Study to Evaluate the Efficacy and Safety of Filgotinib in the Induction and Maintenance of Remission in Adults With Moderately to Severely Active Ulcerative Colitis
NCT ID: NCT02914522
Last Updated: 2021-04-21
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
1351 participants
INTERVENTIONAL
2016-11-14
2020-03-31
Brief Summary
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Participants who complete the study, or met protocol specified efficacy discontinuation criteria will have the option to enter a separate, long-term extension (LTE) study (Gilead Study GS-US-418-3899: NCT02914535).
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Induction Study (Cohort A): Filgotinib 200 mg
Participants in Cohort A (biologic-naive) received filgotinib 200 milligrams (mg) and placebo-to-match (PTM) filgotinib 100 mg orally once daily for 10 weeks.
Filgotinib
Tablet(s) administered orally once daily
PTM filgotinib
Tablet(s) administered orally once daily
Induction Study (Cohort A): Filgotinib 100 mg
Participants in Cohort A (biologic-naive) received filgotinib 100 mg and PTM filgotinib 200 mg orally once daily for 10 weeks.
Filgotinib
Tablet(s) administered orally once daily
PTM filgotinib
Tablet(s) administered orally once daily
Induction Study (Cohort A): Placebo
Participants in Cohort A (biologic-naive) received PTM filgotinib 200 mg and PTM filgotinib 100 mg orally once daily for 10 weeks.
PTM filgotinib
Tablet(s) administered orally once daily
Induction Study (Cohort B): Filgotinib 200 mg
Participants in Cohort B (biologic-experienced) received filgotinib 200 mg and PTM filgotinib 100 mg orally once daily for 10 weeks.
Filgotinib
Tablet(s) administered orally once daily
PTM filgotinib
Tablet(s) administered orally once daily
Induction Study (Cohort B): Filgotinib 100 mg
Participants in Cohort B (biologic-experienced) received filgotinib 100 mg and PTM filgotinib 200 mg orally once daily for 10 weeks.
Filgotinib
Tablet(s) administered orally once daily
PTM filgotinib
Tablet(s) administered orally once daily
Induction Study (Cohort B): Placebo
Participants in Cohort B (biologic-experienced) received PTM filgotinib 200 mg and PTM filgotinib 100 mg orally once daily for 10 weeks.
PTM filgotinib
Tablet(s) administered orally once daily
Maintenance Study: Filgotinib 200 mg From Induction Filgotinib 200 mg
Participants in the Filgotinib 200 mg arm who completed the Induction Study and achieved either Endoscopy/Bleeding/Stool Frequency (EBS) remission or Mayo Clinic Score (MCS) response at Week 10 were re-randomized at Week 11 into the Maintenance Study to receive filgotinib 200 mg and PTM filgotinib 100 mg for an additional 47 weeks (up to Week 58).
Filgotinib
Tablet(s) administered orally once daily
PTM filgotinib
Tablet(s) administered orally once daily
Maintenance Study: Placebo From Induction Filgotinib 200 mg
Participants in the Filgotinib 200 mg arm who completed the Induction Study and achieved either EBS remission or MCS response at Week 10 were re-randomized at Week 11 into the Maintenance Study to receive PTM filgotinib orally once daily for an additional 47 weeks (up to Week 58).
PTM filgotinib
Tablet(s) administered orally once daily
Maintenance Study: Filgotinib 100 mg From Induction Filgotinib 100 mg
Participants in the Filgotinib 100 mg arm who completed the Induction Study and achieved either EBS remission or MCS response at Week 10 were re-randomized at Week 11 into the Maintenance Study to receive filgotinib 100 mg and PTM filgotinib 200 mg for an additional 47 weeks (up to Week 58).
Filgotinib
Tablet(s) administered orally once daily
PTM filgotinib
Tablet(s) administered orally once daily
Maintenance Study: Placebo From Induction Filgotinib 100 mg
Participants in the Filgotinib 100 mg arm who completed the Induction Study and achieved either EBS remission or MCS response at Week 10 were rerandomized at Week 11 into the Maintenance Study to receive PTM filgotinib orally once daily for an additional 47 weeks (up to Week 58).
PTM filgotinib
Tablet(s) administered orally once daily
Maintenance Study: Placebo From Induction Placebo
Participants in the Placebo arm who completed the Induction Study and achieved either EBS remission or MCS response at Week 10 were re-randomized at Week 11 into the Maintenance Study to receive PTM filgotinib for an additional 47 weeks (up to Week 58).
PTM filgotinib
Tablet(s) administered orally once daily
Interventions
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Filgotinib
Tablet(s) administered orally once daily
PTM filgotinib
Tablet(s) administered orally once daily
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Documented diagnosis of UC of at least 6 months AND with a minimum disease extent of 15 cm from the anal verge. Documentation should include endoscopic and histopathologic evidence of UC.
* A surveillance colonoscopy is required at screening in individuals with a history of UC for 8 or more years, if one was not performed in the prior 24 months
* Moderately to severely active UC
* Previously demonstrated an inadequate clinical response, loss of response to, or intolerance to at least 1 of the following agents (depending on current country treatment recommendations/guidelines): corticosteroids, immunomodulators, tumor necrosis factor alpha (TNFa) antagonists, or vedolizumab
Exclusion Criteria
* Active tuberculosis (TB) or history of latent TB that has not been treated
* Use of any concomitant prohibited medications as described in the protocol
18 Years
75 Years
ALL
No
Sponsors
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Galapagos NV
INDUSTRY
Gilead Sciences
INDUSTRY
Responsible Party
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Principal Investigators
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Gilead Study Director
Role: STUDY_DIRECTOR
Gilead Sciences
Locations
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Digestive Health Specialists of the Southeast
Dothan, Alabama, United States
Mayo Clinic Arizona
Scottsdale, Arizona, United States
VA Long Beach Healthcare System
Long Beach, California, United States
Cedars Sinai Medical Center
Los Angeles, California, United States
South Denver Gastroenterology, PC
Lone Tree, Colorado, United States
Connecticut GI PC-Research Division
Farmington, Connecticut, United States
UF Health at Shands Hospital
Gainesville, Florida, United States
Florida Research Institute
Lakewood Rch, Florida, United States
University of Miami Crohn's and Colitis Center
Miami, Florida, United States
Cordova Research Institute
Miami, Florida, United States
Gastroenterology Group of Naples
Naples, Florida, United States
Advanced Medical Research Center
Port Orange, Florida, United States
Tampa General Hospital
Tampa, Florida, United States
Shafran Gastroenterology Center
Winter Park, Florida, United States
Florida Medical Clinic, P.A.
Zephyrhills, Florida, United States
Gastroenterology Associates of Central Georgia, LLC
Macon, Georgia, United States
Gastrointestinal Specialists of Georgia
Marietta, Georgia, United States
Atlanta Gastroenterology Specialist, PC
Suwanee, Georgia, United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States
University of Louisville, Clinical Trials Unit
Louisville, Kentucky, United States
Delta Research Partners, LLC
Monroe, Louisiana, United States
Louisiana Research Center, LLC
Shreveport, Louisiana, United States
Investigative Clinical Research
Annapolis, Maryland, United States
MGG Group Co., Inc., Chevy Chase Clinical Research
Chevy Chase, Maryland, United States
Gastro Center of Maryland
Columbia, Maryland, United States
Meritus Center for Clinical Research
Hagerstown, Maryland, United States
Massachusetts General Hospital - Crohn's and Colitis Center
Boston, Massachusetts, United States
Clinical Research Institute of Michigan, LLC
Chesterfield, Michigan, United States
Center for Digestive Health
Troy, Michigan, United States
Mayo Clinic
Rochester, Minnesota, United States
Kansas City Research Institute
Kansas City, Missouri, United States
Washington University School of Medicine
St Louis, Missouri, United States
NY Scientific
Brooklyn, New York, United States
NYU Langone Long Island Clinical Research Associates
Great Neck, New York, United States
Carolina's GI Research, LLC
Raleigh, North Carolina, United States
Fargo Gastroenterology and Hepatology Clinic
Fargo, North Dakota, United States
Consultants for Clinical Research
Cincinnati, Ohio, United States
UC Health Physicians Clifton
Cincinnati, Ohio, United States
Great Lakes Gastroenterology Research, LLC
Mentor, Ohio, United States
Gastroenterology Associates of Orangeburg
Orangeburg, South Carolina, United States
Rapid City Medical Center
Rapid City, South Dakota, United States
WR-ClinSearch, LLC
Chattanooga, Tennessee, United States
Gastro One
Germantown, Tennessee, United States
Quality Medical Research
Nashville, Tennessee, United States
Vanderbilt University Medical Center - IBD Clinic
Nashville, Tennessee, United States
San Antonio Military Medical Center
Fort Sam Houston, Texas, United States
DHAT Research Institute
Garland, Texas, 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
Clinical Associates in Research Therapeutics of America, LLC
San Antonio, Texas, United States
Gastroenterology Research of San Antonio
San Antonio, Texas, United States
Texas Digestive Disease Consultants
San Marcos, Texas, United States
Texas Digestive Disease Consultants
Southlake, Texas, United States
Spring Gastroenterology
The Woodlands, Texas, United States
HP Clinical Research
Bountiful, Utah, United States
University of Virginia Health System
Charlottesville, Virginia, United States
Gastroenterology Associates Of Tidewater
Chesapeake, Virginia, United States
Emeritas Research Group LLC
Lansdowne Town Center, Virginia, United States
McGuire DVAMC
Richmond, Virginia, United States
University of Wisconsin Hospital & Clinics
Madison, Wisconsin, United States
Allegiance Research Specialists, LLC
Wauwatosa, Wisconsin, United States
Instituto de Investigaciones Clinicas Mar del Plata
Mar del Plata, , Argentina
Instituto Médico Cer
Quilmes, , Argentina
St. Vincent's Hospital Sydney
Darlinghurst, New South Wales, Australia
Nepean Hospital
Kingswood, New South Wales, Australia
Coastal Digestive Health
Mountain Creek, Queensland, Australia
Mater Misericordiae Ltd
South Brisbane, Queensland, Australia
Princess Alexandra Hospital
Woolloongabba, Queensland, Australia
The Queen Elizabeth Hospital
Woodville South, South Australia, Australia
Monash Medical Centre
Clayton, Victoria, Australia
Footscray Hospital
Footscray, Victoria, Australia
Austin Health
Heidelberg, Victoria, Australia
Cabrini Hospital
Malvern, Victoria, Australia
Alfred Hospital
Melbourne, Victoria, Australia
Universitatsklinik Innsbruck
Innsbruck, , Austria
AKH-Medizinische Universitat Wien
Vienna, , Austria
GZA Ziekenhuizen campus Sint-Vincentius
Antwerp, , Belgium
CUB Hopital Erasme
Brussels, , Belgium
Universitair Ziekenhuis Leuven
Leuven, , Belgium
Centre Hospitalier Chretien (CHC) - Clinique Saint-Joseph
Liège, , Belgium
MHAT Sveti Pantaleymon - Pleven OOD
Pleven, , Bulgaria
"MDHAT Dr. St.Cherkezov" AD
Veliko Tarnovo, , Bulgaria
MHAT "Sveta Petka" AD
Vidin, , Bulgaria
University of Calgary, Heritage Medical Research Clinic
Calgary, Alberta, Canada
The Gordon and Leslie Diamond Health Care Centre
Vancouver, British Columbia, Canada
Hamilton Health Sciences Corporation, McMaster University Medical Centre
Hamilton, Ontario, Canada
Royal University Hospital
Saskatoon, Saskatchewan, Canada
Toronto Digestive Disease Associates Inc.
Vaughan, , Canada
Clinical Hospital Dubrava
Zagreb, , Croatia
University Hospital Center Zagreb
Zagreb, , Croatia
Hepato-Gastroenterologie HK, s.r.o.
Hradec Králové, , Czechia
Oblastni nemocnice Mlada Boleslav, a.s., nemocnice Stredoceskeho kraje, Gastroenterologicke oddeleni
Mladá Boleslav, , Czechia
G.E.P. Clinic, s r.o.
Prague, , Czechia
ISCARE a.s. (Klinicke centrum ISCARE), Klinicke a vyzkumne centrum pro strevni zanety
Prague, , Czechia
CHU Amiens Picardie
Amiens, , France
CHU de Caen
Caen, , 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-Bicêtre, , 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
Institut Mutualiste Montsouris
Paris, , France
CHU de Bordeaux - Hopital Haut Leveque
Pessac, , France
Centre Hospitalier Universitaire de Lyon Sud
Pierre-Bénite, , France
Centre Hospitalier Universitaire de Rennes - Hopital Pontchaillou
Rennes, , 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
Vandœuvre-lès-Nancy, , France
Unimed Ajara LLC - Batumi Referral Hospital
Batumi, , Georgia
Medi Club Georgia LLC
Tbilisi, , Georgia
Ltd. Unimed Kakheti - Telavi Referral Hospital
Telavi, , Georgia
Charite Universitatsmedizin Berlin
Berlin, , Germany
Charite - Universitatsmedizin Berlin
Berlin, , Germany
DRK Kliniken Berlin - Westend - Klinik fuer Innere Medizin
Berlin, , Germany
Stadtisches Klinikum Braunschweig gGmbH
Braunschweig, , Germany
Universitaetsklinik Koln
Cologne, , Germany
Agaplesion Markus Krankenhaus
Frankfurt am Main, , Germany
Universitatsklinikum Freiburg
Freiburg im Breisgau, , Germany
Asklepios Westklinikum Hamburg
Hamburg, , Germany
Medizinische Hochschule Hannover
Hannover, , Germany
Gastroenterologische Gemeinschaftspraxis Herne
Herne, , Germany
Universitatsklinikum Jena
Jena, , Germany
Universitatsklinikum Schleswig-Holstein
Kiel, , Germany
EUGASTRO GmbH
Leipzig, , Germany
Klinikum Luneburg
Lüneburg, , Germany
Gastroenterologische Gemeinschaftspraxis Minden
Minden, , Germany
Klinikum der Universitat Munchen - Grosshadern
München, , Germany
Universitaetsklinikum Tuebingen
Tübingen, , Germany
Universitatsklinikum Ulm, Zentrum Fur Innere Medizin
Ulm, , Germany
General Hospital of Athens "Hippokratio", 2nd Internal Medicine Clinic of Athens University, Hepato-gastroenterology Unit
Athens, , Greece
General Hospital of Nikaias "Agios Pentelleimon", Gastroenterology Department
Athens, , 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, , 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
Mosonmagyaróvár, , Hungary
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
Gleneagles Global Hospitals
Hyderabad, , India
Citizens Specialty Hospital
Hyderabad, , India
Centre for Liver Research & Diagnostics
Hyderabad, , India
S.R.KallaMemorial Gastro.&General Hospital,
Jaipur, , India
S.M.S Medical College & Hospitals
Jaipur, , India
School of Digestive & Liver Diseases
Kolkata, , 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
All India Institute of Medical Sciences
New Delhi, , India
Grant Medical Foundation Ruby Hall Clinic
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
Samvedana Hospital
Varanasi, , India
Beaumont Hospital
Dublin, , Ireland
Soroka Medical Center
Beersheba, , Israel
Bnai Zion Medical Center
Haifa, , Israel
Rambam Health Care Campus
Haifa, , Israel
Shaare Zedek Medical Center
Jerusalem, , Israel
Hadassah Medical Center
Jerusalem, , Israel
Rabin Medical Center
Petah Tikva, , Israel
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
Milan, , Italy
UOC Gastroenterologia
Padua, , Italy
Azienda Ospedaliero-Universitaria Pisana - Presidio Ospedaliero Cisanello
Pisa, , Italy
UOC Gastroenterologia ed Endoscopia Digestiva
Roma, , Italy
Istituto Clinico Humanitas
Rozzano, , Italy
Medical Hospital, Tokyo Medical and Dental University
Bunkyō City, , Japan
Fukuoka University Chikushi Hospital
Chikushino-shi, , Japan
Hokkaido P.W.F.A.C Sapporo-Kosei General Hospital
Chūōku, , Japan
Japanese Red Cross Fukuoka Hospital
Fukuoka, , Japan
Tokai University Hachioji Hospital
Hachioji-shi, , 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, , Japan
Kurume University Hospital
Kurume-shi, , Japan
Hidaka Coloproctology Clinic
Kurume-shi, , Japan
University Hospital, Kyoto Prefectural University of Medicine
Kyoto, , Japan
The Jikei University Hospital
Minatoku, , Japan
Kitasato University Kitasato Institute Hospital
Minatoku, , Japan
Kyorin University Hospital
Mitaka-shi, , Japan
Iwate Medical University Hospital
Morioka, , Japan
Aichi Medical University Hospital
Nagakute-shi, , Japan
Nagasaki University Hospital
Nagasaki, , Japan
Saiseikai Niigata Daini Hospital
Nishiku, , Japan
Hyogo College of Medicine College Hospital
Nishinomiya, , Japan
Okayama University Hospital
Okayama, , Japan
Wakakusa-Daiichi Hospital
Osaka, , Japan
Ishida IBD Clinic
Ōita, , Japan
Kinshukai Infusion Clinic
Ōsaka, , Japan
Osaka City University Hospital
Ōsaka, , Japan
Shiga University of Medical Science Hospital
Ōtsu, , Japan
Saga-Ken Medical Centre Koseikan
Saga, , Japan
Saga University Hospital
Saga, , Japan
Kitasato University Hospital, THE KITASATO INSTITUTE
Sagamihara, , Japan
Tokito Clinic
Saitama, , Japan
Toho University Sakura Medical Center
Sakura, , Japan
Sapporo Tokushukai Hospital
Sapporo, , Japan
Sapporo Higashi Tokushukai Hospital
Sapporo, , Japan
National Hospital Organization Sendai Medical Center
Sendai, , Japan
Tokyo Yamate Medical Center
Shinjuku-ku, , Japan
Osaka University Hospital
Suita, , Japan
Kagawa Prefectural Central Hospital
Takamatsu, , 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, , Japan
Colo-proctology Center Matsushima Clinic
Yokohama, , Japan
Yokohama Health Medicine Association Kannai Suzuki Clinic
Yokohama, , Japan
University Kebangsaan Malaysia Medical Centre
Cheras, , Malaysia
Hospital Pulau Pinang
George Town, , Malaysia
Hospital Queen Elizabeth
Kota Kinabalu, , Malaysia
PCR-Phylasis Clinicas Research S. de R.L. de C.V.
Cuautitlán Izcalli, , Mexico
Academic Medical Center (AMC)
Amsterdam, , Netherlands
Gelre Hospital
Apeldoorn, , Netherlands
University Medical Center Utrecht
Utrecht, , Netherlands
Christchurch Hospital
Christchurch, , 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
Vestre Viken Hospital Trust, Baerum Hospital
Drammen, , Norway
Akerskus University Hospital
Lørenskog, , Norway
Uniwersytecki Szpital Kliniczny w Bialymstoku, Klinika Gastroenterologii i Chorob Wewnetrznych
Bialystok, , Poland
VITAMED Galaj i Cichomski spolka jawna
Bydgoszcz, , Poland
Gabinet Lekarski Janusz Rudzinski
Bydgoszcz, , Poland
NZOZ INTER-MED, Centrum Endoskopowe
Częstochowa, , Poland
Niepubliczny Zaklad Opieki Zdrowotnej ALL-MEDICUS
Katowice, , Poland
Gabinet Endoskopii Przewodu Pokarmowego
Krakow, , Poland
Krakowskie Centrum Medyczne Sp. z o.o
Krakow, , 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 organiczna 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, 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 Zdrowia MDM
Warsaw, , Poland
Bodyclinic
Warsaw, , Poland
Centralny Szpital Kliniczny Ministerstwa Spraw Wewnetrznych i Administacji w Warszawie
Warsaw, , Poland
Niepubliczny Zaklad Opieki Zrodotnej VIVAMED Jadwige Miecz
Warsaw, , Poland
Centrum Medyczne Oporow
Wroclaw, , Poland
Hospital da Senhora da Oliveira Guimaraes, E.P.E.
Guimarães, , Portugal
Centro Hospitalar de Sao Joao, EPE
Porto, , Portugal
SC MedLife SA, Gastroenterologie
Bucharest, , Romania
Spitalul Clinic Colentina - Sectia de Spitulal Clinic Colentina, Gastroenterologie
Bucharest, , Romania
Cabinet Medical Individual Dr Tirnaveanue Amelita, Gastroenterologie
Oradea, , Romania
Cabinet Particular Policlinic Algomed SRL
Timișoara, , Romania
State Budgetary Healthcare Institution "Chelyabinski Regional Clinical Hospital"
Chelyabinsk, , Russia
State Budgetary Institution of Health Irkustsk Order "Badge of Honor" Regional Clinical Hospital
Irkutsk, , Russia
Federal State Budgetary Institution of Science Federal Research Center of Nutrition, Biotechnology and Food Safety
Moscow, , Russia
State Budgetary Healthcare Institution of Moscow "City Clinical Hospital # 24 of Healthcare Department of Moscow"
Moscow, , Russia
State Budgetary Healthcare Institution of Moscow Region "Moscow Regional Clinical Research Institute n.a. M.F. Vladimirskiy"
Moscow, , Russia
State Budgetary Healthcare Institution of Nizhny Novgorod Region "Nizhny Novgorod Regional Clinical Hospital n.a. N.A.
Nizhny Novgorod, , Russia
State Budgetary Institution of Health of Novosibirsk Region "City Clinical Hospital #12"
Novosibirsk, , Russia
State Budgetary Healthcare Institution of the Novosibirsk Region "State Novosibirsk Regional Clinical Hospital"
Novosibirsk, , Russia
Saint Petersburg State Budgetary Healthcare Institution "City Polyclinic #38"
Saint Petersburg, , Russia
"Riat" LLC
Saint Petersburg, , Russia
"Scientific Research Centre ECO-safety" LLC
Saint Petersburg, , Russia
"PolyClinic EXPERT" LLC
Saint Petersburg, , Russia
State Healthcare Institution "Regional Clinical Hospital"
Saratov, , Russia
Treatment and Prevention Interdistrict Institution "Smolenskie kliniki" LLC
Smolensk, , Russia
State Autonomous Health Institution of the Tyumen Region "Multidisciplinary Consultative and Diagnostic Center"
Tyumen, , Russia
Zvezdara University Medical Center
Belgrade, , Serbia
Singapore General Hospital
Singapore, , Singapore
KM Management, s.r.o., Gastroenterologicke a hepatologicke centrum Nitra
Nitra, , Slovakia
Dr MJ Prins
Cape Town, , South Africa
Peermed Clinical Trial Centre
Johannesburg, , South Africa
The Catholic University of Korea, St. Vincent's Hospital
Suwon, Gyeonggi-do, South Korea
Pusan National University Hospital
Busan, , South Korea
Yeungnam University Hospital
Daegu, , South Korea
Kangbuk Samsung Hospital
Seoul, , South Korea
Yonsei University Health System, Severance Hospital
Seoul, , South Korea
Asan Medical Center
Seoul, , South Korea
Division of Gastroenterology, Department of Medicine, Samsung Medical Center
Seoul, , South Korea
Hyung Hee University Hospital
Seoul, , South Korea
Yonsei University Wonju Severance Christian Hospital
Wŏnju, , South Korea
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 Rocio
Seville, , Spain
Danderyds Sjukhus AB
Danderyd, , Sweden
Skane University Hospital
Malmo, , Sweden
Akademiska Sjukhuset
Uppsala, , Sweden
Gastroenterologische Praxis Balsiger, Seibold und Partner
Bern, , Switzerland
Universitatsspital Zurich
Zurich, , Switzerland
Changhua Christian Hospital
Chang-hua, , Taiwan
National Taiwan University Hospital
Taipei, , Taiwan
Mackay Memorial Hospital, Taipei
Taipei, , Taiwan
Chang Gung Medical Foundation, Chang Gung Memorial Hospital, Linkou Branch
Taoyuan District, , Taiwan
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
Municipal Health Care Institution "Kharkiv City Clinical Hospital #2 named after prof. O. O. Shalimov", Proctology Department
Kharkiv, , Ukraine
L.T. Mala State Institution "National Institute of Therapy of National Academy of Medical Sciences of Ukraine"
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
Odesa Clinical Railway Hospital Branch of "Healthcare Center" of Public joint stock company "Ukrainian Railway"
Odesa, , Ukraine
Municipal Institution "Odesa Regional Clinical Hospital", Regional Gastroenterology Center based on Surgery Department
Odesa, , Ukraine
Ternopil University Hospital, Regional Center of Gastroenterology with Hepatology
Ternopil, , Ukraine
Vinnytsia Regional Clinical Hospital of War Veterans, Therapy Department #1
Vinnytsia, , Ukraine
M.I. Pyrogov Vinnytsia Regional Clinical Hospital, Gastroenterology Department
Vinnytsia, , Ukraine
Medical Center LLC "Health Clinic"
Vinnytsia, , Ukraine
Municipal Institution "Zaporizhzhya Regional Clinical Hospital" of Zaporizhzhya Regional Council
Zaporizhzhya, , Ukraine
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, , United Kingdom
Biomedical Research Unit
Nottingham, , United Kingdom
Oxford University Hospitals NHS Foundation 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 Kingdom
Countries
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References
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Nakase H, Danese S, Reinisch W, Ritter T, Liang Y, Wendt E, Levesque BG, Yoon OK, Tian Y, Zhuo L, Karouzakis E, Bauer Y, Oortwijn A, Kaise T, Malkov VA, Hibi T. Mediators of Filgotinib Treatment Effects in Ulcerative Colitis: Exploring Circulating Biomarkers in the Phase 2b/3 SELECTION Study. Inflamm Bowel Dis. 2025 Apr 10;31(4):1095-1108. doi: 10.1093/ibd/izae278.
Schreiber S, Feagan BG, Louis E, Hisamatsu T, Hibi T, Dron L, Jamoul C, Patel H, Harris K, Taliadouros V, Oortwijn A, Peyrin-Biroulet L. Distinct trajectories of symptomatic response in ulcerative colitis during filgotinib therapy: A post hoc analysis from the SELECTION study. United European Gastroenterol J. 2024 Nov;12(9):1243-1255. doi: 10.1002/ueg2.12686. Epub 2024 Oct 25.
Watanabe K, Peyrin-Biroulet L, Danese S, Fujitani Y, Faes M, Oortwijn A, Lindsay JO, Rogler G, Hibi T. Impact of Concomitant Thiopurine on the Efficacy and Safety of Filgotinib in Patients with Ulcerative Colitis: Post Hoc Analysis of the Phase 2b/3 SELECTION Study. J Crohns Colitis. 2024 Jun 3;18(6):801-811. doi: 10.1093/ecco-jcc/jjad201.
Schreiber 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.
Vermeire 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.
Lu X, Zhou ZY, Xin Y, Wang MJ, Gray E, Jairath V, Lindsay JO. Matching-Adjusted Indirect Comparisons of Filgotinib vs Vedolizumab, Tofacitinib, and Ustekinumab for Moderately to Severely Active Ulcerative Colitis. Inflamm Bowel Dis. 2024 Jan 5;30(1):64-77. doi: 10.1093/ibd/izad037.
Dotan I, Feagan BG, Taliadouros V, Oortwijn A, Rudolph C, de Haas A, Santermans E, Hsieh J, Peyrin-Biroulet L, Hibi T. Efficacy of Filgotinib in Patients with Ulcerative Colitis by Line of Therapy in the Phase 2b/3 SELECTION Trial. J Crohns Colitis. 2023 Aug 21;17(8):1207-1216. doi: 10.1093/ecco-jcc/jjad039.
Schreiber S, Feagan BG, Peyrin-Biroulet L, Vermeire S, Faes M, Harris K, Oortwijn A, Daniele P, Patel H, Danese S. Filgotinib Improved Health-Related Quality of Life and Led to Comprehensive Disease Control in Individuals with Ulcerative Colitis: Data from the SELECTION Trial. J Crohns Colitis. 2023 Jun 16;17(6):863-875. doi: 10.1093/ecco-jcc/jjad018.
Loftus EV, Vermeire S, Feagan BG, Le Brun FO, Oortwijn A, Moerch U, Sandborn WJ, Hibi T. Corticosteroid-Sparing Effects of Filgotinib in Moderately to Severely Active Ulcerative Colitis: Data from the Phase 2b/3 SELECTION Study. J Crohns Colitis. 2023 Mar 18;17(2):211-220. doi: 10.1093/ecco-jcc/jjac122.
Feagan BG, Danese S, Loftus EV Jr, Vermeire S, Schreiber S, Ritter T, Fogel R, Mehta R, Nijhawan S, Kempinski R, Filip R, Hospodarskyy I, Seidler U, Seibold F, Beales ILP, Kim HJ, McNally J, Yun C, Zhao S, Liu X, Hsueh CH, Tasset C, Besuyen R, Watanabe M, Sandborn WJ, Rogler G, Hibi T, Peyrin-Biroulet L. Filgotinib as induction and maintenance therapy for ulcerative colitis (SELECTION): a phase 2b/3 double-blind, randomised, placebo-controlled trial. Lancet. 2021 Jun 19;397(10292):2372-2384. doi: 10.1016/S0140-6736(21)00666-8. Epub 2021 Jun 3.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2016-001392-78
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
GS-US-418-3898
Identifier Type: -
Identifier Source: org_study_id
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