This study, involving patients from 32 sites across the U.S. over a five-year period, was designed to determine if much earlier treatment within a month of the appearance of initial symptoms and before a definite diagnosis had been made would delay the onset of new neurological symptoms compared to initiation of therapy more than two years after the onset of symptoms.
"The study actually evolved from an earlier investigation, known as the CHAMPS study," explains Kinkel. CHAMPS, a two-year blinded placebo controlled trial in which 383 MS patients were treated weekly with either Avonex or a placebo, found that those individuals who received Avonex experienced a 44 percent decrease in the rate of developing a second MS attack that would qualify them for a diagnosis of MS compared with the patients who received a placebo.
"We were extremely pleased with the outcome of the CHAMPS trial," notes Kinkel. "But we realized that because disabling MS symptoms such as difficulty walking and thinking that does not improve may not appear in patients for many years. We would have to conduct a much longer study to determine if Avonex actually slowed the progression of these debilitating symptoms."
To test the medication's long-term effectiveness, the study followed 203 patients, half of whom had been receiving Avonex from the onset of the CHAMPS trial (immediately after demonstrating MS symptoms) and half of whom began treatment with Avonex at a later point, following their second MS attack (or two or more years after their first attack). The study found that patients who began treatment with Avonex immediately after their first attack had a 35 perce
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Contact: Bonnie Prescott
bprescot@bidmc.harvard.edu
617-667-7306
Beth Israel Deaconess Medical Center
20-Sep-2003