Long Term Extension Study to Assess the Safety and Efficacy of Filgotinib in Adults With Rheumatoid Arthritis
FINCH 4
A Multicenter, Open-label, Long Term Extension Study to Assess the Safety and Efficacy of Filgotinib in Subjects With Rheumatoid Arthritis
2 other identifiers
interventional
2,731
32 countries
345
Brief Summary
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 rheumatoid-arthritis
Started Feb 2017
Longer than P75 for phase_3 rheumatoid-arthritis
345 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 17, 2017
CompletedFirst Posted
Study publicly available on registry
January 19, 2017
CompletedStudy Start
First participant enrolled
February 28, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 16, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
May 16, 2025
CompletedJuly 3, 2025
July 1, 2025
8.2 years
January 17, 2017
July 1, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
Proportion of Participants Experiencing Adverse Events (AEs)
Up to 6 years
Proportion of Participants Experiencing Clinically Significant Laboratory Abnormalities
Up to 6 years
Secondary Outcomes (1)
Proportion of Participants Achieving American College of Rheumatology- N (ACR-N) Response in Each Arm
Up to 6 years
Study Arms (4)
Blinded Phase: Filgotinib 200 mg
EXPERIMENTALFilgotinib 200 mg plus placebo to match (PTM) filgotinib 100 mg for up to 6 years
Blinded Phase: Filgotinib 100 mg
EXPERIMENTALFilgotinib 100 mg plus PTM filgotinib 200 mg for up to 6 years
Open Label Phase: Filgotinib 200 mg
EXPERIMENTALFilgotinib 200 mg for up to 6 years
Open Label Phase: Filgotinib 100 mg
EXPERIMENTALFilgotinib 100 mg for up to 6 years
Interventions
Tablet(s) administered orally once daily
Tablet(s) administered orally once daily
Eligibility Criteria
You may qualify if:
- 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
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Alfasigma S.p.A.lead
- Gilead Sciencescollaborator
Study Sites (345)
Rheumatology Associates of North Alabama, PC
Huntsville, Alabama, 35801, United States
Arthrocare, Arthritis Care & Research PC
Gilbert, Arizona, 85234, United States
Arizona Arthritis & Rheumatology Associates, P.C.
Phoenix, Arizona, 85037, United States
Arizona Arthritis & Rheumatology Associates, P.C.
Tucson, Arizona, 85704, United States
Medvin Clinical Research
Covina, California, 91722, United States
C.V. Mehta M.D. Medical Corporation
Hemet, California, 92543, United States
University of California San Diego (UCSD) - Perlman Ambulatory Clinic
La Jolla, California, 92037, United States
Keck Medicine of USC- Division of Rheumatology
Los Angeles, California, 90033, United States
Desert Medical Advances
Palm Desert, California, 92260, United States
Stanford University Hospitals and Clinics (Immunology & Rheumatology)
Palo Alto, California, 94305, United States
C.V. Mehta Medical Corporation
Riverside, California, 92518, United States
Inland Rheumatology Clinical Trials, Inc.
Upland, California, 91786, United States
Desert Valley Medical Group
Victorville, California, 92395, United States
Medvin Clinical Research
Whittier, California, 90602, United States
AARDS Research, Inc.
Aventura, Florida, 33180, United States
Clinical Research of West Florida, Inc.
Clearwater, Florida, 33765, United States
Omega Research Consultants, LLC
DeBary, Florida, 32713, United States
University of Florida College of Medicine, Jacksonville - Rheumatology Research
Jacksonville, Florida, 32207, United States
Suncoast Research Group, LLC
Miami, Florida, 33135, United States
San Marcus Research Clinic, Inc.
Miami Lakes, Florida, 33014, United States
Suncoast Clinical Research, Inc.
New Port Richey, Florida, 34652, United States
Omega Research Consultants LLC
Orlando, Florida, 32804, United States
IRIS Research and Development, LLC
Plantation, Florida, 33324, United States
Jefrey D. Lieberman, MD, P.C.
Decatur, Georgia, 30033, United States
Springfield Clinic
Springfield, Illinois, 62702, United States
University of Kansas Medical Center
Kansas City, Kansas, 66160, United States
Heartland Research Associates, LLC
Wichita, Kansas, 67207, United States
Center For Arthritis and Osteoporosis
Elizabethtown, Kentucky, 42701, United States
Bluegrass Community Research, Inc.
Lexington, Kentucky, 40504, United States
Klein & Associates, M.D., P.A.
Cumberland, Maryland, 21502, United States
Arthritis Treatment Center
Frederick, Maryland, 21702, United States
Klein & Associates, M.D., P.A.
Hagerstown, Maryland, 21740, United States
The Center For Rheumatology And Bone Research
Wheaton, Maryland, 20902, United States
Clinical Pharmacology Study Group
Worcester, Massachusetts, 01605, United States
Umass Memorial Medical Center- Memorial Campus
Worcester, Massachusetts, 01605, United States
Henry Ford Health System
Detroit, Michigan, 48202, United States
Shores Rheumatology, PC
Saint Clair Shores, Michigan, 48081, United States
St. Paul Rheumatology, PA
Eagan, Minnesota, 55121, United States
Arthritis Associates, PLLC
Hattiesburg, Mississippi, 39402, United States
North Mississippi Medical Clinics, Inc.
Tupelo, Mississippi, 38801, United States
Clayton Medical Research, P.C.
St Louis, Missouri, 63117, United States
Arthritis Consultants, Inc.
St Louis, Missouri, 63141, United States
Physician Research Collaboration, LLC
Lincoln, Nebraska, 68516, United States
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756, United States
Arthritis & Osteoporosis Associates
Freehold, New Jersey, 07728, United States
Ocean Rheumatology, PA
Toms River, New Jersey, 08755, United States
Albuquerque Clinical Trials, Inc.
Albuquerque, New Mexico, 87102, United States
NYU Langone Ambulatory Care Brooklyn Heights
Brooklyn, New York, 11201, United States
Weill Cornell Physicians At Brooklyn Heights
Brooklyn, New York, 11201, United States
Joint And Muscle Research Institute
Charlotte, North Carolina, 28204, United States
Physicians East, PA
Greenville, North Carolina, 27834, United States
PMG Research of Salisbury
Salisbury, North Carolina, 28144, United States
Paramount Medical Research & Consulting, LLC
Middleburg Heights, Ohio, 44130, United States
Health Research of Oklahoma
Oklahoma City, Oklahoma, 73103, United States
The Oklahoma Center For Arthritis Therapy & Research, Inc.
Tulsa, Oklahoma, 74104, United States
East Penn Rheumatology Associates
Bethlehem, Pennsylvania, 18015, United States
Altoona Center for Clinical Research
Duncansville, Pennsylvania, 16635, United States
Arthritis Group, PC
Philadelphia, Pennsylvania, 19152, United States
Clinical Research Center of Reading LLC
Wyomissing, Pennsylvania, 19610, United States
PA Regional Center For Arthritis And Osteoporosis Research
Wyomissing, Pennsylvania, 19610, United States
Articularis Healthcare Inc., dba Columbia Arthritis Center, PA
Columbia, South Carolina, 29204, United States
Carolina Rheumatology & Neurology Assoc., PC
Myrtle Beach, South Carolina, 29572, United States
Articularis Healthcare Group d/b/a ACME Research
Orangeburg, South Carolina, 29118, United States
Articularis Healthcare Group d/b/a Low Country Rheumatology
Summerville, South Carolina, 29486, United States
Ramesh C. Gupta, M.D.
Memphis, Tennessee, 38119, United States
Diagnostic Group
Beaumont, Texas, 77701, United States
Trinity Universal Research Associates, Inc
Carrollton, Texas, 75007, United States
Adriana Pop-Moody MD Clinic PA
Corpus Christi, Texas, 78404, United States
Arthritis Centers Of Texas
Dallas, Texas, 75246, United States
Southwest Rheumatology Research, LLC
Mesquite, Texas, 75150, United States
Trinity Universal Research Associates, Inc
Plano, Texas, 75024, United States
Arthritis & Osteoporosis Center of South Texas
San Antonio, Texas, 78232, United States
Ceim Investigaciones Medicas Srl
Ciudad Autonoma, Buenos Aires, 1425, Argentina
CIMEL
Buenos Aires, B1824KAJ, Argentina
Onganizacion Medica de Investigacion S.A (OMI)
Ciudad Autonoma Buenos Aires, C1015ABO, Argentina
Mautalen Salud e Investigación
Ciudad Autonoma Buenos Aires, C1128AAF, Argentina
Consultorios Reumatológicos Pampa
Ciudad Autonoma de Buenos Aire, C1428DZF, Argentina
Investigaciones Reumatologicas Y Osteologicas (IRO) SRL
Ciudad Autonoma, C1114AHH, Argentina
Instituto De Reumatologia
Mendoza, 5500, Argentina
Instituto Médico Cer
Quilmes, B1878DVB, Argentina
Instituto Iari
San Isidro, Argentina
Cer San Juan, Centro Polivalente de Asistencia e Investigacion Clinica
San Juan, CP5400, Argentina
Centro Medico Privado de Reumatología
San Miguel de Tucumán, T4000AXL, Argentina
Rheumatology Research Unit
Maroochydore, Queensland, 4558, Australia
RK Will Pty Ltd
Victoria Park, Western Australia, 6100, Australia
Southern Clinical Research Pty Ltd
Hobart, 7000, Australia
Cliniques Universitaires Saint-Luc
Brussels, 1200, Belgium
Reumaclinic Genk
Genk, 3600, Belgium
Universitaire Ziekenhuizen (UZ) Leuven - Gasthuisberg
Leuven, 3000, Belgium
Zna Jan Palfijn
Merksem, 2170, Belgium
"Medical Center Help" EOOD
Dobrich, 9300, Bulgaria
"Medical Center- Hipokrat 2000" OOD
Haskovo, 6300, Bulgaria
"UMHAT - Kaspela" EOOD
Plovdiv, 4001, Bulgaria
"MHAT Lyulin" EAD, Department of Rheumatology
Sofia, 1336, Bulgaria
Medical Center "N. I. Pirogov" EOOD
Sofia, 1612, Bulgaria
"DCC Equita" EOOD
Varna, 9000, Bulgaria
MHAT "Sveta Petka" AD, Department of Internal Diseases
Vidin, 3700, Bulgaria
The Waterside Clinic
Barrie, L4M6L2, Canada
Centre De Recherche Musculo Squelettique
Trois-Rivières, G8Z1Y2, Canada
Quantum Research Santiago
Santiago, 7500588, Chile
Someal SA
Santiago, 7510186, Chile
Centro Medico De Reumatologia
Temuco, 4790928, Chile
MUDr. Michaela Blahova, revmatologicka ambulance s.r.o.
Brno, 60200, Czechia
L.K.N. Arthrocentrum, s.r.o.
Hlučín, 748 01, Czechia
MUDr. Rosypalová, S.R.O.
Ostrava-Poruba, 70800, Czechia
Revmatologicky ustav
Prague, 12850, Czechia
Revmatologicka Ambulance
Prague, 140 00, Czechia
Revmatologicka ambulance, Nuselska Poliklinika
Prague, 14000, Czechia
Arthrocentrum spol.s.r.o.
Prague Praha 10, 10100, Czechia
Medical Plus, S.R.O.
Uherské Hradiště, 68601, Czechia
Hôpital Lapeyronie, Service d'Immuno-Rhumatologic
Montpellier, 34295, France
Rheumapraxis Dr. med. Reiner Kurthen
Aachen, 52064, Germany
Schlosspark-Klinik
Berlin, 14059, Germany
Centrum f. inn. Diagn. und Therap. Rheumatologie/Immunologie
Frankfurt am Main, 60590, Germany
HRF II, Hamburger Rheuma Forsch. Zentrum II, MVZ f. Rheumatologie und Autoimmuned. Hamb. GmbH/ Dr. A. Everding GbR
Hamburg, 20095, Germany
Rheumazentrum Ratungen-Studienambulanz GbR
Ratingen, 40878, Germany
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
Hong Kong, Hong Kong
Betegapolo-Irgalmasrend Budai Irgalmasrendi Korhaz
Budapest, 1023, Hungary
Revita Reumatológiai Kft.
Budapest, 1027, Hungary
Markhot Ferenc Oktatokorhaz es Rendelointezet; Reumatologiai Osztaly
Eger, 3300, Hungary
Bekes Megyei Kozponti Korhaz, Pandy Kalman Tagkorhaz, Reumatologiai Osztaly
Gyula, 5700, Hungary
Bacs Kiskun Megyei Korhaz Szedgedi Tudomanyegyetem Altalanos Orvostudomanyi Kar Oktatokorhaz Kalocsai Szent Kereszt Korh
Kalocsa, 6300, Hungary
Pest Megyei Flor Ferenc Korhaz, Reumatologiai-es Fizioterapias Osztaly
Kistarcsa, 2143, Hungary
Csongrad Megyei Dr. Bugyi Istvan Korhaz; Mozgasszervi Rehabilitacios Osztaly
Szentes, 6600, Hungary
C-Med Rehabilitacios es Diagnosztikai Kozpont. Reumatologia
Székesfehérvár, 8000, Hungary
Panchshil Hospital, Dep
Ahmedabad, 380005, India
B.J. Medical College and Civil Hospital
Ahmedabad, 380016, India
Chanre Rheumatology and Immunology Centre and Research
Bangalore, 560010, India
Chennai Meenakshi Multispeciality Hospital Ltd
Chennai, 600004, India
All India Institute of Medical Sciences
Delhi, 110029, India
Medanta - The Medicity
Gūrgaon, 122001, India
Gleneagles Global Hospitals
Hyderabad, 500004, India
Nizams Institute of Medical Sciences
Hyderabad, 50082, India
Shri Nidaan Hospital and Hope Fertility Centre
Jaipur, 302001, India
SR Kalla Memorial Gastro and General Hospital
Jaipur, 302001, India
Santokba Durlabhji Memorial Hospital Cum Medical Research Institute
Jaipur, 302015, India
Apollo Gleneagles Hospitals, Kolkata
Kolkata, 700 054, India
Medical College & Hospital, Kolkata
Kolkata, 700073, India
Department of Rheumatology, KG Medical University
Lucknow, 226018, India
Kasturba Medical College Hospital
Mangalore, 575001, India
Vinaya Hospital and Research Centre
Mangalore, 575003, India
JSS Medical College and Hospital
Mysuru, 570004, India
Suretech Hospital and Research Centre Pvt Ltd
Nagpur, 440012, India
Maharaja Agrasen Hospital
New Delhi, 110026, India
Sir Ganga Ram Hospital
New Delhi, 110060, India
Centre for Rheumatic Disease, Hermes Doctor House
Pune, 411001, India
Deenanath Mangeshkar Hospital and Research Centre
Pune, 411004, India
Krishna Institute of Medical Sciences
Secunderabad, India
Rajiv Gandhi Institute of Medical Sciences and Government General Hospital
Srikakulam, 532001, India
Nirmal Hospital Private Limited
Surat, 395002, India
Medical College Baroda and Sir Sayajirao General Hospital
Vadodara, 390001, India
King George Hospital
Visakhapatnam, 530002, India
St Vincent's University Hospital
Dublin, Dublin 4, Ireland
Bnai Zion Medical Center
Haifa, 3339419, Israel
The Lady Davis Carmel Medical Center
Haifa, 3436212, Israel
Rabin Medical Center
Petah Tikva, 4941492, Israel
The Chaim Sheba Medical Center
Ramat Gan, 5265601, Israel
Tel Aviv Medical Center
Tel Aviv, 6423906, Israel
Departimento Cardio-toraco-vascolare Gestione delle Malattie Reumatiche e del Connettivo e Malattie Metaboliche dell'osso
Bologna, Bologna, 40138, Italy
Reumatologia
Milan, 20157, Italy
Chibaken Saiseikai Narashino Hospital
Narashino, Chiba, 275-8580, Japan
Medical Corporation Kojyokai Hirose Clinic
Tokorozawa, Saitama, 359-1111, Japan
Honjo Rheumatism Clinic
Takaoka, Toyama, 933-0874, Japan
Chiba University Hospital
Chiba, 2608677, Japan
Kyushu Medical Center
Fukuoka, 810-8563, Japan
National Hospital Organization Kyushu Medical Center
Fukuoka, 810-8563, Japan
Seirei Hamamatsu General Hospital
Hamamatsu, 430-8558, Japan
Hiroshima Rheumatology Clinic
Hiroshima, 730-0017, Japan
Hiroshima Red Cross Hospital & Atomic-bomb Survivors Hospital
Hiroshima, 730-8619, Japan
Hiroshima University Hospital
Hiroshima, 734-8551, Japan
Iizuka Hospital
Iizuka-shi, 820-8505, Japan
Saitama Medical University Hospital
Iruma-gun, 350-0495, Japan
Shimane University Hospital
Izumo, 693-8501, Japan
Kagoshima red cross hospital
Kagoshima, 891-0133, Japan
Matsubara Mayflower Hospital
Katō, 673-1462, Japan
Saitama Medical Center
Kawagoe, 350-8550, Japan
Hospital of the University of Occupational and Environmental Health, Japan
Kitakyushu-shi, 807-8556, Japan
Kobe University Hospital
Kobe, 650-0017, Japan
Kumamoto Orthopaedic Hospital
Kumamoto, 862-0975, Japan
Kurume University Medical Center
Kurume-shi, 839-0863, Japan
University Hospital, Kyoto Prefectural University of Medicine
Kyoto, 602-8566, Japan
Kyoto University Hospital
Kyoto, 606-8507, Japan
Yu Family Clinic
Miyagi-gun, 981-0112, Japan
Zenjinkai Shiminnnomori Hospital
Miyazaki, 880-0122, Japan
Yoshida orthopaedic and rheumatology Clinic
Morioka, 020-0015, Japan
Nagaoka Red Cross Hospital
Nagaoka, 940-2085, Japan
Nagasaki Medical Hospital of Rheumatology
Nagasaki, 850-0832, Japan
Nagoya University Hospital
Nagoya, 466-8560, Japan
The Hospital of Hyogo College of Medine
Nishinomiya, 663-8501, Japan
Okayama Saiseikai General Hospital Outpatient Center
Okayama, 700-0013, Japan
Okayama University Hospital
Okayama, 700-8558, Japan
Ome Municipal General Hospital
Ōme, 198-0042, Japan
National Hospital Organization Sagamihara National Hospital
Sagamihara, 252-0392, Japan
Sanuki Municipal Hospital
Sanuki-shi, 769-2393, Japan
Sagawa Akira Rheumatology Clinic
Sapporo, 060-0001, Japan
Sapporo City General Hospital
Sapporo, 060-8604, Japan
Hokkaido University Hospital
Sapporo, 060-8648, Japan
Hokkaido Medical Center for Rheumatic Diseases
Sapporo, 063-0811, Japan
Sasebo Chuo Hospital
Sasebo-shi, 857-1195, Japan
Azuma Rheumatology Clinic
Sayama-shi, 350-1305, Japan
Niigata Rheumatic Center
Shibata, 957-0054, Japan
Shizuoka Welfare Hospital
Shizuoka, 420-8623, Japan
Osaka University Hospital
Suita-shi, 565-0871, Japan
Inoue Hospital
Takasaki-shi, 370-0053, Japan
St. Luke's International Hospital
Tokyo, 104-8560, Japan
Medical Corporation Uchida Clinic
Tokyo, 130-0013, Japan
Showa University East Hospital
Tokyo, 142-0054, Japan
Toho University Omori Medical Center
Tokyo, 143-8541, Japan
Toho University Ohashi Medical Center
Tokyo, 153-8515, Japan
Setagaya Rheumatic Clinic
Tokyo, 156-0052, Japan
Keio University Hospital
Tokyo, 160-8582, Japan
Teikyo University Hospital
Tokyo, 173-8606, Japan
Yuuai Medical Center
Tomigusuku-shi, 901-0224, Japan
University of Tsukuba Hospital
Tsukuba, 305-8576, Japan
Wakayama Medical University Hospital
Wakayama, 641-8509, Japan
Yokohama Minami Kyousai Hospital
Yokohama, 236-0037, Japan
Hospital Selayang
Batu Caves, Selangor, 68100, Malaysia
University Malaya Medical Centre
Kuala Lumpur, 59100, Malaysia
Centro De Investigación Clínica De Morelia, Sc
Morelia, Michoacán, 58070, Mexico
Kohler & Milstein Research S.A. de C.V.
Mérida, Yucatán, 97070, Mexico
Investigacion y Biomedicina de Chihuahua, S.C.
Chihuahua City, 31000, Mexico
Clinstile, S.A. De C.V.
Mexico City, 06700, Mexico
Clinosar Mexico. S.A. de C. V.
Mexico City, 06760, Mexico
Centro Peninsular De Investigacion Clinica S.C.P.
Mérida, 97000, Mexico
Biologicos Especializados
México, 06700, Mexico
Hospital Universitario Dr. Jose Eleuterio Gonzalez
Monterrey, 64460, Mexico
Middlemore Clinical Trial
Papatoetoe, Auckland, 2025, New Zealand
Optimal Clinical Trials, Level 2
Auckland, 1010, New Zealand
Waikato Hospital
Hamilton, 3240, New Zealand
Clinical Trial Unit, CCHDB, Wellington Hospital
Newtown, 6021, New Zealand
Clinical Trials Unit, Timaru Hospital
Timaru, 7910, New Zealand
Gabinet Internistyczno-Reumatologiczny Piotr Adrian Klimiuk
Bialystok, 15-099, Poland
Clinicmed
Bialystok, 15-879, Poland
Szpital Uniwersytecki Nr 2, Klinka Reumatologii I Ukladowych Chorob Tkanki Lacznej
Bydgoszcz, 85168, Poland
Niepubliczny Zaklad Opieki Zdrowotnej BIF-MED S.C.
Bytom, 41-902, Poland
Nszoz Unica Cr
Dabrówka, 62096, Poland
Centrum Kliniczno-Badawcze J. Brzezicki
Elblag, 82300, Poland
Centrum Medyczne Pratia Gdynia
Gdynia, 81-338, Poland
NZOZ Centrum Medyczna Sw. Lukasza w Kartuzach
Kartuzy, 83300, Poland
SILMEDIC Spolka z ograniczona odpowiedzialnoscia w Swindniku, Oddzial w Katowicach
Katowice, 40-282, Poland
Nzoz Centrum Medyczne Promimed
Krakow, 31-637, Poland
Twoja Przychodnia -Centrum Medyzcne Nowa Sol
Nowa Sól, 67-100, Poland
Synexus Polska Sp. z.o.o. Oddzial w Porznaniu
Poznan, 60-702, Poland
Centrum Badan Klinicznych S.C. Wieslawa Porawska, Lukasz Porawski
Poznan, 60-733, Poland
Ai Centrum Medyczne
Poznan, 61-113, Poland
Samodzielny Publiczny Zespol Opieki Zdrowotnej w Tomaszowie Lubelskim Lubelskim; Oddzial Reumatologiczy
Tomaszów Lubelski, 22-600, Poland
Nasz Lekarz Przychodnie Medyczne
Torun, 87100, Poland
Reumatika -Centrum Reumatologii NZOZ
Warsaw, 02-691, Poland
Centrum Medyczne AMED Warszawa Targówek
Warsaw, 03291, Poland
Centrum Medyczne Oporow
Wroclaw, 52416, Poland
Spitalul Judetean de Urgenta Bacau, Sectia Reumatologie
Bacau, 600114, Romania
S.C. Ianuli Med Consult S.R.L.
Bucharest, 010976, Romania
Spitalul Clinic ,, Sf. Maria", Sectia Reumatologie
Bucharest, 011172, Romania
Spitalul Clinic,, Sf. Maria"", Departamentul de Medicina Interna si Reumatologie
Bucharest, 011172, Romania
Spitalul Clinic Judetean de Urgenta Tirgu Mures
Târgu Mureş, 540136, Romania
Territorial State Budgetary Healthcare Institution "Territorial Clinical Hospital"
Barnaul, 656024, Russia
State Budgetary Healthcare Institution, Chelyabinsk Regional Clinical Hospital
Chelyabinsk, 454076, Russia
FSBEI of HE "Kazan State Medical University" of Ministry of Healthcare of the Russia Federation, Department of hospital therapy
Kazan', 420103, Russia
Medical Center Maximum Zdorovia LLC
Kemerovo, 650066, Russia
Kemerovo State Medical University on the base of Regional Clinical Hospital for War Veterans
Kemerovo, 650099, Russia
Municipal Clinical Hospital No. 15 named after O.M. Filatov
Moscow, 111539, Russia
City Clinical Hospital #4 of Department of Healthcare of Moscow City
Moscow, 115093, Russia
M. Vladimirsky Moscow Regional Research Clinical Institute
Moscow, 129110, Russia
Municipal Clinical Hospital No. 40 Department of healthcare of Moscow City
Moscow, 129301, Russia
Nizhny Novgorod City Clinical Hospital #5
Nizhny Novgorod, 603005, Russia
Saint-Petersburg State Budgetary Healthcare Institution "Clinical rheumatology hospital # 25"
Saint Petersburg, 190068, Russia
LLC Polyclinic of Private Security Personnel
Saint Petersburg, 192007, Russia
State Healthcare Institution, Regional Clinical Hospital
Saratov, 410053, Russia
LLC BioMed
Vladimir, 600005, Russia
State Autonomous Healthcare Institution of Yaroslavl region "Clinical Hospital for Emergency Medical Care n. a. N. V. Solovyev"
Yaroslavl, 150003, Russia
Institute Of Rheumatology
Belgrade, 11000, Serbia
Military Medical Academy, Clinic of Rheumatology
Belgrade, 11000, Serbia
Clinical Hospital Center Bezanijska Kosa
Belgrade, 11080, Serbia
Institute For Treatment And Rehabilitation Niska Banja
Niška Banja, 18205, Serbia
Neštátna Reumatologická Ambulancia
Bratislava, 841 04, Slovakia
Reumex S.R.O.
Rimavská Sobota, 97901, Slovakia
LERAM s.r.o.
Topoľčany, 95501, Slovakia
Arthritis Clinical Trial Centre
Cape Town, 7505, South Africa
Netcare St. Augustine's Hospital
Durban, 4001, South Africa
Umhlanga Netcare Medical Centre
Durban, 4319, South Africa
Charlotte Maxeke Johannesburg Academic Hospital
Johannesburg, 2193, South Africa
Winelands Medical Research Centre
Stellenbosch, South Africa
Pusan National University Hospital
Busan, 49241, South Korea
Kyungpook National University Hospital
Daegu, 41944, South Korea
Daegu Catholic University Medical Center
Daegu, 42472, South Korea
Chungnam National University Hospital
Daejeon, 35015, South Korea
Eulji University Hospital
Daejeon, 35233, South Korea
Chonnam National University Hospital
Gwangju, 61469, South Korea
Inha University Hospital
Incheon, 22332, South Korea
Chonbuk National University Medical School
Jeonju, 54907, South Korea
Seoul National University Hospital
Seoul, 03080, South Korea
Hanyang University Seoul Hospital
Seoul, 04763, South Korea
Konkuk University Medical Center
Seoul, 05030, South Korea
Asan Medical Center
Seoul, 05505, South Korea
Chung-Ang University Hospital Institutional Review Board
Seoul, 06973, South Korea
SMG-SNU Boramae Medical Center
Seoul, 07061, South Korea
Complejo Hospitalario Universitario de Santiago
A Coruña, 15706, Spain
Hospital Universitario Cruces
Barakaldo, 48903, Spain
Hospital General Universitario Gregorio Maranon
Madrid, 28007, Spain
Hospital Universitario Ramon y Cajal
Madrid, 28034, Spain
Hospital Regional Universitario de Malaga
Málaga, 29009, Spain
Corporacio Santiaria Parc Tauli
Sabadell, 08208, Spain
Clínica Gaias
Santiago de Compostela, 15702, Spain
Hospital HM Nuestra Senora de la Esperanza
Santiago de Compostela, 15705, Spain
Hospital Clinico Universitario de Valencia
Valencia, 46010, Spain
Changhua Christian Hospital
Changhua, 500, Taiwan
Kaohsiung Veterans General Hospital
Kaohsiung City, 813, Taiwan
Chang Gung Memorial Hospital, Keelung
Keelung, 204, Taiwan
Chung Shan Medical University Hospital
Taichung, 40201, Taiwan
China Medical University Hospital
Taichung, 404, Taiwan
Chi Mei Hospital, Chi Mei Medical Center
Tainan, 710, Taiwan
National Taiwan University Hospital
Taipei, 100, Taiwan
Taipei Medical University Hospital
Taipei, 110, Taiwan
Tri-Service General Hospital
Taipei, 11490, Taiwan
Chang Gung Medical Foundation, Chang Gung Memorial Hospital, Linkou Branch
Taoyuan District, 333, Taiwan
Phramongkutklao Hospital, Division of Rheumatology, Department of Medicine
Bangkok, 10400, Thailand
Rajavithi Hospital, Rheumatology and Allergy Unit
Bangkok, 10400, Thailand
Faculty of Medicine Siriraj Hospital, Mahidol University, Division of Rheumatology, Department of Medicine
Bangkok, 10700, Thailand
Maharaj Nakorn Chiang Mai Hospital, Faculty of Medicine, Chiang Mai University
Chiang Mai, 50200, Thailand
Faculty of Medicine, Prince of Songkla University, Songklanagarind Hospital
Songkhla, 90110, Thailand
Municipal Institution Dnipropetrovsk 6th City Clinical Hospital of Dnipropetrovsk Regional Council
Dnipro, 49074, Ukraine
Municipal Nonprofit Enterprise of the Kharkiv Regional Council, Regional Hospital for War Veterans, Department of Therapy #1
Kharkiv, 61019, Ukraine
State Institution "National Institute of Therapy named after L.T. Maloyi" of National Academy of Medical Sciences of Ukraine"
Kharkiv, 61039, Ukraine
Municipal Institution of Heath Care "Regional Clinical Hospital-Center Of Emergency Medicine & Disaster Medicine"
Kharkiv, 61058, Ukraine
Municipal Nonprofit Enterprise "City Clinical Hospital #13" of the Kharkiv City Council, Department of Therapy
Kharkiv, 61124, Ukraine
Minicipal Institution "Kherson City Clinical Hospital n. a. Afanasiy and Olga Tropinykh", Department of Therapy #1
Kherson, 73000, Ukraine
Kyiv Oleksandrivska City Clinical Hospital, Department of Rheumatology # 2
Kyiv, 01601, Ukraine
Kyiv City Clinical Hospital #6, Department of Therapy
Kyiv, 03126, Ukraine
State Institution National Scientific Center M.D. Strazhesko Institute of Cardiology of NAMS of Ukraine
Kyiv, 03680, Ukraine
Municipal Institution of Kyiv Regional Council "Kyiv Regional Clinical Hospital", Highly Specialized Therapeutic Department
Kyiv, 04107, Ukraine
Lutsk City Clinical Hospital
Lutsk, 43024, Ukraine
Municipal Institution of Lviv Regional Council "Lviv Regional Clinical Hospital" Department of Rheumatology
Lviv, 79010, Ukraine
Municipal Nonprofit Enterprise "4-th City Clinical Hospital in Lviv", Department of Rheumatology
Lviv, 79011, Ukraine
Municipal Institution Odesa Regional Clinical Hospital, Polyclinic Department
Odesa, 65025, Ukraine
Vinnytsya Regional Clinical Hospital named after M. I. Pyrogova, Department of Rheumatology
Vinnytsia, 21018, Ukraine
City Clinical Hospital #1, Department of Rheumatology
Vinnytsia, 21029, Ukraine
Medical Centre Modern Clinic, LLC
Zaporizhzhya, 69005, Ukraine
Municipal Institution "City Hospital #1", Department of Therapy
Zaporizhzhya, 69104, Ukraine
Municipal Institution City Hospital #7, Department of Therapy
Zaporizhzhya, 69118, Ukraine
NHS Lothian, Western General Hospital
Edinburgh, EH4 2XU, United Kingdom
Princess Alexandra Hospital
Harlow, CM201QX, United Kingdom
Northumbria Healthcare NHS Foundation Trust
North Shields, NE29 8NH, United Kingdom
Warrington and Halton Hospitals Nhs Foundation Trust
Warrington, WA5 1QG, United Kingdom
Related Publications (3)
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.
PMID: 39506562DERIVEDBalsa 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.
PMID: 37747626DERIVEDCombe 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.
PMID: 36205910DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Alfasigma Study Director
Alfasigma S.p.A.
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Masking Details
- This study was originally designed and initiated as a double-blind study but the study design will change to open-label following implementation of the protocol amendment # 4.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 17, 2017
First Posted
January 19, 2017
Study Start
February 28, 2017
Primary Completion
May 16, 2025
Study Completion
May 16, 2025
Last Updated
July 3, 2025
Record last verified: 2025-07
Data Sharing
- IPD Sharing
- Will not share