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Safety and Efficacy of Natalizumab in Combination With Avonex in the Treatment of Multiple Sclerosis
This study has been completed.
First Received: February 15, 2002   Last Updated: June 17, 2009   History of Changes
Sponsor: Biogen Idec
Collaborator: Elan Pharmaceuticals
Information provided by: Biogen Idec
ClinicalTrials.gov Identifier: NCT00030966
  Purpose

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).


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

Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title: 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

Resource links provided by NLM:

MedlinePlus related topics: Multiple Sclerosis
Drug Information available for: Interferon beta 1a Natalizumab
U.S. FDA Resources

Further study details as provided by Biogen Idec:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • If this combination reduces MRI lesions and the overall rate of clinical relapses [ Time Frame: 1 year and 2 years ] [ Designated as safety issue: No ]

Enrollment: 1200
Study Start Date: January 2002
Study Completion Date: December 2005
Primary Completion Date: April 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Group 1: Experimental
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.
Group 2: Placebo Comparator
Adding placebo monthly infusion to Avonex weekly injection for up to 116 weeks.
Drug: Placebo
Placebo monthly infusion for up to 116 weeks.

  Eligibility

Ages Eligible for Study:   18 Years to 55 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
  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00030966

  Hide Study Locations
Locations
United States, Alabama
University of Alabama-Birmingham, Department of Neurology
Birmingham, Alabama, United States, 35233
United States, Arizona
Phoenix Neurological Associates, Ltd.
Phoenix, Arizona, United States, 85008
United States, Arkansas
University of Arkansas For Medical Sciences
Little Rock, Arkansas, United States, 72205
United States, California
Kaiser-Permanente Medical Center
Redwood City, California, United States, 94063
USC MS Comprehensive Care Center
Los Angeles, California, United States, 90033
MS Center at UCSF
San Francisco, California, United States, 94117
University of California - Irvine
Irvine, California, United States, 92697
United States, Colorado
Healthsouth Rehabilitation Hospital
Colorado Springs, Colorado, United States, 80910
University of Colorado MS Center
Denver, Colorado, United States, 80262
United States, Connecticut
Griffin Hospital
Derby, Connecticut, United States, 06418
United States, District of Columbia
Georgetown Univesity Hospital, Research Pharmacy
Washington, District of Columbia, United States, 20007
George Washington University MS Center
Washington, District of Columbia, United States, 20037
United States, Florida
North Ridge NeuroScience Center
Ft. Lauderdale, Florida, United States, 33334
Maitland Neurology
Maitland, Florida, United States, 32751
University of Miami, Department of Neurology
Miami, Florida, United States, 33136
United States, Georgia
The Multiple Sclerosis Center of Atlanta
Atlanta, Georgia, United States, 30327
Marietta Neurological Associates
Marietta, Georgia, United States, 30060
United States, Illinois
Alexian Brothers Center for Clinical Research
Elk Grove Village, Illinois, United States, 60007
Loyola Medical Center
Maywood, Illinois, United States, 60153
Northwestern University, Department of Neurology
Chicago, Illinois, United States, 60611
Springfield Clinic Neuroscience Institute
Springfield, Illinois, United States, 62702
Consultants in Neurology Northbrook
Northbrook, Illinois, United States, 60062
Rush-Presbyterian St. Luke's Medical Center
Chicago, Illinois, United States, 60612
United States, Indiana
Indiana University Medical Center
Indianapolis, Indiana, United States, 46202
United States, Iowa
Mercy Hospital Outpatient Pharmacy
Des Moines, Iowa, United States, 50314
United States, Louisiana
LSU Neurolgoy Clinic in New Orleans
New Orleans, Louisiana, United States, 70112
United States, Maine
Maine Neurology
Scarborough, Maine, United States, 04074-8926
United States, Maryland
University of Maryland Hospital, Department of Neurology
Baltimore, Maryland, United States, 21201
United States, Massachusetts
University of Massachusetts Memorial Medical Center
Worcester, Massachusetts, United States, 01655-0138
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
United States, Michigan
Michigan State University MS Clinic
East Lansing, Michigan, United States, 48824
Henry Ford Hospital
Detroit, Michigan, United States, 48202-2608
Michigan Institute for Neurological Disorders
Farmington Hills, Michigan, United States, 48334
United States, Minnesota
Noran Neurological Clinic
Minneapolis, Minnesota, United States, 55404
United States, Mississippi
University of Mississippi Medical Center
Jackson, Mississippi, United States, 39216-4505
United States, Missouri
St. John's Mercy Medical Center
St. Louis, Missouri, United States, 63141
United States, New Jersey
Bernard W. Gimbel MS Center
Teaneck, New Jersey, United States, 07666
United States, New York
Buffalo General Hospital, Department of Neurology
Buffalo, New York, United States, 14203
SUNY Upstate Medical University
Syracuse, New York, United States, 13210
Strong Health Pharmacy Services
Rochester, New York, United States, 14642
Maimonides Medical Center, Division of Neurology
Brooklyn, New York, United States, 11219
University Hospital at Stony Brook
Stony Brook, New York, United States, 11794
New York State Psychiatric Institution
New York, New York, United States, 10032
Staten Island University Hospital
Staten Island, New York, United States, 10305
New York Hospital - Cornell Medical Center
New York, New York, United States, 10021
MS Care Center
New York, New York, United States, 10003
Albany Medical Center
Albany, New York, United States, 12208
St. Luke's Roosevelt Hospital, MS Research & Treatment Center
New York, New York, United States, 10019
Upstate Clinical Research, LLC
Albany, New York, United States, 12205
United States, North Carolina
Wake Forest University School of Medicine, Department of Neurology
Winston-Salem, North Carolina, United States, 27157
Raleigh Neurology Associates
Raleigh, North Carolina, United States, 27607
MS Center at Carolinas Medical Center
Charlotte, North Carolina, United States, 28232-2861
United States, Ohio
Riverhills Neurology
Cincinnati, Ohio, United States, 45219
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
United States, Oregon
Providence Saint Vincent Medical Center
Portland, Oregon, United States, 97225
United States, Pennsylvania
Allegheny Singer Research Institute
Pittsburgh, Pennsylvania, United States, 15212
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Greenstein Neurology Associates & MS Institute
Philadelphia, Pennsylvania, United States, 19146
University of Pittsburgh, Department of Neurology
Pittsburgh, Pennsylvania, United States, 15213
Geisinger Medical Center
Danville, Pennsylvania, United States, 17822
United States, Tennessee
University of Tennessee - Memphis
Memphis, Tennessee, United States, 38163
Vanderbilt Medical Center
Nashville, Tennessee, United States, 37215
United States, Texas
Option Care Infusion
Dallas, Texas, United States, 75226
Central Texas Neurology
Round Rock, Texas, United States, 78681
UTSW Medical School
Dallas, Texas, United States, 75235-9036
Baylor Methodist International MS Center
Houston, Texas, United States, 77030
United States, Vermont
Fletcher Allen Health Care
Burlington, Vermont, United States, 05401
United States, Virginia
University of Virginia Health Sciences
Charlottesville, Virginia, United States, 22908
Neurological Associates, Inc.
Richmond, Virginia, United States, 23226
United States, Washington
MS Research Center
Seattle, Washington, United States, 98195
Virginia Mason Medical Center
Seattle, Washington, United States, 98111
United States, Wisconsin
St. Francis Hospital, Center for Neurological Disorders
Milwaukee, Wisconsin, United States, 53215
Austria
Universitatsklinik fur Neurologie
Innsbruck, Austria, 6020
Universitatsklinik fur Neurologie
Graz, Austria, 8036
Belgium
Elisabeth Ziekenhuis
Sijsele, Belgium, 8340
Hopital Universitaire U.L.B. Erasme
Brussels, Belgium, 1780
France
Hopital neurologique Pierre Werth
Lyon, France, 69394
Hopital Pellegrin Tripode, Neurologie
Bordeaux, France, 33076
Germany
Medizinische Hochschule Hannover, Neurologische Klinik
Hannover, Germany, 30625
Fachbereich Neurologie und Klinische Neurophysiologie
Wiesbaden, Germany, 65191
Judisches Krankenhaus
Berlin, Germany, 13347
Städtische Kliniken Osnabrück
Osnabrück, Germany, 49076
Asklepios Klinik Schildautal
Seesen/Harz, Germany, 38723
Neurologische Abteilung
Henningsdorf, Germany, 16761
Universitaetsklinikum Giessen, Oberarzt Neurologie
Giessen, Germany, 35390
Israel
Hadassah Hebrew Uni Hospital, Department of Neurology
Jerusalem, Israel
Sheba Medical Center, MS Center
Tel Hashomer, Israel, 52621
Italy
Universita di Genova, Clinica Neurologica
Genova, Italy, 16132
Sponsors and Collaborators
Biogen Idec
Elan Pharmaceuticals
Investigators
Study Director: Michael Panzara, MD, MPH Biogen Idec
Principal Investigator: Richard A Rudick, MD The Cleveland Clinic
  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:
Rudick RA, Stuart WH, Calabresi PA, Confavreux C, Galetta SL, Radue EW, Lublin FD, Weinstock-Guttman B, Wynn DR, Lynn F, Panzara MA, Sandrock AW; SENTINEL Investigators. Natalizumab plus interferon beta-1a for relapsing multiple sclerosis. N Engl J Med. 2006 Mar 2;354(9):911-23.

Responsible Party: Biogen Idec ( Biogen Idec MD )
Study ID Numbers: C-1802
Study First Received: February 15, 2002
Last Updated: June 17, 2009
ClinicalTrials.gov Identifier: NCT00030966     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by Biogen Idec:
Multiple Sclerosis
MS

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

ClinicalTrials.gov processed this record on November 25, 2009



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