Long Term Extension Study to Assess the Safety and Efficacy of Filgotinib in Adults With Rheumatoid Arthritis (FINCH 4)

July 1, 2025 updated by: Alfasigma S.p.A.

A Multicenter, Open-label, Long Term Extension Study to Assess the Safety and Efficacy of Filgotinib in Subjects With Rheumatoid Arthritis

The primary objective of this study is to evaluate the long-term safety and tolerability of filgotinib in participants who have completed one of the parent studies of filgotinib in rheumatoid arthritis (RA).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
2731

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • 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 Investigacion
      • Ciudad Autonoma de Buenos Aire, Argentina, C1428DZF
        • Consultorios Reumatológicos Pampa
      • Mendoza, Argentina, 5500
        • Instituto de Reumatologia
      • Quilmes, Argentina, B1878DVB
        • Instituto Medico 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 Medico Privado de Reumatologia
    • Buenos Aires
      • Ciudad Autonoma, Buenos Aires, Argentina, 1425
        • Ceim Investigaciones Medicas Srl
  • Australia
      • 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
  • Belgium
      • Brussels, Belgium, 1200
        • Cliniques Universitaires Saint-luc
      • Genk, Belgium, 3600
        • ReumaClinic Genk
      • Leuven, Belgium, 3000
        • Universitaire Ziekenhuizen (UZ) Leuven - Gasthuisberg
      • Merksem, Belgium, 2170
        • ZNA Jan Palfijn
  • Bulgaria
      • 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
  • Canada
      • Barrie, Canada, L4M6L2
        • The Waterside Clinic
      • Trois Rivieres, Canada, G8Z1Y2
        • Centre de Recherche Musculo Squelettique
  • Chile
      • Santiago, Chile, 7500588
        • Quantum Research Santiago
      • Santiago, Chile, 7510186
        • Someal SA
      • Temuco, Chile, 4790928
        • Centro Medico De Reumatologia
  • Czechia
      • Brno, Czechia, 60200
        • MUDr. Michaela Blahova, revmatologicka ambulance s.r.o.
      • Hlucin, Czechia, 748 01
        • L.K.N. Arthrocentrum, s.r.o.
      • Ostrava-Poruba, Czechia, 70800
        • MUDr. Rosypalová, S.R.O.
      • Prague 2, Czechia, 12850
        • Revmatologicky ustav
      • Prague Praha 10, Czechia, 10100
        • Arthrocentrum spol.s.r.o.
      • Praha 4, Czechia, 140 00
        • Revmatologicka ambulance
      • Praha 4, Czechia, 14000
        • Revmatologicka ambulance, Nuselska Poliklinika
      • Uherske Hradiste, Czechia, 68601
        • MEDICAL PLUS, s.r.o.
  • France
      • Montpellier Cedex 5, France, 34295
        • Hôpital Lapeyronie, Service d'Immuno-Rhumatologic
  • Germany
      • Aachen, Germany, 52064
        • Rheumapraxis Dr. med. Reiner Kurthen
      • Berlin, Germany, 14059
        • Schlosspark-Klinik
      • Frankfurt am Main, Germany, 60590
        • Centrum f. inn. Diagn. und Therap. Rheumatologie/Immunologie
      • Hamburg, Germany, 20095
        • HRF II, Hamburger Rheuma Forsch. Zentrum II, MVZ f. Rheumatologie und Autoimmuned. Hamb. GmbH/ Dr. A. Everding GbR
      • Ratingen, Germany, 40878
        • Rheumazentrum Ratungen-Studienambulanz GbR
  • Hong Kong
      • 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
  • Hungary
      • Budapest, Hungary, 1023
        • Betegapolo-Irgalmasrend Budai Irgalmasrendi Korhaz
      • Budapest, Hungary, 1027
        • Revita Reumatológiai Kft.
      • Eger, Hungary, 3300
        • Markhot Ferenc Oktatokorhaz es Rendelointezet; Reumatologiai Osztaly
      • Gyula, Hungary, 5700
        • Bekes Megyei Kozponti Korhaz, Pandy Kalman Tagkorhaz, Reumatologiai Osztaly
      • Kalocsa, Hungary, 6300
        • Bacs Kiskun Megyei Korhaz Szedgedi Tudomanyegyetem Altalanos Orvostudomanyi Kar Oktatokorhaz Kalocsai Szent Kereszt Korh
      • Kistarcsa, Hungary, 2143
        • Pest Megyei Flor Ferenc Korhaz, Reumatologiai-es Fizioterapias Osztaly
      • Szentes, Hungary, 6600
        • Csongrad Megyei Dr. Bugyi Istvan Korhaz; Mozgasszervi Rehabilitacios Osztaly
      • Székesfehérvár, Hungary, 8000
        • C-Med Rehabilitacios es Diagnosztikai Kozpont. Reumatologia
  • India
      • 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
  • Ireland
      • Dublin, Ireland, DUBLIN 4
        • St Vincent's University Hospital
  • Israel
      • 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
  • Italy
      • Bologna, Italy, 40138
        • Departimento Cardio-toraco-vascolare Gestione delle Malattie Reumatiche e del Connettivo e Malattie Metaboliche dell'osso
      • Milano, Italy, 20157
        • Reumatologia
  • Japan
      • 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
  • Korea, Republic of
      • Busan-si, Korea, Republic of, 49241
        • Pusan National University Hospital
      • Daegu, Korea, Republic of, 41944
        • Kyungpook National University Hospital
      • Daegu, Korea, Republic of, 42472
        • Daegu Catholic University Medical Center
      • Daejeon, Korea, Republic of, 35015
        • Chungnam national university hospital
      • Daejeon, Korea, Republic of, 35233
        • Eulji University Hospital
      • Gwangju, Korea, Republic of, 61469
        • Chonnam National University Hospital
      • Incheon, Korea, Republic of, 22332
        • Inha University Hospital
      • Jeonju, Korea, Republic of, 54907
        • Chonbuk National University Medical School
      • Seoul, Korea, Republic of, 03080
        • Seoul National University Hospital
      • Seoul, Korea, Republic of, 05030
        • Konkuk University Medical Center
      • Seoul, Korea, Republic of, 05505
        • Asan Medical Center
      • Seoul, Korea, Republic of, 04763
        • Hanyang University Seoul Hospital
      • Seoul, Korea, Republic of, 06973
        • Chung-Ang University Hospital Institutional Review Board
      • Seoul, Korea, Republic of, 07061
        • SMG-SNU Boramae Medical Center
  • Malaysia
      • Kuala Lumpur, Malaysia, 59100
        • University Malaya Medical Centre
    • Selangor
      • Batu Caves, Selangor, Malaysia, 68100
        • Hospital Selayang
  • Mexico
      • 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 González
    • Michoacan
      • Morelia, Michoacan, Mexico, 58070
        • Centro De Investigación Clínica De Morelia, Sc
    • Yucatan
      • Mérida, Yucatan, Mexico, 97070
        • Kohler & Milstein Research S.A. De C.V.
  • New Zealand
      • 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
  • Poland
      • Bialystok, Poland, 15-099
        • Gabinet Internistyczno-Reumatologiczny Piotr Adrian Klimiuk
      • Bialystok, Poland, 15-879
        • ClinicMed
      • Bydgoszcz, Poland, 85168
        • Szpital Uniwersytecki Nr 2, Klinka Reumatologii I Ukladowych Chorob Tkanki Lacznej
      • Bytom, Poland, 41-902
        • Niepubliczny Zaklad Opieki Zdrowotnej BIF-MED S.C.
      • Dabrówka, Poland, 62096
        • NSZOZ Unica CR
      • Elblag, Poland, 82300
        • Centrum Kliniczno-Badawcze J. Brzezicki
      • Gdynia, Poland, 81-338
        • Centrum Medyczne Pratia Gdynia
      • Kartuzy, Poland, 83300
        • NZOZ Centrum Medyczna Sw. Lukasza w Kartuzach
      • Katowice, Poland, 40-282
        • SILMEDIC Spolka z ograniczona odpowiedzialnoscia w Swindniku, Oddzial w Katowicach
      • Krakow, Poland, 31-637
        • NZOZ Centrum Medyczne ProMiMed
      • Nowa Sol, Poland, 67-100
        • Twoja Przychodnia -Centrum Medyzcne Nowa Sol
      • Poznan, Poland, 60-702
        • Synexus Polska Sp. z.o.o. Oddzial w Porznaniu
      • Poznan, Poland, 60-733
        • Centrum Badan Klinicznych S.C. Wieslawa Porawska, Lukasz Porawski
      • Poznan, Poland, 61-113
        • AI Centrum Medyczne
      • Tomaszów Lubelski, Poland, 22-600
        • Samodzielny Publiczny Zespol Opieki Zdrowotnej w Tomaszowie Lubelskim Lubelskim; Oddzial Reumatologiczy
      • Torun, Poland, 87100
        • Nasz Lekarz Przychodnie Medyczne
      • Warszawa, Poland, 02-691
        • Reumatika -Centrum Reumatologii NZOZ
      • Warszawa, Poland, 03291
        • Centrum Medyczne AMED Warszawa Targowek
      • Wroclaw, Poland, 52416
        • Centrum Medyczne Oporow
  • Romania
      • 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
  • Russian Federation
      • Barnaul, Russian Federation, 656024
        • Territorial State Budgetary Healthcare Institution "Territorial Clinical Hospital"
      • Chelyabinsk, Russian Federation, 454076
        • State Budgetary Healthcare Institution, Chelyabinsk Regional Clinical Hospital
      • Kazan, Russian Federation, 420103
        • FSBEI of HE "Kazan State Medical University" of Ministry of Healthcare of the Russia Federation, Department of hospital therapy
      • Kemerovo, Russian Federation, 650066
        • Medical Center Maximum Zdorovia LLC
      • Kemerovo, Russian Federation, 650099
        • Kemerovo State Medical University on the base of Regional Clinical Hospital for War Veterans
      • Moscow, Russian Federation, 111539
        • Municipal Clinical Hospital No. 15 named after O.M. Filatov
      • Moscow, Russian Federation, 115093
        • City Clinical Hospital #4 of Department of Healthcare of Moscow City
      • Moscow, Russian Federation, 129110
        • M. Vladimirsky Moscow Regional Research Clinical Institute
      • Moscow, Russian Federation, 129301
        • Municipal Clinical Hospital No. 40 Department of healthcare of Moscow City
      • Nizhny Novgorod, Russian Federation, 603005
        • Nizhny Novgorod City Clinical Hospital #5
      • Saint Petersburg, Russian Federation, 190068
        • Saint-Petersburg State Budgetary Healthcare Institution "Clinical rheumatology hospital # 25"
      • Saratov, Russian Federation, 410053
        • State Healthcare Institution, Regional Clinical Hospital
      • St.Petersburg, Russian Federation, 192007
        • LLC Polyclinic of Private Security Personnel
      • Vladimir, Russian Federation, 600005
        • LLC BioMed
      • Yaroslavl, Russian Federation, 150003
        • State Autonomous Healthcare Institution of Yaroslavl region "Clinical Hospital for Emergency Medical Care n. a. N. V. Solovyev"
  • Serbia
      • 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
  • Slovakia
      • Bratislava, Slovakia, 841 04
        • Neštátna Reumatologická Ambulancia
      • Rimavská Sobota, Slovakia, 97901
        • Reumex S.R.O.
      • Topolcany, Slovakia, 95501
        • LERAM s.r.o.
  • South Africa
      • Cape Town, South Africa, 7505
        • Arthritis Clinical Trial Centre
      • Durban, South Africa, 4001
        • Netcare St. Augustine's Hospital
      • Durban, South Africa, 4319
        • Umhlanga Netcare Medical Centre
      • Johannesburg, South Africa, 2193
        • Charlotte Maxeke Johannesburg Academic Hospital
      • Stellenbosch, South Africa
        • Winelands Medical Research Centre
  • Spain
      • Barakaldo, Spain, 48903
        • Hospital Universitario Cruces
      • La Coruña, Spain, 15706
        • Complejo Hospitalario Universitario de Santiago
      • Madrid, Spain, 28034
        • Hospital Universitario Ramon y Cajal
      • Madrid, Spain, 28007
        • Hospital General Universitario Gregorio Marañon
      • Málaga, Spain, 29009
        • Hospital Regional Universitario de Malaga
      • Sabadell, Spain, 08208
        • Corporacio Santiaria Parc Tauli
      • Santiago de Compostela, Spain, 15702
        • Clinica Gaias
      • Santiago de Compostela, Spain, 15705
        • Hospital HM Nuestra Señora de la Esperanza
      • Valencia, Spain, 46010
        • Hospital Clínico Universitario de Valencia
  • Taiwan
      • 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
  • Thailand
      • 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
  • Ukraine
      • Dnipro, Ukraine, 49074
        • Municipal Institution Dnipropetrovsk 6th City Clinical Hospital of Dnipropetrovsk Regional Council
      • Kharkiv, Ukraine, 61019
        • Municipal Nonprofit Enterprise of the Kharkiv Regional Council, Regional Hospital for War Veterans, Department of Therapy #1
      • 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"
      • Kharkiv, Ukraine, 61124
        • Municipal Nonprofit Enterprise "City Clinical Hospital #13" of the Kharkiv City Council, Department of Therapy
      • 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
      • 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
      • 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
      • Odesa, Ukraine, 65025
        • Municipal Institution Odesa Regional Clinical Hospital, Polyclinic Department
      • Vinnytsia, Ukraine, 21029
        • City Clinical Hospital #1, Department of Rheumatology
      • Vinnytsya, Ukraine, 21018
        • Vinnytsya Regional Clinical Hospital named after M. I. Pyrogova, Department of Rheumatology
      • 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
  • United Kingdom
      • Edinburgh, United Kingdom, EH4 2XU
        • NHS Lothian, Western General Hospital
      • Harlow, United Kingdom, CM201QX
        • Princess Alexandra Hospital
      • North Shields, United Kingdom, NE29 8NH
        • Northumbria Healthcare NHS Foundation Trust
      • Warrington, United Kingdom, WA5 1QG
        • Warrington and Halton Hospitals NHS Foundation Trust
  • United States
    • Alabama
      • Huntsville, Alabama, United States, 35801
        • Rheumatology Associates of North Alabama, PC
    • Arizona
      • Gilbert, Arizona, United States, 85234
        • Arthrocare, Arthritis Care & Research PC
      • Phoenix, Arizona, United States, 85037
        • Arizona Arthritis & Rheumatology Associates, P.C.
      • Tucson, Arizona, United States, 85704
        • Arizona Arthritis & Rheumatology Associates, P.C.
    • California
      • Covina, California, United States, 91722
        • Medvin Clinical Research
      • Hemet, California, United States, 92543
        • C.V. Mehta M.D. Medical Corporation
      • La Jolla, California, United States, 92037
        • University of California San Diego (UCSD) - Perlman Ambulatory Clinic
      • Los Angeles, California, United States, 90033
        • Keck Medicine of USC- Division of Rheumatology
      • Palm Desert, California, United States, 92260
        • Desert Medical Advances
      • Palo Alto, California, United States, 94305
        • Stanford University Hospitals and Clinics (Immunology & Rheumatology)
      • Riverside, California, United States, 92518
        • C.V. Mehta Medical Corporation
      • Upland, California, United States, 91786
        • Inland Rheumatology Clinical Trials, Inc.
      • Victorville, California, United States, 92395
        • Desert Valley Medical Group
      • Whittier, California, United States, 90602
        • Medvin Clinical Research
    • Florida
      • Aventura, Florida, United States, 33180
        • AARDS Research, Inc.
      • Clearwater, Florida, United States, 33765
        • Clinical Research of West Florida, Inc.
      • Debary, Florida, United States, 32713
        • Omega Research Consultants, LLC
      • Jacksonville, Florida, United States, 32207
        • University of Florida College of Medicine, Jacksonville - Rheumatology Research
      • Miami, Florida, United States, 33135
        • Suncoast Research Group, LLC
      • Miami Lakes, Florida, United States, 33014
        • San Marcus Research Clinic, Inc.
      • New Port Richey, Florida, United States, 34652
        • Suncoast Clinical Research, Inc.
      • Orlando, Florida, United States, 32804
        • Omega Research Consultants LLC
      • Plantation, Florida, United States, 33324
        • IRIS Research and Development, LLC
    • Georgia
      • Decatur, Georgia, United States, 30033
        • Jefrey D. Lieberman, MD, P.C.
    • Illinois
      • Springfield, Illinois, United States, 62702
        • Springfield Clinic
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • University of Kansas Medical Center
      • Wichita, Kansas, United States, 67207
        • Heartland Research Associates, LLC
    • Kentucky
      • Elizabethtown, Kentucky, United States, 42701
        • Center for Arthritis and Osteoporosis
      • Lexington, Kentucky, United States, 40504
        • Bluegrass Community Research, Inc.
    • Maryland
      • Cumberland, Maryland, United States, 21502
        • Klein & Associates, M.D., P.A.
      • Frederick, Maryland, United States, 21702
        • Arthritis Treatment Center
      • Hagerstown, Maryland, United States, 21740
        • Klein & Associates, M.D., P.A.
      • Wheaton, Maryland, United States, 20902
        • The Center for Rheumatology and Bone Research
    • Massachusetts
      • Worcester, Massachusetts, United States, 01605
        • Clinical Pharmacology Study Group
      • Worcester, Massachusetts, United States, 01605
        • UMass Memorial Medical Center- Memorial Campus
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Henry Ford Health System
      • Saint Clair Shores, Michigan, United States, 48081
        • Shores Rheumatology, PC
    • Minnesota
      • Eagan, Minnesota, United States, 55121
        • St. Paul Rheumatology, PA
    • Mississippi
      • Hattiesburg, Mississippi, United States, 39402
        • Arthritis Associates, PLLC
      • Tupelo, Mississippi, United States, 38801
        • North Mississippi Medical Clinics, Inc.
    • Missouri
      • Saint Louis, Missouri, United States, 63141
        • Arthritis Consultants, Inc.
      • Saint Louis, Missouri, United States, 63117
        • Clayton Medical Research, P.C.
    • Nebraska
      • Lincoln, Nebraska, United States, 68516
        • Physician Research Collaboration, LLC
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03756
        • Dartmouth-Hitchcock Medical Center
    • New Jersey
      • Freehold, New Jersey, United States, 07728
        • Arthritis & Osteoporosis Associates
      • Toms River, New Jersey, United States, 08755
        • Ocean Rheumatology, PA
    • New Mexico
      • Albuquerque, New Mexico, United States, 87102
        • Albuquerque Clinical Trials, Inc.
    • New York
      • Brooklyn, New York, United States, 11201
        • NYU Langone Ambulatory Care Brooklyn Heights
      • Brooklyn, New York, United States, 11201
        • Weill Cornell Physicians At Brooklyn Heights
    • North Carolina
      • Charlotte, North Carolina, United States, 28204
        • Joint and Muscle Research Institute
      • Greenville, North Carolina, United States, 27834
        • Physicians East, PA
      • Salisbury, North Carolina, United States, 28144
        • PMG Research of Salisbury
    • Ohio
      • Middleburg Heights, Ohio, United States, 44130
        • Paramount Medical Research & Consulting, LLC
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73103
        • Health Research of Oklahoma
      • Tulsa, Oklahoma, United States, 74104
        • The Oklahoma Center For Arthritis Therapy & Research, Inc.
    • Pennsylvania
      • Bethlehem, Pennsylvania, United States, 18015
        • East Penn Rheumatology Associates
      • Duncansville, Pennsylvania, United States, 16635
        • Altoona Center For Clinical Research
      • Philadelphia, Pennsylvania, United States, 19152
        • Arthritis Group, PC
      • Wyomissing, Pennsylvania, United States, 19610
        • PA Regional Center for Arthritis and Osteoporosis Research
      • Wyomissing, Pennsylvania, United States, 19610
        • Clinical Research Center of Reading LLC
    • South Carolina
      • Columbia, South Carolina, United States, 29204
        • Articularis Healthcare Inc., dba Columbia Arthritis Center, PA
      • Myrtle Beach, South Carolina, United States, 29572
        • Carolina Rheumatology & Neurology Assoc., PC
      • Orangeburg, South Carolina, United States, 29118
        • Articularis Healthcare Group d/b/a ACME Research
      • Summerville, South Carolina, United States, 29486
        • Articularis Healthcare Group d/b/a Low Country Rheumatology
    • Tennessee
      • Memphis, Tennessee, United States, 38119
        • Ramesh C. Gupta, M.D.
    • Texas
      • Beaumont, Texas, United States, 77701
        • Diagnostic Group
      • Carrollton, Texas, United States, 75007
        • Trinity Universal Research Associates, Inc
      • Corpus Christi, Texas, United States, 78404
        • Adriana Pop-Moody MD Clinic PA
      • Dallas, Texas, United States, 75246
        • Arthritis Centers Of Texas
      • Mesquite, Texas, United States, 75150
        • SouthWest Rheumatology Research, LLC
      • Plano, Texas, United States, 75024
        • Trinity Universal Research Associates, Inc
      • San Antonio, Texas, United States, 78232
        • Arthritis & Osteoporosis Center of South Texas

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Key Inclusion Criteria:

  • Males or females who may benefit from filgotinib as judged by the investigator AND who completed a Gilead sponsored filgotinib parent study for RA as outlined below:

    • Have completed GS-US-417-0301, GS-US-417-0302 or GS-US-417-0303 on study drug

      • OR
    • Have completed GS-US-417-0302 on standard of care therapy due to RA non-responder status
  • Females of childbearing potential must have a negative pregnancy test prior to first dose of study drug in the long term extension (LTE)
  • Females of childbearing potential who engage in heterosexual intercourse must agree to protocol-approved methods of contraception

Key Exclusion Criteria:

  • Diagnosis of an autoimmune or inflammatory joint disease other than RA, which would put the participant at risk by participating in the study or would interfere with study assessments/data interpretation, per judgment of the investigator
  • Known hypersensitivity to the study drug or its excipients
  • Any medical condition which would put the participant at risk by participating in the study or would interfere with study assessments/data interpretation, per judgment of the investigator

NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Blinded Phase: Filgotinib 200 mg
Filgotinib 200 mg plus placebo to match (PTM) filgotinib 100 mg for up to 6 years
Drug: Filgotinib
Tablet(s) administered orally once daily
Other Names:
  • GS-6034
  • GLPG0634
Drug: Placebo to match filgotinib
Tablet(s) administered orally once daily
Experimental: Blinded Phase: Filgotinib 100 mg
Filgotinib 100 mg plus PTM filgotinib 200 mg for up to 6 years
Drug: Filgotinib
Tablet(s) administered orally once daily
Other Names:
  • GS-6034
  • GLPG0634
Drug: Placebo to match filgotinib
Tablet(s) administered orally once daily
Experimental: Open Label Phase: Filgotinib 200 mg
Filgotinib 200 mg for up to 6 years
Drug: Filgotinib
Tablet(s) administered orally once daily
Other Names:
  • GS-6034
  • GLPG0634
Experimental: Open Label Phase: Filgotinib 100 mg
Filgotinib 100 mg for up to 6 years
Drug: Filgotinib
Tablet(s) administered orally once daily
Other Names:
  • GS-6034
  • GLPG0634

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Proportion of Participants Experiencing Adverse Events (AEs)
Time Frame: Up to 6 years
Up to 6 years
Proportion of Participants Experiencing Clinically Significant Laboratory Abnormalities
Time Frame: Up to 6 years
Up to 6 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Proportion of Participants Achieving American College of Rheumatology- N (ACR-N) Response in Each Arm
Time Frame: Up to 6 years
Up to 6 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Alfasigma S.p.A.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Gilead Sciences

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Alfasigma Study Director, Alfasigma S.p.A.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 28, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 16, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 16, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 17, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 17, 2017

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 19, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 3, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 1, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • GS-US-417-0304
  • 2016-003630-25 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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