AzTrials
AzTrials

Rheumatoid ArthritisPhase 3FINCH 4NCT03025308

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

A Phase 3 study testing Filgotinib in people with Rheumatoid Arthritis, run by Alfasigma S.p.A. at 345 sites in 32 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Rheumatoid Arthritis
What is being tested?
Filgotinib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
2,731 participants
Where
345 sitesin 32 countries
Study dates
28 Feb 2017to 16 May 2025
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

345 sites in 32 countries.

345 sites in 32 countries

United States72 sites

  • Albuquerque Clinical Trials, Inc.

    Albuquerque, New Mexico, 87102

  • AARDS Research, Inc.

    Aventura, Florida, 33180

  • Diagnostic Group

    Beaumont, Texas, 77701

  • East Penn Rheumatology Associates

    Bethlehem, Pennsylvania, 18015

  • NYU Langone Ambulatory Care Brooklyn Heights

    Brooklyn, New York, 11201

  • Weill Cornell Physicians At Brooklyn Heights

    Brooklyn, New York, 11201

  • Trinity Universal Research Associates, Inc

    Carrollton, Texas, 75007

  • Joint And Muscle Research Institute

    Charlotte, North Carolina, 28204

  • Clinical Research of West Florida, Inc.

    Clearwater, Florida, 33765

  • Articularis Healthcare Inc., dba Columbia Arthritis Center, PA

    Columbia, South Carolina, 29204

  • Adriana Pop-Moody MD Clinic PA

    Corpus Christi, Texas, 78404

  • Medvin Clinical Research

    Covina, California, 91722

  • Klein & Associates, M.D., P.A.

    Cumberland, Maryland, 21502

  • Arthritis Centers Of Texas

    Dallas, Texas, 75246

  • Omega Research Consultants, LLC

    DeBary, Florida, 32713

  • Jefrey D. Lieberman, MD, P.C.

    Decatur, Georgia, 30033

  • Henry Ford Health System

    Detroit, Michigan, 48202

  • Altoona Center for Clinical Research

    Duncansville, Pennsylvania, 16635

  • St. Paul Rheumatology, PA

    Eagan, Minnesota, 55121

  • Center For Arthritis and Osteoporosis

    Elizabethtown, Kentucky, 42701

  • Arthritis Treatment Center

    Frederick, Maryland, 21702

  • Arthritis & Osteoporosis Associates

    Freehold, New Jersey, 07728

  • Arthrocare, Arthritis Care & Research PC

    Gilbert, Arizona, 85234

  • Physicians East, PA

    Greenville, North Carolina, 27834

  • Klein & Associates, M.D., P.A.

    Hagerstown, Maryland, 21740

  • Arthritis Associates, PLLC

    Hattiesburg, Mississippi, 39402

  • C.V. Mehta M.D. Medical Corporation

    Hemet, California, 92543

  • Rheumatology Associates of North Alabama, PC

    Huntsville, Alabama, 35801

  • University of Florida College of Medicine, Jacksonville - Rheumatology Research

    Jacksonville, Florida, 32207

  • University of Kansas Medical Center

    Kansas City, Kansas, 66160

  • University of California San Diego (UCSD) - Perlman Ambulatory Clinic

    La Jolla, California, 92037

  • Dartmouth-Hitchcock Medical Center

    Lebanon, New Hampshire, 03756

  • Bluegrass Community Research, Inc.

    Lexington, Kentucky, 40504

  • Physician Research Collaboration, LLC

    Lincoln, Nebraska, 68516

  • Keck Medicine of USC- Division of Rheumatology

    Los Angeles, California, 90033

  • Ramesh C. Gupta, M.D.

    Memphis, Tennessee, 38119

  • Southwest Rheumatology Research, LLC

    Mesquite, Texas, 75150

  • Suncoast Research Group, LLC

    Miami, Florida, 33135

  • San Marcus Research Clinic, Inc.

    Miami Lakes, Florida, 33014

  • Paramount Medical Research & Consulting, LLC

    Middleburg Heights, Ohio, 44130

  • Carolina Rheumatology & Neurology Assoc., PC

    Myrtle Beach, South Carolina, 29572

  • Suncoast Clinical Research, Inc.

    New Port Richey, Florida, 34652

  • Health Research of Oklahoma

    Oklahoma City, Oklahoma, 73103

  • Articularis Healthcare Group d/b/a ACME Research

    Orangeburg, South Carolina, 29118

  • Omega Research Consultants LLC

    Orlando, Florida, 32804

  • Desert Medical Advances

    Palm Desert, California, 92260

  • Stanford University Hospitals and Clinics (Immunology & Rheumatology)

    Palo Alto, California, 94305

  • Arthritis Group, PC

    Philadelphia, Pennsylvania, 19152

  • Arizona Arthritis & Rheumatology Associates, P.C.

    Phoenix, Arizona, 85037

  • Trinity Universal Research Associates, Inc

    Plano, Texas, 75024

  • IRIS Research and Development, LLC

    Plantation, Florida, 33324

  • C.V. Mehta Medical Corporation

    Riverside, California, 92518

  • Shores Rheumatology, PC

    Saint Clair Shores, Michigan, 48081

  • PMG Research of Salisbury

    Salisbury, North Carolina, 28144

  • Arthritis & Osteoporosis Center of South Texas

    San Antonio, Texas, 78232

  • Springfield Clinic

    Springfield, Illinois, 62702

  • Clayton Medical Research, P.C.

    St Louis, Missouri, 63117

  • Arthritis Consultants, Inc.

    St Louis, Missouri, 63141

  • Articularis Healthcare Group d/b/a Low Country Rheumatology

    Summerville, South Carolina, 29486

  • Ocean Rheumatology, PA

    Toms River, New Jersey, 08755

  • Arizona Arthritis & Rheumatology Associates, P.C.

    Tucson, Arizona, 85704

  • The Oklahoma Center For Arthritis Therapy & Research, Inc.

    Tulsa, Oklahoma, 74104

  • North Mississippi Medical Clinics, Inc.

    Tupelo, Mississippi, 38801

  • Inland Rheumatology Clinical Trials, Inc.

    Upland, California, 91786

  • Desert Valley Medical Group

    Victorville, California, 92395

  • The Center For Rheumatology And Bone Research

    Wheaton, Maryland, 20902

  • Medvin Clinical Research

    Whittier, California, 90602

  • Heartland Research Associates, LLC

    Wichita, Kansas, 67207

  • Clinical Pharmacology Study Group

    Worcester, Massachusetts, 01605

  • Umass Memorial Medical Center- Memorial Campus

    Worcester, Massachusetts, 01605

  • Clinical Research Center of Reading LLC

    Wyomissing, Pennsylvania, 19610

  • PA Regional Center For Arthritis And Osteoporosis Research

    Wyomissing, Pennsylvania, 19610

Other trials in United States

Japan56 sites

  • Chiba University Hospital

    Chiba, 2608677

  • Kyushu Medical Center

    Fukuoka, 810-8563

  • National Hospital Organization Kyushu Medical Center

    Fukuoka, 810-8563

  • Seirei Hamamatsu General Hospital

    Hamamatsu, 430-8558

  • Hiroshima Rheumatology Clinic

    Hiroshima, 730-0017

  • Hiroshima Red Cross Hospital & Atomic-bomb Survivors Hospital

    Hiroshima, 730-8619

  • Hiroshima University Hospital

    Hiroshima, 734-8551

  • Iizuka Hospital

    Iizuka-shi, 820-8505

  • Saitama Medical University Hospital

    Iruma-gun, 350-0495

  • Shimane University Hospital

    Izumo, 693-8501

  • Kagoshima red cross hospital

    Kagoshima, 891-0133

  • Matsubara Mayflower Hospital

    Katō, 673-1462

  • Saitama Medical Center

    Kawagoe, 350-8550

  • Hospital of the University of Occupational and Environmental Health, Japan

    Kitakyushu-shi, 807-8556

  • Kobe University Hospital

    Kobe, 650-0017

  • Kumamoto Orthopaedic Hospital

    Kumamoto, 862-0975

  • Kurume University Medical Center

    Kurume-shi, 839-0863

  • University Hospital, Kyoto Prefectural University of Medicine

    Kyoto, 602-8566

  • Kyoto University Hospital

    Kyoto, 606-8507

  • Yu Family Clinic

    Miyagi-gun, 981-0112

  • Zenjinkai Shiminnnomori Hospital

    Miyazaki, 880-0122

  • Yoshida orthopaedic and rheumatology Clinic

    Morioka, 020-0015

  • Nagaoka Red Cross Hospital

    Nagaoka, 940-2085

  • Nagasaki Medical Hospital of Rheumatology

    Nagasaki, 850-0832

  • Nagoya University Hospital

    Nagoya, 466-8560

  • Chibaken Saiseikai Narashino Hospital

    Narashino, Chiba, 275-8580

  • The Hospital of Hyogo College of Medine

    Nishinomiya, 663-8501

  • Okayama Saiseikai General Hospital Outpatient Center

    Okayama, 700-0013

  • Okayama University Hospital

    Okayama, 700-8558

  • Ome Municipal General Hospital

    Ōme, 198-0042

  • National Hospital Organization Sagamihara National Hospital

    Sagamihara, 252-0392

  • Sanuki Municipal Hospital

    Sanuki-shi, 769-2393

  • Sagawa Akira Rheumatology Clinic

    Sapporo, 060-0001

  • Sapporo City General Hospital

    Sapporo, 060-8604

  • Hokkaido University Hospital

    Sapporo, 060-8648

  • Hokkaido Medical Center for Rheumatic Diseases

    Sapporo, 063-0811

  • Sasebo Chuo Hospital

    Sasebo-shi, 857-1195

  • Azuma Rheumatology Clinic

    Sayama-shi, 350-1305

  • Niigata Rheumatic Center

    Shibata, 957-0054

  • Shizuoka Welfare Hospital

    Shizuoka, 420-8623

  • Osaka University Hospital

    Suita-shi, 565-0871

  • Honjo Rheumatism Clinic

    Takaoka, Toyama, 933-0874

  • Inoue Hospital

    Takasaki-shi, 370-0053

  • Medical Corporation Kojyokai Hirose Clinic

    Tokorozawa, Saitama, 359-1111

  • St. Luke's International Hospital

    Tokyo, 104-8560

  • Medical Corporation Uchida Clinic

    Tokyo, 130-0013

  • Showa University East Hospital

    Tokyo, 142-0054

  • Toho University Omori Medical Center

    Tokyo, 143-8541

  • Toho University Ohashi Medical Center

    Tokyo, 153-8515

  • Setagaya Rheumatic Clinic

    Tokyo, 156-0052

  • Keio University Hospital

    Tokyo, 160-8582

  • Teikyo University Hospital

    Tokyo, 173-8606

  • Yuuai Medical Center

    Tomigusuku-shi, 901-0224

  • University of Tsukuba Hospital

    Tsukuba, 305-8576

  • Wakayama Medical University Hospital

    Wakayama, 641-8509

  • Yokohama Minami Kyousai Hospital

    Yokohama, 236-0037

Other trials in Japan

India27 sites

  • Panchshil Hospital, Dep

    Ahmedabad, 380005

  • B.J. Medical College and Civil Hospital

    Ahmedabad, 380016

  • Chanre Rheumatology and Immunology Centre and Research

    Bangalore, 560010

  • Chennai Meenakshi Multispeciality Hospital Ltd

    Chennai, 600004

  • All India Institute of Medical Sciences

    Delhi, 110029

  • Medanta - The Medicity

    Gūrgaon, 122001

  • Gleneagles Global Hospitals

    Hyderabad, 500004

  • Nizams Institute of Medical Sciences

    Hyderabad, 50082

  • Shri Nidaan Hospital and Hope Fertility Centre

    Jaipur, 302001

  • SR Kalla Memorial Gastro and General Hospital

    Jaipur, 302001

  • Santokba Durlabhji Memorial Hospital Cum Medical Research Institute

    Jaipur, 302015

  • Apollo Gleneagles Hospitals, Kolkata

    Kolkata, 700 054

  • Medical College & Hospital, Kolkata

    Kolkata, 700073

  • Department of Rheumatology, KG Medical University

    Lucknow, 226018

  • Kasturba Medical College Hospital

    Mangalore, 575001

  • Vinaya Hospital and Research Centre

    Mangalore, 575003

  • JSS Medical College and Hospital

    Mysuru, 570004

  • Suretech Hospital and Research Centre Pvt Ltd

    Nagpur, 440012

  • Maharaja Agrasen Hospital

    New Delhi, 110026

  • Sir Ganga Ram Hospital

    New Delhi, 110060

  • Centre for Rheumatic Disease, Hermes Doctor House

    Pune, 411001

  • Deenanath Mangeshkar Hospital and Research Centre

    Pune, 411004

  • Krishna Institute of Medical Sciences

    Secunderabad

  • Rajiv Gandhi Institute of Medical Sciences and Government General Hospital

    Srikakulam, 532001

  • Nirmal Hospital Private Limited

    Surat, 395002

  • Medical College Baroda and Sir Sayajirao General Hospital

    Vadodara, 390001

  • King George Hospital

    Visakhapatnam, 530002

Other trials in India

Poland19 sites

  • Gabinet Internistyczno-Reumatologiczny Piotr Adrian Klimiuk

    Bialystok, 15-099

  • Clinicmed

    Bialystok, 15-879

  • Szpital Uniwersytecki Nr 2, Klinka Reumatologii I Ukladowych Chorob Tkanki Lacznej

    Bydgoszcz, 85168

  • Niepubliczny Zaklad Opieki Zdrowotnej BIF-MED S.C.

    Bytom, 41-902

  • Nszoz Unica Cr

    Dabrówka, 62096

  • Centrum Kliniczno-Badawcze J. Brzezicki

    Elblag, 82300

  • Centrum Medyczne Pratia Gdynia

    Gdynia, 81-338

  • NZOZ Centrum Medyczna Sw. Lukasza w Kartuzach

    Kartuzy, 83300

  • SILMEDIC Spolka z ograniczona odpowiedzialnoscia w Swindniku, Oddzial w Katowicach

    Katowice, 40-282

  • Nzoz Centrum Medyczne Promimed

    Krakow, 31-637

  • Twoja Przychodnia -Centrum Medyzcne Nowa Sol

    Nowa Sól, 67-100

  • Synexus Polska Sp. z.o.o. Oddzial w Porznaniu

    Poznan, 60-702

  • Centrum Badan Klinicznych S.C. Wieslawa Porawska, Lukasz Porawski

    Poznan, 60-733

  • Ai Centrum Medyczne

    Poznan, 61-113

  • Samodzielny Publiczny Zespol Opieki Zdrowotnej w Tomaszowie Lubelskim Lubelskim; Oddzial Reumatologiczy

    Tomaszów Lubelski, 22-600

  • Nasz Lekarz Przychodnie Medyczne

    Torun, 87100

  • Reumatika -Centrum Reumatologii NZOZ

    Warsaw, 02-691

  • Centrum Medyczne AMED Warszawa Targówek

    Warsaw, 03291

  • Centrum Medyczne Oporow

    Wroclaw, 52416

Other trials in Poland

Ukraine19 sites

  • Municipal Institution Dnipropetrovsk 6th City Clinical Hospital of Dnipropetrovsk Regional Council

    Dnipro, 49074

  • Municipal Nonprofit Enterprise of the Kharkiv Regional Council, Regional Hospital for War Veterans, Department of Therapy #1

    Kharkiv, 61019

  • State Institution "National Institute of Therapy named after L.T. Maloyi" of National Academy of Medical Sciences of Ukraine"

    Kharkiv, 61039

  • Municipal Institution of Heath Care "Regional Clinical Hospital-Center Of Emergency Medicine & Disaster Medicine"

    Kharkiv, 61058

  • Municipal Nonprofit Enterprise "City Clinical Hospital #13" of the Kharkiv City Council, Department of Therapy

    Kharkiv, 61124

  • Minicipal Institution "Kherson City Clinical Hospital n. a. Afanasiy and Olga Tropinykh", Department of Therapy #1

    Kherson, 73000

  • Kyiv Oleksandrivska City Clinical Hospital, Department of Rheumatology # 2

    Kyiv, 01601

  • Kyiv City Clinical Hospital #6, Department of Therapy

    Kyiv, 03126

  • State Institution National Scientific Center M.D. Strazhesko Institute of Cardiology of NAMS of Ukraine

    Kyiv, 03680

  • Municipal Institution of Kyiv Regional Council "Kyiv Regional Clinical Hospital", Highly Specialized Therapeutic Department

    Kyiv, 04107

  • Lutsk City Clinical Hospital

    Lutsk, 43024

  • Municipal Institution of Lviv Regional Council "Lviv Regional Clinical Hospital" Department of Rheumatology

    Lviv, 79010

  • Municipal Nonprofit Enterprise "4-th City Clinical Hospital in Lviv", Department of Rheumatology

    Lviv, 79011

  • Municipal Institution Odesa Regional Clinical Hospital, Polyclinic Department

    Odesa, 65025

  • Vinnytsya Regional Clinical Hospital named after M. I. Pyrogova, Department of Rheumatology

    Vinnytsia, 21018

  • City Clinical Hospital #1, Department of Rheumatology

    Vinnytsia, 21029

  • Medical Centre Modern Clinic, LLC

    Zaporizhzhya, 69005

  • Municipal Institution "City Hospital #1", Department of Therapy

    Zaporizhzhya, 69104

  • Municipal Institution City Hospital #7, Department of Therapy

    Zaporizhzhya, 69118

Other trials in Ukraine

Russia15 sites

  • Territorial State Budgetary Healthcare Institution "Territorial Clinical Hospital"

    Barnaul, 656024

  • State Budgetary Healthcare Institution, Chelyabinsk Regional Clinical Hospital

    Chelyabinsk, 454076

  • FSBEI of HE "Kazan State Medical University" of Ministry of Healthcare of the Russia Federation, Department of hospital therapy

    Kazan', 420103

  • Medical Center Maximum Zdorovia LLC

    Kemerovo, 650066

  • Kemerovo State Medical University on the base of Regional Clinical Hospital for War Veterans

    Kemerovo, 650099

  • Municipal Clinical Hospital No. 15 named after O.M. Filatov

    Moscow, 111539

  • City Clinical Hospital #4 of Department of Healthcare of Moscow City

    Moscow, 115093

  • M. Vladimirsky Moscow Regional Research Clinical Institute

    Moscow, 129110

  • Municipal Clinical Hospital No. 40 Department of healthcare of Moscow City

    Moscow, 129301

  • Nizhny Novgorod City Clinical Hospital #5

    Nizhny Novgorod, 603005

  • Saint-Petersburg State Budgetary Healthcare Institution "Clinical rheumatology hospital # 25"

    Saint Petersburg, 190068

  • LLC Polyclinic of Private Security Personnel

    Saint Petersburg, 192007

  • State Healthcare Institution, Regional Clinical Hospital

    Saratov, 410053

  • LLC BioMed

    Vladimir, 600005

  • State Autonomous Healthcare Institution of Yaroslavl region "Clinical Hospital for Emergency Medical Care n. a. N. V. Solovyev"

    Yaroslavl, 150003

Other trials in Russia

South Korea14 sites

  • Pusan National University Hospital

    Busan, 49241

  • Kyungpook National University Hospital

    Daegu, 41944

  • Daegu Catholic University Medical Center

    Daegu, 42472

  • Chungnam National University Hospital

    Daejeon, 35015

  • Eulji University Hospital

    Daejeon, 35233

  • Chonnam National University Hospital

    Gwangju, 61469

  • Inha University Hospital

    Incheon, 22332

  • Chonbuk National University Medical School

    Jeonju, 54907

  • Seoul National University Hospital

    Seoul, 03080

  • Hanyang University Seoul Hospital

    Seoul, 04763

  • Konkuk University Medical Center

    Seoul, 05030

  • Asan Medical Center

    Seoul, 05505

  • Chung-Ang University Hospital Institutional Review Board

    Seoul, 06973

  • SMG-SNU Boramae Medical Center

    Seoul, 07061

Other trials in South Korea

Argentina11 sites

  • CIMEL

    Buenos Aires, B1824KAJ

  • Ceim Investigaciones Medicas Srl

    Ciudad Autonoma, Buenos Aires, 1425

  • Investigaciones Reumatologicas Y Osteologicas (IRO) SRL

    Ciudad Autonoma, C1114AHH

  • Onganizacion Medica de Investigacion S.A (OMI)

    Ciudad Autonoma Buenos Aires, C1015ABO

  • Mautalen Salud e Investigación

    Ciudad Autonoma Buenos Aires, C1128AAF

  • Consultorios Reumatológicos Pampa

    Ciudad Autonoma de Buenos Aire, C1428DZF

  • Instituto De Reumatologia

    Mendoza, 5500

  • Instituto Médico Cer

    Quilmes, B1878DVB

  • Instituto Iari

    San Isidro

  • Cer San Juan, Centro Polivalente de Asistencia e Investigacion Clinica

    San Juan, CP5400

  • Centro Medico Privado de Reumatología

    San Miguel de Tucumán, T4000AXL

Other trials in Argentina

Taiwan10 sites

  • Changhua Christian Hospital

    Changhua, 500

  • Kaohsiung Veterans General Hospital

    Kaohsiung City, 813

  • Chang Gung Memorial Hospital, Keelung

    Keelung, 204

  • Chung Shan Medical University Hospital

    Taichung, 40201

  • China Medical University Hospital

    Taichung, 404

  • Chi Mei Hospital, Chi Mei Medical Center

    Tainan, 710

  • National Taiwan University Hospital

    Taipei, 100

  • Taipei Medical University Hospital

    Taipei, 110

  • Tri-Service General Hospital

    Taipei, 11490

  • Chang Gung Medical Foundation, Chang Gung Memorial Hospital, Linkou Branch

    Taoyuan, 333

Other trials in Taiwan

Spain9 sites

  • Complejo Hospitalario Universitario de Santiago

    A Coruña, 15706

  • Hospital Universitario Cruces

    Barakaldo, 48903

  • Hospital General Universitario Gregorio Maranon

    Madrid, 28007

  • Hospital Universitario Ramon y Cajal

    Madrid, 28034

  • Hospital Regional Universitario de Malaga

    Málaga, 29009

  • Corporacio Santiaria Parc Tauli

    Sabadell, 08208

  • Clínica Gaias

    Santiago de Compostela, 15702

  • Hospital HM Nuestra Senora de la Esperanza

    Santiago de Compostela, 15705

  • Hospital Clinico Universitario de Valencia

    Valencia, 46010

Other trials in Spain

Czechia8 sites

  • MUDr. Michaela Blahova, revmatologicka ambulance s.r.o.

    Brno, 60200

  • L.K.N. Arthrocentrum, s.r.o.

    Hlučín, 748 01

  • MUDr. Rosypalová, S.R.O.

    Ostrava-Poruba, 70800

  • Revmatologicky ustav

    Prague, 12850

  • Revmatologicka Ambulance

    Prague, 140 00

  • Revmatologicka ambulance, Nuselska Poliklinika

    Prague, 14000

  • Arthrocentrum spol.s.r.o.

    Prague Praha 10, 10100

  • Medical Plus, S.R.O.

    Uherské Hradiště, 68601

Other trials in Czechia

Hungary8 sites

  • Betegapolo-Irgalmasrend Budai Irgalmasrendi Korhaz

    Budapest, 1023

  • Revita Reumatológiai Kft.

    Budapest, 1027

  • Markhot Ferenc Oktatokorhaz es Rendelointezet; Reumatologiai Osztaly

    Eger, 3300

  • Bekes Megyei Kozponti Korhaz, Pandy Kalman Tagkorhaz, Reumatologiai Osztaly

    Gyula, 5700

  • Bacs Kiskun Megyei Korhaz Szedgedi Tudomanyegyetem Altalanos Orvostudomanyi Kar Oktatokorhaz Kalocsai Szent Kereszt Korh

    Kalocsa, 6300

  • Pest Megyei Flor Ferenc Korhaz, Reumatologiai-es Fizioterapias Osztaly

    Kistarcsa, 2143

  • C-Med Rehabilitacios es Diagnosztikai Kozpont. Reumatologia

    Székesfehérvár, 8000

  • Csongrad Megyei Dr. Bugyi Istvan Korhaz; Mozgasszervi Rehabilitacios Osztaly

    Szentes, 6600

Other trials in Hungary

Mexico8 sites

  • Investigacion y Biomedicina de Chihuahua, S.C.

    Chihuahua City, 31000

  • Kohler & Milstein Research S.A. de C.V.

    Mérida, Yucatán, 97070

  • Centro Peninsular De Investigacion Clinica S.C.P.

    Mérida, 97000

  • Biologicos Especializados

    México, 06700

  • Clinstile, S.A. De C.V.

    Mexico City, 06700

  • Clinosar Mexico. S.A. de C. V.

    Mexico City, 06760

  • Hospital Universitario Dr. Jose Eleuterio Gonzalez

    Monterrey, 64460

  • Centro De Investigación Clínica De Morelia, Sc

    Morelia, Michoacán, 58070

Other trials in Mexico

Bulgaria7 sites

  • "Medical Center Help" EOOD

    Dobrich, 9300

  • "Medical Center- Hipokrat 2000" OOD

    Haskovo, 6300

  • "UMHAT - Kaspela" EOOD

    Plovdiv, 4001

  • "MHAT Lyulin" EAD, Department of Rheumatology

    Sofia, 1336

  • Medical Center "N. I. Pirogov" EOOD

    Sofia, 1612

  • "DCC Equita" EOOD

    Varna, 9000

  • MHAT "Sveta Petka" AD, Department of Internal Diseases

    Vidin, 3700

Other trials in Bulgaria

Germany5 sites

  • Rheumapraxis Dr. med. Reiner Kurthen

    Aachen, 52064

  • Schlosspark-Klinik

    Berlin, 14059

  • Centrum f. inn. Diagn. und Therap. Rheumatologie/Immunologie

    Frankfurt am Main, 60590

  • HRF II, Hamburger Rheuma Forsch. Zentrum II, MVZ f. Rheumatologie und Autoimmuned. Hamb. GmbH/ Dr. A. Everding GbR

    Hamburg, 20095

  • Rheumazentrum Ratungen-Studienambulanz GbR

    Ratingen, 40878

Other trials in Germany

Israel5 sites

  • Bnai Zion Medical Center

    Haifa, 3339419

  • The Lady Davis Carmel Medical Center

    Haifa, 3436212

  • Rabin Medical Center

    Petah Tikva, 4941492

  • The Chaim Sheba Medical Center

    Ramat Gan, 5265601

  • Tel Aviv Medical Center

    Tel Aviv, 6423906

Other trials in Israel

New Zealand5 sites

  • Optimal Clinical Trials, Level 2

    Auckland, 1010

  • Waikato Hospital

    Hamilton, 3240

  • Clinical Trial Unit, CCHDB, Wellington Hospital

    Newtown, 6021

  • Middlemore Clinical Trial

    Papatoetoe, Auckland, 2025

  • Clinical Trials Unit, Timaru Hospital

    Timaru, 7910

Other trials in New Zealand

Romania5 sites

  • Spitalul Judetean de Urgenta Bacau, Sectia Reumatologie

    Bacau, 600114

  • S.C. Ianuli Med Consult S.R.L.

    Bucharest, 010976

  • Spitalul Clinic ,, Sf. Maria", Sectia Reumatologie

    Bucharest, 011172

  • Spitalul Clinic,, Sf. Maria"", Departamentul de Medicina Interna si Reumatologie

    Bucharest, 011172

  • Spitalul Clinic Judetean de Urgenta Tirgu Mures

    Târgu Mureş, 540136

Other trials in Romania

South Africa5 sites

  • Arthritis Clinical Trial Centre

    Cape Town, 7505

  • Netcare St. Augustine's Hospital

    Durban, 4001

  • Umhlanga Netcare Medical Centre

    Durban, 4319

  • Charlotte Maxeke Johannesburg Academic Hospital

    Johannesburg, 2193

  • Winelands Medical Research Centre

    Stellenbosch

Other trials in South Africa

Thailand5 sites

  • Phramongkutklao Hospital, Division of Rheumatology, Department of Medicine

    Bangkok, 10400

  • Rajavithi Hospital, Rheumatology and Allergy Unit

    Bangkok, 10400

  • Faculty of Medicine Siriraj Hospital, Mahidol University, Division of Rheumatology, Department of Medicine

    Bangkok, 10700

  • Maharaj Nakorn Chiang Mai Hospital, Faculty of Medicine, Chiang Mai University

    Chiang Mai, 50200

  • Faculty of Medicine, Prince of Songkla University, Songklanagarind Hospital

    Songkhla, 90110

Other trials in Thailand

Belgium4 sites

  • Cliniques Universitaires Saint-Luc

    Brussels, 1200

  • Reumaclinic Genk

    Genk, 3600

  • Universitaire Ziekenhuizen (UZ) Leuven - Gasthuisberg

    Leuven, 3000

  • Zna Jan Palfijn

    Merksem, 2170

Other trials in Belgium

Serbia4 sites

  • Institute Of Rheumatology

    Belgrade, 11000

  • Military Medical Academy, Clinic of Rheumatology

    Belgrade, 11000

  • Clinical Hospital Center Bezanijska Kosa

    Belgrade, 11080

  • Institute For Treatment And Rehabilitation Niska Banja

    Niška Banja, 18205

Other trials in Serbia

United Kingdom4 sites

  • NHS Lothian, Western General Hospital

    Edinburgh, EH4 2XU

  • Princess Alexandra Hospital

    Harlow, CM201QX

  • Northumbria Healthcare NHS Foundation Trust

    North Shields, NE29 8NH

  • Warrington and Halton Hospitals Nhs Foundation Trust

    Warrington, WA5 1QG

Other trials in United Kingdom

Australia3 sites

  • Southern Clinical Research Pty Ltd

    Hobart, 7000

  • Rheumatology Research Unit

    Maroochydore, Queensland, 4558

  • RK Will Pty Ltd

    Victoria Park, Western Australia, 6100

Other trials in Australia

Chile3 sites

  • Quantum Research Santiago

    Santiago, 7500588

  • Someal SA

    Santiago, 7510186

  • Centro Medico De Reumatologia

    Temuco, 4790928

Other trials in Chile

Hong Kong3 sites

  • Department of Medicine & Theraputics, The Chinese University of Hong Kong

    Hong Kong

  • Department of Medicine, Queen Mary Hospital

    Hong Kong

  • Tuen Mun Hospital

    Hong Kong

Other trials in Hong Kong

Slovakia3 sites

  • Neštátna Reumatologická Ambulancia

    Bratislava, 841 04

  • Reumex S.R.O.

    Rimavská Sobota, 97901

  • LERAM s.r.o.

    Topoľčany, 95501

Other trials in Slovakia

Canada2 sites

  • The Waterside Clinic

    Barrie, L4M6L2

  • Centre De Recherche Musculo Squelettique

    Trois-Rivières, G8Z1Y2

Other trials in Canada

Italy2 sites

  • Departimento Cardio-toraco-vascolare Gestione delle Malattie Reumatiche e del Connettivo e Malattie Metaboliche dell'osso

    Bologna, 40138

  • Reumatologia

    Milan, 20157

Other trials in Italy

Malaysia2 sites

  • Hospital Selayang

    Batu Caves, Selangor, 68100

  • University Malaya Medical Centre

    Kuala Lumpur, 59100

Other trials in Malaysia

France1 site

  • Hôpital Lapeyronie, Service d'Immuno-Rhumatologic

    Montpellier, 34295

Other trials in France

Ireland1 site

  • St Vincent's University Hospital

    Dublin, Dublin 4

Other trials in Ireland

About this study

Official title: 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).

Being tested
Filgotinib, Placebo to match filgotinib
Medical subject headings
Arthritis, Rheumatoid

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • FilgotinibDrug

    Also called GS-6034, GLPG0634

    Tablet(s) administered orally once daily

  • Placebo to match filgotinibDrug

    Tablet(s) administered orally once daily

Study groups in NCT03025308
Study groupRoleWhat they receive
Blinded Phase: Filgotinib 200 mgExperimentalFilgotinib 200 mg plus placebo to match (PTM) filgotinib 100 mg for up to 6 years
Receives: Drug: Filgotinib; Drug: Placebo to match filgotinib
Blinded Phase: Filgotinib 100 mgExperimentalFilgotinib 100 mg plus PTM filgotinib 200 mg for up to 6 years
Receives: Drug: Filgotinib; Drug: Placebo to match filgotinib
Open Label Phase: Filgotinib 200 mgExperimentalFilgotinib 200 mg for up to 6 years
Receives: Drug: Filgotinib
Open Label Phase: Filgotinib 100 mgExperimentalFilgotinib 100 mg for up to 6 years
Receives: Drug: Filgotinib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants Who Reported Treatment-Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)

    An adverse event (AE) was any untoward medical occurrence in a clinical study participant after administration of an investigational product, whether or not considered related to the study treatment. An SAE was defined as any untoward medical occurrence that, at any dose, resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect or significant medical event. A TEAE was any AE with an onset date on or after the study drug start date and no later than 30 days after permanent discontinuation of study drug or premature discontinuation of study drug.

    Measured: Day 1 to Week 376 (end of study)

  2. Number of Participants Who Reported Treatment-Emergent Graded Laboratory Abnormalities in Serum Chemistry Parameters

    Treatment-emergent laboratory abnormalities were defined as an increase of at least one toxicity grade from the LTE baseline at any post-baseline time point, up to and including 30 days after the last study drug dose for subjects who permanently discontinued treatment. Abnormalities were graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 4.03, as Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe), and Grade 4 (life-threatening). Blood samples were collected by venipuncture in the arm at the specified time points. The laboratory values outside the normal range were flagged and the clinical relevance was determined by Medical Monitor and Clinical Investigators.

    Measured: Day 1 to Week 376 (end of study)

  3. Number of Participants Who Reported Treatment-Emergent Graded Laboratory Abnormalities in Hematology Parameters

    Treatment-emergent laboratory abnormalities were defined as an increase of at least one toxicity grade from the LTE baseline at any post-baseline time point, up to and including 30 days after the last study drug dose for subjects who permanently discontinued treatment. Abnormalities were graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 4.03, as Grade 1 (mild), Grade 2 (moderate), and Grade 3 (severe) and Grade 4 (life-threatening). Blood samples were collected by venipuncture in the arm at the specified time points. The laboratory values outside the normal range were flagged and the clinical relevance was determined by Medical Monitor and Clinical Investigators.

    Measured: Day 1 to Week 376 (end of study)

  4. Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)

    SBP and DBP were collected at specified timepoints after participants had remained in a resting position for at least 5 minutes. The LTE baseline value was defined as the last available value collected on or prior to the date of the first dose of any study drug in the LTE. Change from the LTE baseline to a postbaseline visit was defined as the postbaseline value minus the LTE baseline value.

    Measured: Baseline and At Week 312

  5. Change From Baseline in Pulse Rate

    Pulse rate was collected at specified timepoints after participants had remained in a resting position for at least 5 minutes. The LTE baseline value was defined as the last available value collected on or prior to the date of the first dose of any study drug in the LTE. Change from the LTE baseline to a postbaseline visit was defined as the postbaseline value minus the LTE baseline value.

    Measured: Baseline and At Week 312

  6. Change From Baseline in Respiration Rate

    Changes in respiration rates were collected at specified timepoints after participants had remained in a resting position for at least 5 minutes. The LTE baseline value was defined as the last available value collected on or prior to the date of the first dose of any study drug in the LTE. Change from the LTE baseline to a postbaseline visit was defined as the postbaseline value minus the LTE baseline value.

    Measured: Baseline and At Week 312

Secondary outcomes (1)

  1. Percentage of Participants Who Achieved American College of Rheumatology (ACR) for 20, 50 and 70

    ACR is the improvement from the parent study baseline in swollen joint count (66 joints) where joints were classified as swollen or not swollen, tender joint count (68) where scoring was performed on different aspects of tenderness, and improvement in 3 of 5 items: Subject pain assessment: pain score form Health Assessment Questionnaire Disability Index (HAQ-DI; scale 0=no difficulty to 3=unable to do) was calculated; Subject global assessment of disease activity: a horizontal visual analog scale (VAS; 0=best to 10=worst) was used to assess the participants arthritis status; Physicians global assessment of disease activity: A horizontal VAS (0=best to 10=worst) was used; Subject's assessment of physical function: HAQ-DI (scale 0=no difficulty to 3=unable to do) was used to calculate participants physical function and Acute-phase reactant value: C-reactive level protein is measured. ACR20, 50 and 70 responders were participants with at least 20%, 50% and 70% achievement respectively.

    Measured: At Week 312

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Jan 2017 (estimated)
  2. Study start28 Feb 2017
  3. Primary completion16 May 2025
  4. Study completion16 May 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
2,731 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03025308
Sponsor's protocol ID
GS-US-417-0304
Other IDs
2016-003630-25, 2016
Acronym
FINCH 4
Status last verified
Jun 2026
First submitted
17 Jan 2017
Last updated
27 Jul 2026
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Tanaka Y, Kondo A, Isaji H, Van Beneden K, Mutter R, Takeuchi T. Integrated Safety Analysis of Filgotinib in Japanese Patients With Moderately to Severely Active Rheumatoid Arthritis Over a Treatment Duration of up to 5 Years. Mod Rheumatol. 2026 Mar 17:roag029. doi: 10.1093/mr/roag029. Online ahead of print.

    PubMed 41841789

  • 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.

    PubMed 39506562

  • Balsa A, Wassenberg S, Tanaka Y, Tournadre A, Orzechowski HD, Rajendran V, Lendl U, Stiers PJ, Watson C, Caporali R, Galloway J, Verschueren P. Effect of Filgotinib on Body Mass Index (BMI) and Effect of Baseline BMI on the Efficacy and Safety of Filgotinib in Rheumatoid Arthritis. Rheumatol Ther. 2023 Dec;10(6):1555-1574. doi: 10.1007/s40744-023-00599-1. Epub 2023 Sep 25.

    PubMed 37747626

  • Combe B, Besuyen R, Gomez-Centeno A, Matsubara T, Sancho Jimenez JJ, Yin Z, Buch MH. Geographic Analysis of the Safety and Efficacy of Filgotinib in Rheumatoid Arthritis. Rheumatol Ther. 2023 Feb;10(1):35-51. doi: 10.1007/s40744-022-00494-1. Epub 2022 Oct 7.

    PubMed 36205910

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Filgotinib in people with Rheumatoid Arthritis, run by Alfasigma S.p.A. at 345 sites in 32 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 345 sites in United States, Japan, India, Poland, Ukraine and 27 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 27 Jul 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants Who Reported Treatment-Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) (time frame: Day 1 to Week 376 (end of study)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03025308, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2026; AzTrials last refreshed its copy on 26 Oct 2026.

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