Efficacy and Safety of GSK3196165 (Otilimab) Versus Placebo and Sarilumab in Participants With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Biological Disease-modifying Antirheumatic Drug (DMARDs) and/or Janus Kinase (JAK) Inhibitors

PHASE3CompletedINTERVENTIONAL
Enrollment

550

Participants

Timeline

Start Date

October 31, 2019

Primary Completion Date

September 15, 2021

Study Completion Date

February 1, 2022

Conditions
Arthritis, Rheumatoid
Interventions
BIOLOGICAL

GSK3196165 (Otilimab)

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

BIOLOGICAL

Sarilumab

Sarilumab solution in PFS to be administered SC.

DRUG

Placebo to GSK3196165/ Sarilumab

Placebo sterile 0.9 percentage (%) weight by volume (w/v) sodium chloride solution in vial/PFS to be administered SC.

DRUG

csDMARDs

Stable dose of csDMARD(s) as SoC.

Trial Locations (131)

184

GSK Investigational Site, Pretoria

1023

GSK Investigational Site, Budapest

1426

GSK Investigational Site, Ciudad Autonoma de Buenos Aires

1619

GSK Investigational Site, Kempton Park

1643

GSK Investigational Site, San Isidro

3080

GSK Investigational Site, Seoul

4319

GSK Investigational Site, Durban

5400

GSK Investigational Site, San Juan

7000

GSK Investigational Site, Mons

7500

GSK Investigational Site, Cape Town

7600

GSK Investigational Site, Stellenbosch

8000

GSK Investigational Site, Székesfehérvár

15006

GSK Investigational Site, A Coruña

15706

GSK Investigational Site, Santiago de Compostela

24768

GSK Investigational Site, Rendsburg

29601

GSK Investigational Site, Greenville

30265

GSK Investigational Site, Newnan

30318

GSK Investigational Site, Atlanta

32207

GSK Investigational Site, Jacksonville

32713

GSK Investigational Site, DeBary

33014

GSK Investigational Site, Miami Lakes

33134

GSK Investigational Site, Miami

33155

GSK Investigational Site, Miami

33165

GSK Investigational Site, Miami

33173

GSK Investigational Site, Miami

33511

GSK Investigational Site, Brandon

33613

GSK Investigational Site, Tampa

33614

GSK Investigational Site, Tampa

37126

GSK Investigational Site, Verona

39008

GSK Investigational Site, Santander

39120

GSK Investigational Site, Magdeburg

45242

GSK Investigational Site, Cincinnati

45417

GSK Investigational Site, Dayton

46010

GSK Investigational Site, Valencia

58701

GSK Investigational Site, Minot

60076

GSK Investigational Site, Skokie

60607

GSK Investigational Site, Chicago

63141

GSK Investigational Site, St Louis

65691

GSK Investigational Site, Brno

68516

GSK Investigational Site, Lincoln

70200

GSK Investigational Site, Ostrava

73104

GSK Investigational Site, Oklahoma City

73112

GSK Investigational Site, Oklahoma City

75024

GSK Investigational Site, Plano

76034

GSK Investigational Site, Colleyville

76231

GSK Investigational Site, Šiauliai

76710

GSK Investigational Site, Waco

77065

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

77845

GSK Investigational Site, College Station

78229

GSK Investigational Site, San Antonio

78666

GSK Investigational Site, San Marcos

78731

GSK Investigational Site, Austin

79410

GSK Investigational Site, Lubbock

85032

GSK Investigational Site, Phoenix

85210

GSK Investigational Site, Mesa

85351

GSK Investigational Site, Sun City

85704

GSK Investigational Site, Tucson

90602

GSK Investigational Site, Whittier

91042

GSK Investigational Site, Tujunga

91722

GSK Investigational Site, Covina

91786

GSK Investigational Site, Upland

92128

GSK Investigational Site, San Diego

03756

GSK Investigational Site, Lebanon

C1046AAQ

GSK Investigational Site, Ciudad Autonoma Buenos Aires

C1417

GSK Investigational Site, Ciudad Autonoma Buenos Aires

C1430EGF

GSK Investigational Site, Ciudad Autonoma Buenos Aires

B1900AXI

GSK Investigational Site, La Palta

B7600FYK

GSK Investigational Site, Mar del Plata

B2900DMH

GSK Investigational Site, San Nicolás de los Arroyos

C1426BOR

GSK Investigational Site, Buenos Aires

C1430CKE

GSK Investigational Site, Buenos Aires

L4M 6L2

GSK Investigational Site, Barrie

L6T 0G1

GSK Investigational Site, Brampton

G8Z 1Y2

GSK Investigational Site, Trois-Rivières

638 00

GSK Investigational Site, Brno

128 50

GSK Investigational Site, Prague

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

D-20095

GSK Investigational Site, Hamburg

H-8200

GSK Investigational Site, Veszprém

455-8530

GSK Investigational Site, Aichi

457-8511

GSK Investigational Site, Aichi

460-0001

GSK Investigational Site, Aichi

270-2296

GSK Investigational Site, Chiba

807-8555

GSK Investigational Site, Fukuoka

060-8648

GSK Investigational Site, Hokkaido

063-0811

GSK Investigational Site, Hokkaido

673-1462

GSK Investigational Site, Hyōgo

675-1392

GSK Investigational Site, Hyōgo

312-0057

GSK Investigational Site, Ibaraki

891-0133

GSK Investigational Site, Kagoshima

245-8575

GSK Investigational Site, Kanagawa

781-0112

GSK Investigational Site, Kochi

862-0976

GSK Investigational Site, Kumamoto

980-8574

GSK Investigational Site, Miyagi

857-1195

GSK Investigational Site, Nagasaki

359-1111

GSK Investigational Site, Saitama

104-8560

GSK Investigational Site, Tokyo

142-0054

GSK Investigational Site, Tokyo

LT-92288

GSK Investigational Site, Klaipėda

15-879

GSK Investigational Site, Bialystok

85-168

GSK Investigational Site, Bydgoszcz

80-382

GSK Investigational Site, Gdansk

81-537

GSK Investigational Site, Gdynia

40-040

GSK Investigational Site, Katowice

40-282

GSK Investigational Site, Katowice

30-363

GSK Investigational Site, Krakow

90-127

GSK Investigational Site, Lodz

60-702

GSK Investigational Site, Poznan

60-773

GSK Investigational Site, Poznan

96-500

GSK Investigational Site, Sochaczew

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

50-381

GSK Investigational Site, Wroclaw

0002

GSK Investigational Site, Pretoria

400-711

GSK Investigational Site, Incheon

03722

GSK Investigational Site, Seoul

04763

GSK Investigational Site, Seoul

03203

GSK Investigational Site, Elche

RM1 3PJ

GSK Investigational Site, Romford

HA6 2RN

GSK Investigational Site, Northwood

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Iqvia Pty Ltd

INDUSTRY

lead

GlaxoSmithKline

INDUSTRY

NCT04134728 - Efficacy and Safety of GSK3196165 (Otilimab) Versus Placebo and Sarilumab in Participants With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Biological Disease-modifying Antirheumatic Drug (DMARDs) and/or Janus Kinase (JAK) Inhibitors | Biotech Hunter | Biotech Hunter