Long-term Safety and Efficacy of GSK3196165 (Otilimab) in the Treatment of Rheumatoid Arthritis (RA)

PHASE3TerminatedINTERVENTIONAL
Enrollment

2,916

Participants

Timeline

Start Date

May 12, 2020

Primary Completion Date

February 24, 2023

Study Completion Date

February 24, 2023

Conditions
Arthritis, Rheumatoid
Interventions
BIOLOGICAL

Otilimab (GSK3196165)

GSK3196165 solution in vial/pre-filled syringe (PFS) and auto injector (AI) to be administered SC.

DRUG

csDMARD(s)

Stable dose of csDMARD(s) as standard of care (SoC).

Trial Locations (375)

184

GSK Investigational Site, Pretoria

1023

GSK Investigational Site, Budapest

GSK Investigational Site, Kyiv

1036

GSK Investigational Site, Budapest

1426

GSK Investigational Site, Ciudad Autonoma de Buenos Aires

1431

GSK Investigational Site, Sofia

1606

GSK Investigational Site, Sofia

1612

GSK Investigational Site, Sofia

1619

GSK Investigational Site, Kempton Park

1643

GSK Investigational Site, San Isidro

1784

GSK Investigational Site, Sofia

2002

GSK Investigational Site, Kyiv

2113

GSK Investigational Site, Johannesburg

2193

GSK Investigational Site, Johannesburg

2700

GSK Investigational Site, Blagoevgrad

3080

GSK Investigational Site, Seoul

3700

GSK Investigational Site, Vidin

4000

GSK Investigational Site, Plovdiv

4222

GSK Investigational Site, Gold Coast

4319

GSK Investigational Site, Durban

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

6500

GSK Investigational Site, Baja

6600

GSK Investigational Site, Szentes

6700

GSK Investigational Site, México

7000

GSK Investigational Site, Mons

GSK Investigational Site, Rousse

7130

GSK Investigational Site, Somerset West

7405

GSK Investigational Site, Cape Town

7500

GSK Investigational Site, Cape Town

7530

GSK Investigational Site, Bellville

7600

GSK Investigational Site, Stellenbosch

8000

GSK Investigational Site, Székesfehérvár

8200

GSK Investigational Site, Veszprém

8230

GSK Investigational Site, Balatonfüred

9301

GSK Investigational Site, Bloemfontein

10000

GSK Investigational Site, Prague

10002

GSK Investigational Site, Zhytomyr

10050

GSK Investigational Site, Tongliao

10117

GSK Investigational Site, Tallinn

10128

GSK Investigational Site, Tallinn

10400

GSK Investigational Site, Bangkok

GSK Investigational Site, Rajathevee

11000

GSK Investigational Site, Belgrade

11201

GSK Investigational Site, Brooklyn

12850

GSK Investigational Site, Prague

13419

GSK Investigational Site, Tallinn

13620

GSK Investigational Site, Seongnam-si

15006

GSK Investigational Site, A Coruña

15706

GSK Investigational Site, Santiago de Compostela. La Coruña.

16499

GSK Investigational Site, Suwon-si, Gyeonggi-do

18009

GSK Investigational Site, Cherkasy

20095

GSK Investigational Site, Hamburg

20902

GSK Investigational Site, Wheaton

21001

GSK Investigational Site, Vinnytsia

21018

GSK Investigational Site, Vinnytsia

21029

GSK Investigational Site, Vinnytsia

21050

GSK Investigational Site, Vinnytsia

21100

GSK Investigational Site, Mexicali

22332

GSK Investigational Site, Incheon

24768

GSK Investigational Site, Rendsburg

27408

GSK Investigational Site, Greensboro

29486

GSK Investigational Site, Summerville

29601

GSK Investigational Site, Greenville

30060

GSK Investigational Site, Marietta

30214

GSK Investigational Site, Fayetteville

30318

GSK Investigational Site, Atlanta

31151

GSK Investigational Site, Cheonan-si

32117

GSK Investigational Site, Daytona Beach

32207

GSK Investigational Site, Jacksonville

32835

GSK Investigational Site, Orlando

33014

GSK Investigational Site, Miami Lakes

33016

GSK Investigational Site, Miami Lakes

33134

GSK Investigational Site, Miami

33155

GSK Investigational Site, Miami

33157

GSK Investigational Site, Palmetto Bay

33165

GSK Investigational Site, Miami

33173

GSK Investigational Site, Miami

33180

GSK Investigational Site, Aventura

33321

GSK Investigational Site, Tamarac

33511

GSK Investigational Site, Brandon

33603

GSK Investigational Site, Tampa

33614

GSK Investigational Site, Tampa

33765

GSK Investigational Site, Clearwater

34270

GSK Investigational Site, Durango

34652

GSK Investigational Site, New Port Richey

36011

GSK Investigational Site, Poltava

36207

GSK Investigational Site, Anniston

37000

GSK Investigational Site, León

39008

GSK Investigational Site, Santander

39120

GSK Investigational Site, Magdeburg

41009

GSK Investigational Site, Seville

41200

GSK Investigational Site, Klang

41944

GSK Investigational Site, Daegu

42101

GSK Investigational Site, Bowling Green

42202

GSK Investigational Site, Częstochowa

43005

GSK Investigational Site, Lutsk

43024

GSK Investigational Site, Lutsk

44130

GSK Investigational Site, Guadalajara

44650

GSK Investigational Site, Guadalajara

45242

GSK Investigational Site, Cincinnati

45377

GSK Investigational Site, Vandalia

46010

GSK Investigational Site, Valencia

47715

GSK Investigational Site, Evansville

48375

GSK Investigational Site, Novi

48439

GSK Investigational Site, Grand Blanc

48910

GSK Investigational Site, Lansing

50106

GSK Investigational Site, Tartu

50708

GSK Investigational Site, Tartu

53217

GSK Investigational Site, Glendale

58701

GSK Investigational Site, Minot

59100

GSK Investigational Site, Kuala Lumpur

60076

GSK Investigational Site, Skokie

61039

GSK Investigational Site, Kharkiv

61124

GSK Investigational Site, Kharkiv

61176

GSK Investigational Site, Kharkiv

61469

GSK Investigational Site, Gwangju

63141

GSK Investigational Site, St Louis

65025

GSK Investigational Site, Odesa

65691

GSK Investigational Site, Brno

67207

GSK Investigational Site, Wichita

68516

GSK Investigational Site, Lincoln

69014

GSK Investigational Site, Zaporizhzhia

69065

GSK Investigational Site, Zaporizhzia

70200

GSK Investigational Site, Ostrava

70300

GSK Investigational Site, Seremban, Negeri Sembilan

70601

GSK Investigational Site, Lake Charles

71203

GSK Investigational Site, Monroe

73099

GSK Investigational Site, Yukon

73103

GSK Investigational Site, Oklahoma City

73104

GSK Investigational Site, Oklahoma City

73112

GSK Investigational Site, Oklahoma City

75024

GSK Investigational Site, Plano

75231

GSK Investigational Site, Dallas

76008

GSK Investigational Site, Ivano-Frankivsk

76034

GSK Investigational Site, Colleyville

76231

GSK Investigational Site, Šiauliai

76710

GSK Investigational Site, Waco

77065

GSK Investigational Site, Houston

77084

GSK Investigational Site, Houston

77089

GSK Investigational Site, Houston

77090

GSK Investigational Site, Houston

77375

GSK Investigational Site, Tomball

77382

GSK Investigational Site, The Woodlands

77521

GSK Investigational Site, Baytown

78213

GSK Investigational Site, San Luis Potosí City

78731

GSK Investigational Site, Austin

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

85032

GSK Investigational Site, Phoenix

85037

GSK Investigational Site, Phoenix

85210

GSK Investigational Site, Mesa

85297

GSK Investigational Site, Gilbert

85306

GSK Investigational Site, Glendale

85704

GSK Investigational Site, Tucson

86001

GSK Investigational Site, Flagstaff

90602

GSK Investigational Site, Whittier

91405

GSK Investigational Site, Van Nuys

91722

GSK Investigational Site, Covina

91786

GSK Investigational Site, Upland

92064

GSK Investigational Site, Poway

92108

GSK Investigational Site, San Diego

92128

GSK Investigational Site, San Diego

96000

GSK Investigational Site, Sibu

97070

GSK Investigational Site, Mérida

100015

GSK Investigational Site, Beijing

100144

GSK Investigational Site, Beijing

110026

GSK Investigational Site, New Delhi

110221

GSK Investigational Site, Barranquilla

GSK Investigational Site, Bogotá

115404

GSK Investigational Site, Moscow

115522

GSK Investigational Site, Moscow

121000

GSK Investigational Site, Jinzhou

129110

GSK Investigational Site, Moscow

130021

GSK Investigational Site, Changchun

133000

GSK Investigational Site, Yanji

140044

GSK Investigational Site, Córdoba

141060

GSK Investigational Site, Korolyov

150003

GSK Investigational Site, Yaroslavl

150007

GSK Investigational Site, Yaroslavl

150062

GSK Investigational Site, Yaroslavl

170036

GSK Investigational Site, Tver'

190068

GSK Investigational Site, Saint Petersburg

197022

GSK Investigational Site, Saint Petersburg

200040

GSK Investigational Site, Shanghai

210008

GSK Investigational Site, Nanjing

214025

GSK Investigational Site, Smolensk

221009

GSK Investigational Site, Xuzhou

225000

GSK Investigational Site, Yangzhou

225300

GSK Investigational Site, Taizhou

233004

GSK Investigational Site, Bengbu

300052

GSK Investigational Site, Tianjin

302001

GSK Investigational Site, Jaipur

302006

GSK Investigational Site, Jaipur

310005

GSK Investigational Site, Hangzhou

313000

GSK Investigational Site, Huzhou

330006

GSK Investigational Site, Nanchang

337055

GSK Investigational Site, Pingxiang

380005

GSK Investigational Site, Ahmedabad

380016

GSK Investigational Site, Ahmedabad

395002

GSK Investigational Site, Surat

410012

GSK Investigational Site, Saratov

410013

GSK Investigational Site, Changsha

411004

GSK Investigational Site, Pune

412007

GSK Investigational Site, Zhuzhou

430030

GSK Investigational Site, Wuhan

432063

GSK Investigational Site, Ulyanovsk

440009

GSK Investigational Site, Nagpur

440012

GSK Investigational Site, Nagpur

500018

GSK Investigational Site, Hyderabad

510080

GSK Investigational Site, Guangzhou

541001

GSK Investigational Site, Guilin

580021

GSK Investigational Site, Hubli

590010

GSK Investigational Site, Belagavi

610041

GSK Investigational Site, Chengdu

620043

GSK Investigational Site, Yekaterinburg

620102

GSK Investigational Site, Yekaterinburg

630091

GSK Investigational Site, Novosibirsk

630099

GSK Investigational Site, Novosibirsk

634061

GSK Investigational Site, Tomsk

644024

GSK Investigational Site, Omsk

650066

GSK Investigational Site, Kemerovo

650070

GSK Investigational Site, Kemerovo

660022

GSK Investigational Site, Krasnoyarsk

680003

GSK Investigational Site, Bucaramanga

700020

GSK Investigational Site, Kolkata

03756

GSK Investigational Site, Lebanon

07728

GSK Investigational Site, Freehold

C1046AAQ

GSK Investigational Site, Ciudad Autonoma Buenos Aires

C1114ABH

GSK Investigational Site, Ciudad Autonoma Buenos Aires

C1417

GSK Investigational Site, Ciudad Autonoma Buenos Aires

C1430EGF

GSK Investigational Site, Ciudad Autonoma Buenos Aires

C1128AAF

GSK Investigational Site, Ciudad Autonoma de Buenos Aires

C1431FWO

GSK Investigational Site, Ciudad Autonoma de Buenos Aires

B1900AXI

GSK Investigational Site, La Palta

B7600FYK

GSK Investigational Site, Mar del Plata

B1878GEG

GSK Investigational Site, Quilmes

B2900DMH

GSK Investigational Site, San Nicolás de los Arroyos

X5003DCE

GSK Investigational Site, Córdoba

S2000DSV

GSK Investigational Site, Rosario

T4000AXL

GSK Investigational Site, San Miguel de Tucumán

T4000BRD

GSK Investigational Site, San Miguel de Tucumán

C1426BOR

GSK Investigational Site, Buenos Aires

C1430CKE

GSK Investigational Site, Buenos Aires

C1015ABO

GSK Investigational Site, Ciudad Autonoma Buenos Aires

X5000AVE

GSK Investigational Site, Nueva Cordoba

A4400ANW

GSK Investigational Site, Salta

L6T 0G1

GSK Investigational Site, Brampton

G8Z 1Y2

GSK Investigational Site, Trois-Rivières

050051

GSK Investigational Site, Shijiazhuang

014010

GSK Investigational Site, Baotou

638 00

GSK Investigational Site, Brno

140 00

GSK Investigational Site, Prague

GSK Investigational Site, Praha 4 Nusle

148 00

GSK Investigational Site, Prague

150 06

GSK Investigational Site, Prague

686 01

GSK Investigational Site, Uherské Hradiště

760 01

GSK Investigational Site, Zlín

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

270-2296

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

060-8648

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

231-8682

GSK Investigational Site, Kanagawa

232-0024

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

862-0975

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

359-1111

GSK Investigational Site, Saitama

104-8560

GSK Investigational Site, Tokyo

113-8431

GSK Investigational Site, Tokyo

113-8519

GSK Investigational Site, Tokyo

142-8666

GSK Investigational Site, Tokyo

153-8515

GSK Investigational Site, Tokyo

198-0042

GSK Investigational Site, Tokyo

649-2211

GSK Investigational Site, Wakayama

750-8520

GSK Investigational Site, Yamaguchi

LV2164

GSK Investigational Site, Ādaži

LV-3401

GSK Investigational Site, Liepāja

LT-45130

GSK Investigational Site, Kaunas

LT-50128

GSK Investigational Site, Kaunas

LT-92288

GSK Investigational Site, Klaipėda

LT-01117

GSK Investigational Site, Vilnius

06700

GSK Investigational Site, Mexico City

15-351

GSK Investigational Site, Bialystok

15-879

GSK Investigational Site, Bialystok

85-065

GSK Investigational Site, Bydgoszcz

85-168

GSK Investigational Site, Bydgoszcz

82-300

GSK Investigational Site, Elblag

80-382

GSK Investigational Site, Gdansk

81-338

GSK Investigational Site, Gdynia

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

30-363

GSK Investigational Site, Krakow

30-510

GSK Investigational Site, Krakow

90-127

GSK Investigational Site, Lodz

90-644

GSK Investigational Site, Lodz

20-362

GSK Investigational Site, Lublin

20-582

GSK Investigational Site, Lublin

67-100

GSK Investigational Site, Nowa Sól

10-117

GSK Investigational Site, Olsztyn

60-529

GSK Investigational Site, Poznan

60-702

GSK Investigational Site, Poznan

60-773

GSK Investigational Site, Poznan

61-113

GSK Investigational Site, Poznan

08-110

GSK Investigational Site, Siedlce

96-500

GSK Investigational Site, Sochaczew

28-200

GSK Investigational Site, Staszów

87-100

GSK Investigational Site, Torun

00-465

GSK Investigational Site, Warsaw

00-874

GSK Investigational Site, Warsaw

01-192

GSK Investigational Site, Warsaw

02-118

GSK Investigational Site, Warsaw

02-673

GSK Investigational Site, Warsaw

02-793

GSK Investigational Site, Warsaw

50-381

GSK Investigational Site, Wroclaw

52-416

GSK Investigational Site, Wroclaw

22-400

GSK Investigational Site, Zamość

0002

GSK Investigational Site, Pretoria

431-070

GSK Investigational Site, Anyang-si

03722

GSK Investigational Site, Seoul

05505

GSK Investigational Site, Seoul

06591

GSK Investigational Site, Seoul

08003

GSK Investigational Site, Barcelona

08035

GSK Investigational Site, Barcelona

?03203

GSK Investigational Site, Elche

02125

GSK Investigational Site, Kyiv

03037

GSK Investigational Site, Kyiv

03049

GSK Investigational Site, Kyiv

04054

GSK Investigational Site, Kyiv

BR5 3QG

GSK Investigational Site, Orpington

HA6 2RN

GSK Investigational Site, Northwood

CV3 4FJ

GSK Investigational Site, Coventry

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Iqvia Pty Ltd

INDUSTRY

lead

GlaxoSmithKline

INDUSTRY

NCT04333147 - Long-term Safety and Efficacy of GSK3196165 (Otilimab) in the Treatment of Rheumatoid Arthritis (RA) | Biotech Hunter | Biotech Hunter