Safety and Efficacy of Natalizumab in the Treatment of Multiple Sclerosis
The purpose of this study is to determine the safety and efficacy of natalizumab in the treatment of individuals who have been diagnosed with relapsing remitting multiple sclerosis (MS). It is hoped that natalizumab will prevent certain types of white blood cells from moving out of the bloodstream into organs, including the brain, that are being damaged by autoimmune disease (a disease in which the body's own immune system attacks certain organs). These white blood cells are thought to cause inflammation that can result in lesions (small areas of damage) in the brain. These lesions are thought to be the cause of relapses and disability in MS.
Multiple Sclerosis, Relapsing-Remitting
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study to Determine the Safety and Efficacy of Natalizumab in Subjects With Relapsing-Remitting Multiple Sclerosis|
- The primary objectives of this study are to determine whether natalizumab, when compared with placebo, is effective in reducing the rate of clinical relapses at 1 year and, in slowing the progression of disability at 2 years. [ Time Frame: 1 year and 2 years ] [ Designated as safety issue: No ]
- Reduction in MRI changes and clinical relapses [ Time Frame: 1 year ] [ Designated as safety issue: No ]
|Study Start Date:||November 2001|
|Study Completion Date:||January 2005|
|Primary Completion Date:||November 2004 (Final data collection date for primary outcome measure)|
Experimental: Group 1
Natalizumab 300 mg, IV
Natalizumab 300 mg IV infusion, every 4 weeks, for up to 116 weeks.
Other Name: Tysabri
Placebo Comparator: Group 2
Placebo IV infusion
Placebo, IV infusion, every 4 weeks, for up to 116 weeks.
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|Study Director:||Michael Panzara, MD, MPH||Biogen Idec|
|Principal Investigator:||Chris Polman, MD||VU Medical Centre|