Evaluation of Sarilumab (SAR153191/REGN88) on Top of Methotrexate in Rheumatoid Arthritis Patients

PHASE2/PHASE3CompletedINTERVENTIONAL
Enrollment

1,675

Participants

Timeline

Start Date

March 31, 2010

Primary Completion Date

October 31, 2013

Study Completion Date

October 31, 2013

Conditions
Rheumatoid Arthritis
Interventions
DRUG

Sarilumab

"Pharmaceutical form: solution for injection~Route of administration: subcutaneous"

DRUG

Placebo (for sarilumab)

"Pharmaceutical form: solution for injection~Route of administration: subcutaneous"

DRUG

Methotrexate

Same weekly dose as received prior to enrollment

DRUG

Folic Acid

According to local standard

Trial Locations (262)

76

Investigational Site Number 356008, New Delhi

100

Investigational Site Number 158001, Taipei

333

Investigational Site Number 158002, Linkou District

1008

Investigational Site Number 608001, Manila

1023

Investigational Site Number 348006, Budapest

1027

Investigational Site Number 348014, Budapest

1100

Investigational Site Number 040002, Vienna

1619

Investigational Site Number 710004, Kempton Park

1704

Investigational Site Number 032010, Ramos Mejía

2000

Investigational Site Number 032001, Rosario

2013

Investigational Site Number 710001, Johannesburg

2035

Investigational Site Number 036011, Sydney

2050

Investigational Site Number 036003, Camperdown

2065

Investigational Site Number 036006, St Leonards

2605

Investigational Site Number 036010, Garran

2800

Investigational Site Number 032009, Zárate

3001

Investigational Site Number 554003, Tauranga

3065

Investigational Site Number 036012, Fitzroy

3081

Investigational Site Number 036004, Heidelberg West

3105

Investigational Site Number 578006, Tønsberg

3145

Investigational Site Number 036002, Malvern East

3168

Investigational Site Number 036005, Clayton

3300

Investigational Site Number 348011, Eger

3600

Investigational Site Number 056003, Genk

3980

Investigational Site Number 348005, Sátoraljaújhely

4000

Investigational Site Number 032005, Buenos Aires

Investigational Site Number 032004, San Miguel de Tucumán

Investigational Site Number 056001, Liège

4001

Investigational Site Number 710003, Durban

4029

Investigational Site Number 036009, Herston

4032

Investigational Site Number 348003, Debrecen

4043

Investigational Site Number 348010, Debrecen

4091

Investigational Site Number 710002, Durban

4558

Investigational Site Number 036001, Maroochydore

4604

Investigational Site Number 578004, Kristiansand

5011

Investigational Site Number 036007, Woodville

6000

Investigational Site Number 608003, Cebu City

6100

Investigational Site Number 036014, Victoria Park

6726

Investigational Site Number 484003, Mexico City

7405

Investigational Site Number 710011, Cape Town

7530

Investigational Site Number 710007, Cape Town

7600

Investigational Site Number 710010, Stellenbosch

8001

Investigational Site Number 710009, Cape Town

8002

Investigational Site Number 554004, Christchurch

8036

Investigational Site Number 040001, Graz

8200

Investigational Site Number 348004, Veszprém

9025

Investigational Site Number 348013, Gy?r

10016

Investigational Site Number 840056, New York

10128

Investigational Site Number 233001, Tallinn

10400

Investigational Site Number 764001, Bangkok

10700

Investigational Site Number 764003, Bangkok

11527

Investigational Site Number 300001, Athens

11850

Investigational Site Number 484001, Mexico City

12161

Investigational Site Number 276007, Berlin

Investigational Site Number 276008, Berlin

12850

Investigational Site Number 203001, Prague

13419

Investigational Site Number 233002, Tallinn

15006

Investigational Site Number 724009, A Coruña

15705

Investigational Site Number 724012, Santiago de Compostela

16635

Investigational Site Number 840009, Duncansville

18015

Investigational Site Number 840010, Bethlehem

19611

Investigational Site Number 840062, Reading

20902

Investigational Site Number 840013, Wheaton

21502

Investigational Site Number 840073, Cumberland

21702

Investigational Site Number 840055, Frederick

22081

Investigational Site Number 276005, Hamburg

22147

Investigational Site Number 276013, Hamburg

28100

Investigational Site Number 246003, Pori

28601

Investigational Site Number 840068, Hickory

29204

Investigational Site Number 840058, Columbia

29406

Investigational Site Number 840016, North Charleston

30033

Investigational Site Number 840028, Decatur

30060

Investigational Site Number 840027, Marietta

30322

Investigational Site Number 840003, Atlanta

30990

Investigational Site Number 458001, Ipoh

31134

Investigational Site Number 276006, Hildesheim

32209

Investigational Site Number 840041, Jacksonville

32806

Investigational Site Number 840006, Orlando

33155

Investigational Site Number 840048, Miami

33458

Investigational Site Number 840067, Jupiter

34239

Investigational Site Number 840060, Sarasota

34270

Investigational Site Number 484008, Durango

34684

Investigational Site Number 840063, Palm Harbor

34698

Investigational Site Number 840050, Dunedin

35205

Investigational Site Number 840004, Birmingham

35340

Investigational Site Number 792001, Izmir

36207

Investigational Site Number 840070, Anniston

38305

Investigational Site Number 840025, Jackson

40504

Investigational Site Number 840015, Lexington

41008

Investigational Site Number 724007, Seville

43606

Investigational Site Number 840044, Toledo

44652

Investigational Site Number 276001, Herne

44690

Investigational Site Number 484002, Guadalajara

49008

Investigational Site Number 804003, Dnipropetrovsk

52140

Investigational Site Number 484007, Metepec

60590

Investigational Site Number 276003, Frankfurt am Main

60612

Investigational Site Number 840046, Chicago

61022

Investigational Site Number 804010, Kharkiv

63117

Investigational Site Number 840066, St Louis

63801

Investigational Site Number 203005, Brno

64000

Investigational Site Number 484005, Monterrey

68114

Investigational Site Number 840071, Omaha

68601

Investigational Site Number 203002, Uherské Hradiště

69120

Investigational Site Number 276012, Heidelberg

69600

Investigational Site Number 804009, Zaporizhzhia

71110

Investigational Site Number 300002, Heraklion

73103

Investigational Site Number 840002, Oklahoma City

74104

Investigational Site Number 840011, Tulsa

74135

Investigational Site Number 840065, Tulsa

74801

Investigational Site Number 203004, Hlučín

75150

Investigational Site Number 840074, Mesquite

75231

Investigational Site Number 840001, Dallas

75235

Investigational Site Number 840022, Dallas

75390

Investigational Site Number 840012, Dallas

77034

Investigational Site Number 840020, Houston

79005

Investigational Site Number 804005, Lviv

79424

Investigational Site Number 840069, Lubbock

83114

Investigational Site Number 804002, Donetsk

83404

Investigational Site Number 840018, Idaho Falls

85234

Investigational Site Number 840072, Gilbert

90211

Investigational Site Number 840029, Beverly Hills

91054

Investigational Site Number 276004, Erlangen

91786

Investigational Site Number 840049, Upland

92260

Investigational Site Number 840007, Palm Desert

93586

Investigational Site Number 458002, Kuching

94143

Investigational Site Number 840008, San Francisco

94354

Investigational Site Number 840021, Santa Maria

95017

Investigational Site Number 804006, Simferopol

97000

Investigational Site Number 484004, Mérida

Investigational Site Number 484009, Mérida

98405

Investigational Site Number 840061, Tacoma

107014

Investigational Site Number 643004, Moscow

115404

Investigational Site Number 643020, Moscow

115522

Investigational Site Number 643001, Moscow

117997

Investigational Site Number 643002, Moscow

121359

Investigational Site Number 643012, Moscow

122001

Investigational Site Number 356002, New Delhi

190068

Investigational Site Number 643007, Saint Petersburg

192242

Investigational Site Number 643008, Saint Petersburg

196247

Investigational Site Number 643014, Saint Petersburg

220037

Investigational Site Number 112002, Minsk

220116

Investigational Site Number 112001, Minsk

226003

Investigational Site Number 356011, Lucknow

226014

Investigational Site Number 356013, Lucknow

380009

Investigational Site Number 356015, Ahmedabad

390026

Investigational Site Number 643016, Ryazan

400008

Investigational Site Number 356010, Mumbai

400012

Investigational Site Number 356004, Mumbai

400347

Investigational Site Number 642003, Bucharest

410053

Investigational Site Number 643011, Saratov

443095

Investigational Site Number 643010, Samara

450005

Investigational Site Number 643013, Ufa

500003

Investigational Site Number 356012, Hyderabad

500004

Investigational Site Number 356005, Hyderabad

560079

Investigational Site Number 356007, Bangalore

600004

Investigational Site Number 356003, Chennai

630099

Investigational Site Number 643009, Novosibirsk

650066

Investigational Site Number 643017, Kemerovo

650099

Investigational Site Number 643006, Kemerovo

800578

Investigational Site Number 642005, Galati

810019

Investigational Site Number 642006, Brăila

2570017

Investigational Site Number 152007, Viña del Mar

3460000

Investigational Site Number 152014, Talca

7500922

Investigational Site Number 152012, Santiago

Unknown

Investigational Site Number 032007, Buenos Aires

Investigational Site Number 032008, Buenos Aires

Investigational Site Number 032003, Córdoba

Investigational Site Number 152005, Osorno

Investigational Site Number 152010, Port Montt

Investigational Site Number 152001, Santiago

Investigational Site Number 152002, Santiago

Investigational Site Number 152008, Santiago

Investigational Site Number 152009, Santiago

Investigational Site Number 152011, Santiago

Investigational Site Number 152013, Santiago

Investigational Site Number 152004, Valdivia

Investigational Site Number 152006, Viña del Mar

Investigational Site Number 170004, Barranquilla

Investigational Site Number 170001, Bogotá

Investigational Site Number 170003, Bogotá

Investigational Site Number 170006, Bogotá

Investigational Site Number 170008, Bogotá

Investigational Site Number 170007, Bucaramanga

Investigational Site Number 170009, Bucaramanga

Investigational Site Number 170002, Medellín

Investigational Site Number 818001, Cairo

Investigational Site Number 818002, Cairo

Investigational Site Number 458003, Putrajaya

Investigational Site Number 554002, Rotorua

Investigational Site Number 554001, Timaru

Investigational Site Number 608002, Manila

Investigational Site Number 620002, Lisbon

Investigational Site Number 642004, Bucharest

Investigational Site Number 642010, Bucharest

Investigational Site Number 642008, Ploieşti

Investigational Site Number 710008, Pretoria

Investigational Site Number 410001, Incheon

Investigational Site Number 410002, Seoul

Investigational Site Number 792005, Ankara

C1015ABO

Investigational Site Number 032006, Caba

X5004BAL

Investigational Site Number 032002, Córdoba

B7600

Investigational Site Number 032012, Mar del Plata

B1878DVB

Investigational Site Number 032011, Quilmes

13015-001

Investigational Site Number 076008, Campinas

13083-970

Investigational Site Number 076012, Campinas

80060-240

Investigational Site Number 076001, Curitiba

74110-120

Investigational Site Number 076006, Goiânia

36010-570

Investigational Site Number 076010, Juiz de Fora

90610-000

Investigational Site Number 076004, Porto Alegre

20551-030

Investigational Site Number 076005, Rio de Janeiro

40050-410

Investigational Site Number 076011, Salvador

04039-901

Investigational Site Number 076002, São Paulo

04230 000

Investigational Site Number 076003, São Paulo

29055 450

Investigational Site Number 076013, Vitória

L7R 1E2

Investigational Site Number 124004, Burlington

L5M 2V8

Investigational Site Number 124003, Mississauga

L3Y 3R7

Investigational Site Number 124008, Newmarket

L2N 7E4

Investigational Site Number 124002, St. Catharines

M5T 2S8

Investigational Site Number 124005, Toronto

M9R 2Y8

Investigational Site Number 124001, Toronto

R3A 1M3

Investigational Site Number 124012, Winnipeg

00290

Investigational Site Number 246001, Helsinki

05800

Investigational Site Number 246002, Hyvinkää

06108

Investigational Site Number 276015, Halle

546 36

Investigational Site Number 300003, Thessaloniki

H-9700

Investigational Site Number 348015, Szombathely

411 001

Investigational Site Number 356001, Maharashtra

LT-50009

Investigational Site Number 440001, Kaunas

LT-08661

Investigational Site Number 440002, Vilnius

6419 PC

Investigational Site Number 528002, Heerlen

15-354

Investigational Site Number 616002, Bialystok

15-461

Investigational Site Number 616003, Bialystok

30-510

Investigational Site Number 616001, Krakow

20-607

Investigational Site Number 616005, Lublin

87-100

Investigational Site Number 616006, Torun

02-118

Investigational Site Number 616004, Warsaw

50-044

Investigational Site Number 616012, Wroclaw

3814-501

Investigational Site Number 620003, Aveiro

1649-035

Investigational Site Number 620001, Lisbon

010976

Investigational Site Number 642001, Bucharest

020983

Investigational Site Number 642002, Bucharest

0075

Investigational Site Number 710005, Pretoria

0182

Investigational Site Number 710006, Pretoria

431-070

Investigational Site Number 410014, Anyang

602-739

Investigational Site Number 410006, Busan

700-721

Investigational Site Number 410004, Daegu

705-718

Investigational Site Number 410013, Daegu

302-799

Investigational Site Number 410005, Daejeon

501-757

Investigational Site Number 410010, Gwangju

400-711

Investigational Site Number 410009, Incheon

561-712

Investigational Site Number 410011, Jeonju

110-744

Investigational Site Number 410007, Seoul

133-792

Investigational Site Number 410012, Seoul

150-713

Investigational Site Number 410003, Seoul

443-721

Investigational Site Number 410008, Suwon

08025

Investigational Site Number 724010, Barcelona

08208

Investigational Site Number 724011, Sabadell

01330

Investigational Site Number 792003, Adana

06100

Investigational Site Number 792002, Ankara

07059

Investigational Site Number 792004, Antalya

01023

Investigational Site Number 804008, Kyiv

03151

Investigational Site Number 804004, Kyiv

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Regeneron Pharmaceuticals

INDUSTRY

lead

Sanofi

INDUSTRY