Safety and Efficacy of Natalizumab in Combination With Avonex in the Treatment of Multiple Sclerosis
- Conditions
- Multiple Sclerosis, Relapsing-Remitting
- Interventions
- Drug: Placebo
- Registration Number
- NCT00030966
- Lead Sponsor
- Biogen
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1200
- 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.
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group 1 Natalizumab Adding natalizumab monthly infusion to Avonex weekly injection for up to 116 weeks. Group 2 Placebo Adding placebo monthly infusion to Avonex weekly injection for up to 116 weeks.
- Primary Outcome Measures
Name Time Method 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
Name Time Method If this combination reduces MRI lesions and the overall rate of clinical relapses 1 year and 2 years
Trial Locations
- Locations (87)
Mercy Hospital Outpatient Pharmacy
🇺🇸Des Moines, Iowa, United States
University of Pittsburgh, Department of Neurology
🇺🇸Pittsburgh, Pennsylvania, United States
Asklepios Klinik Schildautal
🇩🇪Seesen/Harz, Germany
Brigham and Women's Hospital
🇺🇸Boston, Massachusetts, United States
MS Care Center
🇺🇸New York, New York, United States
Michigan Institute for Neurological Disorders
🇺🇸Farmington Hills, Michigan, United States
Staten Island University Hospital
🇺🇸Staten Island, New York, United States
New York State Psychiatric Institution
🇺🇸New York, New York, United States
Upstate Clinical Research, LLC
🇺🇸Albany, New York, United States
Hospital of the University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
UTSW Medical School
🇺🇸Dallas, Texas, United States
Cleveland Clinic Foundation
🇺🇸Cleveland, Ohio, United States
Elisabeth Ziekenhuis
🇧🇪Sijsele, Belgium
University of Tennessee - Memphis
🇺🇸Memphis, Tennessee, United States
Universitatsklinik fur Neurologie
🇦🇹Innsbruck, Austria
University of Miami, Department of Neurology
🇺🇸Miami, Florida, United States
Riverhills Neurology
🇺🇸Cincinnati, Ohio, United States
Baylor Methodist International MS Center
🇺🇸Houston, Texas, United States
University of California - Irvine
🇺🇸Irvine, California, United States
USC MS Comprehensive Care Center
🇺🇸Los Angeles, California, United States
The Multiple Sclerosis Center of Atlanta
🇺🇸Atlanta, Georgia, United States
Loyola Medical Center
🇺🇸Maywood, Illinois, United States
Indiana University Medical Center
🇺🇸Indianapolis, Indiana, United States
Springfield Clinic Neuroscience Institute
🇺🇸Springfield, Illinois, United States
Consultants in Neurology Northbrook
🇺🇸Northbrook, Illinois, United States
St. John's Mercy Medical Center
🇺🇸St. Louis, Missouri, United States
Buffalo General Hospital, Department of Neurology
🇺🇸Buffalo, New York, United States
St. Luke's Roosevelt Hospital, MS Research & Treatment Center
🇺🇸New York, New York, United States
Albany Medical Center
🇺🇸Albany, New York, United States
Strong Health Pharmacy Services
🇺🇸Rochester, New York, United States
Raleigh Neurology Associates
🇺🇸Raleigh, North Carolina, United States
Geisinger Medical Center
🇺🇸Danville, Pennsylvania, United States
Greenstein Neurology Associates & MS Institute
🇺🇸Philadelphia, Pennsylvania, United States
Option Care Infusion
🇺🇸Dallas, Texas, United States
Central Texas Neurology
🇺🇸Round Rock, Texas, United States
University of Virginia Health Sciences
🇺🇸Charlottesville, Virginia, United States
Virginia Mason Medical Center
🇺🇸Seattle, Washington, United States
Noran Neurological Clinic
🇺🇸Minneapolis, Minnesota, United States
Healthsouth Rehabilitation Hospital
🇺🇸Colorado Springs, Colorado, United States
University of Mississippi Medical Center
🇺🇸Jackson, Mississippi, United States
University of Alabama-Birmingham, Department of Neurology
🇺🇸Birmingham, Alabama, United States
Phoenix Neurological Associates, Ltd.
🇺🇸Phoenix, Arizona, United States
MS Center at UCSF
🇺🇸San Francisco, California, United States
University of Colorado MS Center
🇺🇸Denver, Colorado, United States
Henry Ford Hospital
🇺🇸Detroit, Michigan, United States
St. Francis Hospital, Center for Neurological Disorders
🇺🇸Milwaukee, Wisconsin, United States
Vanderbilt Medical Center
🇺🇸Nashville, Tennessee, United States
Providence Saint Vincent Medical Center
🇺🇸Portland, Oregon, United States
Wake Forest University School of Medicine, Department of Neurology
🇺🇸Winston-Salem, North Carolina, United States
Kaiser-Permanente Medical Center
🇺🇸Redwood City, California, United States
Griffin Hospital
🇺🇸Derby, Connecticut, United States
George Washington University MS Center
🇺🇸Washington, District of Columbia, United States
North Ridge NeuroScience Center
🇺🇸Ft. Lauderdale, Florida, United States
Maitland Neurology
🇺🇸Maitland, Florida, United States
Marietta Neurological Associates
🇺🇸Marietta, Georgia, United States
Alexian Brothers Center for Clinical Research
🇺🇸Elk Grove Village, Illinois, United States
Rush-Presbyterian St. Luke's Medical Center
🇺🇸Chicago, Illinois, United States
Northwestern University, Department of Neurology
🇺🇸Chicago, Illinois, United States
University of Maryland Hospital, Department of Neurology
🇺🇸Baltimore, Maryland, United States
New York Hospital - Cornell Medical Center
🇺🇸New York, New York, United States
University Hospital at Stony Brook
🇺🇸Stony Brook, New York, United States
MS Center at Carolinas Medical Center
🇺🇸Charlotte, North Carolina, United States
SUNY Upstate Medical University
🇺🇸Syracuse, New York, United States
Allegheny Singer Research Institute
🇺🇸Pittsburgh, Pennsylvania, United States
Hopital Universitaire U.L.B. Erasme
🇧🇪Brussels, Belgium
MS Research Center
🇺🇸Seattle, Washington, United States
Fletcher Allen Health Care
🇺🇸Burlington, Vermont, United States
Städtische Kliniken Osnabrück
🇩🇪Osnabrück, Germany
Universitaetsklinikum Giessen, Oberarzt Neurologie
🇩🇪Giessen, Germany
Medizinische Hochschule Hannover, Neurologische Klinik
🇩🇪Hannover, Germany
Hopital neurologique Pierre Werth
🇫🇷Lyon, France
Neurologische Abteilung
🇩🇪Henningsdorf, Germany
Maimonides Medical Center, Division of Neurology
🇺🇸Brooklyn, New York, United States
Fachbereich Neurologie und Klinische Neurophysiologie
🇩🇪Wiesbaden, Germany
University of Massachusetts Memorial Medical Center
🇺🇸Worcester, Massachusetts, United States
University of Arkansas For Medical Sciences
🇺🇸Little Rock, Arkansas, United States
Hadassah Hebrew Uni Hospital, Department of Neurology
🇮🇱Jerusalem, Israel
Georgetown Univesity Hospital, Research Pharmacy
🇺🇸Washington, District of Columbia, United States
Judisches Krankenhaus
🇩🇪Berlin, Germany
Hopital Pellegrin Tripode, Neurologie
🇫🇷Bordeaux, France
Universita di Genova, Clinica Neurologica
🇮🇹Genova, Italy
Maine Neurology
🇺🇸Scarborough, Maine, United States
Sheba Medical Center, MS Center
🇮🇱Tel Hashomer, Israel
Bernard W. Gimbel MS Center
🇺🇸Teaneck, New Jersey, United States
Michigan State University MS Clinic
🇺🇸East Lansing, Michigan, United States
Neurological Associates, Inc.
🇺🇸Richmond, Virginia, United States
LSU Neurolgoy Clinic in New Orleans
🇺🇸New Orleans, Louisiana, United States