评估 Filgotinib 在成年类风湿性关节炎患者中的安全性和有效性的长期扩展研究 (FINCH 4)
2026年6月29日 更新者：Alfasigma S.p.A.
一项多中心、开放标签、长期扩展研究，以评估 Filgotinib 在类风湿性关节炎患者中的安全性和有效性
本研究的主要目的是评估 filgotinib 在完成类风湿性关节炎（ RA ）母体研究之一的参与者中的长期安全性和耐受性。
研究概览
研究类型
介入性
注册 (实际的)
2731
阶段
- 第三阶段
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Dnipro、乌克兰、49074
- Municipal Institution Dnipropetrovsk 6th City Clinical Hospital of Dnipropetrovsk Regional Council
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Kharkiv、乌克兰、61019
- Municipal Nonprofit Enterprise of the Kharkiv Regional Council, Regional Hospital for War Veterans, Department of Therapy #1
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Kharkiv、乌克兰、61039
- State Institution "National Institute of Therapy named after L.T. Maloyi" of National Academy of Medical Sciences of Ukraine"
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Kharkiv、乌克兰、61058
- Municipal Institution of Heath Care "Regional Clinical Hospital-Center Of Emergency Medicine & Disaster Medicine"
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Kharkiv、乌克兰、61124
- Municipal Nonprofit Enterprise "City Clinical Hospital #13" of the Kharkiv City Council, Department of Therapy
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Kherson、乌克兰、73000
- Minicipal Institution "Kherson City Clinical Hospital n. a. Afanasiy and Olga Tropinykh", Department of Therapy #1
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Kyiv、乌克兰、01601
- Kyiv Oleksandrivska City Clinical Hospital, Department of Rheumatology # 2
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Kyiv、乌克兰、03126
- Kyiv City Clinical Hospital #6, Department of Therapy
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Kyiv、乌克兰、03680
- State Institution National Scientific Center M.D. Strazhesko Institute of Cardiology of NAMS of Ukraine
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Kyiv、乌克兰、04107
- Municipal Institution of Kyiv Regional Council "Kyiv Regional Clinical Hospital", Highly Specialized Therapeutic Department
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Lutsk、乌克兰、43024
- Lutsk City Clinical Hospital
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Lviv、乌克兰、79010
- Municipal Institution of Lviv Regional Council "Lviv Regional Clinical Hospital" Department of Rheumatology
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Lviv、乌克兰、79011
- Municipal Nonprofit Enterprise "4-th City Clinical Hospital in Lviv", Department of Rheumatology
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Odesa、乌克兰、65025
- Municipal Institution Odesa Regional Clinical Hospital, Polyclinic Department
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Vinnytsia、乌克兰、21029
- City Clinical Hospital #1, Department of Rheumatology
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Vinnytsia、乌克兰、21018
- Vinnytsya Regional Clinical Hospital named after M. I. Pyrogova, Department of Rheumatology
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Zaporizhzhya、乌克兰、69005
- Medical Centre Modern Clinic, LLC
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Zaporizhzhya、乌克兰、69104
- Municipal Institution "City Hospital #1", Department of Therapy
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Zaporizhzhya、乌克兰、69118
- Municipal Institution City Hospital #7, Department of Therapy
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Haifa、以色列、3339419
- Bnai Zion Medical Center
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Haifa、以色列、3436212
- The Lady Davis Carmel Medical Center
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Petah Tikva、以色列、4941492
- Rabin Medical Center
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Ramat Gan、以色列、5265601
- The Chaim Sheba Medical Center
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Tel Aviv、以色列、6423906
- Tel Aviv Medical Center
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Barnaul、俄罗斯、656024
- Territorial State Budgetary Healthcare Institution "Territorial Clinical Hospital"
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Chelyabinsk、俄罗斯、454076
- State Budgetary Healthcare Institution, Chelyabinsk Regional Clinical Hospital
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Kazan'、俄罗斯、420103
- FSBEI of HE "Kazan State Medical University" of Ministry of Healthcare of the Russia Federation, Department of hospital therapy
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Kemerovo、俄罗斯、650066
- Medical Center Maximum Zdorovia LLC
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Kemerovo、俄罗斯、650099
- Kemerovo State Medical University on the base of Regional Clinical Hospital for War Veterans
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Moscow、俄罗斯、111539
- Municipal Clinical Hospital No. 15 named after O.M. Filatov
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Moscow、俄罗斯、115093
- City Clinical Hospital #4 of Department of Healthcare of Moscow City
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Moscow、俄罗斯、129110
- M. Vladimirsky Moscow Regional Research Clinical Institute
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Moscow、俄罗斯、129301
- Municipal Clinical Hospital No. 40 Department of healthcare of Moscow City
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Nizhny Novgorod、俄罗斯、603005
- Nizhny Novgorod City Clinical Hospital #5
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Saint Petersburg、俄罗斯、190068
- Saint-Petersburg State Budgetary Healthcare Institution "Clinical rheumatology hospital # 25"
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Saint Petersburg、俄罗斯、192007
- LLC Polyclinic of Private Security Personnel
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Saratov、俄罗斯、410053
- State Healthcare Institution, Regional Clinical Hospital
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Vladimir、俄罗斯、600005
- LLC BioMed
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Yaroslavl、俄罗斯、150003
- State Autonomous Healthcare Institution of Yaroslavl region "Clinical Hospital for Emergency Medical Care n. a. N. V. Solovyev"
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Dobrich、保加利亚、9300
- "Medical Center Help" EOOD
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Haskovo、保加利亚、6300
- "Medical Center- Hipokrat 2000" OOD
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Plovdiv、保加利亚、4001
- "UMHAT - Kaspela" EOOD
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Sofia、保加利亚、1336
- "MHAT Lyulin" EAD, Department of Rheumatology
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Sofia、保加利亚、1612
- Medical Center "N. I. Pirogov" EOOD
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Varna、保加利亚、9000
- "DCC Equita" EOOD
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Vidin、保加利亚、3700
- MHAT "Sveta Petka" AD, Department of Internal Diseases
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Barrie、加拿大、L4M6L2
- The Waterside Clinic
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Trois-Rivières、加拿大、G8Z1Y2
- Centre de Recherche Musculo Squelettique
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Budapest、匈牙利、1023
- Betegapolo-Irgalmasrend Budai Irgalmasrendi Korhaz
-
Budapest、匈牙利、1027
- Revita Reumatológiai Kft.
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Eger、匈牙利、3300
- Markhot Ferenc Oktatokorhaz es Rendelointezet; Reumatologiai Osztaly
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Gyula、匈牙利、5700
- Bekes Megyei Kozponti Korhaz, Pandy Kalman Tagkorhaz, Reumatologiai Osztaly
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Kalocsa、匈牙利、6300
- Bacs Kiskun Megyei Korhaz Szedgedi Tudomanyegyetem Altalanos Orvostudomanyi Kar Oktatokorhaz Kalocsai Szent Kereszt Korh
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Kistarcsa、匈牙利、2143
- Pest Megyei Flor Ferenc Korhaz, Reumatologiai-es Fizioterapias Osztaly
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Szentes、匈牙利、6600
- Csongrad Megyei Dr. Bugyi Istvan Korhaz; Mozgasszervi Rehabilitacios Osztaly
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Székesfehérvár、匈牙利、8000
- C-Med Rehabilitacios es Diagnosztikai Kozpont. Reumatologia
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Cape Town、南非、7505
- Arthritis Clinical Trial Centre
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Durban、南非、4001
- Netcare St. Augustine's Hospital
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Durban、南非、4319
- Umhlanga Netcare Medical Centre
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Johannesburg、南非、2193
- Charlotte Maxeke Johannesburg Academic Hospital
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Stellenbosch、南非
- Winelands Medical Research Centre
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Ahmedabad、印度、380005
- Panchshil Hospital, Dep
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Ahmedabad、印度、380016
- B.J. Medical College and Civil Hospital
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Bangalore、印度、560010
- ChanRe Rheumatology and Immunology Centre and Research
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Chennai、印度、600004
- Chennai Meenakshi Multispeciality Hospital Ltd
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Delhi、印度、110029
- All India Institute of Medical Sciences
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Gurgaon、印度、122001
- Medanta - The Medicity
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Hyderabad、印度、500004
- Gleneagles Global Hospitals
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Hyderabad、印度、50082
- Nizams Institute of Medical Sciences
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Jaipur、印度、302001
- Shri Nidaan Hospital and Hope Fertility Centre
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Jaipur、印度、302001
- SR Kalla Memorial Gastro and General Hospital
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Jaipur、印度、302015
- Santokba Durlabhji Memorial Hospital Cum Medical Research Institute
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Kolkata、印度、700 054
- Apollo Gleneagles Hospitals, Kolkata
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Kolkata、印度、700073
- Medical College & Hospital, Kolkata
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Lucknow、印度、226018
- Department of Rheumatology, KG Medical University
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Mangalore、印度、575001
- Kasturba Medical College Hospital
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Mangalore、印度、575003
- Vinaya Hospital and Research Centre
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Mysuru、印度、570004
- JSS Medical College and Hospital
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Nagpur、印度、440012
- Suretech Hospital and Research Centre Pvt Ltd
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New Delhi、印度、110060
- Sir Ganga Ram Hospital
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New Delhi、印度、110026
- Maharaja Agrasen Hospital
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Pune、印度、411001
- Centre for Rheumatic Disease, Hermes Doctor House
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Pune、印度、411004
- Deenanath Mangeshkar Hospital and Research Centre
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Secunderabad、印度
- Krishna Institute of medical sciences
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Srikakulam、印度、532001
- Rajiv Gandhi Institute of Medical Sciences and Government General Hospital
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Surat、印度、395002
- Nirmal Hospital Private Limited
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Vadodara、印度、390001
- Medical College Baroda and Sir Sayajirao General Hospital
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Visakhapatnam、印度、530002
- King George Hospital
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Changhua、台湾、500
- Changhua Christian Hospital
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Kaohsiung City、台湾、813
- Kaohsiung Veterans General Hospital
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Keelung、台湾、204
- Chang Gung Memorial Hospital, Keelung
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Taichung、台湾、404
- China Medical University Hospital
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Taichung、台湾、40201
- Chung Shan Medical University Hospital
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Tainan、台湾、710
- Chi Mei Hospital, Chi Mei Medical Center
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Taipei、台湾、100
- National Taiwan University Hospital
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Taipei、台湾、110
- Taipei Medical University Hospital
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Taipei、台湾、11490
- Tri-Service General Hospital
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Taoyuan、台湾、333
- Chang Gung Medical Foundation, Chang Gung Memorial Hospital, Linkou Branch
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Belgrade、塞尔维亚、11000
- Institute of Rheumatology
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Belgrade、塞尔维亚、11080
- Clinical Hospital Center Bezanijska Kosa
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Belgrade、塞尔维亚、11000
- Military Medical Academy, Clinic of Rheumatology
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Niška Banja、塞尔维亚、18205
- Institute for Treatment and Rehabilitation Niska Banja
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Chihuahua City、墨西哥、31000
- Investigacion y Biomedicina de Chihuahua, S.C.
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Mexico City、墨西哥、06700
- Clinstile, S.A. de C.V.
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Mexico City、墨西哥、06760
- Clinosar Mexico. S.A. de C. V.
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Monterrey、墨西哥、64460
- Hospital Universitario Dr. Jose Eleuterio González
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Mérida、墨西哥、97000
- Centro Peninsular De Investigacion Clinica S.C.P.
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México、墨西哥、06700
- Biologicos Especializados
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Michoacán
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Morelia、Michoacán、墨西哥、58070
- Centro De Investigación Clínica De Morelia, Sc
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Yucatán
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Mérida、Yucatán、墨西哥、97070
- Kohler & Milstein Research S.A. De C.V.
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Aachen、德国、52064
- Rheumapraxis Dr. med. Reiner Kurthen
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Berlin、德国、14059
- Schlosspark-Klinik
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Frankfurt am Main、德国、60590
- Centrum f. inn. Diagn. und Therap. Rheumatologie/Immunologie
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Hamburg、德国、20095
- HRF II, Hamburger Rheuma Forsch. Zentrum II, MVZ f. Rheumatologie und Autoimmuned. Hamb. GmbH/ Dr. A. Everding GbR
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Ratingen、德国、40878
- Rheumazentrum Ratungen-Studienambulanz GbR
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Bologna、意大利、40138
- Departimento Cardio-toraco-vascolare Gestione delle Malattie Reumatiche e del Connettivo e Malattie Metaboliche dell'osso
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Milan、意大利、20157
- Reumatologia
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Brno、捷克语、60200
- MUDr. Michaela Blahova, revmatologicka ambulance s.r.o.
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Hlučín、捷克语、748 01
- L.K.N. Arthrocentrum, s.r.o.
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Ostrava-Poruba、捷克语、70800
- MUDr. Rosypalová, S.R.O.
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Prague、捷克语、12850
- Revmatologicky Ustav
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Prague、捷克语、140 00
- Revmatologicka ambulance
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Prague、捷克语、14000
- Revmatologicka ambulance, Nuselska Poliklinika
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Prague Praha 10、捷克语、10100
- Arthrocentrum spol.s.r.o.
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Uherské Hradiště、捷克语、68601
- Medical Plus, S.R.O.
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Bratislava、斯洛伐克、841 04
- Neštátna Reumatologická Ambulancia
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Rimavská Sobota、斯洛伐克、97901
- Reumex S.R.O.
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Topoľčany、斯洛伐克、95501
- LERAM s.r.o.
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Auckland、新西兰、1010
- Optimal Clinical Trials, Level 2
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Hamilton、新西兰、3240
- Waikato Hospital
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Newtown、新西兰、6021
- Clinical Trial Unit, CCHDB, Wellington Hospital
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Timaru、新西兰、7910
- Clinical Trials Unit, Timaru Hospital
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Auckland
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Papatoetoe、Auckland、新西兰、2025
- Middlemore Clinical Trial
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Chiba、日本、2608677
- Chiba University Hospital
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Fukuoka、日本、810-8563
- National Hospital Organization Kyushu Medical Center
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Fukuoka、日本、810-8563
- Kyushu Medical Center
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Hamamatsu、日本、430-8558
- Seirei Hamamatsu General Hospital
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Hiroshima、日本、730-8619
- Hiroshima Red Cross Hospital & Atomic-bomb Survivors Hospital
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Hiroshima、日本、734-8551
- Hiroshima University Hospital
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Hiroshima、日本、730-0017
- Hiroshima Rheumatology Clinic
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Iizuka-shi、日本、820-8505
- Iizuka Hospital
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Iruma-gun、日本、350-0495
- Saitama Medical University Hospital
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Izumo、日本、693-8501
- Shimane University Hospital
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Kagoshima、日本、891-0133
- Kagoshima red cross hospital
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Katō、日本、673-1462
- Matsubara Mayflower Hospital
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Kawagoe、日本、350-8550
- Saitama Medical Center
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Kitakyushu-shi、日本、807-8556
- Hospital of the University of Occupational and Environmental Health, Japan
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Kobe、日本、650-0017
- Kobe University Hospital
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Kumamoto、日本、862-0975
- Kumamoto Orthopaedic Hospital
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Kurume-shi、日本、839-0863
- Kurume University Medical Center
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Kyoto、日本、602-8566
- University Hospital, Kyoto Prefectural University of Medicine
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Kyoto、日本、606-8507
- Kyoto University Hospital
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Miyagi-gun、日本、981-0112
- Yu Family Clinic
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Miyazaki、日本、880-0122
- Zenjinkai Shiminnnomori Hospital
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Morioka、日本、020-0015
- Yoshida orthopaedic and rheumatology Clinic
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Nagaoka、日本、940-2085
- Nagaoka Red Cross Hospital
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Nagasaki、日本、850-0832
- Nagasaki Medical Hospital of Rheumatology
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Nagoya、日本、466-8560
- Nagoya University Hospital
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Nishinomiya、日本、663-8501
- The Hospital of Hyogo College of Medine
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Okayama、日本、700-8558
- Okayama University Hospital
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Okayama、日本、700-0013
- Okayama Saiseikai General Hospital Outpatient Center
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Sagamihara、日本、252-0392
- National Hospital Organization Sagamihara National Hospital
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Sanuki-shi、日本、769-2393
- Sanuki Municipal Hospital
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Sapporo、日本、060-8648
- Hokkaido University Hospital
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Sapporo、日本、060-0001
- Sagawa Akira Rheumatology Clinic
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Sapporo、日本、060-8604
- Sapporo City General Hospital
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Sapporo、日本、063-0811
- Hokkaido Medical Center for Rheumatic Diseases
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Sasebo-shi、日本、857-1195
- Sasebo Chuo Hospital
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Sayama-shi、日本、350-1305
- Azuma Rheumatology Clinic
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Shibata、日本、957-0054
- Niigata Rheumatic Center
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Shizuoka、日本、420-8623
- Shizuoka Welfare Hospital
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Suita-shi、日本、565-0871
- Osaka University Hospital
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Takasaki-shi、日本、370-0053
- Inoue Hospital
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Tokyo、日本、143-8541
- Toho University Omori Medical Center
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Tokyo、日本、160-8582
- Keio University Hospital
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Tokyo、日本、104-8560
- St. Luke's International Hospital
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Tokyo、日本、130-0013
- Medical Corporation Uchida Clinic
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Tokyo、日本、142-0054
- Showa University East Hospital
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Tokyo、日本、153-8515
- Toho University Ohashi Medical Center
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Tokyo、日本、156-0052
- Setagaya Rheumatic Clinic
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Tokyo、日本、173-8606
- Teikyo University Hospital
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Tomigusuku-shi、日本、901-0224
- Yuuai Medical Center
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Tsukuba、日本、305-8576
- University of Tsukuba Hospital
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Wakayama、日本、641-8509
- Wakayama Medical University Hospital
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Yokohama、日本、236-0037
- Yokohama Minami Kyousai Hospital
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Ōme、日本、198-0042
- Ome Municipal General Hospital
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Chiba
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Narashino、Chiba、日本、275-8580
- Chibaken Saiseikai Narashino Hospital
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Saitama
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Tokorozawa、Saitama、日本、359-1111
- Medical Corporation Kojyokai Hirose Clinic
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Toyama
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Takaoka、Toyama、日本、933-0874
- Honjo Rheumatism Clinic
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Santiago、智利、7500588
- Quantum Research Santiago
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Santiago、智利、7510186
- Someal SA
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Temuco、智利、4790928
- Centro Medico De Reumatologia
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Brussels、比利时、1200
- Cliniques Universitaires Saint-Luc
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Genk、比利时、3600
- ReumaClinic Genk
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Leuven、比利时、3000
- Universitaire Ziekenhuizen (UZ) Leuven - Gasthuisberg
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Merksem、比利时、2170
- ZNA Jan Palfijn
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Montpellier、法国、34295
- Hôpital Lapeyronie, Service d'Immuno-Rhumatologic
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Bialystok、波兰、15-099
- Gabinet Internistyczno-Reumatologiczny Piotr Adrian Klimiuk
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Bialystok、波兰、15-879
- ClinicMed
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Bydgoszcz、波兰、85168
- Szpital Uniwersytecki Nr 2, Klinka Reumatologii I Ukladowych Chorob Tkanki Lacznej
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Bytom、波兰、41-902
- Niepubliczny Zaklad Opieki Zdrowotnej BIF-MED S.C.
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Dabrówka、波兰、62096
- NSZOZ Unica CR
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Elblag、波兰、82300
- Centrum Kliniczno-Badawcze J. Brzezicki
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Gdynia、波兰、81-338
- Centrum Medyczne Pratia Gdynia
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Kartuzy、波兰、83300
- NZOZ Centrum Medyczna Sw. Lukasza w Kartuzach
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Katowice、波兰、40-282
- SILMEDIC Spolka z ograniczona odpowiedzialnoscia w Swindniku, Oddzial w Katowicach
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Krakow、波兰、31-637
- NZOZ Centrum Medyczne ProMiMed
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Nowa Sól、波兰、67-100
- Twoja Przychodnia -Centrum Medyzcne Nowa Sol
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Poznan、波兰、60-702
- Synexus Polska Sp. z.o.o. Oddzial w Porznaniu
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Poznan、波兰、60-733
- Centrum Badan Klinicznych S.C. Wieslawa Porawska, Lukasz Porawski
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Poznan、波兰、61-113
- AI Centrum Medyczne
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Tomaszów Lubelski、波兰、22-600
- Samodzielny Publiczny Zespol Opieki Zdrowotnej w Tomaszowie Lubelskim Lubelskim; Oddzial Reumatologiczy
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Torun、波兰、87100
- Nasz Lekarz Przychodnie Medyczne
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Warsaw、波兰、02-691
- Reumatika -Centrum Reumatologii NZOZ
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Warsaw、波兰、03291
- Centrum Medyczne AMED Warszawa Targówek
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Wroclaw、波兰、52416
- Centrum Medyczne Oporow
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Bangkok、泰国、10400
- Phramongkutklao Hospital, Division of Rheumatology, Department of Medicine
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Bangkok、泰国、10400
- Rajavithi Hospital, Rheumatology and Allergy Unit
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Bangkok、泰国、10700
- Faculty of Medicine Siriraj Hospital, Mahidol University, Division of Rheumatology, Department of Medicine
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Chiang Mai、泰国、50200
- Maharaj Nakorn Chiang Mai Hospital, Faculty of Medicine, Chiang Mai University
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Songkhla、泰国、90110
- Faculty of Medicine, Prince of Songkla University, Songklanagarind Hospital
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Hobart、澳大利亚、7000
- Southern Clinical Research Pty Ltd
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Queensland
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Maroochydore、Queensland、澳大利亚、4558
- Rheumatology Research Unit
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Western Australia
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Victoria Park、Western Australia、澳大利亚、6100
- RK Will Pty Ltd
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Dublin、爱尔兰、DUBLIN 4
- St Vincent's University Hospital
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Bacau、罗马尼亚、600114
- Spitalul Judetean de Urgenta Bacau, Sectia Reumatologie
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Bucharest、罗马尼亚、010976
- S.C. Ianuli Med Consult S.R.L.
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Bucharest、罗马尼亚、011172
- Spitalul Clinic ,, Sf. Maria", Sectia Reumatologie
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Bucharest、罗马尼亚、011172
- Spitalul Clinic,, Sf. Maria"", Departamentul de Medicina Interna si Reumatologie
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Târgu Mureş、罗马尼亚、540136
- Spitalul Clinic Judetean de Urgenta Tirgu Mures
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Alabama
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Huntsville、Alabama、美国、35801
- Rheumatology Associates of North Alabama, PC
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Arizona
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Gilbert、Arizona、美国、85234
- Arthrocare, Arthritis Care & Research PC
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Phoenix、Arizona、美国、85037
- Arizona Arthritis & Rheumatology Associates, P.C.
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Tucson、Arizona、美国、85704
- Arizona Arthritis & Rheumatology Associates, P.C.
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California
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Covina、California、美国、91722
- Medvin Clinical Research
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Hemet、California、美国、92543
- C.V. Mehta M.D. Medical Corporation
-
La Jolla、California、美国、92037
- University of California San Diego (UCSD) - Perlman Ambulatory Clinic
-
Los Angeles、California、美国、90033
- Keck Medicine of USC- Division of Rheumatology
-
Palm Desert、California、美国、92260
- Desert Medical Advances
-
Palo Alto、California、美国、94305
- Stanford University Hospitals and Clinics (Immunology & Rheumatology)
-
Riverside、California、美国、92518
- C.V. Mehta Medical Corporation
-
Upland、California、美国、91786
- Inland Rheumatology Clinical Trials, Inc.
-
Victorville、California、美国、92395
- Desert Valley Medical Group
-
Whittier、California、美国、90602
- Medvin Clinical Research
-
-
Florida
-
Aventura、Florida、美国、33180
- AARDS Research, Inc.
-
Clearwater、Florida、美国、33765
- Clinical Research of West Florida, Inc.
-
DeBary、Florida、美国、32713
- Omega Research Consultants, LLC
-
Jacksonville、Florida、美国、32207
- University of Florida College of Medicine, Jacksonville - Rheumatology Research
-
Miami、Florida、美国、33135
- Suncoast Research Group, LLC
-
Miami Lakes、Florida、美国、33014
- San Marcus Research Clinic, Inc.
-
New Port Richey、Florida、美国、34652
- Suncoast Clinical Research, Inc.
-
Orlando、Florida、美国、32804
- Omega Research Consultants LLC
-
Plantation、Florida、美国、33324
- IRIS Research and Development, LLC
-
-
Georgia
-
Decatur、Georgia、美国、30033
- Jefrey D. Lieberman, MD, P.C.
-
-
Illinois
-
Springfield、Illinois、美国、62702
- Springfield Clinic
-
-
Kansas
-
Kansas City、Kansas、美国、66160
- University of Kansas Medical Center
-
Wichita、Kansas、美国、67207
- Heartland Research Associates, LLC
-
-
Kentucky
-
Elizabethtown、Kentucky、美国、42701
- Center For Arthritis and Osteoporosis
-
Lexington、Kentucky、美国、40504
- Bluegrass Community Research, Inc.
-
-
Maryland
-
Cumberland、Maryland、美国、21502
- Klein & Associates, M.D., P.A.
-
Frederick、Maryland、美国、21702
- Arthritis Treatment Center
-
Hagerstown、Maryland、美国、21740
- Klein & Associates, M.D., P.A.
-
Wheaton、Maryland、美国、20902
- The Center For Rheumatology And Bone Research
-
-
Massachusetts
-
Worcester、Massachusetts、美国、01605
- Clinical Pharmacology Study Group
-
Worcester、Massachusetts、美国、01605
- Umass Memorial Medical Center- Memorial Campus
-
-
Michigan
-
Detroit、Michigan、美国、48202
- Henry Ford Health System
-
Saint Clair Shores、Michigan、美国、48081
- Shores Rheumatology, PC
-
-
Minnesota
-
Eagan、Minnesota、美国、55121
- St. Paul Rheumatology, PA
-
-
Mississippi
-
Hattiesburg、Mississippi、美国、39402
- Arthritis Associates, PLLC
-
Tupelo、Mississippi、美国、38801
- North Mississippi Medical Clinics, Inc.
-
-
Missouri
-
St Louis、Missouri、美国、63141
- Arthritis Consultants, Inc.
-
St Louis、Missouri、美国、63117
- Clayton Medical Research, P.C.
-
-
Nebraska
-
Lincoln、Nebraska、美国、68516
- Physician Research Collaboration, LLC
-
-
New Hampshire
-
Lebanon、New Hampshire、美国、03756
- Dartmouth-Hitchcock Medical Center
-
-
New Jersey
-
Freehold、New Jersey、美国、07728
- Arthritis & Osteoporosis Associates
-
Toms River、New Jersey、美国、08755
- Ocean Rheumatology, PA
-
-
New Mexico
-
Albuquerque、New Mexico、美国、87102
- Albuquerque Clinical Trials, Inc.
-
-
New York
-
Brooklyn、New York、美国、11201
- NYU Langone Ambulatory Care Brooklyn Heights
-
Brooklyn、New York、美国、11201
- Weill Cornell Physicians At Brooklyn Heights
-
-
North Carolina
-
Charlotte、North Carolina、美国、28204
- Joint and Muscle Research Institute
-
Greenville、North Carolina、美国、27834
- Physicians East, PA
-
Salisbury、North Carolina、美国、28144
- PMG Research of Salisbury
-
-
Ohio
-
Middleburg Heights、Ohio、美国、44130
- Paramount Medical Research & Consulting, LLC
-
-
Oklahoma
-
Oklahoma City、Oklahoma、美国、73103
- Health Research of Oklahoma
-
Tulsa、Oklahoma、美国、74104
- The Oklahoma Center For Arthritis Therapy & Research, Inc.
-
-
Pennsylvania
-
Bethlehem、Pennsylvania、美国、18015
- East Penn Rheumatology Associates
-
Duncansville、Pennsylvania、美国、16635
- Altoona Center for Clinical Research
-
Philadelphia、Pennsylvania、美国、19152
- Arthritis Group, PC
-
Wyomissing、Pennsylvania、美国、19610
- PA Regional Center for Arthritis and Osteoporosis Research
-
Wyomissing、Pennsylvania、美国、19610
- Clinical Research Center of Reading LLC
-
-
South Carolina
-
Columbia、South Carolina、美国、29204
- Articularis Healthcare Inc., dba Columbia Arthritis Center, PA
-
Myrtle Beach、South Carolina、美国、29572
- Carolina Rheumatology & Neurology Assoc., PC
-
Orangeburg、South Carolina、美国、29118
- Articularis Healthcare Group d/b/a ACME Research
-
Summerville、South Carolina、美国、29486
- Articularis Healthcare Group d/b/a Low Country Rheumatology
-
-
Tennessee
-
Memphis、Tennessee、美国、38119
- Ramesh C. Gupta, M.D.
-
-
Texas
-
Beaumont、Texas、美国、77701
- Diagnostic Group
-
Carrollton、Texas、美国、75007
- Trinity Universal Research Associates, Inc
-
Corpus Christi、Texas、美国、78404
- Adriana Pop-Moody MD Clinic PA
-
Dallas、Texas、美国、75246
- Arthritis Centers Of Texas
-
Mesquite、Texas、美国、75150
- Southwest Rheumatology Research, LLC
-
Plano、Texas、美国、75024
- Trinity Universal Research Associates, Inc
-
San Antonio、Texas、美国、78232
- Arthritis & Osteoporosis Center of South Texas
-
-
-
-
-
Edinburgh、英国、EH4 2XU
- NHS Lothian, Western General Hospital
-
Harlow、英国、CM201QX
- Princess Alexandra Hospital
-
North Shields、英国、NE29 8NH
- Northumbria Healthcare NHS Foundation Trust
-
Warrington、英国、WA5 1QG
- Warrington and Halton Hospitals Nhs Foundation Trust
-
-
-
-
-
A Coruña、西班牙、15706
- Complejo Hospitalario Universitario de Santiago
-
Barakaldo、西班牙、48903
- Hospital Universitario Cruces
-
Madrid、西班牙、28034
- Hospital Universitario Ramón y Cajal
-
Madrid、西班牙、28007
- Hospital General Universitario Gregorio Marañón
-
Málaga、西班牙、29009
- Hospital Regional Universitario de Málaga
-
Sabadell、西班牙、08208
- Corporacio Santiaria Parc Tauli
-
Santiago de Compostela、西班牙、15702
- Clinica Gaias
-
Santiago de Compostela、西班牙、15705
- Hospital HM Nuestra Senora de la Esperanza
-
Valencia、西班牙、46010
- Hospital Clínico Universitario de Valencia
-
-
-
-
-
Buenos Aires、阿根廷、B1824KAJ
- CIMeL
-
Ciudad Autonoma、阿根廷、C1114AHH
- Investigaciones Reumatologicas Y Osteologicas (IRO) SRL
-
Ciudad Autonoma Buenos Aires、阿根廷、C1015ABO
- Onganizacion Medica de Investigacion S.A (OMI)
-
Ciudad Autonoma Buenos Aires、阿根廷、C1128AAF
- Mautalen Salud e investigación
-
Ciudad Autonoma de Buenos Aire、阿根廷、C1428DZF
- Consultorios Reumatológicos Pampa
-
Mendoza、阿根廷、5500
- Instituto de Reumatologia
-
Quilmes、阿根廷、B1878DVB
- Instituto Medico CER
-
San Isidro、阿根廷
- Instituto Iari
-
San Juan、阿根廷、CP5400
- CER San Juan, Centro Polivalente de Asistencia e Investigacion Clinica
-
San Miguel de Tucumán、阿根廷、T4000AXL
- Centro Medico Privado de Reumatologia
-
-
Buenos Aires
-
Ciudad Autonoma、Buenos Aires、阿根廷、1425
- Ceim Investigaciones Medicas Srl
-
-
-
-
-
Busan、韩国、49241
- Pusan National University Hospital
-
Daegu、韩国、42472
- Daegu Catholic University Medical Center
-
Daegu、韩国、41944
- Kyungpook National University Hospital
-
Daejeon、韩国、35015
- Chungnam National University Hospital
-
Daejeon、韩国、35233
- Eulji University Hospital
-
Gwangju、韩国、61469
- Chonnam National University Hospital
-
Incheon、韩国、22332
- Inha University Hospital
-
Jeonju、韩国、54907
- Chonbuk National University Medical School
-
Seoul、韩国、03080
- Seoul National University Hospital
-
Seoul、韩国、05505
- Asan Medical Center
-
Seoul、韩国、05030
- Konkuk University Medical Center
-
Seoul、韩国、04763
- Hanyang University Seoul Hospital
-
Seoul、韩国、07061
- SMG-SNU Boramae Medical Center
-
Seoul、韩国、06973
- Chung-Ang University Hospital Institutional Review Board
-
-
-
-
-
Hong Kong、香港
- Department of Medicine & Theraputics, The Chinese University of Hong Kong
-
Hong Kong、香港
- Department of Medicine, Queen Mary Hospital
-
Hong Kong、香港
- Tuen Mun Hospital
-
-
-
-
-
Kuala Lumpur、马来西亚、59100
- University Malaya Medical Centre
-
-
Selangor
-
Batu Caves、Selangor、马来西亚、68100
- Hospital Selayang
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
描述
关键纳入标准：
根据研究者的判断，可能受益于 filgotinib 并且完成了 Gilead 赞助的 filgotinib 父母 RA 研究的男性或女性如下所述：
已完成研究药物的 GS-US-417-0301、GS-US-417-0302 或 GS-US-417-0303
- 或者
- 由于 RA 无反应状态，已完成 GS-US-417-0302 标准护理治疗
- 具有生育潜力的女性在长期延长期 (LTE) 中首次服用研究药物之前必须进行阴性妊娠试验
- 从事异性性交的具有生育潜力的男性和女性必须同意协议批准的避孕方法
关键排除标准：
- 诊断为 RA 以外的自身免疫性或炎症性关节病，根据研究者的判断，这会使参与者因参与研究而处于危险之中，或者会干扰研究评估/数据解释
- 已知对研究药物或其赋形剂过敏
- 根据研究者的判断，任何会使参与者因参与研究而面临风险或会干扰研究评估/数据解释的医疗状况
注意：其他协议定义的包含/排除标准可能适用。
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：盲法阶段：Filgotinib 200 mg
Filgotinib 200 mg 加安慰剂匹配 (PTM) filgotinib 100 mg 长达 6 年
|
片剂每天口服一次
其他名称：
片剂每天口服一次
|
|
实验性的：盲法阶段：Filgotinib 100 mg
Filgotinib 100 mg 加 PTM filgotinib 200 mg 长达 6 年
|
片剂每天口服一次
其他名称：
片剂每天口服一次
|
|
实验性的：开放标签阶段：Filgotinib 200 mg
Filgotinib 200 mg 长达 6 年
|
片剂每天口服一次
其他名称：
|
|
实验性的：开放标签阶段：Filgotinib 100 mg
Filgotinib 100 mg 长达 6 年
|
片剂每天口服一次
其他名称：
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Number of Participants Who Reported Treatment-Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)
大体时间：Day 1 to Week 376 (end of study)
|
An adverse event (AE) was any untoward medical occurrence in a clinical study participant after administration of an investigational product, whether or not considered related to the study treatment.
An SAE was defined as any untoward medical occurrence that, at any dose, resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect or significant medical event.
A TEAE was any AE with an onset date on or after the study drug start date and no later than 30 days after permanent discontinuation of study drug or premature discontinuation of study drug.
|
Day 1 to Week 376 (end of study)
|
|
Number of Participants Who Reported Treatment-Emergent Graded Laboratory Abnormalities in Serum Chemistry Parameters
大体时间：Day 1 to Week 376 (end of study)
|
Treatment-emergent laboratory abnormalities were defined as an increase of at least one toxicity grade from the LTE baseline at any post-baseline time point, up to and including 30 days after the last study drug dose for subjects who permanently discontinued treatment.
Abnormalities were graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 4.03, as Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe), and Grade 4 (life-threatening).
Blood samples were collected by venipuncture in the arm at the specified time points.
The laboratory values outside the normal range were flagged and the clinical relevance was determined by Medical Monitor and Clinical Investigators.
|
Day 1 to Week 376 (end of study)
|
|
Number of Participants Who Reported Treatment-Emergent Graded Laboratory Abnormalities in Hematology Parameters
大体时间：Day 1 to Week 376 (end of study)
|
Treatment-emergent laboratory abnormalities were defined as an increase of at least one toxicity grade from the LTE baseline at any post-baseline time point, up to and including 30 days after the last study drug dose for subjects who permanently discontinued treatment.
Abnormalities were graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 4.03, as Grade 1 (mild), Grade 2 (moderate), and Grade 3 (severe) and Grade 4 (life-threatening).
Blood samples were collected by venipuncture in the arm at the specified time points.
The laboratory values outside the normal range were flagged and the clinical relevance was determined by Medical Monitor and Clinical Investigators.
|
Day 1 to Week 376 (end of study)
|
|
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
大体时间：Baseline and At Week 312
|
SBP and DBP were collected at specified timepoints after participants had remained in a resting position for at least 5 minutes.
The LTE baseline value was defined as the last available value collected on or prior to the date of the first dose of any study drug in the LTE.
Change from the LTE baseline to a postbaseline visit was defined as the postbaseline value minus the LTE baseline value.
|
Baseline and At Week 312
|
|
Change From Baseline in Pulse Rate
大体时间：Baseline and At Week 312
|
Pulse rate was collected at specified timepoints after participants had remained in a resting position for at least 5 minutes.
The LTE baseline value was defined as the last available value collected on or prior to the date of the first dose of any study drug in the LTE.
Change from the LTE baseline to a postbaseline visit was defined as the postbaseline value minus the LTE baseline value.
|
Baseline and At Week 312
|
|
Change From Baseline in Respiration Rate
大体时间：Baseline and At Week 312
|
Changes in respiration rates were collected at specified timepoints after participants had remained in a resting position for at least 5 minutes.
The LTE baseline value was defined as the last available value collected on or prior to the date of the first dose of any study drug in the LTE.
Change from the LTE baseline to a postbaseline visit was defined as the postbaseline value minus the LTE baseline value.
|
Baseline and At Week 312
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Percentage of Participants Who Achieved American College of Rheumatology (ACR) for 20, 50 and 70
大体时间：At Week 312
|
ACR is the improvement from the parent study baseline in swollen joint count (66 joints) where joints were classified as swollen or not swollen, tender joint count (68) where scoring was performed on different aspects of tenderness, and improvement in 3 of 5 items: Subject pain assessment: pain score form Health Assessment Questionnaire Disability Index (HAQ-DI; scale 0=no difficulty to 3=unable to do) was calculated; Subject global assessment of disease activity: a horizontal visual analog scale (VAS; 0=best to 10=worst) was used to assess the participants arthritis status; Physicians global assessment of disease activity: A horizontal VAS (0=best to 10=worst) was used; Subject's assessment of physical function: HAQ-DI (scale 0=no difficulty to 3=unable to do) was used to calculate participants physical function and Acute-phase reactant value: C-reactive level protein is measured.
ACR20, 50 and 70 responders were participants with at least 20%, 50% and 70% achievement respectively.
|
At Week 312
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Combe B, Besuyen R, Gomez-Centeno A, Matsubara T, Sancho Jimenez JJ, Yin Z, Buch MH. Geographic Analysis of the Safety and Efficacy of Filgotinib in Rheumatoid Arthritis. Rheumatol Ther. 2023 Feb;10(1):35-51. doi: 10.1007/s40744-022-00494-1. Epub 2022 Oct 7.
- Tanaka Y, Kondo A, Isaji H, Van Beneden K, Mutter R, Takeuchi T. Integrated Safety Analysis of Filgotinib in Japanese Patients With Moderately to Severely Active Rheumatoid Arthritis Over a Treatment Duration of up to 5 Years. Mod Rheumatol. 2026 Mar 17:roag029. doi: 10.1093/mr/roag029. Online ahead of print.
- Tanaka Y, Matsubara T, Atsumi T, Amano K, Ishiguro N, Hirata S, Yamaoka K, Combe BG, Nash P, Genovese M, Pechonkina A, Liu J, Kondo A, Fukada H, De Leonardis F, Takeuchi T. Safety and efficacy of filgotinib in Japanese patients with rheumatoid arthritis: Week 156 interim results in FINCH 4. Mod Rheumatol. 2025 Apr 8;35(3):425-433. doi: 10.1093/mr/roae099.
- Balsa A, Wassenberg S, Tanaka Y, Tournadre A, Orzechowski HD, Rajendran V, Lendl U, Stiers PJ, Watson C, Caporali R, Galloway J, Verschueren P. Effect of Filgotinib on Body Mass Index (BMI) and Effect of Baseline BMI on the Efficacy and Safety of Filgotinib in Rheumatoid Arthritis. Rheumatol Ther. 2023 Dec;10(6):1555-1574. doi: 10.1007/s40744-023-00599-1. Epub 2023 Sep 25.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2017年2月28日
初级完成 (实际的)
2025年5月16日
研究完成 (实际的)
2025年5月16日
研究注册日期
首次提交
2017年1月17日
首先提交符合 QC 标准的
2017年1月17日
首次发布 (估计的)
2017年1月19日
研究记录更新
最后更新发布 (实际的)
2026年7月27日
上次提交的符合 QC 标准的更新
2026年6月29日
最后验证
2026年6月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.