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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT02914535
Other study ID # GS-US-418-3899
Secondary ID 2016-002765-58
Status Active, not recruiting
Phase Phase 3
First received
Last updated
Start date February 23, 2017
Est. completion date September 2026

Study information

Verified date November 2023
Source Galapagos NV
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The primary objective of this study is to observe the long-term safety of filgotinib in adults who have completed or met protocol specified efficacy discontinuation criteria in a prior filgotinib treatment study in ulcerative colitis (UC).


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 1173
Est. completion date September 2026
Est. primary completion date September 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Key Inclusion Criteria: - Must have the ability to understand and sign a written informed consent form (ICF), which must be obtained prior to initiation of study procedures associated with this trial - Must have enrolled in Gilead-sponsored UC parent protocol GS US 418-3898 or any other Gilead/Galapagos-sponsored filgotinib treatment study for UC - Must have completed all required procedures or met protocol-specified efficacy discontinuation criteria in a prior filgotinib treatment study for UC - Females of childbearing potential must have a negative pregnancy test at Day 1 - Female individuals of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception for the duration described - Willingness to refrain from live or attenuated vaccines during the study and for 12 weeks after last dose of study drug Key Exclusion Criteria: - Known hypersensitivity to the study drug - Any chronic medical condition (including, but not limited to, cardiac or pulmonary disease, alcohol or drug abuse) that, in the opinion of the Investigator or sponsor, would make the subject unsuitable for the study or would prevent compliance with the study protocol - Females of reproductive potential who are unwilling to abide by protocol-specified contraceptive methods as defined - Use of prohibited medications as outlined in the protocol NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Filgotinib
Tablet(s) administered orally once daily
Placebo
Tablet(s) administered orally once daily

Locations

Country Name City State
Argentina Instituto de Investigaciones Clinicas Mar del Plata Mar del Plata
Argentina Instituto Médico Cer Quilmes
Australia Monash Medical Centre Clayton New South Wales
Australia St. Vincent's Hospital Sydney Darlinghurst New South Wales
Australia Footscray Hospital Footscray Victoria
Australia Nepean Hospital Kingswood New South Wales
Australia Cabrini Hospital Malvern Victoria
Australia Alfred Hospital Melbourne Victoria
Australia Coastal Digestive Health Mountain Creek Queensland
Australia Mater Misericordiae Ltd South Brisbane Queensland
Australia The Queen Elizabeth Hospital Woodville South South Australia
Australia Princess Alexandra Hospital Woolloongabba Queensland
Austria Universitatsklinik Innsbruck Innsbruck
Austria AKH-Medizinische Universitat Wien Wien
Belgium GZA Ziekenhuizen, campus Sint-Vincentius Antwerpen
Belgium CUB Hopital Erasme Brussel
Belgium Universitair Ziekenhuis Leuven Leuven
Belgium Centre Hospitalier Chretien (CHC) - Clinique Saint-Joseph Liège
Bulgaria MHAT Sveti Pantaleymon- Pleven OOD Pleven
Bulgaria "MDHAT Dr. St.Cherkezov" AD Veliko Tarnovo
Bulgaria MHAT "Sveta Petka" AD Vidin
Canada University of Calgary, Heritage Medical Research Clinic Calgary Alberta
Canada Hamilton Health Sciences Corporation, McMaster University Medical Centre Hamilton Ontario
Canada Royal University Hospital Saskatoon Saskatchewan
Canada The Gordon and Leslie Diamond Health Care Centre Vancouver British Columbia
Canada Toronto Digestive Disease Associates Inc. Vaughan Ontario
Croatia Clinical Hospital Dubrava Zagreb
Croatia University Hospital Center Zagreb Zagreb
Czechia Hepato-Gastroenterology HK, s.r.o. Hradec Kralove
Czechia Oblastni nemocnice Mlada Boleslav, a.s., nemocnice Stredoceskeho kraje, Gastroenterologicke oddeleni Mlada Boleslav
Czechia G.E.P. Clinic, s r.o. Praha 3
Czechia ISCARE a.s. (Klinicke centrum ISCARE), Klinicke a vyzkumne centrum pro strevni zanety Praha 9
France CHU Amiens Picardie Amiens Cedex 1
France CHU de Caen Caen Cedex 9
France CHU de Clermont-Ferrand - Hopital d'Estaing Clermont-Ferrand
France APHP - Hopital Beaujon - Clichy - Universite Paris VII Clichy
France CHU de Dijon Bourgogne - Hopital Francois Mitterand Dijon
France CHU Grenoble Alpes La Tronche
France Hopital Universitaire de Bicetre Le Kremlin Bicetre
France Centre Hospitalier Regional Universitaire de Lille Lille
France Hopital Nord Marseille
France CHU de Montpellier-Hopital Saint Eloi Montpellier
France CHU Hotel-Dieu Nantes
France Hopital de l'Archet 2 Nice
France CHU de Bordeaux - Hopital Haut Leveque Pessac
France Centre Hospitalier Universitaire de Lyon Sud Pierre-Benite
France Centre Hospitalier Universitaire de Rennes - Hopital Pontchaillou Rennes Cedex 9
France CHU de Saint Etienne - Hopital Nord Saint Priest en Jarez
France CHU de Toulouse - Hopital Rangueil Toulouse
France CHU de Nancy - Hopital Brabois Adultes Vandoeuvre Les Nancy
Georgia Unimed Ajara LLC - Batumi Referral Hospital Batumi
Georgia Medi Club Georgia LLC Tbilisi
Germany Charite - Universitatsmedizin Berlin Berlin
Germany Charite Universitaetsmedizin Berlin Berlin
Germany DRK Kliniken Berlin - Westend - Klinik fuer Innere Medizin Berlin
Germany Stadtisches Klinikum Braunschweig gGmbH Braunschweig
Germany Agaplesion Markus Krankenhaus Frankfurt am Main
Germany Universitatsklinikum Freiburg Freiburg
Germany Asklepios Westklinikum Hamburg Hamburg
Germany Medizinische Hochschule Hannover Hannover
Germany Gastroenterologische Gemeinschaftspraxis Herne Herne
Germany Universitatsklinikum Jena Jena
Germany Universitatsklinikum Schleswig-Holstein Kiel Schleswig Holstein
Germany Universitaetsklinik Koln Koln
Germany EUGASTRO GmbH Leipzig
Germany Klinikum Luneburg Lüneburg
Germany Gastroenterologische Gemeinschaftspraxis Minden Minden
Germany Klinikum der Universitat Munchen - Grosshadern Muenchen
Germany Universitaetsklinikum Tuebingen Tuebingen
Germany Universitatsklinikum Ulm, Zentrum Fur Innere Medizin Ulm
Greece General Hospital of Athens "Hippokratio", 2nd Internal Medicine Clinic of Athens University, Hepato-gastroenterology Unit Athens
Hong Kong Princess Margaret Hospital Hong Kong
Hong Kong Queen Mary Hospital Hong Kong
Hong Kong Department of Medicine & Therapeutics, The Chinese University of Hong Kong, Prince of Wales Hospital Shatin
Hungary Bekes Megyei Kosponti Korhaz, Dr. Rethy Pal Tagkorhaz, IV. Belgyogyaszat - 2. Gasztroenterologia Bekescsaba
Hungary Del-pesti Centrumkorhaz - Orszagos Hematologiai es Infektologiai Intezet, Kozponti Felnott Szakrendelo Budapest
Hungary Szent Janos Korhaz es Eszak-budai Egitett Korhazak, I. Belgyogyaszati - Gasztroenterologiai Osztaly Budapest
Hungary Debreceni Egyetem Klinikai Kozpont, II. sz. Belgyogyaszati Klinika, Gasztroenterologia Debrecen
Hungary Bugat Pal Korhaz, Belgyogyaszat Gyöngyös
Hungary Karolina Korhaz es Rendelointezet, Altalanos Belgyogyaszat-Gasztroenterologia Mosonmagyarovar
India Kaizen Hospital Ahmedabad
India M S Ramaiah Medical College and Hospital Bangalore
India Apollo Speciality Hospital Chennai
India VGM Hospital Institute of Gastroenterology Coimbatore
India Centre for Liver Research & Diagnostics Hyderabad
India Citizens Specialty Hospital Hyderabad
India Gleneagles Global Hospitals Hyderabad
India S.M.S Medical College & Hospitals Jaipur
India SR Kalla Memorial Gastro and General Hospital Jaipur
India Dayanand Medical College & Hospital Ludhiana
India Kasturba Medical College (KMC) Hospital Mangaluru
India Lokmanya Tilak Municipal General Hospital Mumbai
India Midas Multispeciality Hospital Pvt. Ltd Nagpur
India Suretech Hospital & Research Centre Ltd Nagpur
India Grant Medical Foundation Ruby Hall Clinic Pune
India Shree Giriraj Multispeciality Hospital Rajkot
India Gandhi Hospital Secunderabad
India Surat Institute of Digestive Sciences Surat
India Kasturba Hospital Medical College Udupi
India Sterling Hospital Vadodara
India Samvedna Hospital Varanasi
Ireland Beaumont Hospital Dublin
Israel Bnai Zion Medical Center Haifa
Israel Rambam Medical Health Care Campus Haifa
Israel Hadassah Medical Center Jerusalem
Israel Shaare Zedek Medical Center Jerusalem
Israel Rabin Medical Center Petah Tikva
Italy UOC Gastroenterologia II Castellana Grotte
Italy U.O. Fisiopatologia Digestiva Catanzaro
Italy Ospedale Clinicizzato SS. Annunziata - Dipartimento di Medicina Chieti
Italy Endocsopia Digestiva Centralizzata - ASST Fatebenefratelli Sacco, Ospedale Fatebenefratelli e Oftalmico Milano
Italy UOC Gastroenterologia Padova
Italy Azienda Ospedaliero-Universitaria Pisana - Presidio Ospedaliero Cisanello Pisa
Italy UOC Gastroenterologia ed Endoscopia Digestiva Roma
Italy Istituto Clinico Humanitas Rozzano
Japan Medical Hospital, Tokyo Medical and Dental University Bunkyo-ku
Japan Fukuoka University Chikushi Hospital Chikushino-shi
Japan Hokkaido P.W.F.A.C Sapporo-Kosei General Hospital Chuo-ku
Japan Japanese Red Cross Fukuoka Hospital Fukuoka-shi
Japan Tokai University Hachioji Hospital Hachioji
Japan Hiroshima University Hospital Hiroshima
Japan Fukuoka University Hospital Jonan-ku
Japan Ofuna Chuo Hospital Kamakura
Japan Kitakyushu City Hospital Organization Kitakyushu Municipal Medical Center Kitakyushu-shi
Japan Yamanashi Prefectural Central Hospital Kofu-shi
Japan Hidaka Coloproctology Clinic Kurume-shi
Japan Kurume University Hospital Kurume-shi
Japan University Hospital, Kyoto Prefectural University of Medicine Kyoto-shi
Japan Kitasato University Kitasato Institute Hospital Minato-ku
Japan The Jikei University Hospital Minato-Ku
Japan Kyorin University Hospital Mitaka-shi
Japan Iwate Medical University Hospital Morioka-shi
Japan Aichi Medical University Hospital Nagakute-shi
Japan Nagasaki University Hospital Nagasaki-shi Nagasaki
Japan Saiseikai Niigata Daini Hospital Nishi-ku
Japan Hyogo College of Medicine College Hospital Nishinomiya
Japan Ishida IBD Clinic Oita-shi
Japan Okayama University Hospital Okayama-city
Japan Kinshukai Infusion Clinic Osaka
Japan Osaka City University Hospital Osaka
Japan Wakakusa-Daiichi Hospital Osaka
Japan Shiga University of Medical Science Hospital Otsu
Japan Saga University Hospital Saga
Japan Saga-Ken Medical Centre Koseikan Saga-shi
Japan Kitasato University Hospital,THE KITASATO INSTITUTE Sagamihara
Japan Tokito Clinic Saitama
Japan Toho University Sakura Medical Center Sakura
Japan Sapporo Higashi Tokushukai Hospital Sapporo-shi
Japan National Hospital Organization Sendai Medical Center Sendai
Japan Tokyo Yamate Medical Center Shinjuku-ku
Japan Osaka University Hospital Suita Osaka
Japan Kagawa Prefectural Central Hospital Takamatsu-shi
Japan National Hospital Organization Takasaki General Medical Center Takasaki-shi
Japan Osaka Medical College Hospital Takatsuki
Japan Ieda Hospital Toyota-shi
Japan Wakayama Medical University Hospital Wakayama-shi
Japan Colo-proctology Center Matsushima Clinic Yokohama-shi
Korea, Republic of Pusan National University Hospital Busan
Korea, Republic of Yeungnam University Hospital Daegu
Korea, Republic of Asan Medical Center Seoul
Korea, Republic of Division of Gastroenterology, Department of Medicine, Samsung Medical Center Seoul
Korea, Republic of Kangbuk Samsung Hospital Seoul
Korea, Republic of Kyung Hee University Hospital Seoul
Korea, Republic of Yonsei University Health System, Severance Hospital Seoul
Korea, Republic of The Catholic University of Korea, St. Vincent's Hospital Suwon-si Gyeonggi-do
Korea, Republic of Yonsei University Wonju Severance Christian Hospital Wonju
Malaysia Hospital Pulau Pinang George Town
Malaysia Hospital Queen Elizabeth Kota Kinabalu
Mexico PCR-Phylasis Clinicas Research S. de R.L. de C.V. Cuautitlán Izcalli
Netherlands Academic Medical Center (AMC) Amsterdam
Netherlands Gelre Hospital Apeldoorn
Netherlands University Medical Center Utrecht Utrecht
New Zealand Christchurch Hospital Christchurch
New Zealand Auckland City Hospital Grafton
New Zealand Wellington Hospital Newtown
New Zealand Bay of Plenty District Health Board - Tauranga Hospital Tauranga
Poland Uniwersytecki Szpital Kliniczny w Bialymstoku, Klinika Gastroenterologii i Chorob Wewnetrznych Bialystok
Poland Gabinet Lekarski Janusz Rudzinski Bydgoszcz
Poland VITAMED Galaj i Cichomski spólka jawna Bydgoszcz
Poland NZOZ INTER-MED, Centrum Endoskopowe Czestochowa
Poland Niepubliczny Zaklad Opieki Zdrowotnej ALL-MEDICUS Katowice
Poland Gabinet Endoskopii Przewodu Pokarmowego Krakow
Poland Krakowskie Centrum Medyczne Sp. z o.o Kraków
Poland Centrum Opieki Zdrowotnej Orkan-Med Stec-Michalska Sp. J. Ksawerów
Poland Santa Familia, Centrum Badan, Profilaktyki i Leczenia Lodz
Poland Centrum Innowacyjnych Terapii Sp. z o.o. Piaseczno
Poland Clinical Research Center Spolka z ograniczna odpowiedzialnoscia Medic-R Sp. k. Poznan
Poland Gabinet Lekarski Dr. Hab. N. Med. Bartosz Korczowski Rzeszów
Poland Endoskopia Sp. z o.o. Sopot
Poland Twoja Przychodnia-Szczecinskie Centrum Medyczne Szczecin
Poland GASTROMED Kopon, Zmudzinski i Wspolnicy Sp. j. Specjalistyczne Centrum Gastrologii i Endoskopii Torun
Poland H-T.Centrum Medyczne Spolka z Ograniczona Odpowiedzialnoscia Sp.K. Tychy
Poland Bodyclinic Warszawa
Poland Centralny Szpital Kliniczny Ministerstwa Spraw Wewnetrznych i Administacji w Warszawie Warszawa
Poland Centrum Zdrowia MDM Warszawa
Poland Niepubliczny Zaklad Opieki Zrodotnej VIVAMED Jadwige Miecz Warszawa
Poland Centrum Medyczne Oporow Wroclaw
Portugal Hospital da Senhora da Oliveira Guimaraes, E.P.E. Guimaraes
Portugal Centro Hospitalar de Sao Joao, EPE Porto
Romania MedLife, Gastroenterologie Bucuresti
Romania Spitalul Clinic Colentina - Sectia de Spitulal Clinic Colentina, Gastroenterologie Bucuresti
Romania Cabinet Medical Individual Dr Tirnaveanue Amelita, Gastroenterologie Oradea
Romania Cabinet Particular Policlinic Algomed SRL Timisoara
Russian Federation State Budgetary Healthcare Institution "Chelyabinski Regional Clinical Hospital" Chelyabinsk
Russian Federation State Budgetary Institution of Health Irkustsk Order "Badge of Honor" Regional Clinical Hospital Irkutsk
Russian Federation Federal State Budgetary Institution of Science Federal Research Center of Nutrition, Biotechnology and Food Safety Moscow
Russian Federation State Budgetary Healthcare Institution of Moscow "City Clinical Hospital # 24 of Healthcare Department of Moscow" Moscow
Russian Federation State Budgetary Healthcare Institution of Moscow Region "Moscow Regional Clinical Research Institute n.a. M.F. Vladimirskiy" Moscow
Russian Federation State Budgetary Healthcare Institution of Nizhny Novgorod Region "Nizhny Novgorod Regional Clinical Hospital n.a. N.A. Nizhniy Novgorod
Russian Federation State Budgetary Healthcare Institution of the Novosibirsk Region "State Novosibirsk Regional Clinical Hospital" Novosibirsk
Russian Federation State Budgetary Institution of Health of Novosibirsk Region "City Clinical Hospital #12" Novosibirsk
Russian Federation "Riat" LLC Saint Petersburg
Russian Federation "Scientific Research Centre ECO-safety" LLC Saint-Petersburg
Russian Federation Saint Petersburg State Budgetary Healthcare Institution "City Polyclinic #38" Saint-Petersburg
Russian Federation State Healthcare Institution "Regional Clinical Hospital" Saratov
Russian Federation Treatment and Prevention Interdistrict Institution "Smolenskie kliniki" LLC Smolensk
Russian Federation Tyumen Regional State Autonomous Healthcare Institution << Consulting and Diagnostic Centre <<Endos>> Tyumen
Serbia Zvezdara University Medical Center Belgrade
Singapore Singapore General Hospital Singapore
Slovakia KM Management, s.r.o., Gastroenterologicke a hepatologicke centrum Nitra Nitra
South Africa Dr MJ Prins Cape Town
South Africa Peermed Clinical Trial Centre Johannesburg
Spain Centro Medico Teknon Barcelona
Spain Hospital Clinico San Carlos Madrid
Spain Hospital Universitario de Fuenlabrada Madrid
Spain Hospital Universitario Central de Asturias Oviedo
Spain Hospital Universitario Virgen del Rocío Sevilla
Sweden Skane University Hospital Malmo
Sweden Danderyd University Hospital Corp Stockholm
Sweden Akademiska Sjukhuset Uppsala
Switzerland Gastroenterologische Praxis Balsiger, Seibold und Partner Bern
Switzerland Universitätsspital Zürich Zurich
Taiwan Changhua Christian Hospital Changhua
Taiwan Mackay Memorial Hospital, Taipei Taipei
Taiwan National Taiwan University Hospital Taipei
Taiwan Chang Gung Medical Foundation, Chang Gung Memorial Hospital, Linkou Branch Taoyuan
Ukraine Municipal Institution "Cherkasy Regional Hospital of Cherkasy Regional Council", Gastroenterology Department Cherkasy
Ukraine Municipal City Clinical Hospital of the Emergency Medical Care, 1 st Therapy Department. Danylo Halytsky Lviv National Medical Chernivtsi
Ukraine Regional Municipal Institution "Chernivtsi Regional Clinical Hospital", Surgical Department Chernivtsi
Ukraine State Institution "Institute of Gastroenterology of National Academy of Medical Sciences of Ukraine" Dnipropetrovsk
Ukraine Ivanto-Frankivsk Central City Clinic Hospital, Therapy Department #1. State Higher Education Institution Ivano-Frankivsk National Ivano-Frankivsk
Ukraine L.T. Mala State Institution "National Institute of Therapy of National Academy of Medical Sciences of Ukraine" Kharkiv
Ukraine Municipal Health Care Institution "Kharkiv City Clinical Hospital #2 named after prof. O. O. Shalimov", Proctology Department Kharkiv
Ukraine Municipal Institution of Health Care "Regional Hospital of War Veterans", Therapeutic Department No1 Kharkiv
Ukraine Kyiv City Clinical Hospital No. 18, Proctology Department Kyiv
Ukraine Municipal Non-profit Enterprise "Consultative and Diagnostic Center" of Pechersk District of Kyiv, Therapy Department Kyiv
Ukraine Municipal Institution "Odesa Regional Clinical Hospital", Regional Gastroenterology Center based on Surgery Department Odessa
Ukraine Odesa Clinical Railway Hospital Branch of "Healthcare Center" of Public joint stock company "Ukrainian Railway" Odessa
Ukraine Ternopil University Hospital, Regional Center of Gastroenterology with Hepatology Ternopil
Ukraine M.I. Pyrogov Vinnytsia Regional Clinical Hospital, Gastroenterology Department Vinnytsia
Ukraine Medical Center LLC "Health Clinic" Vinnytsia
Ukraine Vinnytsia Regional Clinical Hospital of War Veterans, Therapy Department #1 Vinnytsia
Ukraine Municipal Institution "Zaporizhzhya Regional Clinical Hospital" of Zaporizhzhya Regional Council Zaporizhzhya
United Kingdom The Pennine Acute Hospitals NHS Trust Bury
United Kingdom Cambridge University Hospital NHS Foundation Trust Cambridge
United Kingdom Royal Derby Hospital Derby
United Kingdom NHS Lothian Edinburgh
United Kingdom Glasgow Clinical Research Facility - Queen Elizabeth University Hospital Glasgow
United Kingdom NHS Greater Glasgow and Clyde Glasgow
United Kingdom Wycombe Hospital High Wycombe
United Kingdom Imperial College Healthcare NHS Trust, St Mary's Hospital London
United Kingdom Norfolk and Norwich University Hospital NHS Foundation Trust Norwich Norfolk
United Kingdom Biomedical Research Unit Nottingham
United Kingdom Oxford University Hospitals NHS Trust Oxford
United Kingdom St Helens and Knowsley Teaching Hospitals NHS Trust Prescot
United Kingdom Southampton National Institute for Health Research, Wellcome Trust Clinical Research Facility Southampton
United States Investigative Clinical Research Annapolis Maryland
United States Massachusetts General Hospital - Crohn's and Colitis Center Boston Massachusetts
United States NY Scientific Brooklyn New York
United States University of Virginia Health System Charlottesville Virginia
United States Gastroenterology Associates of Tidewater Chesapeake Virginia
United States Clinical Research Institute of Michigan, LLC Chesterfield Michigan
United States MGG Group Co., Inc., Chevy Chase Clinical Research Chevy Chase Maryland
United States Consultants for Clinical Research Cincinnati Ohio
United States UC Health Physicians Clifton Cincinnati Ohio
United States Gastro Center of Maryland Columbia Maryland
United States Digestive Health Specialists Of The Southeast Dothan Alabama
United States Fargo Gastroenterology and Hepatology Clinic Fargo North Dakota
United States Connecticut GI PC-Research Division Farmington Connecticut
United States San Antonio Military Medical Center Fort Sam Houston Texas
United States UF Clinical Research Center Gainesville Florida
United States DHAT Research Institute Garland Texas
United States Gastro One Germantown Tennessee
United States NYU Langone Long Island Clinical Research Associates Great Neck New York
United States Meritus Center for Clinical Research Hagerstown Maryland
United States Baylor College of Medicine - Baylor Medical Center Houston Texas
United States The University of Texas Health Science Center at Houston Houston Texas
United States University of Iowa Hospitals and Clinics Iowa City Iowa
United States Kansas City Research Institute Kansas City Missouri
United States Florida Research Institute Lakewood Ranch Florida
United States South Denver Gastroenterology, PC Lone Tree Colorado
United States VA Long Beach Healthcare System Long Beach California
United States Cedars Sinai Medical Center Los Angeles California
United States University of Louisville, Clinical Trials Unit Louisville Kentucky
United States Gastroenterology Associates Of Central Georgia, LLC Macon Georgia
United States University of Wisconsin Hospital & Clinics Madison Wisconsin
United States Gastrointestinal Specialists of Georgia Marietta Georgia
United States Great Lakes Gastroenterology Research, LLC Mentor Ohio
United States Cordova Research Institute Miami Florida
United States University of Miami Crohn's and Colitis Center Miami Florida
United States Delta Research Partners, LLC Monroe Louisiana
United States Gastroenterology Group of Naples Naples Florida
United States Quality Medical Research Nashville Tennessee
United States Vanderbilt University Medical Center - IBD Clinic Nashville Tennessee
United States Gastroenterology Associates of Orangeburg Orangeburg South Carolina
United States Advanced Medical Research Center Port Orange Florida
United States Carolina's GI Research LLC Raleigh North Carolina
United States Rapid City Medical Center Rapid City South Dakota
United States McGuire DVAMC Richmond Virginia
United States Mayo Clinic Rochester Minnesota
United States Washington University School of Medicine Saint Louis Missouri
United States Clinical Associates in Research Therapeutics of America, LLC San Antonio Texas
United States Gastroenterology Research of San Antonio San Antonio Texas
United States TDDC San Marcos San Marcos Texas
United States Mayo Clinic Arizona Scottsdale Arizona
United States Louisiana Research Center, LLC Shreveport Louisiana
United States Texas Digestive Disease Consultants Southlake Texas
United States Atlanta Gastroenterology Specialist, PC Suwanee Georgia
United States Tampa General Hospital Tampa Florida
United States Spring Gastroenterology The Woodlands Texas
United States Center for Digestive Health Research Troy Michigan
United States Allegiance Research Specialists, LLC Wauwatosa Wisconsin
United States Florida Medical Clinic, P.A Zephyrhills Florida

Sponsors (2)

Lead Sponsor Collaborator
Galapagos NV Gilead Sciences

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Austria,  Belgium,  Bulgaria,  Canada,  Croatia,  Czechia,  France,  Georgia,  Germany,  Greece,  Hong Kong,  Hungary,  India,  Ireland,  Israel,  Italy,  Japan,  Korea, Republic of,  Malaysia,  Mexico,  Netherlands,  New Zealand,  Poland,  Portugal,  Romania,  Russian Federation,  Serbia,  Singapore,  Slovakia,  South Africa,  Spain,  Sweden,  Switzerland,  Taiwan,  Ukraine,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Overall Safety Profile of Filgotinib Evaluated by Proportion of Participants Experiencing Adverse Events and Abnormal Clinical Laboratory Tests Up to 336 weeks plus 30 days
Secondary Change From Baseline in Components of Mayo Clinic Score (MCS) Baseline and up to 336 weeks
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