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Langsiktig utvidelsesstudie for å vurdere sikkerheten og effekten av filgotinib hos voksne med revmatoid artritt (FINCH 4)

1. juli 2025 oppdatert av: Alfasigma S.p.A.

En multisenter, åpen, langsiktig utvidelsesstudie for å vurdere sikkerheten og effekten av filgotinib hos personer med revmatoid artritt

Hovedmålet med denne studien er å evaluere den langsiktige sikkerheten og toleransen til filgotinib hos deltakere som har fullført en av foreldrestudiene med filgotinib ved revmatoid artritt (RA).

Studieoversikt

Studietype

Intervensjonell

Registrering (Faktiske)

2731

Fase

  • Fase 3

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

      • Buenos Aires, Argentina, B1824KAJ
        • CIMeL
      • Ciudad Autonoma, Argentina, C1114AHH
        • Investigaciones Reumatologicas Y Osteologicas (IRO) SRL
      • Ciudad Autonoma Buenos Aires, Argentina, C1015ABO
        • Onganizacion Medica de Investigacion S.A (OMI)
      • Ciudad Autonoma Buenos Aires, Argentina, C1128AAF
        • Mautalen Salud e Investigación
      • Ciudad Autonoma de Buenos Aire, Argentina, C1428DZF
        • Consultorios Reumatológicos Pampa
      • Mendoza, Argentina, 5500
        • Instituto de Reumatologia
      • Quilmes, Argentina, B1878DVB
        • Instituto Médico CER
      • San Isidro, Argentina
        • Instituto Iari
      • San Juan, Argentina, CP5400
        • CER San Juan, Centro Polivalente de Asistencia e Investigacion Clinica
      • San Miguel de Tucuman, Argentina, T4000AXL
        • Centro Médico Privado de Reumatología
    • Buenos Aires
      • Ciudad Autonoma, Buenos Aires, Argentina, 1425
        • Ceim Investigaciones Medicas Srl
      • Hobart, Australia, 7000
        • Southern Clinical Research Pty Ltd
    • Queensland
      • Maroochydore, Queensland, Australia, 4558
        • Rheumatology Research Unit
    • Western Australia
      • Victoria Park, Western Australia, Australia, 6100
        • RK Will Pty Ltd
      • Brussels, Belgia, 1200
        • Cliniques universitaires Saint-Luc
      • Genk, Belgia, 3600
        • ReumaClinic Genk
      • Leuven, Belgia, 3000
        • Universitaire Ziekenhuizen (UZ) Leuven - Gasthuisberg
      • Merksem, Belgia, 2170
        • ZNA Jan Palfijn
      • Dobrich, Bulgaria, 9300
        • "Medical Center Help" EOOD
      • Haskovo, Bulgaria, 6300
        • "Medical Center- Hipokrat 2000" OOD
      • Plovdiv, Bulgaria, 4001
        • "UMHAT - Kaspela" EOOD
      • Sofia, Bulgaria, 1336
        • "MHAT Lyulin" EAD, Department of Rheumatology
      • Sofia, Bulgaria, 1612
        • Medical Center "N. I. Pirogov" EOOD
      • Varna, Bulgaria, 9000
        • "DCC Equita" EOOD
      • Vidin, Bulgaria, 3700
        • MHAT "Sveta Petka" AD, Department of Internal Diseases
      • Barrie, Canada, L4M6L2
        • The Waterside Clinic
      • Trois Rivieres, Canada, G8Z1Y2
        • Centre de Recherche Musculo Squelettique
      • Santiago, Chile, 7500588
        • Quantum Research Santiago
      • Santiago, Chile, 7510186
        • Someal SA
      • Temuco, Chile, 4790928
        • Centro Medico De Reumatologia
      • Barnaul, Den russiske føderasjonen, 656024
        • Territorial State Budgetary Healthcare Institution "Territorial Clinical Hospital"
      • Chelyabinsk, Den russiske føderasjonen, 454076
        • State Budgetary Healthcare Institution, Chelyabinsk Regional Clinical Hospital
      • Kazan, Den russiske føderasjonen, 420103
        • FSBEI of HE "Kazan State Medical University" of Ministry of Healthcare of the Russia Federation, Department of hospital therapy
      • Kemerovo, Den russiske føderasjonen, 650066
        • Medical Center Maximum Zdorovia LLC
      • Kemerovo, Den russiske føderasjonen, 650099
        • Kemerovo State Medical University on the base of Regional Clinical Hospital for War Veterans
      • Moscow, Den russiske føderasjonen, 111539
        • Municipal Clinical Hospital No. 15 named after O.M. Filatov
      • Moscow, Den russiske føderasjonen, 115093
        • City Clinical Hospital #4 of Department of Healthcare of Moscow City
      • Moscow, Den russiske føderasjonen, 129110
        • M. Vladimirsky Moscow Regional Research Clinical Institute
      • Moscow, Den russiske føderasjonen, 129301
        • Municipal Clinical Hospital No. 40 Department of healthcare of Moscow City
      • Nizhny Novgorod, Den russiske føderasjonen, 603005
        • Nizhny Novgorod City Clinical Hospital #5
      • Saint Petersburg, Den russiske føderasjonen, 190068
        • Saint-Petersburg State Budgetary Healthcare Institution "Clinical rheumatology hospital # 25"
      • Saratov, Den russiske føderasjonen, 410053
        • State Healthcare Institution, Regional Clinical Hospital
      • St.Petersburg, Den russiske føderasjonen, 192007
        • LLC Polyclinic of Private Security Personnel
      • Vladimir, Den russiske føderasjonen, 600005
        • LLC BioMed
      • Yaroslavl, Den russiske føderasjonen, 150003
        • State Autonomous Healthcare Institution of Yaroslavl region "Clinical Hospital for Emergency Medical Care n. a. N. V. Solovyev"
    • Alabama
      • Huntsville, Alabama, Forente stater, 35801
        • Rheumatology Associates of North Alabama, PC
    • Arizona
      • Gilbert, Arizona, Forente stater, 85234
        • Arthrocare, Arthritis Care & Research PC
      • Phoenix, Arizona, Forente stater, 85037
        • Arizona Arthritis & Rheumatology Associates, P.C.
      • Tucson, Arizona, Forente stater, 85704
        • Arizona Arthritis & Rheumatology Associates, P.C.
    • California
      • Covina, California, Forente stater, 91722
        • Medvin Clinical Research
      • Hemet, California, Forente stater, 92543
        • C.V. Mehta M.D. Medical Corporation
      • La Jolla, California, Forente stater, 92037
        • University of California San Diego (UCSD) - Perlman Ambulatory Clinic
      • Los Angeles, California, Forente stater, 90033
        • Keck Medicine of USC- Division of Rheumatology
      • Palm Desert, California, Forente stater, 92260
        • Desert Medical Advances
      • Palo Alto, California, Forente stater, 94305
        • Stanford University Hospitals and Clinics (Immunology & Rheumatology)
      • Riverside, California, Forente stater, 92518
        • C.V. Mehta Medical Corporation
      • Upland, California, Forente stater, 91786
        • Inland Rheumatology Clinical Trials, Inc.
      • Victorville, California, Forente stater, 92395
        • Desert Valley Medical Group
      • Whittier, California, Forente stater, 90602
        • Medvin Clinical Research
    • Florida
      • Aventura, Florida, Forente stater, 33180
        • AARDS Research, Inc.
      • Clearwater, Florida, Forente stater, 33765
        • Clinical Research of West Florida, Inc.
      • Debary, Florida, Forente stater, 32713
        • Omega Research Consultants, LLC
      • Jacksonville, Florida, Forente stater, 32207
        • University of Florida College of Medicine, Jacksonville - Rheumatology Research
      • Miami, Florida, Forente stater, 33135
        • Suncoast Research Group, LLC
      • Miami Lakes, Florida, Forente stater, 33014
        • San Marcus Research Clinic, Inc.
      • New Port Richey, Florida, Forente stater, 34652
        • Suncoast Clinical Research, Inc.
      • Orlando, Florida, Forente stater, 32804
        • Omega Research Consultants LLC
      • Plantation, Florida, Forente stater, 33324
        • IRIS Research and Development, LLC
    • Georgia
      • Decatur, Georgia, Forente stater, 30033
        • Jefrey D. Lieberman, MD, P.C.
    • Illinois
      • Springfield, Illinois, Forente stater, 62702
        • Springfield Clinic
    • Kansas
      • Kansas City, Kansas, Forente stater, 66160
        • University of Kansas Medical Center
      • Wichita, Kansas, Forente stater, 67207
        • Heartland Research Associates, LLC
    • Kentucky
      • Elizabethtown, Kentucky, Forente stater, 42701
        • Center for Arthritis and Osteoporosis
      • Lexington, Kentucky, Forente stater, 40504
        • Bluegrass Community Research, Inc.
    • Maryland
      • Cumberland, Maryland, Forente stater, 21502
        • Klein & Associates, M.D., P.A.
      • Frederick, Maryland, Forente stater, 21702
        • Arthritis Treatment Center
      • Hagerstown, Maryland, Forente stater, 21740
        • Klein & Associates, M.D., P.A.
      • Wheaton, Maryland, Forente stater, 20902
        • The Center for Rheumatology and Bone Research
    • Massachusetts
      • Worcester, Massachusetts, Forente stater, 01605
        • Clinical Pharmacology Study Group
      • Worcester, Massachusetts, Forente stater, 01605
        • UMass Memorial Medical Center- Memorial Campus
    • Michigan
      • Detroit, Michigan, Forente stater, 48202
        • Henry Ford Health System
      • Saint Clair Shores, Michigan, Forente stater, 48081
        • Shores Rheumatology, PC
    • Minnesota
      • Eagan, Minnesota, Forente stater, 55121
        • St. Paul Rheumatology, PA
    • Mississippi
      • Hattiesburg, Mississippi, Forente stater, 39402
        • Arthritis Associates, PLLC
      • Tupelo, Mississippi, Forente stater, 38801
        • North Mississippi Medical Clinics, Inc.
    • Missouri
      • Saint Louis, Missouri, Forente stater, 63141
        • Arthritis Consultants, Inc.
      • Saint Louis, Missouri, Forente stater, 63117
        • Clayton Medical Research, P.C.
    • Nebraska
      • Lincoln, Nebraska, Forente stater, 68516
        • Physician Research Collaboration, LLC
    • New Hampshire
      • Lebanon, New Hampshire, Forente stater, 03756
        • Dartmouth-Hitchcock Medical Center
    • New Jersey
      • Freehold, New Jersey, Forente stater, 07728
        • Arthritis & Osteoporosis Associates
      • Toms River, New Jersey, Forente stater, 08755
        • Ocean Rheumatology, PA
    • New Mexico
      • Albuquerque, New Mexico, Forente stater, 87102
        • Albuquerque Clinical Trials, Inc.
    • New York
      • Brooklyn, New York, Forente stater, 11201
        • NYU Langone Ambulatory Care Brooklyn Heights
      • Brooklyn, New York, Forente stater, 11201
        • Weill Cornell Physicians At Brooklyn Heights
    • North Carolina
      • Charlotte, North Carolina, Forente stater, 28204
        • Joint and Muscle Research Institute
      • Greenville, North Carolina, Forente stater, 27834
        • Physicians East, PA
      • Salisbury, North Carolina, Forente stater, 28144
        • PMG Research of Salisbury
    • Ohio
      • Middleburg Heights, Ohio, Forente stater, 44130
        • Paramount Medical Research & Consulting, LLC
    • Oklahoma
      • Oklahoma City, Oklahoma, Forente stater, 73103
        • Health Research of Oklahoma
      • Tulsa, Oklahoma, Forente stater, 74104
        • The Oklahoma Center For Arthritis Therapy & Research, Inc.
    • Pennsylvania
      • Bethlehem, Pennsylvania, Forente stater, 18015
        • East Penn Rheumatology Associates
      • Duncansville, Pennsylvania, Forente stater, 16635
        • Altoona Center for Clinical Research
      • Philadelphia, Pennsylvania, Forente stater, 19152
        • Arthritis Group, PC
      • Wyomissing, Pennsylvania, Forente stater, 19610
        • PA Regional Center for Arthritis and Osteoporosis Research
      • Wyomissing, Pennsylvania, Forente stater, 19610
        • Clinical Research Center of Reading LLC
    • South Carolina
      • Columbia, South Carolina, Forente stater, 29204
        • Articularis Healthcare Inc., dba Columbia Arthritis Center, PA
      • Myrtle Beach, South Carolina, Forente stater, 29572
        • Carolina Rheumatology & Neurology Assoc., PC
      • Orangeburg, South Carolina, Forente stater, 29118
        • Articularis Healthcare Group d/b/a ACME Research
      • Summerville, South Carolina, Forente stater, 29486
        • Articularis Healthcare Group d/b/a Low Country Rheumatology
    • Tennessee
      • Memphis, Tennessee, Forente stater, 38119
        • Ramesh C. Gupta, M.D.
    • Texas
      • Beaumont, Texas, Forente stater, 77701
        • Diagnostic Group
      • Carrollton, Texas, Forente stater, 75007
        • Trinity Universal Research Associates, Inc
      • Corpus Christi, Texas, Forente stater, 78404
        • Adriana Pop-Moody MD Clinic PA
      • Dallas, Texas, Forente stater, 75246
        • Arthritis Centers Of Texas
      • Mesquite, Texas, Forente stater, 75150
        • SouthWest Rheumatology Research, LLC
      • Plano, Texas, Forente stater, 75024
        • Trinity Universal Research Associates, Inc
      • San Antonio, Texas, Forente stater, 78232
        • Arthritis & Osteoporosis Center of South Texas
      • Montpellier Cedex 5, Frankrike, 34295
        • Hôpital Lapeyronie, Service d'Immuno-Rhumatologic
      • Hong Kong, Hong Kong
        • Department of Medicine & Theraputics, The Chinese University of Hong Kong
      • Hong Kong, Hong Kong
        • Department of Medicine, Queen Mary Hospital
      • Hong Kong, Hong Kong
        • Tuen Mun Hospital
      • Ahmedabad, India, 380005
        • Panchshil Hospital, Dep
      • Ahmedabad, India, 380016
        • B.J. Medical College and Civil Hospital
      • Bangalore, India, 560010
        • ChanRe Rheumatology and Immunology Centre and Research
      • Chennai, India, 600004
        • Chennai Meenakshi Multispeciality Hospital Ltd
      • Delhi, India, 110029
        • All India Institute of Medical Sciences
      • Gurgaon, India, 122001
        • Medanta - The Medicity
      • Hyderabad, India, 500004
        • Gleneagles Global Hospitals
      • Hyderabad, India, 50082
        • Nizams Institute of Medical Sciences
      • Jaipur, India, 302001
        • Shri Nidaan Hospital and Hope Fertility Centre
      • Jaipur, India, 302001
        • SR Kalla Memorial Gastro and General Hospital
      • Jaipur, India, 302015
        • Santokba Durlabhji Memorial Hospital Cum Medical Research Institute
      • Kolkata, India, 700 054
        • Apollo Gleneagles Hospitals, Kolkata
      • Kolkata, India, 700073
        • Medical College & Hospital, Kolkata
      • Lucknow, India, 226018
        • Department of Rheumatology, KG Medical University
      • Mangalore, India, 575001
        • Kasturba Medical College Hospital
      • Mangalore, India, 575003
        • Vinaya Hospital and Research Centre
      • Mysuru, India, 570004
        • JSS Medical College and Hospital
      • Nagpur, India, 440012
        • Suretech Hospital and Research Centre Pvt Ltd
      • New Delhi, India, 110060
        • Sir Ganga Ram Hospital
      • New Delhi, India, 110026
        • Maharaja Agrasen Hospital
      • Pune, India, 411001
        • Centre for Rheumatic Disease, Hermes Doctor House
      • Pune, India, 411004
        • Deenanath Mangeshkar Hospital and Research Centre
      • Secunderabad, India
        • Krishna Institute of Medical Sciences
      • Srikakulam, India, 532001
        • Rajiv Gandhi Institute of Medical Sciences and Government General Hospital
      • Surat, India, 395002
        • Nirmal Hospital Private Limited
      • Vadodara, India, 390001
        • Medical College Baroda and Sir Sayajirao General Hospital
      • Visakhapatnam, India, 530002
        • King George Hospital
      • Dublin, Irland, DUBLIN 4
        • St Vincent's University Hospital
      • Haifa, Israel, 3339419
        • Bnai Zion Medical Center
      • Haifa, Israel, 3436212
        • The Lady Davis Carmel Medical Center
      • Petah Tikva, Israel, 4941492
        • Rabin Medical Center
      • Ramat Gan, Israel, 5265601
        • The Chaim Sheba Medical Center
      • Tel Aviv, Israel, 6423906
        • Tel Aviv Medical Center
      • Bologna, Italia, 40138
        • Departimento Cardio-toraco-vascolare Gestione delle Malattie Reumatiche e del Connettivo e Malattie Metaboliche dell'osso
      • Milano, Italia, 20157
        • Reumatologia
      • Chiba-shi, Japan, 2608677
        • Chiba University Hospital
      • Fukuoka, Japan, 810-8563
        • National Hospital Organization Kyushu Medical Center
      • Fukuoka, Japan, 810-8563
        • Kyushu Medical Center
      • Hamamatsu, Japan, 430-8558
        • Seirei Hamamatsu General Hospital
      • Hiroshima, Japan, 730-8619
        • Hiroshima Red Cross Hospital & Atomic-bomb Survivors Hospital
      • Hiroshima, Japan, 734-8551
        • Hiroshima University Hospital
      • Hiroshima-shi, Japan, 730-0017
        • Hiroshima Rheumatology Clinic
      • Iizuka-shi, Japan, 820-8505
        • Iizuka Hospital
      • Iruma-gun, Japan, 350-0495
        • Saitama Medical University Hospital
      • Izumo, Japan, 693-8501
        • Shimane University Hospital
      • Kagoshima-shi, Japan, 891-0133
        • Kagoshima red cross hospital
      • Kato, Japan, 673-1462
        • Matsubara Mayflower Hospital
      • Kawagoe, Japan, 350-8550
        • Saitama Medical Center
      • Kitakyushu-shi, Japan, 807-8556
        • Hospital of the University of Occupational and Environmental Health, Japan
      • Kobe, Japan, 650-0017
        • Kobe University Hospital
      • Kumamoto-shi, Japan, 862-0975
        • Kumamoto Orthopaedic Hospital
      • Kurume-shi, Japan, 839-0863
        • Kurume University Medical Center
      • Kyoto, Japan, 602-8566
        • University Hospital, Kyoto Prefectural University of Medicine
      • Kyoto-shi, Japan, 606-8507
        • Kyoto University Hospital
      • Miyagi-gun, Japan, 981-0112
        • Yu Family Clinic
      • Miyazaki, Japan, 880-0122
        • Zenjinkai Shiminnnomori Hospital
      • Morioka-shi, Japan, 020-0015
        • Yoshida orthopaedic and rheumatology Clinic
      • Nagaoka, Japan, 940-2085
        • Nagaoka Red Cross Hospital
      • Nagasaki-shi, Japan, 850-0832
        • Nagasaki Medical Hospital of Rheumatology
      • Nagoya, Japan, 466-8560
        • Nagoya University Hospital
      • Nishinomiya, Japan, 663-8501
        • The Hospital of Hyogo College of Medine
      • Okayama, Japan, 700-8558
        • Okayama University Hospital
      • Okayama-city, Japan, 700-0013
        • Okayama Saiseikai General Hospital Outpatient Center
      • Ome, Japan, 198-0042
        • Ome Municipal General Hospital
      • Sagamihara, Japan, 252-0392
        • National Hospital Organization Sagamihara National Hospital
      • Sanuki-shi, Japan, 769-2393
        • Sanuki Municipal Hospital
      • Sapporo, Japan, 060-8648
        • Hokkaido University Hospital
      • Sapporo, Japan, 060-0001
        • Sagawa Akira Rheumatology Clinic
      • Sapporo, Japan, 060-8604
        • Sapporo City General Hospital
      • Sapporo, Japan, 063-0811
        • Hokkaido Medical Center for Rheumatic Diseases
      • Sasebo-shi, Japan, 857-1195
        • Sasebo Chuo Hospital
      • Sayama-shi, Japan, 350-1305
        • Azuma Rheumatology Clinic
      • Shibata-City, Japan, 957-0054
        • Niigata Rheumatic Center
      • Shizuoka, Japan, 420-8623
        • Shizuoka Welfare Hospital
      • Suita-shi, Japan, 565-0871
        • Osaka University Hospital
      • Takasaki-shi, Japan, 370-0053
        • Inoue Hospital
      • Tokyo, Japan, 143-8541
        • Toho University Omori Medical Center
      • Tokyo, Japan, 160-8582
        • Keio university hospital
      • Tokyo, Japan, 104-8560
        • St. Luke's International Hospital
      • Tokyo, Japan, 130-0013
        • Medical Corporation Uchida Clinic
      • Tokyo, Japan, 142-0054
        • Showa University East Hospital
      • Tokyo, Japan, 153-8515
        • Toho University Ohashi Medical Center
      • Tokyo, Japan, 156-0052
        • Setagaya Rheumatic Clinic
      • Tokyo, Japan, 173-8606
        • Teikyo University Hospital
      • Tomigusuku-shi, Japan, 901-0224
        • YUUAI Medical Center
      • Tsukuba-shi, Japan, 305-8576
        • University of Tsukuba Hospital
      • Wakayama, Japan, 641-8509
        • Wakayama Medical University Hospital
      • Yokohama-shi, Japan, 236-0037
        • Yokohama Minami Kyousai Hospital
    • Chiba
      • Narashino, Chiba, Japan, 275-8580
        • Chibaken Saiseikai Narashino Hospital
    • Saitama
      • Tokorozawa, Saitama, Japan, 359-1111
        • Medical Corporation Kojyokai Hirose Clinic
    • Toyama
      • Takaoka, Toyama, Japan, 933-0874
        • Honjo Rheumatism Clinic
      • Busan-si, Korea, Republikken, 49241
        • Pusan National University Hospital
      • Daegu, Korea, Republikken, 41944
        • Kyungpook National University Hospital
      • Daegu, Korea, Republikken, 42472
        • Daegu Catholic University Medical Center
      • Daejeon, Korea, Republikken, 35015
        • Chungnam National University Hospital
      • Daejeon, Korea, Republikken, 35233
        • Eulji University Hospital
      • Gwangju, Korea, Republikken, 61469
        • Chonnam National University Hospital
      • Incheon, Korea, Republikken, 22332
        • Inha University Hospital
      • Jeonju, Korea, Republikken, 54907
        • Chonbuk National University Medical School
      • Seoul, Korea, Republikken, 03080
        • Seoul National University Hospital
      • Seoul, Korea, Republikken, 05030
        • Konkuk University Medical Center
      • Seoul, Korea, Republikken, 05505
        • Asan Medical Center
      • Seoul, Korea, Republikken, 04763
        • Hanyang University Seoul Hospital
      • Seoul, Korea, Republikken, 06973
        • Chung-Ang University Hospital Institutional Review Board
      • Seoul, Korea, Republikken, 07061
        • SMG-SNU Boramae Medical Center
      • Kuala Lumpur, Malaysia, 59100
        • University Malaya Medical Centre
    • Selangor
      • Batu Caves, Selangor, Malaysia, 68100
        • Hospital Selayang
      • Chihuahua, Mexico, 31000
        • Investigacion y Biomedicina de Chihuahua, S.C.
      • Ciudad de Mexico, Mexico, 06700
        • Clinstile, S.A. de C.V.
      • Ciudad de México, Mexico, 06760
        • Clinosar Mexico. S.A. de C. V.
      • Merida, Mexico, 97000
        • Centro Peninsular De Investigacion Clinica S.C.P.
      • Mexico, Mexico, 06700
        • Biológicos Especializados
      • Monterrey, Mexico, 64460
        • Hospital Universitario Dr. Jose Eleuterio Gonzalez
    • Michoacan
      • Morelia, Michoacan, Mexico, 58070
        • Centro De Investigación Clínica De Morelia, Sc
    • Yucatan
      • Mérida, Yucatan, Mexico, 97070
        • Köhler & Milstein Research S.A. de C.V.
      • Auckland, New Zealand, 1010
        • Optimal Clinical Trials, Level 2
      • Hamilton, New Zealand, 3240
        • Waikato Hospital
      • Newtown, New Zealand, 6021
        • Clinical Trial Unit, CCHDB, Wellington Hospital
      • Timaru, New Zealand, 7910
        • Clinical Trials Unit, Timaru Hospital
    • Auckland
      • Papatoetoe, Auckland, New Zealand, 2025
        • Middlemore Clinical Trial
      • Bialystok, Polen, 15-099
        • Gabinet Internistyczno-Reumatologiczny Piotr Adrian Klimiuk
      • Bialystok, Polen, 15-879
        • ClinicMed
      • Bydgoszcz, Polen, 85168
        • Szpital Uniwersytecki Nr 2, Klinka Reumatologii I Ukladowych Chorob Tkanki Lacznej
      • 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
      • 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
      • Krakow, Polen, 31-637
        • NZOZ Centrum Medyczne ProMiMed
      • Nowa Sol, Polen, 67-100
        • Twoja Przychodnia -Centrum Medyzcne Nowa Sol
      • Poznan, Polen, 60-702
        • Synexus Polska Sp. z.o.o. Oddzial w Porznaniu
      • Poznan, Polen, 60-733
        • Centrum Badan Klinicznych S.C. Wieslawa Porawska, Lukasz Porawski
      • Poznan, Polen, 61-113
        • AI Centrum Medyczne
      • Tomaszów Lubelski, Polen, 22-600
        • Samodzielny Publiczny Zespol Opieki Zdrowotnej w Tomaszowie Lubelskim Lubelskim; Oddzial Reumatologiczy
      • Torun, Polen, 87100
        • Nasz Lekarz Przychodnie Medyczne
      • Warszawa, Polen, 02-691
        • Reumatika -Centrum Reumatologii NZOZ
      • Warszawa, Polen, 03291
        • Centrum Medyczne AMED Warszawa Targowek
      • Wroclaw, Polen, 52416
        • Centrum Medyczne Oporow
      • Bacau, Romania, 600114
        • Spitalul Judetean de Urgenta Bacau, Sectia Reumatologie
      • Bucuresti, Romania, 010976
        • S.C. Ianuli Med Consult S.R.L.
      • Bucuresti, Romania, 011172
        • Spitalul Clinic ,, Sf. Maria", Sectia Reumatologie
      • Bucuresti, Romania, 011172
        • Spitalul Clinic,, Sf. Maria"", Departamentul de Medicina Interna si Reumatologie
      • Targu-Mures, Romania, 540136
        • Spitalul Clinic Judetean de Urgenta Tirgu Mures
      • Belgrade, Serbia, 11000
        • Institute of Rheumatology
      • Belgrade, Serbia, 11080
        • Clinical Hospital Center Bezanijska Kosa
      • Belgrade, Serbia, 11000
        • Military Medical Academy, Clinic of Rheumatology
      • Niska Banja, Serbia, 18205
        • Institute for Treatment and Rehabilitation Niska Banja
      • Bratislava, Slovakia, 841 04
        • Neštátna Reumatologická Ambulancia
      • Rimavská Sobota, Slovakia, 97901
        • Reumex S.R.O.
      • Topolcany, Slovakia, 95501
        • LERAM s.r.o.
      • Barakaldo, Spania, 48903
        • Hospital Universitario Cruces
      • La Coruña, Spania, 15706
        • Complejo Hospitalario Universitario de Santiago
      • Madrid, Spania, 28034
        • Hospital Universitario Ramon y Cajal
      • Madrid, Spania, 28007
        • Hospital General Universitario Gregorio Marañon
      • Málaga, Spania, 29009
        • Hospital Regional Universitario de Málaga
      • Sabadell, Spania, 08208
        • Corporacio Santiaria Parc Tauli
      • Santiago de Compostela, Spania, 15702
        • Clinica Gaias
      • Santiago de Compostela, Spania, 15705
        • Hospital HM Nuestra Señora de la Esperanza
      • Valencia, Spania, 46010
        • Hospital Clinico Universitario de Valencia
      • Edinburgh, Storbritannia, EH4 2XU
        • NHS Lothian, Western General Hospital
      • Harlow, Storbritannia, CM201QX
        • Princess Alexandra Hospital
      • North Shields, Storbritannia, NE29 8NH
        • Northumbria Healthcare NHS Foundation Trust
      • Warrington, Storbritannia, WA5 1QG
        • Warrington and Halton Hospitals NHS Foundation Trust
      • Cape Town, Sør-Afrika, 7505
        • Arthritis Clinical Trial Centre
      • Durban, Sør-Afrika, 4001
        • Netcare St. Augustine's Hospital
      • Durban, Sør-Afrika, 4319
        • Umhlanga Netcare Medical Centre
      • Johannesburg, Sør-Afrika, 2193
        • Charlotte Maxeke Johannesburg Academic Hospital
      • Stellenbosch, Sør-Afrika
        • Winelands Medical Research Centre
      • Changhua City, Taiwan, 500
        • Changhua Christian Hospital
      • Kaohsiung, Taiwan, 813
        • Kaohsiung Veterans General Hospital
      • Keelung, Taiwan, 204
        • Chang Gung Memorial Hospital, Keelung
      • Taichung, Taiwan, 40201
        • Chung Shan Medical University Hospital
      • Taichung City, Taiwan, 404
        • China Medical University Hospital
      • Tainan City, 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
      • 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
      • Chiangmai, Thailand, 50200
        • Maharaj Nakorn Chiang Mai Hospital, Faculty of Medicine, Chiang Mai University
      • Songkla, Thailand, 90110
        • Faculty of Medicine, Prince of Songkla University, Songklanagarind Hospital
      • Brno, Tsjekkia, 60200
        • MUDr. Michaela Blahova, revmatologicka ambulance s.r.o.
      • Hlucin, Tsjekkia, 748 01
        • L.K.N. Arthrocentrum, s.r.o.
      • Ostrava-Poruba, Tsjekkia, 70800
        • MUDr. Rosypalová, S.R.O.
      • Prague 2, Tsjekkia, 12850
        • Revmatologicky Ustav
      • Prague Praha 10, Tsjekkia, 10100
        • Arthrocentrum spol.s.r.o.
      • Praha 4, Tsjekkia, 140 00
        • Revmatologicka ambulance
      • Praha 4, Tsjekkia, 14000
        • Revmatologicka ambulance, Nuselska Poliklinika
      • Uherske Hradiste, Tsjekkia, 68601
        • MEDICAL PLUS, s.r.o.
      • Aachen, Tyskland, 52064
        • Rheumapraxis Dr. med. Reiner Kurthen
      • 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
      • 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
      • 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
      • Kherson, Ukraina, 73000
        • Minicipal Institution "Kherson City Clinical Hospital n. a. Afanasiy and Olga Tropinykh", Department of Therapy #1
      • Kyiv, Ukraina, 01601
        • Kyiv Oleksandrivska City Clinical Hospital, Department of Rheumatology # 2
      • Kyiv, Ukraina, 03126
        • Kyiv City Clinical Hospital #6, Department of Therapy
      • Kyiv, Ukraina, 03680
        • State Institution National Scientific Center M.D. Strazhesko Institute of Cardiology of NAMS of Ukraine
      • Kyiv, Ukraina, 04107
        • Municipal Institution of Kyiv Regional Council "Kyiv Regional Clinical Hospital", Highly Specialized Therapeutic Department
      • Lutsk, Ukraina, 43024
        • Lutsk City Clinical Hospital
      • 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
      • Odesa, Ukraina, 65025
        • Municipal Institution Odesa Regional Clinical Hospital, Polyclinic Department
      • Vinnytsia, Ukraina, 21029
        • City Clinical Hospital #1, Department of Rheumatology
      • Vinnytsya, Ukraina, 21018
        • Vinnytsya Regional Clinical Hospital named after M. I. Pyrogova, Department of Rheumatology
      • Zaporizhzhya, Ukraina, 69005
        • Medical Centre Modern Clinic, LLC
      • Zaporizhzhya, Ukraina, 69104
        • Municipal Institution "City Hospital #1", Department of Therapy
      • Zaporizhzhya, Ukraina, 69118
        • Municipal Institution City Hospital #7, Department of Therapy
      • Budapest, Ungarn, 1023
        • Betegapolo-Irgalmasrend Budai Irgalmasrendi Korhaz
      • Budapest, Ungarn, 1027
        • Revita Reumatológiai Kft.
      • 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
      • 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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Beskrivelse

Viktige inkluderingskriterier:

  • Hanner eller kvinner som kan ha nytte av filgotinib som bedømt av etterforskeren OG som fullførte en Gilead-sponset filgotinib-foreldrestudie for RA som skissert nedenfor:

    • Har fullført GS-US-417-0301, GS-US-417-0302 eller GS-US-417-0303 på studiemedisin

      • ELLER
    • Har fullført GS-US-417-0302 på standardbehandling på grunn av RA ikke-responder-status
  • Kvinner i fertil alder må ha en negativ graviditetstest før første dose studiemedisin i langtidsforlengelse (LTE)
  • Fertile menn og kvinner som deltar i heterofile samleie må godta protokollgodkjente prevensjonsmetoder

Nøkkelekskluderingskriterier:

  • Diagnose av en annen autoimmun eller inflammatorisk leddsykdom enn RA, som ville sette deltakeren i fare ved å delta i studien eller ville forstyrre studievurderinger/datatolkning, etter vurdering av etterforskeren
  • Kjent overfølsomhet overfor studiemedikamentet eller dets hjelpestoffer
  • Enhver medisinsk tilstand som ville sette deltakeren i fare ved å delta i studien eller ville forstyrre studievurderinger/datatolkning, etter etterforskerens vurdering

MERK: Andre protokolldefinerte inkluderings-/eksklusjonskriterier kan gjelde.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Blindfase: Filgotinib 200 mg
Filgotinib 200 mg pluss placebo for å matche (PTM) filgotinib 100 mg i opptil 6 år
Tablett(er) administrert oralt én gang daglig
Andre navn:
  • GS-6034
  • GLPG0634
Tablett(er) administrert oralt én gang daglig
Eksperimentell: Blindfase: Filgotinib 100 mg
Filgotinib 100 mg pluss PTM filgotinib 200 mg i opptil 6 år
Tablett(er) administrert oralt én gang daglig
Andre navn:
  • GS-6034
  • GLPG0634
Tablett(er) administrert oralt én gang daglig
Eksperimentell: Åpen etikettfase: Filgotinib 200 mg
Filgotinib 200 mg i opptil 6 år
Tablett(er) administrert oralt én gang daglig
Andre navn:
  • GS-6034
  • GLPG0634
Eksperimentell: Åpen etikettfase: Filgotinib 100 mg
Filgotinib 100 mg i opptil 6 år
Tablett(er) administrert oralt én gang daglig
Andre navn:
  • GS-6034
  • GLPG0634

Hva måler studien?

Primære resultatmål

Resultatmål
Tidsramme
Andel deltakere som opplever uønskede hendelser (AE)
Tidsramme: Inntil 6 år
Inntil 6 år
Andel av deltakere som opplever klinisk signifikante laboratorieavvik
Tidsramme: Inntil 6 år
Inntil 6 år

Sekundære resultatmål

Resultatmål
Tidsramme
Andel av deltakere som oppnår American College of Rheumatology-N (ACR-N) respons i hver arm
Tidsramme: Inntil 6 år
Inntil 6 år

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Samarbeidspartnere

Etterforskere

  • Studieleder: Alfasigma Study Director, Alfasigma S.p.A.

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

28. februar 2017

Primær fullføring (Faktiske)

16. mai 2025

Studiet fullført (Faktiske)

16. mai 2025

Datoer for studieregistrering

Først innsendt

17. januar 2017

Først innsendt som oppfylte QC-kriteriene

17. januar 2017

Først lagt ut (Antatt)

19. januar 2017

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

3. juli 2025

Siste oppdatering sendt inn som oppfylte QC-kriteriene

1. juli 2025

Sist bekreftet

1. juli 2025

Mer informasjon

Begreper knyttet til denne studien

Andre studie-ID-numre

  • GS-US-417-0304
  • 2016-003630-25 (EudraCT-nummer)

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Ja

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

produkt produsert i og eksportert fra USA

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Kliniske studier på Leddgikt

Kliniske studier på Filgotinib

Abonnere