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

Tracking Information
First Submitted Date  ICMJE November 30, 2001
First Posted Date  ICMJE December 3, 2001
Last Update Posted Date January 9, 2017
Study Start Date  ICMJE November 2001
Actual Primary Completion Date November 2004   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 15, 2009)
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 Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 15, 2009)
Reduction in MRI changes and clinical relapses [ Time Frame: 1 year ]
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Efficacy of Natalizumab in the Treatment of Multiple Sclerosis
Official Title  ICMJE 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
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 Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Multiple Sclerosis, Relapsing-Remitting
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • Experimental: Group 1
    Natalizumab 300 mg, IV
    Intervention: Drug: Natalizumab
  • Placebo Comparator: Group 2
    Placebo IV infusion
    Intervention: Drug: Placebo
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 12, 2006)
900
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE January 2005
Actual Primary Completion Date November 2004   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium,   Canada,   Czech Republic,   France,   Germany,   Netherlands,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00027300
Other Study ID Numbers  ICMJE C-1801
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Biogen Idec Medical Director, Biogen Idec
Original Responsible Party Not Provided
Current Study Sponsor  ICMJE Biogen
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Elan Pharmaceuticals
Investigators  ICMJE
Study Director: Michael Panzara, MD, MPH Biogen
Principal Investigator: Chris Polman, MD VU Medical Centre
PRS Account Biogen
Verification Date January 2017

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