2,106
Participants
Start Date
July 4, 2017
Primary Completion Date
September 1, 2021
Study Completion Date
September 1, 2021
Olokizumab 64 mg SC q4w
160 mg/mL sterile solution for SC injection in a 2 mL clear Type I glass vial with target volume of 0.4 mL or in the pre-filled syringe (PFS).PFS is composed of a 1 mL clear Type I glass barrel vial with target volume of 0.4 mL.
Olokizumab 64 mg SC q2w
160 mg/mL sterile solution for SC injection in a 2 mL clear Type I glass vial with target volume of 0.4 mL or in the pre-filled syringe (PFS). PFS is composed of a 1 mL clear Type I glass barrel vial with target volume of 0.4 mL.
Concomitant treatment
"Methotrexate 15 to 25 mg/week (or ≥ 10 mg/week if there was documented intolerance to higher doses). (Subject maintained their stable dose and route (oral, SC, or IM) during the core study and for ≥ 12 additional weeks of OLE.)~Folic acid ≥ 5 mg per week or equivalent"
Chang Gung Memorial Hospital, Linkou, Taoyuan District
Chi Mei Medical Center, Yung Kang Branch, Tainan City
Clinexpert Kft., Budapest
Obudai Egeszsegugyi Centrum Kft., Budapest
"NMTH Tsar Boris III", Sofia
"MHAT Lyulin, EAD", Sofia
"Medical Center Excelsior, OOD", Sofia
"UMHAT Sv. Ivan Rilski, EAD", Sofia
"MC Synexus - Sofia, EOOD", Sofia
Clinicos Asociados BOCM S.C., Mexico City
Centro de Investigacion Clínica GRAMEL S.C, Mexico City
UMHAT Pulmed OOD, Plovdiv
"UMHAT Kaspela, EOOD", Plovdiv
MDHAT 'Dr. Stefan Cherkezov', AD, Veliko Tarnovo
MAV Korhaz es Rendelointezet, Szolnok
Hospital Privado Centro Medico de Cordoba, Córdoba
CER San Juan Centro Polivalente de Asistencia e Inv. Clinica, San Juan
Medizinski Zentar-1-Sevlievo EOOD, Sevlievo
DCC 'Sv. Pantaleymon' OOD, Pleven
Comite Mexicano Para la Prevencion de Osteoporosis AC, Mexico City
Kiskunhalasi Semmelweis Korhaz, Kiskunhalas
Principal SMO Kft., Baja
The Catholic University of Korea, Seoul St. Mary's Hospital, Seoul
Clinstile, S.A. de C.V., Mexico City
MHAT - Ruse, AD, Rousse
DRC Szekesfehervar, Székesfehérvár
Vital-Medicina Kft., Veszprém
DRC Gyogyszervizsgalo Kozpont Kft., Balatonfüred
MHAT - Shumen, AD, Shumen
Klinische Forschung Berlin-Mitte GmbH, Berlin
NYU Langone ambulatory care, Brooklyn
East Tallinn Central Hospital, Tallinn
Altoona Center for Clinical Research, P.C., Duncansville
Arthritis Group, Philadelphia
Javed Rheumatology Associates, Newark
HRF Hamburger Rheuma Forschungszentrum, Hamburg
The Center for Rheumatology and Bone Research, Wheaton
Klein and Associates, M.D., P.A., Hagerstown
Medication Management, LLC, Greensboro
Carolina Arthritis Associates, Wilmington
Cape Fear Arthritis Care, Leland
Low Country Rheumatology, PA, Summerville
Marietta Rheumatology Associates, PC, Marietta
Arthritis Center of North Georgia, Gainesville
Investigacion y Biomedicina de Chihuahua, S.C., Chihuahua City
Omega Research Consultants, Orlando
Reliable Clinical Research, LLC, Hialeah
Family Clinical Trials, LLC., Pembroke Pines
Pharmax Research Clinic, Miami
Medical Research Center of Miami, Miami
Suncoast Research Group, LLC, Miami
RASF - Clinical Research Center, Boca Raton
AdventHealth Medical Group, PA, Tampa
Lovelace Scientific Resources, Inc., Venice
Arthritis Research of Florida, INC, Palm Harbor
Eulji University Hospital, Daejeon
North MS Medical Clinics, Inc., Tupelo
SMO.MD GmbH, Magdeburg
Studienambulanz Dr. Wassenberg, Ratingen
Graves Gilbert Clinic, Bowling Green
Clinical Research Source, Inc., Toledo
Clinica de Investigacion en Reumatologia y Obesidad S.C., Guadalajara
Centro de Estudios de Investigacion Basica y Clinica SC, Guadalajara
Republican Kaunas Hospital, Public Institution, Kaunas
Cincinnati Rheumatic Disease Study Group, Cincinnati
STAT Research, Inc., Dayton
AA MRC LLC Ahmed Arif Medical Research Center, Grand Blanc
Meditrials OU, Tartu
Rheumapraxis Dr. med. Reiner Kurthen, Aachen
Clinical Research Institute S.C., Mexico City
Trinity Medical Group, Minot
Glacier View Research Institute-Rheumatology, Kalispell
Kerckhoff-Klinik gGmbH, Bad Nauheim
Alytus Regional S. Kudirkos Hospital, Public Institution, Alytus
Jeju National University Hospital, Jeju City
Accelerium S. de R.L. de C.V., Monterrey
Universidad Autonoma de Nuevo Leon, Hospital Universitario Dr. Jose Eleuterio Gonzalez, Monterrey
University of Kansas Hospital, Kansas City
Physician Research Collaboration, Lincoln
Vesalion s.r.o., Ostrava
The Arthritis & Diabetes Clinic, Inc., Monroe
CHI St. Vincent Hot Springs, Hot Springs
Health Research of Oklahoma, PLLC, Oklahoma City
Lynn Health Science Institute, Oklahoma City
Clinica de Artritis Temprana S.A.S, Santiago de Cali
Precision Comprehensive Clinical Research Solutions, Colleyville
Siauliai Republican Hospital, Public Institution, Šiauliai
Therapeutic Concepts Rheumatology,LLC, Houston
Rheumatology Clinic of Houston, P.A., Houston
Houston Institute For Clinical Research, Houston
Accurate Clinical Mangemnt - Partner, Houston
Accurate Clinical Research, Inc., Houston
DM Clinical Research, Tomball
Advanced Rheumatology of Houston, The Woodlands
Pioneer Research Solutions, Inc., Cypress
Accurate Clinical Management., LLC, Baytown
Accurate Clinical Research, Inc., League City
CTCenter MaVe s.r.o., Olomouc
Centro de Alta Especialidad en Reumatología e Investigación del Potosí, S.C., San Luis Potosí City
Dr Alex De Jesus Rheumatology, P.A., San Antonio
Austin Regional Clinic, P.A., Austin
Amarillo Center for Clinical Research, Amarillo
West Texas Clinical Research, Lubbock
Centro de Reumatologia y Ortopedia SAS, Barranquilla
Denver Arthritis Clinic, Denver
Institute of Arthritis Research, Idaho Falls
Arizona Arthritis & Rheumatology Associates, P.C., Phoenix
AZ Arthritis & Rheum' Research, Mesa
Arizona Arthritis & Rheumatology Research, PLLC, Sun City
Lovelace Scientific Resources, Inc., Albuquerque
Medvin Clinical Research, Whittier
Advanced Medical Research, LLC, La Palma
Center for Rheumatology Research, Comprehensive Rheumatology Center, West Hills
Medvin Clinical Research, Covina
Inland Rheumatology Clinical Trials, Inc., Upland
Rheumatology Center of San Diego, San Diego
Klaipeda University Hospital, Public Institution, Klaipėda
C.V Mehta MD Med Corp.., Hemet
Stanford University School of Medicine, Palo Alto
East Bay Rheumatology Medical Group, Inc., San Leandro
Arthritis Northwest, PLLC, Spokane
Centro de Investigacion en Reumatologia y Especialidades Medicas SAS. CIREEM, Bogotá
Fundacion Instituto de Reumatologia Fernando Chalem, Bogotá
"State Budgetary Healthcare Institution City Clinical Hospital # 15 n.a O.M. Filatov of Moscow Healtheare Department", Moscow
"SBHI of Moscow City Clinical Hospital #4 of Moscow Healthcare Departament", Moscow
"FSBSI Scientific Research Institute of Rheumatology n.a. V.A. Nasonova", Moscow
"SBHI of Moscow City Clinical Hospital No.1 n.a. Pirogov Healthcare Department of Moscow", Moscow
"FSAEI HE First MSMU n.a. I.M. Sechenov of the Ministry of Health of the Russian Federation University Clinical Hospital No.1", Moscow
"FSAEI HE First MSMU n.a. I.M. Sechenov of the Ministry of Health of the Russian Federation", Moscow
"FSAEI HE First MSMU n.a. I.M. Sechenov of the Ministry of Health of the Russian Federation", Moscow
"State Autonomous Helthcare Institution of Yaroslavl region Clinical Hospital of Emergency Care n.a. Solovyev", Yaroslavl
"SBHI Yaroslavl Regional Clinical Hospital, Rheumatology department", Yaroslavl
"SBHI of the Republic of Karelia Republican Hospital named after V.A. Baranov", Petrozavodsk
"SPb SBHI Clinical Rheumatological Hospital #25, Fourth Rheumatology Unit", Saint Petersburg
"FSBI National Medical Research Center n.a. V.A.Almazov of the Ministry of Healthcare of the Russian Federation", Saint Petersburg
Vitebsk Clinical Hospital, Vitebsk
"Private Healthcare Institution Clinical Hospital Russian Railways-Medicine of City Smolensk", Smolensk
Minsk City Clinical Hospital #1, Minsk
"State Healthcare Institution of Tula region Tula Regional Clinical Hospital", Tula
"Budgetary Healthcare Institution Kursk Regional Clinical Hospital of Healthcare Committee of Kursk region", Kursk
"FSBEI HE Rostov State Medical Unversity of Ministry of Health of the Russian Federation", Rostov-on-Don
"FSBEI HE StSMU MOH Russia based on SBHI of Stavropol Region Stavropol Regional Clinical Hospital", Stavropol
"FSBEI HE 'Ryazan State Medical University n.a. I.P.Pavlov of the Ministry of Health of Russian Federation", Ryazan
"FSBEI HE Saratov SMU n.a. V.I.Razumovsky of Ministry of Health of Russian Federation", Saratov
"State Healthcare Institution Regional Clinical Hospital", Saratov
"FSBEI HE Kazan State Medical University of the Ministry of Health of the Russian Federation on the base of SAHI Republican Clinical Hospital of the Ministry of Health of Tatarstan Republic", Kazan'
"State Healthcare Institution Ulyanovsk Regional Clinical Hospital", Ulyanovsk
"State Budgetary Healthcare Institution Republican Clinical Hospital n.a. G.G. Kuvatov", Ufa
"SBHI of Vladimir Region Regional Clinical Hospital, Rheumatology Departament", Vladimir
"SBHI of Nizhegorodsky Region State Clinical Hospital #5 of Nizhegorodsky District of Nizhny Novgorod", Nizhny Novgorod
"SBHI of Nizhny Novgorod Region Nizhny Novgorod Regional Clinical Hospital n.a.Semashko", Nizhny Novgorod
"State Autonomous Healthcare Institution of Sverdlovsk Region Sverdlovsk Regional Clinical Hospital No.1", Yekaterinburg
"FSBEI HE Ural State Medical University of Ministry of Health of Russian Federation based on MBI Central City Clinical Hospital No.6", Yekaterinburg
"State Autonomous Healthcare Institution of Novosibirsk region City Polyclinic #1", Novosibirsk
"LLC Clinical Diagnostic Center Ultramed", Omsk
"Budgetary Healthcare Institution of Omsk Region Regional Clinical Hospital", Omsk
"SAHI of Kemerovo region Regional Clinical Hospital for War Veterans", Kemerovo
"Medical Center LLC Maksimum Zdoroviya", Kemerovo
"FSBEI HE Altai State Medical University of the Ministry of Healthcare of Russian Federation", Barnaul
Medicity S.A.S., Bucaramanga
Valerius Medical Group, Los Alamitos
New England Research Associates LLC, Bridgeport
Clinical Pharmacology Study Group, Worcester
Arthritis & Osteoporosis Associates, PA, Freehold
Centro de Investigaciones Medicas Mar del Plata, Mar del Plata
Instituto Medico CER, Quilmes
Instituto de Investigaciones Clinicas Quilmes, Quilmes
Sanatorio San Martin, Venado Tuerto
Centro Medico Privado de Reumatologia, San Miguel de Tucumán
Instituto de Investigaciones Clinicas-Mar del Plata, Buenos Aires
Organizacion Medica de Investigacion (OMI), Ciudad Autonoma Buenos Aires
APRILLUS Asistencia e Investigacion, Ciudad Autonoma Buenos Aires
Instituto Centenario, Ciudad Autonoma Buenos Aires
Instituto DAMIC Fundacion Rusculleda, Córdoba
Centro de Investigaciones Reumatológicas, San Miguel de Tucumán
Clinica de Higado y Aparato Digestivo, Santa Fe
HUWC - UFC - Hospital Universitário Walter Cantídio - Universidade Federal do Ceará, Fortaleza
CEDOES - Diagnóstico e Pesquisa, Vitória
CIP - Centro Internacional de Pesquisa, Goiânia
CMiP - Centro Mineiro de Pesquisa, Juiz de Fora
CETI - Centro de Estudos em Terapias Inovadoras Ltda., Curitiba
Clinilive - Clínica do Idoso e Pesquisa Clínica, Maringá
Hospital Bruno Born, Lajeado
LMK Serviços Médicos S/S Ltda, Pôrto Alegre
Clínica de Neoplasias Litoral Ltda., Itajaí
Faculdade de Medicina do ABC, Santo André
Centro Multidisciplinar de Estudos Clínicos - CEMEC, São Bernardo do Campo
CCBR Brasil Centro de Pesquisas e Análises Clínicas Ltda., Rio de Janeiro
CPCLIN - Centro de Pesquisas Clínicas Ltda., São Paulo
Associação de Assistência à Criança Deficiente - AACD, São Paulo
CCR Brno s.r.o, Brno
IMEDICA s.r.o., Brno
Revmatologie s.r.o., Brno
Nemocnice Jihlava p.o., Jihlava
MUDr Gabriela Simkova Ordinace Lekare Specialisty Interna Revmatologie, Kladno
ARTROSCAN s.r.o., Ostrava - Trebovice
ARTHROHELP s.r.o., Pardubice
CCR Czech, a.s., Pardubice
CLINTRIAL s.r.o., Prague
Revmatologicky ustav, Prague
CCR Prague s.r.o., Prague
MUDR Zuzana URBANOVA Revmatologie, Prague
MUDR Zuzana URBANOVA Revmatologie, Praha 4 Nusle
Affidea Praha s.r.o., Prague
Fakultni nemocnice v Motole, Prague
Medical Plus s.r.o., Uherské Hradiště
PV - MEDICAL, s.r.o., Zlín
Dr.Saulite-Kandevica Private Practice, Liepāja
Center Outpatient Clinic, Public Institution, Vilnius
Vilnius University Hospital Santariskiu Clinics, Public Institution, Vilnius
CERMED, Bialystok
ZDROWIE Osteo-Medic, Bialystok
Szpital Uniwersytecki nr 2 im.dr J. Biziela, Bydgoszcz
MCBK Iwona Czajkowska Anna Podrażka- Szczepaniak S.C., Grodzisk Mazowiecki
Polimedica Centrum Badań, Profilaktyki I Leczenia, Kielce
CCBR - Lodz - PL, Lodz
Centrum Medyczne AMED, Lodz
ETYKA Osrodek Badan Klinicznych, Olsztyn
Szpital Wojewodzki im. Prymasa Kardynala Stefana Wyszynskiego, Sieradz
Clinmed Research, Skierniewice
RCMed, Sochaczew
KO-MED Centra Kliniczne Staszow, Staszów
Samodzielny Publiczny ZOZ Tomaszow Lubelski, Tomaszów Lubelski
Nasz lekarz Przychodnie Medyczne, Torun
Medycyna Kliniczna, Warsaw
Rheuma Medicus Zaklad Opieki Zdrowotnej, Warsaw
McM Polimedica, Warsaw
KO-MED Centra Kliniczne Zamosc, Zamość
Santa Familia Centrum Badan, Profilaktyki i Leczenia, Zgierz
Hallym University Sacred Heart Hospital, Anyang-si
Ajou University Hospital, Suwon
Chonnam National University Hospital, Gwangju
Severance Hospital, Yonsei University No. 31 Office, Pediatric Oncology Clinic, Seoul
Torbay Hospital, Torquay
Whipps Cross University Hospital, London
Royal Free Hospital, London
Basingstoke and North Hampshire Hospital, Basingstoke
Maidstone Hospital, Maidstone
Arrowe Park Hospital, Metropolitan Borough of Wirral
Collaborators (1)
IQVIA Pvt. Ltd
INDUSTRY
OCT Clinical Trials
OTHER
R-Pharm International, LLC
INDUSTRY