The purpose of this study is to determine if natalizumab in combination with AVONEX is safe and effective in delaying progression of individuals diagnosed with relapsing remitting Multiple Sclerosis (MS).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
1,200
Natalizumab, 300 mg, monthly IV infusion for up to 116 weeks.
Placebo monthly infusion for up to 116 weeks.
Primary objectives of this study are to determine if natalizumab is effective in reducing the rate of clinical relapse at 1 year and in slowing the progression of disability at 2 years as measured by EDSS.
Time frame: 1 year and 2 years
If this combination reduces MRI lesions and the overall rate of clinical relapses
Time frame: 1 year and 2 years
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University of Alabama-Birmingham, Department of Neurology
Birmingham, Alabama, United States
Phoenix Neurological Associates, Ltd.
Phoenix, Arizona, United States
University of Arkansas For Medical Sciences
Little Rock, Arkansas, United States
University of California - Irvine
Irvine, California, United States
USC MS Comprehensive Care Center
Los Angeles, California, United States
Kaiser-Permanente Medical Center
Redwood City, California, United States
MS Center at UCSF
San Francisco, California, United States
Healthsouth Rehabilitation Hospital
Colorado Springs, Colorado, United States
University of Colorado MS Center
Denver, Colorado, United States
Griffin Hospital
Derby, Connecticut, United States
...and 78 more locations