Nipocalimab ved moderat til alvorlig Sjogrens sykdom (DAFFODIL)
2. november 2026 oppdatert av: Janssen Research & Development, LLC
En randomisert, placebokontrollert, dobbeltblind, multisenter fase 3-protokoll for å vurdere effektiviteten og sikkerheten til Nipocalimab hos voksne med moderat til alvorlig Sjogrens sykdom (SjD)
The purpose of this study is to evaluate the clinical efficacy and safety of nipocalimab in participants with moderate to severe Sjogren's disease (SjD).
Studieoversikt
Status
Aktiv, ikke rekrutterende
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
This clinical development program for nipocalimab in SjD includes 2 identical double blind, placebo-controlled studies to evaluate the efficacy, safety, and tolerability of nipocalimab in participants greater than or equal to (>=) 18 years of age with moderate to severe SjD.
Studietype
Intervensjonell
Registrering (Faktiske)
655
Fase
- Fase 3
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Buenos Aires, Argentina, B1643CRO
- Instituto Medico De Alta Complejidad (IMAC)
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Buenos Aires, Argentina, B1663GJE
- Centro de Investigacion San Miguel CISM
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CABA, Argentina, C1128AAF
- Mautalen Salud e Investigacion
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Cdad Autonoma de Buenos Aires, Argentina, C1123AAO
- Centro Medico del Dr. Javier Gerardo Tartaglione
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Ciudad de Buenos Aires, Argentina, C1055
- Centro de Investigacion en Enfermedades Reumaticas CIER
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Ciudad de Buenos Aires, Argentina, C1414
- Centro Medico Barrio Parque. Swiss Medical Group
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Ciudad de Buenos Aires, Argentina, C1428
- Cosultorios Reumatologógicos Pampa
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Quilmes, Argentina, B1878DVB
- Cer Instituto Medico
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San Fernando, Argentina, B1646GHP
- MR Medicina Reumatologica
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San Miguel de Tucumán, Argentina, T4000AXL
- Centro de Investigaciones Medicas Tucuman
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Brasília, Brasil, 70390 700
- Instituto D Or de Pesquisa e Ensino 1
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Curitiba, Brasil, 80030 110
- Ceti - Centro de Estudos Em Terapias Inovadoras
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Porto Alegre, Brasil, 90035-001
- Hospital Moinhos de Vento
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Porto Alegre, Brasil, 90480 000
- LMK Servicos Medicos S S
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Porto Alegre, Brasil, 90035 903
- Hospital De Clinicas De Porto Alegre
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Ribeirão Preto, Brasil, 14048 900
- Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto
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Salvador, Brasil, 41253-190
- IDOR - Regional Bahia
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Salvador, Brasil, 40150 150
- SER - Servicos Especializados em Reumatologia da Bahia
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São José do Rio Preto, Brasil, 15090-000
- Funfarme Sjrp
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São Paulo, Brasil, 04266 010
- CEPIC Centro Paulista de Investigacao Clinica e Servicos Medicos
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São Paulo, Brasil, 05403 000
- Hospital Das Clinicas Da Faculdade De Medicina Da USP
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São Paulo, Brasil, 01243 020
- Hospital Samaritano de Sao Paulo
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Vitória, Brasil, 29055 450
- CEDOES Centro de Pesquisa Clinica e Diagnostico do Espirito Santo Ltda
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Plovdiv, Bulgaria, 4001
- UMHAT Kaspela
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Plovdiv, Bulgaria, 4002
- Medical Center Artmed
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Rousse, Bulgaria, 7003
- Medical Center Teodora
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Sofia, Bulgaria, 1431
- St Ivan Rilski University Multiprofile Hospital For Active Treatment
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Sofia, Bulgaria, 1431
- Diagnostic-Consultative Center (DCC) Aleksandrovska
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Sofia, Bulgaria, 1606
- Military Medical Academy Multiprofile Hospital for Active Treatment Sofia
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Sofia, Bulgaria, 1336
- Lyulin Multi Profile Hospital For Active Medical Treatment
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Varna, Bulgaria, 9010
- MHAT 'St. Marina' EAD
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Varna, Bulgaria, 9000
- Diagnostic Consultative Center - DCC Equita EOOD
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Ontario
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Windsor, Ontario, Canada, N8X 1T3
- Dr Sabeen Anwar Medicine Professional Corporation
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Quebec
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Rimouski, Quebec, Canada, G5L 5T1
- Hospital Regional de Rimouski
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Trois-Rivières, Quebec, Canada, G9A 3X2
- Centre de Recherche Musculo Squelettique
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Aarhus, Danmark, 8200
- Aarhus University Hospital
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Copenhagen, Danmark, 2100
- Rigshospitalet
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Køge, Danmark, 4600
- Zealand University Hospital
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California
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Chula Vista, California, Forente stater, 91910
- Advanced Clinical Research Center
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La Palma, California, Forente stater, 90623
- Arthritis & Osteoporosis Medical Center - La Palma
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Mission Viejo, California, Forente stater, 92691
- Providence Medical Foundation
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Monterey Park, California, Forente stater, 91754
- NovaMed Research
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San Leandro, California, Forente stater, 94578
- Medvin Clinical Research San Leandro
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Santa Monica, California, Forente stater, 90404
- Providence Saint John s Health Center
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Tustin, California, Forente stater, 92780
- Solace Clinical Research California
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Upland, California, Forente stater, 91786
- Inland Rheumatology Clinical Trials Inc.
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Colorado
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Denver, Colorado, Forente stater, 80230
- Denver Arthritis Clinic
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Florida
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Clearwater, Florida, Forente stater, 33765
- Clinical Research of West Florida Inc
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Jacksonville, Florida, Forente stater, 32256
- UF Health Rheumatology
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New Port Richey, Florida, Forente stater, 34652
- Suncoast Clinical Research
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Sarasota, Florida, Forente stater, 34239
- Sarasota Arthritis Center
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South Miami, Florida, Forente stater, 33143
- BioResearch Partner
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Georgia
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Suwanee, Georgia, Forente stater, 30024
- Immunology and Rheumatology Research Associates LLC
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Illinois
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Skokie, Illinois, Forente stater, 60076
- Clinical Investigation Specialists - Clinic of Robert Hozman
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Willowbrook, Illinois, Forente stater, 60527
- Willow Rheumatology and Wellness PLLC
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Iowa
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Iowa City, Iowa, Forente stater, 52242
- University of Iowa Hospital and Clinics
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Kansas
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Kansas City, Kansas, Forente stater, 66160
- University of Kansas Medical Center
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Michigan
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Saint Clair Shores, Michigan, Forente stater, 48081
- Clinical Research Institute of Michigan, LLC
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Minnesota
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Eagan, Minnesota, Forente stater, 55123
- St. Paul Rheumatology P A
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Missouri
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Kansas City, Missouri, Forente stater, 64151
- AARA Clinical Research- Kansas City Physicians Partners
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New Jersey
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Voorhees Township, New Jersey, Forente stater, 08043
- Arthritis Rheumatic And Back Disease Associates
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New York
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New York, New York, Forente stater, 10016
- Pioneer Clinical Research NY
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New York, New York, Forente stater, 10016
- NYU Langone Health - Clinical and Translational Science Institute
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North Carolina
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Charlotte, North Carolina, Forente stater, 28204
- Joint and Muscle Research Institute
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Charlotte, North Carolina, Forente stater, 28211
- Atrium Health SouthPark Rheumatology
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Salisbury, North Carolina, Forente stater, 28144
- Onsite Clinical Solutions
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Ohio
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Fairborn, Ohio, Forente stater, 45324
- Wright State Physicians Health Center
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Oklahoma
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Oklahoma City, Oklahoma, Forente stater, 73116
- Rheumatology Associates of Oklahoma
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Oklahoma City, Oklahoma, Forente stater, 73104
- OMRF Rheumatology Center of Excellence
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Pennsylvania
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Duncansville, Pennsylvania, Forente stater, 16635
- Altoona Center For Clinical Research
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Philadelphia, Pennsylvania, Forente stater, 19114
- Clinical Research Philadelphia
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South Carolina
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Summerville, South Carolina, Forente stater, 29486
- Low Country Rheumatology PA
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Tennessee
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Jackson, Tennessee, Forente stater, 38305
- West Tennessee Research Institute
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Murfreesboro, Tennessee, Forente stater, 37128
- AARA Clinical Research - Murfreesboro Medical Clinic
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Texas
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Amarillo, Texas, Forente stater, 79124
- Amarillo Medical Specialists LLP
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Plano, Texas, Forente stater, 75024
- Texas Rheumatology Research Institute LLC
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Sugar Land, Texas, Forente stater, 77479
- Fort Bend Rheumatology Associates PLLC
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The Woodlands, Texas, Forente stater, 77382
- Advanced Rheumatology of Houston
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Utah
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Layton, Utah, Forente stater, 84041
- Alpine Research TC LLC
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Virginia
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Chesapeake, Virginia, Forente stater, 23320
- Tidewater Clinical Research
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Washington
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Bellevue, Washington, Forente stater, 98004
- Overlake Arthritis and Osteoporosis Center
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Brest, Frankrike, 29200
- CHU de Brest - Hopital de la Cavale Blanche
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Dijon, Frankrike, 21000
- CHU Dijon Bourgogne - Hopital Francois Mitterrand
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Le Kremlin-Bicêtre, Frankrike, 94270
- Hopital Bicetre Aphp Hopitaux Universitaires Paris Sud
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Lille, Frankrike, 59037
- CHRU de Lille Hopital Claude Huriez
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Montpellier, Frankrike, 34090
- CHRU Montpellier Hopital Lapeyronie
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Saint-Priest-en-Jarez, Frankrike, 42270
- CHU Saint Etienne Hopital Nord
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Strasbourg, Frankrike, 67200
- CHRU de Strasbourg - Hopital de Hautepierre
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Talence, Frankrike, 33400
- CHU Bordeaux
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Hong Kong, Hong Kong
- Queen Mary Hospital
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Hong Kong, Hong Kong
- Tuen Mun Hospital
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Ashkelon, Israel, 7830604
- Barzilai Medical Center
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Haifa, Israel, 3109601
- Rambam Health Care Campus
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Haifa, Israel, 34362
- Carmel Medical Center
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Har Poriyya, Israel, 1528001
- Tzafon Medical Center Poria
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Nahariya, Israel, 2210001
- Galil Medical Center
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Petah Tikva, Israel, 4941492
- Rabin Medical Center
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Ramat Gan, Israel, 5262100
- Sheba Medical Center
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Tel Aviv, Israel
- Sourasky Medical Center
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Milan, Italia, 20122
- Centro Specialistico Ortopedico Traumatologico Gaetano Pini CTO
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Milan, Italia, 20132
- Ospedale San Raffaele
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Palermo, Italia, 90127
- Azienda Ospedaliero Universitaria Policlinico Paolo Giaccone
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Perugia, Italia, 06129
- Azienda Ospedaliera di Perugia Ospedale S.Maria della Misericordia
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Pisa, Italia, 56126
- Azienda Ospedaliero Universitaria Pisana
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Roma, Italia, 00161
- Umberto I Policlinico di Roma
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Roma, Italia, 00168
- Fondazione Policlinico Universitario A Gemelli IRCCS
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Roma, Italia, 128
- Campus Bio Medico di Roma
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Rozzano, Italia, 20089
- Istituto Clinico Humanitas
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Udine, Italia, 33100
- Ospedale S. Maria Della Misericordia
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Chūōku, Japan, 104 8560
- St. Luke's International Hospital
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Fuchū, Japan, 183 8524
- Tokyo Metropolitan Tama Medical Center
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Fukuoka, Japan, 810 8563
- National Hospital Organization Kyushu Medical Center
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Kawachi-Nagano, Japan, 586 8521
- National Hospital Organization Osaka Minami Medical Center
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Naha, Japan, 900 0015
- Shinkenko Clinic
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Okayama, Japan, 700 8557
- Okayama City General Medical Center Okayama City Hospital
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Sapporo, Japan, 060 8648
- Hokkaido University Hospital
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Sasebo, Japan, 857 1195
- Sasebo Chuo Hospital
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Sendai, Japan, 983 0005
- Tohoku Medical And Pharmaceutical University Hospital
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Shimotsuga Gun, Japan, 321 0293
- Dokkyo Medical University Hospital
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Sumida Ku, Japan, 130 8575
- Tokyo Metropolitan Bokutoh Hospital
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Tokyo, Japan, 173 8610
- Nihon University Itabashi Hospital
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Beijing, Kina, 100191
- Peking University Third Hospital
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Beijing, Kina, 100050
- Beiijing Friendship Hospital, Capital Medical University
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Changsha, Kina, 410008
- Xiangya Hospital Central South University
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Changzhou, Kina, 213164
- Changzhou No 2 Peoples Hospital
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Chengdu, Kina, 610041
- West China Hospital Sichuan University
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Dazhou, Kina, 635002
- Dazhou Central Hospital
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Ganzhou, Kina, 341006
- First Affiliated Hospital of Gannan Medical University
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Guangzhou, Kina, 510275
- Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
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Guiyang, Kina, 550004
- The Affiliated Hospital of Guizhou Medical University
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Hangzhou, Kina, 311608
- The Second Affiliated Hospital of Zhejiang University College of Medicine
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Hefei, Kina, 230001
- Anhui Provincial Hospital
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Jinan, Kina, 250021
- Shandong Provincial Hospital
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Jinhua, Kina, 321013
- Jinhua municipal central hospital
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Linyi, Kina, 276002
- Linyi City People Hospital
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Nanchang, Kina, 330019
- The First Affiliated Hospital of NanChang University
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Nanchong, Kina, 637503
- Affiliated Hospital of North Sichuan Medical College
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Nanjing, Kina, 210009
- Zhongda Hospital Southeast University
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Nanning, Kina, 530000
- The People's Hospital of Guangxi Zhuang Autonomous Region
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Ningbo, Kina, 315041
- Ningbo medical center lihuili hospital
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Shanghai, Kina, 200031
- Huashan Hospital affiliated to Fudan University
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Shanwei, Kina, 516601
- Shenshan Medical Center Memorial Hospital of Sun Yat Sen University
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Shijiazhuang, Kina, 050004
- The Second Hospital of Hebei Medical University
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Taiyuan, Kina, 030000
- Shanxi Academy of Medical Sciences
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Tianjin, Kina, 300384
- Tianjin First Central Hospital
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Wenzhou, Kina, 325000
- The First Affiliated Hospital of Wenzhou Medical University
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Xiamen, Kina, 361003
- The first affiliated hospital of xiamen university
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Xinxiang, Kina, 453099
- Xinxiang Central Hospital
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Xuzhou, Kina, 221000
- The Affiliated Hospital of Xuzhou Medical University
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Yinchuan, Kina, 750031
- People s Hospital of Ningxia Hui Autonomous Region
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Zhongshan, Kina, 528401
- Zhongshan Traditional Chinese Medicine Hospital
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Culiacán, Mexico, 80000
- Centro de Investigacion de Tratamientos Innovadores de Sinaloa
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Guadalajara, Mexico, 44650
- Clinica de Investigacion en Reumatologia y Obesidad
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Mexico City, Mexico, 06720
- Centro Medico Nacional Siglo XXI IMSS
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Mexico D F, Mexico, 14080
- Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
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Mérida, Mexico, 97070
- Medical Care & Research SA de CV
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México, Mexico, 06700
- CITER Centro de Investigacion y Tratamiento de las Enfermedades Reumaticas S A de C V
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Querétaro, Mexico, 76070
- SMIQ S de R L de C V
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San Luis Potosí City, Mexico, 78213
- Centro de Alta Especialidad en Reumatologia e Investigacion del Potosi
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Enschede, Nederland, 7512 KZ
- Medisch Spectrum Twente
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Oslo, Norge, 0372
- Oslo universitetssykehus HF, Rikshospitalet
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Stavanger, Norge, 4011
- Stavanger University Hospital
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Bydgoszcz, Polen, 85 065
- MICS Centrum Medyczne Bydgoszcz
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Bydgoszcz, Polen, 85 168
- Szpital Uniwersytecki nr 2 im dr Jana Biziela w Bydgoszczy
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Dębica, Polen, 39 200
- ETG Debica
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Krakow, Polen, 30-002
- Malopolskie Badania Kliniczne Sp z o o
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Krakow, Polen, 31 501
- Futuremeds Krakow
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Lublin, Polen, 20 412
- ETG Lublin Poradnie Specjalistyczne
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Olsztyn, Polen, 10 117
- Etyka Osrodek Badan Klinicznych Tomasz Pesta S K A
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Poznan, Polen, 61 113
- AI Centrum Medyczne
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Siedlce, Polen, 08 110
- ETG Siedlce
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Warsaw, Polen, 02 637
- Narodowy Instytut Geriatrii Reumatologii i Rehabilitacji im prof dr hab med Eleonory Reicher
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Warsaw, Polen, 00 874
- MICS Centrum Medyczne Warszawa
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Warsaw, Polen, 03 291
- FutureMeds Targowek
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Wroclaw, Polen, 52 416
- Centrum Medyczne Oporow
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Wroclaw, Polen, 53 673
- FutureMeds Wroclaw
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Lisbon, Portugal, 1649 035
- Uls Santa Maria - Hosp. Santa Maria
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Lisbon, Portugal, 1050 034
- Ipr Inst Port de Reumatologia
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Lisbon, Portugal, 1349 019
- Uls Lisboa Ocidental - Hosp. Egas Moniz
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Vila Nova de Gaia, Portugal, 4434 502
- Uls Gaia Espinho
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Bucharest, Romania, 020125
- Spitalul Clinic Colentina
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Bucharest, Romania, 011172
- Spitalul Clinic Sf Maria
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Bucharest, Romania, 030463
- Policlinica CCBR SRL
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Bucharest, Romania, 041312
- Hiperdia SA
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Cluj-Napoca, Romania, 400006
- Spitalul Clinic Judetean de Urgenta Cluj
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Craiova, Romania, 200347
- Medisof Diagnostic S R L
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Timișoara, Romania, 300133
- Selfmed Clinique S.R.L.
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Barcelona, Spania, 08041
- Hosp. de La Santa Creu I Sant Pau
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Barcelona, Spania, 08035
- Hosp Univ Vall D Hebron
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Barcelona, Spania, 08034
- Hosp. Cima Sanitas Barcelona
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Huelva, Spania, 21005
- Hosp. Gral. Juan Ramon Jimenez
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Madrid, Spania, 28041
- Hosp. Univ. 12 de Octubre
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Pamplona, Spania, 310008
- Hosp. de Navarra
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Santander, Spania, 39008
- Hosp. Univ. Marques de Valdecilla
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Seville, Spania, 41010
- Hosp. Infanta Luisa
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Cambridge, Storbritannia, CB2 0QQ
- Cambridge University Hospitals NHS Foundation Trust
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Doncaster, Storbritannia, DN2 5LT
- Doncaster Royal Infirmary
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Greater London, Storbritannia, E1 4DG
- Barts Health NHS Trust
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Leeds, Storbritannia, LS7 4SA
- Leeds Teaching Hospitals NHS Trust
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Liverpool, Storbritannia, L9 7AL
- University Hospital Aintree
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London, Storbritannia, TW7 6AF
- West Middlesex University Hospital
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Peterborough, Storbritannia, PE3 9GZ
- Peterborough City Hospital
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Swindon, Storbritannia, SN3 6BB
- Great Western Hospital
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Basel, Sveits, 4031
- Universitatsspital Basel
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Sankt Gallen, Sveits, 9000
- Kantonsspital St Gallen
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Gwangju, Sør -Korea, 61469
- Chonnam National University Hospital
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Seongnam-si, Sør -Korea, 13620
- Seoul National University Bundang Hospital
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Seoul, Sør -Korea, 03080
- Seoul National University Hospital
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Seoul, Sør -Korea, 05030
- Konkuk University Medical Center
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Seoul, Sør -Korea, 06591
- The Catholic University of Korea Seoul St Mary s Hospital
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Seoul, Sør -Korea, 04763
- Hanyang University Medical Center
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Suwon, Sør -Korea, 16499
- Ajou University Hospital
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Suwon, Sør -Korea, 16247
- The Catholic university of Korea, St. Vincent's Hospital
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Hsinchu, Taiwan, 302058
- NTU Biomedical Park Hospital
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Kaohsiung City, Taiwan, 81362
- Kaohsiung Veterans General Hospital
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Kaohsiung City, Taiwan, 833
- Kaohsiung Chang Gung Memorial Hospital
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New Taipei City, Taiwan, 23561
- Taipei Medical University Shuang Ho Hospital
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Taichung, Taiwan, 404332
- China Medical University Hospital
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Taipei, Taiwan, 11217
- Taipei Veterans General Hospital
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Taoyuan, Taiwan, 333
- Linkou Chang Gung Memorial Hospital
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Brno, Tsjekkia, 63800
- Revmatologie s r o
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Karvina Frystat, Tsjekkia, 73301
- Revimex Pro s r o
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Ostrava, Tsjekkia, 722 00
- Artroscan s r o
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Prague, Tsjekkia, 140 00
- Nuselska Poliklinika
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Uherské Hradiště, Tsjekkia, 68601
- MEDICAL PLUS Research, s.r.o.
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Ankara, Tyrkia (Türkiye), 06800
- Ankara Bilkent City Hospital
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Ankara, Tyrkia (Türkiye), 06560
- Gazi University Medical Faculty
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Ankara, Tyrkia (Türkiye), 06010
- Gulhane Training and Research Hospital
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Bursa, Tyrkia (Türkiye), 16059
- Uludag University Medical Faculty
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Istanbul, Tyrkia (Türkiye), 34899
- Marmara University Istanbul Pendik Education and Research Hospital
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Konya, Tyrkia (Türkiye), 42090
- Necmettin Erbakan University
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Cologne, Tyskland, 51149
- Krankenhaus Porz am Rhein
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Dresden, Tyskland, 01307
- Universitatsklinikum Carl Gustav Carus Dresden
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Erlangen, Tyskland, 91054
- Universitatsklinikum Erlangen Medizinische Klinik 3
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Freiburg im Breisgau, Tyskland, 79106
- Universitatsklinikum Freiburg
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Hamburg, Tyskland, 20095
- Hamburger Rheuma Forschungszentrum II
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Hanover, Tyskland, 30625
- Medizinische Hochschule Hannover
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Herne, Tyskland, 44649
- Rheumazentrum Ruhrgebiet
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München, Tyskland, 80336
- Klinikum der Universitaet Muenchen
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München, Tyskland, 81667
- Medicover Muenchen Ost MVZ
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Ratingen, Tyskland, 40878
- Rheumazentrum Ratingen
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Würzburg, Tyskland, 97080
- Universitaetsklinikum Wuerzburg
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Budapest, Ungarn, 1033
- Clinexpert Kft
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Budapest, Ungarn, 1097
- Del Pesti Centrumkorhaz Orszagos Hematologiai es Infektologiai Intezet Szent Laszlo Telephely
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Budapest, Ungarn, 1027
- Betegapolo Irgalmas Rend Budai Irgalmasrendi Korhaz
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Budapest, Ungarn, 1023
- Semmelweis Egyetem Reumatologiai es Immunologiai Klinika
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Debrecen, Ungarn, 4032
- Debreceni Egyetem Klinikai Kozpont
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Szeged, Ungarn, 6725
- Szegedi Tudomanyegyetem
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Székesfehérvár, Ungarn, 8000
- Vita Verum Medical Egeszsegugyi Szolgaltato Bt
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Graz, Østerrike, 8036
- Medizinische Universitaet Graz
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Salzburg, Østerrike, 5020
- SCRI CCCIT gem GmbH
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Stockerau, Østerrike, 2000
- LK Weinviertel Stockerau
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Vienna, Østerrike, 1090
- Medizinische Universitaet Wien
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Vienna, Østerrike, 1130
- Wiener Gesundheitsverbund Klinik Hietzing
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:-
- Medically stable on the basis of physical examination, medical history, vital signs, clinical laboratory tests, and 12-lead electrocardiogram (ECG) performed at screening
- Meets criteria for diagnosis of SjD by the 2016 American College of Rheumatology/European Alliance of Associations for Rheumatology (ACR/EULAR) classification criteria
- Seropositive for antibodies to Ro/SSA (Ro60 and/or Ro52) at screening
- Total ClinESSDAI score greater than or equal to (>=) 5 at screening
- Participants of childbearing potential must have a negative highly sensitive serum (beta-hCG) pregnancy test at screening and a negative urine pregnancy test at Week 0 prior to randomization
Exclusion Criteria:
- Has a history of severe, progressive and/or uncontrolled hepatic, gastrointestinal, renal, pulmonary, cardiovascular, psychiatric, neurological or musculoskeletal disorder, hypertension, and/or any other medical or uncontrolled autoimmune disorder or clinically significant abnormalities in screening laboratory
- Known allergies, hypersensitivity, or intolerance to nipocalimab or its excipients or excipients used in the placebo formulation
- Has any confirmed or suspected clinical immunodeficiency syndrome not related to treatment of his/her SjD or has a family history of congenital or hereditary immunodeficiency
- Has shown a previous severe immediate hypersensitivity reaction, such as anaphylaxis, to therapeutic proteins (for example [e.g.], monoclonal antibodies, intravenous immunoglobulin)
- Has any unstable or progressive manifestation of SjD that is likely to warrant escalation in therapy beyond permitted background medications
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Firemannsrom
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Nipocalimab
Participants will receive nipocalimab subcutaneously (SC) along with standard of care treatments. At the Week 48 visit, eligible participants from both studies will have the option to enter an open-label long-term extension (OLE) phase, where they will continue to receive nipocalimab until Week 143 or until the study intervention is discontinued and participants opt to withdraw from the study. |
Nipocalimab SC.
Andre navn:
Protocol-defined topical and systemic standard of care background treatments. |
|
Placebo komparator: Placebo
Participants will receive placebo subcutaneously along with standard of care treatments. At the Week 48 visit, eligible participants from both studies will have the option to enter an OLE phase, where they will receive nipocalimab until Week 143 or until the study intervention is discontinued and participants opt to withdraw from the study. |
Protocol-defined topical and systemic standard of care background treatments. Placebo SC. |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Change from Baseline in Clinical European League Against Rheumatism Sjogren's Syndrome Disease Activity Index (ClinESSDAI) Score at Week 48
Tidsramme: Baseline to Week 48
|
ClinESSDAI is a validated tool used in clinical studies to measure the systemic disease activity in participants with SjD. The ClinESSDAI includes 11 domains divided into 3-4 activity levels, where zero represents no activity and low, medium, and high scores can vary in numerical value depending on the domain being measured. A higher score represents worse disease symptoms. |
Baseline to Week 48
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Improvement from Baseline in Minimal Clinically Important Improvement (MCII) in ClinESSDAI Score at Week 48
Tidsramme: Baseline to Week 48
|
The ClinESSDAI is a validated tool used in clinical studies to measure the systemic disease activity in participants with Sjogren's syndrome. |
Baseline to Week 48
|
|
Improvement from Baseline in ClinESSDAI Score at Week 48 in Participants with High Immunoglobulin (IgG) Levels at Baseline
Tidsramme: Baseline to Week 48
|
ClinESSDAI is a validated tool used in clinical studies to measure the systemic disease activity in participants with SjD. |
Baseline to Week 48
|
|
Change from Baseline in ClinESSDAI Score at Week 8
Tidsramme: Baseline to Week 8
|
ClinESSDAI is a validated tool used in clinical studies to measure the systemic disease activity in participants with SjD. |
Baseline to Week 8
|
|
Change from Baseline in Stimulated Salivary Flow Rate at Week 48
Tidsramme: Baseline to Week 48
|
Stimulated salivary flow is considered a reliable and objective method to evaluate glandular function in SjD patients. |
Baseline to Week 48
|
|
Change from Baseline in Sjogren's Symptoms Dryness Score at Week 48
Tidsramme: Baseline to Week 48
|
Participants will be asked to report the worst severity of their dryness symptoms on a 0 to 10 numeric rating scale (NRS), with score 0 indicating "No [specific symptom]" and score 10 indicating "Severe [specific symptom]". Higher scores reflect greater symptom severity. Change from baseline in Sjogren's Symptoms dryness score at Week 48 for US, US reference regions, and other non-US regions will be reported. |
Baseline to Week 48
|
|
Change from Baseline in Sjogren's Symptoms Joint Pain Score at Week 48
Tidsramme: Baseline to Week 48
|
Participants will be asked to report the worst severity of their joint pain symptoms on a 0 to 10 numeric rating scale (NRS), with score 0 indicating "No [specific symptom]" and score 10 indicating "Severe [specific symptom]". Higher scores reflect greater symptom severity. Change from baseline in Sjogren's Symptoms joint pain score at Week 48 for US, US reference regions, and other non-US regions will be reported. |
Baseline to Week 48
|
|
Change from Baseline in EULAR Sjogren's Syndrome Patient Reported Index (ESSPRI) Score At Week 48
Tidsramme: Baseline to Week 48
|
ESSPRI is a participant-reported assessment of the severity of dryness, fatigue, and pain associated with primary Sjogren's Syndrome. Participants are asked to rate the severity of dryness, fatigue, and pain on a 0 to 10 NRS, with score 0 indicating "No [specific symptom]" and score 10 indicating "Severe [specific symptom]". A global score, calculated as the mean of the 3 domain scores, ranges from 0 to 10, with higher scores reflecting greater (worse) symptom severity. Change from baseline in Sjogren's Symptoms score at Week 48 for EU, UK & EU reference regions will be reported. |
Baseline to Week 48
|
|
Change from Baseline in Functional Assessment of Chronic Illness Therapy Fatigue (FACIT) Fatigue Score at Week 48
Tidsramme: Baseline to Week 48
|
FACIT-Fatigue version 4.0 is a 13-item questionnaire that assesses participant-reported fatigue and its impact upon daily activities and function over the past 7 days. Participants will be asked to answer each question using a 5-point Likert scale (0=Not at all; 1=A little bit; 2=Somewhat; 3=Quite a bit; and 4=Very much). FACIT-Fatigue has a total score range from 0 to 52, with 0 being the worst possible score and 52 the best. |
Baseline to Week 48
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Etterforskere
- Studieleder: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
4. desember 2024
Primær fullføring (Antatt)
1. januar 2028
Studiet fullført (Antatt)
18. mai 2029
Datoer for studieregistrering
Først innsendt
18. desember 2024
Først innsendt som oppfylte QC-kriteriene
18. desember 2024
Først lagt ut (Faktiske)
19. desember 2024
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
3. november 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
2. november 2026
Sist bekreftet
1. november 2026
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
- Muskel- og skjelettsykdommer
- Munnsykdommer
- Stomatognatiske sykdommer
- Leddgikt
- Leddsykdommer
- Revmatiske sykdommer
- Bindevevssykdommer
- Autoimmune sykdommer
- Sykdommer i immunsystemet
- Øyesykdommer
- Leddgikt, revmatoid
- Xerostomi
- Spyttkjertelsykdommer
- Syndromer med tørre øyne
- Tåreapparatsykdommer
- Hud- og bindevevssykdommer
- Sjøgrens syndrom
Andre studie-ID-numre
- 80202135SJS3001
- 80202135SJS3001 (Annen identifikator: Janssen Research & Development, LLC)
- 2024-513965-38-00 (Registeridentifikator: EUCT number)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
JA
IPD-planbeskrivelse
The data sharing policy of Johnson & Johnson Innovative Medicine is available at www.innovativemedicine.jnj.com/our-innovation/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Ja
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .