Efficacy and Safety of Sarilumab and Adalimumab Monotherapy in Patients With Rheumatoid Arthritis (SARIL-RA-MONARCH)

PHASE3CompletedINTERVENTIONAL
Enrollment

369

Participants

Timeline

Start Date

January 28, 2015

Primary Completion Date

January 20, 2016

Study Completion Date

December 29, 2020

Conditions
Rheumatoid Arthritis
Interventions
DRUG

Sarilumab

Pharmaceutical form: solution for injection in pre-filled syringe; Route of administration: SC

DRUG

Adalimumab

Pharmaceutical form: solution for injection in pre-filled syringe; Route of administration: SC

DRUG

Placebo (for sarilumab)

Pharmaceutical form: solution for injection in pre-filled syringe; Route of administration: SC

DRUG

Placebo (for adalimumab)

Pharmaceutical form: solution for injection in pre-filled syringe; Route of administration: SC

Trial Locations (86)

1027

Investigational Site Number 348025, Budapest

1033

Investigational Site Number 348020, Budapest

1036

Investigational Site Number 348022, Budapest

1619

Investigational Site Number 710004, Kempton Park

7405

Investigational Site Number 710011, Cape Town

7500

Investigational Site Number 710007, Cape Town

8200

Investigational Site Number 348023, Veszprém

9700

Investigational Site Number 348024, Szombathely

12850

Investigational Site Number 203001, Prague

14800

Investigational Site Number 203033, Prague

15705

Investigational Site Number 724012, Santiago de Compostela

19958

Investigational Site Number 840130, Lewes

21018

Investigational Site Number 804011, Vinnitsya

21100

Investigational Site Number 804043, Vinnitsya

21502

Investigational Site Number 840073, Cumberland

21740

Investigational Site Number 840202, Hagerstown

28210

Investigational Site Number 840402, Charlotte

28601

Investigational Site Number 840406, Hickory

29010

Investigational Site Number 724001, Málaga

32174

Investigational Site Number 840128, Ormond Beach

33134

Investigational Site Number 840229, Coral Gables

33614

Investigational Site Number 840140, Tampa

33708

Investigational Site Number 840403, St. Petersburg

34362

Investigational Site Number 376031, Haifa

35233

Investigational Site Number 410004, Daejeon

36011

Investigational Site Number 804049, Poltava

41009

Investigational Site Number 724007, Seville

42601

Investigational Site Number 410005, Daegu

43005

Investigational Site Number 804037, Lutsk

44130

Investigational Site Number 840404, Middleburg Heights

48504

Investigational Site Number 840232, Flint

48903

Investigational Site Number 724003, Barakaldo

49074

Investigational Site Number 276021, Osnabrück

50937

Investigational Site Number 276058, Cologne

52621

Investigational Site Number 376030, Ramat Gan

61058

Investigational Site Number 804048, Kharkiv

64239

Investigational Site Number 376011, Tel Aviv

68516

Investigational Site Number 840112, Lincoln

73103

Investigational Site Number 840127, Oklahoma City

75150

Investigational Site Number 840074, Mesquite

76018

Investigational Site Number 804029, Ivano-Frankivsk

78278

Investigational Site Number 376032, Ashkelon

79010

Investigational Site Number 804046, Lviv

90606

Investigational Site Number 840141, Whittier

90808

Investigational Site Number 840400, Long Beach

91723

Investigational Site Number 840407, Covina

115404

Investigational Site Number 643020, Moscow

115522

Investigational Site Number 643001, Moscow

121374

Investigational Site Number 643031, Moscow

125284

Investigational Site Number 643030, Moscow

192242

Investigational Site Number 643008, Saint Petersburg

410053

Investigational Site Number 643011, Saratov

650000

Investigational Site Number 643006, Kemerovo

800578

Investigational Site Number 642005, Galati

810019

Investigational Site Number 642006, Brăila

4790928

Investigational Site Number 152015, Temuco IX Region

5311092

Investigational Site Number 152005, Osorno

7501126

Investigational Site Number 152002, Santiago

8207257

Investigational Site Number 152050, Santiago

Unknown

Investigational Site Number 152001, Puerto Varas

Investigational Site Number 152014, Talca

Investigational Site Number 152007, Viña del Mar

Investigational Site Number 203030, Prague

Investigational Site Number 616015, Elblag

686 01

Investigational Site Number 203002, Uherské Hradiště

LIMA 27

Investigational Site Number 604003, Lima

LIMA 41

Investigational Site Number 604005, Lima

Lima29

Investigational Site Number 604022, Lima

41-902

Investigational Site Number 616056, Bytom

20-582

Investigational Site Number 616005, Lublin

20-954

Investigational Site Number 616030, Lublin

05-830

Investigational Site Number 616055, Nadarzyn

61-397

Investigational Site Number 616018, Poznan

71-252

Investigational Site Number 616016, Szczecin

02-118

Investigational Site Number 616004, Warsaw

03-291

Investigational Site Number 616031, Warsaw

010976

Investigational Site Number 642001, Bucharest

011172

Investigational Site Number 642010, Bucharest

020983

Investigational Site Number 642002, Bucharest

01830

Investigational Site Number 410006, Seoul

03080

Investigational Site Number 410001, Seoul

08034

Investigational Site Number 724015, Barcelona

08208

Investigational Site Number 724011, Barcelona / Sabadell

01103

Investigational Site Number 804014, Kyiv

02125

Investigational Site Number 804047, Kyiv

E11 1NR

Investigational Site Number 826001, Leytonstone

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Regeneron Pharmaceuticals

INDUSTRY

lead

Sanofi

INDUSTRY