Langsigtet forlængelsesundersøgelse for at vurdere sikkerheden og effektiviteten af filgotinib hos voksne med reumatoid arthritis (FINCH 4)
29. juni 2026 opdateret af: Alfasigma S.p.A.
Et multicenter, åbent, langsigtet forlængelsesstudie for at vurdere sikkerheden og effektiviteten af filgotinib hos personer med reumatoid arthritis
Det primære formål med denne undersøgelse er at evaluere den langsigtede sikkerhed og tolerabilitet af filgotinib hos deltagere, som har gennemført et af forældreundersøgelserne af filgotinib til behandling af reumatoid arthritis (RA).
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
2731
Fase
- Fase 3
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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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 Médico 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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Barrie, Canada, L4M6L2
- The Waterside Clinic
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Trois-Rivières, Canada, G8Z1Y2
- Centre de Recherche Musculo Squelettique
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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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Edinburgh, Det Forenede Kongerige, EH4 2XU
- NHS Lothian, Western General Hospital
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Harlow, Det Forenede Kongerige, CM201QX
- Princess Alexandra Hospital
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North Shields, Det Forenede Kongerige, NE29 8NH
- Northumbria Healthcare NHS Foundation Trust
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Warrington, Det Forenede Kongerige, WA5 1QG
- Warrington and Halton Hospitals Nhs Foundation Trust
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Alabama
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Huntsville, Alabama, Forenede Stater, 35801
- Rheumatology Associates of North Alabama, PC
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Arizona
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Gilbert, Arizona, Forenede Stater, 85234
- Arthrocare, Arthritis Care & Research PC
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Phoenix, Arizona, Forenede Stater, 85037
- Arizona Arthritis & Rheumatology Associates, P.C.
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Tucson, Arizona, Forenede Stater, 85704
- Arizona Arthritis & Rheumatology Associates, P.C.
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California
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Covina, California, Forenede Stater, 91722
- Medvin Clinical Research
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Hemet, California, Forenede Stater, 92543
- C.V. Mehta M.D. Medical Corporation
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La Jolla, California, Forenede Stater, 92037
- University of California San Diego (UCSD) - Perlman Ambulatory Clinic
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Los Angeles, California, Forenede Stater, 90033
- Keck Medicine of USC- Division of Rheumatology
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Palm Desert, California, Forenede Stater, 92260
- Desert Medical Advances
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Palo Alto, California, Forenede Stater, 94305
- Stanford University Hospitals and Clinics (Immunology & Rheumatology)
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Riverside, California, Forenede Stater, 92518
- C.V. Mehta Medical Corporation
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Upland, California, Forenede Stater, 91786
- Inland Rheumatology Clinical Trials, Inc.
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Victorville, California, Forenede Stater, 92395
- Desert Valley Medical Group
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Whittier, California, Forenede Stater, 90602
- Medvin Clinical Research
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Florida
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Aventura, Florida, Forenede Stater, 33180
- AARDS Research, Inc.
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Clearwater, Florida, Forenede Stater, 33765
- Clinical Research of West Florida, Inc.
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DeBary, Florida, Forenede Stater, 32713
- Omega Research Consultants, LLC
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Jacksonville, Florida, Forenede Stater, 32207
- University of Florida College of Medicine, Jacksonville - Rheumatology Research
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Miami, Florida, Forenede Stater, 33135
- Suncoast Research Group, LLC
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Miami Lakes, Florida, Forenede Stater, 33014
- San Marcus Research Clinic, Inc.
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New Port Richey, Florida, Forenede Stater, 34652
- Suncoast Clinical Research, Inc.
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Orlando, Florida, Forenede Stater, 32804
- Omega Research Consultants LLC
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Plantation, Florida, Forenede Stater, 33324
- IRIS Research and Development, LLC
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Georgia
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Decatur, Georgia, Forenede Stater, 30033
- Jefrey D. Lieberman, MD, P.C.
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Illinois
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Springfield, Illinois, Forenede Stater, 62702
- Springfield Clinic
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Kansas
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Kansas City, Kansas, Forenede Stater, 66160
- University of Kansas Medical Center
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Wichita, Kansas, Forenede Stater, 67207
- Heartland Research Associates, LLC
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Kentucky
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Elizabethtown, Kentucky, Forenede Stater, 42701
- Center For Arthritis and Osteoporosis
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Lexington, Kentucky, Forenede Stater, 40504
- Bluegrass Community Research, Inc.
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Maryland
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Cumberland, Maryland, Forenede Stater, 21502
- Klein & Associates, M.D., P.A.
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Frederick, Maryland, Forenede Stater, 21702
- Arthritis Treatment Center
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Hagerstown, Maryland, Forenede Stater, 21740
- Klein & Associates, M.D., P.A.
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Wheaton, Maryland, Forenede Stater, 20902
- The Center For Rheumatology And Bone Research
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Massachusetts
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Worcester, Massachusetts, Forenede Stater, 01605
- Clinical Pharmacology Study Group
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Worcester, Massachusetts, Forenede Stater, 01605
- Umass Memorial Medical Center- Memorial Campus
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Michigan
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Detroit, Michigan, Forenede Stater, 48202
- Henry Ford Health System
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Saint Clair Shores, Michigan, Forenede Stater, 48081
- Shores Rheumatology, PC
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Minnesota
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Eagan, Minnesota, Forenede Stater, 55121
- St. Paul Rheumatology, PA
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Mississippi
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Hattiesburg, Mississippi, Forenede Stater, 39402
- Arthritis Associates, PLLC
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Tupelo, Mississippi, Forenede Stater, 38801
- North Mississippi Medical Clinics, Inc.
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Missouri
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St Louis, Missouri, Forenede Stater, 63141
- Arthritis Consultants, Inc.
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St Louis, Missouri, Forenede Stater, 63117
- Clayton Medical Research, P.C.
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Nebraska
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Lincoln, Nebraska, Forenede Stater, 68516
- Physician Research Collaboration, LLC
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New Hampshire
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Lebanon, New Hampshire, Forenede Stater, 03756
- Dartmouth-Hitchcock Medical Center
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New Jersey
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Freehold, New Jersey, Forenede Stater, 07728
- Arthritis & Osteoporosis Associates
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Toms River, New Jersey, Forenede Stater, 08755
- Ocean Rheumatology, PA
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New Mexico
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Albuquerque, New Mexico, Forenede Stater, 87102
- Albuquerque Clinical Trials, Inc.
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New York
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Brooklyn, New York, Forenede Stater, 11201
- NYU Langone Ambulatory Care Brooklyn Heights
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Brooklyn, New York, Forenede Stater, 11201
- Weill Cornell Physicians At Brooklyn Heights
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North Carolina
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Charlotte, North Carolina, Forenede Stater, 28204
- Joint and Muscle Research Institute
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Greenville, North Carolina, Forenede Stater, 27834
- Physicians East, PA
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Salisbury, North Carolina, Forenede Stater, 28144
- PMG Research of Salisbury
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Ohio
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Middleburg Heights, Ohio, Forenede Stater, 44130
- Paramount Medical Research & Consulting, LLC
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Oklahoma
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Oklahoma City, Oklahoma, Forenede Stater, 73103
- Health Research of Oklahoma
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Tulsa, Oklahoma, Forenede Stater, 74104
- The Oklahoma Center For Arthritis Therapy & Research, Inc.
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Pennsylvania
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Bethlehem, Pennsylvania, Forenede Stater, 18015
- East Penn Rheumatology Associates
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Duncansville, Pennsylvania, Forenede Stater, 16635
- Altoona Center for Clinical Research
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Philadelphia, Pennsylvania, Forenede Stater, 19152
- Arthritis Group, PC
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Wyomissing, Pennsylvania, Forenede Stater, 19610
- PA Regional Center for Arthritis and Osteoporosis Research
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Wyomissing, Pennsylvania, Forenede Stater, 19610
- Clinical Research Center of Reading LLC
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South Carolina
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Columbia, South Carolina, Forenede Stater, 29204
- Articularis Healthcare Inc., dba Columbia Arthritis Center, PA
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Myrtle Beach, South Carolina, Forenede Stater, 29572
- Carolina Rheumatology & Neurology Assoc., PC
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Orangeburg, South Carolina, Forenede Stater, 29118
- Articularis Healthcare Group d/b/a ACME Research
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Summerville, South Carolina, Forenede Stater, 29486
- Articularis Healthcare Group d/b/a Low Country Rheumatology
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Tennessee
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Memphis, Tennessee, Forenede Stater, 38119
- Ramesh C. Gupta, M.D.
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Texas
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Beaumont, Texas, Forenede Stater, 77701
- Diagnostic Group
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Carrollton, Texas, Forenede Stater, 75007
- Trinity Universal Research Associates, Inc
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Corpus Christi, Texas, Forenede Stater, 78404
- Adriana Pop-Moody MD Clinic PA
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Dallas, Texas, Forenede Stater, 75246
- Arthritis Centers Of Texas
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Mesquite, Texas, Forenede Stater, 75150
- Southwest Rheumatology Research, LLC
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Plano, Texas, Forenede Stater, 75024
- Trinity Universal Research Associates, Inc
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San Antonio, Texas, Forenede Stater, 78232
- Arthritis & Osteoporosis Center of South Texas
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Montpellier, Frankrig, 34295
- Hôpital Lapeyronie, Service d'Immuno-Rhumatologic
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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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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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Chihuahua City, Mexico, 31000
- Investigacion y Biomedicina de Chihuahua, S.C.
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Mexico City, Mexico, 06700
- Clinstile, S.A. de C.V.
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Mexico City, Mexico, 06760
- Clinosar Mexico. S.A. de C. V.
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Monterrey, Mexico, 64460
- Hospital Universitario Dr. Jose Eleuterio González
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Mérida, Mexico, 97000
- Centro Peninsular De Investigacion Clinica S.C.P.
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México, Mexico, 06700
- Biologicos Especializados
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Michoacán
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Morelia, Michoacán, Mexico, 58070
- Centro De Investigación Clínica De Morelia, Sc
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Yucatán
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Mérida, Yucatán, Mexico, 97070
- Kohler & Milstein Research S.A. De C.V.
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Auckland, New Zealand, 1010
- Optimal Clinical Trials, Level 2
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Hamilton, New Zealand, 3240
- Waikato Hospital
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Newtown, New Zealand, 6021
- Clinical Trial Unit, CCHDB, Wellington Hospital
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Timaru, New Zealand, 7910
- Clinical Trials Unit, Timaru Hospital
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Auckland
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Papatoetoe, Auckland, New Zealand, 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.
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Dabrówka, Polen, 62096
- NSZOZ Unica CR
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Elblag, Polen, 82300
- Centrum Kliniczno-Badawcze J. Brzezicki
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Gdynia, Polen, 81-338
- Centrum Medyczne Pratia Gdynia
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Kartuzy, Polen, 83300
- NZOZ Centrum Medyczna Sw. Lukasza w Kartuzach
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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, Rumænien, 600114
- Spitalul Judetean de Urgenta Bacau, Sectia Reumatologie
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Bucharest, Rumænien, 010976
- S.C. Ianuli Med Consult S.R.L.
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Bucharest, Rumænien, 011172
- Spitalul Clinic ,, Sf. Maria", Sectia Reumatologie
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Bucharest, Rumænien, 011172
- Spitalul Clinic,, Sf. Maria"", Departamentul de Medicina Interna si Reumatologie
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Târgu Mureş, Rumænien, 540136
- Spitalul Clinic Judetean de Urgenta Tirgu Mures
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Barnaul, Rusland, 656024
- Territorial State Budgetary Healthcare Institution "Territorial Clinical Hospital"
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Chelyabinsk, Rusland, 454076
- State Budgetary Healthcare Institution, Chelyabinsk Regional Clinical Hospital
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Kazan', Rusland, 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, Rusland, 650066
- Medical Center Maximum Zdorovia LLC
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Kemerovo, Rusland, 650099
- Kemerovo State Medical University on the base of Regional Clinical Hospital for War Veterans
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Moscow, Rusland, 111539
- Municipal Clinical Hospital No. 15 named after O.M. Filatov
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Moscow, Rusland, 115093
- City Clinical Hospital #4 of Department of Healthcare of Moscow City
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Moscow, Rusland, 129110
- M. Vladimirsky Moscow Regional Research Clinical Institute
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Moscow, Rusland, 129301
- Municipal Clinical Hospital No. 40 Department of healthcare of Moscow City
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Nizhny Novgorod, Rusland, 603005
- Nizhny Novgorod City Clinical Hospital #5
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Saint Petersburg, Rusland, 190068
- Saint-Petersburg State Budgetary Healthcare Institution "Clinical rheumatology hospital # 25"
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Saint Petersburg, Rusland, 192007
- LLC Polyclinic of Private Security Personnel
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Saratov, Rusland, 410053
- State Healthcare Institution, Regional Clinical Hospital
-
Vladimir, Rusland, 600005
- LLC BioMed
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Yaroslavl, Rusland, 150003
- State Autonomous Healthcare Institution of Yaroslavl region "Clinical Hospital for Emergency Medical Care n. a. N. V. Solovyev"
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-
-
-
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Belgrade, Serbien, 11000
- Institute of Rheumatology
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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, Slovakiet, 841 04
- Neštátna Reumatologická Ambulancia
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Rimavská Sobota, Slovakiet, 97901
- Reumex S.R.O.
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Topoľčany, Slovakiet, 95501
- LERAM s.r.o.
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-
-
-
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A Coruña, Spanien, 15706
- Complejo Hospitalario Universitario de Santiago
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Barakaldo, Spanien, 48903
- Hospital Universitario Cruces
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Madrid, Spanien, 28034
- Hospital Universitario Ramon y Cajal
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Madrid, Spanien, 28007
- Hospital General Universitario Gregorio Marañón
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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
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Valencia, Spanien, 46010
- Hospital Clínico Universitario de Valencia
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-
-
-
-
Cape Town, Sydafrika, 7505
- Arthritis Clinical Trial Centre
-
Durban, Sydafrika, 4001
- Netcare St. Augustine's Hospital
-
Durban, Sydafrika, 4319
- Umhlanga Netcare Medical Centre
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Johannesburg, Sydafrika, 2193
- Charlotte Maxeke Johannesburg Academic Hospital
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Stellenbosch, Sydafrika
- Winelands Medical Research Centre
-
-
-
-
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Busan, Sydkorea, 49241
- Pusan National University Hospital
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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
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Seoul, Sydkorea, 03080
- Seoul National University Hospital
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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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-
-
-
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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
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Taipei, Taiwan, 11490
- Tri-Service General Hospital
-
Taoyuan, Taiwan, 333
- Chang Gung Medical Foundation, Chang Gung Memorial Hospital, Linkou Branch
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-
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Bangkok, Thailand, 10400
- Phramongkutklao Hospital, Division of Rheumatology, Department of Medicine
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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
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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
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-
-
-
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Brno, Tjekkiet, 60200
- MUDr. Michaela Blahova, revmatologicka ambulance s.r.o.
-
Hlučín, Tjekkiet, 748 01
- L.K.N. Arthrocentrum, s.r.o.
-
Ostrava-Poruba, Tjekkiet, 70800
- MUDr. Rosypalová, S.R.O.
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Prague, Tjekkiet, 12850
- Revmatologicky Ustav
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Prague, Tjekkiet, 140 00
- Revmatologicka ambulance
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Prague, Tjekkiet, 14000
- Revmatologicka ambulance, Nuselska Poliklinika
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Prague Praha 10, Tjekkiet, 10100
- Arthrocentrum spol.s.r.o.
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Uherské Hradiště, Tjekkiet, 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
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Frankfurt am Main, Tyskland, 60590
- Centrum f. inn. Diagn. und Therap. Rheumatologie/Immunologie
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Hamburg, Tyskland, 20095
- HRF II, Hamburger Rheuma Forsch. Zentrum II, MVZ f. Rheumatologie und Autoimmuned. Hamb. GmbH/ Dr. A. Everding GbR
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Ratingen, Tyskland, 40878
- Rheumazentrum Ratungen-Studienambulanz GbR
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-
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Dnipro, Ukraine, 49074
- Municipal Institution Dnipropetrovsk 6th City Clinical Hospital of Dnipropetrovsk Regional Council
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Kharkiv, Ukraine, 61019
- Municipal Nonprofit Enterprise of the Kharkiv Regional Council, Regional Hospital for War Veterans, Department of Therapy #1
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Kharkiv, Ukraine, 61039
- State Institution "National Institute of Therapy named after L.T. Maloyi" of National Academy of Medical Sciences of Ukraine"
-
Kharkiv, Ukraine, 61058
- Municipal Institution of Heath Care "Regional Clinical Hospital-Center Of Emergency Medicine & Disaster Medicine"
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Kharkiv, Ukraine, 61124
- Municipal Nonprofit Enterprise "City Clinical Hospital #13" of the Kharkiv City Council, Department of Therapy
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Kherson, Ukraine, 73000
- Minicipal Institution "Kherson City Clinical Hospital n. a. Afanasiy and Olga Tropinykh", Department of Therapy #1
-
Kyiv, Ukraine, 01601
- Kyiv Oleksandrivska City Clinical Hospital, Department of Rheumatology # 2
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Kyiv, Ukraine, 03126
- Kyiv City Clinical Hospital #6, Department of Therapy
-
Kyiv, Ukraine, 03680
- State Institution National Scientific Center M.D. Strazhesko Institute of Cardiology of NAMS of Ukraine
-
Kyiv, Ukraine, 04107
- Municipal Institution of Kyiv Regional Council "Kyiv Regional Clinical Hospital", Highly Specialized Therapeutic Department
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Lutsk, Ukraine, 43024
- Lutsk City Clinical Hospital
-
Lviv, Ukraine, 79010
- Municipal Institution of Lviv Regional Council "Lviv Regional Clinical Hospital" Department of Rheumatology
-
Lviv, Ukraine, 79011
- Municipal Nonprofit Enterprise "4-th City Clinical Hospital in Lviv", Department of Rheumatology
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Odesa, Ukraine, 65025
- Municipal Institution Odesa Regional Clinical Hospital, Polyclinic Department
-
Vinnytsia, Ukraine, 21029
- City Clinical Hospital #1, Department of Rheumatology
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Vinnytsia, Ukraine, 21018
- Vinnytsya Regional Clinical Hospital named after M. I. Pyrogova, Department of Rheumatology
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Zaporizhzhya, Ukraine, 69005
- Medical Centre Modern Clinic, LLC
-
Zaporizhzhya, Ukraine, 69104
- Municipal Institution "City Hospital #1", Department of Therapy
-
Zaporizhzhya, Ukraine, 69118
- Municipal Institution City Hospital #7, Department of Therapy
-
-
-
-
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Budapest, Ungarn, 1023
- Betegapolo-Irgalmasrend Budai Irgalmasrendi Korhaz
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Budapest, Ungarn, 1027
- Revita Reumatológiai Kft.
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Eger, Ungarn, 3300
- Markhot Ferenc Oktatokorhaz es Rendelointezet; Reumatologiai Osztaly
-
Gyula, Ungarn, 5700
- Bekes Megyei Kozponti Korhaz, Pandy Kalman Tagkorhaz, Reumatologiai Osztaly
-
Kalocsa, Ungarn, 6300
- Bacs Kiskun Megyei Korhaz Szedgedi Tudomanyegyetem Altalanos Orvostudomanyi Kar Oktatokorhaz Kalocsai Szent Kereszt Korh
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Kistarcsa, Ungarn, 2143
- Pest Megyei Flor Ferenc Korhaz, Reumatologiai-es Fizioterapias Osztaly
-
Szentes, Ungarn, 6600
- Csongrad Megyei Dr. Bugyi Istvan Korhaz; Mozgasszervi Rehabilitacios Osztaly
-
Székesfehérvár, Ungarn, 8000
- C-Med Rehabilitacios es Diagnosztikai Kozpont. Reumatologia
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Beskrivelse
Nøgleinklusionskriterier:
Mænd eller kvinder, der kan have gavn af filgotinib som vurderet af investigator, OG som gennemførte en Gilead-sponsoreret filgotinib-forælderundersøgelse for RA som beskrevet nedenfor:
Har gennemført GS-US-417-0301, GS-US-417-0302 eller GS-US-417-0303 på studielægemidlet
- ELLER
- Har gennemført GS-US-417-0302 på standardbehandling på grund af RA non-responder status
- Kvinder i den fødedygtige alder skal have en negativ graviditetstest før første dosis af undersøgelseslægemidlet i den langsigtede forlængelse (LTE)
- Mænd og kvinder i den fødedygtige alder, der deltager i heteroseksuelt samleje, skal acceptere protokol-godkendte præventionsmetoder
Nøgleekskluderingskriterier:
- Diagnose af en anden autoimmun eller inflammatorisk ledsygdom end RA, som ville sætte deltageren i fare ved at deltage i undersøgelsen eller ville forstyrre undersøgelsesvurderinger/datafortolkning, efter investigators vurdering
- Kendt overfølsomhed over for undersøgelseslægemidlet eller dets hjælpestoffer
- Enhver medicinsk tilstand, der ville bringe deltageren i fare ved at deltage i undersøgelsen eller ville forstyrre undersøgelsesvurderinger/datafortolkning, efter investigatorens vurdering
BEMÆRK: Andre protokoldefinerede inklusions-/eksklusionskriterier kan være gældende.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Blindfase: Filgotinib 200 mg
Filgotinib 200 mg plus placebo til match (PTM) filgotinib 100 mg i op til 6 år
|
Tabletter indgivet oralt én gang dagligt
Andre navne:
Tabletter indgivet oralt én gang dagligt
|
|
Eksperimentel: Blindfase: Filgotinib 100 mg
Filgotinib 100 mg plus PTM filgotinib 200 mg i op til 6 år
|
Tabletter indgivet oralt én gang dagligt
Andre navne:
Tabletter indgivet oralt én gang dagligt
|
|
Eksperimentel: Open Label fase: Filgotinib 200 mg
Filgotinib 200 mg i op til 6 år
|
Tabletter indgivet oralt én gang dagligt
Andre navne:
|
|
Eksperimentel: Open Label fase: Filgotinib 100 mg
Filgotinib 100 mg i op til 6 år
|
Tabletter indgivet oralt én gang dagligt
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Number of Participants Who Reported Treatment-Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Percentage of Participants Who Achieved American College of Rheumatology (ACR) for 20, 50 and 70
Tidsramme: 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
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Efterforskere
- Studieleder: Alfasigma Study Director, Alfasigma S.p.A.
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle 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.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
28. februar 2017
Primær færdiggørelse (Faktiske)
16. maj 2025
Studieafslutning (Faktiske)
16. maj 2025
Datoer for studieregistrering
Først indsendt
17. januar 2017
Først indsendt, der opfyldte QC-kriterier
17. januar 2017
Først opslået (Anslået)
19. januar 2017
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
27. juli 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
29. juni 2026
Sidst verificeret
1. juni 2026
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- GS-US-417-0304
- 2016-003630-25 (EudraCT nummer)
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ja
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
produkt fremstillet i og eksporteret fra U.S.A.
Ingen
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .