An Evaluation of Sarilumab Plus Methotrexate Compared to Etanercept Plus Methotrexate in RA Patients Not Responding to Adalimumab Plus Methotrexate

PHASE3TerminatedINTERVENTIONAL
Enrollment

776

Participants

Timeline

Start Date

April 30, 2013

Primary Completion Date

January 31, 2015

Study Completion Date

January 31, 2015

Conditions
Rheumatoid Arthritis
Interventions
DRUG

Sarilumab

Pharmaceutical form: Solution for injection in pre-filled syringe; Route of administration: Subcutaneous

DRUG

Etanercept

Pharmaceutical form: Solution for injection in pre-filled syringe; Route of administration: Subcutaneous

DRUG

Methotrexate

Dispensed according to local practice.

DRUG

Placebo (for sarilumab)

DRUG

Placebo (for etanercept)

DRUG

Adalimumab

Pharmaceutical form: Solution for injection in pre-filled syringe; Route of administration: Subcutaneous

Trial Locations (257)

0

Investigational Site Number 170016, Bogotá

14

Investigational Site Number 604010, Lima

402

Investigational Site Number 158006, Taipei

500

Investigational Site Number 158010, Changhua

622

Investigational Site Number 158004, Chiayi City

807

Investigational Site Number 158012, Kaohsiung City

833

Investigational Site Number 158011, Kaohsiung City

1023

Investigational Site Number 348001, Budapest

Investigational Site Number 554007, Auckland

Investigational Site Number 554011, Nelson

2050

Investigational Site Number 036020, Camperdown

2500

Investigational Site Number 348021, Esztergom

3081

Investigational Site Number 036004, Heidelberg West

3100

Investigational Site Number 484029, Deleg. Benito Juárez

3204

Investigational Site Number 554005, Hamilton

4000

Investigational Site Number 032005, San Miguel de Tucumán

4031

Investigational Site Number 348010, Debrecen

5011

Investigational Site Number 036007, Woodville

5700

Investigational Site Number 348008, Gyula

6100

Investigational Site Number 036014, Victoria Park

6726

Investigational Site Number 484052, Mexico City

7405

Investigational Site Number 710011, Cape Town

7500

Investigational Site Number 710007, Cape Town

7600

Investigational Site Number 710010, Stellenbsoch

9016

Investigational Site Number 554010, Dunedin

9025

Investigational Site Number 348013, Gy?r

10016

Investigational Site Number 840056, New York

10330

Investigational Site Number 764002, Bangkok

10400

Investigational Site Number 764010, Bangkok

10990

Investigational Site Number 458014, George Town

11000

Investigational Site Number 203032, Prague

11527

Investigational Site Number 300010, Athens

12161

Investigational Site Number 276007, Berlin

Investigational Site Number 276057, Berlin

12850

Investigational Site Number 203001, Prague

14004

Investigational Site Number 724043, Córdoba

14059

Investigational Site Number 203031, Prague

14800

Investigational Site Number 203033, Prague

14974

Investigational Site Number 276053, Ludwigsfelde

15006

Investigational Site Number 724009, A Coruña

15261

Investigational Site Number 840117, Pittsburgh

15586

Investigational Site Number 458013, Kota Bharu

15705

Investigational Site Number 724012, Santiago de Compostela

16011

Investigational Site Number 380004, Genova

16132

Investigational Site Number 380005, Genova

20003

Investigational Site Number 840203, Washington D.C.

21200

Investigational Site Number 484010, Mexicali

Investigational Site Number 484026, Mexicali

21502

Investigational Site Number 840073, Cumberland

21740

Investigational Site Number 840202, Hagerstown

22010

Investigational Site Number 484051, Tijuana

22147

Investigational Site Number 276013, Hamburg

26301

Investigational Site Number 840124, Clarksburg

28034

Investigational Site Number 724042, Madrid

28046

Investigational Site Number 724041, Madrid

28100

Investigational Site Number 246003, Pori

28850

Investigational Site Number 724040, Madrid

29009

Investigational Site Number 724001, Málaga

29406

Investigational Site Number 840016, North Charleston

30990

Investigational Site Number 458001, Ipoh

31000

Investigational Site Number 250008, Toulouse

31020

Investigational Site Number 484023, Chihuahua City

31048

Investigational Site Number 376001, Haifa

31096

Investigational Site Number 376010, Haifa

32174

Investigational Site Number 840128, Ormond Beach

33612

Investigational Site Number 840207, Tampa

33756

Investigational Site Number 840210, Clearwater

34239

Investigational Site Number 840060, Sarasota

34295

Investigational Site Number 250002, Montpellier

34362

Investigational Site Number 376031, Haifa

34684

Investigational Site Number 840063, Palm Harbor

35205

Investigational Site Number 840004, Birmingham

37064

Investigational Site Number 380042, Valeggio sul Mincio

38305

Investigational Site Number 840025, Jackson

38801

Investigational Site Number 840037, Tupelo

39216

Investigational Site Number 840200, Jackson

40002

Investigational Site Number 764011, Khon Kaen

43024

Investigational Site Number 804030, Lutsk

44158

Investigational Site Number 484013, Guadalajara

44620

Investigational Site Number 484018, Guadalajara

44649

Investigational Site Number 276001, Herne

46250

Investigational Site Number 840213, Indianapolis

48910

Investigational Site Number 840150, Lansing

49008

Investigational Site Number 804003, Dnipropetrovsk

49015

Investigational Site Number 840204, Battle Creek

50141

Investigational Site Number 380002, Florence

52621

Investigational Site Number 376030, Ramat Gan

Investigational Site Number 376034, Tel Litwinsky

56429

Investigational Site Number 300014, N. Efkarpia

61022

Investigational Site Number 804010, Kharkiv

61057

Investigational Site Number 804001, Kharkiv

64239

Investigational Site Number 376011, Tel Aviv

65025

Investigational Site Number 804032, Odesa

65026

Investigational Site Number 804022, Odesa

65117

Investigational Site Number 804012, Odesa

67010

Investigational Site Number 380041, L’Aquila

68100

Investigational Site Number 458012, Batu Caves

68516

Investigational Site Number 840112, Lincoln

69118

Investigational Site Number 804028, Zaporizhzhya

70300

Investigational Site Number 458011, Seremban

70601

Investigational Site Number 840109, Lake Charles

71110

Investigational Site Number 300002, Heraklion

74014

Investigational Site Number 250005, Paris

75150

Investigational Site Number 840074, Mesquite

75181

Investigational Site Number 250004, Paris

75400

Investigational Site Number 458010, Malacca

76001

Investigational Site Number 203006, Zlín

76018

Investigational Site Number 804029, Ivano-Frankivsk

78220

Investigational Site Number 484025, San Luis

78278

Investigational Site Number 376032, Ashkelon

79005

Investigational Site Number 804005, Lviv

79010

Investigational Site Number 804033, Lviv

79013

Investigational Site Number 804020, Lviv

80054

Investigational Site Number 250003, Amiens

80230

Investigational Site Number 840201, Denver

83114

Investigational Site Number 804002, Donetsk

83404

Investigational Site Number 840018, Idaho Falls

85925

Investigational Site Number 250001, La Roche-sur-Yon

90100

Investigational Site Number 246030, Oulu

91056

Investigational Site Number 276051, Erlangen

91120

Investigational Site Number 376035, Jerusalem

91205

Investigational Site Number 840212, Glendale

91360

Investigational Site Number 840211, Thousand Oaks

91786

Investigational Site Number 840049, Upland

92395

Investigational Site Number 840205, Victorville

93586

Investigational Site Number 458002, Kuching

95017

Investigational Site Number 804021, Simferopol

97000

Investigational Site Number 484004, Mérida

98405

Investigational Site Number 840061, Tacoma

117556

Investigational Site Number 643052, Moscow

119049

Investigational Site Number 643021, Moscow

121374

Investigational Site Number 643031, Moscow

125284

Investigational Site Number 643030, Moscow

130083

Investigational Site Number 642022, Târgovişte

150003

Investigational Site Number 643057, Yaroslavl

192242

Investigational Site Number 643008, Saint Petersburg

214019

Investigational Site Number 643059, Smolensk

400006

Investigational Site Number 642012, Bucharest

410012

Investigational Site Number 643011, Saratov

443095

Investigational Site Number 643010, Samara

450005

Investigational Site Number 643013, Ufa

630091

Investigational Site Number 643022, Novosibirsk

650099

Investigational Site Number 643006, Kemerovo

660022

Investigational Site Number 643056, Krasnoyarsk

700127

Investigational Site Number 642013, Iași

700656

Investigational Site Number 642014, Iași

800578

Investigational Site Number 642005, Galati

5311092

Investigational Site Number 152005, Osorno

7510047

Investigational Site Number 152018, Santiago

06810

Investigational Site Number 840209, Danbury

C1015ABO

Investigational Site Number 032052, Buenos Aires

C1426AAL

Investigational Site Number 032050, Buenos Aires

Unknown

Investigational Site Number 032053, La Plata

Investigational Site Number 032051, San Miguel de Tucumán

Investigational Site Number 076016, Curitiba

Investigational Site Number 152001, Santiago

Investigational Site Number 152002, Santiago

Investigational Site Number 152011, Santiago

Investigational Site Number 152015, Temuco

Investigational Site Number 170001, Bogotá

Investigational Site Number 170007, Bucaramanga

Investigational Site Number 170009, Bucaramanga

Investigational Site Number 170041, Medellín

Investigational Site Number 203030, Prague

Investigational Site Number 218003, Cuenca

Investigational Site Number 246032, Tampere

Investigational Site Number 250007, Bobigny

Investigational Site Number 250006, Strasbourg

Investigational Site Number 276058, Cologne

Investigational Site Number 276050, Rostock

Investigational Site Number 300012, Pátrai

Investigational Site Number 484027, Ciudad Obregón

Investigational Site Number 616015, Elblag

Investigational Site Number 616061, Krakow

Investigational Site Number 642041, Bacau

Investigational Site Number 642004, Bucharest

Investigational Site Number 642023, Bucharest

Investigational Site Number 642042, Bucharest

Investigational Site Number 643058, Saint Peterburg

Investigational Site Number 643050, Voronezh

Investigational Site Number 643051, Yaroslavl

Investigational Site Number 764003, Bangkok Noi

Investigational Site Number 804024, Donetsk

Investigational Site Number 804011, Kyiv

Investigational Site Number 804031, Zhytomyr

Investigational Site Number 826023, Barnsley

Investigational Site Number 826026, Durham

Investigational Site Number 826027, Durham

S200PBJ

Investigational Site Number 032013, Rosario

B2800DGH

Investigational Site Number 032009, Zárate

80060-240

Investigational Site Number 076001, Curitiba

74110-120

Investigational Site Number 076006, Goiânia

36010-570

Investigational Site Number 076010, Juiz de Fora

20551-030

Investigational Site Number 076005, Rio de Janeiro

29055 450

Investigational Site Number 076013, Vitória

NAP

Investigational Site Number 170040, Bogotá

702 00

Investigational Site Number 203004, Ostrava

686 01

Investigational Site Number 203002, Uherské Hradiště

0593

Investigational Site Number 218001, Guayaquil

Investigational Site Number 218002, Quito

00290

Investigational Site Number 246001, Helsinki

05800

Investigational Site Number 246002, Hyvinkää

01109

Investigational Site Number 276056, Dresden

01307

Investigational Site Number 276055, Dresden

LV-3401

Investigational Site Number 428002, Liepāja

LV-1038

Investigational Site Number 428001, Riga

LV 3601

Investigational Site Number 428003, Ventspils

LT-50009

Investigational Site Number 440005, Kaunas

LT-92288

Investigational Site Number 440006, Klaipėda

LT- 35144

Investigational Site Number 440010, Panevezys

08661

Investigational Site Number 440011, Vilnius

06700

Investigational Site Number 484017, México

021

Investigational Site Number 604001, Lima

LIMA 01

Investigational Site Number 604009, Lima

LIMA 11

Investigational Site Number 604012, Lima

Lima 33

Investigational Site Number 604007, Lima

LIMA 41

Investigational Site Number 604005, Lima

Lima36

Investigational Site Number 604020, Lima

85-168

Investigational Site Number 616019, Bydgoszcz

41-902

Investigational Site Number 616054, Bytom

13-200

Investigational Site Number 616052, Działdowo

31-121

Investigational Site Number 616057, Krakow

31-209

Investigational Site Number 616059, Krakow

20-607

Investigational Site Number 616005, Lublin

32-400

Investigational Site Number 616063, Myślenice

61-397

Investigational Site Number 616018, Poznan

41-200

Investigational Site Number 616013, Sosnowiec

27-200

Investigational Site Number 616056, Starachowice

71-252

Investigational Site Number 616016, Szczecin

43-450

Investigational Site Number 616058, Ustroń

02-653

Investigational Site Number 616051, Warsaw

96-300

Investigational Site Number 616053, Żyrardów

010976

Investigational Site Number 642001, Bucharest

020125

Investigational Site Number 642040, Bucharest

020983

Investigational Site Number 642002, Bucharest

0002

Investigational Site Number 710008, Pretoria

0182

Investigational Site Number 710006, Pretoria

602-715

Investigational Site Number 410020, Busan

602-739

Investigational Site Number 410006, Busan

561-712

Investigational Site Number 410013, Daegu

Investigational Site Number 410011, Jeonju

301-721

Investigational Site Number 410005, Daejeon

120-752

Investigational Site Number 410016, Seoul

133-792

Investigational Site Number 410015, Seoul

135-710

Investigational Site Number 410022, Seoul

138-736

Investigational Site Number 410023, Seoul

158-710

Investigational Site Number 410021, Seoul

443-721

Investigational Site Number 410008, Suwon

08208

Investigational Site Number 724011, Sabadell

04114

Investigational Site Number 804025, Kiev

01023

Investigational Site Number 804023, Kyiv

01103

Investigational Site Number 804014, Kyiv

03680

Investigational Site Number 804027, Kyiv

B15 2TH

Investigational Site Number 826022, Birmingham

DY1 2HQ

Investigational Site Number 826021, Dudley

CM20 1QX

Investigational Site Number 826020, Harlow

WN6 9EP

Investigational Site Number 826025, Wigan

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Regeneron Pharmaceuticals

INDUSTRY

lead

Sanofi

INDUSTRY

NCT01764997 - An Evaluation of Sarilumab Plus Methotrexate Compared to Etanercept Plus Methotrexate in RA Patients Not Responding to Adalimumab Plus Methotrexate | Biotech Hunter | Biotech Hunter