Filgotinib in the Induction and Maintenance of Remission in Adults With Moderately to Severely Active Crohn's Disease
NCT ID: NCT02914561
Last Updated: 2023-12-18
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
PHASE3
1372 participants
INTERVENTIONAL
2016-10-31
2022-11-11
Brief Summary
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Participants who complete the study, or do not meet protocol response or remission criteria at Week 10 will have the option to enter a separate long-term extension (LTE) study (Study GS-US-419-3896).
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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Cohort A: Filgotinib 200 (mg) (Induction Study)
Biologic naïve and biologic experienced participants received filgotinib 200 milligram (mg) with placebo-to-match (PTM) filgotinib 100 mg tablet orally once daily, for a period of 10 weeks.
Filgotinib
Filgotinib tablets administered orally once daily.
Placebo
Placebo administered orally once daily.
Cohort A: Filgotinib 100 mg (Induction Study)
Biologic naïve and biologic experienced participants received filgotinib 100 mg with PTM filgotinib 200 mg tablet orally once daily, for a period of 10 weeks.
Filgotinib
Filgotinib tablets administered orally once daily.
Placebo
Placebo administered orally once daily.
Cohort A: Placebo (Induction Study)
Biologic naïve and biologic experienced participants received PTM filgotinib 200 mg and PTM filgotinib 100 mg tablet orally once daily, for a period of 10 weeks.
Filgotinib
Filgotinib tablets administered orally once daily.
Placebo
Placebo administered orally once daily.
Cohort B: Filgotinib 200 mg (Induction Study)
Biologic experienced participants received filgotinib 200 mg with PTM filgotinib 100 mg tablet orally once daily, for a period of 10 weeks.
Filgotinib
Filgotinib tablets administered orally once daily.
Placebo
Placebo administered orally once daily.
Cohort B: Filgotinib 100 mg (Induction Study)
Biologic experienced participants received filgotinib 100 mg with PTM filgotinib 200 mg tablet orally once daily, for a period of 10 weeks.
Filgotinib
Filgotinib tablets administered orally once daily.
Placebo
Placebo administered orally once daily.
Cohort B: Placebo (Induction Study)
Biologic experienced participants received PTM filgotinib 200 mg with PTM filgotinib 100 mg tablet orally once daily, for a period of 10 weeks.
Filgotinib
Filgotinib tablets administered orally once daily.
Placebo
Placebo administered orally once daily.
Filgotinib 200 mg to Filgotinib 200 mg (Maintenance Study)
Participants who received filgotinib 200 mg in induction study and who achieved either clinical remission by PRO2 or endoscopic response at Week 10 were re-randomized to the maintenance study and received filgotinib 200 mg and PTM filgotinib 100 mg tablet orally once daily, up to Week 58.
Filgotinib
Filgotinib tablets administered orally once daily.
Filgotinib 200 mg to Placebo (Maintenance Study)
Participants who received filgotinib 200 mg in induction study and who achieved either clinical remission by PRO2 or endoscopic response at Week 10 were re-randomized to the maintenance study and received PTM filgotinib 100 mg and PTM filgotinib 200 mg tablet orally once daily, up to Week 58.
Filgotinib
Filgotinib tablets administered orally once daily.
Placebo
Placebo administered orally once daily.
Filgotinib 100 mg to Filgotinib 100 mg (Maintenance Study)
Participants who received filgotinib 100 mg in induction study and who achieved either clinical remission by PRO2 or endoscopic response at Week 10 were re-randomized to the maintenance study and received filgotinib 100 mg and PTM filgotinib 200 mg tablet orally once daily, up to Week 58.
Filgotinib
Filgotinib tablets administered orally once daily.
Filgotinib 100 mg to Placebo (Maintenance Study)
Participants who received filgotinib 100 mg in induction study and who achieved either clinical remission by PRO2 or endoscopic response at Week 10 were re-randomized to the maintenance study and received PTM filgotinib 200 mg and PTM filgotinib 100 mg tablet orally once daily, up to Week 58.
Filgotinib
Filgotinib tablets administered orally once daily.
Placebo
Placebo administered orally once daily.
Placebo to Placebo (Maintenance Study)
Participants who received placebo in induction study and who achieved either clinical remission by PRO2 or endoscopic response at Week 10 were re-randomized to the maintenance study and received PTM filgotinib 100 mg and PTM filgotinib 200 mg tablet orally once daily, up to Week 58.
Placebo
Placebo administered orally once daily.
Interventions
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Filgotinib
Filgotinib tablets administered orally once daily.
Placebo
Placebo administered orally once daily.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Moderately to severely active CD
* Cohort A (Biologic Naïve): 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 and immunomodulators
* Cohort A (Biologic Experienced): 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) or discontinuation of use of at least one of the following agents for reasons other than inadequate clinical response, loss of response or intolerance: tumor necrosis factor alpha (TNFa) antagonists, vedolizumab, and ustekinumab
* Cohort B (Biologic Experienced): 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): TNFa antagonists, vedolizumab, and ustekinumab
Exclusion Criteria
* Presence of ulcerative colitis, indeterminate colitis, ischemic colitis, fulminant colitis, or toxic mega-colon
* Active tuberculosis (TB) or history of latent TB that has not been treated
* Use of any prohibited concomitant medications as described in the study protocol
18 Years
75 Years
ALL
No
Sponsors
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Gilead Sciences
INDUSTRY
Galapagos NV
INDUSTRY
Responsible Party
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Principal Investigators
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Galapagos Study Director
Role: STUDY_DIRECTOR
Galapagos NV
Locations
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Digestive Health Specialists of the Southeast
Dothan, Alabama, United States
Arizona Digestive Health - Sun City
Sun City, Arizona, United States
Southern California Research Center, Inc.
Coronado, California, United States
VVCRD Research
Garden Grove, California, United States
UC San Diego Health System
La Jolla, California, United States
Cedars Sinai Medical Center
Los Angeles, California, United States
Inland Empire Clinical Trials, LLC
Rialto, California, United States
Kaiser Permanente
San Francisco, California, United States
Clearview Medical Research, LLC
Santa Clarita, California, United States
University of Colorado Denver and Hospital
Aurora, Colorado, United States
South Denver Gastroenterology, PC
Lone Tree, Colorado, United States
Connecticut GI, PC-Research Division
Farmington, Connecticut, United States
Medstar Georgetown University Hospital (Patient Exams)
Washington D.C., District of Columbia, United States
Advanced Research, LLC
Coral Springs, Florida, United States
UF Clinical Research Center
Gainesville, Florida, United States
Florida Research Institute
Lakewood Rch, Florida, United States
Florida Center for Gastroenterology
Largo, Florida, United States
University of Miami Crohn's and Colitis Center
Miami, Florida, United States
Advanced Pharma CR
Miami, Florida, United States
Cordova Research Institute
Miami, Florida, United States
Vista Health Research, LLC
Miami, Florida, United States
Gastroenterology Group of Naples
Naples, Florida, United States
Center for Interventional Endoscopy - AdventHealth Orlando
Orlando, Florida, United States
Gulf Region Clinical Research Institute
Pensacola, 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
Illinois Gastroenterology Group - Arlington Heights
Arlington Heights, Illinois, United States
Northwestern University, Feinberg School of Medicine
Chicago, Illinois, United States
University of Chicago Medical Center
Chicago, Illinois, United States
Illinois Gastroenterology Group - Gurnee
Gurnee, Illinois, United States
Indiana University Health University Hospital
Indianapolis, Indiana, United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States
University of Kansas Medical Center
Kansas City, Kansas, United States
University of Louisville, School of Medicine
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
University of Maryland Medical Center
Baltimore, 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
Spectrum Health Butterworth Hospital
Grand Rapids, Michigan, United States
Mayo Clinic
Rochester, Minnesota, United States
University of Mississippi Medical Center
Jackson, Mississippi, United States
Kansas City Research Institute
Kansas City, Missouri, United States
Washington University School of Medicine
St Louis, Missouri, United States
Las Vegas Medical Research
Las Vegas, Nevada, United States
AGA Clinical Research Associates, LLC
Egg Harbor, New Jersey, United States
NY Scientific
Brooklyn, New York, United States
NYU Langone Long Island Clinical Research Associates
Great Neck, New York, United States
New York University School of Medicine/NYU Gastroenterology Associates
New York, New York, United States
Lenox Hill Hospital
New York, New York, United States
Premier Medical Group of the Hudson Valley
Poughkeepsie, New York, United States
Charlotte Gastroenterology & Hepatology, PLLC
Charlotte, North Carolina, 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
Paramount Medical Research & Consulting, LLC
Middleburg Heights, Ohio, United States
Options Health Research LLC
Tulsa, Oklahoma, United States
Great Lakes Medical Research, LLC
Harrisburg, Pennsylvania, United States
Gastroenterology Associates of Orangeburg
Orangeburg, South Carolina, 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
Texas Clinical Research Institute
Arlington, Texas, United States
Pinnacle Clinical Research
Austin, Texas, United States
Inquest Clinical Research
Baytown, Texas, United States
San Antonio Military Medical Center
Fort Sam Houston, Texas, United States
DHAT Research Institute
Garland, Texas, United States
Kelsey-Seybold Clinic
Houston, Texas, United States
Baylor College of Medicine- Baylor Medical Center
Houston, Texas, United States
The Methodist Hospital
Houston, Texas, United States
The University of Texas Health Science Center at Houston
Houston, Texas, United States
Centex Studies, Inc.
Houston, Texas, United States
Gulf Coast Research Group
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
Pinnacle Clinical Research
San Antonio, Texas, United States
TDDC San Marcos
San Marcos, Texas, United States
Texas Digestive Disease Consultants (IP Shipment)
Southlake, Texas, United States
Spring Gastroenterology
The Woodlands, Texas, United States
Tyler Research Institute, LLC
Tyler, Texas, United States
HP Clinical Research
Bountiful, Utah, United States
University of Virginia Health System
Charlottesville, Virginia, United States
Charlottesville Medical Research Center, LLC
Charlottesville, Virginia, United States
Gastroenterology Associates of Tidewater
Chesapeake, Virginia, United States
Emeritas Research Group LLC
Leesburg, Virginia, United States
McGuire DVAMC, GI (111N)
Richmond, Virginia, United States
Virginia Commonwealth University
Richmond, Virginia, United States
University of Wisconsin Hospital & Clinics
Madison, Wisconsin, United States
Wisconsin Center for Advanced Research, a division of GI Associates, LLC
Milwaukee, Wisconsin, United States
Fundacion Estudios Clinicos CiRec
Rosario, , Argentina
Royal Prince Alfred Hospital
Camperdown, New South Wales, Australia
Monash Medical Centre
Clayton, New South Wales, Australia
St. Vincent's Hospital Sydney
Darlinghurst, New South Wales, Australia
Nepean Hospital
Kingswood, New South Wales, Australia
Wollongong Hospital
Wollongong, New South Wales, Australia
Coastal Digestive Health
Mountain Creek, Queensland, Australia
Coral Sea Clinical Research Institute (Mackay)
North Mackay, Queensland, Australia
Mater Misericordiae Ltd
South Brisbane, Queensland, Australia
Princess Alexandra Hospital
Woolloongabba, Queensland, Australia
Flinders Medical Centre
Bedford Park, South Australia, Australia
The Queen Elizabeth Hospital
Woodville South, South Australia, Australia
Emeritus Research
Camberwell, Victoria, Australia
Footscray Hospital
Footscray, Victoria, Australia
Austin Health
Heidelberg, Victoria, Australia
Cabrini Hospital
Malvern, Victoria, Australia
Alfred Hospital
Melbourne, Victoria, Australia
Royal Melbourne Hospital
Parkville, Victoria, Australia
Universitatsklinik Innsbruck
Innsbruck, , Austria
AKH-Medizinische Universitat Wien
Vienna, , Austria
GZA Ziekenhuizen campus Sint-Vincentius
Antwerp, , Belgium
Imelda General Hospital
Bonheiden, , Belgium
CUB Hopital Erasme
Brussels, , Belgium
Universitair Ziekenhuis Gent
Ghent, , Belgium
Universitair Ziekenhuis Leuven
Leuven, , Belgium
Centre Hospitalier Chretien (CHC) - Clinique Saint-Joseph
Liège, , Belgium
CHR Citadelle
Liège, , Belgium
AZ Delta Campus Wilgenstraat
Roeselare, , Belgium
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, , Bulgaria
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
The Gordon and Leslie Diamond Health Care Centre
Vancouver, , Canada
Toronto Digestive Disease Associates Inc.
Vaughan, , Canada
Percuro Clinical Research Ltd.
Victoria, , Canada
University Hospital Center Osijek
Osijek, , Croatia
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
Thomayerova nemocnice, Interni klinika 3. LF UK a TN (Interni Oddeleni)
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
Centre Hospitalier Intercommunal de Creteil
Créteil, , 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
Hopital Saint Joseph
Marseille, , France
CHU de Montpellier-Hopital Saint Eloi
Montpellier, , France
Centre d'Investigation Clinique - 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-Bénite, , France
CH Annecy Genevois - Site d'Annecy
Pringy, , France
Centre Hospitalier Universitaire de Rennes - Hopital Pontchaillou
Rennes, , France
CHU de Saint-Etienne - Hopital Nord
Saint-Priest-en-Jarez, , France
Nouvel Hopital Civil
Strasbourg, , France
Hopitaux Universitaires de Strasbourg - Hopital de Hautepierre
Strasbourg, , 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 Universitaetsmedizin Berlin
Berlin, , Germany
Gastro-Studien
Berlin, , Germany
Charite - Universitatsmedizin Berlin
Berlin, , Germany
DRK Kliniken Berlin - Westend - Klinik fuer Innere Medizin
Berlin, , Germany
Stadtisches Klinikum Braunschweig gGmbH
Braunschweig, , Germany
Universitatsklinik Koln
Cologne, , Germany
Agaplesion Markus Krankenhaus
Frankfurt am Main, , Germany
CED Studien UG, Interdisciplinary Crohn Colitis Center (iCCC) Rhein-Main
Frankfurt am Main, , Germany
Universitatsklinikum Freiburg
Freiburg im Breisgau, , Germany
Asklepios Westklinikum Hamburg
Hamburg, , Germany
Medizinische Hochschule Hannover
Hanover, , Germany
Universitatsklinikum Heidelberg
Heidelberg, , Germany
Praxis fur Gastroenterologie
Heidelberg, , Germany
Gastroenterologische Gemeinschaftspraxis Herne
Herne, , Germany
Universitatsklinikum Jena
Jena, , Germany
Universitatsklinikum Schleswig-Holstein
Kiel, , Germany
EUGASTRO GmbH
Leipzig, , Germany
Universitatsklinikum Leipzig
Leipzig, , Germany
Klinikum Luneburg
Lüneburg, , Germany
Gastroenterologische Gemeinschaftspraxis Minden
Minden, , Germany
Klinikum der Universitat Munchen - Grosshadern
München, , Germany
Universitaetsmedizin Rostock, Zentrum fuer Innere Medizin
Rostock, , 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
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
Pátrai, , Greece
General Hospital of Thessaloniki "Hippokratio", 4th Internal Medicine Department of Aristotle University of Thessaloniki
Thessaloniki, , 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
Tuen Mun Hospital
Tuenmen, , Hong Kong
Bekes Megyei Kosponti Korhaz, Dr. Rethy Pal Tagkorhaz, IV. Belgyogyaszat - 2. Gasztroenterologia
Békéscsaba, , Hungary
Szent Margit Korhaz, Gasztroenterológiai Osztály
Budapest, , 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
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
Landspitali University Hospital
Reykjavik, , Iceland
S.P. Medical College & AG of Hospitals
Bikaner, Rajasthan, India
Kaizen Hospital
Ahmedabad, , India
Gastroplus Digestive Disease Centre Pvt Ltd
Ahmedabad, , India
Sal Hospital and Medical Institute
Ahmedabad, , India
Victoria Hospital, Bangalore Medical College and Research Institute
Bangalore, , India
M S Ramaiah Medical College and Hospital
Bangalore, , India
KLES Dr. Prabhakar Kore Hospital & MRC
Belagavi, , India
BGS Global Hospital
Bengaluru, , India
Apollo Speciality Hospital
Chennai, , India
VGM Hospital Institute of Gastroenterology
Coimbatore, , India
Maharaja Agrasen Hospital
Delhi, , India
Lourdes Hospital
Ernākulam, , India
PVS Memorial Hospital Private Limited
Ernākulam, , India
Fortis Medical Research Institute
Gurgaon, , India
Institute of Digestive & Liver Diseases
Guwahati, , India
Gleneagles Global Hospitals
Hyderabad, , India
Citizens Specialty Hospital
Hyderabad, , India
Aware Gleneagles Global Hospitals
Hyderabad, , India
Centre for Liver Research & Diagnostics
Hyderabad, , India
Asian Institute of Gastroenterology Pvt Ltd
Hyderabad, , India
S.R.Kalla Memorial Gastro.&General Hospital
Jaipur, , India
S.M.S Medical College & Hospitals
Jaipur, , India
GSVM Medical College
Kanpur, , India
Lakeshore Hospital and Research Centre Ltd.
Kochi, , India
Amrita Institute of Medical Sciences and Research Centre
Kochi, , India
School of Digestive & Liver Diseases
Kolkata, , India
Apollo Gleneagles Hospitals
Kolkata, , India
King George's Medical University
Lucknow, , India
Dayanand Medical College & Hospital
Ludhiana, , India
Kasturba Medical College (KMC) Hospital
Mangaluru, , India
Seth G.S Medical College & KEM Hospital
Mumbai, , India
Lokmanya Tilak Municipal General Hospital
Mumbai, , India
Midas Multispeciality Hospital Pvt. Ltd
Nagpur, , India
Suretech Hospital & Research Centre Ltd
Nagpur, , India
Max Smart Super Speciality Hospital
New Delhi, , India
All India Institute of Medical Sciences
New Delhi, , India
Dr. B.L. Kapur Memorial Hospital
New Delhi, , India
Fortis Flt. Lt. Rajan Dhall Hospital
New Delhi, , India
S.L Raheja Hospital
Pārel, , 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
BAPS Pramukh Swami Hospital
Surat, , India
Kasturba Hospital Medical College
Udupi, , India
Sterling Hospital
Vadodara, , India
Samvedna Hospital
Varanasi, , India
St. Vincent's University Hospital
Dublin, , Ireland
Beaumont Hospital
Dublin, , Ireland
Wellcome Trust HRB Clinical Research Facility
Dublin, , Ireland
University Hospital Galway
Galway, , Ireland
Emek Medical Center
Afula, , Israel
Soroka Medical Center
Beersheba, , Israel
Bnai Zion Medical Center
Haifa, , Israel
Rambam Health Care Campus
Haifa, , Israel
The Edith Wolfson Medical Center
Holon, , Israel
Shaare Zedek Medical Center
Jerusalem, , Israel
Hadassah Medical Center
Jerusalem, , Israel
Meir Medical Center
Kefar Sava, , Israel
Rabin Medical Center
Petah Tikva, , Israel
The Chaim Sheba Medical Center
Ramat Gan, , Israel
Tel Aviv Sourasky Medical Center
Tel Aviv, , Israel
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
Florence, , Italy
Endoscopia Digestiva Centralizzata
Milan, , Italy
UO Gastroenterologia
Modena, , Italy
UOC Gastroenterologia
Padua, , Italy
Azienda Ospedaliero-Universitaria Pisana - Presidio Ospedaliero Cisanello
Pisa, , Italy
UOC di Gastroenterologia ed Endoscopia Digestiva
Roma, , Italy
Istituto Clinico Humanitas
Rozzano, , Italy
A.O. Ordine Mauriziano di Torino
Torino, , Italy
Ohmori Toshihide gastro-intestinal Clinic
Ageo-shi, , Japan
Tokyo Medical and Dental University Hospital
Bunkyō City, , Japan
Hokkaido P.W.F.A.C Sapporo-Kosei General Hospital
Chūōku, , Japan
Japanese Red Cross Fukuoka Hospital
Fukuoka, , Japan
Tokai University Hachioji Hospital
Hachiōji, , Japan
Medical corporation Ryowakai, Hamamatsu South Hospital
Hamamatsu, , Japan
Hiroshima Prefectural Hospital
Hiroshima, , Japan
Hiroshima University Hospital
Hiroshima, , Japan
Fukuoka University Hospital
Jonan-ku, , Japan
Nanpuh Hospital
Kagoshima, , Japan
Ofuna Chuo Hospital
Kamakura, , Japan
Tsujinaka Hospital
Kashiwa, , 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, , 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
Nagoya City University Hospital
Nagoya, , Japan
Saiseikai Niigata Daini Hospital
Nishiku, , Japan
Hyogo College of Medicine College Hospital
Nishinomiya, , Japan
Okayama University Hospital
Okayama, , Japan
Kinshukai Infusion Clinic
Osaka, , Japan
Osaka City University Hospital
Osaka, , Japan
Wakakusa-Daiichi Hospital
Osaka, , Japan
Ishida IBD Clinic
Ōita, , 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
Yokohama Health Medicine Association Kannai Suzuki Clinic
Yokohama, , Japan
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, , Malaysia
NZW Alkmaar (Noordwest Ziekenhuisgroep)
Alkmaar, , Netherlands
VU University Medical Centre
Amsterdam, , Netherlands
Academic Medical Center (AMC)
Amsterdam, , Netherlands
Gelre Hospital
Apeldoorn, , Netherlands
University Medical Center Groningen (UMCG)
Groningen, , Netherlands
Maastricht University Medical Centre
Maastricht, , Netherlands
Erasmus University Medical Center
Rotterdam, , Netherlands
Elisabeth-TweeSteden Hospital
Tilburg, , Netherlands
University Medical Center Utrecht
Utrecht, , Netherlands
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, , New Zealand
Vestre Viken Hospital Trust, Baerum Hospital
Drammen, , Norway
Uniwersytecki Szpital Kliniczny w Bialymstoku, Klinika Gastroenterologii i Chorob Wewnetrznych
Bialystok, , Poland
VITAMED Galaj i Cichomski spolka jawna
Bydgoszcz, , Poland
Szpital Uniwersytecki nr 2 im. Dr. Jana Biziela w Bydgoszczy, Centrum Endoskopii Zabiegowej, Poradnia Chorob Jelitowych
Bydgoszcz, , Poland
Gabinet Lekarski Janusz Rudzinski
Bydgoszcz, , Poland
NZOZ INTER-MED, Centrum Endoskopowe
Częstochowa, , Poland
Niepubliczny Zaklad Opieki Zdrowotnej ALL-MEDICUS
Katowice, , Poland
Centrum Medyczno-Diagnostyczne Prima-Med
Krakow, , Poland
Gabinet Endoskopii Przewodu Pokarmowego
Krakow, , Poland
Krakowskie Centrum Medyczne Sp. z o.o.
Krakow, , Poland
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Uniwerstyeckiego Szpitala Klinicznego nr 1 im. Norbert Barlickiego
Lodz, , Poland
Trialmed Crs
Piotrkow Trybunalski, , Poland
Clinical Research Center Spolka z ograniczna odpowiedzialnoscia Medic-R Sp. k.
Poznan, , Poland
Gabinet Lekarski Dr. Hab. N. Med. Bartosz Korczowski
Rzeszów, , Poland
Endoskopia Sp. Z o.o.
Sopot, , Poland
Twoja Przychodnia-Szczecinskie Centrum Medyczne
Szczecin, , Poland
GASTROMED Kopon, 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
WIP Warsaw IBD Point Profesor Kierkus
Warsaw, , Poland
Centralny Szpital Kliniczny Ministerstwa Spraw Wewnetrznych i Administacji w Warszawie
Warsaw, , Poland
Centrum Onkologii - Instytut im. Marii Sklodowskiej-Curie
Warsaw, , Poland
Medical Concierge Centrum Medyczne
Warsaw, , Poland
Niepubliczny Zaklad Opieki Zrodotnej VIVAMED Jadwige Miecz
Warsaw, , Poland
Bodyclinic
Warsaw, , Poland
Centrum Medyczne Oporow
Wroclaw, , Poland
Centrum Medyczne
Wroclaw, , Poland
Hospital de Braga
Braga, , Portugal
Centro Hospitalar e Universitario de Coimbra, E.P.E.
Coimbra, , Portugal
Centro Hospitalar Cova de Beira, EPE
Covilha, , Portugal
Centro Hospitalar do Algarve EPE
Faro, , Portugal
Hospital da Senhora da Oliveira Guimaraes, E.P.E.
Guimarães, , Portugal
Hospital Beatriz Angelo
Loures, , Portugal
Centro Hospitalar de Sao Joao, EPE
Porto, , Portugal
Unidade Local de Saude do Alto Minho, EPE
Viana do Castelo, , Portugal
SC MedLife SA, Gastroenterologie
Bucharest, , Romania
Spitalul Universitar de Urgenta Militar Central Dr. Carol Davila - Sectia Clinica de Gastroenterologie
Bucharest, , Romania
S.C. Centrul Medical Sana S.R.L., Gastroenterologie
Bucharest, , Romania
Delta Health Care/ Ponderas Academic Hospital
Bucharest, , Romania
Spitalul Clinic Colentina, Gastroenterologie
Bucharest, , Romania
MedLife, Gastroenterologie
Bucharest, , Romania
Spitalul Universitar de Urgenta Bucuresti - Sectia Medicina Interna II
Bucharest, , Romania
Gastromedica SRL, Gastroenterologie
Iași, , Romania
Cabinet Particular Policlinic Algomed SRL
Timișoara, , Romania
Centrul Medical Tuculanu, Gastroenterologie
Timișoara, , Romania
S.C. Policlinica Dr. Citu S.R.L.- Gastroenterologie
Timișoara, , Romania
State Budgetary Healthcare Institute "Chelyabinsk Regional Clinical Hospital"
Chelyabinsk, , Russia
State Budgetary Institution of Health Irkustsk Order "Badge of Honor" Regional Clinical Hospital
Irkutsk, , 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 Healthcare Institution of the Novosibirsk Region "State Novosibirsk Regional Clinical Hospital"
Novosibirsk, , Russia
State Budgetary Institution of Health of Novosibirsk Region "City Clinical Hospital #12"
Novosibirsk, , Russia
Saint Petersburg State Budgetary Healthcare Institution "City Polyclinic #38"
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
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, , Serbia
National University Hospital
Singapore, , Singapore
Singapore General Hospital
Singapore, , Singapore
Tan Tock Seng Hospital
Singapore, , Singapore
Changi General Hospital
Singapore, , Singapore
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.
Prešov, , Slovakia
Dr MJ Prins
Cape Town, , South Africa
Dr John P Wright
Cape Town, , South Africa
Peermed Clinical Trial Centre
Johannesburg, , South Africa
Pusan National University Hospital
Busan, , South Korea
Yeungnam University Hospital
Daegu, , South Korea
Kyung Hee University Hospital
Guri-si, , South Korea
Hanyang University Guri Hospital
Gyeonggi-do, , South Korea
CHA Bundang Medical Center, CHA University
Seongnam-si, , South Korea
Seoul National University Hospital
Seoul, , 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
The Catholic University of Korea, St. Vincent's Hospital
Suwon, , South Korea
Yonsei University Wonju Severance Christian Hospital
Wŏnju, , South Korea
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 General Universitario Gregorio Maranon
Madrid, , Spain
Hospital Clinico San Carlos
Madrid, , Spain
Hospital Universitario de Fuenlabrada
Madrid, , Spain
Hospital Universitario Central de Asturias
Oviedo, , Spain
Complejo Hospitalario Universitario de Pontevedra
Pontevedra, , Spain
Hospital de Sagunto
Sagunto, , Spain
Hospital Universitario Virgen del Rocio
Seville, , Spain
Hospital de Galdakao-Usandolo
Usansolo, , Spain
National Hospital of Sri Lanka
Colombo, , Sri Lanka
Teaching hospital Karapitiya
Galle, , Sri Lanka
Kandy Teaching Hospital
Kandy, , Sri Lanka
Colombo North Teaching Hospital
Ragama, , Sri Lanka
Danderyds Sjukhus AB
Danderyd, , Sweden
Akademiska Sjukhuset
Uppsala, , Sweden
Gastroenterologische Praxis Balsiger, Seibold und Partner
Bern, , Switzerland
Universitatsspital Zurich
Zurich, , Switzerland
Changhua Christian Hospital
Changhua, , Taiwan
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, , 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
National Taiwan University Hospital
Taipei, , Taiwan
Mackay Memorial Hospital, Taipei
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 District, , Taiwan
Bukovinian State Medical University
Chernivtsi, , Ukraine
Municipal City Clinical Hospital of the Emergency Medical Care, 1 st Therapy Department. Danylo Halytsky Lviv National Medical
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
Odesa, , Ukraine
Ternopil University Hospital, Regional Center of Gastroenterology with Hepatology
Ternopil, , Ukraine
Municipal Institution "Uzhgorod District Hospital", Therapy Department
Uzhhorod, , Ukraine
Vinnytsia Regional Clinical Hospital of War Veterans, Therapy Department #1
Vinnytsia, , Ukraine
Medical Center LLC "Health Clinic"
Vinnytsia, , Ukraine
M.I. Pyrogov Vinnytsia Regional Clinical Hospital, Gastroenterology Department
Vinnytsia, , Ukraine
Municipal Institution "Zaporizhzhya Regional Clinical Hospital" of Zaporizhzhya Regional Council
Zaporizhzhya, , Ukraine
Norfolk and Norwich University Hospital NHS Foundation Trust
Norwich, Norfolk, United Kingdom
Queen Elizabeth Hospital
Birmingham, , United Kingdom
The Pennine Acute Hospitals NHS Trust
Bury, , United Kingdom
Cambridge University Hospital NHS Foundation Trust
Cambridge, , United Kingdom
Royal Derby Hospital
Derby, , United Kingdom
NHS Lothian
Edinburgh, , United Kingdom
Medical Outpatient Department
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
Hull Royal Infirmary
Hull, , United Kingdom
Imperial College Healthcare NHS Trust, St Mary's Hospital
London, , 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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Vermeire S, Schreiber S, Rubin DT, D'Haens G, Reinisch W, Watanabe M, Mehta R, Roblin X, Beales I, Gietka P, Hibi T, Hospodarskyy I, Ritter T, Genovese MC, Kwon P, Santermans E, Le Brun FO, Barron R, Masior T, Danese S. Efficacy and safety of filgotinib as induction and maintenance therapy for Crohn's disease (DIVERSITY): a phase 3, double-blind, randomised, placebo-controlled trial. Lancet Gastroenterol Hepatol. 2025 Feb;10(2):138-153. doi: 10.1016/S2468-1253(24)00272-3. Epub 2024 Dec 2.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2016-001367-36
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
GS-US-419-3895
Identifier Type: -
Identifier Source: org_study_id