Efficacy and Safety of GSK3196165 Versus Placebo and Tofacitinib in Participants With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Conventional Synthetic (cs)/Biologic (b) Disease Modifying Anti-rheumatic Drugs (DMARDs)

PHASE3TerminatedINTERVENTIONAL
Enrollment

1,764

Participants

Timeline

Start Date

June 5, 2019

Primary Completion Date

October 29, 2021

Study Completion Date

January 18, 2023

Conditions
Arthritis, Rheumatoid
Interventions
BIOLOGICAL

GSK3196165 (Otilimab)

GSK3196165 solution in vial/pre-filled syringe (PFS) was administered SC.

DRUG

Tofacitinib

Tofacitinib capsule (over encapsulated 5mg tablet) was administered orally.

DRUG

Placebo

Placebo matching GSK3196165 and Tofacitinib was administered.

Trial Locations (269)

1000

GSK Investigational Site, Sofia

1023

GSK Investigational Site, Budapest

1036

GSK Investigational Site, Budapest

1431

GSK Investigational Site, Sofia

1606

GSK Investigational Site, Sofia

1612

GSK Investigational Site, Sofia

1784

GSK Investigational Site, Sofia

2145

GSK Investigational Site, Westmead

2700

GSK Investigational Site, Blagoevgrad

3080

GSK Investigational Site, Seoul

3081

GSK Investigational Site, Heidelberg West

3128

GSK Investigational Site, Box Hill

3700

GSK Investigational Site, Vidin

4000

GSK Investigational Site, Plovdiv

4222

GSK Investigational Site, Gold Coast

5000

GSK Investigational Site, Córdoba

5011

GSK Investigational Site, Woodville

5400

GSK Investigational Site, San Juan

GSK Investigational Site, Sevlievo

5800

GSK Investigational Site, Pleven

6000

GSK Investigational Site, Stara Zagora

6600

GSK Investigational Site, Szentes

7000

GSK Investigational Site, Hobart

GSK Investigational Site, Rousse

7002

GSK Investigational Site, Rousse

8000

GSK Investigational Site, Székesfehérvár

10050

GSK Investigational Site, Tongliao

10117

GSK Investigational Site, Tallinn

GSK Investigational Site, Berlin

10128

GSK Investigational Site, Tallinn

10400

GSK Investigational Site, Bangkok

GSK Investigational Site, Rajathevee

11201

GSK Investigational Site, Brooklyn

13419

GSK Investigational Site, Tallinn

13620

GSK Investigational Site, Seongnam-si

14068

GSK Investigational Site, Anyang-Si, Gyeonggi-do

15224

GSK Investigational Site, Pittsburgh

16499

GSK Investigational Site, Suwon

16635

GSK Investigational Site, Duncansville

19610

GSK Investigational Site, Wyomissing

20095

GSK Investigational Site, Hamburg

21740

GSK Investigational Site, Hagerstown

24768

GSK Investigational Site, Rendsburg

27408

GSK Investigational Site, Greensboro

29204

GSK Investigational Site, Columbia

29486

GSK Investigational Site, Summerville

29572

GSK Investigational Site, Myrtle Beach

30060

GSK Investigational Site, Marietta

30510

GSK Investigational Site, Krakow

32117

GSK Investigational Site, Daytona Beach

32607

GSK Investigational Site, Gainesville

33016

GSK Investigational Site, Hialeah

33063

GSK Investigational Site, Margate

33134

GSK Investigational Site, Miami

33155

GSK Investigational Site, Miami

33157

GSK Investigational Site, Palmetto Bay

33180

GSK Investigational Site, Aventura

33321

GSK Investigational Site, Tamarac

33486

GSK Investigational Site, Boca Raton

33606

GSK Investigational Site, Tampa

33705

GSK Investigational Site, St. Petersburg

33765

GSK Investigational Site, Clearwater

34652

GSK Investigational Site, New Port Richey

39008

GSK Investigational Site, Santander

39120

GSK Investigational Site, Magdeburg

40002

GSK Investigational Site, Muang

41009

GSK Investigational Site, Seville

41944

GSK Investigational Site, Daegu

42101

GSK Investigational Site, Bowling Green

42202

GSK Investigational Site, Częstochowa

42601

GSK Investigational Site, Daegu

44650

GSK Investigational Site, Guadalajara

46000

GSK Investigational Site, Cahors

47715

GSK Investigational Site, Evansville

48375

GSK Investigational Site, Novi

48439

GSK Investigational Site, Grand Blanc

48910

GSK Investigational Site, Lansing

50015

GSK Investigational Site, Medellín

50106

GSK Investigational Site, Tartu

50406

GSK Investigational Site, Tartu

53217

GSK Investigational Site, Glendale

58701

GSK Investigational Site, Minot

61469

GSK Investigational Site, Gwangju

67207

GSK Investigational Site, Wichita

70601

GSK Investigational Site, Lake Charles

71203

GSK Investigational Site, Monroe

73099

GSK Investigational Site, Yukon

73103

GSK Investigational Site, Oklahoma City

75231

GSK Investigational Site, Dallas

76034

GSK Investigational Site, Colleyville

77034

GSK Investigational Site, Houston

77065

GSK Investigational Site, Houston

77084

GSK Investigational Site, Houston

77375

GSK Investigational Site, Tomball

78213

GSK Investigational Site, San Luis Potosí City

78229

GSK Investigational Site, San Antonio

78404

GSK Investigational Site, Corpus Christi

78745

GSK Investigational Site, Austin

79124

GSK Investigational Site, Amarillo

79410

GSK Investigational Site, Lubbock

80010

GSK Investigational Site, Pärnu

80020

GSK Investigational Site, Barranquilla

80230

GSK Investigational Site, Denver

80528

GSK Investigational Site, Fort Collins

83404

GSK Investigational Site, Idaho Falls

85210

GSK Investigational Site, Mesa

85306

GSK Investigational Site, Glendale

85724

GSK Investigational Site, Tucson

86001

GSK Investigational Site, Flagstaff

87102

GSK Investigational Site, Albuquerque

91405

GSK Investigational Site, Van Nuys

92064

GSK Investigational Site, Poway

92108

GSK Investigational Site, San Diego

92506

GSK Investigational Site, Riverside

92780

GSK Investigational Site, Tustin

95661

GSK Investigational Site, Roseville

97070

GSK Investigational Site, Mérida

100032

GSK Investigational Site, Beijing

100144

GSK Investigational Site, Beijing

110221

GSK Investigational Site, Bogotá

111539

GSK Investigational Site, Moscow

115404

GSK Investigational Site, Moscow

115522

GSK Investigational Site, Moscow

121000

GSK Investigational Site, Jinzhou

129110

GSK Investigational Site, Moscow

130012

GSK Investigational Site, Changchun

130021

GSK Investigational Site, Changchun

133000

GSK Investigational Site, Yanji

141060

GSK Investigational Site, Korolyov

150007

GSK Investigational Site, Yaroslavl

150030

GSK Investigational Site, Yaroslavl

150062

GSK Investigational Site, Yaroslavl

190068

GSK Investigational Site, Saint Petersburg

200040

GSK Investigational Site, Shanghai

210008

GSK Investigational Site, Nanjing

210009

GSK Investigational Site, Nanjing

213003

GSK Investigational Site, Changzhou

221009

GSK Investigational Site, Xuzhou

224001

GSK Investigational Site, Yancheng

225000

GSK Investigational Site, Yangzhou

225300

GSK Investigational Site, Taizhou

233004

GSK Investigational Site, Bengbu

300052

GSK Investigational Site, Tianjin

310005

GSK Investigational Site, Hangzhou

313000

GSK Investigational Site, Huzhou

330006

GSK Investigational Site, Nanchang

332000

GSK Investigational Site, Jiujiang

410013

GSK Investigational Site, Changsha

412007

GSK Investigational Site, Zhuzhou

430030

GSK Investigational Site, Wuhan

432063

GSK Investigational Site, Ulyanovsk

510080

GSK Investigational Site, Guangzhou

510630

GSK Investigational Site, Guangzhou

541001

GSK Investigational Site, Guilin

610041

GSK Investigational Site, Chengdu

620102

GSK Investigational Site, Yekaterinburg

630091

GSK Investigational Site, Novosibirsk

630099

GSK Investigational Site, Novosibirsk

634050

GSK Investigational Site, Tomsk

644024

GSK Investigational Site, Omsk

650066

GSK Investigational Site, Kemerovo

650070

GSK Investigational Site, Kemerovo

660123

GSK Investigational Site, Krasnoyarsk

680003

GSK Investigational Site, Bucaramanga

710061

GSK Investigational Site, Xi'an

01605

GSK Investigational Site, Worcester

07728

GSK Investigational Site, Freehold

37909-1907

GSK Investigational Site, Knoxville

C1114ABH

GSK Investigational Site, Ciudad Autonoma Buenos Aires

C1430EGF

GSK Investigational Site, Ciudad Autonoma Buenos Aires

B1878GEG

GSK Investigational Site, Quilmes

X5003DCE

GSK Investigational Site, Córdoba

T4000AXL

GSK Investigational Site, San Miguel de Tucumán

T4000BRD

GSK Investigational Site, San Miguel de Tucumán

C1128AAF

GSK Investigational Site, Buenos Aires

C1015ABO

GSK Investigational Site, Ciudad Autonoma Buenos Aires

050051

GSK Investigational Site, Shijiazhuang

014010

GSK Investigational Site, Baotou

01307

GSK Investigational Site, Dresden

455-8530

GSK Investigational Site, Aichi

457-8511

GSK Investigational Site, Aichi

466-8560

GSK Investigational Site, Aichi

260-8712

GSK Investigational Site, Chiba

284-0003

GSK Investigational Site, Chiba

804-0025

GSK Investigational Site, Fukuoka

807-8555

GSK Investigational Site, Fukuoka

814-0180

GSK Investigational Site, Fukuoka

820-8505

GSK Investigational Site, Fukuoka

734-8551

GSK Investigational Site, Hiroshima

053-8567

GSK Investigational Site, Hokkaido

060-0001

GSK Investigational Site, Hokkaido

060-8604

GSK Investigational Site, Hokkaido

060-8648

GSK Investigational Site, Hokkaido

063-0811

GSK Investigational Site, Hokkaido

085-0032

GSK Investigational Site, Hokkaido

673-1462

GSK Investigational Site, Hyōgo

675-1392

GSK Investigational Site, Hyōgo

312-0057

GSK Investigational Site, Ibaraki

761-0793

GSK Investigational Site, Kagawa

891-0133

GSK Investigational Site, Kagoshima

222-0036

GSK Investigational Site, Kanagawa

231-8682

GSK Investigational Site, Kanagawa

232-0024

GSK Investigational Site, Kanagawa

236-0004

GSK Investigational Site, Kanagawa

245-8575

GSK Investigational Site, Kanagawa

252-0392

GSK Investigational Site, Kanagawa

780-8522

GSK Investigational Site, Kochi

781-0112

GSK Investigational Site, Kochi

862-0976

GSK Investigational Site, Kumamoto

980-8574

GSK Investigational Site, Miyagi

983-8512

GSK Investigational Site, Miyagi

380-8582

GSK Investigational Site, Nagano

850-0832

GSK Investigational Site, Nagasaki

852-8501

GSK Investigational Site, Nagasaki

857-1195

GSK Investigational Site, Nagasaki

940-2085

GSK Investigational Site, Niigata

957-0054

GSK Investigational Site, Niigata

700-0013

GSK Investigational Site, Okayama

700-8557

GSK Investigational Site, Okayama

700-8607

GSK Investigational Site, Okayama

843-0393

GSK Investigational Site, Saga

359-1111

GSK Investigational Site, Saitama

430-8558

GSK Investigational Site, Shizuoka

104-8560

GSK Investigational Site, Tokyo

113-8431

GSK Investigational Site, Tokyo

113-8519

GSK Investigational Site, Tokyo

142-0054

GSK Investigational Site, Tokyo

142-8666

GSK Investigational Site, Tokyo

153-8515

GSK Investigational Site, Tokyo

198-0042

GSK Investigational Site, Tokyo

204-8585

GSK Investigational Site, Tokyo

683-8504

GSK Investigational Site, Tottori

649-2211

GSK Investigational Site, Wakayama

750-8520

GSK Investigational Site, Yamaguchi

06700

GSK Investigational Site, Mexico City

15-879

GSK Investigational Site, Bialystok

85-065

GSK Investigational Site, Bydgoszcz

82-300

GSK Investigational Site, Elblag

80-382

GSK Investigational Site, Gdansk

81-537

GSK Investigational Site, Gdynia

05-825

GSK Investigational Site, Grodzisk Mazowiecki

40-040

GSK Investigational Site, Katowice

40-282

GSK Investigational Site, Katowice

30-033

GSK Investigational Site, Krakow

90-127

GSK Investigational Site, Lodz

90-644

GSK Investigational Site, Lodz

20-582

GSK Investigational Site, Lublin

34-400

GSK Investigational Site, Nowy Targ

10-117

GSK Investigational Site, Olsztyn

60-702

GSK Investigational Site, Poznan

61-113

GSK Investigational Site, Poznan

08-110

GSK Investigational Site, Siedlce

96-500

GSK Investigational Site, Sochaczew

01-192

GSK Investigational Site, Warsaw

02-793

GSK Investigational Site, Warsaw

50-088

GSK Investigational Site, Wroclaw

52-416

GSK Investigational Site, Wroclaw

330-721

GSK Investigational Site, Cheonan-si

400-711

GSK Investigational Site, Incheon

04763

GSK Investigational Site, Seoul

05505

GSK Investigational Site, Seoul

06591

GSK Investigational Site, Seoul

120-752

GSK Investigational Site, Seoul

134-727

GSK Investigational Site, Seoul

08003

GSK Investigational Site, Barcelona

08035

GSK Investigational Site, Barcelona

RM1 3PJ

GSK Investigational Site, Romford

HA6 2RN

GSK Investigational Site, Northwood

CV8 1JD

GSK Investigational Site, Kenilworth

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Iqvia Pty Ltd

INDUSTRY

lead

GlaxoSmithKline

INDUSTRY