Safety and Efficacy of Natalizumab in Combination With Avonex in the Treatment of Multiple Sclerosis

June 17, 2009 updated by: Biogen

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study to Determine the Safety and Efficacy of Natalizumab, When Added to Avonex® (Interferon Beta-1a), in Subjects With Relapsing-Remitting Multiple Sclerosis

The purpose of this study is to determine if natalizumab in combination with AVONEX is safe and effective in delaying progression of individuals diagnosed with relapsing remitting Multiple Sclerosis (MS).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1200

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

  • Austria
      • Graz, Austria, 8036
        • Universitätsklinik für Neurologie
      • Innsbruck, Austria, 6020
        • Universitätsklinik für Neurologie
  • Belgium
      • Brussels, Belgium, 1780
        • Hopital Universitaire U.L.B. Erasme
      • Sijsele, Belgium, 8340
        • Elisabeth Ziekenhuis
  • France
      • Bordeaux, France, 33076
        • Hopital Pellegrin Tripode, Neurologie
      • Lyon, France, 69394
        • Hopital neurologique Pierre Werth
  • Germany
      • Berlin, Germany, 13347
        • Jüdisches Krankenhaus
      • Giessen, Germany, 35390
        • Universitaetsklinikum Giessen, Oberarzt Neurologie
      • Hannover, Germany, 30625
        • Medizinische Hochschule Hannover, Neurologische Klinik
      • Henningsdorf, Germany, 16761
        • Neurologische Abteilung
      • Osnabrück, Germany, 49076
        • Städtische Kliniken Osnabrück
      • Seesen/Harz, Germany, 38723
        • Asklepios Klinik Schildautal
      • Wiesbaden, Germany, 65191
        • Fachbereich Neurologie und Klinische Neurophysiologie
  • Israel
      • Jerusalem, Israel
        • Hadassah Hebrew Uni Hospital, Department of Neurology
      • Tel Hashomer, Israel, 52621
        • Sheba Medical Center, MS Center
  • Italy
      • Genova, Italy, 16132
        • Universita di Genova, Clinica Neurologica
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35233
        • University of Alabama-Birmingham, Department of Neurology
    • Arizona
      • Phoenix, Arizona, United States, 85008
        • Phoenix Neurological Associates, Ltd.
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • University of Arkansas for Medical Sciences
    • California
      • Irvine, California, United States, 92697
        • University of California - Irvine
      • Los Angeles, California, United States, 90033
        • USC MS Comprehensive Care Center
      • Redwood City, California, United States, 94063
        • Kaiser-Permanente Medical Center
      • San Francisco, California, United States, 94117
        • MS Center at UCSF
    • Colorado
      • Colorado Springs, Colorado, United States, 80910
        • Healthsouth Rehabilitation Hospital
      • Denver, Colorado, United States, 80262
        • University of Colorado MS Center
    • Connecticut
      • Derby, Connecticut, United States, 06418
        • Griffin Hospital
    • District of Columbia
      • Washington, District of Columbia, United States, 20007
        • Georgetown Univesity Hospital, Research Pharmacy
      • Washington, District of Columbia, United States, 20037
        • George Washington University MS Center
    • Florida
      • Ft. Lauderdale, Florida, United States, 33334
        • North Ridge NeuroScience Center
      • Maitland, Florida, United States, 32751
        • Maitland Neurology
      • Miami, Florida, United States, 33136
        • University of Miami, Department of Neurology
    • Georgia
      • Atlanta, Georgia, United States, 30327
        • The Multiple Sclerosis Center of Atlanta
      • Marietta, Georgia, United States, 30060
        • Marietta Neurological Associates
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern University, Department of Neurology
      • Chicago, Illinois, United States, 60612
        • Rush-Presbyterian St. Luke's Medical Center
      • Elk Grove Village, Illinois, United States, 60007
        • Alexian Brothers Center for Clinical Research
      • Maywood, Illinois, United States, 60153
        • Loyola Medical Center
      • Northbrook, Illinois, United States, 60062
        • Consultants in Neurology Northbrook
      • Springfield, Illinois, United States, 62702
        • Springfield Clinic Neuroscience Institute
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Indiana University Medical Center
    • Iowa
      • Des Moines, Iowa, United States, 50314
        • Mercy Hospital Outpatient Pharmacy
    • Louisiana
      • New Orleans, Louisiana, United States, 70112
        • LSU Neurolgoy Clinic in New Orleans
    • Maine
      • Scarborough, Maine, United States, 04074-8926
        • Maine Neurology
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • University of Maryland Hospital, Department of Neurology
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Brigham and Women's Hospital
      • Worcester, Massachusetts, United States, 01655-0138
        • University of Massachusetts Memorial Medical Center
    • Michigan
      • Detroit, Michigan, United States, 48202-2608
        • Henry Ford Hospital
      • East Lansing, Michigan, United States, 48824
        • Michigan State University MS Clinic
      • Farmington Hills, Michigan, United States, 48334
        • Michigan Institute for Neurological Disorders
    • Minnesota
      • Minneapolis, Minnesota, United States, 55404
        • Noran Neurological Clinic
    • Mississippi
      • Jackson, Mississippi, United States, 39216-4505
        • University of Mississippi Medical Center
    • Missouri
      • St. Louis, Missouri, United States, 63141
        • St. John's Mercy Medical Center
    • New Jersey
      • Teaneck, New Jersey, United States, 07666
        • Bernard W. Gimbel MS Center
    • New York
      • Albany, New York, United States, 12208
        • Albany Medical Center
      • Albany, New York, United States, 12205
        • Upstate Clinical Research, LLC
      • Brooklyn, New York, United States, 11219
        • Maimonides Medical Center, Division of Neurology
      • Buffalo, New York, United States, 14203
        • Buffalo General Hospital, Department of Neurology
      • New York, New York, United States, 10021
        • New York Hospital - Cornell Medical Center
      • New York, New York, United States, 10003
        • MS Care Center
      • New York, New York, United States, 10019
        • St. Luke's Roosevelt Hospital, MS Research & Treatment Center
      • New York, New York, United States, 10032
        • New York State Psychiatric Institution
      • Rochester, New York, United States, 14642
        • Strong Health Pharmacy Services
      • Staten Island, New York, United States, 10305
        • Staten Island University Hospital
      • Stony Brook, New York, United States, 11794
        • University Hospital at Stony Brook
      • Syracuse, New York, United States, 13210
        • Suny Upstate Medical University
    • North Carolina
      • Charlotte, North Carolina, United States, 28232-2861
        • MS Center at Carolinas Medical Center
      • Raleigh, North Carolina, United States, 27607
        • Raleigh Neurology Associates
      • Winston-Salem, North Carolina, United States, 27157
        • Wake Forest University School of Medicine, Department of Neurology
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • Riverhills Neurology
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic Foundation
    • Oregon
      • Portland, Oregon, United States, 97225
        • Providence Saint Vincent Medical Center
    • Pennsylvania
      • Danville, Pennsylvania, United States, 17822
        • Geisinger Medical Center
      • Philadelphia, Pennsylvania, United States, 19104
        • Hospital of the University of Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19146
        • Greenstein Neurology Associates & MS Institute
      • Pittsburgh, Pennsylvania, United States, 15212
        • Allegheny Singer Research Institute
      • Pittsburgh, Pennsylvania, United States, 15213
        • University of Pittsburgh, Department of Neurology
    • Tennessee
      • Memphis, Tennessee, United States, 38163
        • University of Tennessee - Memphis
      • Nashville, Tennessee, United States, 37215
        • Vanderbilt Medical Center
    • Texas
      • Dallas, Texas, United States, 75226
        • Option Care Infusion
      • Dallas, Texas, United States, 75235-9036
        • UTSW Medical School
      • Houston, Texas, United States, 77030
        • Baylor Methodist International MS Center
      • Round Rock, Texas, United States, 78681
        • Central Texas Neurology
    • Vermont
      • Burlington, Vermont, United States, 05401
        • Fletcher Allen Health Care
    • Virginia
      • Charlottesville, Virginia, United States, 22908
        • University of Virginia Health Sciences
      • Richmond, Virginia, United States, 23226
        • Neurological Associates, Inc.
    • Washington
      • Seattle, Washington, United States, 98111
        • Virginia Mason Medical Center
      • Seattle, Washington, United States, 98195
        • MS Research Center
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53215
        • St. Francis Hospital, Center for Neurological Disorders

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 55 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
  • Between the ages of 18 and 55, inclusive
  • Baseline EDSS score between 0.0 and 5.0, inclusive
  • Have been treated with Avonex for at least the 12 months prior to randomization
  • Have experienced at least one relapse (while on Avonex) within the 12 months prior to randomization.
  • Cranial MRI scan demonstrating lesions 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 within 50 days of randomization
  • A clinically significant infectious illness within 30 days prior to randomization
  • History of, or abnormal lab result, indicative of significant disease, that in the opinion of the investigator, would preclude the administration of a recombinant humanized antibody immunomodulating agent or Avonex 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 at 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
Adding natalizumab monthly infusion to Avonex weekly injection for up to 116 weeks.
Drug: Natalizumab
Natalizumab, 300 mg, monthly IV infusion for up to 116 weeks.
Other Names:
  • Tysabri
Placebo Comparator: Group 2
Adding placebo monthly infusion to Avonex weekly injection for up to 116 weeks.
Drug: Placebo
Placebo monthly infusion for up to 116 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Primary objectives of this study are to determine if natalizumab is effective in reducing the rate of clinical relapse at 1 year and in slowing the progression of disability at 2 years as measured by EDSS.
Time Frame: 1 year and 2 years
1 year and 2 years

Secondary Outcome Measures

Outcome Measure
Time Frame
If this combination reduces MRI lesions and the overall rate of clinical relapses
Time Frame: 1 year and 2 years
1 year and 2 years

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: Richard A Rudick, MD, The Cleveland Clinic

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

January 1, 2002

Primary Completion (Actual)

April 1, 2005

Study Completion (Actual)

December 1, 2005

Study Registration Dates

First Submitted

February 15, 2002

First Submitted That Met QC Criteria

February 15, 2002

First Posted (Estimate)

February 18, 2002

Study Record Updates

Last Update Posted (Estimate)

June 18, 2009

Last Update Submitted That Met QC Criteria

June 17, 2009

Last Verified

June 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C-1802

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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