Last updated on December 2018

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 an Existing Medication Called a Tumour Necrosis Factor Alpha Inhibitor But Have Active Disease


Brief description of study

The purpose of this study is to determine how safe and effective the study drug Olokizumab is, in patients with Rheumatoid Arthritis (RA) who are already receiving, but not fully responding to treatment with an existing medication called a tumour necrosis factor alpha inhibitor

Detailed Study Description

The goal of this Phase III study is to assess the safety, tolerability, and efficacy of OKZ in subjects with moderately to severely active RA who have responded inadequately to TNFi therapy. The primary endpoint of the trial is at Week 12. Olokizumab is expected to reduce the disease activity and improve physical function. The study is expected to provide safety information in a large group of subjects over at least a 24 week period.

Clinical Study Identifier: NCT02760433

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Rheumatology Associates Of North Alabama- RANA
Huntsville, AL United States
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Saima Chohan

Arizona Arthritis & Rheumatology Associates, P.C.
Glendale, AZ United States
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Ratinder Kaur

CHI St. Vincent Hot Springs
Hot Springs, AR United States
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Little Rock Diagnostic Clinic, PA
Little Rock, AR United States
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Arthur Mabaquiao

TriWest Research Associates, LLC
El Cajon, CA United States
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Saint Jude Heritage Medical Grp
Fullerton, CA United States
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Chandrakant Mehta

MD Med Corp.
Hemet, CA United States
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Gerald Ho

Advanced Medical Research, LLC
Lakewood, CA United States
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Andre Babajanians

Riverside Medical Clinic
Riverside, CA United States
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Clark Neuwelt

East Bay Rheumatology Medical Group, Inc.
San Leandro, CA United States
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Orrin M Troum and Medical Associates
Santa Monica, CA United States
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Mark Genovese

Stanford University School of Medicine
Stanford, CA United States
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Eric Lee

Inland Rheumatology Clinical Trials, Inc.
Upland, CA United States
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Alpine Clinical Research Center
Boulder, CO United States
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Christopher Antolini

Denver Arthritis Clinic
Denver, CO United States
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Joseph Forstot

RASF - Clinical Research Center
Boca Raton, FL United States
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Mark Kutner

Suncoast Research
Miami, FL United States
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Jeanne-Elyse Cedeno

Family Clinical Trials, LLC.
Pembroke Pines, FL United States
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Harris McIlwain

McIlwain Medical Group, PA
Tampa, FL United States
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Craig Scoville

Institute of Arthritis Research
Idaho Falls, ID United States
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University of Kansas Medical Center Research Institute, Inc.
Kansas City, KS United States
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Asad Fraser

Graves Gilbert Clinic
Bowling Green, KY United States
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Research Integrity, LLC.
Owensboro, KY United States
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Jyothi Mallepalli

The Arthritis & Diabetes Clinic, Inc.
Monroe, LA United States
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Klein and Associates, M.D., P.A.
Cumberland, MD United States
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Mary Howell

Klein and Associates, M.D., P.A.
Hagerstown, MD United States
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Herbert Baraf

The Center for Rheumatology and Bone Research
Wheaton, MD United States
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Roger Diegel

Glacier View Research Instutute-Rheumatology
Kalispell, MT United States
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Westroads Clinical Research
Omaha, NE United States
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Hisham El-Kadi

Arthritis & Osteoporosis Associates, PA
Freehold, NJ United States
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Michael McGuire

Lovelace Scientific Resources, Inc.
Albuquerque, NM United States
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Center for Rheumatology
Albany, NY United States
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David Goddard

Weill Cornell Brain & Spine Center
New York, NY United States
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Nilamadhab Mishra

Medication Management, LLC
Greensboro, NC United States
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Mark Harris

Carolina Arthritis Associates
Wilmington, NC United States
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Michael Luggen

Cincinnati Rheumatic Disease Study Group
Cincinnati, OH United States
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Sanford Wolfe

STAT Research, Inc.
Dayton, OH United States
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Edward Goldberger

Clinical Research Source, Inc.
Perrysburg, OH United States
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James Udell

Arthritis Group
Philadelphia, PA United States
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William Edwards

Low Country Research Center
Charleston, SC United States
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Constantine Saadeh

Allergy Asthma Rheumatology Treatment Specialist (ARTS)
Amarillo, TX United States
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Tina Bunch

Austin Regional Clinic, P.A.
Austin, TX United States
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Sabeen Najam

Accurate Clinical Research, Inc.
Baytown, TX United States
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Accurate Clinical Management LLC
Houston, TX United States
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Samuel Pegram

Rheumatic Disease Clinical Research Center, LLC
Houston, TX United States
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Philip Waller

Accurate Clinical Research, Inc.
Houston, TX United States
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Qaiser Rehman

Rheumatology Clinic of Houston, P.A.
Houston, TX United States
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Houston Institute For Clinical Research
Houston, TX United States
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Asif Cochinwala

Pioneer Research Solutions, Inc.
Houston, TX United States
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Arthritis & Osteoporosis Associates LLP
Lubbock, TX United States
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Prashanth Sunkureddi

Accurate Clinical Research, Inc.
Nassau Bay, TX United States
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Alex De Jesus

Dr. Alex De Jesus Rheumatology, P.A.
San Antonio, TX United States
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The Center For Arthritis and Rheumatic Diseases
Chesapeake, VA United States
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Fabian Risueño

Hospital Italiano Regional del Sur
Bahia Blanca, Argentina
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Gladys Alicia Testa

Centro de Investigaciones Medicas Mar del Plata
Mar del Plata, Argentina
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Juan Pablo Gulin

Instituto de Investigaciones Clinicas-Mar del Plata
Mar del Plata, Argentina
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Jose Luis Velasco Zamora

Instituto de Investigaciones Clinicas Quilmes
Quilmes, Argentina
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Judith Carrio

Clinica de Higado y Aparato Digestivo
Rosario, Argentina
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Juan Carlos Raggio

Sanatorio Delta
Rosario, Argentina
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Rosana Gallo

Sanatorio San Martin
Venado Tuerto, Argentina
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Alberto Jorge Spindler

Centro Medico Privado de Reumatologia
San Miguel de Tucuman, Argentina
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Eleonora del Valle Lucero

Centro de Investigaciones Reumatol gicas
San Miguel de Tucuman, Argentina
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Patricio Tate

Organizacion Medica de Investigacion (OMI)
Ciudad Autonoma Buenos Aires, Argentina
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Pablo Alejandro Mannucci

APRILLUS
Ciudad Autonoma Buenos aires, Argentina
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Pablo Jorge Maid

Centro de Investigacion en Enfermedades Reumaticas CIER
Ciudad Autonoma Buenos Aires, Argentina
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Cecilia Asnal

Instituto Centenario
Ciudad Autonoma Buenos Aires, Argentina
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Eduardo Kerzberg

Hospital General de Agudos Dr. J. M. Ramos Mejia
Ciudad Autonoma Buenos Aires, Argentina
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Horacio Oscar Venarotti

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

Consultora Integral de Salud S.R.L.
Cordoba, Argentina
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Gisela Constanza Subils

Instituto DAMIC Fundacion Rusculleda
Cordoba, Argentina
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Alejandro Jose Alvarellos

Hospital Privado Centro Medico de Cordoba
Cordoba, Argentina
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Jose Luis Cristian Moreno

Centro Polivalente de Asistencia e Inv. Clinica CER
San Juan, Argentina
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Leonardo Ribeiro Sampaio

HUWC - UFC - Hospital Universit rio Walter Cant dio - Universidade Federal do Cear
Fortaleza, Brazil
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Antônio Scafuto Scotton

CMiP - Centro Mineiro de Pesquisa
Juiz de Fora, Brazil
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Sebastião Cézar Radominski

CETI - Centro de Estudos em Terapias Inovadoras Ltda.
Curitiba, Brazil
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Jussara Marilu Bohn

Hospital Bruno Born
Lajeado, Brazil
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Mauro Waldemar Keiserman

LMK Servi os M dicos S/S Ltda
Porto Alegre, Brazil
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Luís Roimicher

HUCFF-UFRJ - Hospital Universit rio Clementino Fraga Filho - Universidade Federal do Rio de Janeiro
Rio de Janeiro, Brazil
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Filipe Martins de Mello

Cl nica de Neoplasias Litoral Ltda.
Santa Catarina, Brazil
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Morton Aaron Scheinberg

Hospital Abreu Sodr - AACD
Sao Paulo, Brazil
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Carlo Caballero

Fundacion Hospital Universidad del Norte
Barranquilla, Colombia
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Juan Jose Jaller Raad

Centro de Reumatologia y Ortopedia SAS
Barranquilla, Colombia
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Philippe Chalem

Fundacion Instituto de Reumatologia Fernando Chalem
Bogota, Colombia
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Diego Luis Saaibi

Medicity S.A.S.
Bucaramanga, Colombia
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Carlos Enrique Toro

Clinica de Artritis Temprana S.A.
Cali, Colombia
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Klara Sirova

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

MEDICAL PLUS s.r.o.
Uherske Hradiste, Czechia
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Petr Vitek

PV - Medical, s.r.o.
Zlin, Czechia
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Ramona Koenig

Kerckhoff-Klinik gGmbH
Bad Nauheim, Germany
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Frank Behrens

CIRI - Centrum f r Innovative Diagnostik und Therapie GmbH
Frankfurt, Germany
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Rheumazentrum Prof. Dr. G. Neeck
Bad Doberan, Germany
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Cornelia Kuehne

SMO.MD GmbH
Magdeburg, Germany
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Reiner Kurthen

Rheumapraxis Dr. med. Reiner Kurthen
Aachen, Germany
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Gerd-Ruediger Burmester

Charite Universitaetsmedizin Berlin - Campus Charite Mitte
Berlin, Germany
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Andrea Everding

HRF Hamburger Rheuma Forschungszentrum
Hamburg, Germany
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Juergen Wollenhaupt

Schoen Klinik Hamburg Eilbek
Hamburg, Germany
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Eszter Simoncsics

Clinexpert Egeszsegugyi Szolg. es Ker. Kft.
Budapest, Hungary
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Magdolna Nagy

Obudai Egeszsegugyi Centrum
Budapest, Hungary
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Attila Kovacs

MAV Korhaz s Rendelointezet
Szolnok, Hungary
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Edit Drescher

Vital Medical Center
Veszprem, Hungary
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Chang-Hee Suh

Ajou University Hospital
Suwon-si, Korea, Republic of
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Seung-Geun Lee

Pusan National University Hospital
Busan, Korea, Republic of
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Seung Cheol Shim

Chungnam National University Hospital
Daejeon, Korea, Republic of
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Mi-Kyoung Lim

Eulji University Hospital
Daejeon, Korea, Republic of
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Shin-Seok Lee

Chonnam National University Hospital
Gwangju, Korea, Republic of
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Hyun Ah Kim

Hallym University Sacred Heart Hospital
Gyeonggi-do, Korea, Republic of
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Yong-Beom Park

Severance Hospital, Yonsei University
Seoul, Korea, Republic of
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Hanyang University Seoul Hospital
Seoul, Korea, Republic of
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Ji Hyeon Ju

The Catholic University of Korea, Seoul St. Mary's Hospital
Seoul, Korea, Republic of
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Luis Jara Quezada

Centro de Investigacion Cl nica GRAMEL S.C
Mexico, Mexico
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Favio Edmundo Enriquez Sosa

Clinstile, S.A. de C.V.
Mexico, Mexico
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Miguel Saavedra Salinas

Clinical Research Institute S.C.
Tlalnepantla, Mexico
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Sergio Duran Barragan

Clinica de Investigacion en Reumatologia y Obesidad S.C.
Guadalajara, Mexico
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Ignacio Garcia Valladares

entro de Estudios de Investigacion Basica y Clinica SC
Guadalajara, Mexico
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Edmundo De la Garza Ramos

Accelerium S. de R.L. de C.V.
Monterrey, Mexico
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Arturo Villarreal Ortega

Hospital y Clinica OCA SA de CV
Monterrey, Mexico
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Diana Flores Alvarado

Universidad Autonoma de Nuevo Leon, Hospital Universitario Dr. Jose Eleuterio Gonzalez
Monterrey, Mexico
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Juan Rizo Rodriguez

Centro de Alta Especialidad en Reumatolog a e Investigaci n del Potos , S.C.
San Luis Potosi, Mexico
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Cesar Pacheco Tena

Investigacion y Biomedicina de Chihuahua, S.C.
Chihuahua, Mexico
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Iwona Dankiewicz-Fares

Szpital Uniwersytecki nr 2 im.dr J. Biziela
Bydgoszcz, Poland
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Krystyna Jedrychowicz-Rosiak

McBk S.C.
Grodzisk Mazowiecki, Poland
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Mirella Wojtecka-Grabka

Polimedica Centrum Bada , Profilaktyki I Leczenia
Kielce, Poland
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Anna Dudek

Centrum Medyczne AMED
Lodz, Poland
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Robert Kolacinski

Szpital Wojewodzki im. Prymasa Kardynala Stefana Wyszynskiego
Sieradz, Poland
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Andrzej Kaminski

Samodzielny Publiczny ZOZ Tomaszow Lubelski
Tomaszow Lubelski, Poland
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Anna Rowinska-Osuch

McM Polimedica
Warszawa, Poland
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Santa Familia Centrum Badan, Profilaktyki i Leczenia
Zgierz, Poland
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Medical Center LLC "Maksimum Zdoroviya"
Kemerovo, Russian Federation
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SAHI of Kemerovo region "Regional Clinical Hospital for War Veterans"
Kemerovo, Russian Federation
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Natalia Vezikova

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

FSBSI "Scientific Research Institute of Rheumatology n.a. V.A. Nasonova"
Moscow, Russian Federation
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Hacettepe University Medical Faculty Hospital, Rheumatology Departament
Ankara, Turkey
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Istanbul University, Istanbul Medical Faculty Internal Diseases Departament, Rheumatology Discipline
Istanbul, Turkey
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Istanbul University, Cerrahpasa Faculty o Medicine, Departament of Internal Medicine, Division of Rheumatology
Istanbul, Turkey
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SPb SBHI "Clinical Rheumatological Hospital #25", Fourth Rheumatology Unit
Saint Petersburg, Russian Federation
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Evgeniya Shmidt

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

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

SBHI of Stavropol Region "Stavropol Regional Clinical Hospital"
Stavropol', Russian Federation
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State Autonomous Healthcare Institution "Republican Clinical Hospital of Ministry of Health of Tatarstan Republic
Kazan', Russian Federation
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Samy Metyas

Medvin Clinical Research
Covina, CA United States
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Kwabena Ayesu

Omega Research Consultants
Orlando, FL United States
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Mark Turner

Advanced Clinical Research
Meridian, ID United States
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Charles Birbara

Clinical Pharmacology Study Group
Worcester, MA United States
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Tamar Brionez

Advanced Rheumatology of Houston
Woodville, TX United States
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Suzanne Gharib

The Rheumatology Group PLLC
South Charleston, WV United States
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David Snow

Cape Fear Arthritis Care
Leland, NC United States
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Medvin Clinical Research
Whittier, CA United States
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Sheerin Javed

Javed Rheumatology Associates
Newark, DE United States
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Marta Bognar

Arthritis Center of North Georgia
Gainesville, GA United States
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Erdal Diri

Trinity Medical Group
Minot, ND United States
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Dhiman Basu

Precision Comprehensive Clinical Research Solutions
Grapevine, TX United States
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Celso Ricardo Emerich de Abreu

CEDOES - Diagn stico e Pesquisa
Vitória, Brazil
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Antônio Carlos Ximenes

CIP - Centro Internacional de Pesquisa
Goiânia, Brazil
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Antônio Carlos de Silva

Clinilive - Cl nica do Idoso e Pesquisa Cl nica
Maringá, Brazil
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Sônia Maria Alvarenga Anti Loduca ...

Faculdade de Medicina do ABC
Santo André, Brazil
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Anna Maura Ferreira Fernandes

Hospital Estadual M rio Covas
Santo André, Brazil
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Thaís Rohde Pavan

Hospital S o Vicente de Paulo
Rio Grande, Brazil
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Flora Maria D'Andrea Marcolino

CPCLIN - Centro de Pesquisas Cl nicas Ltda.
São Paulo, Brazil
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Patricia Julieta Velez Sanchez

Centro de Investigacion en Reumatologia y Especialidades Medicas SAS. CIREEM
Bogotá, Colombia
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Javier Dario Marquez Hernandez

Hospital Pablo Tob n Uribe
Medellín, Colombia
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Ki Won Moon

Kangwon National University Hospital
Chuncheon, Korea, Republic of
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Wan Hee Yoo

Chonbuk National University Hospital
Chungbuk, Korea, Republic of
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Jinseok Kim

Jeju National University Hospital
Jeju, Korea, Republic of
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Recruitment Status: Open


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