Ignite Creation Date:
2024-05-05 @ 6:31 PM
Last Modification Date:
2024-10-26 @ 9:34 AM
Study NCT ID:
NCT00493077
Status:
COMPLETED
Last Update Posted:
2008-01-30
First Post:
2007-06-25
Brief Title:
Safety of Avonex Treatment in Multiple Sclerosis Patients With Neutralizing Antibodies to Interferon Beta Therapy
Sponsor:
Biogen
Organization:
Biogen
Study Overview
Official Title:
A Swedish Multi-Centre Prospective Open Label Study Safety of Avonex Treatment in Multiple Sclerosis Patients Who Are NAB Positive on Previous sc Interferon Beta Therapy
Status:
COMPLETED
Status Verified Date:
2008-01
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:
SAFE
Brief Summary:
This study is to find out the safety and effectiveness of Avonex interferon-beta-1a Therapy in patients who have developed neutralizing antibodies during previous interferon-beta treatment
Detailed Description:
This is a multi-centre prospective open label non-comparative phase IV trial Eligible patients will receive treatment with IFN-beta-1a AVONEX 30 mcg im once weekly for 12 monthsThe patients will be examined clinically and NAb titres will be performed at screening and after 12 months Adverse event source verification will be performed during the documentation period
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