Långsiktig förlängningsstudie för att bedöma säkerheten och effekten av filgotinib hos vuxna med reumatoid artrit (FINCH 4)
29 juni 2026 uppdaterad av: Alfasigma S.p.A.
En multicenter, öppen, långsiktig förlängningsstudie för att bedöma säkerheten och effekten av filgotinib hos patienter med reumatoid artrit
Det primära syftet med denna studie är att utvärdera den långsiktiga säkerheten och tolerabiliteten för filgotinib hos deltagare som har genomfört en av moderstudierna av filgotinib vid reumatoid artrit (RA).
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Faktisk)
2731
Fas
- Fas 3
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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Buenos Aires, Argentina, B1824KAJ
- CIMeL
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Ciudad Autonoma, Argentina, C1114AHH
- Investigaciones Reumatologicas Y Osteologicas (IRO) SRL
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Ciudad Autonoma Buenos Aires, Argentina, C1015ABO
- Onganizacion Medica de Investigacion S.A (OMI)
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Ciudad Autonoma Buenos Aires, Argentina, C1128AAF
- Mautalen Salud e investigación
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Ciudad Autonoma de Buenos Aire, Argentina, C1428DZF
- Consultorios Reumatológicos Pampa
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Mendoza, Argentina, 5500
- Instituto de Reumatologia
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Quilmes, Argentina, B1878DVB
- Instituto Medico CER
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San Isidro, Argentina
- Instituto Iari
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San Juan, Argentina, CP5400
- CER San Juan, Centro Polivalente de Asistencia e Investigacion Clinica
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San Miguel de Tucumán, Argentina, T4000AXL
- Centro Medico Privado de Reumatologia
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Buenos Aires
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Ciudad Autonoma, Buenos Aires, Argentina, 1425
- Ceim Investigaciones Medicas Srl
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Hobart, Australien, 7000
- Southern Clinical Research Pty Ltd
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Queensland
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Maroochydore, Queensland, Australien, 4558
- Rheumatology Research Unit
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Western Australia
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Victoria Park, Western Australia, Australien, 6100
- RK Will Pty Ltd
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Brussels, Belgien, 1200
- Cliniques Universitaires Saint-Luc
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Genk, Belgien, 3600
- ReumaClinic Genk
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Leuven, Belgien, 3000
- Universitaire Ziekenhuizen (UZ) Leuven - Gasthuisberg
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Merksem, Belgien, 2170
- ZNA Jan Palfijn
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Dobrich, Bulgarien, 9300
- "Medical Center Help" EOOD
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Haskovo, Bulgarien, 6300
- "Medical Center- Hipokrat 2000" OOD
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Plovdiv, Bulgarien, 4001
- "UMHAT - Kaspela" EOOD
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Sofia, Bulgarien, 1336
- "MHAT Lyulin" EAD, Department of Rheumatology
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Sofia, Bulgarien, 1612
- Medical Center "N. I. Pirogov" EOOD
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Varna, Bulgarien, 9000
- "DCC Equita" EOOD
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Vidin, Bulgarien, 3700
- MHAT "Sveta Petka" AD, Department of Internal Diseases
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Santiago, Chile, 7500588
- Quantum Research Santiago
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Santiago, Chile, 7510186
- Someal SA
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Temuco, Chile, 4790928
- Centro Medico De Reumatologia
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Montpellier, Frankrike, 34295
- Hôpital Lapeyronie, Service d'Immuno-Rhumatologic
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Alabama
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Huntsville, Alabama, Förenta staterna, 35801
- Rheumatology Associates of North Alabama, PC
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Arizona
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Gilbert, Arizona, Förenta staterna, 85234
- Arthrocare, Arthritis Care & Research PC
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Phoenix, Arizona, Förenta staterna, 85037
- Arizona Arthritis & Rheumatology Associates, P.C.
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Tucson, Arizona, Förenta staterna, 85704
- Arizona Arthritis & Rheumatology Associates, P.C.
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California
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Covina, California, Förenta staterna, 91722
- Medvin Clinical Research
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Hemet, California, Förenta staterna, 92543
- C.V. Mehta M.D. Medical Corporation
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La Jolla, California, Förenta staterna, 92037
- University of California San Diego (UCSD) - Perlman Ambulatory Clinic
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Los Angeles, California, Förenta staterna, 90033
- Keck Medicine of USC- Division of Rheumatology
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Palm Desert, California, Förenta staterna, 92260
- Desert Medical Advances
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Palo Alto, California, Förenta staterna, 94305
- Stanford University Hospitals and Clinics (Immunology & Rheumatology)
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Riverside, California, Förenta staterna, 92518
- C.V. Mehta Medical Corporation
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Upland, California, Förenta staterna, 91786
- Inland Rheumatology Clinical Trials, Inc.
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Victorville, California, Förenta staterna, 92395
- Desert Valley Medical Group
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Whittier, California, Förenta staterna, 90602
- Medvin Clinical Research
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Florida
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Aventura, Florida, Förenta staterna, 33180
- AARDS Research, Inc.
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Clearwater, Florida, Förenta staterna, 33765
- Clinical Research of West Florida, Inc.
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DeBary, Florida, Förenta staterna, 32713
- Omega Research Consultants, LLC
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Jacksonville, Florida, Förenta staterna, 32207
- University of Florida College of Medicine, Jacksonville - Rheumatology Research
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Miami, Florida, Förenta staterna, 33135
- Suncoast Research Group, LLC
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Miami Lakes, Florida, Förenta staterna, 33014
- San Marcus Research Clinic, Inc.
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New Port Richey, Florida, Förenta staterna, 34652
- Suncoast Clinical Research, Inc.
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Orlando, Florida, Förenta staterna, 32804
- Omega Research Consultants LLC
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Plantation, Florida, Förenta staterna, 33324
- IRIS Research and Development, LLC
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Georgia
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Decatur, Georgia, Förenta staterna, 30033
- Jefrey D. Lieberman, MD, P.C.
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Illinois
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Springfield, Illinois, Förenta staterna, 62702
- Springfield Clinic
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Kansas
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Kansas City, Kansas, Förenta staterna, 66160
- University of Kansas Medical Center
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Wichita, Kansas, Förenta staterna, 67207
- Heartland Research Associates, LLC
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Kentucky
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Elizabethtown, Kentucky, Förenta staterna, 42701
- Center For Arthritis and Osteoporosis
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Lexington, Kentucky, Förenta staterna, 40504
- Bluegrass Community Research, Inc.
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Maryland
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Cumberland, Maryland, Förenta staterna, 21502
- Klein & Associates, M.D., P.A.
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Frederick, Maryland, Förenta staterna, 21702
- Arthritis Treatment Center
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Hagerstown, Maryland, Förenta staterna, 21740
- Klein & Associates, M.D., P.A.
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Wheaton, Maryland, Förenta staterna, 20902
- The Center For Rheumatology And Bone Research
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Massachusetts
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Worcester, Massachusetts, Förenta staterna, 01605
- Clinical Pharmacology Study Group
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Worcester, Massachusetts, Förenta staterna, 01605
- Umass Memorial Medical Center- Memorial Campus
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Michigan
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Detroit, Michigan, Förenta staterna, 48202
- Henry Ford Health System
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Saint Clair Shores, Michigan, Förenta staterna, 48081
- Shores Rheumatology, PC
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Minnesota
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Eagan, Minnesota, Förenta staterna, 55121
- St. Paul Rheumatology, PA
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Mississippi
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Hattiesburg, Mississippi, Förenta staterna, 39402
- Arthritis Associates, PLLC
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Tupelo, Mississippi, Förenta staterna, 38801
- North Mississippi Medical Clinics, Inc.
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Missouri
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St Louis, Missouri, Förenta staterna, 63141
- Arthritis Consultants, Inc.
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St Louis, Missouri, Förenta staterna, 63117
- Clayton Medical Research, P.C.
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Nebraska
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Lincoln, Nebraska, Förenta staterna, 68516
- Physician Research Collaboration, LLC
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New Hampshire
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Lebanon, New Hampshire, Förenta staterna, 03756
- Dartmouth-Hitchcock Medical Center
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New Jersey
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Freehold, New Jersey, Förenta staterna, 07728
- Arthritis & Osteoporosis Associates
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Toms River, New Jersey, Förenta staterna, 08755
- Ocean Rheumatology, PA
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New Mexico
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Albuquerque, New Mexico, Förenta staterna, 87102
- Albuquerque Clinical Trials, Inc.
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New York
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Brooklyn, New York, Förenta staterna, 11201
- NYU Langone Ambulatory Care Brooklyn Heights
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Brooklyn, New York, Förenta staterna, 11201
- Weill Cornell Physicians At Brooklyn Heights
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North Carolina
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Charlotte, North Carolina, Förenta staterna, 28204
- Joint and Muscle Research Institute
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Greenville, North Carolina, Förenta staterna, 27834
- Physicians East, PA
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Salisbury, North Carolina, Förenta staterna, 28144
- PMG Research of Salisbury
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Ohio
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Middleburg Heights, Ohio, Förenta staterna, 44130
- Paramount Medical Research & Consulting, LLC
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Oklahoma
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Oklahoma City, Oklahoma, Förenta staterna, 73103
- Health Research of Oklahoma
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Tulsa, Oklahoma, Förenta staterna, 74104
- The Oklahoma Center For Arthritis Therapy & Research, Inc.
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Pennsylvania
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Bethlehem, Pennsylvania, Förenta staterna, 18015
- East Penn Rheumatology Associates
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Duncansville, Pennsylvania, Förenta staterna, 16635
- Altoona Center for Clinical Research
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Philadelphia, Pennsylvania, Förenta staterna, 19152
- Arthritis Group, PC
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Wyomissing, Pennsylvania, Förenta staterna, 19610
- PA Regional Center for Arthritis and Osteoporosis Research
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Wyomissing, Pennsylvania, Förenta staterna, 19610
- Clinical Research Center of Reading LLC
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South Carolina
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Columbia, South Carolina, Förenta staterna, 29204
- Articularis Healthcare Inc., dba Columbia Arthritis Center, PA
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Myrtle Beach, South Carolina, Förenta staterna, 29572
- Carolina Rheumatology & Neurology Assoc., PC
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Orangeburg, South Carolina, Förenta staterna, 29118
- Articularis Healthcare Group d/b/a ACME Research
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Summerville, South Carolina, Förenta staterna, 29486
- Articularis Healthcare Group d/b/a Low Country Rheumatology
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Tennessee
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Memphis, Tennessee, Förenta staterna, 38119
- Ramesh C. Gupta, M.D.
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Texas
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Beaumont, Texas, Förenta staterna, 77701
- Diagnostic Group
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Carrollton, Texas, Förenta staterna, 75007
- Trinity Universal Research Associates, Inc
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Corpus Christi, Texas, Förenta staterna, 78404
- Adriana Pop-Moody MD Clinic PA
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Dallas, Texas, Förenta staterna, 75246
- Arthritis Centers Of Texas
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Mesquite, Texas, Förenta staterna, 75150
- Southwest Rheumatology Research, LLC
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Plano, Texas, Förenta staterna, 75024
- Trinity Universal Research Associates, Inc
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San Antonio, Texas, Förenta staterna, 78232
- Arthritis & Osteoporosis Center of South Texas
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Hong Kong, Hong Kong
- Department of Medicine & Theraputics, The Chinese University of Hong Kong
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Hong Kong, Hong Kong
- Department of Medicine, Queen Mary Hospital
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Hong Kong, Hong Kong
- Tuen Mun Hospital
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Ahmedabad, Indien, 380005
- Panchshil Hospital, Dep
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Ahmedabad, Indien, 380016
- B.J. Medical College and Civil Hospital
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Bangalore, Indien, 560010
- ChanRe Rheumatology and Immunology Centre and Research
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Chennai, Indien, 600004
- Chennai Meenakshi Multispeciality Hospital Ltd
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Delhi, Indien, 110029
- All India Institute of Medical Sciences
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Gurgaon, Indien, 122001
- Medanta - The Medicity
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Hyderabad, Indien, 500004
- Gleneagles Global Hospitals
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Hyderabad, Indien, 50082
- Nizams Institute of Medical Sciences
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Jaipur, Indien, 302001
- Shri Nidaan Hospital and Hope Fertility Centre
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Jaipur, Indien, 302001
- SR Kalla Memorial Gastro and General Hospital
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Jaipur, Indien, 302015
- Santokba Durlabhji Memorial Hospital Cum Medical Research Institute
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Kolkata, Indien, 700 054
- Apollo Gleneagles Hospitals, Kolkata
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Kolkata, Indien, 700073
- Medical College & Hospital, Kolkata
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Lucknow, Indien, 226018
- Department of Rheumatology, KG Medical University
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Mangalore, Indien, 575001
- Kasturba Medical College Hospital
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Mangalore, Indien, 575003
- Vinaya Hospital and Research Centre
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Mysuru, Indien, 570004
- JSS Medical College and Hospital
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Nagpur, Indien, 440012
- Suretech Hospital and Research Centre Pvt Ltd
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New Delhi, Indien, 110060
- Sir Ganga Ram Hospital
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New Delhi, Indien, 110026
- Maharaja Agrasen Hospital
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Pune, Indien, 411001
- Centre for Rheumatic Disease, Hermes Doctor House
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Pune, Indien, 411004
- Deenanath Mangeshkar Hospital and Research Centre
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Secunderabad, Indien
- Krishna Institute of medical sciences
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Srikakulam, Indien, 532001
- Rajiv Gandhi Institute of Medical Sciences and Government General Hospital
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Surat, Indien, 395002
- Nirmal Hospital Private Limited
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Vadodara, Indien, 390001
- Medical College Baroda and Sir Sayajirao General Hospital
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Visakhapatnam, Indien, 530002
- King George Hospital
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Dublin, Irland, DUBLIN 4
- St Vincent's University Hospital
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Haifa, Israel, 3339419
- Bnai Zion Medical Center
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Haifa, Israel, 3436212
- The Lady Davis Carmel Medical Center
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Petah Tikva, Israel, 4941492
- Rabin Medical Center
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Ramat Gan, Israel, 5265601
- The Chaim Sheba Medical Center
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Tel Aviv, Israel, 6423906
- Tel Aviv Medical Center
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Bologna, Italien, 40138
- Departimento Cardio-toraco-vascolare Gestione delle Malattie Reumatiche e del Connettivo e Malattie Metaboliche dell'osso
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Milan, Italien, 20157
- Reumatologia
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Chiba, Japan, 2608677
- Chiba University Hospital
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Fukuoka, Japan, 810-8563
- National Hospital Organization Kyushu Medical Center
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Fukuoka, Japan, 810-8563
- Kyushu Medical Center
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Hamamatsu, Japan, 430-8558
- Seirei Hamamatsu General Hospital
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Hiroshima, Japan, 730-8619
- Hiroshima Red Cross Hospital & Atomic-bomb Survivors Hospital
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Hiroshima, Japan, 734-8551
- Hiroshima University Hospital
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Hiroshima, Japan, 730-0017
- Hiroshima Rheumatology Clinic
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Iizuka-shi, Japan, 820-8505
- Iizuka Hospital
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Iruma-gun, Japan, 350-0495
- Saitama Medical University Hospital
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Izumo, Japan, 693-8501
- Shimane University Hospital
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Kagoshima, Japan, 891-0133
- Kagoshima red cross hospital
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Katō, Japan, 673-1462
- Matsubara Mayflower Hospital
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Kawagoe, Japan, 350-8550
- Saitama Medical Center
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Kitakyushu-shi, Japan, 807-8556
- Hospital of the University of Occupational and Environmental Health, Japan
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Kobe, Japan, 650-0017
- Kobe University Hospital
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Kumamoto, Japan, 862-0975
- Kumamoto Orthopaedic Hospital
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Kurume-shi, Japan, 839-0863
- Kurume University Medical Center
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Kyoto, Japan, 602-8566
- University Hospital, Kyoto Prefectural University of Medicine
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Kyoto, Japan, 606-8507
- Kyoto University hospital
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Miyagi-gun, Japan, 981-0112
- Yu Family Clinic
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Miyazaki, Japan, 880-0122
- Zenjinkai Shiminnnomori Hospital
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Morioka, Japan, 020-0015
- Yoshida orthopaedic and rheumatology Clinic
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Nagaoka, Japan, 940-2085
- Nagaoka Red Cross Hospital
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Nagasaki, Japan, 850-0832
- Nagasaki Medical Hospital of Rheumatology
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Nagoya, Japan, 466-8560
- Nagoya University Hospital
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Nishinomiya, Japan, 663-8501
- The Hospital of Hyogo College of Medine
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Okayama, Japan, 700-8558
- Okayama University Hospital
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Okayama, Japan, 700-0013
- Okayama Saiseikai General Hospital Outpatient Center
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Sagamihara, Japan, 252-0392
- National Hospital Organization Sagamihara National Hospital
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Sanuki-shi, Japan, 769-2393
- Sanuki Municipal Hospital
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Sapporo, Japan, 060-8648
- Hokkaido University Hospital
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Sapporo, Japan, 060-0001
- Sagawa Akira Rheumatology Clinic
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Sapporo, Japan, 060-8604
- Sapporo City General Hospital
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Sapporo, Japan, 063-0811
- Hokkaido Medical Center for Rheumatic Diseases
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Sasebo-shi, Japan, 857-1195
- Sasebo Chuo Hospital
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Sayama-shi, Japan, 350-1305
- Azuma Rheumatology Clinic
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Shibata, Japan, 957-0054
- Niigata Rheumatic Center
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Shizuoka, Japan, 420-8623
- Shizuoka Welfare Hospital
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Suita-shi, Japan, 565-0871
- Osaka University Hospital
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Takasaki-shi, Japan, 370-0053
- Inoue Hospital
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Tokyo, Japan, 143-8541
- Toho University Omori Medical Center
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Tokyo, Japan, 160-8582
- Keio University Hospital
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Tokyo, Japan, 104-8560
- St. Luke's International Hospital
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Tokyo, Japan, 130-0013
- Medical Corporation Uchida Clinic
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Tokyo, Japan, 142-0054
- Showa University East Hospital
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Tokyo, Japan, 153-8515
- Toho University Ohashi Medical Center
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Tokyo, Japan, 156-0052
- Setagaya Rheumatic Clinic
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Tokyo, Japan, 173-8606
- Teikyo University Hospital
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Tomigusuku-shi, Japan, 901-0224
- Yuuai Medical Center
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Tsukuba, Japan, 305-8576
- University of Tsukuba Hospital
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Wakayama, Japan, 641-8509
- Wakayama Medical University Hospital
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Yokohama, Japan, 236-0037
- Yokohama Minami Kyousai Hospital
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Ōme, Japan, 198-0042
- Ome Municipal General Hospital
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Chiba
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Narashino, Chiba, Japan, 275-8580
- Chibaken Saiseikai Narashino Hospital
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Saitama
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Tokorozawa, Saitama, Japan, 359-1111
- Medical Corporation Kojyokai Hirose Clinic
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Toyama
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Takaoka, Toyama, Japan, 933-0874
- Honjo Rheumatism Clinic
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-
-
-
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Barrie, Kanada, L4M6L2
- The Waterside Clinic
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Trois-Rivières, Kanada, G8Z1Y2
- Centre de Recherche Musculo Squelettique
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-
-
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Kuala Lumpur, Malaysia, 59100
- University Malaya Medical Centre
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Selangor
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Batu Caves, Selangor, Malaysia, 68100
- Hospital Selayang
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-
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Chihuahua City, Mexiko, 31000
- Investigacion y Biomedicina de Chihuahua, S.C.
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Mexico City, Mexiko, 06700
- Clinstile, S.A. de C.V.
-
Mexico City, Mexiko, 06760
- Clinosar Mexico. S.A. de C. V.
-
Monterrey, Mexiko, 64460
- Hospital Universitario Dr. José Eleuterio González
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Mérida, Mexiko, 97000
- Centro Peninsular De Investigacion Clinica S.C.P.
-
México, Mexiko, 06700
- Biologicos Especializados
-
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Michoacán
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Morelia, Michoacán, Mexiko, 58070
- Centro De Investigación Clínica De Morelia, Sc
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Yucatán
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Mérida, Yucatán, Mexiko, 97070
- Kohler & Milstein Research S.A. De C.V.
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Auckland, Nya Zeeland, 1010
- Optimal Clinical Trials, Level 2
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Hamilton, Nya Zeeland, 3240
- Waikato Hospital
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Newtown, Nya Zeeland, 6021
- Clinical Trial Unit, CCHDB, Wellington Hospital
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Timaru, Nya Zeeland, 7910
- Clinical Trials Unit, Timaru Hospital
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Auckland
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Papatoetoe, Auckland, Nya Zeeland, 2025
- Middlemore Clinical Trial
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Bialystok, Polen, 15-099
- Gabinet Internistyczno-Reumatologiczny Piotr Adrian Klimiuk
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Bialystok, Polen, 15-879
- ClinicMed
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Bydgoszcz, Polen, 85168
- Szpital Uniwersytecki Nr 2, Klinka Reumatologii I Ukladowych Chorob Tkanki Lacznej
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Bytom, Polen, 41-902
- Niepubliczny Zaklad Opieki Zdrowotnej BIF-MED S.C.
-
Dabrówka, Polen, 62096
- NSZOZ Unica CR
-
Elblag, Polen, 82300
- Centrum Kliniczno-Badawcze J. Brzezicki
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Gdynia, Polen, 81-338
- Centrum Medyczne Pratia Gdynia
-
Kartuzy, Polen, 83300
- NZOZ Centrum Medyczna Sw. Lukasza w Kartuzach
-
Katowice, Polen, 40-282
- SILMEDIC Spolka z ograniczona odpowiedzialnoscia w Swindniku, Oddzial w Katowicach
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Krakow, Polen, 31-637
- NZOZ Centrum Medyczne ProMiMed
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Nowa Sól, Polen, 67-100
- Twoja Przychodnia -Centrum Medyzcne Nowa Sol
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Poznan, Polen, 60-702
- Synexus Polska Sp. z.o.o. Oddzial w Porznaniu
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Poznan, Polen, 60-733
- Centrum Badan Klinicznych S.C. Wieslawa Porawska, Lukasz Porawski
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Poznan, Polen, 61-113
- AI Centrum Medyczne
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Tomaszów Lubelski, Polen, 22-600
- Samodzielny Publiczny Zespol Opieki Zdrowotnej w Tomaszowie Lubelskim Lubelskim; Oddzial Reumatologiczy
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Torun, Polen, 87100
- Nasz Lekarz Przychodnie Medyczne
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Warsaw, Polen, 02-691
- Reumatika -Centrum Reumatologii NZOZ
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Warsaw, Polen, 03291
- Centrum Medyczne AMED Warszawa Targówek
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Wroclaw, Polen, 52416
- Centrum Medyczne Oporow
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Bacau, Rumänien, 600114
- Spitalul Judetean de Urgenta Bacau, Sectia Reumatologie
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Bucharest, Rumänien, 010976
- S.C. Ianuli Med Consult S.R.L.
-
Bucharest, Rumänien, 011172
- Spitalul Clinic ,, Sf. Maria", Sectia Reumatologie
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Bucharest, Rumänien, 011172
- Spitalul Clinic,, Sf. Maria"", Departamentul de Medicina Interna si Reumatologie
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Târgu Mureş, Rumänien, 540136
- Spitalul Clinic Judetean de Urgenta Tirgu Mures
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Barnaul, Ryssland, 656024
- Territorial State Budgetary Healthcare Institution "Territorial Clinical Hospital"
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Chelyabinsk, Ryssland, 454076
- State Budgetary Healthcare Institution, Chelyabinsk Regional Clinical Hospital
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Kazan', Ryssland, 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, Ryssland, 650066
- Medical Center Maximum Zdorovia LLC
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Kemerovo, Ryssland, 650099
- Kemerovo State Medical University on the base of Regional Clinical Hospital for War Veterans
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Moscow, Ryssland, 111539
- Municipal Clinical Hospital No. 15 named after O.M. Filatov
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Moscow, Ryssland, 115093
- City Clinical Hospital #4 of Department of Healthcare of Moscow City
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Moscow, Ryssland, 129110
- M. Vladimirsky Moscow Regional Research Clinical Institute
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Moscow, Ryssland, 129301
- Municipal Clinical Hospital No. 40 Department of healthcare of Moscow City
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Nizhny Novgorod, Ryssland, 603005
- Nizhny Novgorod City Clinical Hospital #5
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Saint Petersburg, Ryssland, 190068
- Saint-Petersburg State Budgetary Healthcare Institution "Clinical rheumatology hospital # 25"
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Saint Petersburg, Ryssland, 192007
- LLC Polyclinic of Private Security Personnel
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Saratov, Ryssland, 410053
- State Healthcare Institution, Regional Clinical Hospital
-
Vladimir, Ryssland, 600005
- LLC BioMed
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Yaroslavl, Ryssland, 150003
- State Autonomous Healthcare Institution of Yaroslavl region "Clinical Hospital for Emergency Medical Care n. a. N. V. Solovyev"
-
-
-
-
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Belgrade, Serbien, 11000
- Institute of Rheumatology
-
Belgrade, Serbien, 11080
- Clinical Hospital Center Bezanijska Kosa
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Belgrade, Serbien, 11000
- Military Medical Academy, Clinic of Rheumatology
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Niška Banja, Serbien, 18205
- Institute for Treatment and Rehabilitation Niska Banja
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-
-
-
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Bratislava, Slovakien, 841 04
- Neštátna Reumatologická Ambulancia
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Rimavská Sobota, Slovakien, 97901
- Reumex S.R.O.
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Topoľčany, Slovakien, 95501
- LERAM s.r.o.
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-
-
-
-
A Coruña, Spanien, 15706
- Complejo Hospitalario Universitario de Santiago
-
Barakaldo, Spanien, 48903
- Hospital Universitario Cruces
-
Madrid, Spanien, 28034
- Hospital Universitario Ramon y Cajal
-
Madrid, Spanien, 28007
- Hospital General Universitario Gregorio Marañon
-
Málaga, Spanien, 29009
- Hospital Regional Universitario de Málaga
-
Sabadell, Spanien, 08208
- Corporacio Santiaria Parc Tauli
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Santiago de Compostela, Spanien, 15702
- Clinica Gaias
-
Santiago de Compostela, Spanien, 15705
- Hospital HM Nuestra Senora de la Esperanza
-
Valencia, Spanien, 46010
- Hospital Clinico Universitario de Valencia
-
-
-
-
-
Edinburgh, Storbritannien, EH4 2XU
- NHS Lothian, Western General Hospital
-
Harlow, Storbritannien, CM201QX
- Princess Alexandra Hospital
-
North Shields, Storbritannien, NE29 8NH
- Northumbria Healthcare NHS Foundation Trust
-
Warrington, Storbritannien, WA5 1QG
- Warrington and Halton Hospitals Nhs Foundation Trust
-
-
-
-
-
Cape Town, Sydafrika, 7505
- Arthritis Clinical Trial Centre
-
Durban, Sydafrika, 4001
- Netcare St. Augustine's Hospital
-
Durban, Sydafrika, 4319
- Umhlanga Netcare Medical Centre
-
Johannesburg, Sydafrika, 2193
- Charlotte Maxeke Johannesburg Academic Hospital
-
Stellenbosch, Sydafrika
- Winelands Medical Research Centre
-
-
-
-
-
Busan, Sydkorea, 49241
- Pusan National University Hospital
-
Daegu, Sydkorea, 42472
- Daegu Catholic University Medical Center
-
Daegu, Sydkorea, 41944
- Kyungpook National University Hospital
-
Daejeon, Sydkorea, 35015
- Chungnam National University Hospital
-
Daejeon, Sydkorea, 35233
- Eulji University Hospital
-
Gwangju, Sydkorea, 61469
- Chonnam National University Hospital
-
Incheon, Sydkorea, 22332
- Inha University Hospital
-
Jeonju, Sydkorea, 54907
- Chonbuk National University Medical School
-
Seoul, Sydkorea, 03080
- Seoul National University Hospital
-
Seoul, Sydkorea, 05505
- Asan Medical Center
-
Seoul, Sydkorea, 05030
- Konkuk University Medical Center
-
Seoul, Sydkorea, 04763
- Hanyang University Seoul Hospital
-
Seoul, Sydkorea, 07061
- SMG-SNU Boramae Medical Center
-
Seoul, Sydkorea, 06973
- Chung-Ang University Hospital Institutional Review Board
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-
-
-
-
Changhua, Taiwan, 500
- Changhua Christian Hospital
-
Kaohsiung City, Taiwan, 813
- Kaohsiung Veterans General Hospital
-
Keelung, Taiwan, 204
- Chang Gung Memorial Hospital, Keelung
-
Taichung, Taiwan, 404
- China Medical University Hospital
-
Taichung, Taiwan, 40201
- Chung Shan Medical University Hospital
-
Tainan, Taiwan, 710
- Chi Mei Hospital, Chi Mei Medical Center
-
Taipei, Taiwan, 100
- National Taiwan University Hospital
-
Taipei, Taiwan, 110
- Taipei Medical University Hospital
-
Taipei, Taiwan, 11490
- Tri-Service General Hospital
-
Taoyuan, Taiwan, 333
- Chang Gung Medical Foundation, Chang Gung Memorial Hospital, Linkou Branch
-
-
-
-
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Bangkok, Thailand, 10400
- Phramongkutklao Hospital, Division of Rheumatology, Department of Medicine
-
Bangkok, Thailand, 10400
- Rajavithi Hospital, Rheumatology and Allergy Unit
-
Bangkok, Thailand, 10700
- Faculty of Medicine Siriraj Hospital, Mahidol University, Division of Rheumatology, Department of Medicine
-
Chiang Mai, Thailand, 50200
- Maharaj Nakorn Chiang Mai Hospital, Faculty of Medicine, Chiang Mai University
-
Songkhla, Thailand, 90110
- Faculty of Medicine, Prince of Songkla University, Songklanagarind Hospital
-
-
-
-
-
Brno, Tjeckien, 60200
- MUDr. Michaela Blahova, revmatologicka ambulance s.r.o.
-
Hlučín, Tjeckien, 748 01
- L.K.N. Arthrocentrum, s.r.o.
-
Ostrava-Poruba, Tjeckien, 70800
- MUDr. Rosypalová, S.R.O.
-
Prague, Tjeckien, 12850
- Revmatologicky Ustav
-
Prague, Tjeckien, 140 00
- Revmatologicka ambulance
-
Prague, Tjeckien, 14000
- Revmatologicka ambulance, Nuselska Poliklinika
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Prague Praha 10, Tjeckien, 10100
- Arthrocentrum spol.s.r.o.
-
Uherské Hradiště, Tjeckien, 68601
- Medical Plus, S.R.O.
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-
-
-
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Aachen, Tyskland, 52064
- Rheumapraxis Dr. med. Reiner Kurthen
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Berlin, Tyskland, 14059
- Schlosspark-Klinik
-
Frankfurt am Main, Tyskland, 60590
- Centrum f. inn. Diagn. und Therap. Rheumatologie/Immunologie
-
Hamburg, Tyskland, 20095
- HRF II, Hamburger Rheuma Forsch. Zentrum II, MVZ f. Rheumatologie und Autoimmuned. Hamb. GmbH/ Dr. A. Everding GbR
-
Ratingen, Tyskland, 40878
- Rheumazentrum Ratungen-Studienambulanz GbR
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-
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-
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Dnipro, Ukraina, 49074
- Municipal Institution Dnipropetrovsk 6th City Clinical Hospital of Dnipropetrovsk Regional Council
-
Kharkiv, Ukraina, 61019
- Municipal Nonprofit Enterprise of the Kharkiv Regional Council, Regional Hospital for War Veterans, Department of Therapy #1
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Kharkiv, Ukraina, 61039
- State Institution "National Institute of Therapy named after L.T. Maloyi" of National Academy of Medical Sciences of Ukraine"
-
Kharkiv, Ukraina, 61058
- Municipal Institution of Heath Care "Regional Clinical Hospital-Center Of Emergency Medicine & Disaster Medicine"
-
Kharkiv, Ukraina, 61124
- Municipal Nonprofit Enterprise "City Clinical Hospital #13" of the Kharkiv City Council, Department of Therapy
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Kherson, Ukraina, 73000
- Minicipal Institution "Kherson City Clinical Hospital n. a. Afanasiy and Olga Tropinykh", Department of Therapy #1
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Kyiv, Ukraina, 01601
- Kyiv Oleksandrivska City Clinical Hospital, Department of Rheumatology # 2
-
Kyiv, Ukraina, 03126
- Kyiv City Clinical Hospital #6, Department of Therapy
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Kyiv, Ukraina, 03680
- State Institution National Scientific Center M.D. Strazhesko Institute of Cardiology of NAMS of Ukraine
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Kyiv, Ukraina, 04107
- Municipal Institution of Kyiv Regional Council "Kyiv Regional Clinical Hospital", Highly Specialized Therapeutic Department
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Lutsk, Ukraina, 43024
- Lutsk City Clinical Hospital
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Lviv, Ukraina, 79010
- Municipal Institution of Lviv Regional Council "Lviv Regional Clinical Hospital" Department of Rheumatology
-
Lviv, Ukraina, 79011
- Municipal Nonprofit Enterprise "4-th City Clinical Hospital in Lviv", Department of Rheumatology
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Odesa, Ukraina, 65025
- Municipal Institution Odesa Regional Clinical Hospital, Polyclinic Department
-
Vinnytsia, Ukraina, 21029
- City Clinical Hospital #1, Department of Rheumatology
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Vinnytsia, Ukraina, 21018
- Vinnytsya Regional Clinical Hospital named after M. I. Pyrogova, Department of Rheumatology
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Zaporizhzhya, Ukraina, 69005
- Medical Centre Modern Clinic, LLC
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Zaporizhzhya, Ukraina, 69104
- Municipal Institution "City Hospital #1", Department of Therapy
-
Zaporizhzhya, Ukraina, 69118
- Municipal Institution City Hospital #7, Department of Therapy
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-
-
-
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Budapest, Ungern, 1023
- Betegapolo-Irgalmasrend Budai Irgalmasrendi Korhaz
-
Budapest, Ungern, 1027
- Revita Reumatológiai Kft.
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Eger, Ungern, 3300
- Markhot Ferenc Oktatokorhaz es Rendelointezet; Reumatologiai Osztaly
-
Gyula, Ungern, 5700
- Bekes Megyei Kozponti Korhaz, Pandy Kalman Tagkorhaz, Reumatologiai Osztaly
-
Kalocsa, Ungern, 6300
- Bacs Kiskun Megyei Korhaz Szedgedi Tudomanyegyetem Altalanos Orvostudomanyi Kar Oktatokorhaz Kalocsai Szent Kereszt Korh
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Kistarcsa, Ungern, 2143
- Pest Megyei Flor Ferenc Korhaz, Reumatologiai-es Fizioterapias Osztaly
-
Szentes, Ungern, 6600
- Csongrad Megyei Dr. Bugyi Istvan Korhaz; Mozgasszervi Rehabilitacios Osztaly
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Székesfehérvár, Ungern, 8000
- C-Med Rehabilitacios es Diagnosztikai Kozpont. Reumatologia
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Beskrivning
Viktiga inkluderingskriterier:
Hanar eller kvinnor som kan ha nytta av filgotinib enligt bedömningen av utredaren OCH som genomförde en Gilead-sponsrad filgotinib-föräldrastudie för RA enligt beskrivningen nedan:
Har slutfört GS-US-417-0301, GS-US-417-0302 eller GS-US-417-0303 på studieläkemedlet
- ELLER
- Har slutfört GS-US-417-0302 på standardbehandling på grund av RA non-responder status
- Kvinnor i fertil ålder måste ha ett negativt graviditetstest före första dosen av studieläkemedlet i långtidsförlängning (LTE)
- Fertila män och kvinnor som deltar i heterosexuella samlag måste gå med på protokollgodkända preventivmetoder
Viktiga uteslutningskriterier:
- Diagnos av en annan autoimmun eller inflammatorisk ledsjukdom än RA, som skulle sätta deltagaren i riskzonen genom att delta i studien eller skulle störa studiebedömningar/datatolkning, enligt utredarens bedömning
- Känd överkänslighet mot studieläkemedlet eller dess hjälpämnen
- Varje medicinskt tillstånd som skulle utsätta deltagaren för risk genom att delta i studien eller skulle störa studiebedömningar/datatolkning, enligt utredarens bedömning
OBS: Andra protokolldefinierade kriterier för inkludering/uteslutning kan gälla.
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: Blindad fas: Filgotinib 200 mg
Filgotinib 200 mg plus placebo för att matcha (PTM) filgotinib 100 mg i upp till 6 år
|
Tablett(er) administreras oralt en gång dagligen
Andra namn:
Tablett(er) administreras oralt en gång dagligen
|
|
Experimentell: Blindad fas: Filgotinib 100 mg
Filgotinib 100 mg plus PTM filgotinib 200 mg i upp till 6 år
|
Tablett(er) administreras oralt en gång dagligen
Andra namn:
Tablett(er) administreras oralt en gång dagligen
|
|
Experimentell: Open Label Fas: Filgotinib 200 mg
Filgotinib 200 mg i upp till 6 år
|
Tablett(er) administreras oralt en gång dagligen
Andra namn:
|
|
Experimentell: Open Label Fas: Filgotinib 100 mg
Filgotinib 100 mg i upp till 6 år
|
Tablett(er) administreras oralt en gång dagligen
Andra namn:
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Number of Participants Who Reported Treatment-Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)
Tidsram: 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
Tidsram: 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
Tidsram: 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)
Tidsram: 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
Tidsram: 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
Tidsram: 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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Percentage of Participants Who Achieved American College of Rheumatology (ACR) for 20, 50 and 70
Tidsram: 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
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Samarbetspartners
Utredare
- Studierektor: Alfasigma Study Director, Alfasigma S.p.A.
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Allmänna publikationer
- 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.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
28 februari 2017
Primärt slutförande (Faktisk)
16 maj 2025
Avslutad studie (Faktisk)
16 maj 2025
Studieregistreringsdatum
Först inskickad
17 januari 2017
Först inskickad som uppfyllde QC-kriterierna
17 januari 2017
Första postat (Beräknad)
19 januari 2017
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
27 juli 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
29 juni 2026
Senast verifierad
1 juni 2026
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- GS-US-417-0304
- 2016-003630-25 (EudraCT-nummer)
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Ja
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
produkt tillverkad i och exporterad från U.S.A.
Nej
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .