Filgotinib in Long-Term Extension Study of Adults With Ulcerative Colitis
SELECTIONLTE
A Long-Term Extension Study to Evaluate the Safety of Filgotinib in Subjects With Ulcerative Colitis
2 other identifiers
interventional
1,173
37 countries
320
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Feb 2017
Longer than P75 for phase_3
320 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 22, 2016
CompletedFirst Posted
Study publicly available on registry
September 26, 2016
CompletedStudy Start
First participant enrolled
February 23, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 1, 2026
February 6, 2025
February 1, 2025
9.5 years
September 22, 2016
February 5, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Change From Baseline in Components of Mayo Clinic Score (MCS)
Baseline and up to 336 weeks
Study Arms (5)
Filgotinib 200 mg (blinded dosing)
EXPERIMENTALFilgotinib 200 mg + placebo to match filgotinib 100 mg for up to 336 weeks
Filgotinib 100 mg (blinded dosing)
EXPERIMENTALFilgotinib 100 mg + placebo to match filgotinib 200 mg for up to 336 weeks
Placebo (blinded dosing)
PLACEBO COMPARATORPlacebo to match filgotinib 200 mg + placebo to match filgotinib 100 mg for up to 336 weeks
Filgotinib 200 mg (open-label)
EXPERIMENTALFilgotinib 200 mg for up to 336 weeks
Filgotinib 100 mg (open-label)
EXPERIMENTALFilgotinib 100 mg for up to 336 weeks
Interventions
Tablet(s) administered orally once daily
Tablet(s) administered orally once daily
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Alfasigma S.p.A.lead
- Gilead Sciencescollaborator
Study Sites (323)
Digestive Health Specialists Of The Southeast
Dothan, Alabama, 36305, United States
Mayo Clinic Arizona
Scottsdale, Arizona, 85259, United States
VA Long Beach Healthcare System
Long Beach, California, 90822, United States
Cedars Sinai Medical Center
Los Angeles, California, 90048, United States
South Denver Gastroenterology, PC
Lone Tree, Colorado, 80124, United States
Connecticut GI PC-Research Division
Farmington, Connecticut, 06032, United States
UF Clinical Research Center
Gainesville, Florida, 32610, United States
Florida Research Institute
Lakewood Rch, Florida, 34211, United States
University of Miami Crohn's and Colitis Center
Miami, Florida, 33136, United States
Cordova Research Institute
Miami, Florida, 33155, United States
Gastroenterology Group of Naples
Naples, Florida, 34102, United States
Advanced Medical Research Center
Port Orange, Florida, 32127, United States
Tampa General Hospital
Tampa, Florida, 33606, United States
Florida Medical Clinic, P.A
Zephyrhills, Florida, 33540, United States
Gastroenterology Associates Of Central Georgia, LLC
Macon, Georgia, 31201, United States
Gastrointestinal Specialists of Georgia
Marietta, Georgia, 30060, United States
Atlanta Gastroenterology Specialist, PC
Suwanee, Georgia, 30024, United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242, United States
University of Louisville, Clinical Trials Unit
Louisville, Kentucky, 40202, United States
Delta Research Partners, LLC
Monroe, Louisiana, 71201, United States
Louisiana Research Center, LLC
Shreveport, Louisiana, 71105, United States
Investigative Clinical Research
Annapolis, Maryland, 21401, United States
MGG Group Co., Inc., Chevy Chase Clinical Research
Chevy Chase, Maryland, 20815, United States
Gastro Center of Maryland
Columbia, Maryland, 21045, United States
Meritus Center for Clinical Research
Hagerstown, Maryland, 21742, United States
Massachusetts General Hospital - Crohn's and Colitis Center
Boston, Massachusetts, 02114, United States
Clinical Research Institute of Michigan, LLC
Chesterfield, Michigan, 48047, United States
Center for Digestive Health Research
Troy, Michigan, 48098, United States
Mayo Clinic
Rochester, Minnesota, 55905, United States
Kansas City Research Institute
Kansas City, Missouri, 64131, United States
Washington University School of Medicine
St Louis, Missouri, 63110, United States
NY Scientific
Brooklyn, New York, 11235, United States
NYU Langone Long Island Clinical Research Associates
Great Neck, New York, 11021, United States
Carolina's GI Research LLC
Raleigh, North Carolina, 27607, United States
Fargo Gastroenterology and Hepatology Clinic
Fargo, North Dakota, 58103, United States
Consultants for Clinical Research
Cincinnati, Ohio, 45219, United States
UC Health Physicians Clifton
Cincinnati, Ohio, 45219, United States
Great Lakes Gastroenterology Research, LLC
Mentor, Ohio, 44060, United States
Gastroenterology Associates of Orangeburg
Orangeburg, South Carolina, 29118, United States
Rapid City Medical Center
Rapid City, South Dakota, 57701, United States
Gastro One
Germantown, Tennessee, 38138, United States
Quality Medical Research
Nashville, Tennessee, 37211, United States
Vanderbilt University Medical Center - IBD Clinic
Nashville, Tennessee, 37212-1375, United States
San Antonio Military Medical Center
Fort Sam Houston, Texas, 78219, United States
DHAT Research Institute
Garland, Texas, 75044, United States
Baylor College of Medicine - Baylor Medical Center
Houston, Texas, 77030, United States
The University of Texas Health Science Center at Houston
Houston, Texas, 77030, United States
Clinical Associates in Research Therapeutics of America, LLC
San Antonio, Texas, 78212, United States
Gastroenterology Research of San Antonio
San Antonio, Texas, 78229, United States
TDDC San Marcos
San Marcos, Texas, 78666, United States
Texas Digestive Disease Consultants
Southlake, Texas, 76092, United States
Spring Gastroenterology
The Woodlands, Texas, 77380, United States
University of Virginia Health System
Charlottesville, Virginia, 22908, United States
Gastroenterology Associates of Tidewater
Chesapeake, Virginia, 23320, United States
McGuire DVAMC
Richmond, Virginia, 23249, United States
University of Wisconsin Hospital & Clinics
Madison, Wisconsin, 53705, United States
Allegiance Research Specialists, LLC
Wauwatosa, Wisconsin, 53225, United States
Instituto de Investigaciones Clinicas Mar del Plata
Mar del Plata, B7600FZN, Argentina
Instituto Médico Cer
Quilmes, B1878, Argentina
Monash Medical Centre
Clayton, New South Wales, 3168, Australia
St. Vincent's Hospital Sydney
Darlinghurst, New South Wales, 2010, Australia
Nepean Hospital
Kingswood, New South Wales, 2747, Australia
Coastal Digestive Health
Mountain Creek, Queensland, 4557, Australia
Mater Misericordiae Ltd
South Brisbane, Queensland, 4101, Australia
Princess Alexandra Hospital
Woolloongabba, Queensland, 4102, Australia
The Queen Elizabeth Hospital
Woodville South, South Australia, 5011, Australia
Footscray Hospital
Footscray, Victoria, 3011, Australia
Cabrini Hospital
Malvern, Victoria, 3144, Australia
Alfred Hospital
Melbourne, Victoria, 3004, Australia
Universitatsklinik Innsbruck
Innsbruck, 6020, Austria
AKH-Medizinische Universitat Wien
Vienna, 1090, Austria
GZA Ziekenhuizen, campus Sint-Vincentius
Antwerp, 2018, Belgium
CUB Hopital Erasme
Brussels, 1070, Belgium
Universitair Ziekenhuis Leuven
Leuven, 3000, Belgium
Centre Hospitalier Chretien (CHC) - Clinique Saint-Joseph
Liège, 4000, Belgium
MHAT Sveti Pantaleymon- Pleven OOD
Pleven, 5800, Bulgaria
"MDHAT Dr. St.Cherkezov" AD
Veliko Tarnovo, 5000, Bulgaria
MHAT "Sveta Petka" AD
Vidin, 3700, Bulgaria
University of Calgary, Heritage Medical Research Clinic
Calgary, Alberta, T2N 4Z6, Canada
The Gordon and Leslie Diamond Health Care Centre
Vancouver, British Columbia, V5Z 1M9, Canada
Hamilton Health Sciences Corporation, McMaster University Medical Centre
Hamilton, Ontario, L8S 4K1, Canada
Toronto Digestive Disease Associates Inc.
Vaughan, Ontario, L4L 4Y7, Canada
Royal University Hospital
Saskatoon, Saskatchewan, S7N 0W8, Canada
Clinical Hospital Dubrava
Zagreb, 10000, Croatia
University Hospital Center Zagreb
Zagreb, 10000, Croatia
Hepato-Gastroenterology HK, s.r.o.
Hradec Králové, 500 12, Czechia
Oblastni nemocnice Mlada Boleslav, a.s., nemocnice Stredoceskeho kraje, Gastroenterologicke oddeleni
Mladá Boleslav, 293 01, Czechia
G.E.P. Clinic, s r.o.
Prague, 130 00, Czechia
ISCARE a.s. (Klinicke centrum ISCARE), Klinicke a vyzkumne centrum pro strevni zanety
Prague, 190 00, Czechia
CHU Amiens Picardie
Amiens, 80054, France
CHU de Caen
Caen, 14033, France
CHU de Clermont-Ferrand - Hopital d'Estaing
Clermont-Ferrand, 63003, France
APHP - Hopital Beaujon - Clichy - Universite Paris VII
Clichy, 92110, France
CHU de Dijon Bourgogne - Hopital Francois Mitterand
Dijon, 21079, France
CHU Grenoble Alpes
La Tronche, 38700, France
Hopital Universitaire de Bicetre
Le Kremlin-Bicêtre, 94270, France
Centre Hospitalier Regional Universitaire de Lille
Lille, 59000, France
Hopital Nord
Marseille, 13915, France
CHU de Montpellier-Hopital Saint Eloi
Montpellier, 34295, France
CHU Hotel-Dieu
Nantes, 44093, France
Hopital de l'Archet 2
Nice, 06202, France
CHU de Bordeaux - Hopital Haut Leveque
Pessac, 33600, France
Centre Hospitalier Universitaire de Lyon Sud
Pierre-Bénite, 69495, France
Centre Hospitalier Universitaire de Rennes - Hopital Pontchaillou
Rennes, 35033, France
CHU de Saint Etienne - Hopital Nord
Saint-Priest-en-Jarez, 42055, France
CHU de Toulouse - Hopital Rangueil
Toulouse, 31059, France
CHU de Nancy - Hopital Brabois Adultes
Vandœuvre-lès-Nancy, 54511, France
Unimed Ajara LLC - Batumi Referral Hospital
Batumi, 6010, Georgia
Medi Club Georgia LLC
Tbilisi, 0160, Georgia
Universitatsklinikum Schleswig-Holstein
Kiel, Schleswig-Holstein, 24105, Germany
Charite Universitaetsmedizin Berlin
Berlin, 10117, Germany
Charite - Universitatsmedizin Berlin
Berlin, 13353, Germany
DRK Kliniken Berlin - Westend - Klinik fuer Innere Medizin
Berlin, 14050, Germany
Stadtisches Klinikum Braunschweig gGmbH
Braunschweig, 38126, Germany
Universitaetsklinik Koln
Cologne, 50937, Germany
Agaplesion Markus Krankenhaus
Frankfurt am Main, 60431, Germany
Universitatsklinikum Freiburg
Freiburg im Breisgau, 79106, Germany
Asklepios Westklinikum Hamburg
Hamburg, 22559, Germany
Medizinische Hochschule Hannover
Hanover, 30625, Germany
Gastroenterologische Gemeinschaftspraxis Herne
Herne, 44623, Germany
Universitatsklinikum Jena
Jena, 07747, Germany
EUGASTRO GmbH
Leipzig, 04103, Germany
Klinikum Luneburg
Lüneburg, 21339, Germany
Gastroenterologische Gemeinschaftspraxis Minden
Minden, 32423, Germany
Klinikum der Universitat Munchen - Grosshadern
München, 81377, Germany
Universitaetsklinikum Tuebingen
Tübingen, 72074, Germany
Universitatsklinikum Ulm, Zentrum Fur Innere Medizin
Ulm, 89081, Germany
General Hospital of Athens "Hippokratio", 2nd Internal Medicine Clinic of Athens University, Hepato-gastroenterology Unit
Athens, 11527, Greece
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
Bekes Megyei Kosponti Korhaz, Dr. Rethy Pal Tagkorhaz, IV. Belgyogyaszat - 2. Gasztroenterologia
Békéscsaba, 5600, Hungary
Del-pesti Centrumkorhaz - Orszagos Hematologiai es Infektologiai Intezet, Kozponti Felnott Szakrendelo
Budapest, 1097, Hungary
Szent Janos Korhaz es Eszak-budai Egitett Korhazak, I. Belgyogyaszati - Gasztroenterologiai Osztaly
Budapest, 1125, Hungary
Debreceni Egyetem Klinikai Kozpont, II. sz. Belgyogyaszati Klinika, Gasztroenterologia
Debrecen, 4032, Hungary
Bugat Pal Korhaz, Belgyogyaszat
Gyöngyös, 3200, Hungary
Karolina Korhaz es Rendelointezet, Altalanos Belgyogyaszat-Gasztroenterologia
Mosonmagyaróvár, 9200, Hungary
Kaizen Hospital
Ahmedabad, 380052, India
M S Ramaiah Medical College and Hospital
Bangalore, 560054, India
Apollo Speciality Hospital
Chennai, 600035, India
VGM Hospital Institute of Gastroenterology
Coimbatore, 641005, India
Gleneagles Global Hospitals
Hyderabad, 500004, India
Citizens Specialty Hospital
Hyderabad, 500019, India
Centre for Liver Research & Diagnostics
Hyderabad, 500058, India
SR Kalla Memorial Gastro and General Hospital
Jaipur, 302001, India
S.M.S Medical College & Hospitals
Jaipur, 302004, India
Dayanand Medical College & Hospital
Ludhiana, 141001, India
Kasturba Medical College (KMC) Hospital
Mangaluru, 575001, India
Lokmanya Tilak Municipal General Hospital
Mumbai, 400022, India
Midas Multispeciality Hospital Pvt. Ltd
Nagpur, 440010, India
Suretech Hospital & Research Centre Ltd
Nagpur, 440012, India
Grant Medical Foundation Ruby Hall Clinic
Pune, 411001, India
Shree Giriraj Multispeciality Hospital
Rajkot, 360002, India
Gandhi Hospital
Secunderabad, 500003, India
Surat Institute of Digestive Sciences
Surat, 395002, India
Kasturba Hospital Medical College
Udupi, 576104, India
Sterling Hospital
Vadodara, 390007, India
Samvedna Hospital
Varanasi, 221005, India
Beaumont Hospital
Dublin, 9, Ireland
Bnai Zion Medical Center
Haifa, 31048, Israel
Rambam Medical Health Care Campus
Haifa, 3109601, Israel
Shaare Zedek Medical Center
Jerusalem, 9103102, Israel
Hadassah Medical Center
Jerusalem, 9112001, Israel
Rabin Medical Center
Petah Tikva, 4941492, Israel
UOC Gastroenterologia II
Castellana Grotte, 70013, Italy
U.O. Fisiopatologia Digestiva
Catanzaro, 88100, Italy
Ospedale Clinicizzato SS. Annunziata - Dipartimento di Medicina
Chieti, 66100, Italy
Endocsopia Digestiva Centralizzata - ASST Fatebenefratelli Sacco, Ospedale Fatebenefratelli e Oftalmico
Milan, 20121, Italy
UOC Gastroenterologia
Padua, 35128, Italy
Azienda Ospedaliero-Universitaria Pisana - Presidio Ospedaliero Cisanello
Pisa, 56124, Italy
UOC Gastroenterologia ed Endoscopia Digestiva
Roma, 128, Italy
Istituto Clinico Humanitas
Rozzano, 20089, Italy
Nagasaki University Hospital
Nagasaki, Nagasaki, 8528501, Japan
Osaka University Hospital
Suita, Osaka, 565-0871, Japan
Medical Hospital, Tokyo Medical and Dental University
Bunkyō City, 113-8519, Japan
Fukuoka University Chikushi Hospital
Chikushino-shi, 818-8502, Japan
Hokkaido P.W.F.A.C Sapporo-Kosei General Hospital
Chūōku, 060-0033, Japan
Japanese Red Cross Fukuoka Hospital
Fukuoka, 815-8555, Japan
Tokai University Hachioji Hospital
Hachiōji, 192-0032, Japan
Hiroshima University Hospital
Hiroshima, 734-8551, Japan
Fukuoka University Hospital
Jonan-ku, 814-0180, Japan
Ofuna Chuo Hospital
Kamakura, 247-0056, Japan
Kitakyushu City Hospital Organization Kitakyushu Municipal Medical Center
Kitakyushu-shi, 802-0077, Japan
Yamanashi Prefectural Central Hospital
Kofu, 400-8506, Japan
Kurume University Hospital
Kurume-shi, 830-0011, Japan
Hidaka Coloproctology Clinic
Kurume-shi, 839-0809, Japan
University Hospital, Kyoto Prefectural University of Medicine
Kyoto, 602-8566, Japan
The Jikei University Hospital
Minatoku, 105-8471, Japan
Kitasato University Kitasato Institute Hospital
Minatoku, 108-8642, Japan
Kyorin University Hospital
Mitaka-shi, 181-8611, Japan
Iwate Medical University Hospital
Morioka, 020-8505, Japan
Aichi Medical University Hospital
Nagakute-shi, 480-1195, Japan
Saiseikai Niigata Daini Hospital
Nishiku, 950-1104, Japan
Hyogo College of Medicine College Hospital
Nishinomiya, 663-8501, Japan
Okayama University Hospital
Okayama, 700-8558, Japan
Kinshukai Infusion Clinic
Osaka, 530-0011, Japan
Osaka City University Hospital
Osaka, 545-8586, Japan
Wakakusa-Daiichi Hospital
Osaka, 579-8056, Japan
Ishida IBD Clinic
Ōita, 870-0823, Japan
Shiga University of Medical Science Hospital
Ōtsu, 520-2192, Japan
Saga-Ken Medical Centre Koseikan
Saga, 840-8571, Japan
Saga University Hospital
Saga, 849-8501, Japan
Kitasato University Hospital,THE KITASATO INSTITUTE
Sagamihara, 252-0375, Japan
Tokito Clinic
Saitama, 336-0963, Japan
Toho University Sakura Medical Center
Sakura, 285-8741, Japan
Sapporo Higashi Tokushukai Hospital
Sapporo, 065-0033, Japan
National Hospital Organization Sendai Medical Center
Sendai, 983-8520, Japan
Tokyo Yamate Medical Center
Shinjuku-ku, 169-0073, Japan
Kagawa Prefectural Central Hospital
Takamatsu, 760-8557, Japan
National Hospital Organization Takasaki General Medical Center
Takasaki-shi, 3700829, Japan
Osaka Medical College Hospital
Takatsuki, 569-8686, Japan
Ieda Hospital
Toyota-shi, 470-1219, Japan
Wakayama Medical University Hospital
Wakayama, 641-8509, Japan
Colo-proctology Center Matsushima Clinic
Yokohama, 220-0045, Japan
Hospital Pulau Pinang
George Town, 10990, Malaysia
Hospital Queen Elizabeth
Kota Kinabalu, 88586, Malaysia
PCR-Phylasis Clinicas Research S. de R.L. de C.V.
Cuautitlán Izcalli, 54750, Mexico
Academic Medical Center (AMC)
Amsterdam, 1100, Netherlands
Gelre Hospital
Apeldoorn, 7334, Netherlands
University Medical Center Utrecht
Utrecht, 3584 CX, Netherlands
Christchurch Hospital
Christchurch, 8011, New Zealand
Auckland City Hospital
Grafton, 1023, New Zealand
Wellington Hospital
Newtown, 6021, New Zealand
Bay of Plenty District Health Board - Tauranga Hospital
Tauranga, 3112, New Zealand
Uniwersytecki Szpital Kliniczny w Bialymstoku, Klinika Gastroenterologii i Chorob Wewnetrznych
Bialystok, 15-276, Poland
VITAMED Galaj i Cichomski spólka jawna
Bydgoszcz, 85-079, Poland
Gabinet Lekarski Janusz Rudzinski
Bydgoszcz, 85-681, Poland
NZOZ INTER-MED, Centrum Endoskopowe
Częstochowa, 42-217, Poland
Niepubliczny Zaklad Opieki Zdrowotnej ALL-MEDICUS
Katowice, 40-659, Poland
Gabinet Endoskopii Przewodu Pokarmowego
Krakow, 31-009, Poland
Krakowskie Centrum Medyczne Sp. z o.o
Krakow, 31-501, Poland
Centrum Opieki Zdrowotnej Orkan-Med Stec-Michalska Sp. J.
Ksawerów, 95-054, Poland
Santa Familia, Centrum Badan, Profilaktyki i Leczenia
Lodz, 90-302, Poland
Centrum Innowacyjnych Terapii Sp. z o.o.
Piaseczno, 05-500, Poland
Clinical Research Center Spolka z ograniczna odpowiedzialnoscia Medic-R Sp. k.
Poznan, 60-848, Poland
Gabinet Lekarski Dr. Hab. N. Med. Bartosz Korczowski
Rzeszów, 35-301, Poland
Endoskopia Sp. z o.o.
Sopot, 81-756, Poland
Twoja Przychodnia-Szczecinskie Centrum Medyczne
Szczecin, 71-434, Poland
GASTROMED Kopon, Zmudzinski i Wspolnicy Sp. j. Specjalistyczne Centrum Gastrologii i Endoskopii
Torun, 87-100, Poland
H-T.Centrum Medyczne Spolka z Ograniczona Odpowiedzialnoscia Sp.K.
Tychy, 43-100, Poland
Centrum Zdrowia MDM
Warsaw, 00-635, Poland
Centralny Szpital Kliniczny Ministerstwa Spraw Wewnetrznych i Administacji w Warszawie
Warsaw, 02-507, Poland
Niepubliczny Zaklad Opieki Zrodotnej VIVAMED Jadwige Miecz
Warsaw, 03-580, Poland
Bodyclinic
Warsaw, 03-712, Poland
Centrum Medyczne Oporow
Wroclaw, 52-416, Poland
Hospital da Senhora da Oliveira Guimaraes, E.P.E.
Guimarães, 4835-044, Portugal
Centro Hospitalar de Sao Joao, EPE
Porto, 4200-319, Portugal
MedLife, Gastroenterologie
Bucharest, 010719, Romania
Spitalul Clinic Colentina - Sectia de Spitulal Clinic Colentina, Gastroenterologie
Bucharest, 020125, Romania
Cabinet Medical Individual Dr Tirnaveanue Amelita, Gastroenterologie
Oradea, 410066, Romania
Cabinet Particular Policlinic Algomed SRL
Timișoara, 300002, Romania
State Budgetary Healthcare Institution "Chelyabinski Regional Clinical Hospital"
Chelyabinsk, 454076, Russia
State Budgetary Institution of Health Irkustsk Order "Badge of Honor" Regional Clinical Hospital
Irkutsk, 669079, Russia
Federal State Budgetary Institution of Science Federal Research Center of Nutrition, Biotechnology and Food Safety
Moscow, 115446, Russia
State Budgetary Healthcare Institution of Moscow "City Clinical Hospital # 24 of Healthcare Department of Moscow"
Moscow, 127015, Russia
State Budgetary Healthcare Institution of Moscow Region "Moscow Regional Clinical Research Institute n.a. M.F. Vladimirskiy"
Moscow, 129110, Russia
State Budgetary Healthcare Institution of Nizhny Novgorod Region "Nizhny Novgorod Regional Clinical Hospital n.a. N.A.
Nizhny Novgorod, 603126, Russia
State Budgetary Institution of Health of Novosibirsk Region "City Clinical Hospital #12"
Novosibirsk, 630084, Russia
State Budgetary Healthcare Institution of the Novosibirsk Region "State Novosibirsk Regional Clinical Hospital"
Novosibirsk, 630087, Russia
Saint Petersburg State Budgetary Healthcare Institution "City Polyclinic #38"
Saint Petersburg, 191015, Russia
"Riat" LLC
Saint Petersburg, 193163, Russia
"Scientific Research Centre ECO-safety" LLC
Saint Petersburg, 196143, Russia
State Healthcare Institution "Regional Clinical Hospital"
Saratov, 410053, Russia
Treatment and Prevention Interdistrict Institution "Smolenskie kliniki" LLC
Smolensk, 214019, Russia
Tyumen Regional State Autonomous Healthcare Institution << Consulting and Diagnostic Centre <<Endos>>
Tyumen, 625026, Russia
Zvezdara University Medical Center
Belgrade, 3810-972, Serbia
Singapore General Hospital
Singapore, 169608, Singapore
KM Management, s.r.o., Gastroenterologicke a hepatologicke centrum Nitra
Nitra, 950 01, Slovakia
Dr MJ Prins
Cape Town, 7500, South Africa
Peermed Clinical Trial Centre
Johannesburg, 1619, South Africa
The Catholic University of Korea, St. Vincent's Hospital
Suwon, Gyeonggi-do, 16247, South Korea
Pusan National University Hospital
Busan, 49241, South Korea
Yeungnam University Hospital
Daegu, 42415, South Korea
Kangbuk Samsung Hospital
Seoul, 03181, South Korea
Yonsei University Health System, Severance Hospital
Seoul, 03722, South Korea
Asan Medical Center
Seoul, 05505, South Korea
Division of Gastroenterology, Department of Medicine, Samsung Medical Center
Seoul, 06351, South Korea
Kyung Hee University Hospital
Seoul, 130-872, South Korea
Yonsei University Wonju Severance Christian Hospital
Wŏnju, 220-701, South Korea
Centro Medico Teknon
Barcelona, 08022, Spain
Hospital Clinico San Carlos
Madrid, 28040, Spain
Hospital Universitario de Fuenlabrada
Madrid, 28942, Spain
Hospital Universitario Central de Asturias
Oviedo, 33006, Spain
Hospital Universitario Virgen del Rocío
Seville, 41013, Spain
Skane University Hospital
Malmo, SE-205-02, Sweden
Danderyd University Hospital Corp
Stockholm, 182 88, Sweden
Akademiska Sjukhuset
Uppsala, 75185, Sweden
Gastroenterologische Praxis Balsiger, Seibold und Partner
Bern, 3012, Switzerland
Universitätsspital Zürich
Zurich, 8091, Switzerland
Changhua Christian Hospital
Changhua, 500, Taiwan
National Taiwan University Hospital
Taipei, 100, Taiwan
Mackay Memorial Hospital, Taipei
Taipei, 10449, Taiwan
Chang Gung Medical Foundation, Chang Gung Memorial Hospital, Linkou Branch
Taoyuan District, 33305, Taiwan
Municipal Institution "Cherkasy Regional Hospital of Cherkasy Regional Council", Gastroenterology Department
Cherkasy, 18000, Ukraine
Municipal City Clinical Hospital of the Emergency Medical Care, 1 st Therapy Department. Danylo Halytsky Lviv National Medical
Chernivtsi, 58000, Ukraine
Regional Municipal Institution "Chernivtsi Regional Clinical Hospital", Surgical Department
Chernivtsi, 58000, Ukraine
State Institution "Institute of Gastroenterology of National Academy of Medical Sciences of Ukraine"
Dnipropetrovsk, 49000, Ukraine
Ivanto-Frankivsk Central City Clinic Hospital, Therapy Department #1. State Higher Education Institution Ivano-Frankivsk National
Ivano-Frankivsk, 76018, Ukraine
Municipal Health Care Institution "Kharkiv City Clinical Hospital #2 named after prof. O. O. Shalimov", Proctology Department
Kharkiv, 61037, Ukraine
L.T. Mala State Institution "National Institute of Therapy of National Academy of Medical Sciences of Ukraine"
Kharkiv, 61039, Ukraine
Municipal Institution of Health Care "Regional Hospital of War Veterans", Therapeutic Department No1
Kharkiv, 63101, Ukraine
Kyiv City Clinical Hospital No. 18, Proctology Department
Kyiv, 01030, Ukraine
Municipal Non-profit Enterprise "Consultative and Diagnostic Center" of Pechersk District of Kyiv, Therapy Department
Kyiv, 1103, Ukraine
Odesa Clinical Railway Hospital Branch of "Healthcare Center" of Public joint stock company "Ukrainian Railway"
Odesa, 65010, Ukraine
Municipal Institution "Odesa Regional Clinical Hospital", Regional Gastroenterology Center based on Surgery Department
Odesa, 65025, Ukraine
Ternopil University Hospital, Regional Center of Gastroenterology with Hepatology
Ternopil, 46002, Ukraine
Vinnytsia Regional Clinical Hospital of War Veterans, Therapy Department #1
Vinnytsia, 21005, Ukraine
M.I. Pyrogov Vinnytsia Regional Clinical Hospital, Gastroenterology Department
Vinnytsia, 21018, Ukraine
Medical Center LLC "Health Clinic"
Vinnytsia, 21029, Ukraine
Municipal Institution "Zaporizhzhya Regional Clinical Hospital" of Zaporizhzhya Regional Council
Zaporizhzhya, 69600, Ukraine
Norfolk and Norwich University Hospital NHS Foundation Trust
Norwich, Norfolk, NR4 7UY, United Kingdom
The Pennine Acute Hospitals NHS Trust
Bury, BL9 7TD, United Kingdom
Cambridge University Hospital NHS Foundation Trust
Cambridge, CB2 0QQ, United Kingdom
Royal Derby Hospital
Derby, DE22 3NE, United Kingdom
NHS Lothian
Edinburgh, EH4 2XU, United Kingdom
Glasgow Clinical Research Facility - Queen Elizabeth University Hospital
Glasgow, G51 4TF, United Kingdom
NHS Greater Glasgow and Clyde
Glasgow, G52 3NQ, United Kingdom
Wycombe Hospital
High Wycombe, HP11 2TT, United Kingdom
Imperial College Healthcare NHS Trust, St Mary's Hospital
London, W2 1NY, United Kingdom
Biomedical Research Unit
Nottingham, NG7 2UH, United Kingdom
Oxford University Hospitals NHS Trust
Oxford, OX3 9DU, United Kingdom
St Helens and Knowsley Teaching Hospitals NHS Trust
Prescot, L35 5DR, United Kingdom
Southampton National Institute for Health Research, Wellcome Trust Clinical Research Facility
Southampton, SO16 6YD, United Kingdom
Related Publications (3)
Feagan BG, Matsuoka K, Rogler G, Laharie D, Vermeire S, Danese S, Loftus EV Jr, Beales I, Schreiber S, Kim HJ, Faes M, de Haas A, Masior T, Rudolph C, Peyrin-Biroulet L. Long-term safety and efficacy of filgotinib for the treatment of moderately to severely active ulcerative colitis: Interim analysis from up to 4 years of follow-up in the SELECTION open-label long-term extension study. Aliment Pharmacol Ther. 2024 Sep;60(5):563-584. doi: 10.1111/apt.18158. Epub 2024 Jul 31.
PMID: 39086130DERIVEDSchreiber S, Rogler G, Watanabe M, Vermeire S, Maaser C, Danese S, Faes M, Van Hoek P, Hsieh J, Moerch U, Zhou Y, de Haas A, Rudolph C, Oortwijn A, Loftus EV Jr. Integrated safety analysis of filgotinib for ulcerative colitis: Results from SELECTION and SELECTIONLTE. Aliment Pharmacol Ther. 2023 Nov;58(9):874-887. doi: 10.1111/apt.17674. Epub 2023 Sep 18.
PMID: 37718932DERIVEDVermeire S, Feagan BG, Peyrin-Biroulet L, Oortwijn A, Faes M, de Haas A, Rogler G. Withdrawal and Re-treatment with Filgotinib in Ulcerative Colitis: Post Hoc Analyses of the Phase 2b/3 SELECTION and SELECTIONLTE Studies. J Crohns Colitis. 2024 Jan 27;18(1):54-64. doi: 10.1093/ecco-jcc/jjad123.
PMID: 37540206DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Galapagos Study Director
Galapagos NV
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NON RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Masking Details
- Only 3 arms are blinded in this study.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 22, 2016
First Posted
September 26, 2016
Study Start
February 23, 2017
Primary Completion (Estimated)
September 1, 2026
Study Completion (Estimated)
September 1, 2026
Last Updated
February 6, 2025
Record last verified: 2025-02