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

PHASE3CompletedINTERVENTIONAL
Enrollment

1,200

Participants

Timeline

Start Date

January 31, 2002

Primary Completion Date

April 30, 2005

Study Completion Date

December 31, 2005

Conditions
Multiple Sclerosis, Relapsing-Remitting
Interventions
DRUG

Natalizumab

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

DRUG

Placebo

Placebo monthly infusion for up to 116 weeks.

Trial Locations (88)

1780

Hopital Universitaire U.L.B. Erasme, Brussels

6020

Universitatsklinik fur Neurologie, Innsbruck

8036

Universitatsklinik fur Neurologie, Graz

8340

Elisabeth Ziekenhuis, Sijsele

10003

MS Care Center, New York

10019

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

10021

New York Hospital - Cornell Medical Center, New York

10032

New York State Psychiatric Institution, New York

10305

Staten Island University Hospital, Staten Island

11219

Maimonides Medical Center, Division of Neurology, Brooklyn

11794

University Hospital at Stony Brook, Stony Brook

12205

Upstate Clinical Research, LLC, Albany

12208

Albany Medical Center, Albany

13210

SUNY Upstate Medical University, Syracuse

13347

Judisches Krankenhaus, Berlin

14203

Buffalo General Hospital, Department of Neurology, Buffalo

14642

Strong Health Pharmacy Services, Rochester

15212

Allegheny Singer Research Institute, Pittsburgh

15213

University of Pittsburgh, Department of Neurology, Pittsburgh

16132

Universita di Genova, Clinica Neurologica, Genova

16761

Neurologische Abteilung, Henningsdorf

17822

Geisinger Medical Center, Danville

19104

Hospital of the University of Pennsylvania, Philadelphia

19146

Greenstein Neurology Associates & MS Institute, Philadelphia

20007

Georgetown Univesity Hospital, Research Pharmacy, Washington D.C.

20037

George Washington University MS Center, Washington D.C.

21201

University of Maryland Hospital, Department of Neurology, Baltimore

22908

University of Virginia Health Sciences, Charlottesville

23226

Neurological Associates, Inc., Richmond

27157

Wake Forest University School of Medicine, Department of Neurology, Winston-Salem

27607

Raleigh Neurology Associates, Raleigh

30060

Marietta Neurological Associates, Marietta

30327

The Multiple Sclerosis Center of Atlanta, Atlanta

30625

Medizinische Hochschule Hannover, Neurologische Klinik, Hanover

32751

Maitland Neurology, Maitland

33076

Hopital Pellegrin Tripode, Neurologie, Bordeaux

33136

University of Miami, Department of Neurology, Miami

33334

North Ridge NeuroScience Center, Fort Lauderdale

35233

University of Alabama-Birmingham, Department of Neurology, Birmingham

35390

Universitaetsklinikum Giessen, Oberarzt Neurologie, Giessen

37215

Vanderbilt Medical Center, Nashville

38163

University of Tennessee - Memphis, Memphis

38723

Asklepios Klinik Schildautal, Seesen/Harz

44195

Cleveland Clinic Foundation, Cleveland

45219

Riverhills Neurology, Cincinnati

46202

Indiana University Medical Center, Indianapolis

48334

Michigan Institute for Neurological Disorders, Farmington Hills

48824

Michigan State University MS Clinic, East Lansing

49076

Städtische Kliniken Osnabrück, Osnabrück

50314

Mercy Hospital Outpatient Pharmacy, Des Moines

52621

Sheba Medical Center, MS Center, Tel Litwinsky

53215

St. Francis Hospital, Center for Neurological Disorders, Milwaukee

55404

Noran Neurological Clinic, Minneapolis

60007

Alexian Brothers Center for Clinical Research, Elk Grove Village

60062

Consultants in Neurology Northbrook, Northbrook

60153

Loyola Medical Center, Maywood

60611

Northwestern University, Department of Neurology, Chicago

60612

Rush-Presbyterian St. Luke's Medical Center, Chicago

62702

Springfield Clinic Neuroscience Institute, Springfield

63141

St. John's Mercy Medical Center, St Louis

65191

Fachbereich Neurologie und Klinische Neurophysiologie, Wiesbaden

69394

Hopital neurologique Pierre Werth, Lyon

70112

LSU Neurolgoy Clinic in New Orleans, New Orleans

72205

University of Arkansas For Medical Sciences, Little Rock

75226

Option Care Infusion, Dallas

77030

Baylor Methodist International MS Center, Houston

78681

Central Texas Neurology, Round Rock

80262

University of Colorado MS Center, Denver

80910

Healthsouth Rehabilitation Hospital, Colorado Springs

85008

Phoenix Neurological Associates, Ltd., Phoenix

90033

USC MS Comprehensive Care Center, Los Angeles

92697

University of California - Irvine, Irvine

94063

Kaiser-Permanente Medical Center, Redwood City

94117

MS Center at UCSF, San Francisco

97225

Providence Saint Vincent Medical Center, Portland

98111

Virginia Mason Medical Center, Seattle

98195

MS Research Center, Seattle

06418

Griffin Hospital, Derby

04074-8926

Maine Neurology, Scarborough

02115

Brigham and Women's Hospital, Boston

01655-0138

University of Massachusetts Memorial Medical Center, Worcester

48202-2608

Henry Ford Hospital, Detroit

39216-4505

University of Mississippi Medical Center, Jackson

07666

Bernard W. Gimbel MS Center, Teaneck

28232-2861

MS Center at Carolinas Medical Center, Charlotte

75235-9036

UTSW Medical School, Dallas

05401

Fletcher Allen Health Care, Burlington

Unknown

Hadassah Hebrew Uni Hospital, Department of Neurology, Jerusalem

Sponsors

Lead Sponsor

Collaborators (1)

All Listed Sponsors
collaborator

Elan Pharmaceuticals

INDUSTRY

lead

Biogen

INDUSTRY