중등도 내지 중증 쇼그렌병에 대한 니포칼리맙 (DAFFODIL)
2026년 11월 2일 업데이트: Janssen Research & Development, LLC
중등도에서 중증 쇼그렌병(SjD)이 있는 성인을 대상으로 니포칼리맙의 효능과 안전성을 평가하기 위한 무작위, 위약 대조, 이중 맹검, 다기관 3상 프로토콜
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).
연구 개요
상세 설명
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.
연구 유형
중재적
등록 (실제)
655
단계
- 3단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Enschede, 네덜란드, 7512 KZ
- Medisch Spectrum Twente
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Oslo, 노르웨이, 0372
- Oslo universitetssykehus HF, Rikshospitalet
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Stavanger, 노르웨이, 4011
- Stavanger University Hospital
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Hsinchu, 대만, 302058
- NTU Biomedical Park Hospital
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Kaohsiung City, 대만, 81362
- Kaohsiung Veterans General Hospital
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Kaohsiung City, 대만, 833
- Kaohsiung Chang Gung Memorial Hospital
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New Taipei City, 대만, 23561
- Taipei Medical University Shuang Ho Hospital
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Taichung, 대만, 404332
- China Medical University Hospital
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Taipei, 대만, 11217
- Taipei Veterans General Hospital
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Taoyuan, 대만, 333
- Linkou Chang Gung Memorial Hospital
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Gwangju, 대한민국, 61469
- Chonnam National University Hospital
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Seongnam-si, 대한민국, 13620
- Seoul National University Bundang Hospital
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Seoul, 대한민국, 03080
- Seoul National University Hospital
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Seoul, 대한민국, 05030
- Konkuk University Medical Center
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Seoul, 대한민국, 06591
- The Catholic University of Korea Seoul St Mary s Hospital
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Seoul, 대한민국, 04763
- Hanyang University Medical Center
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Suwon, 대한민국, 16499
- Ajou University Hospital
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Suwon, 대한민국, 16247
- The Catholic university of Korea, St. Vincent's Hospital
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Aarhus, 덴마크, 8200
- Aarhus University Hospital
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Copenhagen, 덴마크, 2100
- Rigshospitalet
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Køge, 덴마크, 4600
- Zealand University Hospital
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Cologne, 독일, 51149
- Krankenhaus Porz am Rhein
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Dresden, 독일, 01307
- Universitatsklinikum Carl Gustav Carus Dresden
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Erlangen, 독일, 91054
- Universitatsklinikum Erlangen Medizinische Klinik 3
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Freiburg im Breisgau, 독일, 79106
- Universitatsklinikum Freiburg
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Hamburg, 독일, 20095
- Hamburger Rheuma Forschungszentrum II
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Hanover, 독일, 30625
- Medizinische Hochschule Hannover
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Herne, 독일, 44649
- Rheumazentrum Ruhrgebiet
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München, 독일, 80336
- Klinikum der Universitaet Muenchen
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München, 독일, 81667
- Medicover Muenchen Ost MVZ
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Ratingen, 독일, 40878
- Rheumazentrum Ratingen
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Würzburg, 독일, 97080
- Universitaetsklinikum Wuerzburg
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Bucharest, 루마니아, 020125
- Spitalul Clinic Colentina
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Bucharest, 루마니아, 011172
- Spitalul Clinic Sf Maria
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Bucharest, 루마니아, 030463
- Policlinica CCBR SRL
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Bucharest, 루마니아, 041312
- Hiperdia SA
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Cluj-Napoca, 루마니아, 400006
- Spitalul Clinic Judetean de Urgenta Cluj
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Craiova, 루마니아, 200347
- Medisof Diagnostic S R L
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Timișoara, 루마니아, 300133
- Selfmed Clinique S.R.L.
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Culiacán, 멕시코, 80000
- Centro de Investigacion de Tratamientos Innovadores de Sinaloa
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Guadalajara, 멕시코, 44650
- Clinica de Investigacion en Reumatologia y Obesidad
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Mexico City, 멕시코, 06720
- Centro Medico Nacional Siglo XXI IMSS
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Mexico D F, 멕시코, 14080
- Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
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Mérida, 멕시코, 97070
- Medical Care & Research SA de CV
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México, 멕시코, 06700
- CITER Centro de Investigacion y Tratamiento de las Enfermedades Reumaticas S A de C V
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Querétaro, 멕시코, 76070
- SMIQ S de R L de C V
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San Luis Potosí City, 멕시코, 78213
- Centro de Alta Especialidad en Reumatologia e Investigacion del Potosi
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California
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Chula Vista, California, 미국, 91910
- Advanced Clinical Research Center
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La Palma, California, 미국, 90623
- Arthritis & Osteoporosis Medical Center - La Palma
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Mission Viejo, California, 미국, 92691
- Providence Medical Foundation
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Monterey Park, California, 미국, 91754
- NovaMed Research
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San Leandro, California, 미국, 94578
- Medvin Clinical Research San Leandro
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Santa Monica, California, 미국, 90404
- Providence Saint John s Health Center
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Tustin, California, 미국, 92780
- Solace Clinical Research California
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Upland, California, 미국, 91786
- Inland Rheumatology Clinical Trials Inc.
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Colorado
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Denver, Colorado, 미국, 80230
- Denver Arthritis Clinic
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Florida
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Clearwater, Florida, 미국, 33765
- Clinical Research of West Florida Inc
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Jacksonville, Florida, 미국, 32256
- UF Health Rheumatology
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New Port Richey, Florida, 미국, 34652
- Suncoast Clinical Research
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Sarasota, Florida, 미국, 34239
- Sarasota Arthritis Center
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South Miami, Florida, 미국, 33143
- BioResearch Partner
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Georgia
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Suwanee, Georgia, 미국, 30024
- Immunology and Rheumatology Research Associates LLC
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Illinois
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Skokie, Illinois, 미국, 60076
- Clinical Investigation Specialists - Clinic of Robert Hozman
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Willowbrook, Illinois, 미국, 60527
- Willow Rheumatology and Wellness PLLC
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Iowa
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Iowa City, Iowa, 미국, 52242
- University of Iowa Hospital and Clinics
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Kansas
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Kansas City, Kansas, 미국, 66160
- University of Kansas Medical Center
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Michigan
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Saint Clair Shores, Michigan, 미국, 48081
- Clinical Research Institute of Michigan, LLC
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Minnesota
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Eagan, Minnesota, 미국, 55123
- St. Paul Rheumatology P A
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Missouri
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Kansas City, Missouri, 미국, 64151
- AARA Clinical Research- Kansas City Physicians Partners
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New Jersey
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Voorhees Township, New Jersey, 미국, 08043
- Arthritis Rheumatic And Back Disease Associates
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New York
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New York, New York, 미국, 10016
- Pioneer Clinical Research NY
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New York, New York, 미국, 10016
- NYU Langone Health - Clinical and Translational Science Institute
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North Carolina
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Charlotte, North Carolina, 미국, 28204
- Joint and Muscle Research Institute
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Charlotte, North Carolina, 미국, 28211
- Atrium Health SouthPark Rheumatology
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Salisbury, North Carolina, 미국, 28144
- Onsite Clinical Solutions
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Ohio
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Fairborn, Ohio, 미국, 45324
- Wright State Physicians Health Center
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Oklahoma
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Oklahoma City, Oklahoma, 미국, 73116
- Rheumatology Associates of Oklahoma
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Oklahoma City, Oklahoma, 미국, 73104
- OMRF Rheumatology Center of Excellence
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Pennsylvania
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Duncansville, Pennsylvania, 미국, 16635
- Altoona Center For Clinical Research
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Philadelphia, Pennsylvania, 미국, 19114
- Clinical Research Philadelphia
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South Carolina
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Summerville, South Carolina, 미국, 29486
- Low Country Rheumatology PA
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Tennessee
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Jackson, Tennessee, 미국, 38305
- West Tennessee Research Institute
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Murfreesboro, Tennessee, 미국, 37128
- AARA Clinical Research - Murfreesboro Medical Clinic
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Texas
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Amarillo, Texas, 미국, 79124
- Amarillo Medical Specialists LLP
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Plano, Texas, 미국, 75024
- Texas Rheumatology Research Institute LLC
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Sugar Land, Texas, 미국, 77479
- Fort Bend Rheumatology Associates PLLC
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The Woodlands, Texas, 미국, 77382
- Advanced Rheumatology of Houston
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Utah
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Layton, Utah, 미국, 84041
- Alpine Research TC LLC
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Virginia
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Chesapeake, Virginia, 미국, 23320
- Tidewater Clinical Research
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Washington
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Bellevue, Washington, 미국, 98004
- Overlake Arthritis and Osteoporosis Center
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Plovdiv, 불가리아, 4001
- UMHAT Kaspela
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Plovdiv, 불가리아, 4002
- Medical Center Artmed
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Rousse, 불가리아, 7003
- Medical Center Teodora
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Sofia, 불가리아, 1431
- St Ivan Rilski University Multiprofile Hospital For Active Treatment
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Sofia, 불가리아, 1431
- Diagnostic-Consultative Center (DCC) Aleksandrovska
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Sofia, 불가리아, 1606
- Military Medical Academy Multiprofile Hospital for Active Treatment Sofia
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Sofia, 불가리아, 1336
- Lyulin Multi Profile Hospital For Active Medical Treatment
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Varna, 불가리아, 9010
- MHAT 'St. Marina' EAD
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Varna, 불가리아, 9000
- Diagnostic Consultative Center - DCC Equita EOOD
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Brasília, 브라질, 70390 700
- Instituto D Or de Pesquisa e Ensino 1
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Curitiba, 브라질, 80030 110
- Ceti - Centro de Estudos Em Terapias Inovadoras
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Porto Alegre, 브라질, 90035-001
- Hospital Moinhos de Vento
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Porto Alegre, 브라질, 90480 000
- LMK Servicos Medicos S S
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Porto Alegre, 브라질, 90035 903
- Hospital De Clinicas De Porto Alegre
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Ribeirão Preto, 브라질, 14048 900
- Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto
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Salvador, 브라질, 41253-190
- IDOR - Regional Bahia
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Salvador, 브라질, 40150 150
- SER - Servicos Especializados em Reumatologia da Bahia
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São José do Rio Preto, 브라질, 15090-000
- Funfarme Sjrp
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São Paulo, 브라질, 04266 010
- CEPIC Centro Paulista de Investigacao Clinica e Servicos Medicos
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São Paulo, 브라질, 05403 000
- Hospital Das Clinicas Da Faculdade De Medicina Da USP
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São Paulo, 브라질, 01243 020
- Hospital Samaritano de Sao Paulo
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Vitória, 브라질, 29055 450
- CEDOES Centro de Pesquisa Clinica e Diagnostico do Espirito Santo Ltda
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Basel, 스위스, 4031
- Universitatsspital Basel
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Sankt Gallen, 스위스, 9000
- Kantonsspital St Gallen
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Barcelona, 스페인, 08041
- Hosp. de La Santa Creu I Sant Pau
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Barcelona, 스페인, 08035
- Hosp Univ Vall D Hebron
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Barcelona, 스페인, 08034
- Hosp. Cima Sanitas Barcelona
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Huelva, 스페인, 21005
- Hosp. Gral. Juan Ramon Jimenez
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Madrid, 스페인, 28041
- Hosp. Univ. 12 de Octubre
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Pamplona, 스페인, 310008
- Hosp. de Navarra
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Santander, 스페인, 39008
- Hosp. Univ. Marques de Valdecilla
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Seville, 스페인, 41010
- Hosp. Infanta Luisa
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Buenos Aires, 아르헨티나, B1643CRO
- Instituto Medico De Alta Complejidad (IMAC)
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Buenos Aires, 아르헨티나, B1663GJE
- Centro de Investigacion San Miguel CISM
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CABA, 아르헨티나, C1128AAF
- Mautalen Salud e Investigacion
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Cdad Autonoma de Buenos Aires, 아르헨티나, C1123AAO
- Centro Medico del Dr. Javier Gerardo Tartaglione
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Ciudad de Buenos Aires, 아르헨티나, C1055
- Centro de Investigacion en Enfermedades Reumaticas CIER
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Ciudad de Buenos Aires, 아르헨티나, C1414
- Centro Medico Barrio Parque. Swiss Medical Group
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Ciudad de Buenos Aires, 아르헨티나, C1428
- Cosultorios Reumatologógicos Pampa
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Quilmes, 아르헨티나, B1878DVB
- Cer Instituto Medico
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San Fernando, 아르헨티나, B1646GHP
- MR Medicina Reumatologica
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San Miguel de Tucumán, 아르헨티나, T4000AXL
- Centro de Investigaciones Medicas Tucuman
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Cambridge, 영국, CB2 0QQ
- Cambridge University Hospitals NHS Foundation Trust
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Doncaster, 영국, DN2 5LT
- Doncaster Royal Infirmary
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Greater London, 영국, E1 4DG
- Barts Health NHS Trust
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Leeds, 영국, LS7 4SA
- Leeds Teaching Hospitals NHS Trust
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Liverpool, 영국, L9 7AL
- University Hospital Aintree
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London, 영국, TW7 6AF
- West Middlesex University Hospital
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Peterborough, 영국, PE3 9GZ
- Peterborough City Hospital
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Swindon, 영국, SN3 6BB
- Great Western Hospital
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Graz, 오스트리아, 8036
- Medizinische Universitaet Graz
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Salzburg, 오스트리아, 5020
- SCRI CCCIT gem GmbH
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Stockerau, 오스트리아, 2000
- LK Weinviertel Stockerau
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Vienna, 오스트리아, 1090
- Medizinische Universitaet Wien
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Vienna, 오스트리아, 1130
- Wiener Gesundheitsverbund Klinik Hietzing
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Ashkelon, 이스라엘, 7830604
- Barzilai Medical Center
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Haifa, 이스라엘, 3109601
- Rambam Health Care Campus
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Haifa, 이스라엘, 34362
- Carmel Medical Center
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Har Poriyya, 이스라엘, 1528001
- Tzafon Medical Center Poria
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Nahariya, 이스라엘, 2210001
- Galil Medical Center
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Petah Tikva, 이스라엘, 4941492
- Rabin Medical Center
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Ramat Gan, 이스라엘, 5262100
- Sheba Medical Center
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Tel Aviv, 이스라엘
- Sourasky Medical Center
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Milan, 이탈리아, 20122
- Centro Specialistico Ortopedico Traumatologico Gaetano Pini CTO
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Milan, 이탈리아, 20132
- Ospedale San Raffaele
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Palermo, 이탈리아, 90127
- Azienda Ospedaliero Universitaria Policlinico Paolo Giaccone
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Perugia, 이탈리아, 06129
- Azienda Ospedaliera di Perugia Ospedale S.Maria della Misericordia
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Pisa, 이탈리아, 56126
- Azienda Ospedaliero Universitaria Pisana
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Roma, 이탈리아, 00161
- Umberto I Policlinico di Roma
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Roma, 이탈리아, 00168
- Fondazione Policlinico Universitario A Gemelli IRCCS
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Roma, 이탈리아, 128
- Campus Bio Medico di Roma
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Rozzano, 이탈리아, 20089
- Istituto Clinico Humanitas
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Udine, 이탈리아, 33100
- Ospedale S. Maria Della Misericordia
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Chūōku, 일본, 104 8560
- St. Luke's International Hospital
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Fuchū, 일본, 183 8524
- Tokyo Metropolitan Tama Medical Center
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Fukuoka, 일본, 810 8563
- National Hospital Organization Kyushu Medical Center
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Kawachi-Nagano, 일본, 586 8521
- National Hospital Organization Osaka Minami Medical Center
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Naha, 일본, 900 0015
- Shinkenko Clinic
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Okayama, 일본, 700 8557
- Okayama City General Medical Center Okayama City Hospital
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Sapporo, 일본, 060 8648
- Hokkaido University Hospital
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Sasebo, 일본, 857 1195
- Sasebo Chuo Hospital
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Sendai, 일본, 983 0005
- Tohoku Medical And Pharmaceutical University Hospital
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Shimotsuga Gun, 일본, 321 0293
- Dokkyo Medical University Hospital
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Sumida Ku, 일본, 130 8575
- Tokyo Metropolitan Bokutoh Hospital
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Tokyo, 일본, 173 8610
- Nihon University Itabashi Hospital
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Beijing, 중국, 100191
- Peking University Third Hospital
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Beijing, 중국, 100050
- Beiijing Friendship Hospital, Capital Medical University
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Changsha, 중국, 410008
- Xiangya Hospital Central South University
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Changzhou, 중국, 213164
- Changzhou No 2 Peoples Hospital
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Chengdu, 중국, 610041
- West China Hospital Sichuan University
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Dazhou, 중국, 635002
- Dazhou Central Hospital
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Ganzhou, 중국, 341006
- First Affiliated Hospital of Gannan Medical University
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Guangzhou, 중국, 510275
- Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
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Guiyang, 중국, 550004
- The Affiliated Hospital of Guizhou Medical University
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Hangzhou, 중국, 311608
- The Second Affiliated Hospital of Zhejiang University College of Medicine
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Hefei, 중국, 230001
- Anhui Provincial Hospital
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Jinan, 중국, 250021
- Shandong Provincial Hospital
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Jinhua, 중국, 321013
- Jinhua municipal central hospital
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Linyi, 중국, 276002
- Linyi City People Hospital
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Nanchang, 중국, 330019
- The First Affiliated Hospital of NanChang University
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Nanchong, 중국, 637503
- Affiliated Hospital of North Sichuan Medical College
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Nanjing, 중국, 210009
- Zhongda Hospital Southeast University
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Nanning, 중국, 530000
- The People's Hospital of Guangxi Zhuang Autonomous Region
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Ningbo, 중국, 315041
- Ningbo medical center lihuili hospital
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Shanghai, 중국, 200031
- Huashan Hospital affiliated to Fudan University
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Shanwei, 중국, 516601
- Shenshan Medical Center Memorial Hospital of Sun Yat Sen University
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Shijiazhuang, 중국, 050004
- The Second Hospital of Hebei Medical University
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Taiyuan, 중국, 030000
- Shanxi Academy of Medical Sciences
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Tianjin, 중국, 300384
- Tianjin First Central Hospital
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Wenzhou, 중국, 325000
- The First Affiliated Hospital of Wenzhou Medical University
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Xiamen, 중국, 361003
- The first affiliated hospital of xiamen university
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Xinxiang, 중국, 453099
- Xinxiang Central Hospital
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Xuzhou, 중국, 221000
- The Affiliated Hospital of Xuzhou Medical University
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Yinchuan, 중국, 750031
- People s Hospital of Ningxia Hui Autonomous Region
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Zhongshan, 중국, 528401
- Zhongshan Traditional Chinese Medicine Hospital
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Brno, 체코, 63800
- Revmatologie s r o
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Karvina Frystat, 체코, 73301
- Revimex Pro s r o
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Ostrava, 체코, 722 00
- Artroscan s r o
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Prague, 체코, 140 00
- Nuselska Poliklinika
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Uherské Hradiště, 체코, 68601
- MEDICAL PLUS Research, s.r.o.
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Ontario
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Windsor, Ontario, 캐나다, N8X 1T3
- Dr Sabeen Anwar Medicine Professional Corporation
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Quebec
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Rimouski, Quebec, 캐나다, G5L 5T1
- Hospital Regional de Rimouski
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Trois-Rivières, Quebec, 캐나다, G9A 3X2
- Centre de Recherche Musculo Squelettique
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Ankara, 터키 (Türkiye), 06800
- Ankara Bilkent City Hospital
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Ankara, 터키 (Türkiye), 06560
- Gazi University Medical Faculty
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Ankara, 터키 (Türkiye), 06010
- Gulhane Training and Research Hospital
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Bursa, 터키 (Türkiye), 16059
- Uludag University Medical Faculty
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Istanbul, 터키 (Türkiye), 34899
- Marmara University Istanbul Pendik Education and Research Hospital
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Konya, 터키 (Türkiye), 42090
- Necmettin Erbakan University
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Lisbon, 포르투갈, 1649 035
- Uls Santa Maria - Hosp. Santa Maria
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Lisbon, 포르투갈, 1050 034
- Ipr Inst Port de Reumatologia
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Lisbon, 포르투갈, 1349 019
- Uls Lisboa Ocidental - Hosp. Egas Moniz
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Vila Nova de Gaia, 포르투갈, 4434 502
- Uls Gaia Espinho
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Bydgoszcz, 폴란드, 85 065
- MICS Centrum Medyczne Bydgoszcz
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Bydgoszcz, 폴란드, 85 168
- Szpital Uniwersytecki nr 2 im dr Jana Biziela w Bydgoszczy
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Dębica, 폴란드, 39 200
- ETG Debica
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Krakow, 폴란드, 30-002
- Malopolskie Badania Kliniczne Sp z o o
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Krakow, 폴란드, 31 501
- Futuremeds Krakow
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Lublin, 폴란드, 20 412
- ETG Lublin Poradnie Specjalistyczne
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Olsztyn, 폴란드, 10 117
- Etyka Osrodek Badan Klinicznych Tomasz Pesta S K A
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Poznan, 폴란드, 61 113
- AI Centrum Medyczne
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Siedlce, 폴란드, 08 110
- ETG Siedlce
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Warsaw, 폴란드, 02 637
- Narodowy Instytut Geriatrii Reumatologii i Rehabilitacji im prof dr hab med Eleonory Reicher
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Warsaw, 폴란드, 00 874
- MICS Centrum Medyczne Warszawa
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Warsaw, 폴란드, 03 291
- FutureMeds Targowek
-
Wroclaw, 폴란드, 52 416
- Centrum Medyczne Oporow
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Wroclaw, 폴란드, 53 673
- FutureMeds Wroclaw
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-
-
-
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Brest, 프랑스, 29200
- CHU de Brest - Hopital de la Cavale Blanche
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Dijon, 프랑스, 21000
- CHU Dijon Bourgogne - Hopital Francois Mitterrand
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Le Kremlin-Bicêtre, 프랑스, 94270
- Hopital Bicetre Aphp Hopitaux Universitaires Paris Sud
-
Lille, 프랑스, 59037
- CHRU de Lille Hopital Claude Huriez
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Montpellier, 프랑스, 34090
- CHRU Montpellier Hopital Lapeyronie
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Saint-Priest-en-Jarez, 프랑스, 42270
- CHU Saint Etienne Hopital Nord
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Strasbourg, 프랑스, 67200
- CHRU de Strasbourg - Hopital de Hautepierre
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Talence, 프랑스, 33400
- CHU Bordeaux
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-
-
-
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Budapest, 헝가리, 1033
- Clinexpert Kft
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Budapest, 헝가리, 1097
- Del Pesti Centrumkorhaz Orszagos Hematologiai es Infektologiai Intezet Szent Laszlo Telephely
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Budapest, 헝가리, 1027
- Betegapolo Irgalmas Rend Budai Irgalmasrendi Korhaz
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Budapest, 헝가리, 1023
- Semmelweis Egyetem Reumatologiai es Immunologiai Klinika
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Debrecen, 헝가리, 4032
- Debreceni Egyetem Klinikai Kozpont
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Szeged, 헝가리, 6725
- Szegedi Tudomanyegyetem
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Székesfehérvár, 헝가리, 8000
- Vita Verum Medical Egeszsegugyi Szolgaltato Bt
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-
-
-
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Hong Kong, 홍콩
- Queen Mary Hospital
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Hong Kong, 홍콩
- Tuen Mun Hospital
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
18년 이상 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
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
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 네 배로
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: 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.
다른 이름들:
Protocol-defined topical and systemic standard of care background treatments. |
|
위약 비교기: 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. |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Change from Baseline in Clinical European League Against Rheumatism Sjogren's Syndrome Disease Activity Index (ClinESSDAI) Score at Week 48
기간: 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
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Improvement from Baseline in Minimal Clinically Important Improvement (MCII) in ClinESSDAI Score at Week 48
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
|
공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 연구 책임자: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2024년 12월 4일
기본 완료 (추정된)
2028년 1월 1일
연구 완료 (추정된)
2029년 5월 18일
연구 등록 날짜
최초 제출
2024년 12월 18일
QC 기준을 충족하는 최초 제출
2024년 12월 18일
처음 게시됨 (실제)
2024년 12월 19일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 11월 3일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 11월 2일
마지막으로 확인됨
2026년 11월 1일
추가 정보
이 연구와 관련된 용어
키워드
추가 관련 MeSH 약관
기타 연구 ID 번호
- 80202135SJS3001
- 80202135SJS3001 (기타 식별자: Janssen Research & Development, LLC)
- 2024-513965-38-00 (레지스트리 식별자: EUCT number)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
예
IPD 계획 설명
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
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
예
미국 FDA 규제 기기 제품 연구
아니
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .