Long-term Safety, Tolerability and Effectiveness Study of Ofatumumab in Patients With Relapsing MS

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

1,882

Participants

Timeline

Start Date

December 28, 2018

Primary Completion Date

December 30, 2027

Study Completion Date

September 30, 2028

Conditions
Relapsing Multiple Sclerosis
Interventions
BIOLOGICAL

Ofatumumab

subcutaneous injection of 20 mg ofatumumab every 4 weeks

BIOLOGICAL

Tetanus toxoid (TT) containing vaccine (Td, Tdap)

0.5mL Vial/Syringe Containing 5 limit of flocculation (LF) tetanus toxoid

BIOLOGICAL

13-valent pneumococcal conjugate vaccine (13-PCV)

0.5mL Vial/Syringe

BIOLOGICAL

23-valent pneumococcal polysaccharide vaccine (23-PPV)

0.5mL Vial/Syringe

BIOLOGICAL

Seasonal Quadrivalent influenza vaccine

Seasonal 2020-2021 0.5mL Vial/Syringe (trivalent may be used where quadrivalent is not available)

BIOLOGICAL

Keyhole limpet hemocyanin (KLH) neo-antigen

1mg Vial

Trial Locations (296)

13

Novartis Investigative Site, Lima

27

Novartis Investigative Site, San Isidro

1010

Novartis Investigative Site, Vienna

1086

Novartis Investigative Site, Drammen

1090

Novartis Investigative Site, Vienna

1106

Novartis Investigative Site, Budapest

1113

Novartis Investigative Site, Sofia

1135

Novartis Investigative Site, Budapest

1138

Novartis Investigative Site, Budapest

1200

Novartis Investigative Site, Brussels

1204

Novartis Investigative Site, Budapest

1309

Novartis Investigative Site, Sofia

1413

Novartis Investigative Site, Sofia

1431

Novartis Investigative Site, Sofia

2065

Novartis Investigative Site, St Leonards

2143

Novartis Investigative Site, Kistarcsa

2170

Novartis Investigative Site, Liverpool

2196

Novartis Investigative Site, Rosebank

2305

Novartis Investigative Site, New Lambton Heights

2600

Novartis Investigative Site, Glostrup Municipality

2650

Novartis Investigative Site, Edegem

2930

Novartis Investigative Site, Brasschaat

4000

Novartis Investigative Site, San Miguel de Tucumán

4031

Novartis Investigative Site, Basel

5000

Novartis Investigative Site, Odense C

5800

Novartis Investigative Site, Pleven

6720

Novartis Investigative Site, Szeged

6900

Novartis Investigative Site, Lugano

7623

Novartis Investigative Site, Pécs

8000

Novartis Investigative Site, Bruges

9000

Novartis Investigative Site, Ghent

10000

Novartis Investigative Site, Zagreb

10617

Novartis Investigative Site, Tallinn

11009

Novartis Investigative Site, Cadiz

12110

Ms Ctr Of Northeastern Ny, Latham

13100

Novartis Investigative Site, Sefad

14471

Novartis Investigative Site, Potsdam

17190

Novartis Investigative Site, Salt

19090

Abington Neurological Associates Ltd, Willow Grove

19713

Christiana Care Health Services, Newark

20080

Novartis Investigative Site, Donostia / San Sebastian

20520

Novartis Investigative Site, Turku

22179

Novartis Investigative Site, Hamburg

23456

Sentara Neuroscience Institute, Virginia Beach

27103

PMG Research of Winston Salem, Winston-Salem

27405

Guilford Neurologic Associate Research, Greensboro

27607

Velocity Clinical Research, Raleigh

28006

Novartis Investigative Site, Madrid

28034

Novartis Investigative Site, Madrid

28040

Novartis Investigative Site, Madrid

28204

The Neurological Institute PA, Charlotte

28222

Novartis Investigative Site, Madrid

28223

Novartis Investigative Site, Pozuelo de Alarcón

28806

Asheville Neurology Specialists PA, Asheville

29010

Novartis Investigative Site, Málaga

29303

BG Neurology, Spartanburg

Upstate Clinical Trials LLC, Spartanburg

29605

Premier Neurology, Greenville

30024

Georgia Neurology and Sleep Medicine Assoc, Suwanee

30029

Novartis Investigative Site, Nîmes

30120

Novartis Investigative Site, El Palmar

30625

Novartis Investigative Site, Hanover

30890

Novartis Investigative Site, Barsinghausen

31000

Novartis Investigative Site, Osijek

31238

Novartis Investigative Site, Chihuahua City

31406

Velocity Clinical Research, Savannah

32174

Neurology Associates of Ormond Beach, Ormond Beach

32312

AMO Corporation, Tallahassee

32429

Novartis Investigative Site, Minden

32514

Emerald Coast Neurology, Pensacola

32751

Neurology Associates PA, Maitland

33024

Infinity Clinical Research LLC, Hollywood

33033

Homestead Assoc In Research Inc, Homestead

33100

Novartis Investigative Site, Tampere

33110

Novartis Investigative Site, Mersin

33136

UM Department Of Neurology, Miami

33407

Premiere Research Institute, West Palm Beach

33445

Neurology Offices of South Florida PLLC, Delray Beach

33606

Clinical Research of West Florida Inc, Tampa

33609

Axiom Clinical Research of Florida, Tampa

33612

University Of South Florida, Tampa

33647

Novartis Investigative Site, Bielefeld

33952

Neurostudies Inc, Port Charlotte

34090

Novartis Investigative Site, Montpellier

34098

Novartis Investigative Site, Istanbul

34105

Aqualane Clinical Research, Naples

34147

Novartis Investigative Site, Istanbul

34233

Negroski Neurology, Sarasota

34243

Roskamp Institute Inc, Sarasota

34295

Novartis Investigative Site, Istanbul

34677

MS and Neuromuscular Center of Excellence, Oldsmar

34785

Novartis Investigative Site, Istanbul

35043

Novartis Investigative Site, Marburg

35058

North Central Neurology Associates PC, Cullman

35100

Novartis Investigative Site, Izmir

35340

Novartis Investigative Site, Izmir

35575

Novartis Investigative Site, Izmir

37604

Tri State Mountain Neurology, Johnson

37920

University of Tennessee Medical Ctr, Knoxville

37922

Sibyl Wray MD Neurology PC, Knoxville

38018

Wesley Neurology Clinic, Cordova

40002

Novartis Investigative Site, Khon Kaen

41009

Novartis Investigative Site, Seville

41380

Novartis Investigative Site, Kocaeli

41950

Novartis Investigative Site, Castilleja de la Cuesta

43082

Columbus Neuroscience, Westerville

43214

Ohio Health Research Institute, Columbus

44093

Novartis Investigative Site, Nantes

44195

Cleveland Clinic Foundation, Cleveland

44320

Neurology and Neuroscience Assos, Akron

44791

Novartis Investigative Site, Bochum

45147

Novartis Investigative Site, Essen

46026

Novartis Investigative Site, Valencia

46256

Josephson Wallack Munshower Neurology P.C, Indianapolis

48201

Wayne State University Multiple Sclerosis Clinic, Detroit

48903

Novartis Investigative Site, Barakaldo

50406

Novartis Investigative Site, Tartu

50935

Novartis Investigative Site, Cologne

51000

Novartis Investigative Site, Rijeka

53215

Ascension St Francis Center, Milwaukee

St Luke s Medical Center Aurora, Milwaukee

53792

University of Wisconsin Madison, Madison

54311

Aurora BayCare Medical Center, Green Bay

55200

Novartis Investigative Site, Samsun

57076

Novartis Investigative Site, Siegen

59037

Novartis Investigative Site, Lille

59101

Billings Clinic, Billings

59405

Advanced Neurology Specialists, Great Falls

60062

Consultants in Neurology, Northbrook

60446

Novartis Investigative Site, Poznan

60612

Rush University Medical Center, Chicago

61080

Novartis Investigative Site, Trabzon

63110

WA Uni School Of Med, St Louis

63141

Mercy Research, St Louis

65721

Sharlin Health and Neurology, Ozark

66160

University of Kansas Hospital, Kansas City

66210

College Park Family Care Center, Overland Park

67000

Novartis Investigative Site, Strasbourg

69120

Novartis Investigative Site, Heidelberg

70403

Novartis Investigative Site, Tainan City

70810

The Neuromedical Center, Baton Rouge

71301

Neuro Medical Clinic of Cenla LLC, Alexandria

73104

Multiple Sclerosis Center of Excellence of OMRF, Oklahoma City

75013

Novartis Investigative Site, Paris

75092

Texas Institute for Neurological Disorders, Sherman

78258

Lonestar Neurology of San Antonio, San Antonio

78681

Central TX Neuro Consultants P A, Round Rock

79410

Neurology and Sleep Center, Lubbock

79935

Med Research Inc, El Paso

80045

CU Anschutz Med Campus, Aurora

80210

Colorado Neurological Research PC, Denver

80301

Alpine Clinical Research Center, Boulder

80377

Novartis Investigative Site, München

80528

University of Colorado Health Neurology, Fort Collins

80907

Colorado Springs Neurological Associates, Colorado Springs

81377

Novartis Investigative Site, Munich

81621

Mountain Neuro Research Center PC, Basalt

82008

Novartis Investigative Site, Unterhaching

84103

Rocky Mountain MS Clinic, Salt Lake City

85013

Barrow Neurological Clinics at St Josephs Hospital and MC, Phoenix

86633

Novartis Investigative Site, Neuburg an der Donau

89073

Novartis Investigative Site, Ulm

89106

Cleveland Clinic Foundation, Las Vegas

92835

Fullerton Neuro and Headache Ctr, Fullerton

95445

Novartis Investigative Site, Bayreuth

95817

University of California Davis, Sacramento

96817

Hawaii Pacific Neuroscience LLC, Honolulu

97225

Providence Neurological Services West, Portland

98034

Evergreen Health Multiple Sclerosis Center, Kirkland

98405

MultiCare Research Institute for Research and Innovation, Tacoma

110060

Novartis Investigative Site, New Delhi

125367

Novartis Investigative Site, Moscow

127015

Novartis Investigative Site, Moscow

160012

Novartis Investigative Site, Chandigarh

190000

Novartis Investigative Site, Saint Petersburg

194044

Novartis Investigative Site, Saint Petersburg

197022

Novartis Investigative Site, Saint Petersburg

197376

Novartis Investigative Site, Saint Petersburg

197706

Novartis Investigative Site, Sestroretsk

400008

Novartis Investigative Site, Mumbai

411004

Novartis Investigative Site, Pune

420043

Novartis Investigative Site, Kazan'

430032

Novartis Investigative Site, Saransk

500082

Novartis Investigative Site, Hyderabad

575018

Novartis Investigative Site, Mangalore

603137

Novartis Investigative Site, Nizhny Novgorod

603155

Novartis Investigative Site, Nizhny Novgorod

620109

Novartis Investigative Site, Yekaterinburg

625000

Novartis Investigative Site, Tyumen

630007

Novartis Investigative Site, Novosibirsk

630087

Novartis Investigative Site, Novosibirsk

650066

Novartis Investigative Site, Kemerovo

660049

Novartis Investigative Site, Krasnoyarsk

711103

Novartis Investigative Site, Howrah

2608677

Novartis Investigative Site, Chiba

3109601

Novartis Investigative Site, Haifa

4710243

Novartis Investigative Site, Braga

6423906

Novartis Investigative Site, Tel Aviv

7830604

Novartis Investigative Site, Ashkelon

35233-0271

University of Alabama at Birmingham, Birmingham

33462-6608

Jem Research Institute, Atlantis

02115

Dana Farber Cancer Institute, Boston

02481

Dragonfly Research LLC, Wellesley Hills

48202 2689

Henry Ford Hospital, Detroit

87131-0001

University of New Mexico, Albuquerque

19107-5098

Thomas Jefferson University Hospital, Philadelphia

84132-0001

The University of Utah, Salt Lake City

S2000BZL

Novartis Investigative Site, Rosario

S2000DSW

Novartis Investigative Site, Rosario

C1424BYD

Novartis Investigative Site, Buenos Aires

X5004CDT

Novartis Investigative Site, Córdoba

N6A 5W9

Novartis Investigative Site, London

K1H 8L6

Novartis Investigative Site, Ottawa

M4N 3M5

Novartis Investigative Site, Toronto

J9J 0A5

Novartis Investigative Site, Gatineau

J4V 2J2

Novartis Investigative Site, Greenfield Park

H3A 2B4

Novartis Investigative Site, Montreal

G1J 1Z4

Novartis Investigative Site, Québec

602 00

Novartis Investigative Site, Brno

736 01

Novartis Investigative Site, Havířov

500 05

Novartis Investigative Site, Hradec Králové

586 01

Novartis Investigative Site, Jihlava

779 00

Novartis Investigative Site, Olomouc

532 03

Novartis Investigative Site, Pardubice

100 34

Novartis Investigative Site, Prague

128 08

Novartis Investigative Site, Prague

140 59

Novartis Investigative Site, Prague

150 06

Novartis Investigative Site, Prague

415 29

Novartis Investigative Site, Teplice

06001

Novartis Investigative Site, Nice

01307

Novartis Investigative Site, Dresden

04103

Novartis Investigative Site, Leipzig

115 25

Novartis Investigative Site, Athens

GR 54636

Novartis Investigative Site, Thessaloniki

682 026

Novartis Investigative Site, Kochi

110 017

Novartis Investigative Site, New Delhi

791-0295

Novartis Investigative Site, Tōon

063-0005

Novartis Investigative Site, Sapporo

020-8505

Novartis Investigative Site, Morioka

980 8574

Novartis Investigative Site, Sendai

983 8512

Novartis Investigative Site, Sendai

350 8550

Novartis Investigative Site, Kawagoe

187-8551

Novartis Investigative Site, Kodaira

160 8582

Novartis Investigative Site, Shinjuku-ku

951 8520

Novartis Investigative Site, Niigata

556-0016

Novartis Investigative Site, Osaka

LV-1005

Novartis Investigative Site, Riga

LV 1002

Novartis Investigative Site, Riga

LV-1038

Novartis Investigative Site, Riga

LT 50161

Novartis Investigative Site, Kaunas

LT-08661

Novartis Investigative Site, Vilnius

03100

Novartis Investigative Site, Mexico City

06700

Novartis Investigative Site, Mexico City

6162 BG

Novartis Investigative Site, Sittard-Geleen

1081 HV

Novartis Investigative Site, Amsterdam

3015 GD

Novartis Investigative Site, Rotterdam

01

Novartis Investigative Site, Lima Cercado

85-796

Novartis Investigative Site, Bydgoszcz

80 803

Novartis Investigative Site, Gdansk

80-952

Novartis Investigative Site, Gdansk

36-060

Novartis Investigative Site, Głogów

40 571

Novartis Investigative Site, Katowice

25 726

Novartis Investigative Site, Kielce

90 324

Novartis Investigative Site, Lodz

35 055

Novartis Investigative Site, Rzeszów

02 957

Novartis Investigative Site, Warsaw

51-685

Novartis Investigative Site, Wroclaw

41-800

Novartis Investigative Site, Zabrze

3000-075

Novartis Investigative Site, Coimbra

1169-050

Novartis Investigative Site, Lisbon

1500 650

Novartis Investigative Site, Lisbon

2674-514

Novartis Investigative Site, Loures

4454-513

Novartis Investigative Site, Matosinhos Municipality

4099-001

Novartis Investigative Site, Porto

4520-211

Novartis Investigative Site, Santa Maria da Feira

975 17

Novartis Investigative Site, Banská Bystrica

813 69

Novartis Investigative Site, Bratislava

826 06

Novartis Investigative Site, Bratislava

833 05

Novartis Investigative Site, Bratislava

036 59

Novartis Investigative Site, Martin

950 01

Novartis Investigative Site, Nitra

917 02

Novartis Investigative Site, Trnava

0041

Novartis Investigative Site, Pretoria

08907

Novartis Investigative Site, L'Hospitalet de Llobregat

08003

Novartis Investigative Site, Barcelona

08035

Novartis Investigative Site, Barcelona

08036

Novartis Investigative Site, Barcelona

08041

Novartis Investigative Site, Barcelona

413 45

Novartis Investigative Site, Gothenburg

102 35

Novartis Investigative Site, Stockholm

LU4 0DZ

Novartis Investigative Site, Luton

S10 2JF

Novartis Investigative Site, Sheffield

G51 4TF

Novartis Investigative Site, Glasgow

E1 1BB

Novartis Investigative Site, London

SW17 0QT

Novartis Investigative Site, London

OX3 9DU

Novartis Investigative Site, Oxford

Sponsors
All Listed Sponsors
lead

Novartis Pharmaceuticals

INDUSTRY