Clinical Trial: Safety and Efficacy of Natalizumab in the Treatment of Multiple Sclerosis

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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 Multipl

Brief Summary: 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.

Detailed Summary:
Sponsor: Biogen

Current Primary Outcome: 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 ]

Original Primary Outcome:

Current Secondary Outcome: Reduction in MRI changes and clinical relapses [ Time Frame: 1 year ]

Original Secondary Outcome:

Information By: Biogen

Dates:
Date Received: November 30, 2001
Date Started: November 2001
Date Completion:
Last Updated: January 5, 2017
Last Verified: January 2017