Efficacy and Safety of Ofatumumab Compared to Teriflunomide in Patients With Relapsing Multiple Sclerosis.

PHASE3CompletedINTERVENTIONAL
Enrollment

955

Participants

Timeline

Start Date

August 26, 2016

Primary Completion Date

July 10, 2019

Study Completion Date

October 22, 2020

Conditions
Relapsing Multiple Scelrosis
Interventions
DRUG

Ofatumumab subcutaneous injection

Ofatumumab 20 mg prefilled syringes for subcutaneous injection on days 1, 7, 14, week 4 and every 4 weeks thereafter

DRUG

Teriflunomide-matching placebo capsules

Placebo capsule, matching in appearance to teriflunomide, taken orally once daily

DRUG

Teriflunomide capsule

Teriflunomide 14 mg oral capsule taken once daily

DRUG

Matching placebo of ofatumumab subcutaneous injections

Matching placebo of ofatumumab subcutaneous injections on days 1, 7, 14, week 4 and every 4 weeks thereafter

Trial Locations (178)

27

Novartis Investigative Site, San Isidro

1010

Novartis Investigative Site, Vienna

1086

Novartis Investigative Site, Drammen

1090

Novartis Investigative Site, Vienna

1113

Novartis Investigative Site, Sofia

1200

Novartis Investigative Site, Brussels

1204

Novartis Investigative Site, Budapest

1413

Novartis Investigative Site, Sofia

2170

Novartis Investigative Site, Liverpool

2196

Novartis Investigative Site, Rosebank

2500

Novartis Investigative Site, Esztergom

2650

Novartis Investigative Site, Edegem

4000

Novartis Investigative Site, San Miguel de Tucumán

6900

Novartis Investigative Site, Lugano

9000

Novartis Investigative Site, Ghent

9300

Novartis Investigative Site, Aalst

10000

Novartis Investigative Site, Zagreb

15212

Novartis Investigative Site, Pittsburgh

16132

Novartis Investigative Site, Genova

19090

Novartis Investigative Site, Willow Grove

19713

Novartis Investigative Site, Newark

20014

Novartis Investigative Site, Donostia / San Sebastian

20133

Novartis Investigative Site, Milan

20520

Novartis Investigative Site, Turku

22179

Novartis Investigative Site, Hamburg

27405

Novartis Investigative Site, Greensboro

28006

Novartis Investigative Site, Madrid

28034

Novartis Investigative Site, Madrid

28040

Novartis Investigative Site, Madrid

28202

Novartis Investigative Site, Charlotte

28222

Novartis Investigative Site, Madrid

28223

Novartis Investigative Site, Pozuelo de Alarcón

28806

Novartis Investigative Site, Asheville

29010

Novartis Investigative Site, Málaga

29650

Novartis Investigative Site, Greer

30024

Novartis Investigative Site, Suwanee

30625

Novartis Investigative Site, Hanover

31000

Novartis Investigative Site, Osijek

31238

Novartis Investigative Site, Chihuahua City

32164

Novartis Investigative Site, Palm Coast

32174

Novartis Investigative Site, Ormond Beach

32312

Novartis Investigative Site, Tallahassee

32429

Novartis Investigative Site, Minden

32611

Novartis Investigative Site, Gainesville

32751

Novartis Investigative Site, Maitland

33076

Novartis Investigative Site, Bordeaux

33079

Novartis Investigative Site, Mersin

33100

Novartis Investigative Site, Tampere

33603

Novartis Investigative Site, Tampa

33609

Novartis Investigative Site, Tampa

33612

Novartis Investigative Site, Tampa

33713

Novartis Investigative Site, St. Petersburg

34096

Novartis Investigative Site, Haseki / Istanbul

34205

Novartis Investigative Site, Bradenton

34243

Novartis Investigative Site, Sarasota

34295

Novartis Investigative Site, Montpellier

34471

Novartis Investigative Site, Ocala

34677

Novartis Investigative Site, Oldsmar

35033

Novartis Investigative Site, Rennes

35058

Novartis Investigative Site, Cullman

35128

Novartis Investigative Site, Padua

35340

Novartis Investigative Site, Izmir

37205

Novartis Investigative Site, Nashville

37922

Novartis Investigative Site, Knoxville

38018

Novartis Investigative Site, Cordova

41017

Novartis Investigative Site, Seville

43081

Novartis Investigative Site, Westerville

43214

Novartis Investigative Site, Columbus

43221

Novartis Investigative Site, Columbus

44320

Novartis Investigative Site, Akron

44791

Novartis Investigative Site, Bochum

45147

Novartis Investigative Site, Essen

46011

Novartis Investigative Site, Anderson

46256

Novartis Investigative Site, Indianapolis

48202

Novartis Investigative Site, Detroit

48903

Novartis Investigative Site, Barakaldo

50935

Novartis Investigative Site, Cologne

53188

Novartis Investigative Site, Waukesha

55422

Novartis Investigative Site, Golden Valley

57076

Novartis Investigative Site, Siegen

59101

Novartis Investigative Site, Billings

59405

Novartis Investigative Site, Great Falls

61080

Novartis Investigative Site, Trabzon

63000

Novartis Investigative Site, Clermont-Ferrand

66421

Novartis Investigative Site, Homburg

67098

Novartis Investigative Site, Strasbourg

69120

Novartis Investigative Site, Heidelberg

70403

Novartis Investigative Site, Tainan City

75092

Novartis Investigative Site, Sherman

75401

Novartis Investigative Site, Greenville

75651

Novartis Investigative Site, Paris

79410

Novartis Investigative Site, Lubbock

80045

Novartis Investigative Site, Aurora

80112

Novartis Investigative Site, Centennial

80138

Novartis Investigative Site, Napoli

80210

Novartis Investigative Site, Denver

80301

Novartis Investigative Site, Boulder

80528

Novartis Investigative Site, Fort Collins

80907

Novartis Investigative Site, Colorado Springs

81621

Novartis Investigative Site, Basalt

82008

Novartis Investigative Site, Unterhaching

84058

Novartis Investigative Site, Orem

84103

Novartis Investigative Site, Salt Lake City

84132

Novartis Investigative Site, Salt Lake City

85704

Novartis Investigative Site, Tucson

89081

Novartis Investigative Site, Ulm

97225

Novartis Investigative Site, Portland

98034

Novartis Investigative Site, Kirkland

98122

Novartis Investigative Site, Seattle

98405

Novartis Investigative Site, Tacoma

127015

Novartis Investigative Site, Moscow

141008

Novartis Investigative Site, Ludhiana

197022

Novartis Investigative Site, Saint Petersburg

197110

Novartis Investigative Site, Saint Petersburg

197376

Novartis Investigative Site, Saint Petersburg

400008

Novartis Investigative Site, Mumbai

400012

Novartis Investigative Site, Mumbai

400016

Novartis Investigative Site, Mumbai

411004

Novartis Investigative Site, Pune

420021

Novartis Investigative Site, Kazan'

500018

Novartis Investigative Site, Hyderabad

603137

Novartis Investigative Site, Nizhny Novgorod

620109

Novartis Investigative Site, Yekaterinburg

630087

Novartis Investigative Site, Novosibirsk

660049

Novartis Investigative Site, Krasnoyarsk

1600190

Novartis Investigative Site, Lisbon

2674514

Novartis Investigative Site, Loures

4000001

Novartis Investigative Site, Porto

4454509

Novartis Investigative Site, Matosinhos Municipality

4710243

Novartis Investigative Site, Braga

35233-0271

Novartis Investigative Site, Birmingham

907-280528

Novartis Investigative Site, Fort Collins

06824

Novartis Investigative Site, Fairfield

02481

Novartis Investigative Site, Wellesley

87131-0001

Novartis Investigative Site, Albuquerque

C1428AQK

Novartis Investigative Site, CABA

S2000DSW

Novartis Investigative Site, Rosario

N6A 5A5

Novartis Investigative Site, London

K1H 8L6

Novartis Investigative Site, Ottawa

M4N 3M5

Novartis Investigative Site, Toronto

J4V 2J2

Novartis Investigative Site, Greenfield Park

656 91

Novartis Investigative Site, Brno

736 01

Novartis Investigative Site, Havířov

415 01

Novartis Investigative Site, Teplice

708 52

Novartis Investigative Site, Ostrava-Poruba

100 34

Novartis Investigative Site, Prague

06001

Novartis Investigative Site, Nice

01307

Novartis Investigative Site, Dresden

04103

Novartis Investigative Site, Leipzig

04107

Novartis Investigative Site, Leipzig

110 060

Novartis Investigative Site, New Delhi

00133

Novartis Investigative Site, Roma

00178

Novartis Investigative Site, Rome

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

01

Novartis Investigative Site, Lima Cercado

LIMA 13

Novartis Investigative Site, Lima

36-060

Novartis Investigative Site, Głogów

35 055

Novartis Investigative Site, Rzeszów

02 957

Novartis Investigative Site, Warsaw

51-685

Novartis Investigative Site, Wroclaw

41-800

Novartis Investigative Site, Zabrze

2720-276

Novartis Investigative Site, Amadora

3000-075

Novartis Investigative Site, Coimbra

1169-050

Novartis Investigative Site, Lisbon

1500 650

Novartis Investigative Site, Lisbon

4520 211

Novartis Investigative Site, Santa Maria da Feira

813 69

Novartis Investigative Site, Bratislava

036 59

Novartis Investigative Site, Martin

03426

Novartis Investigative Site, Ružomberok

0041

Novartis Investigative Site, Pretoria

LU4 0DZ

Novartis Investigative Site, Luton

S10 2JF

Novartis Investigative Site, Sheffield

SE5 9RS

Novartis Investigative Site, London

SW17 0QT

Novartis Investigative Site, London

Sponsors
All Listed Sponsors
lead

Novartis Pharmaceuticals

INDUSTRY