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Safety and Efficacy of Natalizumab in the Treatment of Multiple Sclerosis

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ClinicalTrials.gov Identifier: NCT00027300
Recruitment Status : Completed
First Posted : December 3, 2001
Last Update Posted : January 9, 2017
Elan Pharmaceuticals
Information provided by:

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.

Condition or disease Intervention/treatment Phase
Multiple Sclerosis, Relapsing-Remitting Drug: Natalizumab Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 900 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, 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
Study Start Date : November 2001
Actual Primary Completion Date : November 2004
Actual Study Completion Date : January 2005

Resource links provided by the National Library of Medicine

Drug Information available for: Natalizumab

Arm Intervention/treatment
Experimental: Group 1
Natalizumab 300 mg, IV
Drug: Natalizumab
Natalizumab 300 mg IV infusion, every 4 weeks, for up to 116 weeks.
Other Name: Tysabri

Placebo Comparator: Group 2
Placebo IV infusion
Drug: Placebo
Placebo, IV infusion, every 4 weeks, for up to 116 weeks.

Primary Outcome Measures :
  1. 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 ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00027300

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Sponsors and Collaborators
Elan Pharmaceuticals
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Study Director: Michael Panzara, MD, MPH Biogen
Principal Investigator: Chris Polman, MD VU Medical Centre
Additional Information:
Publications of Results:
Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Biogen Idec Medical Director, Biogen Idec
ClinicalTrials.gov Identifier: NCT00027300    
Other Study ID Numbers: C-1801
First Posted: December 3, 2001    Key Record Dates
Last Update Posted: January 9, 2017
Last Verified: January 2017
Keywords provided by Biogen:
Relapsing Remitting Multiple Sclerosis
Additional relevant MeSH terms:
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Multiple Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Immunologic Factors
Physiological Effects of Drugs