Safety and Efficacy of Natalizumab in Combination With Avonex in the Treatment of Multiple Sclerosis
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
1 other identifier
interventional
1,200
7 countries
88
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jan 2002
Typical duration for phase_3
88 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2002
CompletedFirst Submitted
Initial submission to the registry
February 15, 2002
CompletedFirst Posted
Study publicly available on registry
February 18, 2002
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2005
CompletedJune 18, 2009
June 1, 2009
3.2 years
February 15, 2002
June 17, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (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 Outcomes (1)
If this combination reduces MRI lesions and the overall rate of clinical relapses
1 year and 2 years
Study Arms (2)
Group 1
EXPERIMENTALAdding natalizumab monthly infusion to Avonex weekly injection for up to 116 weeks.
Group 2
PLACEBO COMPARATORAdding placebo monthly infusion to Avonex weekly injection for up to 116 weeks.
Interventions
Natalizumab, 300 mg, monthly IV infusion for up to 116 weeks.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Biogenlead
- Elan Pharmaceuticalscollaborator
Study Sites (88)
University of Alabama-Birmingham, Department of Neurology
Birmingham, Alabama, 35233, United States
Phoenix Neurological Associates, Ltd.
Phoenix, Arizona, 85008, United States
University of Arkansas For Medical Sciences
Little Rock, Arkansas, 72205, United States
University of California - Irvine
Irvine, California, 92697, United States
USC MS Comprehensive Care Center
Los Angeles, California, 90033, United States
Kaiser-Permanente Medical Center
Redwood City, California, 94063, United States
MS Center at UCSF
San Francisco, California, 94117, United States
Healthsouth Rehabilitation Hospital
Colorado Springs, Colorado, 80910, United States
University of Colorado MS Center
Denver, Colorado, 80262, United States
Griffin Hospital
Derby, Connecticut, 06418, United States
Georgetown Univesity Hospital, Research Pharmacy
Washington D.C., District of Columbia, 20007, United States
George Washington University MS Center
Washington D.C., District of Columbia, 20037, United States
North Ridge NeuroScience Center
Fort Lauderdale, Florida, 33334, United States
Maitland Neurology
Maitland, Florida, 32751, United States
University of Miami, Department of Neurology
Miami, Florida, 33136, United States
The Multiple Sclerosis Center of Atlanta
Atlanta, Georgia, 30327, United States
Marietta Neurological Associates
Marietta, Georgia, 30060, United States
Northwestern University, Department of Neurology
Chicago, Illinois, 60611, United States
Rush-Presbyterian St. Luke's Medical Center
Chicago, Illinois, 60612, United States
Alexian Brothers Center for Clinical Research
Elk Grove Village, Illinois, 60007, United States
Loyola Medical Center
Maywood, Illinois, 60153, United States
Consultants in Neurology Northbrook
Northbrook, Illinois, 60062, United States
Springfield Clinic Neuroscience Institute
Springfield, Illinois, 62702, United States
Indiana University Medical Center
Indianapolis, Indiana, 46202, United States
Mercy Hospital Outpatient Pharmacy
Des Moines, Iowa, 50314, United States
LSU Neurolgoy Clinic in New Orleans
New Orleans, Louisiana, 70112, United States
Maine Neurology
Scarborough, Maine, 04074-8926, United States
University of Maryland Hospital, Department of Neurology
Baltimore, Maryland, 21201, United States
Brigham and Women's Hospital
Boston, Massachusetts, 02115, United States
University of Massachusetts Memorial Medical Center
Worcester, Massachusetts, 01655-0138, United States
Henry Ford Hospital
Detroit, Michigan, 48202-2608, United States
Michigan State University MS Clinic
East Lansing, Michigan, 48824, United States
Michigan Institute for Neurological Disorders
Farmington Hills, Michigan, 48334, United States
Noran Neurological Clinic
Minneapolis, Minnesota, 55404, United States
University of Mississippi Medical Center
Jackson, Mississippi, 39216-4505, United States
St. John's Mercy Medical Center
St Louis, Missouri, 63141, United States
Bernard W. Gimbel MS Center
Teaneck, New Jersey, 07666, United States
Upstate Clinical Research, LLC
Albany, New York, 12205, United States
Albany Medical Center
Albany, New York, 12208, United States
Maimonides Medical Center, Division of Neurology
Brooklyn, New York, 11219, United States
Buffalo General Hospital, Department of Neurology
Buffalo, New York, 14203, United States
MS Care Center
New York, New York, 10003, United States
St. Luke's Roosevelt Hospital, MS Research & Treatment Center
New York, New York, 10019, United States
New York Hospital - Cornell Medical Center
New York, New York, 10021, United States
New York State Psychiatric Institution
New York, New York, 10032, United States
Strong Health Pharmacy Services
Rochester, New York, 14642, United States
Staten Island University Hospital
Staten Island, New York, 10305, United States
University Hospital at Stony Brook
Stony Brook, New York, 11794, United States
SUNY Upstate Medical University
Syracuse, New York, 13210, United States
MS Center at Carolinas Medical Center
Charlotte, North Carolina, 28232-2861, United States
Raleigh Neurology Associates
Raleigh, North Carolina, 27607, United States
Wake Forest University School of Medicine, Department of Neurology
Winston-Salem, North Carolina, 27157, United States
Riverhills Neurology
Cincinnati, Ohio, 45219, United States
Cleveland Clinic Foundation
Cleveland, Ohio, 44195, United States
Providence Saint Vincent Medical Center
Portland, Oregon, 97225, United States
Geisinger Medical Center
Danville, Pennsylvania, 17822, United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Greenstein Neurology Associates & MS Institute
Philadelphia, Pennsylvania, 19146, United States
Allegheny Singer Research Institute
Pittsburgh, Pennsylvania, 15212, United States
University of Pittsburgh, Department of Neurology
Pittsburgh, Pennsylvania, 15213, United States
University of Tennessee - Memphis
Memphis, Tennessee, 38163, United States
Vanderbilt Medical Center
Nashville, Tennessee, 37215, United States
Option Care Infusion
Dallas, Texas, 75226, United States
UTSW Medical School
Dallas, Texas, 75235-9036, United States
Baylor Methodist International MS Center
Houston, Texas, 77030, United States
Central Texas Neurology
Round Rock, Texas, 78681, United States
Fletcher Allen Health Care
Burlington, Vermont, 05401, United States
University of Virginia Health Sciences
Charlottesville, Virginia, 22908, United States
Neurological Associates, Inc.
Richmond, Virginia, 23226, United States
Virginia Mason Medical Center
Seattle, Washington, 98111, United States
MS Research Center
Seattle, Washington, 98195, United States
St. Francis Hospital, Center for Neurological Disorders
Milwaukee, Wisconsin, 53215, United States
Universitatsklinik fur Neurologie
Graz, 8036, Austria
Universitatsklinik fur Neurologie
Innsbruck, 6020, Austria
Hopital Universitaire U.L.B. Erasme
Brussels, 1780, Belgium
Elisabeth Ziekenhuis
Sijsele, 8340, Belgium
Hopital Pellegrin Tripode, Neurologie
Bordeaux, 33076, France
Hopital neurologique Pierre Werth
Lyon, 69394, France
Judisches Krankenhaus
Berlin, 13347, Germany
Universitaetsklinikum Giessen, Oberarzt Neurologie
Giessen, 35390, Germany
Medizinische Hochschule Hannover, Neurologische Klinik
Hanover, 30625, Germany
Neurologische Abteilung
Henningsdorf, 16761, Germany
Städtische Kliniken Osnabrück
Osnabrück, 49076, Germany
Asklepios Klinik Schildautal
Seesen/Harz, 38723, Germany
Fachbereich Neurologie und Klinische Neurophysiologie
Wiesbaden, 65191, Germany
Hadassah Hebrew Uni Hospital, Department of Neurology
Jerusalem, Israel
Sheba Medical Center, MS Center
Tel Litwinsky, 52621, Israel
Universita di Genova, Clinica Neurologica
Genova, 16132, Italy
Related Publications (2)
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. doi: 10.1056/NEJMoa044396.
PMID: 16510745RESULTStrijbis EM, Coerver E, Mostert J, van Kempen ZLE, Killestein J, Comtois J, Repovic P, Bowen JD, Cutter G, Koch M. Association of age and inflammatory disease activity in the pivotal natalizumab clinical trials in relapsing-remitting multiple sclerosis. J Neurol Neurosurg Psychiatry. 2023 Oct;94(10):792-799. doi: 10.1136/jnnp-2022-330887. Epub 2023 May 12.
PMID: 37173129DERIVED
Related Links
- The web site of the National Multiple Sclerosis Society, an organization dedicated to providing information to individuals with MS, their families and healthcare providers.
- MSActiveSource.com is a resource for news, information and disease management for all individuals touched by multiple sclerosis. This site is sponsored by Biogen.
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Michael Panzara, MD, MPH
Biogen
- PRINCIPAL INVESTIGATOR
Richard A Rudick, MD
The Cleveland Clinic
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
February 15, 2002
First Posted
February 18, 2002
Study Start
January 1, 2002
Primary Completion
April 1, 2005
Study Completion
December 1, 2005
Last Updated
June 18, 2009
Record last verified: 2009-06