Ignite Creation Date:
2024-05-05 @ 12:05 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00232193
Status:
COMPLETED
Last Update Posted:
2011-07-22
First Post:
2005-09-30
Brief Title:
SafetyEffectiveness of Adding Monthly Dexamethasone to Weekly Avonex for MS
Sponsor:
Providence Multiple Sclerosis Center
Organization:
Providence Multiple Sclerosis Center
Study Overview
Official Title:
Steroid Adjunctive Treatment at Initiation of Avonex Therapy for Patients With Mono-Symptomatic or Relapsing-Remitting Multiple Sclerosis
Status:
COMPLETED
Status Verified Date:
2011-07
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:
The purpose of the study is to determine whether giving intravenous dexamethasone every 4 weeks during the first 12 months of weekly Avonex dosing will reduce the progression of functional impairment brain atrophy relapse rate and frequency and new and enlarging brain lesions over the first 24 months of Avonex therapy in patients with relapsing-remitting or mono-symptomatic multiple sclerosis
Detailed Description:
Beta Interferon-1a Avonexwas approved by the FDA in 1996 to treat relapsing-remitting multiple sclerosis Clinical trials have shown evidence in the reduction of relapses and progression of neurological and cognitive disability with the use of Avonex as well as reduction in brain atrophy and new MS lesions on MRI were observed Despite this Avonex does not abolish disease activity therefore there is frequent need for adjunctive therapy such as short courses of corticosteroids
This study will research the value of adding monthly pulsed corticosteroids as adjunctive therapy during the first year of Avonex use to determine asafety and tolerability bif this therapy will reduce the progression of functional impairment and cif this therapy will reduce the progression of whole brain atrophy over a 13 month observation period
This study will research the value of adding monthly pulsed corticosteroids as adjunctive therapy during the first year of Avonex use to determine asafety and tolerability bif this therapy will reduce the progression of functional impairment and cif this therapy will reduce the progression of whole brain atrophy over a 13 month observation 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