To Evaluate The Safety of SAR153191 (REGN88) and Tocilizumab Added to Other RA Drugs in Patients With RA Who Are Not Responding to or Intolerant of Anti-TNF Therapy (SARIL-RA-ASCERTAIN)

PHASE3CompletedINTERVENTIONAL
Enrollment

202

Participants

Timeline

Start Date

March 31, 2013

Primary Completion Date

October 31, 2014

Study Completion Date

October 31, 2014

Conditions
Rheumatoid Arthritis
Interventions
DRUG

sarilumab SAR153191 (REGN88)

Pharmaceutical form: solution Route of administration: subcutaneous

DRUG

tocilizumab

Pharmaceutical form: solution Route of administration: intravenous

DRUG

hydroxychloroquine

Dispensed according to local practice.

DRUG

methotrexate

Dispensed according to local practice.

DRUG

sulfasalazine

Dispensed according to local practice.

DRUG

leflunomide

Dispensed according to local practice.

DRUG

subcutaneous placebo

Pharmaceutical form: solution Route of administration: subcutaneous

DRUG

intravenous placebo

Pharmaceutical form: solution Route of administration: intravenous

Trial Locations (78)

1027

Investigational Site Number 348014, Budapest

1036

Investigational Site Number 348022, Budapest

2143

Investigational Site Number 348016, Kistarcsa

2500

Investigational Site Number 348021, Esztergom

3000

Investigational Site Number 056010, Leuven

3105

Investigational Site Number 578006, Tønsberg

4000

Investigational Site Number 032004, San Miguel de Tucumán

Investigational Site Number 032005, San Miguel de Tucumán

4604

Investigational Site Number 578010, Kristiansand

5000

Investigational Site Number 348009, Szolnok

9700

Investigational Site Number 348015, Szombathely

10138

Investigational Site Number 233010, Tallinn

11120

Investigational Site Number 246010, Riihimäki

11850

Investigational Site Number 484001, México, D.F.

12850

Investigational Site Number 203011, Prague

13419

Investigational Site Number 233002, Tallinn

16132

Investigational Site Number 380005, Genova

19611

Investigational Site Number 840062, Reading

20902

Investigational Site Number 840013, Wheaton

31096

Investigational Site Number 376010, Haifa

33155

Investigational Site Number 840048, Miami

33180

Investigational Site Number 840153, Aventura

33334

Investigational Site Number 840033, Fort Lauderdale

34080

Investigational Site Number 484008, Durango

34684

Investigational Site Number 840155, Palm Harbor

35801

Investigational Site Number 840152, Huntsville

37000

Investigational Site Number 484035, León

39008

Investigational Site Number 724021, Santander

41010

Investigational Site Number 724022, Seville

44280

Investigational Site Number 484036, Zapopan

46063

Investigational Site Number 203009, Liberec

48910

Investigational Site Number 840150, Lansing

50141

Investigational Site Number 380002, Florence

64239

Investigational Site Number 376011, Tel Aviv

75150

Investigational Site Number 840074, Mesquite

75235

Investigational Site Number 840022, Dallas

75246

Investigational Site Number 840156, Dallas

78705

Investigational Site Number 840038, Austin

80903

Investigational Site Number 840151, Colorado Springs

97000

Investigational Site Number 484009, Mérida

115404

Investigational Site Number 643020, Moscow

115522

Investigational Site Number 643001, Moscow

117997

Investigational Site Number 643002, Moscow

121374

Investigational Site Number 643031, Moscow

125284

Investigational Site Number 643030, Moscow

130083

Investigational Site Number 642022, Târgovişte

191186

Investigational Site Number 643032, Saint Petersburg

650066

Investigational Site Number 643017, Kemerovo

810019

Investigational Site Number 642006, Brăila

02115

Investigational Site Number 840154, Boston

C1015ABO

Investigational Site Number 032006, Caba

B1704ETD

Investigational Site Number 032010, Ramos Mejía

S200PBJ

Investigational Site Number 032013, Rosario

Unknown

Investigational Site Number 032015, San Fernando

Investigational Site Number 642010, Bucharest

80060-240

Investigational Site Number 076001, Curitiba

15090-000

Investigational Site Number 076030, São José do Rio Preto

140 00

Investigational Site Number 203010, Prague

00290

Investigational Site Number 246001, Helsinki

1056 AB

Investigational Site Number 528010, Amsterdam

2333 ZA

Investigational Site Number 528001, Leiden

85-168

Investigational Site Number 616019, Bydgoszcz

41-902

Investigational Site Number 616054, Bytom

20-090

Investigational Site Number 616030, Lublin

01-518

Investigational Site Number 616031, Warsaw

02-653

Investigational Site Number 616017, Warsaw

010584

Investigational Site Number 642021, Bucharest

010976

Investigational Site Number 642001, Bucharest

020125

Investigational Site Number 642020, Bucharest

08035

Investigational Site Number 724020, Barcelona

205 02

Investigational Site Number 752004, Malmo

751 85

Investigational Site Number 752002, Uppsala

DN2 5LT

Investigational Site Number 826004, Doncaster

EH4 2XU

Investigational Site Number 826006, Edinburgh

LS7 4SA

Investigational Site Number 826001, Leeds

E11 1NR

Investigational Site Number 826002, London

SO16 6YD

Investigational Site Number 826005, Southampton

WN6 9EP

Investigational Site Number 826025, Wigan

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Regeneron Pharmaceuticals

INDUSTRY

lead

Sanofi

INDUSTRY