Efficacy at 24 Weeks and Safety, Tolerability and Long Term Efficacy of Secukinumab (AIN457) in Patients With Active Rheumatoid Arthritis (RA) and an Inadequate Response to Anti-Tumor Necrosis Factor α (Anti-TNFα) Agents (CAIN457F2309 and CAIN457F2309E1)

PHASE3CompletedINTERVENTIONAL
Enrollment

551

Participants

Timeline

Start Date

September 30, 2011

Primary Completion Date

February 28, 2015

Study Completion Date

February 28, 2015

Conditions
Rheumatoid Arthritis
Interventions
BIOLOGICAL

AIN457

AIN457 (Secukinumab) is a human monoclonal antibody. Secukinumab binds and reduces the activity of Interleukin 17 (IL-17). AIN457 was given as i.v. (10mg/kg) at baseline, week 2 and week 4, and then s.c. (75 or 150mg) every 4 weeks starting at week 8.

BIOLOGICAL

Placebo

Placebo was given as i.v. at baseline, week 2 and week 4, and then s.c. every 4 weeks starting at week 8.

BIOLOGICAL

Abatacept

Abatacept (from 500 to 1000 mg i.v. based on weight) was given as i.v. at baseline, weeks 2 and 4, and then every 4 weeks starting at week 8.

Trial Locations (117)

1023

Novartis Investigative Site, Budapest

1062

Novartis Investigative Site, Budapest

1431

Novartis Investigative Site, Sofia

1505

Novartis Investigative Site, Sofia

1612

Novartis Investigative Site, Sofia

4000

Novartis Investigative Site, Plovdiv

4002

Novartis Investigative Site, Plovdiv

5000

Novartis Investigative Site, Szolnok

5700

Novartis Investigative Site, Gyula

7000

Novartis Investigative Site, Rousse

9023

Novartis Investigative Site, Győr

10117

Novartis Investigative Site, Berlin

11850

Novartis Investigative Site, Mexico City

14059

Novartis Investigative Site, Berlin

15006

Novartis Investigative Site, A Coruña

15706

Novartis Investigative Site, Santiago de Compostela

16132

Novartis Investigative Site, Genova

21100

Novartis Investigative Site, Mexicali

22147

Novartis Investigative Site, Hamburg

22415

Novartis Investigative Site, Hamburg

26301

Novartis Investigative Site, Clarksburg

28046

Novartis Investigative Site, Madrid

29010

Novartis Investigative Site, Málaga

31059

Novartis Investigative Site, Toulouse

32514

Novartis Investigative Site, Pensacola

32806

Novartis Investigative Site, Orlando

33012

Novartis Investigative Site, Hialeah

33026

Novartis Investigative Site, Pembroke Pines

33076

Novartis Investigative Site, Bordeaux

33126

Novartis Investigative Site, Miami

33180

Novartis Investigative Site, Aventura

33324

Novartis Investigative Site, Plantation

33486

Novartis Investigative Site, Boca Raton

33603

Novartis Investigative Site, Tampa

34195

Novartis Investigative Site, Montpellier

34239

Novartis Investigative Site, Sarasota

34684

Novartis Investigative Site, Palm Harbor

35216

Novartis Investigative Site, Vestavia Hills

37067

Novartis Investigative Site, Valeggio sul Mincio

37660

Novartis Investigative Site, Kingsport

38305

Novartis Investigative Site, Jackson

39008

Novartis Investigative Site, Santander

39110

Novartis Investigative Site, Magdeburg

39245

Novartis Investigative Site, Gommern

39261

Novartis Investigative Site, Zerbst

40615

Novartis Investigative Site, Lexington

41009

Novartis Investigative Site, Seville

42101

Novartis Investigative Site, Bowling Green

43701

Novartis Investigative Site, Zanesville

44160

Novartis Investigative Site, Guadalajara

45219

Novartis Investigative Site, Cincinnati

45276

Novartis Investigative Site, Essen

46005

Novartis Investigative Site, Cahors

48910

Novartis Investigative Site, Lansing

49074

Novartis Investigative Site, Osnabrück

50139

Novartis Investigative Site, Florence

50924

Novartis Investigative Site, Cologne

52064

Novartis Investigative Site, Aachen

53100

Novartis Investigative Site, Siena

55121

Novartis Investigative Site, Eagan

60053

Novartis Investigative Site, Morton Grove

62704

Novartis Investigative Site, Springfield

63117

Novartis Investigative Site, Richmond Heights

64020

Novartis Investigative Site, Monterrey

67214

Novartis Investigative Site, Wichita

68114

Novartis Investigative Site, Omaha

73103

Novartis Investigative Site, Oklahoma City

75010

Novartis Investigative Site, Carrollton

75014

Novartis Investigative Site, Paris

75204

Novartis Investigative Site, Dallas

75216

Novartis Investigative Site, Dallas

76710

Novartis Investigative Site, Waco

77034

Novartis Investigative Site, Houston

77479

Novartis Investigative Site, Sugar Land

78731

Novartis Investigative Site, Austin

80000

Novartis Investigative Site, Culiacán

83814

Novartis Investigative Site, Coeur d'Alene

91056

Novartis Investigative Site, Erlangen

91405

Novartis Investigative Site, Van Nuys

91767

Novartis Investigative Site, Pomona

91786

Novartis Investigative Site, Upland

92112

Novartis Investigative Site, Piešťany

94538

Novartis Investigative Site, Freemont

99204

Novartis Investigative Site, Spokane

110221

Novartis Investigative Site, Bogotá

115522

Novartis Investigative Site, Moscow

141060

Novartis Investigative Site, Korolyov

185019

Novartis Investigative Site, Petrozavodsk

197341

Novartis Investigative Site, Saint Petersburg

300053

Novartis Investigative Site, Tula

700195

Novartis Investigative Site, Iași

36207-5710

Novartis Investigative Site, Anniston

06606

Novartis Investigative Site, Bridgeport

02111

Novartis Investigative Site, Boston

66160-7330

Novartis Investigative Site, Kansas City

80060-900

Novartis Investigative Site, Curitiba

22271-100

Novartis Investigative Site, Rio de Janeiro

90610-000

Novartis Investigative Site, Porto Alegre

04023-900

Novartis Investigative Site, São Paulo

04266-010

Novartis Investigative Site, São Paulo

05403-000

Novartis Investigative Site, São Paulo

Unknown

Novartis Investigative Site, Sevlievo

Novartis Investigative Site, Bogotá

Novartis Investigative Site, Barranquilla

A1C 5B8

Novartis Investigative Site, St. John's

G1W 4R4

Novartis Investigative Site, Sainte-Foy

G8Z 1Y2

Novartis Investigative Site, Trois-Rivières

792 01

Novartis Investigative Site, Bruntál

772 00

Novartis Investigative Site, Ostrava

686 01

Novartis Investigative Site, Uherské Hradiště

760 01

Novartis Investigative Site, Zlín

03042

Novartis Investigative Site, Cottbus

04103

Novartis Investigative Site, Leipzig

06100

Novartis Investigative Site, Perugia

06700

Novartis Investigative Site, Mexico City

975 17

Novartis Investigative Site, Banská Bystrica

08208

Novartis Investigative Site, Sabadell

Sponsors
All Listed Sponsors
lead

Novartis Pharmaceuticals

INDUSTRY