Tuesday October 17, 12:53 pm Eastern Time
Published In The New England Journal of Medicine
CLEVELAND, Oct. 17 /PRNewswire/ -- Expanding on the landmark study that was the lead story in the September 28, 2000, issue of the New England Journal of Medicine, researchers announce the launch of the first-ever study that will address the long-term impact of treatment on the natural history of multiple sclerosis (MS). R. Philip Kinkel, MD, Medical Director, Mellen Center for MS Treatment and Research, the Cleveland Clinic Foundation, is the study chairman.
The new study, called CHAMPIONS, is a longitudinal follow-up of the patient groups enrolled in an early MS treatment study conducted between April 1996 and April 1998. That trial -- known as CHAMPS -- demonstrated that early treatment with the multiple sclerosis therapy interferon beta-1a, or Avonex®, can significantly reduce the rate at which individuals at high risk for the disease actually develop clinically definite multiple sclerosis. Avonex also showed a highly significant positive impact in reducing the rate at which patients developed brain abnormalities, or lesions, visible on magnetic resonance imaging scans (MRIs).
The CHAMPS study followed 383 patients who were given weekly injections of Avonex or a placebo after experiencing a first MS-like symptom. Initially planned to last three years, the study was stopped early following a preplanned interim efficacy analysis indicating positive results in the Avonex-treated group. The patients in the placebo group were then given the opportunity to begin treatment.
"The CHAMPS data emphatically indicated the significant benefits of early Avonex treatment compared to placebo," Kinkel said. "Additional studies are needed, however, to better understand the continued benefit of this MS treatment for patients. This study, unique in its design and objectives, will be the only study to date to address the long-term impact of MS treatment." CHAMPIONS will examine Avonex-treated patients for five years of treatment after their first symptom of multiple sclerosis. It also will compare patients treated with Avonex since their first MS symptom (the CHAMPS Avonex group) to those begun on Avonex later (CHAMPS placebo group.)
The goals of the CHAMPIONS study include:
Avonex was approved by the FDA in 1996 and is demonstrated to have beneficial effects when used to treat patients with relapsing forms of MS, including slowing the accumulation of physical disability and decreasing the frequency of clinical exacerbations.
Multiple sclerosis is a chronic disease of the central nervous system that affects approximately 400,000 Americans and about one million individuals worldwide. It is a disease of young adults, mostly women, with onset typically between 20 and 40 years of age. Symptoms of MS may include vision problems, loss of balance, numbness, difficulty walking and paralysis. The cause of the disease is believed to be the destruction of myelin by the immune system. Myelin is the fatty tissue that surrounds and protects the central nervous system nerve fibers and facilitates the flow of nerve impulses to and from the brain. The loss of myelin disrupts the conduction of nerve impulses, producing the symptoms of MS.
Study Chairman Kinkel has been with the Cleveland Clinic since 1991.
He received his medical degree from State University of New York at Buffalo.
He obtained specialty training at the Cleveland Clinic and Millard Fillmore
Health System. As Mellen Center director, Kinkel oversees the state-of-the
art program that provides care for people with multiple sclerosis, conducts
clinical and basis research of multiple sclerosis and educates medical
professionals about the disease. The Edward J. and Louise E. Mellen Center
for Multiple Sclerosis Treatment and Research was founded in 1984.
SOURCE Edward J. and Louise E. Mellen Center for Multiple Sclerosis
Treatment and Research, of the Cleveland Clinic Foundation