Relapsing-remitting Multiple Sclerosis Clinical Trial
Official title:
Steroid Adjunctive Treatment at Initiation of Avonex Therapy for Patients With Mono-Symptomatic or Relapsing-Remitting Multiple Sclerosis
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.
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.
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Observational Model: Case Control, Time Perspective: Prospective
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