AzTrials
AzTrials

Multiple Sclerosis, Relapsing-RemittingPhase 3NCT00030966

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

A Phase 3 study testing Natalizumab in people with Multiple Sclerosis, Relapsing-Remitting, run by Biogen at 88 sites in 7 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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). Read more about this study

Who is it for?
Ages 18 to 55 years
Conditions the study is for
Multiple Sclerosis, Relapsing-Remitting
What is being tested?
Natalizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,200 participants
Where
88 sitesin 7 countries
Study dates
Jan 2002to Dec 2005
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 55 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

88 sites in 7 countries.

88 sites in 7 countries

United States72 sites

  • Upstate Clinical Research, LLC

    Albany, New York, 12205

  • Albany Medical Center

    Albany, New York, 12208

  • The Multiple Sclerosis Center of Atlanta

    Atlanta, Georgia, 30327

  • University of Maryland Hospital, Department of Neurology

    Baltimore, Maryland, 21201

  • University of Alabama-Birmingham, Department of Neurology

    Birmingham, Alabama, 35233

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115

  • Maimonides Medical Center, Division of Neurology

    Brooklyn, New York, 11219

  • Buffalo General Hospital, Department of Neurology

    Buffalo, New York, 14203

  • Fletcher Allen Health Care

    Burlington, Vermont, 05401

  • MS Center at Carolinas Medical Center

    Charlotte, North Carolina, 28232-2861

  • University of Virginia Health Sciences

    Charlottesville, Virginia, 22908

  • Northwestern University, Department of Neurology

    Chicago, Illinois, 60611

  • Rush-Presbyterian St. Luke's Medical Center

    Chicago, Illinois, 60612

  • Riverhills Neurology

    Cincinnati, Ohio, 45219

  • Cleveland Clinic Foundation

    Cleveland, Ohio, 44195

  • Healthsouth Rehabilitation Hospital

    Colorado Springs, Colorado, 80910

  • Option Care Infusion

    Dallas, Texas, 75226

  • UTSW Medical School

    Dallas, Texas, 75235-9036

  • Geisinger Medical Center

    Danville, Pennsylvania, 17822

  • University of Colorado MS Center

    Denver, Colorado, 80262

  • Griffin Hospital

    Derby, Connecticut, 06418

  • Mercy Hospital Outpatient Pharmacy

    Des Moines, Iowa, 50314

  • Henry Ford Hospital

    Detroit, Michigan, 48202-2608

  • Michigan State University MS Clinic

    East Lansing, Michigan, 48824

  • Alexian Brothers Center for Clinical Research

    Elk Grove Village, Illinois, 60007

  • Michigan Institute for Neurological Disorders

    Farmington Hills, Michigan, 48334

  • North Ridge NeuroScience Center

    Fort Lauderdale, Florida, 33334

  • Baylor Methodist International MS Center

    Houston, Texas, 77030

  • Indiana University Medical Center

    Indianapolis, Indiana, 46202

  • University of California - Irvine

    Irvine, California, 92697

  • University of Mississippi Medical Center

    Jackson, Mississippi, 39216-4505

  • University of Arkansas For Medical Sciences

    Little Rock, Arkansas, 72205

  • USC MS Comprehensive Care Center

    Los Angeles, California, 90033

  • Maitland Neurology

    Maitland, Florida, 32751

  • Marietta Neurological Associates

    Marietta, Georgia, 30060

  • Loyola Medical Center

    Maywood, Illinois, 60153

  • University of Tennessee - Memphis

    Memphis, Tennessee, 38163

  • University of Miami, Department of Neurology

    Miami, Florida, 33136

  • St. Francis Hospital, Center for Neurological Disorders

    Milwaukee, Wisconsin, 53215

  • Noran Neurological Clinic

    Minneapolis, Minnesota, 55404

  • Vanderbilt Medical Center

    Nashville, Tennessee, 37215

  • LSU Neurolgoy Clinic in New Orleans

    New Orleans, Louisiana, 70112

  • MS Care Center

    New York, New York, 10003

  • St. Luke's Roosevelt Hospital, MS Research & Treatment Center

    New York, New York, 10019

  • New York Hospital - Cornell Medical Center

    New York, New York, 10021

  • New York State Psychiatric Institution

    New York, New York, 10032

  • Consultants in Neurology Northbrook

    Northbrook, Illinois, 60062

  • Hospital of the University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

  • Greenstein Neurology Associates & MS Institute

    Philadelphia, Pennsylvania, 19146

  • Phoenix Neurological Associates, Ltd.

    Phoenix, Arizona, 85008

  • Allegheny Singer Research Institute

    Pittsburgh, Pennsylvania, 15212

  • University of Pittsburgh, Department of Neurology

    Pittsburgh, Pennsylvania, 15213

  • Providence Saint Vincent Medical Center

    Portland, Oregon, 97225

  • Raleigh Neurology Associates

    Raleigh, North Carolina, 27607

  • Kaiser-Permanente Medical Center

    Redwood City, California, 94063

  • Neurological Associates, Inc.

    Richmond, Virginia, 23226

  • Strong Health Pharmacy Services

    Rochester, New York, 14642

  • Central Texas Neurology

    Round Rock, Texas, 78681

  • MS Center at UCSF

    San Francisco, California, 94117

  • Maine Neurology

    Scarborough, Maine, 04074-8926

  • Virginia Mason Medical Center

    Seattle, Washington, 98111

  • MS Research Center

    Seattle, Washington, 98195

  • Springfield Clinic Neuroscience Institute

    Springfield, Illinois, 62702

  • St. John's Mercy Medical Center

    St Louis, Missouri, 63141

  • Staten Island University Hospital

    Staten Island, New York, 10305

  • University Hospital at Stony Brook

    Stony Brook, New York, 11794

  • SUNY Upstate Medical University

    Syracuse, New York, 13210

  • Bernard W. Gimbel MS Center

    Teaneck, New Jersey, 07666

  • Georgetown Univesity Hospital, Research Pharmacy

    Washington D.C., District of Columbia, 20007

  • George Washington University MS Center

    Washington D.C., District of Columbia, 20037

  • Wake Forest University School of Medicine, Department of Neurology

    Winston-Salem, North Carolina, 27157

  • University of Massachusetts Memorial Medical Center

    Worcester, Massachusetts, 01655-0138

Other trials in United States

Germany7 sites

  • Judisches Krankenhaus

    Berlin, 13347

  • Universitaetsklinikum Giessen, Oberarzt Neurologie

    Giessen, 35390

  • Medizinische Hochschule Hannover, Neurologische Klinik

    Hanover, 30625

  • Neurologische Abteilung

    Henningsdorf, 16761

  • Städtische Kliniken Osnabrück

    Osnabrück, 49076

  • Asklepios Klinik Schildautal

    Seesen/Harz, 38723

  • Fachbereich Neurologie und Klinische Neurophysiologie

    Wiesbaden, 65191

Other trials in Germany

Austria2 sites

  • Universitatsklinik fur Neurologie

    Graz, 8036

  • Universitatsklinik fur Neurologie

    Innsbruck, 6020

Other trials in Austria

Belgium2 sites

  • Hopital Universitaire U.L.B. Erasme

    Brussels, 1780

  • Elisabeth Ziekenhuis

    Sijsele, 8340

Other trials in Belgium

France2 sites

  • Hopital Pellegrin Tripode, Neurologie

    Bordeaux, 33076

  • Hopital neurologique Pierre Werth

    Lyon, 69394

Other trials in France

Israel2 sites

  • Hadassah Hebrew Uni Hospital, Department of Neurology

    Jerusalem

  • Sheba Medical Center, MS Center

    Tel HaShomer, 52621

Other trials in Israel

Italy1 site

  • Universita di Genova, Clinica Neurologica

    Genova, 16132

Other trials in Italy

About this 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

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).

Being tested
Natalizumab, Placebo
Keywords
Multiple Sclerosis, MS
Medical subject headings
Multiple Sclerosis, Relapsing-Remitting, Multiple Sclerosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NatalizumabDrug

    Also called Tysabri

    Natalizumab, 300 mg, monthly IV infusion for up to 116 weeks.

  • PlaceboDrug

    Placebo monthly infusion for up to 116 weeks.

Study groups in NCT00030966
Study groupRoleWhat they receive
Group 1ExperimentalAdding natalizumab monthly infusion to Avonex weekly injection for up to 116 weeks.
Receives: Drug: Natalizumab
Group 2Placebo comparatorAdding placebo monthly infusion to Avonex weekly injection for up to 116 weeks.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 1 year and 2 years

Secondary outcomes (1)

  1. If this combination reduces MRI lesions and the overall rate of clinical relapses

    Measured: 1 year and 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Feb 2002 (estimated)
  2. Study startJan 2002
  3. Primary completionApr 2005
  4. Study completionDec 2005

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
1,200 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00030966
Sponsor's protocol ID
C-1802
Status last verified
Jun 2009
First submitted
15 Feb 2002
Last updated
18 Jun 2009
Results posted
No
Data monitoring committee
Yes

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. doi: 10.1056/NEJMoa044396.

    PubMed 16510745

  • Strijbis 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.

    PubMed 37173129

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Natalizumab in people with Multiple Sclerosis, Relapsing-Remitting, run by Biogen at 88 sites in 7 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Jun 2009. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 88 sites in United States, Germany, Austria, Belgium, France and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00030966, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2009.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in