A Study to Evaluate Efficacy, Safety, and Tolerability of EID of Natalizumab (BG00002) in Participants With RRMS Switching From Treatment With Natalizumab SID in Relation to Continued SID Treatment- Followed by Extension Study Comprising SC and IV Natalizumab Administration

PHASE3CompletedINTERVENTIONAL
Enrollment

585

Participants

Timeline

Start Date

November 27, 2018

Primary Completion Date

January 31, 2023

Study Completion Date

July 24, 2023

Conditions
Multiple Sclerosis, Relapsing-Remitting
Interventions
DRUG

Natalizumab

Natalizumab 300 mg IV infusion.

DRUG

Natalizumab

Natalizumab 300 mg SC injection or IV infusion.

Trial Locations (107)

1070

Cliniques Universitaires de Bruxelles Hopital Erasme, Brussels

1200

Cliniques Universitaires Saint-Luc, Brussels

2050

Brain and Mind Centre, Sydney

2065

Royal North Shore Hospital, St Leonards

2650

UZA, Edegem

3004

The Alfred Hospital, Melbourne

3050

Royal Melbourne Hospital, Parkville

3128

Box Hill Hospital, Box Hill

5112

Lyell McEwin Hospital, Elizabeth Vale

6001

CHU Nice - Hôpital Pasteur, Nice

7100

CHU de Tivoli, La Louvière

10016

NYU Langone Clinical Cancer Center, New York

10029

Mount Sinai Medical Center, New York

10032

Columbia University Hervert Irving Comprehensive Cancer Center, New York

10117

Charité - Campus Charité Mitte, Berlin

11803

Island Neurological Associates, P.C., Plainview

14033

CHU CAEN - Hôpital de la Côte de Nacre, Caen

15213

Magee-Womens Hospital of UPMC, Pittsburgh

19107

Thomas Jefferson University, Philadelphia

20133

Fondazione IRCCS Istituto Neurologico Carlo Besta, Milan

22182

Multiple Sclerosis Center of Greater Washington, Vienna

22908

University Of Virginia, Charlottesville

25198

Hospital Universitari Arnau de Vilanova, Lleida

27157

Wake Forest University Health Sciences, Winston-Salem

28034

Hospital Universitario Ramon y Cajal, Madrid

29010

Hospital Regional Universitario de Malaga, Málaga

30120

Hospital Universitario Virgen de la Arrixaca, El Palmar

30309

Shepherd Center, Inc., Atlanta

30327

Atlanta Neuroscience Institute, Atlanta

33076

Groupe Hospitalier Pellegrin - Hôpital Pellegrin, Bordeaux

33125

University of Miami Miller School of Medicine, Miami

33351

Infinity Clinical Research, LLC, Sunrise

33612

University of South Florida, Tampa

35043

Universitaetsklinikum Giessen und Marburg GmbH Standort Marburg, Marburg

35058

North Central Neurology Associates, P.C., Cullman

35209

Alabama Neurology Associates, Homewood

37215

Vanderbilt University Medical Center, Nashville

37922

Sibyl Wray, MD Neurology, PC, Knoxville

41009

Hospital Universitario Virgen Macarena, Seville

43214

OhioHealth Riverside Methodist Hospital, Columbus

44195

The Cleveland Clinic Foundation, Cleveland

44791

Katholisches Klinikum Bochum gGmbH, Bochum

44800

CHU Nantes - Hopital Nord Laënnec, Saint-Herblain

45147

Universitaetsklinikum Essen, Essen

45267

University of Cincinnati, Cincinnati

45459

Dayton Center for Neurological Disorders, Dayton

48149

Universitaetsklinikum Muenster, Münster

48334

Michigan Institute for Neurological Disorders, Farmington Hills

48867

Memorial Healthcare, Owosso

49506

Michigan State University, Grand Rapids

52363

Chaim Sheba Medical Center, Ramat Gan

53227

Wheaton Franciscan Healthcare, Milwaukee

55422

Minneapolis Clinic of Neurology, Golden Valley

59037

Hopital Roger Salengro - CHU Lille, Lille

60201

NorthShore University HealthSystem, Evanston

60208

Northwestern University, Evanston

63110

Washington University, School of Medicine, St Louis

64711

Neuro Centrum Science GmbH, Erbach im Odenwald

66212

College Park Family Care Center, Overland Park

67091

CHU Strasbourg - Nouvel Hôpital Civil, Strasbourg

70182

Synconcept GmbH - Neuro MVZ, Stuttgart

78681

Central Texas Neurology Consultants, Round Rock

79106

Universitaetsklinikum Freiburg, Freiburg im Breisgau

80131

"Azienda Ospedaliera Universitaria- Università degli Studi della Campania Luigi Vanvitelli", Napoli

80528

Advanced Neurosciences Research, Fort Collins

81675

Klinikum rechts der Isar der TU Muenchen, Munich

84103

Rocky Mountain MS Research Group LLC, Salt Lake City

86077

I.R.C.C.S. Neuromed-Istituto Neurologico Mediterraneo, Pozzilli

89106

Cleveland Clinic Lou Ruvo Center for Brain Health, Las Vegas

90015

Fondazione Istituto G.Giglio di Cefalù, Cefalù

92037

UC San Diego Movement Disorder Center, La Jolla

92607

UCI MIND, Irvine

92653

MS Center of California, Laguna Hills

94304

Stanford Hospital and Clinics, Palo Alto

95123

"Azienda Ospedaliero Universitaria Policlinico Gaspare Rodolico - San Marco (Presidio G. Rodolico)", Catania

96052

Neurologie im Alphamed, Bamberg

97225

Providence Neurological Specialties, Portland

98101

Virginia Mason Medical Center, Seattle

80010-0510

University of Colorado Hospital Anschutz Outpatient Pavillion, Aurora

06824

Yale University, Fairfield

20007-2113

Georgetown University Hospital-Medstar, Washington D.C.

01805

Lahey Clinic Inc. - PARENT ACCOUNT, Burlington

02035

Neurology Center of New England P.C., Foxborough

02130-2075

Beth Israel Deaconess Medical Center, Inc., Jamaica Plain

02481

Dragonfly Research, LLC, Wellesley

02190

South Shore Neurology Associates, Weymouth

07102

RWJ Barnabas Health, Newark

07666

Holy Name Medical Center, Teaneck

27607-6010

Raleigh Neurology Associates, Raleigh

M5B 1W8

St. Michael's Hospital, Toronto

J8Y 1W2

Clinique Neuro-Outaouais, Gatineau

J4V 2J2

Recherche SEPMUS, Greenfield Park

H2X 0A9

CHUM Centre de Recherche, Montreal

H3A 3B4

Montreal Neurological Institute Clinical Research Unit, Montreal

4818 CK

Amphia Ziekenhuis, Molengracht, Breda

3435 CM

St. Antonius Ziekenhuis, Nieuwegein

6162 BG

Zuyderland Medisch Centrum - Sittard-Geleen, Sittard

SE5 9RS

King's College Hospital, London

WC1N 3BG

The National Hospital for Neurology & Neurosurgery, London

L9 7LJ

Walton Centre for Neurology & Neurosurgery., Liverpool

G51 4TF

Queen Elizabeth University Hospital Campus, Glasgow

NE4 5PL

Newcastle University- Clinical Ageing Research Unit, Newcastle upon Tyne

W6 8RF

Charing Cross Hospital, London

NG7 2UH

Nottingham University Hospital, Queen's Medical Centre, Nottingham

M6 8HD

Salford Care Organisation, Salford

S10 2JF

Royal Hallamshire Hospital, Sheffield

SA6 6NL

Morriston Hospital, Swansea

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Biogen

INDUSTRY

NCT03689972 - A Study to Evaluate Efficacy, Safety, and Tolerability of EID of Natalizumab (BG00002) in Participants With RRMS Switching From Treatment With Natalizumab SID in Relation to Continued SID Treatment- Followed by Extension Study Comprising SC and IV Natalizumab Administration | Biotech Hunter | Biotech Hunter