Long Term Extension Study to Assess the Safety and Efficacy of Filgotinib in Adults With Rheumatoid Arthritis (FINCH 4)
Rheumatoid Arthritis
About this trial
This is an interventional treatment trial for Rheumatoid Arthritis
Eligibility Criteria
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)
- Males and 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.
Sites / Locations
- Rheumatology Associates of North Alabama, PC
- Arthrocare, Arthritis Care & Research PC
- Arizona Arthritis & Rheumatology Associates, P.C.
- Arizona Arthritis & Rheumatology Associates, P.C.
- Medvin Clinical Research
- C.V. Mehta M.D. Medical Corporation
- University of California San Diego (UCSD) - Perlman Ambulatory Clinic
- Keck Medicine of USC- Division of Rheumatology
- Desert Medical Advances
- Stanford University Hospitals and Clinics (Immunology & Rheumatology)
- C.V. Mehta Medical Corporation
- Inland Rheumatology Clinical Trials, Inc.
- Desert Valley Medical Group
- Medvin Clinical Research
- AARDS Research, Inc.
- Clinical Research of West Florida, Inc.
- Omega Research Consultants, LLC
- University of Florida College of Medicine, Jacksonville - Rheumatology Research
- San Marcus Research Clinic, Inc.
- Suncoast Research Group, LLC
- Suncoast Clinical Research, Inc.
- Omega Research Consultants LLC
- IRIS Research and Development, LLC
- Jefrey D. Lieberman, MD, P.C.
- Springfield Clinic
- University of Kansas Medical Center
- Heartland Research Associates, LLC
- Center For Arthritis and Osteoporosis
- Bluegrass Community Research, Inc.
- Klein & Associates, M.D., P.A.
- Arthritis Treatment Center
- Klein & Associates, M.D., P.A.
- The Center For Rheumatology And Bone Research
- Clinical Pharmacology Study Group
- Umass Memorial Medical Center- Memorial Campus
- Henry Ford Health System
- Shores Rheumatology, PC
- St. Paul Rheumatology, PA
- Arthritis Associates, PLLC
- North Mississippi Medical Clinics, Inc.
- Clayton Medical Research, P.C.
- Arthritis Consultants, Inc.
- Physician Research Collaboration, LLC
- Dartmouth-Hitchcock Medical Center
- Arthritis & Osteoporosis Associates
- Ocean Rheumatology, PA
- Albuquerque Clinical Trials, Inc.
- NYU Langone Ambulatory Care Brooklyn Heights
- Weill Cornell Physicians At Brooklyn Heights
- Joint And Muscle Research Institute
- Physicians East, PA
- PMG Research of Salisbury
- Paramount Medical Research & Consulting, LLC
- Health Research of Oklahoma
- The Oklahoma Center For Arthritis Therapy & Research, Inc.
- East Penn Rheumatology Associates
- Altoona Center for Clinical Research
- Arthritis Group, PC
- Clinical Research Center of Reading LLC
- PA Regional Center For Arthritis And Osteoporosis Research
- Articularis Healthcare Inc., dba Columbia Arthritis Center, PA
- Carolina Rheumatology & Neurology Assoc., PC
- Articularis Healthcare Group d/b/a ACME Research
- Articularis Healthcare Group d/b/a Low Country Rheumatology
- Ramesh C. Gupta, M.D.
- Diagnostic Group
- Trinity Universal Research Associates, Inc
- Adriana Pop-Moody MD Clinic PA
- Arthritis Centers Of Texas
- Southwest Rheumatology Research, LLC
- Trinity Universal Research Associates, Inc
- Arthritis & Osteoporosis Center of South Texas
- Ceim Investigaciones Medicas Srl
- CIMEL
- Onganizacion Medica de Investigacion S.A (OMI)
- Mautalen Salud e Investigación
- Consultorios Reumatológicos Pampa
- Investigaciones Reumatologicas Y Osteologicas (IRO) SRL
- Instituto De Reumatologia
- Instituto Médico Cer
- Instituto Iari
- Cer San Juan, Centro Polivalente de Asistencia e Investigacion Clinica
- Centro Medico Privado de Reumatología
- Rheumatology Research Unit
- RK Will Pty Ltd
- Southern Clinical Research Pty Ltd
- Cliniques Universitaires Saint-Luc
- Reumaclinic Genk
- Universitaire Ziekenhuizen (UZ) Leuven - Gasthuisberg
- Zna Jan Palfijn
- "Medical Center Help" EOOD
- "Medical Center- Hipokrat 2000" OOD
- "UMHAT - Kaspela" EOOD
- "MHAT Lyulin" EAD, Department of Rheumatology
- Medical Center "N. I. Pirogov" EOOD
- "DCC Equita" EOOD
- MHAT "Sveta Petka" AD, Department of Internal Diseases
- The Waterside Clinic
- Centre De Recherche Musculo Squelettique
- Quantum Research Santiago
- Someal SA
- Centro Medico De Reumatologia
- MUDr. Michaela Blahova, revmatologicka ambulance s.r.o.
- L.K.N. Arthrocentrum, s.r.o.
- MUDr. Rosypalová, S.R.O.
- Revmatologicky ustav
- Arthrocentrum spol.s.r.o.
- Revmatologicka Ambulance
- Revmatologicka ambulance, Nuselska Poliklinika
- Medical Plus, S.R.O.
- Hôpital Lapeyronie, Service d'Immuno-Rhumatologic
- Rheumapraxis Dr. med. Reiner Kurthen
- Schlosspark-Klinik
- Centrum f. inn. Diagn. und Therap. Rheumatologie/Immunologie
- HRF II, Hamburger Rheuma Forsch. Zentrum II, MVZ f. Rheumatologie und Autoimmuned. Hamb. GmbH/ Dr. A. Everding GbR
- Rheumazentrum Ratungen-Studienambulanz GbR
- Department of Medicine & Theraputics, The Chinese University of Hong Kong
- Department of Medicine, Queen Mary Hospital
- Tuen Mun Hospital
- Betegapolo-Irgalmasrend Budai Irgalmasrendi Korhaz
- Revita Reumatológiai Kft.
- Markhot Ferenc Oktatokorhaz es Rendelointezet; Reumatologiai Osztaly
- Bekes Megyei Kozponti Korhaz, Pandy Kalman Tagkorhaz, Reumatologiai Osztaly
- Bacs Kiskun Megyei Korhaz Szedgedi Tudomanyegyetem Altalanos Orvostudomanyi Kar Oktatokorhaz Kalocsai Szent Kereszt Korh
- Pest Megyei Flor Ferenc Korhaz, Reumatologiai-es Fizioterapias Osztaly
- Csongrad Megyei Dr. Bugyi Istvan Korhaz; Mozgasszervi Rehabilitacios Osztaly
- C-Med Rehabilitacios es Diagnosztikai Kozpont. Reumatologia
- Panchshil Hospital, Dep
- B.J. Medical College and Civil Hospital
- Chanre Rheumatology and Immunology Centre and Research
- Chennai Meenakshi Multispeciality Hospital Ltd
- All India Institute of Medical Sciences
- Medanta - The Medicity
- Gleneagles Global Hospitals
- Nizams Institute of Medical Sciences
- Shri Nidaan Hospital and Hope Fertility Centre
- SR Kalla Memorial Gastro and General Hospital
- Santokba Durlabhji Memorial Hospital Cum Medical Research Institute
- Apollo Gleneagles Hospitals, Kolkata
- Medical College & Hospital, Kolkata
- Department of Rheumatology, KG Medical University
- Kasturba Medical College Hospital
- Vinaya Hospital and Research Centre
- JSS Medical College and Hospital
- Suretech Hospital and Research Centre Pvt Ltd
- Maharaja Agrasen Hospital
- Sir Ganga Ram Hospital
- Centre for Rheumatic Disease, Hermes Doctor House
- Deenanath Mangeshkar Hospital and Research Centre
- Krishna Institute of Medical Sciences
- Rajiv Gandhi Institute of Medical Sciences and Government General Hospital
- Nirmal Hospital Private Limited
- Medical College Baroda and Sir Sayajirao General Hospital
- King George Hospital
- St Vincent's University Hospital
- Bnai Zion Medical Center
- The Lady Davis Carmel Medical Center
- Rabin Medical Center
- The Chaim Sheba Medical Center
- Tel Aviv Medical Center
- Departimento Cardio-toraco-vascolare Gestione delle Malattie Reumatiche e del Connettivo e Malattie Metaboliche dell'osso
- Reumatologia
- Chibaken Saiseikai Narashino Hospital
- Medical Corporation Kojyokai Hirose Clinic
- Honjo Rheumatism Clinic
- Chiba University Hospital
- Kyushu Medical Center
- National Hospital Organization Kyushu Medical Center
- Seirei Hamamatsu General Hospital
- Hiroshima Rheumatology Clinic
- Hiroshima Red Cross Hospital & Atomic-bomb Survivors Hospital
- Hiroshima University Hospital
- Iizuka Hospital
- Saitama Medical University Hospital
- Shimane University Hospital
- Kagoshima red cross hospital
- Matsubara Mayflower Hospital
- Saitama Medical Center
- Hospital of the University of Occupational and Environmental Health, Japan
- Kobe University Hospital
- Kumamoto Orthopaedic Hospital
- Kurume University Medical Center
- Kyoto University Hospital
- University Hospital, Kyoto Prefectural University of Medicine
- Yu Family Clinic
- Zenjinkai Shiminnnomori Hospital
- Yoshida orthopaedic and rheumatology Clinic
- Nagaoka Red Cross Hospital
- Nagasaki Medical Hospital of Rheumatology
- Nagoya University Hospital
- The Hospital of Hyogo College of Medine
- Okayama Saiseikai General Hospital Outpatient Center
- Okayama University Hospital
- Ome Municipal General Hospital
- National Hospital Organization Sagamihara National Hospital
- Sanuki Municipal Hospital
- Sagawa Akira Rheumatology Clinic
- Sapporo City General Hospital
- Hokkaido University Hospital
- Hokkaido Medical Center for Rheumatic Diseases
- Sasebo Chuo Hospital
- Azuma Rheumatology Clinic
- Niigata Rheumatic Center
- Shizuoka Welfare Hospital
- Osaka University Hospital
- Inoue Hospital
- St. Luke's International Hospital
- Medical Corporation Uchida Clinic
- Showa University East Hospital
- Toho University Omori Medical Center
- Toho University Ohashi Medical Center
- Setagaya Rheumatic Clinic
- Keio University Hospital
- Teikyo University Hospital
- Yuuai Medical Center
- University of Tsukuba Hospital
- Wakayama Medical University Hospital
- Yokohama Minami Kyousai Hospital
- Pusan National University Hospital
- Kyungpook National University Hospital
- Daegu Catholic University Medical Center
- Chungnam National University Hospital
- Eulji University Hospital
- Chonnam National University Hospital
- Inha University Hospital
- Chonbuk National University Medical School
- Seoul National University Hospital
- Hanyang University Seoul Hospital
- Konkuk University Medical Center
- Asan Medical Center
- Chung-Ang University Hospital Institutional Review Board
- SMG-SNU Boramae Medical Center
- Hospital Selayang
- University Malaya Medical Centre
- Centro De Investigación Clínica De Morelia, Sc
- Kohler & Milstein Research S.A. de C.V.
- Investigacion y Biomedicina de Chihuahua, S.C.
- Clinstile, S.A. De C.V.
- Clinosar Mexico. S.A. de C. V.
- Centro Peninsular De Investigacion Clinica S.C.P.
- Biologicos Especializados
- Hospital Universitario Dr. Jose Eleuterio Gonzalez
- Middlemore Clinical Trial
- Optimal Clinical Trials, Level 2
- Waikato Hospital
- Clinical Trial Unit, CCHDB, Wellington Hospital
- Clinical Trials Unit, Timaru Hospital
- Gabinet Internistyczno-Reumatologiczny Piotr Adrian Klimiuk
- Clinicmed
- Szpital Uniwersytecki Nr 2, Klinka Reumatologii I Ukladowych Chorob Tkanki Lacznej
- Niepubliczny Zaklad Opieki Zdrowotnej BIF-MED S.C.
- Nszoz Unica Cr
- Centrum Kliniczno-Badawcze J. Brzezicki
- Centrum Medyczne Pratia Gdynia
- NZOZ Centrum Medyczna Sw. Lukasza w Kartuzach
- SILMEDIC Spolka z ograniczona odpowiedzialnoscia w Swindniku, Oddzial w Katowicach
- Nzoz Centrum Medyczne Promimed
- Twoja Przychodnia -Centrum Medyzcne Nowa Sol
- Synexus Polska Sp. z.o.o. Oddzial w Porznaniu
- Centrum Badan Klinicznych S.C. Wieslawa Porawska, Lukasz Porawski
- Ai Centrum Medyczne
- Samodzielny Publiczny Zespol Opieki Zdrowotnej w Tomaszowie Lubelskim Lubelskim; Oddzial Reumatologiczy
- Nasz Lekarz Przychodnie Medyczne
- Reumatika -Centrum Reumatologii NZOZ
- Centrum Medyczne AMED Warszawa Targówek
- Centrum Medyczne Oporow
- Spitalul Judetean de Urgenta Bacau, Sectia Reumatologie
- S.C. Ianuli Med Consult S.R.L.
- Spitalul Clinic ,, Sf. Maria", Sectia Reumatologie
- Spitalul Clinic,, Sf. Maria"", Departamentul de Medicina Interna si Reumatologie
- Spitalul Clinic Judetean de Urgenta Tirgu Mures
- Territorial State Budgetary Healthcare Institution "Territorial Clinical Hospital"
- State Budgetary Healthcare Institution, Chelyabinsk Regional Clinical Hospital
- FSBEI of HE "Kazan State Medical University" of Ministry of Healthcare of the Russia Federation, Department of hospital therapy
- Medical Center Maximum Zdorovia LLC
- Kemerovo State Medical University on the base of Regional Clinical Hospital for War Veterans
- Municipal Clinical Hospital No. 15 named after O.M. Filatov
- City Clinical Hospital #4 of Department of Healthcare of Moscow City
- M. Vladimirsky Moscow Regional Research Clinical Institute
- Municipal Clinical Hospital No. 40 Department of healthcare of Moscow City
- Nizhny Novgorod City Clinical Hospital #5
- Saint-Petersburg State Budgetary Healthcare Institution "Clinical rheumatology hospital # 25"
- State Healthcare Institution, Regional Clinical Hospital
- LLC Polyclinic of Private Security Personnel
- LLC BioMed
- State Autonomous Healthcare Institution of Yaroslavl region "Clinical Hospital for Emergency Medical Care n. a. N. V. Solovyev"
- Institute Of Rheumatology
- Military Medical Academy, Clinic of Rheumatology
- Clinical Hospital Center Bezanijska Kosa
- Institute For Treatment And Rehabilitation Niska Banja
- Neštátna Reumatologická Ambulancia
- Reumex S.R.O.
- LERAM s.r.o.
- Arthritis Clinical Trial Centre
- Netcare St. Augustine's Hospital
- Umhlanga Netcare Medical Centre
- Charlotte Maxeke Johannesburg Academic Hospital
- Winelands Medical Research Centre
- Hospital Universitario Cruces
- Complejo Hospitalario Universitario de Santiago
- Hospital General Universitario Gregorio Maranon
- Hospital Universitario Ramon y Cajal
- Hospital Regional Universitario de Malaga
- Corporacio Santiaria Parc Tauli
- Clínica Gaias
- Hospital HM Nuestra Senora de la Esperanza
- Hospital Clinico Universitario de Valencia
- Changhua Christian Hospital
- Kaohsiung Veterans General Hospital
- Chang Gung Memorial Hospital, Keelung
- China Medical University Hospital
- Chung Shan Medical University Hospital
- Chi Mei Hospital, Chi Mei Medical Center
- National Taiwan University Hospital
- Taipei Medical University Hospital
- Tri-Service General Hospital
- Chang Gung Medical Foundation, Chang Gung Memorial Hospital, Linkou Branch
- Phramongkutklao Hospital, Division of Rheumatology, Department of Medicine
- Rajavithi Hospital, Rheumatology and Allergy Unit
- Faculty of Medicine Siriraj Hospital, Mahidol University, Division of Rheumatology, Department of Medicine
- Maharaj Nakorn Chiang Mai Hospital, Faculty of Medicine, Chiang Mai University
- Faculty of Medicine, Prince of Songkla University, Songklanagarind Hospital
- Municipal Institution Dnipropetrovsk 6th City Clinical Hospital of Dnipropetrovsk Regional Council
- Municipal Nonprofit Enterprise of the Kharkiv Regional Council, Regional Hospital for War Veterans, Department of Therapy #1
- State Institution "National Institute of Therapy named after L.T. Maloyi" of National Academy of Medical Sciences of Ukraine"
- Municipal Institution of Heath Care "Regional Clinical Hospital-Center Of Emergency Medicine & Disaster Medicine"
- Municipal Nonprofit Enterprise "City Clinical Hospital #13" of the Kharkiv City Council, Department of Therapy
- Minicipal Institution "Kherson City Clinical Hospital n. a. Afanasiy and Olga Tropinykh", Department of Therapy #1
- Kyiv Oleksandrivska City Clinical Hospital, Department of Rheumatology # 2
- Kyiv City Clinical Hospital #6, Department of Therapy
- State Institution National Scientific Center M.D. Strazhesko Institute of Cardiology of NAMS of Ukraine
- Municipal Institution of Kyiv Regional Council "Kyiv Regional Clinical Hospital", Highly Specialized Therapeutic Department
- Lutsk City Clinical Hospital
- Municipal Institution of Lviv Regional Council "Lviv Regional Clinical Hospital" Department of Rheumatology
- Municipal Nonprofit Enterprise "4-th City Clinical Hospital in Lviv", Department of Rheumatology
- Municipal Institution Odesa Regional Clinical Hospital, Polyclinic Department
- City Clinical Hospital #1, Department of Rheumatology
- Vinnytsya Regional Clinical Hospital named after M. I. Pyrogova, Department of Rheumatology
- Medical Centre Modern Clinic, LLC
- Municipal Institution "City Hospital #1", Department of Therapy
- Municipal Institution City Hospital #7, Department of Therapy
- NHS Lothian, Western General Hospital
- Princess Alexandra Hospital
- Northumbria Healthcare NHS Foundation Trust
- Warrington and Halton Hospitals Nhs Foundation Trust
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Experimental
Experimental
Experimental
Blinded Phase: Filgotinib 200 mg
Blinded Phase: Filgotinib 100 mg
Open Label Phase: Filgotinib 200 mg
Open Label Phase: Filgotinib 100 mg
Filgotinib 200 mg plus placebo to match (PTM) filgotinib 100 mg for up to 6 years
Filgotinib 100 mg plus PTM filgotinib 200 mg for up to 6 years
Filgotinib 200 mg for up to 6 years
Filgotinib 100 mg for up to 6 years