Safety and Efficacy of Natalizumab in the Treatment of Multiple Sclerosis

January 5, 2017 updated by: Biogen

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

900

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Brugge, Belgium, 8000
        • Algemeen Ziekenhuis St. Jan
      • Diepenbeek, Belgium, 3590
        • LUC- University Centre
      • Melsbroek, Belgium, 1820
        • National MS Centrum
  • Canada
      • Halifax, Canada, B3H 1V7
        • MS Research Unit, Center for Clinical Research
      • Ottawa, Canada, K1N 5C7
        • Family Medical Centre
    • British Columbia
      • Vancouver, British Columbia, Canada, V6T 2B5
        • Vancouver Hospital and Health Sciences Center UBC Pavilion, MS Clinical Research Group
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3A 1R9
        • Health Services Centre
    • Ontario
      • Kingston, Ontario, Canada, K7L 2V7
        • Kingston General Hospital, Neurology
      • London, Ontario, Canada, N6A 5A5
        • University Hospital
      • Toronto, Ontario, Canada, M4N 3M5
        • Sunnybrook and Women's College and Health Science Centre
      • Toronto, Ontario, Canada, M5B 1W8
        • University of Toronto, MS Clinic, St. Michael's Hospital
    • Quebec
      • Quebec City, Quebec, Canada, J8Y 1W7
        • CHVO Hull Hospital
  • Czech Republic
      • Brno, Czech Republic, 60200
        • Faculty Hospital Brno Bohunice
      • Brno, Czech Republic, 656 91
        • Faculty Hospital St. Anne
      • Hradec Kralove, Czech Republic, 500 05
        • Faculty Hospital of Hradec Kralove
      • Olomouc, Czech Republic, 775 20
        • Faculty Hospital Olomouc
      • Ostrava, Czech Republic, 70852
        • Faculty Hospital Of Ostrava Poruba
      • Pardubice, Czech Republic, 532 03
        • Hospital Pardubice - Department of Neurology
      • Plzen, Czech Republic, 304 60
        • Faculty Hospital Plzen - Clinic of Neurology
      • Prague, Czech Republic, 2 12802
        • General Teaching Hospital - Neurological Department
      • Prague, Czech Republic, 5 105 06
        • Faculty Hospital Motol - Neurological Clinic
  • France
      • Marseille, France, 13385
        • Hopital de la Timone, Service de Neurologie
      • Rennes, France, 35033
        • CHRU - Hopital de Pontchaillou, Service de Neurologie
  • Germany
      • Bochurn, Germany, 44791
        • St. Josef-Hospital, Neurologische Klinik der Ruhruniversitat Bochum
      • Bydgoszcz, Germany, 85-681
        • Klinika Neurologii
  • Netherlands
      • Amsterdam, Netherlands, 1081 HV
        • Academisch Ziekenhuis VU
  • United Kingdom
      • Essex, United Kingdom, NE1 4LP
        • Oldchurch Hospital
      • Ipswich, United Kingdom, IP4 5PD
        • Ipswich Hospital NHS Trust - Department of Clinical Neurology
      • Leeds, United Kingdom, LS9 7TF
        • St. James University Hospital, Department of Neurology
      • London, United Kingdom, SE1 9RT
        • Guy's Hospital
      • London, United Kingdom, SE5 9RS
        • King's College Hospital
      • London, United Kingdom, SE5 9RS
        • Kings College Hospital, Kings Neuroscience Center
      • Newcastle upon Tyne, United Kingdom, NE1 4LP
        • Royal Victoria Infirmary
      • Oxford, United Kingdom, OX2 0HE
        • The Radcliffe Infirmary, University Department of Clinical Neurology
      • Sheffield, United Kingdom, S10 2JF
        • Royal Hallamshire Hospital
      • Stoke on Trent, United Kingdom, ST4 7LN
        • North Staffordshire Royal Infirmary - Neurology Department
    • London
      • Queen Square, London, United Kingdom, WC1N 3BG
        • Institute of Neurology
      • Whitechapel, London, United Kingdom, E1 1BB
        • The Royal London Hospital
      • Wimbledon, London, United Kingdom, SW20 0NE
        • Atkin's Morely Hospital
  • United States
    • Arizona
      • Scottsdale, Arizona, United States, 85259
        • Mayo Clinic Scottsdale
    • California
      • Berkeley, California, United States, 94705
        • East Bay Region Associates in Neurology
      • Davis, California, United States, 95817-2307
        • UC Davis School of Medicine, Department of Neurology
    • Connecticut
      • New Haven, Connecticut, United States, 06510
        • Yale University School of Medicine, Department of Neurology
    • Florida
      • Miami, Florida, United States, 33136
        • University of Miami School of Medicine, Department of Neurology
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • University of Kansas Medical Center, Department of Neurology
    • Michigan
      • Farmington Hills, Michigan, United States, 48335
        • Michigan Institute for Neurological Disorders
    • Nebraska
      • Omaha, Nebraska, United States, 68198
        • University Of Nebraska Medical Center
    • New Jersey
      • Teaneck, New Jersey, United States, 07666
        • Gimbel MS Center
    • New Mexico
      • Albuquerque, New Mexico, United States, 87131
        • CMRRC
    • Oregon
      • Portland, Oregon, United States, 97201-3098
        • Oregon Health Sciences University, Department of Neurology
    • Pennsylvania
      • Allentown, Pennsylvania, United States, 18103
        • Lehigh Valley Hospital, Neurosciences Research
    • Texas
      • Dallas, Texas, United States, 75214
        • Texas Neurology
    • Washington
      • Seattle, Washington, United States, 98195
        • University of Washington MS Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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 Names:
  • Tysabri
Placebo Comparator: Group 2
Placebo IV infusion
Drug: Placebo
Placebo, IV infusion, every 4 weeks, for up to 116 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
1 year and 2 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Reduction in MRI changes and clinical relapses
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Biogen

Collaborators

Elan Pharmaceuticals

Investigators

  • Study Director: Michael Panzara, MD, MPH, Biogen
  • Principal Investigator: Chris Polman, MD, VU Medical Centre

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2001

Primary Completion (Actual)

November 1, 2004

Study Completion (Actual)

January 1, 2005

Study Registration Dates

First Submitted

November 30, 2001

First Submitted That Met QC Criteria

November 30, 2001

First Posted (Estimate)

December 3, 2001

Study Record Updates

Last Update Posted (Estimate)

January 9, 2017

Last Update Submitted That Met QC Criteria

January 5, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C-1801

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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