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

PHASE3CompletedINTERVENTIONAL
Enrollment

1,648

Participants

Timeline

Start Date

June 6, 2016

Primary Completion Date

August 2, 2019

Study Completion Date

November 5, 2019

Conditions
Rheumatoid Arthritis
Interventions
DRUG

Olokizumab 64mg q4w

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

DRUG

Olokizumab 64mg q2w

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

DRUG

Adalimumab 40mg q2w

0.4 or 0.8 mL prefilled, single-dose syringe

DRUG

Placebo q2w

sodium chloride 0.9% solution supplied in 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 (203)

333

Chang Gung Memorial Hospital, Linkou, Taoyuan District

710

Chi Mei Medical Center, Tainan City

1033

Clinexpert Egeszsegugyi Szolg. es Ker. Kft., Budapest

1036

Obudai Egeszsegugyi Centrum, Budapest

1233

"NMTH Tsar Boris III", Sofia

1336

"MHAT Lyulin, EAD", Sofia

1407

"Medical Center Excelsior, OOD", Sofia

1426

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

1431

UMHAT Sv. Ivan Rilski EAD, Sofia

1784

MC Synexus - Sofia EOOD, Sofia

3300

Clinicos Asociados BOCM S.C., Mexico City

4000

UMHAT Pulmed OOD, Plovdiv

5000

MDHAT 'Dr. Stefan Cherkezov', AD, Veliko Tarnovo

MAV Korhaz és Rendelointezet, Szolnok

5016

Hospital Privado Centro Medico de Cordoba S.A, Córdoba

5400

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

Medizinski Zentar-1-Sevlievo EOOD, Sevlievo

6100

Cryptex Investigacion Clinica S.C, Mexico City

6400

Kiskunhalasi Semmelweis Korhaz, Kiskunhalas

6500

Principal SMO Kft., Baja

6606

New England Research Associates LLC, Bridgeport

7002

MHAT - Ruse, AD, Rousse

8000

DRC Szekesfehervar, Székesfehérvár

8200

Vital Medical Center, Veszprém

8230

DRC Gyogyszervizsgalo Kozpont Kft., Balatonfüred

9700

MHAT - Shumen, AD, Shumen

10117

Klinische Forschung Berlin-Mitte GmbH, Berlin

11201

NYU Langone ambulatory care, Brooklyn

11312

East Tallinn Central Hospital, Tallinn

13496

CHA Bundang Medical Center, Gyeonggi-do

16635

Altoona Center for Clinical Research, P.C., Duncansville

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

28451

Cape Fear Arthritis Care, Leland

29486

Low Country Rheumatology, PA, Summerville

30060

Marietta Rheumatology Associates, PC, Marietta

30501

Arthritis Center of North Georgia, Gainesville

31000

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

32810

Omega Research Consultants, Orlando

33012

Reliable Clinical Research, LLC, Hialeah

33026

Family Clinical Trials, LLC., Pembroke Pines

33126

Pharmax Research Clinic, Inc., Miami

33134

Medical Research Center of Miami, Miami

33486

RASF - Clinical Research Center, Boca Raton

33614

AdventHealth Medical Group, PA, Tampa

34292

Lovelace Scientific Resources, Inc., Venice

34684

Arthritis Research, Palm Harbor

35233

Eulji University Hospital, Daejeon

38801

North MS Medical Clinics, Inc., Tupelo

39120

SMO.MD GmbH, Magdeburg

40878

Studienambulanz Dr. Wassenberg, Northeim

42101

Graves Gilbert Clinic, Bowling Green

43606

Clinical Research Source, Inc., Toledo

44650

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

44690

Centro de Estudios de Investigacion Basica y Clinica SC, Guadalajara

45130

Republican Kaunas Hospital, Public Institution, Kaunas

45417

STAT Research, Inc., Dayton

48439

AA MRC LLC Ahmed Arif Medical Research Center, Grand Blanc

50406

Medita Kliinik OÜ, Tartu

52064

Rheumapraxis Dr. med. Reiner Kurthen, Aachen

54055

Clinical Research Institute S.C., México

58701

Trinity Medical Group, Minot

59901

Glacier View Research Instutute-Rheumatology, Kalispell

60200

CCR Brno s.r.o, Brno

61231

Kerckhoff-Klinik gGmbH, Bad Nauheim

61469

Chonnam National University Hospital, Gwangju

62114

Alytаus Regional S. Kudirkos Hospital, Public Institution, Alytus

62702

Springfield Clinic, LLP, Springfield

63241

Jeju National University Hospital, Jeju City

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

68516

Physician Resrch Collaboration, Lincoln

70200

Vesalion s.r.o., Ostrava

71203

The Arthritis & Diabetes Clinic, Inc., Monroe

73103

Health Research of Oklahoma, PLLC, Oklahoma City

73112

Lynn Health Science Institute, Oklahoma City

76001

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

76034

Precision Comprehensive Clinical Research Solutions, Grapevine

76231

Siauliai Republican Hospital, Public Institution, Šiauliai

77065

Rheumatology Clinic of Houston, P.A., Houston

77084

Accurate Clinical Research, Houston

77089

Accurate Clinical Mangemnt LLC, Houston

Accurate Clinical Research, Inc., Houston

77375

DM Clinical Research, Tomball

77382

Advanced Rheumatology of Houston, Houston

77521

Accurate Clinical Management LLC, Baytown

77573

Accurate Clinical Research, Inc., League City

77702

Pioneer Research Solutions, Inc., Beaumont

77900

CTCenter MaVe s.r.o., Olomouc

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

80230

Denver Arthritis Clinic, Denver

83404

Institute of Arthritis Research, Idaho Falls

85032

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

85210

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

85351

Arizona Arthritis & Rheumatology Research, PLLC, Sun City

90602

Medvin Clinical Research, Whittier

91607

Center for Rheumatology Research, West Hills

91722

Medvin Clinical Research, Covina

91786

Inland Rheumatology Clinical Trials, Upland

92020

TriWest Research Associates, El Cajon

92128

Rheumatology Center of San Diego, San Diego

92288

Klaipeda University Hospital, Public Institution, Klaipėda

92543

MD Med Corp., Hemet

93454

Pacific Arthritis Center Medical Grpoup, Santa Maria

94578

East Bay Rheumatology Medical Group, Inc., San Leandro

99204

Arthritis Northwest, PLLC, Spokane

110221

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

111211

Fundacion Instituto de Reumatologia Fernando Chalem, Bogotá

111539

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

115522

Institute n a Nasonova, Moscow

119435

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

185019

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

190068

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

214025

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

450005

Hospital n a Kuvatov, Ufa

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

680003

Medicity S.A.S., Bucaramanga

900591

"Spitalul Clinic Judetean de Urgenta Sf. Apostol Andrei Constanta", Constanța

29055450

CEDOES - Diagnóstico e Pesquisa, Vitória

90720-5403

Valerius Medical Group, Los Alamitos

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, Mar del Plata

B1878DVB

Instituto Medico CER, 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

B1878GEG

Institute Investigaciones Clinc Quilme, Buenos Aires

C1015ABO

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

C1046AAQ

APRILLUS Asistencia e Investigacion, Ciudad Autonoma Buenos Aires

C1204AAD

Instituto Centenario, Ciudad Autonoma Buenos Aires

X5003DCE

Instituto DAMIC Fundacion Rusculleda, Córdoba

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

87013-250

Clinilive - Clínica do Idoso e Pesquisa Clínica, Maringá

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

20241-180

CCBR Brasil Centro de Pesquisas e Análises Clínicas Ltda., Rio de Janeiro

88301-215

Clínica de Neoplasias Litoral, Santa Catarina

01228-200

CPCLIN - Centro de Pesquisas Clínicas Ltda., São Paulo

04032-060

Hospital Abreu Sodré - AACD, São Paulo

080020

Centro de Investigacion Medico, Barranquilla

638 00

Revmatologie s.r.o., Brno

586 01

Nemocnice Jihlava p.o, Jihlava

272 01

MUDr. Gabriela Simkova ordinace lekare specialisty interna revmatologie, Kladno

722 00

Artroscan s.r.o., Ostrava - Trebovice

530 02

ARTHROHELP s.r.o., Pardubice

CCR Pardubice, Pardubice

100 00

Clintrial, s.r.o., Prague

128 00

Revmatologicky ustav, Prague

130 00

CCR Prague s.r.o., Prague

140 00

MUDR. Zuzana Urbanova Revmatologie, Prague

MUDR. Zuzana URBANOVA Revmatologie, Praha 4 Nusle

148 00

Affidea Praha, s.r.o., Prague

150 06

Fakultni nemocnice v Motole, Prague

686 01

MEDICAL PLUS s.r.o., Uherské Hradiště

760 01

PV Medical Services s.r.o., Zlín

LV-3401

Dr.Saulite-Kandevica Private Practice, Liepāja

LT-01117

Center Outpatient Clinic, Public Institution, Vilnius

LT-08661

Vilnius University Hospital Santariskiu Clinic, Public Institution, Vilnius

03720

Centro de Investigacion Clínica GRAMEL S.C, México

06700

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

15-351

NZOZ ZDROWIE Osteo-Medic, Bialystok

85-168

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

05-825

MCBK Iwona Czajkowska Anna PodrażkaSzczepaniak S.C., Grodzisk Mazowiecki

25-355

Polimedica Centrum Badań, Profilaktyki I Leczenia, Kielce

91-363

Centrum Medyczne AMED, Lodz

10-117

ETYKA Osrodek Badan Klinicznych, Olsztyn

98-200

Szpital Wojewodzki im. Prymasa Kardynala Stefana Wyszynskiego, Sieradz

90 368

CCBR - Lodz - PL, Skierniewice

96-100

Clinmed Research, Skierniewice

96-500

RCMed, Sochaczew

28-200

KO-MED Centra Kliniczne Staszow, Staszów

22-600

Samodzielny Publiczny ZOZ Tomaszow Lubelski, Tomaszów Lubelski

87-100

"Niepubliczny Zaklad Opieki Zdrowotnej Nasz Lekarz Praktyka Grupowa Lekarzy Rodzinnych z", Torun

00-874

Medycyna Kliniczna, Warsaw

02-118

Rheuma Medicus Zaklad Opieki Zdrowotnej, Warsaw

02-777

McM Polimedica, Warsaw

22-400

KO-MED Centra Kliniczne Zamosc, Zamość

95-100

Santa Familia Centrum Badan, Profilaktyki i Leczenia, Zgierz

03722

Severance Hospital, Yonsei University, Seoul

06591

The Catholic University of Korea, Seoul St. Mary's Hospital, Seoul

TQ2 7AA

Torbay Hospital, Torquay

E11 1NR

Whipps Cross University Hospital, London

NW3 2QG

Royal Free Hospital, London

RG24 9NA

Basingstoke and North Hampshire Hospital, Basingstoke

ME16 9QQ

Maidstone Hospital, Maidstone

CH49 5PE

Arrowe Park Hospital, Metropolitan Borough of Wirral

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Quintiles, Inc.

INDUSTRY

collaborator

OCT Clinical Trials

OTHER

lead

R-Pharm International, LLC

INDUSTRY

NCT02760407 - Evaluation of the Efficacy and Safety of Two Dosing Regimens of Olokizumab (OKZ), Compared to Placebo and Adalimumab, in Subjects With Rheumatoid Arthritis (RA) Who Are Taking Methotrexate But Have Active Disease | Biotech Hunter | Biotech Hunter