Safety/Effectiveness of Adding Monthly Dexamethasone to Weekly Avonex for MS
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.
|Study Design:||Observational Model: Case Control
Time Perspective: Prospective
|Official Title:||Steroid Adjunctive Treatment at Initiation of Avonex Therapy for Patients With Mono-Symptomatic or Relapsing-Remitting Multiple Sclerosis|
|Study Start Date:||December 2003|
|Study Completion Date:||August 2010|
|Primary Completion Date:||December 2008 (Final data collection date for primary outcome measure)|
IFNβ+DS group received lyophilized Avonex 30mcg IM weekly plus dexamethasone 160 mg IV every 4 weeks for 52 weeks and was treated with Avonex 30mcg IM weekly from week 53 to 104
IFNβ group received lyophilized Avonex 30mcg IM weekly for 104 weeks
Beta Interferon-1a (Avonex)was 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: a)safety and tolerability b)if this therapy will reduce the progression of functional impairment, and c)if this therapy will reduce the progression of whole brain atrophy over a 13 month observation period.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00232193
|United States, Oregon|
|Providence MS Center|
|Portland, Oregon, United States, 97225|
|Principal Investigator:||Stanley L. Cohan, M.D., Ph.D.||Providence Multiple Sclerosis Center|