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

PHASE3CompletedINTERVENTIONAL
Enrollment

930

Participants

Timeline

Start Date

September 20, 2016

Primary Completion Date

July 5, 2019

Study Completion Date

July 20, 2020

Conditions
Relapsing Multiple Sclerosis
Interventions
DRUG

Ofatumumab subcutaneous injection

Ofatumumab 20 mg pre-filled 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 (166)

1061

Novartis Investigative Site, Buenos Aires

1106

Novartis Investigative Site, Budapest

1135

Novartis Investigative Site, Budapest

1309

Novartis Investigative Site, Sofia

1431

Novartis Investigative Site, Sofia

2065

Novartis Investigative Site, St Leonards

2143

Novartis Investigative Site, Kistarcsa

2305

Novartis Investigative Site, New Lambton Heights

2930

Novartis Investigative Site, Brasschaat

3900

Novartis Investigative Site, Overpelt

4000

Novartis Investigative Site, Liège

4002

Novartis Investigative Site, Plovdiv

4031

Novartis Investigative Site, Basel

5000

Novartis Investigative Site, Odense C

6725

Novartis Investigative Site, Szeged

8000

Novartis Investigative Site, Bruges

Novartis Investigative Site, Aarhus

10000

Novartis Investigative Site, Zagreb

10617

Novartis Investigative Site, Tallinn

11009

Novartis Investigative Site, Cadiz

12110

Novartis Investigative Site, Latham

13100

Novartis Investigative Site, Sefad

14471

Novartis Investigative Site, Potsdam

17190

Novartis Investigative Site, Salt

20007

Novartis Investigative Site, Washington D.C.

20132

Novartis Investigative Site, Milan

20249

Novartis Investigative Site, Hamburg

21013

Novartis Investigative Site, Gallarate

23456

Novartis Investigative Site, Virginia Beach

27103

Novartis Investigative Site, Winston-Salem

27157

Novartis Investigative Site, Winston-Salem

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Novartis Investigative Site, Raleigh

28204

Novartis Investigative Site, Charlotte

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Novartis Investigative Site, Spartanburg

30029

Novartis Investigative Site, Nîmes

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Novartis Investigative Site, El Palmar

30890

Novartis Investigative Site, Barsinghausen

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Novartis Investigative Site, Savannah

32514

Novartis Investigative Site, Pensacola

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Novartis Investigative Site, Vero Beach

33021

Novartis Investigative Site, Hollywood

33032

Novartis Investigative Site, Miami

33136

Novartis Investigative Site, Miami

33351

Novartis Investigative Site, Sunrise

33407

Novartis Investigative Site, West Palm Beach

33408

Novartis Investigative Site, North Palm Beach

33445

Novartis Investigative Site, Delray Beach

33470

Novartis Investigative Site, Loxahatchee Groves

33952

Novartis Investigative Site, Port Charlotte

34102

Novartis Investigative Site, Naples

34147

Novartis Investigative Site, Istanbul

35040

Novartis Investigative Site, Izmir

35043

Novartis Investigative Site, Marburg

37604

Novartis Investigative Site, Johnson City

37920

Novartis Investigative Site, Knoxville

40002

Novartis Investigative Site, Khon Kaen

41380

Novartis Investigative Site, Kocaeli

44093

Novartis Investigative Site, Nantes

44195

Novartis Investigative Site, Cleveland

46026

Novartis Investigative Site, Valencia

46202

Novartis Investigative Site, Indianapolis

48035

Novartis Investigative Site, Clinton Township

48201

Novartis Investigative Site, Detroit

51000

Novartis Investigative Site, Rijeka

51014

Novartis Investigative Site, Tartu

53215

Novartis Investigative Site, Milwaukee

53792

Novartis Investigative Site, Madison

54035

Novartis Investigative Site, Nancy

54311

Novartis Investigative Site, Green Bay

54956

Novartis Investigative Site, Neenah

55139

Novartis Investigative Site, Samsun

55422

Novartis Investigative Site, Golden Valley

59037

Novartis Investigative Site, Lille

60062

Novartis Investigative Site, Northbrook

60612

Novartis Investigative Site, Chicago

63017

Novartis Investigative Site, Chesterfield

63110

Novartis Investigative Site, St Louis

65191

Novartis Investigative Site, Wiesbaden

65721

Novartis Investigative Site, Ozark

66160

Novartis Investigative Site, Kansas City

66210

Novartis Investigative Site, Overland Park

70810

Novartis Investigative Site, Baton Rouge

71301

Novartis Investigative Site, Alexandria

73104

Novartis Investigative Site, Oklahoma City

75246

Novartis Investigative Site, Dallas

77074

Novartis Investigative Site, Houston

78229

Novartis Investigative Site, San Antonio

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Novartis Investigative Site, San Antonio

78278

Novartis Investigative Site, Ashkelon

78681

Novartis Investigative Site, Round Rock

79935

Novartis Investigative Site, El Paso

80131

Novartis Investigative Site, Napoli

80377

Novartis Investigative Site, München

81377

Novartis Investigative Site, München

82606

Novartis Investigative Site, Bratislava

83305

Novartis Investigative Site, Bratislava

85013

Novartis Investigative Site, Phoenix

86633

Novartis Investigative Site, Neuburg an der Donau

89073

Novartis Investigative Site, Ulm

89106

Novartis Investigative Site, Las Vegas

92835

Novartis Investigative Site, Fullerton

94705

Novartis Investigative Site, Berkeley

94901

Novartis Investigative Site, Nitra

95445

Novartis Investigative Site, Bayreuth

95817

Novartis Investigative Site, Sacramento

96817

Novartis Investigative Site, Honolulu

97517

Novartis Investigative Site, Banská Bystrica

110017

Novartis Investigative Site, New Delhi

125367

Novartis Investigative Site, Moscow

160012

Novartis Investigative Site, Chandigarh

194044

Novartis Investigative Site, Saint Petersburg

197706

Novartis Investigative Site, Sestroretsk

430032

Novartis Investigative Site, Saransk

560054

Novartis Investigative Site, Bangalore

575018

Novartis Investigative Site, Mangalore

603155

Novartis Investigative Site, Nizhny Novgorod

625000

Novartis Investigative Site, Tyumen

630007

Novartis Investigative Site, Novosibirsk

650066

Novartis Investigative Site, Kemerovo

700068

Novartis Investigative Site, Kolkata

6423906

Novartis Investigative Site, Tel Aviv

33462-6608

Novartis Investigative Site, Atlantis

50314-2611

Novartis Investigative Site, Des Moines

S2000BZL

Novartis Investigative Site, Rosario

X5004CDT

Novartis Investigative Site, Córdoba

V6T 1Z3

Novartis Investigative Site, Vancouver

J9J 0A5

Novartis Investigative Site, Gatineau

H3A 2B4

Novartis Investigative Site, Montreal

G1J 1Z4

Novartis Investigative Site, Québec

140 59

Novartis Investigative Site, Praha 4 Krc

500 05

Novartis Investigative Site, Hradec Králové

775 20

Novartis Investigative Site, Olomouc

586 01

Novartis Investigative Site, Jihlava

532 03

Novartis Investigative Site, Pardubice

150 06

Novartis Investigative Site, Prague

DK-2100

Novartis Investigative Site, Copenhagen

D 33647

Novartis Investigative Site, Bielefeld

115 25

Novartis Investigative Site, Athens

115 28

Novartis Investigative Site, Athens

GR 54636

Novartis Investigative Site, Thessaloniki

682 026

Novartis Investigative Site, Kochi

310 9601

Novartis Investigative Site, Haifa

00189

Novartis Investigative Site, Roma

03100

Novartis Investigative Site, Mexico City

6162 BG

Novartis Investigative Site, Sittard-Geleen

1081 HV

Novartis Investigative Site, Amsterdam

3015 CE

Novartis Investigative Site, Rotterdam

85-796

Novartis Investigative Site, Bydgoszcz

80 952

Novartis Investigative Site, Gdansk

80-462

Novartis Investigative Site, Gdansk

80-803

Novartis Investigative Site, Gdansk

40 571

Novartis Investigative Site, Katowice

25 726

Novartis Investigative Site, Kielce

90 324

Novartis Investigative Site, Lodz

00968

Novartis Investigative Site, Guaynabo

917 75

Novartis Investigative Site, Trnava

08026

Novartis Investigative Site, Barcelona

08035

Novartis Investigative Site, Barcelona

08036

Novartis Investigative Site, Barcelona

08907

Novartis Investigative Site, L'Hospitalet de Llobregat

08003

Novartis Investigative Site, Barcelona

413 45

Novartis Investigative Site, Gothenburg

102 35

Novartis Investigative Site, Stockholm

OX3 9DU

Novartis Investigative Site, Headington

G51 4TF

Novartis Investigative Site, Glasgow

E1 1BB

Novartis Investigative Site, London

Sponsors
All Listed Sponsors
lead

Novartis Pharmaceuticals

INDUSTRY