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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT02914600
Other study ID # GS-US-419-3896
Secondary ID 2016-002763-34
Status Terminated
Phase Phase 3
First received
Last updated
Start date March 17, 2017
Est. completion date August 1, 2023

Study information

Verified date August 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 Crohn's disease (CD).


Recruitment information / eligibility

Status Terminated
Enrollment 1188
Est. completion date August 1, 2023
Est. primary completion date August 1, 2023
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 a CD parent protocol, GS-US-419-4015, GS-US-419-4016 or GS-US-419-3895 or any other Gilead/Galapagos sponsored filgotinib treatment study for CD - Females of childbearing potential must have a negative pregnancy test at Day 1 - Female subjects of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception for the duration described in the protocol - Willingness to refrain from live or attenuated vaccines during the study and for 12 weeks after last dose of study drug - Must have completed all required procedures or met protocol specified efficacy discontinuation criteria in a prior filgotinib treatment study for CD 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 individual 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 in the protocol - Use of prohibited medications as outlined in the study 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 Fundacion Estudios Clinicos CiRec Rosario
Australia Emeritus Research Camberwell Victoria
Australia Royal Prince Alfred Hospital Camperdown New South Wales
Australia Monash Medical Centre Clayton Victoria
Australia St. Vincent's Hospital Sydney Darlinghurst New South Wales
Australia Footscray Hospital Footscray Victoria
Australia Austin Health Heidelberg 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 Coral Sea Clinical Research Institute (Mackay) North Mackay Queensland
Australia Royal Melbourne Hospital Parkville Victoria
Australia Mater Misericordiae Ltd South Brisbane Queensland
Australia Wollongong Hospital Wollongong New South Wales
Australia The Queen Elizabeth Hospital Woodville South South Australia
Australia Princess Alexandra Hospital Woolloongabba Queensland
Austria Universitatsklinik Innsbruck Innsbruck
Austria Klinikum Klagenfurt am Wörthersee, Abt. Für Inn. Med. & Gastroenterol, (IMuG), Hepatol., Endokrinol., Rheumatol., & Nephrol. Klagenfurt am Wörthersee
Austria AKH-Medizinische Universitat Wien Wien
Belgium GZA Ziekenhuizen, campus Sint-Vincentius Antwerpen
Belgium Imelda General Hospital Bonheiden
Belgium CUB Hopital Erasme Brussel
Belgium Universitair Ziekenhuis Antwerpen Edegem
Belgium Universitair Ziekenhuis Gent Gent
Belgium Universitair Ziekenhuis Leuven Leuven
Belgium CHR Citadelle Liege
Belgium Centre Hospitalier Chretien (CHC) - Clinique Saint-Joseph Liège
Belgium AZ Delta Roeselare
Bulgaria Medical Center - Complete Medical Solutions OOD Samokov
Bulgaria Medical Center - "Tsaritsa Yoanna" EOOD Sliven
Bulgaria "MDHAT Dr. St.Cherkezov" AD Veliko Tarnovo
Bulgaria MHAT "Sveta Petka" AD Vidin
Canada Barrie GI Associates Barrie
Canada University of Calgary, Heritage Medical Research Clinic Calgary
Canada Hamilton Health Sciences Corporation, McMaster University Medical Centre Hamilton
Canada London Health Sciences Centre - University Hospital London
Canada TIDHI Innovation, Inc. North York
Canada ABP Research Services Oakville
Canada Royal University Hospital Saskatoon
Canada Mount Sinai Hospital Toronto
Canada The Gordon and Leslie Diamond Health Care Centre Vancouver
Canada Toronto Digestive Disease Associates Inc. Vaughan
Canada Percuro Clinical Research Ltd. Victoria
Croatia University Hospital Center Osijek Osijek
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 Thomayerova nemocnice, Interni klinika 3. LF UK a TN Praha 4
Czechia ISCARE a.s. (Klinicke centrum ISCARE), Klinicke a vyzkumne centrum pro strevni zancty 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 Centre Hospitalier Intercommunal de Creteil Créteil Cedex
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 Hopital Saint Joseph 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 CH Annecy Genevois - Site d'Annecy Pringy Cedex
France Centre Hospitalier Universitaire de Rennes - Hopital Pontchaillou Rennes Cedex 9
France CHU de Saint Etienne - Hopital Nord Saint Priest en Jarez
France Hopitaux Universitaires de Strasbourg - Hopital de Hautepierre Strasbourg
France Nouvel Hopital Civil Strasbourg
France CHU de Toulouse - Hopital Rangueil Toulouse
France CHU de Toulouse - Hopital Rangueil Toulouse Cedex 9
France CHU de Nancy - Hopital Brabois Adultes Vandoeuvre-les-Nancy Cedex
Georgia Unimed Ajara LLC - Batumi Referral Hospital Batumi
Georgia Medi Club Georgia LLC Tbilisi
Georgia Ltd. Unimed Kakheti - Telavi Referral Hospital Telavi
Germany Charite - Universitatsmedizin Berlin Berlin
Germany Charite Universitaetsmedizin Berlin Berlin
Germany DRK Kliniken Berlin - Westend - Klinik fuer Innere Medizin Berlin
Germany Medizinisches Versorgungszentrum Delitzsch Berlin
Germany Stadtisches Klinikum Braunschweig gGmbH Braunschweig
Germany Universitatsklinikum Dresden Dresden
Germany Agaplesion Markus Krankenhaus Frankfurt am Main
Germany CED Studien UG, Interdisciplinary Crohn Colitis Center (iCCC) Frankfurt am Main
Germany Universitatsklinikum Freiburg Freiburg
Germany Asklepios Westklinikum Hamburg Hamburg
Germany Medizinische Hochschule Hannover Hannover
Germany Praxis fur Gastroenterologie Heidelberg
Germany Universitatsklinikum Heidelberg Heidelberg
Germany Gastroenterologische Gemeinschaftspraxis Herne Herne
Germany Universitatsklinikum Jena Jena
Germany Universitatsklinikum Schleswig-Holstein Kiel
Germany Universitaetsklinik Koln Koln
Germany EUGASTRO GmbH Leipzig
Germany Universitatsklinikum Leipzig Leipzig
Germany Klinikum Luneburg Lüneburg
Germany Gastroenterologische Gemeinschaftspraxis Minden Minden
Germany Klinikum der Universitat Munchen - Grosshadern Muenchen
Germany Universitaetsmedizin Rostock, Zentrum fuer Innere Medizin Rostock
Germany Universitaetsklinikum Tuebingen Tuebingen
Germany Universitatsklinikum Ulm, Zentrum Fur Innere Medizin Ulm
Greece Hippokration Hospital of Athens Athens
Greece University General Hospital "Attikon", 2nd Propaedeutic Internal Medicine Dept. and Research Unit, Hepatogastroenterology Unit Athens
Greece University General Hospital of Ioannina, Gastroenterology Department, Internal Medicine Division Ioannina
Greece University General Hospital of Patras "Panagia I Voithia", Gastroenterology Department, Internal Medicine Division Patra
Greece Hippokratio General Hospital of Thessaloniki "Hippokratio" 4th Internal Medicine Department of Aristotle University of Thessaloniki Thessaloniki
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
Hong Kong Tuen Mun Hospital Tuen Mun
Hungary Bekes Megyei Kosponti Korhaz, Dr. Rethy Pal Tagkorhaz, IV. Belgyogyaszat - 2. Gasztroenterologia Bekescsaba
Hungary Clinexpert Egeszsegugyi Szolgaltato es Kereskedelmi Kft. Budapest
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 Szent Margit Korhaz, Gasztroenterológiai Osztály 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
Iceland Landspitali University Hospital Reykjavik
India Kaizen Hospital Ahmedabad
India M S Ramaiah Medical College and Hospital Bangalore
India Victoria Hospital, Bangalore Medical College and Research Institute (BMCRI) Bangalore
India Apollo Speciality Hospital Chennai
India VGM Hospital Institute of Gastroenterology Coimbatore
India Lourdes Hospital Ernakulam
India Fortis Memorial Research Institute Gurgaon
India Centre for Liver Research & Diagnostics Hyderabad
India Citizens Specialty Hospital Hyderabad
India Gleneagles Global Hospital Hyderabad
India S.M.S Hospital Jaipur
India SR Kalla Memorial Gastro and General Hospital Jaipur
India Lakeshore Hospital and Research Centre Ltd Kochi Kerala
India School of Digestive & Liver Diseases Kolkata
India King George's Medical University Lucknow
India Dayanand Medical College & Hospital Ludhiana
India Kasturba Medical College (KMC) Hospital Mangaluru
India Lokmanya Tilak Municipal General Hospital Mumbai
India S.L. Raheja Hospital (A Fortis Associate) Mumbai
India Seth G.S. Medical College & KEM Hospital Mumbai
India Midas Multispeciality Hospital Pvt. Ltd Nagpur
India Suretech Hospital & Research Centre Ltd Nagpur
India All India Institute of Medical Sciences New Delhi
India Department of Surgery, B.J. Government Medical College & Sassoon General Hospital Pune
India Grant Medical Foundation Ruby Hall Clinic Pune
India Universal Hospital Pune
India Shree Giriraj Multispeciality Hospital Rajkot
India Gandhi Hospital Secunderabad
India Institute of Gastroenterology & Liver Disease. Sunshine Hospitals 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
Ireland St. Vincent's University Hospital Dublin
Ireland Wellcome Trust HRB Clinical Research Facility Dublin
Ireland University Hospital Galway Galway
Israel Emek Medical Center Afula
Israel Soroka Medical Center Beer-Sheva
Israel Bnai Zion Medical Center Haifa
Israel Rambam Medical Health Care Campus Haifa
Israel The Edith Wolfson Medical Center Holon
Israel Hadassah Medical Center Jerusalem
Israel Shaare Zedek Medical Center Jerusalem
Israel Meir MC Kefar Sava
Israel Rabin Medical Center Petah Tikva
Israel The Chaim Sheba Medical Center Ramat Gan
Israel Tel Aviv Sourasky Medical Center Tel Aviv-Yafo
Italy UOC Gastroenterologia II Castellana Grotte
Italy U.O. Fisiopatologia Digestiva Catanzaro
Italy UOC Medicina Interna Cento
Italy Ospedale Clinicizzato SS. Annunziata - Dipartimento di Medicina Chieti
Italy Gastroenterologia clinica - Azienda Ospedaliero-Universitaria Careggi Firenze
Italy Endocsopia Digestiva Centralizzata Milano
Italy UO Gastroenterologia Modena
Italy UOC Gastroenterologia Padova
Italy Azienda Ospedaliero-Universitaria Pisana - Presidio Ospedaliero Cisanello Pisa
Italy UOC di Gastroenterologia ed Endoscopia Digestiva Roma
Italy UOC Gastroenterologia ed Endoscopia Digestiva Roma
Italy UOC Medicina Interna a Gastroenterologia Roma
Italy Istituto Clinico Humanitas Rozzano
Italy A.S.O. Ordine Mauriziano Di Torino S.C. Torino
Japan Ohmori Toshihide gastro-intestinal Clinic Ageo-shi
Japan Tokyo Medical and Dental University Hospital Bunkyo-ku
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 Prefectural Hospital Hiroshima-shi
Japan Fukuoka University Hospital Jonan-ku
Japan Saitama Medical Center, Saitama Medical University Kawagoe
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
Japan Nagoya City University Hospital Nagoya
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 Osaka City University Hospital Osaka
Japan Wakakusa-Daiichi Hospital Osaka
Japan Kinshukai Infusion Clinic Osaka-City
Japan Shiga University of Medical Science Hospital Otsu
Japan Saga University Hospital Saga
Japan Saga-Ken Medical Centre Koseikan Saga-shi
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 Osaka University Hospital Suita
Japan Kagawa Prefectural Central Hospital Takamatsu-shi
Japan National Hospital Organization Takasaki General Medical Center Takasaki-shi
Japan Ieda Hospital Toyota-shi
Japan Wakayama Medical University Hospital Wakayama-shi
Japan Yokohama Health Medicine Association Kannai Suzuki Clinic Yokohama-shi
Korea, Republic of Pusan National University Hospital Busan
Korea, Republic of Yeungnam University Hospital Daegu
Korea, Republic of Kyung Hee University Hospital Guri-Si
Korea, Republic of Hanyang University Guri Hospital Gyeonggi-do
Korea, Republic of CHA Bundang Medical Center, CHA University Seongnam-si
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 Seoul National 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
Korea, Republic of Yonsei University Wonju Severance Christian Hospital Wonju
Malaysia Universiti Kebangsaan Malaysia Medical Center Cheras
Malaysia Hospital Pulau Pinang George Town
Malaysia Hospital Queen Elizabeth Kota Kinabalu
Malaysia University Malaya Medical Centre Kuala Lumpur
Malaysia Hospital Tengku Ampuan Afzan Kuantan
Netherlands NZW Alkmaar (Noordwest Ziekenhuisgroep) Alkmaar
Netherlands Academic Medical Center (AMC) Amsterdam
Netherlands VU Medisch Centrum Amsterdam
Netherlands Gelre Hospital Apeldoorn
Netherlands Universitair Medisch Centrum Groningen Groningen
Netherlands Maastricht University Medical Centre Maastricht
Netherlands Erasmus University Medical Center Rotterdam
Netherlands Elisabeth-TweeSteden Hospital Tilburg
Netherlands University Medical Center Utrecht Utrecht
New Zealand Christchurch Hospital Christchurch
New Zealand Southern District Health Board - Dunedin Hospital Dunedin
New Zealand Auckland City Hospital Grafton
New Zealand Waikato Hospital Hamilton
New Zealand Wellington Hospital Newtown
New Zealand Bay of Plenty District Health Board - Tauranga Hospital Tauranga
New Zealand Hutt Valley District Health Board - Hutt Valley Hospital Wellington
Poland Uniwersytecki Szpital Kliniczny w Bialymstoku, Klinika Gastroenterologii i Chorob Wewnetrznych Bialystok
Poland Gabinet Lekarski Janusz Rudzinski Bydgoszcz
Poland Szpital Uniwersytecki nr 2 im. Dr. Jana Biziela w Bydgoszczy, Centrum Endoskopii Zabiegowej, Poradnia Chorob Jelitowych 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 Samodzielny Publiczny Zaklad Opieki Zdrowotnej Uniwerstyeckiego Szpitala Klinicznego nr 1 im. Norberta Barlickiego Lodz
Poland Trialmed Crs Piotrków Trybunalski
Poland Clinical Research Center Sp. z o.o. 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, Zmudzkinski i Wspolnicy Sp. j. Specjalistyczne Centrum Gastrologii i Endoskopii Torun
Poland H-T.Centrum Medyczne Spolka z Ograniczona Odpowiedzialnoscia Sp.K. Tychy
Poland Centrum Onkologii - Instytut im. Marii Sklodowskiej-Curie Warsaw
Poland Bodyclinic Warszawa
Poland Centralny Szpital Kliniczny Ministerstwa Spraw Wewnetrznych i Administacji w Warszawie Warszawa
Poland Centrum Zdrowia MDM Warszawa
Poland Medical Concierge Centrum Medyczne Warszawa
Poland Niepubliczny Zaklad Opieki Zrodotnej VIVAMED Jadwige Miecz Warszawa
Poland WIP Warsaw IBD Point Profesor Kierkus Warszawa
Poland Centrum Medyczne Oporow Wroclaw
Portugal Hospital de Braga Braga
Portugal Centro Hospitalar e Universitario de Coimbra, E.P.E. Coimbra
Portugal Centro Hospitalar Cova de Beira, EPE Covilhã
Portugal Centro Hospitalar do Algarve EPE Faro
Portugal Hospital da Senhora da Oliveira Guimaraes, E.P.E. Guimaraes
Portugal Hospital Beatriz Angelo Loures
Portugal Centro Hospitalar de Sao Joao, EPE Porto
Portugal Unidade Local de Saúde do Alto Minho Viana do Castelo
Romania S.C. Centrul Medical Sana S.R.L., Gastroenterologie Bucharest
Romania Spitalul Universitar de Urgenta Bucuresti - Sectia Medicina Interna II Bucharest
Romania Delta Health Care/ Ponderas Academic Hospital Bucuresti
Romania MedLife, Gastroenterologie Bucuresti
Romania MedLife, Gastroenterologie Bucuresti
Romania Spitalul Clinic Colentina - Sectia de Spitulal Clinic Colentina, Gastroenterologie Bucuresti
Romania Spitalul Universitar de Urgenta Militar Central Dr. Carol Davila - Sectia Clinica de Gastroenterologie Bucuresti
Romania Gastromedica SRL, Gastroenterologie Iasi
Romania Cabinet Particular Policlinic Algomed SRL Timisoara
Romania Centrul Medical Tuculanu, Gastroenterologie Timisoara
Romania S.C. Policlinica Dr. Citu S.R.L.- Gastroenterologie 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 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 "PolyClinic EXPERT" 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
Serbia Clinical Center of Serbia Belgrade
Serbia Clinical Hospital Center Zemun Belgrade
Serbia University Hospital Medical Center Bezanijska kosa Belgrade
Serbia Zvezdara University Medical Center Belgrade
Serbia Clinical Center of Vojvodina Novi Sad
Singapore Changi General Hospital Singapore
Singapore National University Hospital Singapore
Singapore Singapore General Hospital Singapore
Singapore Tan Tock Seng Hospital Singapore
Slovakia Cliniq s. r. o., Gastroenterologicke centrum Ruzinov Bratislava
Slovakia KM Management, s.r.o., Gastroenterologicke a hepatologicke centrum Nitra Nitra
Slovakia Gastro I., s.r.o. Presov
South Africa Dr John P Wright Cape Town
South Africa Dr MJ Prins Cape Town
South Africa Peermed Clinical Trial Centre Johannesburg
Spain Hospital Universitari Germans Trias i Pujol Badalona
Spain Centro Medico Teknon Barcelona
Spain Hospital del Mar Barcelona
Spain Complejo Hospitalario Universitario de Ferrol Ferrol
Spain Hospital Universitario de Gran Canaria "Dr. Negrin" Las Palmas de Gran Canaria
Spain Hospital Clinico San Carlos Madrid
Spain Hospital General Universitario Gregorio Maranon Madrid
Spain Hospital Universitario de Fuenlabrada Madrid
Spain Hospital Universitario Central de Asturias Oviedo
Spain Hospital de Montecelo Pontevedra
Spain Hospital de Sagunto Sagunto
Spain Hospital Universitario Virgen del Rocío Sevilla
Spain Hospital de Galdakao-Usandolo Usansolo
Sri Lanka National Hospital of Sri Lanka Colombo
Sri Lanka Karapitiya Teaching Hospital Galle
Sri Lanka Kandy Teaching Hospital Kandy
Sri Lanka Colombo North Teaching Hospital Ragama
Sweden Danderyds Sjukhus AB Danderyd
Sweden Akademiska Sjukhuset Uppsala
Switzerland Intesto Gastroenterologische Praxis & Crohn-Colitis-Zentrum Bern Bern
Switzerland Universitätsspital Zürich Zurich
Taiwan Changhua Christian Hospital Changhua
Taiwan Kaohsiung Medical University Chung-Ho Memorial Hospital Kaohsiung
Taiwan Far Eastern Memorial Hospital New Taipei City
Taiwan Chang Shan Medical University Hospital Taichung
Taiwan China Medical University Hospital Taichung
Taiwan National Cheng Kung University Hospital Tainan City
Taiwan Mackay Memorial Hospital, Taipei Taipei
Taiwan National Taiwan University Hospital Taipei
Taiwan Taipei Veterans General Hospital Taipei
Taiwan Tri-Service General Hospital Taipei
Taiwan Chang Gung Medical Foundation, Chang Gung Memorial Hospital, Linkou Branch Taoyuan
Ukraine Multispecialty Clinical Hospital of Intensive Treatments and Emergency Medical Care 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 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 Treatment and Diagnostic Center of Private Enterprise of Private Production Company "Acinus" Kropyvnytskyi
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 Ternopil Regional Clinical Hospital, Regional Center of Gastroenterology with Hepatology Ternopil
Ukraine Municipal Institution "Uzhgorod District Hospital", Therapy Department Uzhgorod
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 Queen Elizabeth Hospital Birmingham
United Kingdom The Pennine Acute Hospitals NHS Trust Bury
United Kingdom Cambridge University Hospitals NHS Foundation Trust Cambridge
United Kingdom NHS Lothian Edinburgh
United Kingdom Royal Devon and Exeter NHS Foundation Trust Exeter
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 St George's University Hospitals NHS Foundation Trust London
United Kingdom Norfolk and Norwich University Hospital NHS Foundation Trust Norwich Norfolk
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 Texas Clinical Research Institute Arlington Texas
United States Illinois Gastroenterology Group - Arlington Heights Arlington Heights Illinois
United States University of Colorado Denver and Hospital Aurora Colorado
United States Pinnacle Clinical Research Austin Texas
United States University of Maryland Medical Center Baltimore Maryland
United States Inquest Clinical Research Baytown Texas
United States Massachusetts General Hospital - Crohn's and Colitis Center Boston Massachusetts
United States HP Clinical Research Bountiful Utah
United States NY Scientific Brooklyn New York
United States Charlotte Gastroenterology & Hepatology, PLLC Charlotte North Carolina
United States Charlottesville Medical Research Center, LLC Charlottesville Virginia
United States University of Virginia Health System Charlottesville Virginia
United States WR-ClinSearch, LLC Chattanooga Tennessee
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 Northwestern University Feinberg School of Medicine Chicago Illinois
United States The University of Chicago Medical Center (Clinic) Chicago Illinois
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 Advanced Research, LLC Coral Springs Florida
United States Southern California Research Center, Inc. Coronado California
United States Digestive Health Specialists Of The Southeast Dothan Alabama
United States AGA Clinical Research Associates, LLC Egg Harbor Township New Jersey
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 Spectrum Health Butterworth Hospital Grand Rapids Michigan
United States NYU Langone Long Island Clinical Research Associates Great Neck New York
United States Illinois Gastroenterology Group - Gurnee Gurnee Illinois
United States Meritus Center for Clinical Research Hagerstown Maryland
United States Great Lakes Medical Research, LLC Harrisburg Pennsylvania
United States Baylor College of Medicine - McNair Campus Houston Texas
United States Centex Studies, Inc. Houston Texas
United States Gulf Coast Research Group Houston Texas
United States Kelsey-Seybold Clinic Houston Texas
United States The Methodist Hospital Houston Texas
United States The University of Texas Health Science Center at Houston Houston Texas
United States Indiana University Indianapolis Indiana
United States University of Iowa Hospitals and Clinics Iowa City Iowa
United States University of Mississippi Medical Center Jackson Mississippi
United States Kansas City Research Institute Kansas City Missouri
United States University of Kansas Medical Center Kansas City Kansas
United States Florida Research Institute Lakewood Ranch Florida
United States Florida Center for Gastroenterology Largo Florida
United States Las Vegas Medical Research Las Vegas Nevada
United States South Denver Gastroenterology, PC Lone Tree Colorado
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 Advanced Pharma CR, LLC Miami Florida
United States Cordova Research Institute Miami Florida
United States University of Miami Crohn's and Colitis Center Miami Florida
United States Vista Health Research, LLC Miami Florida
United States Paramount Medical Research & Consulting, LLC Middleburg Heights Ohio
United States Wisconsin Center for Advanced Research, a division of GI Associates, LLC Milwaukee Wisconsin
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 Icahn School of Medicine at Mount Sinai New York New York
United States Lenox Hill Hospital New York New York
United States New York University School of Medicine / NYU Gastroenterology Associates New York New York
United States Gastroenterology Associates of Orangeburg Orangeburg South Carolina
United States Center for Interventional Endoscopy - Florida Hospital Orlando Florida
United States Gulf Region Clinical Research Institute Pensacola Florida
United States Advanced Medical Research Center Port Orange Florida
United States Premier Medical Group of the Hudson Valley Poughkeepsie New York
United States Carolina's GI Research LLC Raleigh North Carolina
United States Inland Empire Clinical Trials, LLC Rialto California
United States McGuire DVAMC Richmond Virginia
United States Virginia Commonwealth University 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 Pinnacle Clinical Research San Antonio Texas
United States UC San Diego Health Systems San Diego California
United States Kaiser Permanente San Francisco California
United States TDDC San Marcos San Marcos Texas
United States Clearview Medical Research, LLC Santa Clarita California
United States Louisiana Research Center, LLC Shreveport Louisiana
United States Texas Digestive Disease Consultants Southlake Texas
United States Arizona Digestive Health - Sun City Sun City Arizona
United States Atlanta Gastroenterology Specialist, PC Suwanee Georgia
United States Tampa General Hospital Tampa Florida
United States Spring Gastroenterology The Woodlands Texas
United States Options Health Research LLC Tulsa Oklahoma
United States Tyler Research Institute, LLC Tyler Texas
United States Medstar Georgetown University Hospital Washington District of Columbia
United States Gastroenterology Associates of Western Michigan, PLC d.b.a. West Michigan Clinical Research Center Wyoming Michigan
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,  Iceland,  India,  Ireland,  Israel,  Italy,  Japan,  Korea, Republic of,  Malaysia,  Netherlands,  New Zealand,  Poland,  Portugal,  Romania,  Russian Federation,  Serbia,  Singapore,  Slovakia,  South Africa,  Spain,  Sri Lanka,  Sweden,  Switzerland,  Taiwan,  Ukraine,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Overall Safety Profile of Filgotinib Evaluated by the Percentage of Participants Experiencing Adverse Events and Abnormal Clinical Laboratory Tests Up to 390 weeks plus 30 days
Secondary Change from Baseline in PRO2 Scores PRO2 are patient reported outcomes consisting of 2 items: abdominal pain severity and liquid stool frequency. Baseline and up to 390 weeks
Secondary Change from Baseline in Crohn's Disease Activity Index (CDAI) Scores Baseline and up to 390 weeks
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