Safety and Efficacy of Natalizumab in the Treatment of Multiple Sclerosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00027300
Recruitment Status : Completed
First Posted : December 3, 2001
Last Update Posted : January 9, 2017
Elan Pharmaceuticals
Information provided by:

November 30, 2001
December 3, 2001
January 9, 2017
November 2001
November 2004   (Final data collection date for primary outcome measure)
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 ]
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Complete list of historical versions of study NCT00027300 on Archive Site
Reduction in MRI changes and clinical relapses [ Time Frame: 1 year ]
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Safety and Efficacy of Natalizumab in the Treatment of Multiple Sclerosis
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 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.
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Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Multiple Sclerosis, Relapsing-Remitting
  • Drug: Natalizumab
    Natalizumab 300 mg IV infusion, every 4 weeks, for up to 116 weeks.
    Other Name: Tysabri
  • Drug: Placebo
    Placebo, IV infusion, every 4 weeks, for up to 116 weeks.
  • Experimental: Group 1
    Natalizumab 300 mg, IV
    Intervention: Drug: Natalizumab
  • Placebo Comparator: Group 2
    Placebo IV infusion
    Intervention: Drug: Placebo

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
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January 2005
November 2004   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Diagnosis of MS, as defined by McDonald et al., criteria # 1-4 (McDonald et al., 2001)
  • Between the ages of 18 and 50, inclusive.
  • Baseline EDSS score between 0.0 and 5.0, inclusive.
  • Have experienced at least one relapse within the 12 months prior to randomization.
  • Cranial MRI scan demonstrating lesion(s) consistent with MS.
  • Have given written informed consent to participate in the study.

Exclusion Criteria:

  • Primary progressive, secondary progressive, or progressive relapsing MS.
  • MS relapse has occurred,in the opinion of the investigator, within 50 days prior to randomization and/or the subject has not stabilized from a previous relapse.
  • A clinically significant infectious illness within 30 days prior to randomization.
  • History of, or abnormal laboratory results indicative of any significant cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, gastrointestinal, dermatologic, psychiatric, renal and/or other major disease, that in the opinion of the investigator, would preclude the administration of a recombinant humanized antibody immunomodulating agent for 116 weeks.
  • History of severe allergic or anaphylactic reactions or known drug hypersensitivity.
  • Unable to perform the Timed 25-foot Walk, 9HPT, and PASAT 3.
  • Abnormal blood tests performed at the Screening Visit.
Sexes Eligible for Study: All
18 Years to 50 Years   (Adult)
Contact information is only displayed when the study is recruiting subjects
Belgium,   Canada,   Czech Republic,   France,   Germany,   Netherlands,   United Kingdom,   United States
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Biogen Idec Medical Director, Biogen Idec
Elan Pharmaceuticals
Study Director: Michael Panzara, MD, MPH Biogen
Principal Investigator: Chris Polman, MD VU Medical Centre
January 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP