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

Sponsor
Biogen (Industry)
Overall Status
Completed
CT.gov ID
NCT00030966
Collaborator
Elan Pharmaceuticals (Industry)
1,200
Enrollment
88
Locations
2
Arms
47
Duration (Months)
13.6
Patients Per Site
0.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
1200 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, 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, When Added to Avonex® (Interferon Beta-1a), in Subjects With Relapsing-Remitting Multiple Sclerosis
Study Start Date :
Jan 1, 2002
Actual Primary Completion Date :
Apr 1, 2005
Actual Study Completion Date :
Dec 1, 2005

Arms and Interventions

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.

    Outcome Measures

    Primary Outcome Measures

    1. 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. [1 year and 2 years]

    Secondary Outcome Measures

    1. If this combination reduces MRI lesions and the overall rate of clinical relapses [1 year and 2 years]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 55 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 University of Alabama-Birmingham, Department of Neurology Birmingham Alabama United States 35233
    2 Phoenix Neurological Associates, Ltd. Phoenix Arizona United States 85008
    3 University of Arkansas For Medical Sciences Little Rock Arkansas United States 72205
    4 University of California - Irvine Irvine California United States 92697
    5 USC MS Comprehensive Care Center Los Angeles California United States 90033
    6 Kaiser-Permanente Medical Center Redwood City California United States 94063
    7 MS Center at UCSF San Francisco California United States 94117
    8 Healthsouth Rehabilitation Hospital Colorado Springs Colorado United States 80910
    9 University of Colorado MS Center Denver Colorado United States 80262
    10 Griffin Hospital Derby Connecticut United States 06418
    11 Georgetown Univesity Hospital, Research Pharmacy Washington District of Columbia United States 20007
    12 George Washington University MS Center Washington District of Columbia United States 20037
    13 North Ridge NeuroScience Center Ft. Lauderdale Florida United States 33334
    14 Maitland Neurology Maitland Florida United States 32751
    15 University of Miami, Department of Neurology Miami Florida United States 33136
    16 The Multiple Sclerosis Center of Atlanta Atlanta Georgia United States 30327
    17 Marietta Neurological Associates Marietta Georgia United States 30060
    18 Northwestern University, Department of Neurology Chicago Illinois United States 60611
    19 Rush-Presbyterian St. Luke's Medical Center Chicago Illinois United States 60612
    20 Alexian Brothers Center for Clinical Research Elk Grove Village Illinois United States 60007
    21 Loyola Medical Center Maywood Illinois United States 60153
    22 Consultants in Neurology Northbrook Northbrook Illinois United States 60062
    23 Springfield Clinic Neuroscience Institute Springfield Illinois United States 62702
    24 Indiana University Medical Center Indianapolis Indiana United States 46202
    25 Mercy Hospital Outpatient Pharmacy Des Moines Iowa United States 50314
    26 LSU Neurolgoy Clinic in New Orleans New Orleans Louisiana United States 70112
    27 Maine Neurology Scarborough Maine United States 04074-8926
    28 University of Maryland Hospital, Department of Neurology Baltimore Maryland United States 21201
    29 Brigham and Women's Hospital Boston Massachusetts United States 02115
    30 University of Massachusetts Memorial Medical Center Worcester Massachusetts United States 01655-0138
    31 Henry Ford Hospital Detroit Michigan United States 48202-2608
    32 Michigan State University MS Clinic East Lansing Michigan United States 48824
    33 Michigan Institute for Neurological Disorders Farmington Hills Michigan United States 48334
    34 Noran Neurological Clinic Minneapolis Minnesota United States 55404
    35 University of Mississippi Medical Center Jackson Mississippi United States 39216-4505
    36 St. John's Mercy Medical Center St. Louis Missouri United States 63141
    37 Bernard W. Gimbel MS Center Teaneck New Jersey United States 07666
    38 Upstate Clinical Research, LLC Albany New York United States 12205
    39 Albany Medical Center Albany New York United States 12208
    40 Maimonides Medical Center, Division of Neurology Brooklyn New York United States 11219
    41 Buffalo General Hospital, Department of Neurology Buffalo New York United States 14203
    42 MS Care Center New York New York United States 10003
    43 St. Luke's Roosevelt Hospital, MS Research & Treatment Center New York New York United States 10019
    44 New York Hospital - Cornell Medical Center New York New York United States 10021
    45 New York State Psychiatric Institution New York New York United States 10032
    46 Strong Health Pharmacy Services Rochester New York United States 14642
    47 Staten Island University Hospital Staten Island New York United States 10305
    48 University Hospital at Stony Brook Stony Brook New York United States 11794
    49 SUNY Upstate Medical University Syracuse New York United States 13210
    50 MS Center at Carolinas Medical Center Charlotte North Carolina United States 28232-2861
    51 Raleigh Neurology Associates Raleigh North Carolina United States 27607
    52 Wake Forest University School of Medicine, Department of Neurology Winston-Salem North Carolina United States 27157
    53 Riverhills Neurology Cincinnati Ohio United States 45219
    54 Cleveland Clinic Foundation Cleveland Ohio United States 44195
    55 Providence Saint Vincent Medical Center Portland Oregon United States 97225
    56 Geisinger Medical Center Danville Pennsylvania United States 17822
    57 Hospital of the University of Pennsylvania Philadelphia Pennsylvania United States 19104
    58 Greenstein Neurology Associates & MS Institute Philadelphia Pennsylvania United States 19146
    59 Allegheny Singer Research Institute Pittsburgh Pennsylvania United States 15212
    60 University of Pittsburgh, Department of Neurology Pittsburgh Pennsylvania United States 15213
    61 University of Tennessee - Memphis Memphis Tennessee United States 38163
    62 Vanderbilt Medical Center Nashville Tennessee United States 37215
    63 Option Care Infusion Dallas Texas United States 75226
    64 UTSW Medical School Dallas Texas United States 75235-9036
    65 Baylor Methodist International MS Center Houston Texas United States 77030
    66 Central Texas Neurology Round Rock Texas United States 78681
    67 Fletcher Allen Health Care Burlington Vermont United States 05401
    68 University of Virginia Health Sciences Charlottesville Virginia United States 22908
    69 Neurological Associates, Inc. Richmond Virginia United States 23226
    70 Virginia Mason Medical Center Seattle Washington United States 98111
    71 MS Research Center Seattle Washington United States 98195
    72 St. Francis Hospital, Center for Neurological Disorders Milwaukee Wisconsin United States 53215
    73 Universitatsklinik fur Neurologie Graz Austria 8036
    74 Universitatsklinik fur Neurologie Innsbruck Austria 6020
    75 Hopital Universitaire U.L.B. Erasme Brussels Belgium 1780
    76 Elisabeth Ziekenhuis Sijsele Belgium 8340
    77 Hopital Pellegrin Tripode, Neurologie Bordeaux France 33076
    78 Hopital neurologique Pierre Werth Lyon France 69394
    79 Judisches Krankenhaus Berlin Germany 13347
    80 Universitaetsklinikum Giessen, Oberarzt Neurologie Giessen Germany 35390
    81 Medizinische Hochschule Hannover, Neurologische Klinik Hannover Germany 30625
    82 Neurologische Abteilung Henningsdorf Germany 16761
    83 Städtische Kliniken Osnabrück Osnabrück Germany 49076
    84 Asklepios Klinik Schildautal Seesen/Harz Germany 38723
    85 Fachbereich Neurologie und Klinische Neurophysiologie Wiesbaden Germany 65191
    86 Hadassah Hebrew Uni Hospital, Department of Neurology Jerusalem Israel
    87 Sheba Medical Center, MS Center Tel Hashomer Israel 52621
    88 Universita di Genova, Clinica Neurologica Genova Italy 16132

    Sponsors and Collaborators

    • Biogen
    • Elan Pharmaceuticals

    Investigators

    • Study Director: Michael Panzara, MD, MPH, Biogen
    • Principal Investigator: Richard A Rudick, MD, The Cleveland Clinic

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00030966
    Other Study ID Numbers:
    • C-1802
    First Posted:
    Feb 18, 2002
    Last Update Posted:
    Jun 18, 2009
    Last Verified:
    Jun 1, 2009
    Keywords provided by , ,
    Multiple Sclerosis
    MS
    Additional relevant MeSH terms:
    Multiple Sclerosis
    Multiple Sclerosis, Relapsing-Remitting
    Sclerosis
    Natalizumab

    Study Results

    No Results Posted as of Jun 18, 2009