Can a targeted immune drug calm rare muscle inflammation?
NCT ID NCT05523167
First seen Jul 24, 2026 · Last updated Jul 24, 2026
Summary
This trial tests whether efgartigimod, an injected drug that blocks certain immune antibodies, can improve muscle strength and function in adults with active idiopathic inflammatory myopathy — a group of rare autoimmune diseases that cause muscle inflammation and weakness. About 265 participants with subtypes like dermatomyositis or polymyositis will receive either the drug or a placebo. The main goal is to see if the drug leads to meaningful clinical improvement.
What this could mean
Our plain-language read of the trial. This is informational only — not medical advice or a prediction.
- Active substance
- an experimental drug called efgartigimod, given as a shot under the skin
- What this could lead to
- If it works, this could offer a new treatment option for people with rare inflammatory muscle diseases that cause weakness and disability.
- What could go wrong
- This is an early-to-mid-stage trial, so the drug may not prove effective or safe enough. Side effects from immune suppression are possible.
This is an AI summary of the original study and may miss details. Read our disclaimer.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
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Locations
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A.O. Universitaria Pisana
Pisa, 56126, Italy
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ASU FC - Presidio Ospedaliero Universitario Santa Maria della Misericordia
Udine, 33100, Italy
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AZ Sint Lucas Gent-Campus Sint Lucas
Ghent, 9000, Belgium
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Aintree University Hospital - Liverpool University Hospitals NHS Foundation Trust
Liverpool, L9 7AL, United Kingdom
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Ajou University Hospital
Suwon, 16499, South Korea
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Allgemeines Krankenhaus der Stadt Wien (AKH Wien)
Vienna, 1090, Austria
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American Hospital Network
Tbilisi, 0102, Georgia
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Amsterdam University Medical Center (Amsterdam UMC), Academic Medical Center (AMC)
Amsterdam, 1105 AZ, Netherlands
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Amyotrophic Lateral Sclerosis (ALS) Treatment Center,University of California San Francisco (UCSF)
San Francisco, California, 94143-2202, United States
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Anhui Provincial Hospital
Hefei, 230001, China
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Ankara City Hospital
Ankara, 06800, Turkey (Türkiye)
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Ankara University Medical Faculty
Ankara, 06230, Turkey (Türkiye)
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Athens Medical Center
Athens, 151 25, Greece
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Attikon General University Hospital
Athens, 12462, Greece
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Attune Health Research, Inc
Beverly Hills, California, 90039, United States
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Augusta University
Augusta, Georgia, 30312, United States
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Austin Neuromuscular Center
Austin, Texas, 78759, United States
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Aversi Clinic
Tbilisi, 0160, Georgia
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Azienda Ospedaliera Universitaria Integrata di Verona - Ospedale Borgo Roma
Verona, 37134, Italy
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Azienda Ospedaliera Universitaria Policlinico Consorziale Di Bari - Rheumatology
Bari, 70124, Italy
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Azienda Ospedaliero Universitaria Careggi
Florence, 50139, Italy
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Azienda Ospedaliero Universitaria Citta della Salute e della Scienza di Torino - Presidio Molinette
Torino, 10126, Italy
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Azienda Ospedaliero Universitaria Sant'Andrea
Roma, 00189, Italy
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Bnai Zion Medical Center
Haifa, 31048, Israel
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CITER - Centro de Investigacion y Tratamiento de las Enfermedades Reumaticas S.A. de C.V.
Mexico City, 06700, Mexico
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California Pacific Medical Center - Sutter Health
San Francisco, California, 94109, United States
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Carolina Arthritis Associates
Wilmington, North Carolina, 28401, United States
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Centre Hospitalier Universitaire (CHU) Hopitaux de Rouen
Rouen, 76031, France
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Centre Hospitalier Universitaire Sart Tilman
Liège, 4000, Belgium
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Centre Hospitalier Universitaire de Charleroi
Charleroi, 6042, Belgium
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Centro Dermatologico Schejtman
San Miguel, B1663GKT, Argentina
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Centro Hospitalar Lisboa Norte, E.P.E- Hospital Santa Maria
Lisbon, 1649-035, Portugal
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Centro Hospitalar Universitario de Santo Antonio
Porto, 4099-001, Portugal
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Centro Peninsular De Investigacion Clinica
Mérida, 97000, Mexico
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Centro de Investigaciones Medicas Tucuman
San Miguel de Tucumán, T4000AXL, Argentina
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Centrum Wsparcia Badan Klinicznych Pomorski Uniwersytet Medyczny w Szczecinie
Szczecin, 71-252, Poland
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Charite - Universitaetsmedizin Berlin
Berlin, 10117, Germany
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Chiba-Nishi General Hospital
Matsudo-shi, 270-2251, Japan
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China Medical University (CMU) - First Affiliated Hospital
Shenyang, 110001, China
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China Medical University and Hospital
Taichung, 40402, Taiwan
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Chulalongkorn University - Faculty of Medicine - King Chulalongkorn Memorial Hospital (KCMH)
Bangkok, 10300, Thailand
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Chung Shan Medical University Hospital
Taichung, 402, Taiwan
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Chungnam National University Hospital (CNUH)
Daejeon, 35015, South Korea
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Cleveland Clinic - Main Campus
Cleveland, Ohio, 44195, United States
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Clinical Center of Serbia
Belgrade, 11000, Serbia
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Connolly Hospital Blanchardstown
Dublin, D15 X40D, Ireland
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Consultora Integral de Salud
Córdoba, 5000, Argentina
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Copenhagen University Hospital-Rigshospitalet University Hospital
Copenhagen, 2100, Denmark
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Cyprus Institute of Neurology and Genetics
Nicosia, 2371, Cyprus
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Debreceni Egyetem - University of Debrecen
Debrecen, 4032, Hungary
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Denver Arthritis Clinic
Denver, Colorado, 80230, United States
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Dim Clinica Privada
Ramos Mejía, B1704ETD, Argentina
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Doncaster Royal Infirmary - Doncaster And Bassetlaw Hospitals Nhs Foundation Trust
Doncaster, DN2 5LT, United Kingdom
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Eisenhower Medical Center
Rancho Mirage, California, 92270, United States
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Emory University Hospital, The Emory Clinic
Atlanta, Georgia, 30322, United States
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Fiona Stanley Hospital
Murdoch, 6150, Australia
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First Affiliated Hospital (Henan Medical University - First Affiliated Hospital)-Zhengzhou University
Zhengzhou, 450052, China
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First Affiliated Hospital of Shanxi Medical College
Shanxi, 30001, China
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Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Universita Cattolica del Sacro Cuore
Roma, 00168, Italy
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Framingham Centro Medico
La Plata, B1902COS, Argentina
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Gachon University Gil Medical Center
Incheon, 21565, South Korea
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Genge Partners
Montreal, H4A 3T2, Canada
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Georgetown University Hospital
Washington D.C., District of Columbia, 20007, United States
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Hanyang University Seoul Hospital
Seoul, 04763, South Korea
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Harvard Medical School - Brigham and Women's Hospital (BWH) - The Schuster Family Transplantation Research Center (TRC)
Boston, Massachusetts, 02115-6110, United States
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Hogar Clinica San Juan de Dios
Arequipa, 4018, Peru
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Hokkaido University Hospital - Rheumatology
Sapporo, 060-8648, Japan
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HonorHealth Neurology - Bob Bove Neuroscience Institute - Neurology
Scottsdale, Arizona, 85251, United States
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Hopital Edouard Herriot
Lyon, 69003, France
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Hopitaux Universitaire de Strasbourg-Centre de References des Maladies Autoimmunes
Strasbourg, 67098, France
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Hospital Clinic de Barcelona - Sede Villarroel - Rheumatology
Barcelona, 08036, Spain
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Hospital De Valme
Seville, 9-41014, Spain
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Hospital Do Meixoeiro
Vigo, 36200, Spain
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Hospital General Universitario de Alicante
Alicante, 03010, Spain
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Hospital Nacional Cayetano Heredia
Lima, 31, Peru
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Hospital Universitario 12 de Octubre
Madrid, 451086, Spain
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Hospital Universitario Ramon y Cajal
Madrid, 28034, Spain
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Hospital Universitario y Politecnico La Fe
Valencia, 46026, Spain
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Hospital de la Santa Creu i Sant Pau
Barcelona, 08041, Spain
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Hospital for Special Surgery
New York, New York, 10021, United States
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Hospital of Lithuanian University of Health Sciences Kauno klinikos
Kaunas, 50161, Lithuania
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Huashan Hospital Affiliated to Fudan University
Shanghai, 200000, China
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Huazhong University of Science and Technology - Tongji Medical College - Tongji Hospital
Wuhan, 430030, China
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IRCCS Arcispedale Santa Maria Nuova
Reggio Emilia, 42123, Italy
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IRCCS Istituto Clinico Humanitas - Rheumatology
Rozzano, 20089, Italy
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Institute of Rheumatology
Belgrade, 11000, Serbia
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Instituto Peruano Del Hueso Y La Articulacion Sac-Privado-Lima, Centro De Investigacion Iphar
Lima, 27, Peru
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Investigaciones Clinicas S.A.C.
Lima, 15023, Peru
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Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - Ospedale San Raffaele Hospital
Milan, 20132, Italy
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James Cook University Hospital - South Tees Hospitals NHS Foundation Trust
Middlesbrough, TS4 3BW, United Kingdom
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Japan Community Healthcare Organization Chukyo Hospital
Nagoya, 457-8510, Japan
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Johns Hopkins Medicine - Johns Hopkins Myositis Center
Baltimore, Maryland, 21224, United States
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Juntendo University Hospital - Rheumatology
Tokyo, 113-8431, Japan
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Karolinska Universitestssjukhus Solna
Stockholm, 17164, Sweden
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Keio University Hospital
Tokyo, 160-8582, Japan
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Khon Kaen University
Khon Kaen, 40000, Thailand
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Kings College Hospital NHS Foundation Trust
London, SE5 9RS, United Kingdom
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Kitasato University Hospital (KUH)
Sagamihara-shi, 252-0375, Japan
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Kurume University Hospital
Kurume, 830-0011, Japan
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Kyung Hee University Medical Center
Seoul, 02447, South Korea
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LLC MediClub Georgia
Tbilisi, 0179, Georgia
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LTD New Hospitals
Tbilisi, 0114, Georgia
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LTD Tbilisi Heart Center
Tbilisi, 0186, Georgia
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Leeds Institute of Rheumatic & Musculoskeletal Medicine - University of Leeds
Leeds, LS7 4SA, United Kingdom
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Ludwig-Maximilians-Universitat Munchen Friedrich-Baur-Institut Neurologische Klinik und Poliklinik
München, 80336, Germany
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Maharaj Nakorn Chiang Mai Hospital, Chiang Mai University
Chiang Mai, 50200, Thailand
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Mayo Clinic
Jacksonville, Florida, 32224, United States
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McGovern Medical School -The University of Texas Health Science Center at Houston
Houston, Texas, 77030, United States
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Medical Centre Artmed
Plovdiv, 4002, Bulgaria
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Medical University Innsbruck
Innsbruck, 6020, Austria
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Meir Medical Center
Kfar Saba, 44281, Israel
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Mercy Hospital - Mercy Clinic Neurology Oklahoma City - Neurology
Oklahoma City, Oklahoma, 73120, United States
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Michigan State University - Neurology
East Lansing, Michigan, 48824, United States
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Multiprofile hospital for active treatment Kaspela EOOD
Plovdiv, 4002, Bulgaria
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Nanfang Hospital, Southern Medical University
Guangzhou, 510515, China
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Nanjing Drum Tower Hospital
Nanjing, 210008, China
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Narodny ustav reumatickych chorob
Piešťany, 92112, Slovakia
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National and Kapodistrian University of Athens - Eginition Hospital
Athens, 115 28, Greece
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National and Kapodistrian University of Athens - School of Health Sciences - Faculty of Medicine
Athens, 115 27, Greece
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Necmettin Erbakan University Meram Medical Faculty
Konya, 42090, Turkey (Türkiye)
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Nerve And Muscle Center Of Texas
Houston, Texas, 77030, United States
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Neurocenter of Southern Switzerland
Lugano, 6900, Switzerland
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Neuromuscular Research Center
Phoenix, Arizona, 85028, United States
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Nippon Medical School - Nippon Medical School Hospital
Bunkyō City, 113-8603, Japan
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North West Rheumatology Unit - Our Lady's Hospital
Manorhamilton, F91 X012, Ireland
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Northwell Health
Great Neck, New York, 11021, United States
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Northwestern Memorial Hospital
Chicago, Illinois, 60611, United States
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Oregon Health and Science University
Portland, Oregon, 97239, United States
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Ottawa Hospital Research Institute-Civic Campus
Ottawa, K1Y 4E9, Canada
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Peking Union Medical College Hospital
Beijing, 100730, China
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Peking University First Hospital
Beijing, 100034, China
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Peking University Third Hospital
Beijing, 100191, China
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Phramongkutklao Hospital
Bangkok, 10400, Thailand
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Profound Research LLC - Oceanside
Oceanside, California, 92056, United States
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Rabin Medical Center - Beilinson Campus (Beilinson and Hasharon Hospital)
Petah Tikva, 49100, Israel
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Ramathibodi hospital
Bangkok, 10400, Thailand
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Rambam Health Care Campus
Haifa, 3109601, Israel
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Reference Center Neuro-Muscular Diseases - CHU Paris Group Hospitalier La Pitie Salpetriere-Charles Foix
Paris, 75013, France
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Revmatologicky ustav
Prague, 128 00, Czechia
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Rheumazentrum Ruhrgebiet
Herne, 44649, Germany
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Royal National Hospital for Rheumatic Diseases - Royal United Hospitals Bath NHS Foundation Trust
Bath, BA1 3NG, United Kingdom
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Ruijin Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, 200025, China
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Salford Royal Hospital, Northern Care Alliance NHS Foundation Trust
Salford, M6 8HD, United Kingdom
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San Matteo Hospital
Pavia, 27100, Italy
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Sapporo City Hospital
Sapporo, 060-8604, Japan
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Sasebo Chuo Hospital
Sasebo-shi, 857-1165, Japan
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Semmelweis Egyetem, Institute of Genomic Medicine and Rare Disorders
Budapest, 1083, Hungary
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Seoul National University Hospital
Seoul, 03080, South Korea
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Shanghai Renji Hospital
Shanghai, 200127, China
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Sheba Medical Center - Rheumatology
Ramat Gan, 52621, Israel
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Sichuan Provincial Peoples Hospital
Chengdu, 610072, China
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Siriraj Hospital, Mahidol University of Internal medicine
Bangkok, 10700, Thailand
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St. Josef-Stift Sendenhorst
Sendenhorst, 48324, Germany
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St. Marianna University School of Medicine Hospital
Kawasaki, 216-8511, Japan
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St. Paul Rheumatology, PA
Saint Paul, Minnesota, 55121, United States
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St. Vincents University Hospital
Dublin, D04 T6F4, Ireland
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Stanford Medicine Outpatient Center - Stanford Dermatology Clinic-Stanford University School of Medicine
Redwood City, California, 94063-3132, United States
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Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
Guangzhou, 510000, China
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Szpital Uniwersytecki nr 2 im. Dr Jana Biziela w Bydgoszczy
Bydgoszcz, 85-168, Poland
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Taichung Veterans General Hospital
Taichung, 40705, Taiwan
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Thammasat University Hospital
Pathum Thani, 12120, Thailand
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The First Affiliated Hospital - School of Medicine - ZheJiang University
Hangzhou, 310003, China
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The First Hospital of Jilin University
Changchun, 130021, China
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The First Medical Center
Tbilisi, 0180, Georgia
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The National Hospital for Neurology and Neurosurgery
London, WC1N 3BG, United Kingdom
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The Ohio State University
Columbus, Ohio, 43201, United States
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The Royal Free Hospital - Royal Free London NHS Foundation Trust
London, NW3 2QG, United Kingdom
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The Second Affiliated Hospital Of Nanchang University
Nanchang, 330000, China
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The Second Xiangya Hospital of Central South University
Changsha, 410011, China
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The University of Tokyo Hospital
Tokyo, 113-8655, Japan
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The Wesley Medical Research
Auchenflower, 4066, Australia
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Tohoku University Hospital
Sendai, 980-8574, Japan
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Tokushima University Hospital
Tokushima, 770-8503, Japan
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Tokyo Medical And Dental University Hospital, Faculty of Medicine
Bunkyō City, 113-8519, Japan
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UF Health Rheumatology
Gainesville, Florida, 32610-3008, United States
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USK-WAM Centralny Szpital Weteranow - Szpital Kniniczny ul. Zeromskiego 113
Lodz, 90-549, Poland
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Universidad Autonoma de Madrid (UAM) - Hospital Universitario La Paz
Madrid, 28046, Spain
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Universitaetsklinikum Duesseldorf
Düsseldorf, 40225, Germany
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Universitaetsklinikum Hamburg-Eppendorf
Hamburg, 20246, Germany
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Universitaetsklinikum Tuebingen (UKT)
Tübingen, 72076, Germany
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Universitair Medisch Centrum Utrecht (UMC Utrecht)
Utrecht, 3584 CX, Netherlands
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Universitair Ziekenhuis Leuven Gasthuisberg Campus
Leuven, 3000, Belgium
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Universitatsklinikum Ulm - Standort Oberer Eselsberg
Ulm, 89081, Germany
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Universitatsmedizin Gottingen - Georg-August-Universitat
Göttingen, 37075, Germany
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Universitatsmedizin Mannheim
Mannheim, 68167, Germany
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University Of Kansas Medical Center
Kansas City, Kansas, 66160, United States
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University of California, Irvine
Orange, California, 92868, United States
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University of Ioannina Medical School
Ioannina, 45110, Greece
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University of North Carolina (UNC) School of Medicine
Chapel Hill, North Carolina, 27514-4220, United States
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University of Pittsburg Medical Center
Pittsburgh, Pennsylvania, 15261, United States
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University of South Florida (USF) - Morsani Center (USF Health Carol and Frank Morsani Center for Advanced Healthcare)
Tampa, Florida, 33616, United States
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University of Southern California Norris Comprehensive Cancer Center
Los Angeles, California, 90033, United States
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University of Tsukuba Hospital - Rheumatology
Tsukuba, 305-8576, Japan
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University of Vermont Medical Center - Main Campus
Burlington, Vermont, 05401, United States
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University of Washington Medical Center
Seattle, Washington, 98195, United States
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Vanderbilt University Medical Center (VUMC) - Vanderbilt Rheumatology Clinic
Nashville, Tennessee, 37232-0028, United States
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Vilnius University Hospital Santaros Klinikos
Vilnius, 08661, Lithuania
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Wakayama Medical University Hospital - Dermatology
Wakayama, 641-8509, Japan
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Washington University School of Medicine
St Louis, Missouri, 63110, United States
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Xiangya Hospital Central South University
Changsha, 410008, China
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Yale Cancer Center-Yale University School Of Medicine
New Haven, Connecticut, 06520, United States
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Yamaguchi University Hospital
Ube-shi, 755-8505, Japan
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