Last updated on November 2018

A Study of Ustekinumab in Participants With Active Systemic Lupus Erythematosus


Brief description of study

The purpose of this study is to evaluate the efficacy of ustekinumab in participants with active systemic lupus erythematosus (SLE) who have not adequately responded to one or more standard of care treatments.

Detailed Study Description

This study evaluates the efficacy, safety, and tolerability of ustekinumab in participants with active SLE according to Systemic Lupus International Collaborating Clinics (SLICC) criteria Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score greater than (>=) 6, despite receiving one or more standard-of-care treatments (example, immunomodulators, antimalarial drugs, and/or glucocorticoids). The total duration of the study is up to 182 weeks, consisting of 3 study periods: a screening period (approximately 6 weeks), a double blind period (52 weeks), and an extension period (124 weeks). Other study evaluations will include pharmacokinetics, immunogenicity, biomarkers and pharmacogenomic evaluations. The safety of the participants enrolled in the study will be monitored on an ongoing basis throughout the study.

Clinical Study Identifier: NCT03517722

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Pinnacle Research Group, LLC
Anniston, AL United States
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University of Alabama at Birmingham
Birmingham, AL United States
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Rheumatology Associates of North Alabama, PC
Huntsville, AL United States
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Achieve Clinical Research, LLC
Vestavia Hills, AL United States
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Medvin Clinical Research
Covina, CA United States
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Lugene Eye Institute
Glendale, CA United States
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C.V. Mehta, MD Medical Corp.
Hemet, CA United States
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Advanced Medical Research - Lakewood
Lakewood, CA United States
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Loma Linda University
Loma Linda, CA United States
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Loma Linda University Health Care
Loma Linda, CA United States
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Valerius Medical Group & Research Center
Los Alamitos, CA United States
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Wallace Rheumatic Study Center
Los Angeles, CA United States
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Westlake Medical Research Clinical Trials
Thousand Oaks, CA United States
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University Clinical Investigators, Inc
Tustin, CA United States
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Inland Rheumatology Clinical Trials Inc.
Upland, CA United States
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University of Colorado
Aurora, CO United States
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UPMC Lupus Center of Excellence
New Haven, CT United States
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Stamford Therapeutics Consortium
Stamford, CT United States
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Arthritis and Rheumatic Disease Specialties
Aventura, FL United States
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Bay Area Arthritis and Osteoporosis
Brandon, FL United States
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Centre for Rheumatology, Immunology and Arthritis
Fort Lauderdale, FL United States
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New Horizon Research Center
Miami, FL United States
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Rheumatology Associates of Central Florida, PA
Orlando, FL United States
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Omega Research Consultants
Orlando, FL United States
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Millennium Research
Ormond Beach, FL United States
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Clinical Research of West Florida
Tampa, FL United States
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DeKalb Medical Specialty Center
Decatur, GA United States
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Graves-Gilbert Clinic - Bowling Green
Bowling Green, KY United States
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Arthritis and Diabetes Clinic
Monroe, LA United States
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The Center for Rheumatology and Bone Research
Wheaton, MD United States
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June DO, PC.
Lansing, MI United States
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St Paul Rheumatology PA
Eagan, MN United States
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Oklahoma Medical Research Foundation
Las Vegas, NV United States
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Innovative Health Research
Las Vegas, NV United States
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Albuquerque Center for Rheumatology
Albuquerque, NM United States
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Biomedical Research Alliance Of New York
Lake Success, NY United States
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The Feinstein Institute for Medical Research
Manhasset, NY United States
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Allergy Asthma Immunology of Rochester, PC (AAIR) - Research Center
Rochester, NY United States
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UNC Thurston Arthritis Research Center
Chapel Hill, NC United States
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Joint and Muscle Research Institute
Charlotte, NC United States
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DJL Clinical Research, PLLC
Charlotte, NC United States
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Duke University Medical Center
Durham, NC United States
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PMG Research of Wilmington
Wilmington, NC United States
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OK Center for Arthritis Therapy & Research, Inc.
Tulsa, OK United States
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University of Pittsburgh Medical Center
Pittsburgh, PA United States
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Allegheny Rheumatology/Allegheny Singer Research Institute
Wexford, PA United States
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Columbia Arthritis Center
Columbia, SC United States
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West Tennessee Research Institute
Jackson, TN United States
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Dr. Ramesh Gupta
Memphis, TN United States
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Amarillo Center for Clinical Research
Amarillo, TX United States
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Austin Regional Clinic
Austin, TX United States
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Arthritis Centers of Texas
Dallas, TX United States
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Sun Research Institute
San Antonio, TX United States
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UT Health Science Center at San Antonio
San Antonio, TX United States
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University of Washington
Seattle, WA United States
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Rheumatology & Pulmonary Clinic
Beckley, WV United States
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Investigaciones Reumatol gicas y Osteol gicas SRL
Buenos Aires, Argentina
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Instituto Centenario
Buenos Aires, Argentina
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Centro Privado de Medicina Familiar
Buenos Aires, Argentina
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Hospital Sirio Libanes
Buenos Aires, Argentina
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CEIM Investigaciones Medicas SRL
Buenos Aires, Argentina
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Framingham Centro Medico
Ciudad De La Plata, Argentina
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Hospital Escuela 'Gral. Jose F. de San Martin'
Corrientes, Argentina
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MHAT Trimantium
Plovdiv, Bulgaria
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Diagnostic-Consultative Center (DCC) Aleksandrovska
Sofia, Bulgaria
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UMHAT 'St. Ivan Rilski'
Sofia, Bulgaria
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Medical Centre Synexus
Sofia, Bulgaria
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The First Affiliated Hospital of Baotou Medical University
Baotou, China
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Peking Union Medical College Hospital
Beijing, China
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The First Bethune Hospital of Jilin University
Changchun, China
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The second Xiangya Hospital of Central South University
Changsha, China
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Anhui Province Hospital
Hefei, China
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Qilu Hospital of Shandong University
Jinan, China
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ShangHai Changhai Hospital
Shanghai, China
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Tianjin Medical University General Hospital
Tianjin, China
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Circaribe Sas
Barranquilla, Colombia
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CAYRE. Riesgo de Fractura
Bogota, Colombia
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IPS Medicity SAS
Bucaramanga, Colombia
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Servimed S.A.S
Bucaramanga, Colombia
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Clinica de Artritis Temprana
Cali, Colombia
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Preventive Care Ltda
Chia, Colombia
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Clinica Universitaria Bolivariana
Medellin, Colombia
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Corporacion Medica Monte Sina
Cuenca, Ecuador
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Aga Clinical
Guayaquil, Ecuador
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Hospital de Especialidades Eugenio Espejo
Quito, Ecuador
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Novaclinica
Quito, Ecuador
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Hopital Bic tre - Aphp H pitaux Universitaires Paris-Sud
Le Kremlin Bicetre Cedex, France
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Charite - Universitatsmedizin Berlin (CCM)
Berlin, Germany
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Medizinische Hochschule Hannover
Hannover, Germany
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Rheumazentrum Ruhrgebiet
Herne, Germany
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Rheumatology Unit
Leipzig, Germany
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Universitaetsmedizin Mainz
Mainz, Germany
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Szt, Istvan and Szt. Laszlo
Budapest, Hungary
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Bekes Megyei Pandy Kalman Korhaz
Gyula, Hungary
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Leda Private Clinic
Zalaegerszeg, Hungary
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Chiba East Hospital
Chiba, Japan
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Kyushu Medical Center
Fukuoka, Japan
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Fukushima Medical University Hospital
Fukushima, Japan
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Hiroshima Red Cross Hospital & Atomic-bomb Survivors Hospital
Hiroshima, Japan
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University of Occupational and Environmental Health
Hukuoka, Japan
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Nagasaki University Hospital
Nagasaki, Japan
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National Hospital Organization Nagoya Medical Center
Nagoya, Japan
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Hokkaido University Hospital
Sapporo, Japan
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Sapporo City General Hospital
Sapporo, Japan
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Sasebo Chuo Hospital
Sasebo, Japan
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Tohoku University Hospital
Sendai, Japan
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Keio University Hospital
Shinjuku-Ku, Japan
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National Center for Global Health and Medicine
Shinjuku-Ku, Japan
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St. Luke's International Hospital
Tokyo, Japan
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Daegu Catholic University Medical Center
Daegu, Korea, Republic of
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Inha University Hospital
Incheon, Korea, Republic of
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Chonbuk National Univ Hospital
Jeonju, Korea, Republic of
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Seoul National University Hospital
Seoul, Korea, Republic of
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Konkuk University Medical Center
Seoul, Korea, Republic of
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The Catholic University of Korea Yeouido St. Mary's Hospital
Seoul, Korea, Republic of
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Ajou University Hospital
Suwon, Korea, Republic of
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Lietuvos sveikatos moksl universiteto ligonin Kauno klinik
Kaunas, Lithuania
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Klaipeda University Hospital
Klaipeda, Lithuania
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Vaiku ligonine Vilniaus Universiteto ligon. Santariskiu fil
Vilnius, Lithuania
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Vilnius University Hospital Santariskiu Clinics
Vilnius, Lithuania
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Hospital Nacional Guillermo Almenara Irigoyen
Lima, Peru
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Clinica Anglo Americana - Alfredo Salazar 350 , San Isidro
Lima, Peru
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Instituto de Ginecolog a y Reproducci n
Lima, Peru
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Hospital Nacional Cayetano Heredia
Lima, Peru
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Unidad de Investigaci n de Reumatologia e Inmunologia CSJB
Lima, Peru
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Instituto de Investigacion en Reumatologia SM
Lima, Peru
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Instituto Peruano Del Hueso Y La Articulacion
Lima, Peru
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Southern Philippines Medical Center
Davao, Philippines
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Szpital Uniwersytecki nr 2 im. dr. Jana Biziela w Bydgoszczy
Bydgoszcz, Poland
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Nzoz Bif-Med
Bytom, Poland
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Centrum Medyczne AMED oddzial w Lodzi
Lodz, Poland
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Samodzielny Publiczny Szpital Kliniczny Nr 4 w Lublinie
Lublin, Poland
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Centrum Medyczne Medens S.C. Grupowa Praktyka Lekarska
Sonoswiec, Poland
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Centrum Medyczne Pratia Tychy
Tychy, Poland
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Centrum Medyczne Pratia Warszawa
Warszawa, Poland
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Reumatika-Centrum Reumatologii, NZOZ
Warszawa, Poland
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Uniwersytecki Szpital Kliniczny im. J. Mikulicza-Radeckiego
Wroclaw, Poland
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Instituto Portugues de Reumatologia
Lisboa, Portugal
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Hospital Curry Cabral-Centro Hospital Lisboa Central
Lisboa, Portugal
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Hospital da Luz
Lisboa, Portugal
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ULSAM, EPE - Hospital Conde de Bertiandos
Ponte De Lima, Portugal
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C.H. de Vila Nova de Gaia/Espinho
Vila Nova De Gaia, Portugal
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Centrul Medical de Diagnostic si Tratament Ambulator NEOMED
Brasov, Romania
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Centrul Medical SANA
Bucharest, Romania
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Spitalul Clinic Sf. Maria
Bucharest, Romania
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Centrul Medical Unirea - Regina Maria
Bucuresti, Romania
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Euroclinic Hospital
Bucuresti, Romania
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Spitalul Clinic Colentina
Bucuresti, Romania
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Spitalul Clinic 'Dr. Ioan Cantacuzino'
Bucuresti, Romania
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Centrul Medical Unirea
Bucuresti, Romania
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Med Life
Bucuresti, Romania
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Spitalul Clinic Judetean de Urgenta Cluj Napoca
Cluj-Napoca, Romania
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Spitalul Clinic de Recuperare Iasi
Iasi, Romania
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Regional Clinical Hospital for War Veterans
Kemerovo, Russian Federation
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LLL Medical Center Revma-Med
Kemerovo, Russian Federation
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V A Nassonova Research Institute of Rheumatology - Dept. of Clinical Trials
Moscow, Russian Federation
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Clinical Diagnostic Center 'Ultramed'
Omsk, Russian Federation
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Leningrad region clinical hospital
Saint-Petersburg, Russian Federation
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City Clinical Hospital #31
St. Petersburg, Russian Federation
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Northen-Western State Medical University n.a. I.I. Mechnikov
St.-Petersburg, Russian Federation
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Ulyanovsk Regional Clinical Hospital
Ulyanovsk, Russian Federation
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Clinical Emergency Hospital n.a. N.V. Solovyev
Yaroslavl, Russian Federation
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Institute of Rheumatology Belgrade
Belgrade, Serbia
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Institute of Rheumatology
Belgrade, Serbia
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Military Medical Academy
Belgrade, Serbia
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Clinical Hospital Center Bezanijska Kosa
Belgrade, Serbia
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Clinical Center Kragujevac
Kragujevac, Serbia
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Institute for Treatment and Rehabilitation Niska Banja
Niska Banja, Serbia
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Clinical Center of Vojvodina
Vojvodina, Serbia
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Panorama Medical Centre
Cape Town, South Africa
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Excellentis Clinical trial Consultants
George, South Africa
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Donald Gordon Medical Centre
Johannesburg, South Africa
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Clinical Research Unit, University of Pretoria
Pretoria, South Africa
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Winelands Medical Research Centre
Stellenbosch, South Africa
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Hosp. Univ. Vall D Hebron
Barcelona, Spain
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Hosp. Univ. de Basurto
Bilbao, Spain
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Hosp. Reina Sofia
Cordoba, Spain
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Hosp. Clinico San Carlos
Madrid, Spain
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Hosp. Univ. 12 de Octubre
Madrid, Spain
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Hosp. Univ. Hm Sanchinarro
Madrid, Spain
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Hosp. Infanta Luisa
Sevilla, Spain
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Hosp. Do Meixoeiro
Vigo -Pontevedra, Spain
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Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung, Taiwan
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Chang Gung Memorial Hospital
Kwei-San Hsiang, Taiwan
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Chung Shan Medical University Hospital
Taichung, Taiwan
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China Medical University Hospital
Taichung, Taiwan
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National Taiwan University Hospital
Taipei, Taiwan
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Cathay General Hospital
Taipei, Taiwan
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Taipei Medical University
Taipei, Taiwan
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Taipei Veterans General Hospital
Taipei, Taiwan
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Phramongkutklao Hospital and Medical College
Bangkok, Thailand
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Rajavhiti Hospital
Bangkok, Thailand
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Ramathibodi Hospital
Bangkok, Thailand
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Siriraj Hospital
Bangkok, Thailand
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Songklanagarind hospital
Hat Yai, Thailand
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Chiang Mai University
Muang, Thailand
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Mechnikov Inst, Miska bagatoprofilna likarnia #18
Kharkiv, Ukraine
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M. Kryvyi Rih, Miska Klinichna Likarnia No2
Kryvyi Rih, Ukraine
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Kyiv City Clinical Hospital #3
Kyiv, Ukraine
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Kyivska oblasna klinichna likarnia
Kyiv, Ukraine
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Munnicipal Lviv City Clinical Hospital 4
Lviv, Ukraine
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Odeska oblasna klinichna likarnia
Odesa, Ukraine
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Multidisciplinary Medical Center of Odessa National Medical University (University Clinic 1)
Odessa, Ukraine
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Poltavska oblasna klinichna likarnia im. M.V. Sklifosovskoho
Poltava, Ukraine
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Vinnytsya regional clinical hospital n.a.Pyrogov, VNMU
Vinnytsia, Ukraine
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Naukovo-doslidnyi inst. Reabilit. Pyrogova [Revmatologichne]
Vinnytsia, Ukraine
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Zhytomyr Central City Hospital #1
Zhytomyr, Ukraine
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China-Japan Union Hospital of Jilin University
Changchun, China
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Guangdong General Hospital
Guangzhou, China
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First Affiliated Hospital, Harbin Medical University
Harbin, China
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Jiangsu Province Hospital
Nanjing, China
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Tianjin First Center Hospital
Tianjin, China
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Cochin Hospital
Paris, France
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Hopital Larrey CHU de Toulouse
Toulouse Cedex, France
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Chiba University Hospital
Chiba, Japan
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Southwest Hospital
Chongqing, China
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CHRU Strasbourg
Strasbourg, France
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China-Japan Friendship Hospital
Beijing, China
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The Second Affiliated Hospital of Zhejiang University
Hangzhou, China
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The Second Affiliated Hospital of Kunming Medical University
Kunming, China
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Shanghai Renji Hospital
Shanghai, China
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Renmin Hospital of Wuhan University
Wuhan, China
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The 1st affiliated Hospital of Xi'an Traffic University
Xi'An, China
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Toho University Medical Center, Ohashi Hospital
Meguro-Ku, Japan
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University of Florida
Jacksonville, FL United States
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Emory University
Atlanta, GA United States
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NYU Center for Musculoskeletal Care
New York, NY United States
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University of Rochester Medical Center
Rochester, NY United States
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West China Hospital, Sichuan University
Chengdu, China
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Keck School of Medicine of USC
Los Angeles, CA United States
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Stanford University
Palo Alto, CA United States
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The Third Xiangya Hospital of Central Sourth University
Changsha, China
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Jiangxi Pingxiang People's Hospital
Pingxiang, China
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Tongji Hospital of Tongji Medical College of Huangzhong Univ
Wuhan, China
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Juntendo University Hospital
Tokyo, Japan
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University of Mississippi Medical Center
Jackson, MS United States
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SUNY Upstate Medical University
Syracuse, NY United States
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Centro Medico Privado de Reumatologia
San Miguel De Tucumán, Argentina
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Centro de Investigaci n en Reumatolog a y especialidades m dicas S.A.S. - CIREEM S.A.S.
Bogotá, Colombia
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Funcentra
Montería, Colombia
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Pecsi Tudomanyegyetem
Pécs, Hungary
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Twoja Przychodnia - Centrum Medyczne Nowa Sol
Nowa Sól, Poland
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Hosp. Regional Univ. de Malaga
Málaga, Spain
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Hosp. Univ. Infanta Sofia
San Sebastián De Los Reyes, Spain
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