류마티스 관절염 환자를 대상으로 한 바리시티닙(LY3009104) 연구 (RA-BRIDGE)
2026년 5월 27일 업데이트: Eli Lilly and Company
류마티스 관절염 환자를 대상으로 한 바리시티닙의 무작위, 능동 제어, 병렬 그룹, 3b/4상 연구
이 시판 후 연구는 류마티스 관절염이 있는 참가자에게 투여했을 때 정맥 혈전색전증 사건(VTE)과 관련하여 바리시티닙 대 종양 괴사 인자(TNF) 억제제의 안전성을 비교하기 위해 고안되었습니다.
연구 개요
연구 유형
중재적
등록 (실제)
2659
단계
- 4단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Attikí
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Chaïdári, Attikí, 그리스, 12462
- Attikon General University Hospital
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Kentrikí Makedonía
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Thessaloniki, Kentrikí Makedonía, 그리스, 54642
- Ippokrateio General Hospital of Thessaloniki
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Évros
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Alexandroupoli, Évros, 그리스, 68100
- University Hospital of Alexandroupolis
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Eastern Cape
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Port Elizabeth, Eastern Cape, 남아프리카, 6045
- Netcare Greenacres Hospital
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Free State
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Bloemfontein, Free State, 남아프리카, 9301
- Iatros International
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Bloemfontein, Free State, 남아프리카, 9301
- FARMOVS
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Gauteng
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Kempton Park, Gauteng, 남아프리카, 1619
- Clinresco Centres
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Pretoria, Gauteng, 남아프리카, 0001
- University of Pretoria - Faculty of Health Sciences
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KwaZulu-Natal
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Chatsworth, KwaZulu-Natal, 남아프리카, 4092
- Precise Clinical Solutions
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Umhlanga, KwaZulu-Natal, 남아프리카, 4320
- Netcare Umhlanga Hospital
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Western Cape
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Cape Town, Western Cape, 남아프리카, 7405
- Arthritis Clinical Trial Centre
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Stellenbosch, Western Cape, 남아프리카, 7600
- Winelands Medical Research Centre
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Limburg
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Born, Limburg, 네덜란드, 6121 XK
- PT&R / PreCare Trial & Recruitment
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Provincie Friesland
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Leeuwarden, Provincie Friesland, 네덜란드, 8934 AD
- Medische Centrum Leeuwarden
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Central Jutland
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Silkeborg, Central Jutland, 덴마크, 8600
- Regionshospitalet Silkeborg
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Region Syddanmark
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Svendborg, Region Syddanmark, 덴마크, 5700
- Reumatologisk Ambulatorie, Svendborg Hospital Odense Universitet Hospital
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Berlin, 독일, 14059
- Schlosspark Klinik
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Berlin, 독일, 12163
- Praxis für Rheumatologie und Innere
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Hamburg, 독일, 22391
- Hamburger Rheuma Forschungszentrum I / Dres Raabe & Heintz
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Hamburg, 독일, 20095
- HRF II - Hamburger Rheuma Forschungszentrum II MVZ für Rheumatologie und Autoimmunmedizin Hamburg GmbH / -T
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Hesse
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Frankfurt am Main, Hesse, 독일, 60590
- CIRI- Center of Innovative Diagnostics and Therapeutics Rheumatology/Immunology
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Mecklenburg-Vorpommern
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Bad Doberan, Mecklenburg-Vorpommern, 독일, 18209
- Rheumazentrum Prof.Neeck MVZ
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North Rhine-Westphalia
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Cologne, North Rhine-Westphalia, 독일, 50937
- Universitaetsklinikum Koeln
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Ratingen, North Rhine-Westphalia, 독일, 40878
- Rheumazentrum Ratingen Studienambulanz
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Saxony-Anhalt
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Magdeburg, Saxony-Anhalt, 독일, 39110
- Institut für Präventive Medizin & Klinische Forschung GbR
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Petrozavodsk, 러시아 제국, 185019
- Karelia Republican Hospital V.A. Baranova
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Saratov, 러시아 제국, 410053
- Regional Clinical Hospital of the Saratov Region
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Yaroslavl, 러시아 제국, 150003
- Research & Practice
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Kursk Oblast
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Kursk, Kursk Oblast, 러시아 제국, 305007
- Kursk Regional Clinical Hospital
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Leningradskaya Oblast'
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Saint-Petersburg, Leningradskaya Oblast', 러시아 제국, 194291
- Gbuz Lokb
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Moscow
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Moscow, Moscow, 러시아 제국, 111123
- Moscow Clinical Research Center
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Moscow, Moscow, 러시아 제국, 115522
- Federal State Budgetary Scientific Institution Research Institute Rheumatology named after V.A.Nasonova
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Moscow, Moscow, 러시아 제국, 129110
- M. F. Vladimirskiy Moscow Regional Research Clinical Institute
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Moscow Oblast
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Moscow, Moscow Oblast, 러시아 제국, 119991
- First Moscow State Medical University I.M. Sechenov
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Nizhny Novgorod Oblast
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Nizhny Novgorod, Nizhny Novgorod Oblast, 러시아 제국, 603005
- Nizhny Novgorod City Clinical Hospital Number 5
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Ryazan Oblast
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Ryazan, Ryazan Oblast, 러시아 제국, 390026
- Ryazan Regional Clinical Cardiological Dispensary
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Sankt-Peterburg
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Saint Petersburg, Sankt-Peterburg, 러시아 제국, 191015
- North-Western State Medical University named after I.I.Mechnikov
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Saint Petersburg, Sankt-Peterburg, 러시아 제국, 190068
- Clinical Rheumatology hospital #25
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Tula Oblast
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Tula, Tula Oblast, 러시아 제국, 300053
- Tula Regional Clinical Hospital
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Ulyanovsk Oblast
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Ulyanovsk, Ulyanovsk Oblast, 러시아 제국, 432063
- GUZ UOKB
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Brăila, 루마니아, 810019
- CMI Cristei Dorica
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Brașov County
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Brasov, Brașov County, 루마니아, 500283
- C.M.D.T.A. Neomed
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Bucharest
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Bucharest, Bucharest, 루마니아, 011172
- Spital Clinic Sf. Maria
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Bucharest, Bucharest, 루마니아, 014142
- Delta Health Care
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Bucharest, Bucharest, 루마니아, 30463
- CCBR Clinical Research
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Galați County
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Galati, Galați County, 루마니아, 800578
- Spitalul Clinic Judetean de Urgenta Sf. Apostol Andrei
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Iaşi
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Iași, Iaşi, 루마니아, 707027
- RK Medcenter
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Maramureş
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Baia Mare, Maramureş, 루마니아, 430031
- Spitalul Judeean de Urgen Dr. Constantin Opri Baia Mare
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Vâlcea County
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Râmnicu Vâlcea, Vâlcea County, 루마니아, 240762
- SC Medaudio-Optica SRL
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Vilnius, 리투아니아, 01117
- Centro poliklinika
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Kauno Miestas
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Kaunas, Kauno Miestas, 리투아니아, 45130
- Republican Hospital of Kaunas
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Šiauliai County
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Šiauliai, Šiauliai County, 리투아니아, 76231
- Respublikin Šiauli ligonin
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Arizona
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Flagstaff, Arizona, 미국, 86001
- Arizona Arthritis & Rheumatology Research, PLLC
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Gilbert, Arizona, 미국, 85234
- Arthrocare, Arthritiscare & Research PC
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Glendale, Arizona, 미국, 85306
- Arizona Arthritis & Rheumatology Research, PLLC
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Mesa, Arizona, 미국, 85210
- Arizona Arthritis & Rheumatology Research, PLLC
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Peoria, Arizona, 미국, 85381
- Hope Research Institute
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Phoenix, Arizona, 미국, 85018
- Hope Research Institute
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Tucson, Arizona, 미국, 85704
- Arizona Arthritis & Rheumatology Research, PLLC
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California
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Covina, California, 미국, 91722
- Medvin Clinical Research - Covina
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Fullerton, California, 미국, 92835
- St Joseph Heritage Healthcare
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Huntington Beach, California, 미국, 92648
- Christine Thai, MD
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Irvine, California, 미국, 92604
- Private Practice - Dr. Christine J. Leehealey
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Rancho Mirage, California, 미국, 92270
- Desert Medical Advances
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San Diego, California, 미국, 92128
- Rheumatology Center of San Diego
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San Leandro, California, 미국, 94578
- East Bay Rheumatology Medical Group, Inc
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Tujunga, California, 미국, 91042
- Dan La, MD Inc
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Tustin, California, 미국, 92780
- Robin K. Dore MD, Inc
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Upland, California, 미국, 91786
- Inland Rheumatology & Osteoporosis Medical Group
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Van Nuys, California, 미국, 91405
- Medvin Clinical Research - Weidmann
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Whittier, California, 미국, 90602
- Medvin Clinical Research - Whittier
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Connecticut
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Stamford, Connecticut, 미국, 06905
- Stamford Therapeutics Consortium
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Florida
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Boca Raton, Florida, 미국, 33486
- Rheumatology Associates of South Florida
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Miami, Florida, 미국, 33165
- New Horizon Research Center
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Miami, Florida, 미국, 33135
- Suncoast Research Group
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New Port Richey, Florida, 미국, 34652
- Suncoast Clinical Research, Inc.
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Plantation, Florida, 미국, 33324
- IRIS Research and Development, LLC
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South Miami, Florida, 미국, 33143
- Qps-Mra, Llc
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Tampa, Florida, 미국, 33613
- ForCare Clinical Research
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Georgia
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Atlanta, Georgia, 미국, 30342
- Arthritis & Rheumatology of Georgia
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Gainesville, Georgia, 미국, 30501
- Arthritis Center of North Georgia
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Idaho
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Boise, Idaho, 미국, 83702
- St. Luke's Intermountain Research Center
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Illinois
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Chicago, Illinois, 미국, 60640
- Great Lakes Clinical Trials
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Indiana
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Evansville, Indiana, 미국, 47715
- Qualmedica Research, LLC
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Kansas
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Wichita, Kansas, 미국, 67205
- Alliance for Multispecialty Research, LLC
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Kentucky
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Elizabethtown, Kentucky, 미국, 42701
- Center For Arthritis and Osteoporosis
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Louisiana
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Lake Charles, Louisiana, 미국, 70605
- Accurate Clinical Research
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Maryland
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Wheaton, Maryland, 미국, 20902
- The Center For Rheumatology And Bone Research
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Massachusetts
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Fall River, Massachusetts, 미국, 02721
- NECCR PrimaCare Research
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Michigan
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Brighton, Michigan, 미국, 48116
- University of Michigan
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Grand Rapids, Michigan, 미국, 49546
- West Michigan Rheumatology
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Okemos, Michigan, 미국, 48864
- Advanced Rheumatology, PC
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Missouri
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City of Saint Peters, Missouri, 미국, 63303
- StudyMetrix Research
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Springfield, Missouri, 미국, 65807
- Clinvest Research LLC
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Montana
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Kalispell, Montana, 미국, 59901
- Glacier View Research Institute
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Nebraska
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Lincoln, Nebraska, 미국, 68516
- Physician Research Collaboration, LLC
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Omaha, Nebraska, 미국, 68114
- Westroads Clinical Research, Inc.
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Nevada
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Reno, Nevada, 미국, 89519
- Allied Clinical Research
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New Hampshire
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Lebanon, New Hampshire, 미국, 03756
- Dartmouth-Hitchcock Medical Center
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New Mexico
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Albuquerque, New Mexico, 미국, 87102
- Albuquerque Clinical Trials, Inc.
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Albuquerque, New Mexico, 미국, 87102
- Albuquerque Center For Rheumatology
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Santa Fe, New Mexico, 미국, 87505
- Santa Fe Rheumatology
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North Carolina
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Charlotte, North Carolina, 미국, 28211
- Accellacare - Charlotte
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Durham, North Carolina, 미국, 27704
- M3-Emerging Medical Research, LLC
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Hickory, North Carolina, 미국, 28602
- Piedmont Rheumatology, P.A.
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Leland, North Carolina, 미국, 28451
- Cape Fear Arthritis Care
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Salisbury, North Carolina, 미국, 28144
- PMG Research of Salisbury
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Wilmington, North Carolina, 미국, 28401
- PMG Research of Wilmington, LLC
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Ohio
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Cincinnati, Ohio, 미국, 45242
- Cincinnati Rheumatic Disease Study Group
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Marietta, Ohio, 미국, 45750
- Marietta Memorial Hospital
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Middleburg Heights, Ohio, 미국, 44130
- Paramount Medical Research & Consulting, LLC
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Oklahoma
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Oklahoma City, Oklahoma, 미국, 73104
- Oklahoma Medical Research Foundation
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Oklahoma City, Oklahoma, 미국, 73103
- Health Research of Oklahoma
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Pennsylvania
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Bethlehem, Pennsylvania, 미국, 18015
- East Penn Rheumatology Associates
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Duncansville, Pennsylvania, 미국, 16635
- Altoona Center for Clinical Research
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Wyomissing, Pennsylvania, 미국, 19610
- Clinical Research Center of Reading,LLC
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Wyomissing, Pennsylvania, 미국, 19610
- Pennsylvania Regional Center for Arthritis and Osteoporosis Research
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South Dakota
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Rapid City, South Dakota, 미국, 57701
- Regional Health Clinical Research
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Texas
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Baytown, Texas, 미국, 77521
- Accurate Clinical Management
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College Station, Texas, 미국, 77845
- Arthritis & Osteoporosis Clinic of Brazos Valley
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Houston, Texas, 미국, 77043
- Biopharma Informatic, LLC
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Houston, Texas, 미국, 77089
- Accurate Clinical Research
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Houston, Texas, 미국, 77084
- Accurate Clinical Management - Houston
-
Houston, Texas, 미국, 77089
- Research Physicians Network, LLC
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League City, Texas, 미국, 77573
- Accurate Clinical Research
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San Antonio, Texas, 미국, 78229
- Accurate Clinical Research, Inc.
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San Antonio, Texas, 미국, 78229
- Clinical Trials of Texas, Inc.
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Sugar Land, Texas, 미국, 77479
- Accurate Clinical Management
-
Tomball, Texas, 미국, 77375
- Dynamed Clinical Research, LP d/b/a DM Clinical Research
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Tomball, Texas, 미국, 77377
- DM Clinical Research/Rheumatology Clinic of Houston
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Washington
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Spokane, Washington, 미국, 99204
- Arthritis Northwest, PLLC
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Vancouver, Washington, 미국, 98664
- The Vancouver Clinic
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West Virginia
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Charleston, West Virginia, 미국, 25304
- CAMC Health Education and Research Institute Inc
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Bruxelles-Capitale, Région de
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Brussels, Bruxelles-Capitale, Région de, 벨기에, 1070
- Université Libre de Bruxelles - Hôpital Erasme
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Flanders
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Merksem, Flanders, 벨기에, 2170
- ZNA Jan Palfijn
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Limburg
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Genk, Limburg, 벨기에, 3600
- Reuma Clinic, Locatie Jaarbeurslaan
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Fribourg, 스위스, 1708
- HFR Fribourg - Hôpital Cantonal
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Canton of Basel-City
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Basel, Canton of Basel-City, 스위스, 4056
- University Hospital Basel
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Canton of St. Gallen
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Sankt Gallen, Canton of St. Gallen, 스위스, 9007
- Cantonal Hospital St.Gallen
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-
-
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Córdoba, 스페인, 14004
- Hospital Quirónsalud Córdoba
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Córdoba, 스페인, 14004
- HU Reina Sofia
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Madrid, 스페인, 28041
- Hospital Universitario 12 de Octubre
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Madrid, 스페인, 28046
- Hospital Universitario La Paz
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Seville, 스페인, 41009
- Hospital Universitario Virgen Macarena
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Seville, 스페인, 41010
- Hospital Quiron Infanta Luisa
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A Coruña [La Coruña]
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A Coruña, A Coruña [La Coruña], 스페인, 15006
- Complejo Hospitalario Universitario A Coruna
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Santiago de Compostela, A Coruña [La Coruña], 스페인, 15702
- Clinica Gaias - Santiago
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Alicante
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Elche, Alicante, 스페인, 03202
- Hospital General Universitario de Elche
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Villajoyosa, Alicante, 스페인, 03570
- Hospital Marina Baixa
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Basque Country
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Bilbao, Basque Country, 스페인, 48013
- Osi Bilbao-Basurto
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Catalunya [Cataluña]
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Barcelona, Catalunya [Cataluña], 스페인, 08036
- Hospital Clinic de Barcelona
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Barcelona, Catalunya [Cataluña], 스페인, 08022
- Clinica Sagrada Familia
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Barcelona, Catalunya [Cataluña], 스페인, 08023
- Hospital Quirón Barcelona
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Sabadell, Catalunya [Cataluña], 스페인, 08208
- Corporacio Sanitaria Parc Tauli
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Sant Joan Despí, Catalunya [Cataluña], 스페인, 08970
- Consorci Sanitari Integral. Hospital Moisés Broggi, Sant Joan Despí
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Galicia [Galicia]
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Santiago de Compostela, Galicia [Galicia], 스페인, 15706
- CHUS - Hospital Clinico Universitario
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Madrid, Comunidad de
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Fuenlabrada, Madrid, Comunidad de, 스페인, 28944
- Hospital Universitario de Fuenlabrada
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Getafe, Madrid, Comunidad de, 스페인, 28905
- Hospital Universitario Getafe
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Majadahonda, Madrid, Comunidad de, 스페인, 28222
- Hospital Universitario Puerta de Hierro Majadahonda
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Pontevedra [Pontevedra]
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Vigo, Pontevedra [Pontevedra], 스페인, 36200
- CHUVI- Hospital do Meixoeiro
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Banská Bystrica Region
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Zvolen, Banská Bystrica Region, 슬로바키아, 960 01
- Albamed s.r.o.
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Bratislava Region
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Bratislava, Bratislava Region, 슬로바키아, 851 01
- Romjan s.r.o.
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Košice Region
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Košice, Košice Region, 슬로바키아, 040 11
- Artromac n.o.
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Spišská Nová Ves, Košice Region, 슬로바키아, 05201
- Reumed s.r.o.
-
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Nitra Region
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Topoľčany, Nitra Region, 슬로바키아, 955 01
- LERAM s.r.o.
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Trenčín Region
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Partizánske, Trenčín Region, 슬로바키아, 958 01
- Reumacentrum s.r.o.
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-
-
-
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Liverpool, 영국, L9 7AL
- Aintree University Hospital NHS Foundation Trust
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Wolverhampton, 영국, WV10 0QP
- New Cross Hospital
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Bournemouth
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Christchurch, Bournemouth, 영국, BH23 2JX
- Christchurch Hospital
-
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Devon
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Plymouth, Devon, 영국, Pl6 8DH
- Derriford Hospital
-
Torquay, Devon, 영국, TQ2 7AA
- Torbay Hospital
-
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England
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Dudley, England, 영국, DY1 2HQ
- The Dudley Group NHS Foundation Trust
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London, England, 영국, NW32QG
- Royal Free London NHS Foundation Trust
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Truro, England, 영국, TR1 3LJ
- The Royal Cornwall Hospital
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Essex
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Chelmsford, Essex, 영국, CM1 7ET
- Mid Essex Hospital Services NHS Trust
-
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Hampshire
-
Portsmouth, Hampshire, 영국, PO6 3LY
- Queen Alexandra Hospital
-
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Kingston Upon Hull
-
Hull, Kingston Upon Hull, 영국, HU3 2JZ
- Hull and East Yorkshire Hospitals NHS Trust
-
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North Tyneside
-
Newcastle upon Tyne, North Tyneside, 영국, NE29 8NH
- Northumbria Healthcare NHS Foundation Trust
-
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Nottinghamshire
-
Sutton in Ashfield, Nottinghamshire, 영국, NG17 4JL
- King's Mill Hospital
-
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Waltham Forest
-
London, Waltham Forest, 영국, E11 1NR
- Barts Health NHS Trust - Whipps Cross University Hospital
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-
-
-
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Vienna, 오스트리아, 1100
- Rheuma-Zentrum Oberlaa GmbH
-
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State of Vienna
-
Vienna, State of Vienna, 오스트리아, 1090
- Medizinische Universitat Wien
-
Vienna, State of Vienna, 오스트리아, 1160
- Wilhelminenspital
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-
-
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Central District
-
Kfar Saba, Central District, 이스라엘, 4428164
- Meir Medical Center
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Ramat Gan, Central District, 이스라엘, 5262100
- Sheba Medical Center
-
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Southern District
-
Ashkelon, Southern District, 이스라엘, 7830604
- Barzilai Medical Center
-
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Tell Abīb
-
Tel Aviv, Tell Abīb, 이스라엘, 6423906
- Sourasky Medical Center
-
-
Ḥeifā
-
Haifa, Ḥeifā, 이스라엘, 3109601
- Rambam Health Care Campus
-
Haifa, Ḥeifā, 이스라엘, 3436212
- Carmel Hospital
-
Haifa, Ḥeifā, 이스라엘
- Bnai Zion Medical Center
-
-
-
-
-
Florence, 이탈리아, 50141
- Azienda Ospedaliera Universitaria Careggi
-
Naples, 이탈리아, 80131
- University of Campania Luigi Vanvitelli
-
Verona, 이탈리아, 37100
- Policlinico GB Rossi Borgo Roma
-
-
Abruzzo
-
Chieti, Abruzzo, 이탈리아, 66013
- Clinical Research Center - Universita Degli Studi Gabriele d'Annunzio
-
-
Milano
-
Milan, Milano, 이탈리아, 20157
- Ospedale Luigi Sacco
-
-
Tuscany
-
Siena, Tuscany, 이탈리아, 53100
- Ospedale Le Scotte
-
-
-
-
-
Prague, 체코, 14000
- Revmatologicka ambulance
-
Prague, 체코, 14800
- Affidea Praha, s.r.o.
-
-
Brno-město
-
Brno, Brno-město, 체코, 63800
- Revmatologie.s.r.o.
-
Brno, Brno-město, 체코, 61500
- Revmacentrum MUDr. Mostera, s.r.o.
-
-
Moravian-Silesian Region
-
Ostrava, Moravian-Silesian Region, 체코, 722 00
- Artroscan, s.r.o.
-
-
Ostrava Město
-
Ostrava, Ostrava Město, 체코, 70300
- INREA s.r.o.
-
-
Pardubice Region
-
Pardubice, Pardubice Region, 체코, 53002
- Arthrohelp S.R.O.
-
-
Praha 10
-
Prague, Praha 10, 체코, 100 00
- CLINTRIAL s.r.o.
-
-
Praha 4
-
Prague, Praha 4, 체코, 140 00
- Revmatologie MUDr. Štejfová
-
-
Praha, Hlavní Mešto
-
Prague, Praha, Hlavní Mešto, 체코, 12850
- Revmatologicky Ustav
-
-
South Moravian
-
Brno, South Moravian, 체코, 61141
- REVMACLINIC s.r.o.
-
-
Zlín
-
Uherské Hradiště, Zlín, 체코, 686 01
- Medical Plus
-
Zlín, Zlín, 체코, 760 01
- PV Medical Services s.r.o.
-
-
-
-
-
Edirne, 터키 (Türkiye), 22030
- Trakya University
-
Istanbul, 터키 (Türkiye), 34098
- Istanbul University Cerrahpasa Medical School Internal Diseases Institute
-
Izmir, 터키 (Türkiye), 35620
- Izmir Katip Celebi Ataturk Egitim Arastirma Hastanesi
-
Konya, 터키 (Türkiye)
- Necmettin Erbakan Meram Medical Fac.
-
-
Eskişehir
-
Eskişehir, Eskişehir, 터키 (Türkiye), 26480
- Eskisehir Osmangazi University
-
-
Istanbul
-
Stanbul, Istanbul, 터키 (Türkiye), 34899
- Marmara Universitesi Pendik Egitim Arastirma Hastanesi
-
-
-
-
Greater Poland Voivodeship
-
Poznan, Greater Poland Voivodeship, 폴란드, 61-113
- Ai Centrum Medyczne Sp. Z O.O.
-
Poznan, Greater Poland Voivodeship, 폴란드, 61-397
- Prywatna Praktyka Lekarska Prof. UM dr hab. med. Pawel Hrycaj
-
-
Kuyavian-Pomeranian Voivodeship
-
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 폴란드, 85-168
- Szpital Uniwersytecki Nr 2 w Bydgoszczy, Klinika Reumatologii i Ukladowych Chorób Tkanki Lacznej
-
Torun, Kuyavian-Pomeranian Voivodeship, 폴란드, 87-100
- MICS Centrum Medyczne Toruń
-
-
Lublin Voivodeship
-
Tomaszów Lubelski, Lublin Voivodeship, 폴란드, 22-600
- Samodzielny Publiczny Zespol Opieki Zdrowotnej W Tomaszowie Lubelskim
-
-
Lubusz Voivodeship
-
Nowa Sól, Lubusz Voivodeship, 폴란드, 67-100
- Twoja Przychodnia Centrum Medyczne Nowa Sol
-
-
Masovian Voivodeship
-
Nadarzyn, Masovian Voivodeship, 폴란드, 05-830
- NZOZ Lecznica MAK-MED s.c.
-
Warsaw, Masovian Voivodeship, 폴란드, 02-677
- ETG Warszawa
-
Warsaw, Masovian Voivodeship, 폴란드, 02-665
- Centrum Medyczne Reuma Park
-
Warsaw, Masovian Voivodeship, 폴란드, 00-874
- Medycyna Kliniczna
-
Warsaw, Masovian Voivodeship, 폴란드, 02-118
- Rheuma Medicus- Zaklad Opieki Zdrowotnej
-
Warsaw, Masovian Voivodeship, 폴란드, 03-291
- Centrum Medyczne AMED Warszawa Targówek
-
-
Podlaskie Voivodeship
-
Bialystok, Podlaskie Voivodeship, 폴란드, 15-351
- Osteo Medic sc A. Racewicz, J. Supronik
-
-
Pomeranian Voivodeship
-
Gdansk, Pomeranian Voivodeship, 폴란드, 80-546
- Centrum Badan Klinicznych PI-House sp. z o.o.
-
-
Silesian Voivodeship
-
Bytom, Silesian Voivodeship, 폴란드, 41-902
- BIF-MED
-
Katowice, Silesian Voivodeship, 폴란드, 40-081
- Centrum Medyczne Pratia Katowice
-
Ustroń, Silesian Voivodeship, 폴란드, 43-450
- Slaskie Centrum Reumatologii, Rehabilitacji I Zapobiegania Niepelnosprawnosci Im. Gen.J.Zietka
-
-
Warmian-Masurian Voivodeship
-
Elblag, Warmian-Masurian Voivodeship, 폴란드, 82-300
- Ambulatorium Barbara Bazela
-
-
-
-
-
Caguas, 푸에르토 리코, 00725
- Centro Reumatologico Caguas
-
Ponce, 푸에르토 리코, 00716
- Ponce Medical School Foundation Inc.
-
San Juan, 푸에르토 리코, 00918
- Mindful Medical Research
-
San Juan, 푸에르토 리코, 00909
- Latin Clinical Trial Center
-
San Juan, 푸에르토 리코, 00917
- GCM Medical Group, PSC - Hato Rey Site
-
-
-
-
-
Caluire-et-Cuire, 프랑스, 69300
- Infirmerie Protestante de Lyon
-
Lille, 프랑스, 59037
- Centre Hospitalier Régional Universitaire de Lille - Hôpital Roger Salengro
-
Paris, 프랑스, 75013
- Pitie Salpetriere University Hospital
-
-
Alpes-Maritimes
-
Nice, Alpes-Maritimes, 프랑스, 06000
- CHU de Nice
-
-
Alsace
-
Strasbourg, Alsace, 프랑스, 67098
- CHU Strasbourg-Hautepierre
-
-
Aquitaine
-
Bordeaux, Aquitaine, 프랑스, 33076
- Bordeaux University Hospital - Pellegrin
-
-
Auvergne-Rhône-Alpes
-
Lyon, Auvergne-Rhône-Alpes, 프랑스, 69003
- Hôpital Édouard Herriot
-
-
Centre-Val de Loire
-
Orléans, Centre-Val de Loire, 프랑스, 45067
- Centre Hospitalier Régional d'Orléans
-
-
Haute-Garonne
-
Toulouse, Haute-Garonne, 프랑스, 31059
- Hôpital Pierre-Paul Riquet
-
-
Loire-Atlantique
-
Nantes, Loire-Atlantique, 프랑스, 44093
- Centre Hospitalier Universitaire de Nantes - L' Hopital l'hôtel-Dieu
-
-
Meurthe-et-Moselle
-
Vandœuvre-lès-Nancy, Meurthe-et-Moselle, 프랑스, 54511
- Centre Hospitalier Régional Universitaire de Nancy - Hôpitaux de Brabois
-
-
Vendée
-
La Roche-sur-Yon, Vendée, 프랑스, 85000
- CHD Vendee
-
-
-
-
-
Debrecen, 헝가리, 4032
- Debreceni Egyetem Klinikai Kozpont
-
Debrecen, 헝가리, 4031
- Debreceni Egyetem - Kenézy Gyula Egyetemi Oktatókórház
-
-
Borsod-Abauj Zemplen county
-
Miskolc, Borsod-Abauj Zemplen county, 헝가리, 3529
- CRU Hungary Kft.
-
-
Pest County
-
Budapest, Pest County, 헝가리, 1027
- Revita Clinic
-
Budapest, Pest County, 헝가리, 1033
- Clinexpert Kft.
-
-
Veszprém City
-
Veszprém, Veszprém City, 헝가리, 8200
- Vital Medical Center
-
-
-
-
New South Wales
-
Botany, New South Wales, 호주, 2019
- Optimus Clinical Research
-
Newcastle, New South Wales, 호주, 2292
- Genesis Research Services
-
-
Queensland
-
Maroochydore, Queensland, 호주, 4558
- Rheumatology Research Unit
-
-
Tasmania
-
Hobart, Tasmania, 호주, 7000
- Southern Clinical Research
-
-
Victoria
-
Camberwell, Victoria, 호주, 3124
- Emeritus Research
-
-
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
설명
포함 기준:
참가자는 다음 특성 중 하나 이상이 있어야 합니다.
- 이 연구 이전에 VTE의 문서화된 증거
- 만 60세 이상
- 체질량 지수(BMI)가 30kg/m²(제곱미터당 킬로그램) 이상이거나
- 50세 이상 60세 미만, BMI 25 이상 30kg/m² 미만
- 참가자는 적어도 1개의 질병 수정 항류마티스 약물(DMARD)(합성 또는 생물학적 제제)에 대해 부적절한 반응 또는 과민증이 있어야 합니다.
제외 기준:
- 참가자는 TNF 억제제를 복용하지 않을 이유가 없어야 합니다.
- 참가자는 임신 중이거나 모유 수유 중이어서는 안 됩니다.
- 참가자는 하나 이상의 VTE를 가지고 있지 않아야 합니다.
- 참가자는 암이 없어야 합니다.
- 참가자는 활동성 대상 포진, 심각한 감염, 활동성 결핵 또는 기타 심각한 질병이 없어야 합니다.
- 참가자는 연구 시작 4주 이내에 생백신을 접종하지 않아야 합니다.
- 참가자는 연구 시작 4주 이내에 다른 임상 시험에 참여한 적이 없어야 합니다.
- 참가자는 지난 1년 동안 IV 약물 사용, 기타 불법 약물 남용 또는 만성 알코올 남용 이력이 없어야 합니다.
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: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: Baricitinib 2mg
Participants received 2 milligrams (mg) of baricitinib once daily until the planned number of adjudicated primary endpoint events occurred or until the data monitoring committee (DMC) recommended early termination.
Those with inadequate response at 1-year after start of treatment with baricitinib 2mg could receive rescue treatment with baricitinib 4mg.
|
구두로 관리.
다른 이름들:
|
|
실험적: Baricitinib 4mg
Participants received 4 mg of baricitinib once daily until the planned number of adjudicated primary endpoint events occurred or until the DMC recommended early termination.
|
구두로 관리.
다른 이름들:
|
|
활성 비교기: Tumor Necrosis Factor (TNF) Inhibitor
Participants received a TNF inhibitor (adalimumab or etanercept) administered according to approved local labeling until the planned number of adjudicated primary endpoint events occurred or until the DMC recommended early termination.
|
Administered subcutaneously.
다른 이름들:
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Pooled JAJA and JAJD: Time From First Dose of Study Treatment to First Event of Venous Thromboembolism (VTE) [Combined Baricitinib Dose Versus TNF Inhibitor]
기간: From the first dose of study treatment up to 30 days after the last dose or the last study visit, whichever occurs first (approximately up to 6.1 years for JAJA and 5.3 years for JAJD participants)
|
Time from first dose of study treatment to first event of VTE was evaluated using hazard ratio as the measure of treatment effect, estimated from Cox proportional hazards regression model.
The analysis was based on pooled data from studies JAJA (NCT03915964) and JAJD (NCT04086745) and was stratified by study, with treatment group and randomization stratification factors (VTE history, age/Body Mass Index (BMI) combination, prior inadequate response or intolerance to a TNF inhibitor, and geographic region) as explanatory variables.
|
From the first dose of study treatment up to 30 days after the last dose or the last study visit, whichever occurs first (approximately up to 6.1 years for JAJA and 5.3 years for JAJD participants)
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Pooled JAJA and JAJD: Time From First Dose of Study Treatment to First Event of Venous Thromboembolism (VTE) [Individual Baricitinib Dose Versus TNF Inhibitor]
기간: From the first dose of study treatment up to 30 days after the last dose or the last study visit, whichever occurs first (approximately up to 6.1 years for JAJA and 5.3 years for JAJD participants)
|
Time from first dose of study treatment to first event of VTE was evaluated using hazard ratio as the measure of treatment effect, estimated from Cox proportional hazards regression model.
The analysis was based on pooled data from studies JAJA (NCT03915964) and JAJD (NCT04086745) and was stratified by study, with treatment group and randomization stratification factors (VTE history, age/Body Mass Index (BMI) combination, prior inadequate response or intolerance to a TNF inhibitor, and geographic region) as explanatory variables.
|
From the first dose of study treatment up to 30 days after the last dose or the last study visit, whichever occurs first (approximately up to 6.1 years for JAJA and 5.3 years for JAJD participants)
|
|
Pooled JAJA and JAJD: Time From First Dose of Study Treatment to First Arterial Thromboembolic Event (ATE) [Combined and Individual Baricitinib Dose Versus TNF Inhibitor]
기간: From the first dose of study treatment up to 30 days after the last dose or the last study visit, whichever occurs first (approximately up to 6.1 years for JAJA and 5.3 years for JAJD participants)
|
Time from first dose of study treatment to first ATE was evaluated using hazard ratio as the measure of treatment effect, estimated from Cox proportional hazards regression model.
The analysis was based on pooled data from studies JAJA (NCT03915964) and JAJD (NCT04086745) and was stratified by study, with treatment group and randomization stratification factors (VTE history, age/BMI combination, prior inadequate response or intolerance to a TNF inhibitor, and geographic region) as explanatory variables.
|
From the first dose of study treatment up to 30 days after the last dose or the last study visit, whichever occurs first (approximately up to 6.1 years for JAJA and 5.3 years for JAJD participants)
|
|
Pooled JAJA and JAJD: Time From First Dose of Study Treatment to First Major Adverse Cerebro-Cardiovascular Event (MACE) [Combined and Individual Baricitinib Dose Versus TNF Inhibitor]
기간: From the first dose of study treatment up to 30 days after the last dose or the last study visit, whichever occurs first (approximately up to 6.1 years for JAJA and 5.3 years for JAJD participants)
|
Time from first dose of study treatment to first MACE was evaluated using hazard ratio as the measure of treatment effect, estimated from Cox proportional hazards regression model.
The analysis was based on pooled data from studies JAJA (NCT03915964) and JAJD (NCT04086745) and was stratified by study, with treatment group and randomization stratification factors (VTE history, age/BMI combination, prior inadequate response or intolerance to a TNF inhibitor, and geographic region) as explanatory variables.
|
From the first dose of study treatment up to 30 days after the last dose or the last study visit, whichever occurs first (approximately up to 6.1 years for JAJA and 5.3 years for JAJD participants)
|
|
Pooled JAJA and JAJD: Time From First Dose of Study Treatment to First Malignancy (Excluding Nonmelanoma Skin Cancer [NMSC]) [Combined and Individual Baricitinib Dose Versus TNF Inhibitor]
기간: From the first dose of study treatment up to 30 days after the last dose or the last study visit, whichever occurs first (approximately up to 6.1 years for JAJA and 5.3 years for JAJD participants)
|
Time from first dose of study treatment to first malignancy (excluding NMSC) was evaluated using hazard ratio as the measure of treatment effect, estimated from Cox proportional hazards regression model.
The analysis was based on pooled data from studies JAJA (NCT03915964) and JAJD (NCT04086745) and was stratified by study, with treatment group and randomization stratification factors (VTE history, age/BMI combination, prior inadequate response or intolerance to a TNF inhibitor, and geographic region) as explanatory variables.
|
From the first dose of study treatment up to 30 days after the last dose or the last study visit, whichever occurs first (approximately up to 6.1 years for JAJA and 5.3 years for JAJD participants)
|
|
Pooled JAJA and JAJD: Time From First Dose of Study Treatment to First Opportunistic Infection [Combined and Individual Baricitinib Dose Versus TNF Inhibitor]
기간: From the first dose of study treatment up to 30 days after the last dose or the last study visit, whichever occurs first (approximately up to 6.1 years for JAJA and 5.3 years for JAJD participants)
|
Time from first dose of study treatment to first opportunistic infection was evaluated using hazard ratio as the measure of treatment effect, estimated from Cox proportional hazards regression model.
The analysis was based on pooled data from studies JAJA (NCT03915964) and JAJD (NCT04086745) and was stratified by study, with treatment group and randomization stratification factors (VTE history, age/BMI combination, prior inadequate response or intolerance to a TNF inhibitor, and geographic region) as explanatory variables.
|
From the first dose of study treatment up to 30 days after the last dose or the last study visit, whichever occurs first (approximately up to 6.1 years for JAJA and 5.3 years for JAJD participants)
|
|
Pooled JAJA and JAJD: Time From First Dose of Study Treatment to First Serious Infection [Combined and Individual Baricitinib Dose Versus TNF Inhibitor]
기간: From the first dose of study treatment up to 30 days after the last dose or the last study visit, whichever occurs first (approximately up to 6.1 years for JAJA and 5.3 years for JAJD participants)
|
Time from first dose of study treatment to first serious infection was evaluated using hazard ratio as the measure of treatment effect, estimated from Cox proportional hazards regression model.
The analysis was based on pooled data from studies JAJA (NCT03915964) and JAJD (NCT04086745) and was stratified by study, with treatment group and randomization stratification factors (VTE history, age/BMI combination, prior inadequate response or intolerance to a TNF inhibitor, and geographic region) as explanatory variables.
|
From the first dose of study treatment up to 30 days after the last dose or the last study visit, whichever occurs first (approximately up to 6.1 years for JAJA and 5.3 years for JAJD participants)
|
기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Total Duration of Treatment Exposure for Combined Baricitinib Dose, Individual Baricitinib Dose and TNF Inhibitor
기간: From the date of first dose of study drug up to the last dose (approximately up to 6.1 years)
|
Duration of exposure was calculated as:
Patient-years is calculated as sum of duration of exposure in days for all patients in dosing regimen divided by 365.25. |
From the date of first dose of study drug up to the last dose (approximately up to 6.1 years)
|
공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 연구 책임자: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
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)
2019년 4월 25일
기본 완료 (실제)
2025년 5월 28일
연구 완료 (실제)
2025년 5월 28일
연구 등록 날짜
최초 제출
2019년 4월 12일
QC 기준을 충족하는 최초 제출
2019년 4월 12일
처음 게시됨 (실제)
2019년 4월 16일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 6월 24일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 5월 27일
마지막으로 확인됨
2026년 5월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
- 근골격계 질환
- 관절염
- 관절 질환
- 류마티스 질환
- 결합 조직 질환
- 자가면역질환
- 면역계 질환
- 피부 및 결합 조직 질환
- 관절염, 류마티스
- 항염증제
- 펩타이드
- 아미노산, 펩티드 및 단백질
- 단백질
- 약리학 적 행동
- 화학 작용 및 용도
- 치료 용도
- 항체, 모노클로 날, 인간화
- 항체, 모노클로 날
- 항체
- 면역 글로불린
- 면역 단백질
- 혈액 단백질
- 혈청 글로불린
- 글로불린
- 수용체, 세포 표면
- 막 단백질
- 면역 글로불린 FC 단편
- 면역 글로불린 단편
- 펩티드 단편
- 면역 글로불린 상수 영역
- 수용체, 종양 괴사 인자
- 수용체, 사이토 카인
- 수용체, 면역 학적
- 에타너셉트
- 아달리무맙
- 종양 괴사 인자 억제제
- Baricitinib
기타 연구 ID 번호
- 17172
- I4V-MC-JAJA (기타 식별자: Eli Lilly and Company)
- 2018-003351-37 (EudraCT 번호)
- 2023-508022-10-00 (씨티스)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
예
IPD 계획 설명
익명화된 개별 환자 수준 데이터는 연구 제안 및 서명된 데이터 공유 계약의 승인 시 안전한 액세스 환경에서 제공됩니다.
IPD 공유 기간
데이터는 미국과 EU에서 연구된 적응증의 1차 출판 및 승인 중 더 늦은 시점으로부터 6개월 후에 사용할 수 있습니다.
요청 시 데이터를 무기한 사용할 수 있습니다.
IPD 공유 액세스 기준
연구 제안은 독립적인 검토 패널의 승인을 받아야 하며 연구자는 데이터 공유 계약에 서명해야 합니다.
IPD 공유 지원 정보 유형
- 연구_프로토콜
- 수액
- CSR
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. .