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Safety and Efficacy of Natalizumab in the Treatment of Multiple Sclerosis

This study has been completed.
Sponsor:
Collaborator:
Elan Pharmaceuticals
Information provided by:
Biogen Idec
ClinicalTrials.gov Identifier:
NCT00027300
First received: November 30, 2001
Last updated: June 15, 2009
Last verified: June 2009
History of Changes
  Purpose

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 Intervention Phase
Multiple Sclerosis, Relapsing-Remitting
 Drug: Natalizumab
Drug: Placebo
 Phase 3

Study Type: Interventional
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

Resource links provided by NLM:

Drug Information available for: Natalizumab
U.S. FDA Resources

Further study details as provided by Biogen Idec:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • Reduction in MRI changes and clinical relapses [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Enrollment: 900
Study Start Date: November 2001
Study Completion Date: January 2005
Primary Completion Date: November 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00027300

  Show 53 Study Locations
Sponsors and Collaborators
Biogen Idec
Elan Pharmaceuticals
Investigators
Study Director: Michael Panzara, MD, MPH Biogen Idec
Principal Investigator: Chris Polman, MD VU Medical Centre
  More Information

Additional Information:
The web site of the National Multiple Sclerosis Society, an organization dedicated to providing information to individuals with MS, their families and healthcare providers  This link exits the ClinicalTrials.gov site
MSActiveSource.com is a resource for news, information and disease management for all individuals touched by multiple sclerosis. This site is sponsored by Biogen.  This link exits the ClinicalTrials.gov site

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Biogen Idec Medical Director, Biogen Idec
ClinicalTrials.gov Identifier: NCT00027300     History of Changes
Other Study ID Numbers: C-1801
Study First Received: November 30, 2001
Last Updated: June 15, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by Biogen Idec:
Relapsing Remitting Multiple Sclerosis

Additional relevant MeSH terms:
Multiple Sclerosis
Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
 Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on May 23, 2013