NCT03980483 - Efficacy and Safety of GSK3196165 Versus Placebo and Tofacitinib in Participants With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate | Biotech Hunter

Enrollment

1,537

Participants

Timeline

Start Date

May 16, 2019

Primary Completion Date

September 15, 2021

Study Completion Date

August 16, 2022

Conditions

Arthritis, Rheumatoid

Interventions

BIOLOGICAL

GSK3196165 (Otilimab)

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

DRUG

Tofacitinib 5 mg

Tofacitinib cap (over encapsulated 5mg tablet) to be administered orally.

DRUG

Placebo

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

DRUG

Placebo

Placebo cap (containing lactose) to be administered orally.

Trial Locations (76)

1023

GSK Investigational Site, Budapest

1033

GSK Investigational Site, Budapest

1036

GSK Investigational Site, Budapest

2143

GSK Investigational Site, Kistarcsa

6500

GSK Investigational Site, Baja

6600

GSK Investigational Site, Szentes

8000

GSK Investigational Site, Székesfehérvár

8230

GSK Investigational Site, Balatonfüred

11000

GSK Investigational Site, Belgrade

15006

GSK Investigational Site, A Coruña

15706

GSK Investigational Site, Santiago de Compostela

37126

GSK Investigational Site, Verona

41200

GSK Investigational Site, Klang

42202

GSK Investigational Site, Częstochowa

59100

GSK Investigational Site, Kuala Lumpur

70300

GSK Investigational Site, Seremban, Negeri Sembilan

96000

GSK Investigational Site, Sibu

110060

GSK Investigational Site, New Delhi

115522

GSK Investigational Site, Moscow

130021

GSK Investigational Site, Changchun

140044

GSK Investigational Site, Córdoba

200052

GSK Investigational Site, Shanghai

233004

GSK Investigational Site, Bengbu

302001

GSK Investigational Site, Jaipur

302006

GSK Investigational Site, Jaipur

337055

GSK Investigational Site, Pingxiang

360005

GSK Investigational Site, Rajkot

380005

GSK Investigational Site, Ahmedabad

380013

GSK Investigational Site, Ahmedabad

380016

GSK Investigational Site, Ahmedabad

380054

GSK Investigational Site, Ahmedabad

390001

GSK Investigational Site, Vadodara

395002

GSK Investigational Site, Surat

411004

GSK Investigational Site, Pune

411033

GSK Investigational Site, Pimpri-Chinchwad

411057

GSK Investigational Site, Pune

422005

GSK Investigational Site, Nashik

422101

GSK Investigational Site, Nashik

440009

GSK Investigational Site, Nagpur

440012

GSK Investigational Site, Nagpur

500018

GSK Investigational Site, Hyderabad

560070

GSK Investigational Site, Banglore

580021

GSK Investigational Site, Hubli

590010

GSK Investigational Site, Belagavi

610041

GSK Investigational Site, Chengdu

700020

GSK Investigational Site, Kolkata

H-8200

GSK Investigational Site, Veszprém

15-351

GSK Investigational Site, Bialystok

85-168

GSK Investigational Site, Bydgoszcz

80-382

GSK Investigational Site, Gdansk

81-338

GSK Investigational Site, Gdynia

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

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

96-500

GSK Investigational Site, Sochaczew

28-200

GSK Investigational Site, Staszów