Efficacy at 24 Weeks and Safety, Tolerability and Long Term Efficacy up to 2 Years of Secukinumab (AIN457) in Patients With Active Rheumatoid Arthritis and an Inadequate Response to Anti-TNFα Agents

PHASE3CompletedINTERVENTIONAL
Enrollment

637

Participants

Timeline

Start Date

August 30, 2011

Primary Completion Date

September 9, 2015

Study Completion Date

September 9, 2015

Conditions
Rheumatoid Arthritis
Interventions
BIOLOGICAL

Secukinumab (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.

Trial Locations (142)

1023

Novartis Investigative Site, Budapest

1062

Novartis Investigative Site, Budapest

1200

Novartis Investigative Site, Brussels

3300

Novartis Investigative Site, Eger

3600

Novartis Investigative Site, Genk

4000

Novartis Investigative Site, San Miguel de Tucumán

5000

Novartis Investigative Site, Szolnok

5700

Novartis Investigative Site, Gyula

9000

Novartis Investigative Site, Ghent

10330

Novartis Investigative Site, Bangkok

10400

Novartis Investigative Site, Bangkok

Novartis Investigative Site, Bangkok

11850

Novartis Investigative Site, Mexico City

15237

Novartis Investigative Site, Pittsburgh

20902

Novartis Investigative Site, Wheaton

21100

Novartis Investigative Site, Mexicali

21200

Novartis Investigative Site, Mexicali

27704

Novartis Investigative Site, Durham

28210

Novartis Investigative Site, Charlotte

28801

Novartis Investigative Site, Asheville

29204

Novartis Investigative Site, Columbia

29601

Novartis Investigative Site, Greenville

30114

Novartis Investigative Site, Canton

32806

Novartis Investigative Site, Orlando

33016

Novartis Investigative Site, Hialeah

33143

Novartis Investigative Site, South Miami

33169

Novartis Investigative Site, Miami

33321

Novartis Investigative Site, Tamarac

33612

Novartis Investigative Site, Tampa

33773

Novartis Investigative Site, Largo

34684

Novartis Investigative Site, Palm Harbor

37100

Novartis Investigative Site, Verona

37205

Novartis Investigative Site, Nashville

37604

Novartis Investigative Site, Johnson City

38305

Novartis Investigative Site, Jackson

40002

Novartis Investigative Site, Khon Kaen

42101

Novartis Investigative Site, Bowling Green

44160

Novartis Investigative Site, Guadalajara

45631

Novartis Investigative Site, Gallipolis

46020

Novartis Investigative Site, Pieve di Coriano

50134

Novartis Investigative Site, Florence

50200

Novartis Investigative Site, Chiang Mai

53100

Novartis Investigative Site, Siena

55121

Novartis Investigative Site, Eagan

72205

Novartis Investigative Site, Little Rock

75150

Novartis Investigative Site, Mesquite

75390

Novartis Investigative Site, Dallas

77034

Novartis Investigative Site, Houston

77074

Novartis Investigative Site, Houston

80000

Novartis Investigative Site, Culiacán

84132

Novartis Investigative Site, Salt Lake City

85202

Novartis Investigative Site, Mesa

85253

Novartis Investigative Site, Paradise Valley

85381

Novartis Investigative Site, Peoria

89119

Novartis Investigative Site, Las Vegas

90110

Novartis Investigative Site, Songkhla

90404

Novartis Investigative Site, Santa Monica

90502

Novartis Investigative Site, Torrance

91786

Novartis Investigative Site, Upland

94305

Novartis Investigative Site, Stanford

95100

Novartis Investigative Site, Catania

97239

Novartis Investigative Site, Portland

320013

Novartis Investigative Site, Jaipur

444606

Novartis Investigative Site, Amravati

500003

Novartis Investigative Site, Secunderabad

500004

Novartis Investigative Site, Hyderabad

560043

Novartis Investigative Site, Bangalore

560054

Novartis Investigative Site, Bangalore

33614-7118

Novartis Investigative Site, Tampa

66160-7330

Novartis Investigative Site, Kansas City

C1114AAP

Novartis Investigative Site, Buenos Aires

C1417EYG

Novartis Investigative Site, Buenos Aires

C1181ACH

Novartis Investigative Site, Caba

B8000XAV

Novartis Investigative Site, Lanús

C1419AHN

Novartis Investigative Site, Caba

C1428AZF

Novartis Investigative Site, Ciudad Autonoma de Bs As

X5016KEH

Novartis Investigative Site, Córdoba

S2000CFJ

Novartis Investigative Site, Rosario

S200BHD

Novartis Investigative Site, Rosario

R3A 1M3

Novartis Investigative Site, Winnipeg

L2N 7E4

Novartis Investigative Site, St. Catharines

G1v 3M7

Novartis Investigative Site, Sainte-Foy

Unknown

Novartis Investigative Site, Bucaramanga

Novartis Investigative Site, Bogotá

Novartis Investigative Site, Medellín

Novartis Investigative Site, Panama City

01010

Novartis Investigative Site, Guatemala City

01011

Novartis Investigative Site, Guatemala City

01015

Novartis Investigative Site, Guatemala City

H-8000

Novartis Investigative Site, Székesfehérvár

H-8200

Novartis Investigative Site, Veszprém

400 053

Novartis Investigative Site, Mumbai

411 007

Novartis Investigative Site, Pune

110 060

Novartis Investigative Site, New Delhi

305 001

Novartis Investigative Site, Ajmer

460-0001

Novartis Investigative Site, Nagoya

466-8560

Novartis Investigative Site, Nagoya

260-0801

Novartis Investigative Site, Chiba

284-0003

Novartis Investigative Site, Yotsukaidō

810-8563

Novartis Investigative Site, Fukuoka

813-0017

Novartis Investigative Site, Fukuoka

820-8505

Novartis Investigative Site, Iizuka

807-8556

Novartis Investigative Site, Kitakyushu

370-0053

Novartis Investigative Site, Takasaki

733-0032

Novartis Investigative Site, Hiroshima

060-0001

Novartis Investigative Site, Sapporo

063-0811

Novartis Investigative Site, Sapporo

247-8533

Novartis Investigative Site, Kamakura

210-0013

Novartis Investigative Site, Kawasaki

228-8522

Novartis Investigative Site, Sagamihara

231-8682

Novartis Investigative Site, Yokohama

862-0976

Novartis Investigative Site, Kumamoto

982-0032

Novartis Investigative Site, Taihaku-ku

380-8582

Novartis Investigative Site, Nagano

852-8501

Novartis Investigative Site, Nagasaki

857-1165

Novartis Investigative Site, Sasebo

710-0016

Novartis Investigative Site, Kurashiki

700-8511

Novartis Investigative Site, Okayama

701-0304

Novartis Investigative Site, Tsukubo-gun

599-0212

Novartis Investigative Site, Hannan

586-8521

Novartis Investigative Site, Kawachi-Nagano

545-8586

Novartis Investigative Site, Osaka

350-1103

Novartis Investigative Site, Kawagoe

359-1111

Novartis Investigative Site, Tokorozawa

417-0045

Novartis Investigative Site, Fuji

430-8558

Novartis Investigative Site, Hamamatsu

183-8524

Novartis Investigative Site, Fuchū

174-0071

Novartis Investigative Site, Itabashi-ku

156-0052

Novartis Investigative Site, Setagaya-ku

160-0054

Novartis Investigative Site, Shinjuku-ku

160-8582

Novartis Investigative Site, Shinjuku-ku

933-0874

Novartis Investigative Site, Takaoka

930-0138

Novartis Investigative Site, Toyama

752-0976

Novartis Investigative Site, Shimonoseki

06700

Novartis Investigative Site, Mexico City

0823-01510

Novartis Investigative Site, Panama City

00716

Novartis Investigative Site, Ponce

00909

Novartis Investigative Site, San Juan

06100

Novartis Investigative Site, Ankara

E11 1NR

Novartis Investigative Site, Leytonstone

WS11 2XY

Novartis Investigative Site, Cannock

SP2 8BJ

Novartis Investigative Site, Salisbury

Sponsors
All Listed Sponsors
lead

Novartis Pharmaceuticals

INDUSTRY