
Safety and Efficacy of Avonex in Subjects With Chronic Inflammatory Demyelinating Polyradiculoneuropathy CIDP
Sponsor:
Biogen
Organization:
Biogen
Study Overview
Official Title:
A Randomized Double-Blind Placebo-Controlled Dose-Ranging Study to Determine the Safety and Efficacy of AVONEX When Used in Subjects With Chronic Inflammatory Demyelinating Polyradiculoneuropathy CIDP
Status:
COMPLETED
Status Verified Date:
2010-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to determine whether AVONEX Interferon Beta-1a when compared to placebo reduces the total dose of IVIg that is administered after Visit 5 and through Visit 9 Week 32 End of Study
Detailed Description:
Chronic Inflammatory Demyelinating Polyradiculoneuropathy CIDP is an acquired peripheral neuropathy of unknown origin The etiology is not well understood but is presumed to be immunological Evidence for this comes from observed similarities to Guillain-Barre syndrome and from the favorable response with immunomodulatory treatments
CIDP is a peripheral nervous system demyelinating neuropathy that is sometimes a corollary disorder to the central nervous system demyelination of multiple sclerosis MS The precise mechanisms underlying the pathogenesis are uncertain but a number of those mechanisms support a potential role for immunomodulatory treatments such as interferon beta eg Biogen Idec Incs AVONEX
The rationale for the use of AVONEX in CIDP derives from observations on the pathogenesis of the condition and its similarities to MS the mechanism of action of AVONEX clinical trials that have been performed in CIDP that support a role for IFN-beta and the unmet need that currently exists because of availability and safety issues with existing therapies
This Phase 2b study is a dose-ranging study designed to provide scientific evidence regarding the safety and efficacy of AVONEX in CIDP In addition the study aims to demonstrate the responsiveness and clinical relevance of changes in the MRC sum score and ODSS in CIDP patients
CIDP is a peripheral nervous system demyelinating neuropathy that is sometimes a corollary disorder to the central nervous system demyelination of multiple sclerosis MS The precise mechanisms underlying the pathogenesis are uncertain but a number of those mechanisms support a potential role for immunomodulatory treatments such as interferon beta eg Biogen Idec Incs AVONEX
The rationale for the use of AVONEX in CIDP derives from observations on the pathogenesis of the condition and its similarities to MS the mechanism of action of AVONEX clinical trials that have been performed in CIDP that support a role for IFN-beta and the unmet need that currently exists because of availability and safety issues with existing therapies
This Phase 2b study is a dose-ranging study designed to provide scientific evidence regarding the safety and efficacy of AVONEX in CIDP In addition the study aims to demonstrate the responsiveness and clinical relevance of changes in the MRC sum score and ODSS in CIDP patients
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