Evaluation of the Efficacy and Safety of Two Dosing Regimens of Olokizumab (OKZ), Compared to Placebo, in Subjects With Rheumatoid Arthritis (RA) Who Were Taking an Existing Medication Called a Tumour Necrosis Factor Alpha Inhibitor But Had Active Disease

PHASE3CompletedINTERVENTIONAL
Enrollment

368

Participants

Timeline

Start Date

January 25, 2017

Primary Completion Date

September 12, 2019

Study Completion Date

October 1, 2019

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 provided as either a 10 mL vial or ampoule, depending on market availability. Each placebo will be packed into a cardboard carton to contain 1 vial or ampoule

Trial Locations (116)

1033

Clinexpert Egeszsegugyi Szolg. es Ker. Kft., Budapest

1036

Obudai Egeszsegugyi Centrum, Budapest

1426

Atencion Integral en Reumatologia (AIR), Ciudad Autonoma Buenos Aires

3722

Severance Hospital, Yonsei University, Seoul

5000

MAV Korhaz és Rendelointezet, Szolnok

5016

Hospital Privado Centro Medico de Cordoba S.A, Córdoba

5400

Centro Polivalente de Asistencia e Inv. Clinica CER, San Juan

8200

Vital Medical Center, Veszprém

11201

NYU Langone Ambulatory Care, New York

19152

Arthritis Group, Philadelphia

19713

Javed Rheumatology Associates, Newark

20095

HRF Hamburger Rheuma Forschungszentrum, Hamburg

20902

The Center for Rheumatology and Bone Research, Wheaton

21740

Klein and Associates, M.D., P.A., Hagerstown

27408

Medication Management, LLC, Greensboro

28401

Carolina Arthritis Associates, Wilmington

28451

Cape Fear Arthritis Care, Leland

29486

Low Country Research Center, Charleston

31000

Investigacion y Biomedicina de Chihuahua, S.C., Chihuahua City

32810

Omega Research Consultants, Orlando

33026

Family Clinical Trials, LLC., Pembroke Pines

33135

Suncoast Research Group LLC, Miami

33486

RASF - Clinical Research Center, Boca Raton

33614

AdventHealth Medical Group, PA, Tampa

39120

SMO.MD GmbH, Magdeburg

42101

Graves Gilbert Clinic, Bowling Green

43606

Clinical Research Source, Inc., Perrysburg

44650

Clinica de Investigacion en Reumatologia y Obesidad S.C., Guadalajara

44690

Centro de Estudios de Investigacion Basica y Clinica SC, Guadalajara

45242

Cincinnati Rheumatic Disease Study Group, Cincinnati

45417

STAT Research, Inc., Dayton

53002

CCR Czech, a.s., Pardubice

58701

Trinity Medical Group, Minot

59901

Glacier View Research Instutute-Rheumatology, Kalispell

61231

Kerckhoff-Klinik gGmbH, Bad Nauheim

61469

Chonnam National University Hospital, Gwangju

64000

Accelerium S. de R.L. de C.V., Monterrey

64460

Universidad Autonoma de Nuevo Leon, Hospital Universitario Dr. Jose Eleuterio Gonzalez, Monterrey

66160

University of Kansas Hospital, Kansas City

68601

MEDICAL PLUS s.r.o., Uherské Hradiště

70200

Revmatologie MUDr. Klara Sirova s.r.o., Ostrava - Moravska Ostrava

71203

The Arthritis & Diabetes Clinic, Inc., Monroe

71913

CHI St. Vincent Hot Springs, Hot Springs

76001

Clinica de Artritis Temprana S.A., Santiago de Cali

76034

Precision Comprehensive Clinical Research Solutions, Grapevine

77004

Therapeutic Concepts Rheumatology, LLC, Houston

77065

Rheumatology Clinic of Houston, P.A., Houston

77089

Accurate Clinical Research, Inc., Houston

77382

Advanced Rheumatology of Houston, Woodville

77429

Pioneer Research Solutions, Inc., Houston

77521

Accurate Clinical Research, Inc., Baytown

77573

Accurate Clinical Research, Inc., League City

78213

Centro de Alta Especialidad en Reumatología e Investigación del Potosí, S.C., San Luis Potosí City

78229

Dr. Alex De Jesus Rheumatology, P.A., San Antonio

78731

Austin Regional Clinic, P.A., Austin

79124

Amarillo Center for Clinical Research, Amarillo

79410

Endocrinology, Internal Medicine, Lubbock

80020

Centro de Reumatologia y Ortopedia SAS, Barranquilla

80230

Denver Arthritis Clinic, Denver

83404

Institute of Arthritis Research, Idaho Falls

85032

Arizona Arthritis & Rheumatology Associates, P.C., Phoenix

87114

Lovelace Scientific Resources, Inc., Albuquerque

90623

Advanced Medical Research, LLC, Lakewood

91722

Medvin Clinical Research, Covina

91786

Inland Rheumatology Clinical Trials, Inc., Upland

92506

Riverside Medical Clinic, Riverside

92543

С V Mehta MD Med Corp., Hemet

92835

Saint Jude Heritage Medical Grp, Fullerton

94304

Stanford University School of Medicine, Palo Alto

94578

East Bay Rheumatology Medical Group, Inc., San Leandro

110221

Centro de Investigacion en Reumatologia y Especialidades Medicas SAS. CIREEM, Bogotá

111539

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

115522

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

185019

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

344022

Rostov State Medical Unversity, Rostov-on-Don

355030

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

600023

Regional Clinical Hospital, Vladimir

630099

City Clinical Hospital #1, Novosibirsk

644024

Diagnostic Center Ultramed, Omsk

680003

Medicity S.A.S., Bucaramanga

29055450

CEDOES - Diagnóstico e Pesquisa, Vitória

92020-4124

TriWest Research Associates, LLC, El Cajon

01605

Clinical Pharmacology Study Group, Worcester

07728

Arthritis & Osteoporosis Associates, PA, Freehold

B7600FYK

Centro de Investigaciones Medicas Mar del Plata, Mar del Plata

B7600FZN

Instituto de Investigaciones Clinicas, Mar del Plata

B1878GEG

Instituto de Investigaciones Clinicas Quilmes, Quilmes

S2000CFJ

Clinica de Higado y Aparato Digestivo, Rosario

S2600KUE

Sanatorio San Martin, Venado Tuerto

T4000AXL

Centro Medico Privado de Reumatologia, San Miguel de Tucumán

T4000BRD

Centro de Investigaciones Reumatológicas, San Miguel de Tucumán

C1015ABO

Organizacion Medica de Investigacion (OMI), Ciudad Autonoma Buenos Aires

C1046AAQ

APRILLUS, Ciudad Autonoma Buenos Aires

C1204AAD

Instituto Centenario, Ciudad Autonoma Buenos Aires

60430-370

HUWC - UFC - Hospital Universitário Walter Cantídio - Universidade Federal do Ceará, Fortaleza

74110-120

CIP - Centro Internacional de Pesquisa, Goiânia

36010-570

CMiP - Centro Mineiro de Pesquisa, Juiz de Fora

80030-110

CETI - Centro de Estudos em Terapias Inovadoras Ltda., Curitiba

95900-010

Hospital Bruno Born, Lajeado

90480-000

LMK Serviços Médicos S/S Ltda, Porto Alegre

09060-650

Faculdade de Medicina do ABC, Santo André

09715-090

Centro Multidisciplinar de Estudos Clínicos - CEMEC, São Bernardo do Campo

88301-215

Clínica de Neoplasias Litoral Ltda., Santa Catarina

01228-200

CPCLIN - Centro de Pesquisas Clínicas Ltda., São Paulo

04032-060

Associação de Assistência à Criança Deficiente - AACD, São Paulo

760 01

PV - Medical, s.r.o., Zlín

03720

Centro de Investigacion Clínica GRAMEL S.C, Mexico City

06700

Clinstile, S.A. de C.V., Mexico City

85-168

Szpital Uniwersytecki nr 2 im.dr J. Biziela, Bydgoszcz

05-825

McBk S.C., Grodzisk Mazowiecki

91-363

Centrum Medyczne AMED, Lodz

98-200

Szpital Wojewodzki im. Prymasa Kardynala Stefana Wyszynskiego, Sieradz

22-600

Samodzielny Publiczny ZOZ Tomaszow Lubelski, Tomaszów Lubelski

02-777

McM Polimedica, Warsaw

443-380

Ajou University Hospital, Suwon

431-796

Hallym University Sacred Heart Hospital, Gyeonggi-do

Sponsors
All Listed Sponsors
collaborator

Quintiles, Inc.

INDUSTRY

collaborator

OCT Clinical Trials

OTHER

collaborator

Mene Research

OTHER

lead

R-Pharm International, LLC

INDUSTRY

NCT02760433 - Evaluation of the Efficacy and Safety of Two Dosing Regimens of Olokizumab (OKZ), Compared to Placebo, in Subjects With Rheumatoid Arthritis (RA) Who Were Taking an Existing Medication Called a Tumour Necrosis Factor Alpha Inhibitor But Had Active Disease | Biotech Hunter | Biotech Hunter