Evaluation of the Effectiveness and Safety of Two Dosing Regimens of Olokizumab (OKZ), Compared to Placebo, in Subjects With Rheumatoid Arthritis (RA) Who Are Taking Methotrexate But Have Active Disease

PHASE3CompletedINTERVENTIONAL
Enrollment

428

Participants

Timeline

Start Date

May 19, 2016

Primary Completion Date

August 31, 2018

Study Completion Date

October 31, 2018

Conditions
Rheumatoid Arthritis
Interventions
DRUG

Olokizumab

160 mg/mL sterile solution for SC injection in a 2 mL clear Type I glass vial

DRUG

Placebo

sodium chloride 0.9% solution supplied in polypropylene plastic ampoules of 10 mL cartons to contain 10 ampoules

Trial Locations (40)

1431

"UMHAT Sv. Ivan Rilski, EAD", Sofia

1784

"MC Synexus - Sofia, EOOD", Sofia

4002

"UMHAT Kaspela, EOOD", Plovdiv

5800

DCC 'Sv. Pantaleymon' OOD, Pleven

19049

"State Budgetary Healthcare Institution of Moscow City Clinical Hospital #1 n.a. Pirogov Healthcare Departament of Moscow", Moscow

111539

"State Budgetary Healthcare Institution City Clinical Hospital # 15 n.a O.M. Filatov of Moscow Healtheare Department", Moscow

115093

"SBHI of Moscow City Clinical Hospital #4 of Moscow Healthcare Departament", Moscow

115522

"FSBSI Scientific Research Institute of Rheumatology n.a. V.A. Nasonova", Moscow

119435

"FSBEI HE First Moscow State Medical University n.a. I.M. Sechenov of MoH of Russian Federation, UCH #1", Moscow

"FSBEI HE FMSMU n.a. I.M. Sechenov of MoH of RF, University Hospital #2, Departament of New Drugs Introduction", Moscow

"SBEI HPE First Moscow State Medical University n.a. I.M. Sechenov of MoH of Russian Federation UCH #3", Moscow

150003

"State Autonomous Helthcare Institution of Yaroslavl region Clinical Hospital of Emergency Care n.a. Solovyev", Yaroslavl

150062

"SBHI Yaroslavl Regional Clinical Hospital, Rheumatology department", Yaroslavl

185019

"SBHI of the Republic of Karelia Republican Hospital named after V.A. Baranov", Petrozavodsk

190068

"SPb SBHI Clinical Rheumatological Hospital #25, Fourth Rheumatology Unit", Saint Petersburg

197341

"SBHI North-West Federat Medical Research Center n.a. V.A.Almazov of the Ministry of Healthcare of the Russian Federation", Saint Petersburg

210037

Vitebsk Regional Clinical Hospital, Vitebsk

214025

"Non-governmental Healtheare Institution Regional Clinical Hospital at Smolensk station of OJSC Russian Railways", Smolensk

220013

City Clinical Hospital #1, Minsk

300053

"State Healthcare Institution of Tula region Tula Regional Clinical Hospital", Tula

305007

"Budgetary Healthcare Institution Kursk Regional Clinical Hospital of Healthcare Committee of Kursk region", Kursk

344022

"SBEI HPE Rostov State Medical University of Ministry of Health of the Russian Federation", Rostov-on-Don

355030

"SBHI of Stavropol Region Stavropol Regional Clinical Hospital", Stavropol

390026

Ryazan State Medical University n.a. I.P. Pavlov based on Regional Clinical Cardiology Dispensary, Ryazan

410053

"State Healthcare Institution Regional Clinical Hospital", Saratov

410054

"SBEI HPE SSMU n.a. V.I. Razumovsky of MoH of RF, Clinical Hospital n.a. S.R. Mirotvorcev, Therapeutic Departament", Saratov

420064

"State Autonomous Healthcare Institution Republican Clinical Hospital of Ministry of Health of Tatarstan Republic", Kazan'

432063

"State Healthcare Institution Ulyanovsk Regional Clinical Hospital", Ulyanovsk

450005

"State Budgetary Healthcare Institution Republican Clinical Hospital n.a. G.G. Kuvatov", Ufa

600023

"SBHI of Vladimir Region Regional Clinical Hospital, Rheumatology Departament", Vladimir

603005

City Clinical Hospital №5 of Nizhny Novgorod, Nizhny Novgorod

603126

"SBHI of Nizhny Novgorod Region Nizhny Novgorod Regional Clinical Hospital n.a.Semashko", Nizhny Novgorod

620102

"State Budgetary Healthcare Institution of Sverdlovsk Region Sverdlovsk Regional Clinical Hospital #1", Yekaterinburg

620149

"SBEI HPE Ural State Medical University of MoH of RF based MBI Central City Clinical Hospital #6", Yekaterinburg

630099

"State Autonomous Healthcare Institution of Novosibirsk region City Polyclinic #1", Novosibirsk

644024

"LLC Clinical Diagnostic Center Ultramed", Omsk

644111

"Budgetary Healthcare Institution of Omsk Region Regional Clinical Hospital", Omsk

650000

"SAHI of Kemerovo region Regional Clinical Hospital for War Veterans", Kemerovo

650066

"Medical Center LLC Maksimum Zdoroviya", Kemerovo

656050

"Regional State Budgetary Healthcare Institution Barnaul City Hospital #4", Barnaul

Sponsors
All Listed Sponsors
collaborator

Quintiles, Inc.

INDUSTRY

collaborator

OCT Clinical Trials

OTHER

collaborator

Mene Research

OTHER

lead

R-Pharm International, LLC

INDUSTRY