Filgotinib in Long-Term Extension Study of Adults With Crohn's Disease (DIVERSITY LTE)
July 4, 2024 updated by: Galapagos NV
A Long-Term Extension Study to Evaluate the Safety of Filgotinib in Subjects With Crohn's Disease
The primary objective of this study is to observe the long-term safety of filgotinib in adults who have completed or met protocol specified efficacy discontinuation criteria in a prior filgotinib treatment study in Crohn's disease (CD).
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
1188
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Rosario, Argentina, S2000DEF
- Fundacion Estudios Clinicos CiRec
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New South Wales
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Camperdown, New South Wales, Australia, 2050
- Royal Prince Alfred Hospital
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Darlinghurst, New South Wales, Australia, 2010
- St. Vincent's Hospital Sydney
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Kingswood, New South Wales, Australia, 2747
- Nepean Hospital
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Wollongong, New South Wales, Australia, 2500
- Wollongong Hospital
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Queensland
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Mountain Creek, Queensland, Australia, 4557
- Coastal Digestive Health
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North Mackay, Queensland, Australia, 4740
- Coral Sea Clinical Research Institute (Mackay)
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South Brisbane, Queensland, Australia, 4101
- Mater Misericordiae Ltd
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Woolloongabba, Queensland, Australia, 4102
- Princess Alexandra Hospital
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South Australia
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Woodville South, South Australia, Australia, 5011
- The Queen Elizabeth Hospital
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Victoria
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Camberwell, Victoria, Australia, 3124
- Emeritus Research
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Clayton, Victoria, Australia, 3168
- Monash Medical Centre
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Footscray, Victoria, Australia, 3011
- Footscray Hospital
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Heidelberg, Victoria, Australia, 3084
- Austin Health
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Malvern, Victoria, Australia, 3144
- Cabrini Hospital
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Melbourne, Victoria, Australia, 3004
- Alfred Hospital
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Parkville, Victoria, Australia, 3050
- Royal Melbourne Hospital
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Innsbruck, Austria, 6020
- Universitatsklinik Innsbruck
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Klagenfurt am Wörthersee, Austria, 9020
- Klinikum Klagenfurt am Wörthersee, Abt. Für Inn. Med. & Gastroenterol, (IMuG), Hepatol., Endokrinol., Rheumatol., & Nephrol.
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Wien, Austria, 1090
- AKH-Medizinische Universitat Wien
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Antwerpen, Belgium, 2018
- GZA Ziekenhuizen, campus Sint-Vincentius
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Bonheiden, Belgium, 2820
- Imelda General Hospital
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Brussel, Belgium, 1070
- CUB Hopital Erasme
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Edegem, Belgium, 2650
- Universitair Ziekenhuis Antwerpen
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Gent, Belgium, 9000
- Universitair Ziekenhuis Gent
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Leuven, Belgium, 3000
- Universitair Ziekenhuis Leuven
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Liege, Belgium, 4000
- CHR Citadelle
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Liège, Belgium, 4000
- Centre Hospitalier Chretien (CHC) - Clinique Saint-Joseph
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Roeselare, Belgium, 8800
- AZ Delta
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Samokov, Bulgaria, 2000
- Medical Center - Complete Medical Solutions OOD
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Sliven, Bulgaria, 8800
- Medical Center - "Tsaritsa Yoanna" EOOD
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Veliko Tarnovo, Bulgaria, 5000
- "MDHAT Dr. St.Cherkezov" AD
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Vidin, Bulgaria, 3700
- MHAT "Sveta Petka" AD
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Barrie, Canada, L4M 7G1
- Barrie GI Associates
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Calgary, Canada, T2N 4Z6
- University of Calgary, Heritage Medical Research Clinic
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Hamilton, Canada, L8S 4K1
- Hamilton Health Sciences Corporation, McMaster University Medical Centre
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London, Canada, N6A 5A5
- London Health Sciences Centre - University Hospital
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North York, Canada, M6A 3B4
- TIDHI Innovation, Inc.
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Oakville, Canada, L6L 5L7
- ABP Research Services
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Saskatoon, Canada, S7N 0W8
- Royal University Hospital
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Toronto, Canada, M5T 3L9
- Mount Sinai Hospital
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Vancouver, Canada, V5Z 1M9
- The Gordon and Leslie Diamond Health Care Centre
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Vaughan, Canada, L4L 4Y7
- Toronto Digestive Disease Associates Inc.
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Victoria, Canada, V8V 3P9
- PerCuro Clinical Research Ltd.
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Osijek, Croatia, 31 000
- University Hospital Center Osijek
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Zagreb, Croatia, 10000
- University Hospital Center Zagreb
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Zagreb, Croatia, 10000
- Clinical Hospital Dubrava
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Hradec Kralove, Czechia, 500 12
- Hepato-Gastroenterology HK, s.r.o.
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Mlada Boleslav, Czechia, 293 01
- Oblastni nemocnice Mlada Boleslav, a.s., nemocnice Stredoceskeho kraje, Gastroenterologicke oddeleni
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Praha 3, Czechia, 130 00
- G.E.P. Clinic, s r.o.
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Praha 4, Czechia, 140 00
- Thomayerova nemocnice, Interni klinika 3. LF UK a TN
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Praha 9, Czechia, 190 00
- ISCARE a.s. (Klinicke centrum ISCARE), Klinicke a vyzkumne centrum pro strevni zancty
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Amiens Cedex 1, France, 80054
- CHU Amiens Picardie
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Caen Cedex 9, France, 14033
- CHU de Caen
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Clermont-Ferrand, France, 63003
- CHU de Clermont-Ferrand - Hopital d'Estaing
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Clichy, France, 92110
- APHP - Hopital Beaujon - Clichy - Universite Paris VII
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Créteil Cedex, France, 94010
- Centre Hospitalier Intercommunal de Créteil
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Dijon, France, 21079
- CHU de Dijon Bourgogne - Hopital Francois Mitterand
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La Tronche, France, 38700
- CHU Grenoble Alpes
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Le Kremlin Bicetre, France, 94270
- Hopital Universitaire de Bicetre
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Lille, France, 59000
- Centre Hospitalier Regional Universitaire de Lille
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Marseille, France, 13015
- Hôpital Nord
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Marseille, France, 13285
- Hopital Saint Joseph
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Montpellier, France, 34295
- CHU de Montpellier-Hopital Saint Eloi
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Nantes, France, 44093
- CHU Hotel-Dieu
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Nice, France, 06202
- Hopital de l'Archet 2
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Pessac, France, 33600
- CHU de Bordeaux - Hopital Haut Leveque
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Pierre-Benite, France, 69495
- Centre Hospitalier Universitaire de Lyon Sud
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Pringy Cedex, France, 74374
- CH Annecy Genevois - site d'Annecy
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Rennes Cedex 9, France, 35033
- Centre Hospitalier Universitaire de Rennes - Hopital Pontchaillou
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Saint Priest en Jarez, France, 42055
- CHU de Saint Etienne - Hopital Nord
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Strasbourg, France, 67091
- Nouvel hopital civil
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Strasbourg, France, 67098
- Hôpitaux Universitaires de Strasbourg - Hôpital de Hautepierre
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Toulouse, France, 31059
- CHU de Toulouse - Hopital Rangueil
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Toulouse Cedex 9, France, 31059
- CHU de Toulouse - Hopital Rangueil
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Vandoeuvre-les-Nancy Cedex, France, 54511
- CHU de Nancy - Hopital Brabois Adultes
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Batumi, Georgia, 6010
- Unimed Ajara LLC - Batumi Referral Hospital
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Tbilisi, Georgia, 0160
- Medi Club Georgia LLC
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Telavi, Georgia, 2200
- Ltd. Unimed Kakheti - Telavi Referral Hospital
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Berlin, Germany, 13353
- Charité - Universitätsmedizin Berlin
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Berlin, Germany, 10117
- Charite Universitaetsmedizin Berlin
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Berlin, Germany, 14050
- DRK Kliniken Berlin - Westend - Klinik fuer Innere Medizin
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Berlin, Germany, 10825
- Medizinisches Versorgungszentrum Delitzsch
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Braunschweig, Germany, 38126
- Stadtisches Klinikum Braunschweig gGmbH
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Dresden, Germany, 01307
- Universitätsklinikum Dresden
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Frankfurt am Main, Germany, 60431
- Agaplesion Markus Krankenhaus
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Frankfurt am Main, Germany, 60594
- CED Studien UG, Interdisciplinary Crohn Colitis Center (iCCC)
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Freiburg, Germany, 79106
- Universitatsklinikum Freiburg
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Hamburg, Germany, 22559
- Asklepios Westklinikum Hamburg
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Hannover, Germany, 30625
- Medizinische Hochschule Hannover
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Heidelberg, Germany, 69120
- Universitatsklinikum Heidelberg
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Heidelberg, Germany, 69121
- Praxis fur Gastroenterologie
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Herne, Germany, 44623
- Gastroenterologische Gemeinschaftspraxis Herne
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Jena, Germany, 07747
- Universitatsklinikum Jena
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Kiel, Germany, 24105
- Universitatsklinikum Schleswig-Holstein
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Koln, Germany, 50937
- Universitaetsklinik Koln
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Leipzig, Germany, 04103
- Universitatsklinikum Leipzig
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Leipzig, Germany, 04103
- EUGASTRO GmbH
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Lüneburg, Germany, 21339
- Klinikum Luneburg
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Minden, Germany, 32423
- Gastroenterologische Gemeinschaftspraxis Minden
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Muenchen, Germany, 81377
- Klinikum der Universitat Munchen - Grosshadern
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Rostock, Germany, 18057
- Universitaetsmedizin Rostock, Zentrum fuer Innere Medizin
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Tuebingen, Germany, 72074
- Universitaetsklinikum Tuebingen
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Ulm, Germany, 89081
- Universitatsklinikum Ulm, Zentrum Fur Innere Medizin
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Athens, Greece, 12462
- University General Hospital "Attikon", 2nd Propaedeutic Internal Medicine Dept. and Research Unit, Hepatogastroenterology Unit
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Athens, Greece, 11527
- Hippokration Hospital of Athens
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Ioannina, Greece, 45332
- University General Hospital of Ioannina, Gastroenterology Department, Internal Medicine Division
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Patra, Greece, 26504
- University General Hospital of Patras "Panagia I Voithia", Gastroenterology Department, Internal Medicine Division
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Thessaloniki, Greece, 54642
- Hippokratio General Hospital of Thessaloniki "Hippokratio" 4th Internal Medicine Department of Aristotle University of Thessaloniki
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Hong Kong, Hong Kong
- Queen Mary Hospital
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Hong Kong, Hong Kong
- Princess Margaret Hospital
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Shatin, Hong Kong
- Department of Medicine & Therapeutics, The Chinese University of Hong Kong, Prince of Wales Hospital
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Tuen Mun, Hong Kong
- Tuen Mun Hospital
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Bekescsaba, Hungary, 5600
- Bekes Megyei Kosponti Korhaz, Dr. Rethy Pal Tagkorhaz, IV. Belgyogyaszat - 2. Gasztroenterologia
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Budapest, Hungary, 1032
- Szent Margit Korhaz, Gasztroenterológiai Osztály
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Budapest, Hungary, 1033
- Clinexpert Egészségügyi Szolgáltató és Kereskedelmi Kft.
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Budapest, Hungary, 1097
- Del-pesti Centrumkorhaz - Orszagos Hematologiai es Infektologiai Intezet, Kozponti Felnott Szakrendelo
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Budapest, Hungary, 1125
- Szent Janos Korhaz es Eszak-budai Egitett Korhazak, I. Belgyogyaszati - Gasztroenterologiai Osztaly
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Debrecen, Hungary, 4032
- Debreceni Egyetem Klinikai Kozpont, II. sz. Belgyogyaszati Klinika, Gasztroenterologia
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Gyöngyös, Hungary, 3200
- Bugat Pal Korhaz, Belgyogyaszat
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Mosonmagyarovar, Hungary, 9200
- Karolina Korhaz es Rendelointezet, Altalanos Belgyogyaszat-Gasztroenterologia
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Reykjavik, Iceland, 101
- Landspitali University Hospital
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Ahmedabad, India, 380052
- Kaizen Hospital
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Bangalore, India, 560054
- M S Ramaiah Medical College and Hospital
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Bangalore, India, 560002
- Victoria Hospital, Bangalore Medical College and Research Institute (BMCRI)
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Chennai, India, 600035
- Apollo Speciality Hospital
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Coimbatore, India, 641005
- VGM Hospital Institute of Gastroenterology
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Ernakulam, India, 682012
- Lourdes Hospital
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Gurgaon, India, 122002
- Fortis Memorial Research Institute
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Hyderabad, India, 500004
- Gleneagles Global Hospital
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Hyderabad, India, 500019
- Citizens Specialty Hospital
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Hyderabad, India, 500058
- Centre for Liver Research & Diagnostics
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Jaipur, India, 302001
- SR Kalla Memorial Gastro and General Hospital
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Jaipur, India, 302004
- S.M.S Hospital
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Kolkata, India, 700020
- School of Digestive & Liver Diseases
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Lucknow, India, 226003
- King George's Medical University
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Ludhiana, India, 141001
- Dayanand Medical College & Hospital
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Mangaluru, India, 575001
- Kasturba Medical College (KMC) Hospital
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Mumbai, India, 400022
- Lokmanya Tilak Municipal General Hospital
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Mumbai, India, 400012
- Seth G.S. Medical College & KEM Hospital
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Mumbai, India, 400016
- S.L. Raheja Hospital (A Fortis Associate)
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Nagpur, India, 440010
- Midas Multispeciality Hospital Pvt. Ltd
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Nagpur, India, 440012
- Suretech Hospital & Research Centre Ltd
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New Delhi, India, 110029
- All India Institute of Medical Sciences
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Pune, India, 411001
- Department of Surgery, B.J. Government Medical College & Sassoon General Hospital
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Pune, India, 411001
- Grant Medical Foundation Ruby Hall Clinic
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Pune, India, 411011
- Universal Hospital
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Rajkot, India, 360002
- Shree Giriraj Multispeciality Hospital
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Secunderabad, India, 500003
- Gandhi Hospital
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Secunderabad, India, 500003
- Institute of Gastroenterology & Liver Disease. Sunshine Hospitals
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Surat, India, 395002
- Surat Institute of Digestive Sciences
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Udupi, India, 576104
- Kasturba Hospital Medical College
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Vadodara, India, 390007
- Sterling Hospital
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Varanasi, India, 221005
- Samvedna Hospital
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Kerala
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Kochi, Kerala, India, 682040
- Lakeshore Hospital and Research Centre Ltd
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Dublin, Ireland, 9
- Beaumont Hospital
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Dublin, Ireland, 4
- St. Vincent'S University Hospital
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Dublin, Ireland, DUBLIN 8
- Wellcome Trust HRB Clinical Research Facility
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Galway, Ireland, H91 YR71
- University Hospital Galway
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Afula, Israel, 18101
- Emek Medical Center
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Beer-Sheva, Israel, 8410101
- Soroka Medical Center
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Haifa, Israel, 31048
- Bnai Zion Medical Center
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Haifa, Israel, 3109601
- Rambam Medical Health Care Campus
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Holon, Israel, 5822012
- The Edith Wolfson Medical Center
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Jerusalem, Israel, 9103102
- Shaare Zedek Medical Center
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Jerusalem, Israel, 9112001
- Hadassah Medical Center
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Kefar Sava, Israel, 4428164
- Meir MC
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Petah Tikva, Israel, 4941492
- Rabin Medical Center
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Ramat Gan, Israel, 5265601
- The Chaim Sheba Medical Center
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Tel Aviv-Yafo, Israel, 64239
- Tel Aviv Sourasky Medical Center
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Castellana Grotte, Italy, 70013
- UOC Gastroenterologia II
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Catanzaro, Italy, 88100
- U.O. Fisiopatologia Digestiva
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Cento, Italy, 44042
- UOC Medicina Interna
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Chieti, Italy, 66100
- Ospedale Clinicizzato SS. Annunziata - Dipartimento di Medicina
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Firenze, Italy, 50134
- Gastroenterologia clinica - Azienda Ospedaliero-Universitaria Careggi
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Milano, Italy, 20121
- Endocsopia Digestiva Centralizzata
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Modena, Italy, 40124
- UO Gastroenterologia
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Padova, Italy, 35128
- UOC Gastroenterologia
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Pisa, Italy, 56124
- Azienda Ospedaliero-Universitaria Pisana - Presidio Ospedaliero Cisanello
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Roma, Italy, 00133
- UOC di Gastroenterologia ed Endoscopia Digestiva
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Roma, Italy, 00128
- UOC Gastroenterologia ed Endoscopia Digestiva
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Roma, Italy, 00168
- UOC Medicina Interna a Gastroenterologia
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Rozzano, Italy, 20089
- Istituto Clinico Humanitas
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Torino, Italy, 10122
- A.S.O. Ordine Mauriziano Di Torino S.C.
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Ageo-shi, Japan, 362-0075
- Ohmori Toshihide gastro-intestinal Clinic
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Bunkyo-ku, Japan, 113-8519
- Tokyo Medical and Dental University Hospital
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Chuo-ku, Japan, 060-0033
- Hokkaido P.W.F.A.C Sapporo-Kosei General Hospital
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Fukuoka-shi, Japan, 815-8555
- Japanese Red Cross Fukuoka Hospital
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Hachioji, Japan, 192-0032
- Tokai University Hachioji Hospital
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Hiroshima-shi, Japan, 734-8530
- Hiroshima Prefectural Hospital
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Jonan-ku, Japan, 814-0180
- Fukuoka University Hospital
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Kawagoe, Japan, 350-8550
- Saitama Medical Center, Saitama Medical University
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Kitakyushu-shi, Japan, 802-0077
- Kitakyushu City Hospital Organization Kitakyushu Municipal Medical Center
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Kofu-shi, Japan, 400-8506
- Yamanashi Prefectural Central Hospital
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Kurume-shi, Japan, 839-0809
- Hidaka Coloproctology Clinic
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Kurume-shi, Japan, 830-0011
- Kurume University Hospital
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Kyoto-shi, Japan, 602-8566
- University Hospital, Kyoto Prefectural University of Medicine
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Minato-ku, Japan, 108-8642
- Kitasato University Kitasato Institute Hospital
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Minato-ku, Japan, 105-8471
- The Jikei University Hospital
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Mitaka-shi, Japan, 181-8611
- Kyorin University Hospital
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Morioka-shi, Japan, 020-8505
- Iwate Medical University Hospital
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Nagakute-shi, Japan, 480-1195
- Aichi Medical University Hospital
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Nagasaki-shi, Japan, 8528501
- Nagasaki University Hospital
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Nagoya, Japan, 467-8602
- Nagoya City University Hospital
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Nishi-ku, Japan, 950-1104
- Saiseikai Niigata Daini Hospital
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Nishinomiya, Japan, 663-8501
- Hyogo College of Medicine College Hospital
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Oita-shi, Japan, 870-0823
- Ishida IBD Clinic
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Okayama-city, Japan, 700-8558
- Okayama University Hospital
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Osaka, Japan, 545-8586
- Osaka City University Hospital
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Osaka, Japan, 579-8056
- Wakakusa-Daiichi Hospital
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Osaka-City, Japan, 530-0011
- Kinshukai Infusion Clinic
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Otsu, Japan, 520-2192
- Shiga University of Medical Science Hospital
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Saga, Japan, 849-8501
- Saga University Hospital
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Saga-shi, Japan, 840-8571
- Saga-Ken Medical Centre Koseikan
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Saitama, Japan, 336-0963
- Tokito Clinic
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Sakura, Japan, 285-8741
- Toho University Sakura Medical Center
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Sapporo-shi, Japan, 065-0033
- Sapporo Higashi Tokushukai Hospital
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Sendai, Japan, 983-8520
- National Hospital Organization Sendai Medical Center
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Suita, Japan, 565-0871
- Osaka University Hospital
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Takamatsu-shi, Japan, 760-8557
- Kagawa Prefectural Central Hospital
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Takasaki-shi, Japan, 3700829
- National Hospital Organization Takasaki General Medical Center
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Toyota-shi, Japan, 470-1219
- Ieda Hospital
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Wakayama-shi, Japan, 641-8509
- Wakayama Medical University Hospital
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Yokohama-shi, Japan, 231-0012
- Yokohama Health Medicine Association Kannai Suzuki Clinic
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Busan, Korea, Republic of, 49241
- Pusan National University Hospital
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Daegu, Korea, Republic of, 42415
- Yeungnam University Hospital
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Guri-Si, Korea, Republic of, 471-701
- Kyung Hee University Hospital
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Gyeonggi-do, Korea, Republic of, 11923
- Hanyang University Guri Hospital
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Seongnam-si, Korea, Republic of, 463-712
- CHA Bundang Medical Center, CHA University
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Seoul, Korea, Republic of, 03080
- Seoul National University Hospital
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Seoul, Korea, Republic of, 05505
- Asan Medical Center
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Seoul, Korea, Republic of, 03181
- Kangbuk Samsung Hospital
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Seoul, Korea, Republic of, 03722
- Yonsei University Health System, Severance Hospital
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Seoul, Korea, Republic of, 06351
- Division of Gastroenterology, Department of Medicine, Samsung Medical Center
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Suwon-si, Korea, Republic of, 16247
- The Catholic University of Korea, St. Vincent's Hospital
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Wonju, Korea, Republic of, 220-701
- Yonsei University Wonju Severance Christian Hospital
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Cheras, Malaysia, 56000
- Universiti Kebangsaan Malaysia Medical Center
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George Town, Malaysia, 10990
- Hospital Pulau Pinang
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Kota Kinabalu, Malaysia, 88586
- Hospital Queen Elizabeth
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Kuala Lumpur, Malaysia, 59100
- University Malaya Medical Centre
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Kuantan, Malaysia, 25100
- Hospital Tengku Ampuan Afzan
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Alkmaar, Netherlands, 1815 JD
- NZW Alkmaar (Noordwest Ziekenhuisgroep)
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Amsterdam, Netherlands, 1081 HV
- VU Medisch Centrum
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Amsterdam, Netherlands, 1105 AZ
- Academic Medical Center (AMC)
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Apeldoorn, Netherlands, 7334
- Gelre Hospital
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Groningen, Netherlands, 9700 RB
- Universitair Medisch Centrum Groningen
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Maastricht, Netherlands, 6229 HX
- Maastricht University Medical Centre
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Rotterdam, Netherlands, 3015 CE
- Erasmus University Medical Center
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Tilburg, Netherlands, 5022
- Elisabeth-Tweesteden Hospital
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Utrecht, Netherlands, 3584 CX
- University Medical Center Utrecht
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Christchurch, New Zealand, 8011
- Christchurch Hospital
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Dunedin, New Zealand, 9016
- Southern District Health Board - Dunedin Hospital
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Grafton, New Zealand, 1023
- Auckland City Hospital
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Hamilton, New Zealand, 3240
- Waikato Hospital
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Newtown, New Zealand, 6021
- Wellington Hospital
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Tauranga, New Zealand, 3112
- Bay of Plenty District Health Board - Tauranga Hospital
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Wellington, New Zealand, 5010
- Hutt Valley District Health Board - Hutt Valley Hospital
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Bialystok, Poland, 15-276
- Uniwersytecki Szpital Kliniczny w Bialymstoku, Klinika Gastroenterologii i Chorob Wewnetrznych
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Bydgoszcz, Poland, 85-681
- Gabinet Lekarski Janusz Rudzinski
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Bydgoszcz, Poland, 85-079
- VITAMED Galaj i Cichomski spólka jawna
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Bydgoszcz, Poland, 85-168
- Szpital Uniwersytecki nr 2 im. Dr. Jana Biziela w Bydgoszczy, Centrum Endoskopii Zabiegowej, Poradnia Chorob Jelitowych
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Czestochowa, Poland, 42-217
- NZOZ INTER-MED, Centrum Endoskopowe
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Katowice, Poland, 40-659
- Niepubliczny Zaklad Opieki Zdrowotnej ALL-MEDICUS
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Krakow, Poland, 31-009
- Gabinet Endoskopii Przewodu Pokarmowego
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Kraków, Poland, 31-501
- Krakowskie Centrum Medyczne Sp. z o.o
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Lodz, Poland, 90-153
- Samodzielny Publiczny Zaklad Opieki Zdrowotnej Uniwerstyeckiego Szpitala Klinicznego nr 1 im. Norberta Barlickiego
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Piotrków Trybunalski, Poland, 97-300
- Trialmed CRS
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Poznan, Poland, 60-848
- Clinical Research Center Sp. z o.o. Medic-R sp.k.
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Rzeszów, Poland, 35-301
- Gabinet Lekarski Dr. Hab. N. Med. Bartosz Korczowski
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Sopot, Poland, 81-756
- Endoskopia Sp. z o.o.
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Szczecin, Poland, 71-434
- Twoja Przychodnia-Szczecinskie Centrum Medyczne
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Torun, Poland, 87-100
- GASTROMED Kopon, Zmudzkinski i Wspolnicy Sp. j. Specjalistyczne Centrum Gastrologii i Endoskopii
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Tychy, Poland, 43-100
- H-T.Centrum Medyczne Spolka z Ograniczona Odpowiedzialnoscia Sp.K.
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Warsaw, Poland, 02-781
- Centrum Onkologii - Instytut im. Marii Sklodowskiej-Curie
-
Warszawa, Poland, 00-728
- WIP Warsaw IBD Point Profesor Kierkus
-
Warszawa, Poland, 00-635
- Centrum Zdrowia MDM
-
Warszawa, Poland, 02-798
- Medical Concierge Centrum Medyczne
-
Warszawa, Poland, 02-507
- Centralny Szpital Kliniczny Ministerstwa Spraw Wewnetrznych i Administacji w Warszawie
-
Warszawa, Poland, 03-580
- Niepubliczny Zaklad Opieki Zrodotnej VIVAMED Jadwige Miecz
-
Warszawa, Poland, 03-712
- Bodyclinic
-
Wroclaw, Poland, 52-416
- Centrum Medyczne Oporow
-
-
-
-
-
Braga, Portugal, 4710-243
- Hospital de Braga
-
Coimbra, Portugal, 3000-075
- Centro Hospitalar e Universitário de Coimbra, E.P.E.
-
Covilhã, Portugal, 6200-251
- Centro Hospitalar Cova de Beira, EPE
-
Faro, Portugal, 8000-386
- Centro Hospitalar do Algarve EPE
-
Guimaraes, Portugal, 4835-044
- Hospital da Senhora da Oliveira Guimaraes, E.P.E.
-
Loures, Portugal, 2674-514
- Hospital Beatriz Ângelo
-
Porto, Portugal, 4200-319
- Centro Hospitalar de Sao Joao, EPE
-
Viana do Castelo, Portugal, 4904-858
- Unidade Local de Saúde do Alto Minho
-
-
-
-
-
Bucharest, Romania, 011025
- S.C. Centrul Medical Sana S.R.L., Gastroenterologie
-
Bucharest, Romania, 050098
- Spitalul Universitar de Urgenta Bucuresti - Sectia Medicina Interna II
-
Bucuresti, Romania, 010825
- Spitalul Universitar de Urgenta Militar Central Dr. Carol Davila - Sectia Clinica de Gastroenterologie
-
Bucuresti, Romania, 014142
- Delta Health Care/ Ponderas Academic Hospital
-
Bucuresti, Romania, 031784
- MedLife, Gastroenterologie
-
Bucuresti, Romania, 020125
- Spitalul Clinic Colentina - Sectia de Spitulal Clinic Colentina, Gastroenterologie
-
Bucuresti, Romania, 010719
- MedLife, Gastroenterologie
-
Iasi, Romania, 700506
- Gastromedica SRL, Gastroenterologie
-
Timisoara, Romania, 300002
- Cabinet Particular Policlinic Algomed SRL
-
Timisoara, Romania, 300168
- Centrul Medical Tuculanu, Gastroenterologie
-
Timisoara, Romania, 300594
- S.C. Policlinica Dr. Citu S.R.L.- Gastroenterologie
-
-
-
-
-
Chelyabinsk, Russian Federation, 454076
- State Budgetary Healthcare Institution "Chelyabinski Regional Clinical Hospital"
-
Irkutsk, Russian Federation, 669079
- State Budgetary Institution of Health Irkustsk Order "Badge of Honor" Regional Clinical Hospital
-
Moscow, Russian Federation, 129110
- State Budgetary Healthcare Institution of Moscow Region "Moscow Regional Clinical Research Institute n.a. M.F. Vladimirskiy"
-
Nizhniy Novgorod, Russian Federation, 603126
- State Budgetary Healthcare Institution of Nizhny Novgorod Region "Nizhny Novgorod Regional Clinical Hospital n.a. N.A.
-
Novosibirsk, Russian Federation, 630087
- State Budgetary Healthcare Institution of the Novosibirsk Region "State Novosibirsk Regional Clinical Hospital"
-
Novosibirsk, Russian Federation, 630091
- State Budgetary Institution of Health of Novosibirsk Region "City Clinical Hospital #12"
-
Saint-Petersburg, Russian Federation, 191015
- Saint Petersburg State Budgetary Healthcare Institution "City Polyclinic #38"
-
Saint-Petersburg, Russian Federation, 196143
- "Scientific Research Centre ECO-safety" LLC
-
Saint-Petersburg, Russian Federation, 197110
- "PolyClinic EXPERT" LLC
-
Saratov, Russian Federation, 410053
- State Healthcare Institution "Regional Clinical Hospital"
-
-
-
-
-
Belgrade, Serbia, 11000
- Clinical Hospital Center Zemun
-
Belgrade, Serbia, 3010-777
- University Hospital Medical Center Bezanijska Kosa
-
Belgrade, Serbia, 3618-445
- Clinical Center of Serbia
-
Belgrade, Serbia, 3810-970
- Zvezdara University Medical Center
-
Novi Sad, Serbia, 21000
- Clinical Center of Vojvodina
-
-
-
-
-
Singapore, Singapore, 169608
- Singapore General Hospital
-
Singapore, Singapore, 119074
- National University Hospital
-
Singapore, Singapore, 308433
- Tan Tock Seng Hospital
-
Singapore, Singapore, 529889
- Changi General Hospital
-
-
-
-
-
Bratislava, Slovakia, 82007
- Cliniq s. r. o., Gastroenterologicke centrum Ruzinov
-
Nitra, Slovakia, 950 01
- KM Management, s.r.o., Gastroenterologicke a hepatologicke centrum Nitra
-
Presov, Slovakia, 8001
- Gastro I., s.r.o.
-
-
-
-
-
Cape Town, South Africa, 7500
- Dr MJ Prins
-
Cape Town, South Africa, 7708
- Dr John P Wright
-
Johannesburg, South Africa, 1619
- Peermed Clinical Trial Centre
-
-
-
-
-
Badalona, Spain, 08916
- Hospital Universitari Germans Trias i Pujol
-
Barcelona, Spain, 8003
- Hospital Del Mar
-
Barcelona, Spain, 08022
- Centro Medico Teknon
-
Ferrol, Spain, 15405
- Complejo Hospitalario Universitario de Ferrol
-
Las Palmas de Gran Canaria, Spain, 35010
- Hospital Universitario de Gran Canaria "Dr. Negrin"
-
Madrid, Spain, 28040
- Hospital Clinico San Carlos
-
Madrid, Spain, 28007
- Hospital General Universitario Gregorio Marañón
-
Madrid, Spain, 28942
- Hospital Universitario de Fuenlabrada
-
Oviedo, Spain, 33006
- Hospital Universitario Central de Asturias
-
Pontevedra, Spain, 36071
- Hospital De Montecelo
-
Sagunto, Spain, 46520
- Hospital de Sagunto
-
Sevilla, Spain, 41013
- Hospital Universitario Virgen del Rocío
-
Usansolo, Spain, 48960
- Hospital de Galdakao-Usandolo
-
-
-
-
-
Colombo, Sri Lanka, 00700
- National Hospital of Sri Lanka
-
Galle, Sri Lanka, 80000
- Karapitiya Teaching Hospital
-
Kandy, Sri Lanka, 20000
- Kandy Teaching Hospital
-
Ragama, Sri Lanka, 11010
- Colombo North Teaching Hospital
-
-
-
-
-
Danderyd, Sweden, SE-18288
- Danderyds Sjukhus AB
-
Uppsala, Sweden, 75185
- Akademiska Sjukhuset
-
-
-
-
-
Bern, Switzerland, 3012
- Intesto Gastroenterologische Praxis & Crohn-Colitis-Zentrum Bern
-
Zurich, Switzerland, 8091
- Universitätsspital Zürich
-
-
-
-
-
Changhua, Taiwan, 500
- Changhua Christian Hospital
-
Kaohsiung, Taiwan, 807
- Kaohsiung Medical University Chung-Ho Memorial Hospital
-
New Taipei City, Taiwan, 220
- Far Eastern Memorial Hospital
-
Taichung, Taiwan, 40447
- China Medical University Hospital
-
Taichung, Taiwan, 40201
- Chang Shan Medical University Hospital
-
Tainan City, Taiwan, 7428
- National Cheng Kung University Hospital
-
Taipei, Taiwan, 100
- National Taiwan University Hospital
-
Taipei, Taiwan, 114
- Tri-Service General Hospital
-
Taipei, Taiwan, 112
- Taipei Veterans General Hospital
-
Taipei, Taiwan, 104
- Mackay Memorial Hospital, Taipei
-
Taoyuan, Taiwan, 33305
- Chang Gung Medical Foundation, Chang Gung Memorial Hospital, Linkou Branch
-
-
-
-
-
Chernivtsi, Ukraine, 58000
- Regional Municipal Institution "Chernivtsi Regional Clinical Hospital", Surgical Department
-
Chernivtsi, Ukraine, 58000
- Multispecialty Clinical Hospital of Intensive Treatments and Emergency Medical Care
-
Dnipropetrovsk, Ukraine, 49000
- State Institution "Institute of Gastroenterology of National Academy of Medical Sciences of Ukraine"
-
Ivano-Frankivsk, Ukraine, 76018
- Ivanto-Frankivsk Central City Clinic Hospital, Therapy Department #1. State Higher Education Institution Ivano-Frankivsk National
-
Kharkiv, Ukraine, 61037
- Municipal Health Care Institution "Kharkiv City Clinical Hospital #2 named after prof. O. O. Shalimov", Proctology Department
-
Kharkiv, Ukraine, 63101
- Municipal Institution of Health Care "Regional Hospital of War Veterans", Therapeutic Department No1
-
Kropyvnytskyi, Ukraine, 25006
- Treatment and Diagnostic Center of Private Enterprise of Private Production Company "Acinus"
-
Kyiv, Ukraine, 01030
- Kyiv City Clinical Hospital No. 18, Proctology Department
-
Kyiv, Ukraine, 1103
- Municipal Non-profit Enterprise "Consultative and Diagnostic Center" of Pechersk District of Kyiv, Therapy Department
-
Odessa, Ukraine, 65025
- Municipal Institution "Odesa Regional Clinical Hospital", Regional Gastroenterology Center based on Surgery Department
-
Ternopil, Ukraine, 46002
- Ternopil Regional Clinical Hospital, Regional Center of Gastroenterology with Hepatology
-
Uzhgorod, Ukraine, 88009
- Municipal Institution "Uzhgorod District Hospital", Therapy Department
-
Vinnytsia, Ukraine, 21005
- Vinnytsia Regional Clinical Hospital of War Veterans, Therapy Department #1
-
Vinnytsia, Ukraine, 21018
- M.I. Pyrogov Vinnytsia Regional Clinical Hospital, Gastroenterology Department
-
Vinnytsia, Ukraine, 21029
- Medical Center LLC "Health Clinic"
-
Zaporizhzhya, Ukraine, 69600
- Municipal Institution "Zaporizhzhya Regional Clinical Hospital" of Zaporizhzhya Regional Council
-
-
-
-
-
Birmingham, United Kingdom, B15 2WB
- Queen Elizabeth Hospital
-
Bury, United Kingdom, BL9 7TD
- The Pennine Acute Hospitals NHS Trust
-
Cambridge, United Kingdom, CB20QQ
- Cambridge University Hospitals NHS Foundation Trust
-
Edinburgh, United Kingdom, EH4 2XU
- NHS Lothian
-
Exeter, United Kingdom, EX2 5DW
- Royal Devon and Exeter NHS Foundation Trust
-
Glasgow, United Kingdom, G51 4TF
- Glasgow Clinical Research Facility - Queen Elizabeth University Hospital
-
Glasgow, United Kingdom, G52 3NQ
- NHS Greater Glasgow and Clyde
-
High Wycombe, United Kingdom, HP11 2TT
- Wycombe Hospital
-
London, United Kingdom, W2 1NY
- Imperial College Healthcare NHS Trust, St Mary's Hospital
-
London, United Kingdom, SW17 0QT
- St George's University Hospitals NHS Foundation Trust
-
Oxford, United Kingdom, OX3 9DU
- Oxford University Hospitals NHS Trust
-
Prescot, United Kingdom, L35 5DR
- St Helens and Knowsley Teaching Hospitals NHS Trust
-
Southampton, United Kingdom, SO16 6YD
- Southampton National Institute for Health Research, Wellcome Trust Clinical Research Facility
-
-
Norfolk
-
Norwich, Norfolk, United Kingdom, NR4 7UY
- Norfolk and Norwich University Hospital NHS Foundation Trust
-
-
-
-
Alabama
-
Dothan, Alabama, United States, 36305
- Digestive Health Specialists Of The Southeast
-
-
Arizona
-
Sun City, Arizona, United States, 85351
- Arizona Digestive Health - Sun City
-
-
California
-
Coronado, California, United States, 92118
- Southern California Research Center, Inc.
-
Los Angeles, California, United States, 90048
- Cedars Sinai Medical Center
-
Rialto, California, United States, 92377
- Inland Empire Clinical Trials, LLC
-
San Diego, California, United States, 92093
- UC San Diego Health Systems
-
San Francisco, California, United States, 94118
- Kaiser Permanente
-
Santa Clarita, California, United States, 91351
- Clearview Medical Research, LLC
-
-
Colorado
-
Aurora, Colorado, United States, 80045
- University of Colorado Denver and Hospital
-
Lone Tree, Colorado, United States, 80124
- South Denver Gastroenterology, PC
-
-
Connecticut
-
Farmington, Connecticut, United States, 06032
- Connecticut GI, PC - Research Division
-
-
District of Columbia
-
Washington, District of Columbia, United States, 20007
- MedStar Georgetown University Hospital
-
-
Florida
-
Coral Springs, Florida, United States, 33067
- Advanced Research, LLC
-
Gainesville, Florida, United States, 32610
- UF Clinical Research Center
-
Lakewood Ranch, Florida, United States, 34211
- Florida Research Institute
-
Largo, Florida, United States, 33777
- Florida Center for Gastroenterology
-
Miami, Florida, United States, 33147
- Advanced Pharma Cr, Llc
-
Miami, Florida, United States, 33136
- University of Miami Crohn's and Colitis Center
-
Miami, Florida, United States, 33155
- Cordova Research Institute
-
Miami, Florida, United States, 33176
- Vista Health Research, LLC
-
Naples, Florida, United States, 34102
- Gastroenterology Group of Naples
-
Orlando, Florida, United States, 32803
- Center for Interventional Endoscopy - Florida Hospital
-
Pensacola, Florida, United States, 32514
- Gulf Region Clinical Research Institute
-
Port Orange, Florida, United States, 32127
- Advanced Medical Research Center
-
Tampa, Florida, United States, 33606
- Tampa General Hospital
-
Zephyrhills, Florida, United States, 33540
- Florida Medical Clinic, P.A
-
-
Georgia
-
Macon, Georgia, United States, 31201
- Gastroenterology Associates Of Central Georgia, LLC
-
Marietta, Georgia, United States, 30060
- Gastrointestinal Specialists of Georgia
-
Suwanee, Georgia, United States, 30024
- Atlanta Gastroenterology Specialist, PC
-
-
Illinois
-
Arlington Heights, Illinois, United States, 60005
- Illinois Gastroenterology Group - Arlington Heights
-
Chicago, Illinois, United States, 60611
- Northwestern University Feinberg School of Medicine
-
Chicago, Illinois, United States, 60637
- The University of Chicago Medical Center (Clinic)
-
Gurnee, Illinois, United States, 60031
- Illinois Gastroenterology Group - Gurnee
-
-
Indiana
-
Indianapolis, Indiana, United States, 46202
- Indiana University
-
-
Iowa
-
Iowa City, Iowa, United States, 52242
- University of Iowa Hospitals and Clinics
-
-
Kansas
-
Kansas City, Kansas, United States, 66160
- University of Kansas Medical Center
-
-
Kentucky
-
Louisville, Kentucky, United States, 40202
- University of Louisville, Clinical Trials Unit
-
-
Louisiana
-
Monroe, Louisiana, United States, 71201
- Delta Research Partners, LLC
-
Shreveport, Louisiana, United States, 71105
- Louisiana Research Center, LLC
-
-
Maryland
-
Annapolis, Maryland, United States, 21401
- Investigative Clinical Research
-
Baltimore, Maryland, United States, 21201
- University of Maryland Medical Center
-
Chevy Chase, Maryland, United States, 20815
- MGG Group Co., Inc., Chevy Chase Clinical Research
-
Columbia, Maryland, United States, 21045
- Gastro Center of Maryland
-
Hagerstown, Maryland, United States, 21742
- Meritus Center for Clinical Research
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02114
- Massachusetts General Hospital - Crohn's and Colitis Center
-
-
Michigan
-
Chesterfield, Michigan, United States, 48047
- Clinical Research Institute of Michigan, LLC
-
Grand Rapids, Michigan, United States, 49546
- Spectrum Health Butterworth Hospital
-
Wyoming, Michigan, United States, 49519
- Gastroenterology Associates of Western Michigan, PLC d.b.a. West Michigan Clinical Research Center
-
-
Minnesota
-
Rochester, Minnesota, United States, 55902
- Mayo Clinic
-
-
Mississippi
-
Jackson, Mississippi, United States, 39216
- University of Mississippi Medical Center
-
-
Missouri
-
Kansas City, Missouri, United States, 64131
- Kansas City Research Institute
-
Saint Louis, Missouri, United States, 63110
- Washington University School of Medicine
-
-
Nevada
-
Las Vegas, Nevada, United States, 89113
- Las Vegas Medical Research
-
-
New Jersey
-
Egg Harbor Township, New Jersey, United States, 08234
- AGA Clinical Research Associates, LLC
-
-
New York
-
Brooklyn, New York, United States, 11235
- NY Scientific
-
Great Neck, New York, United States, 11021
- NYU Langone Long Island Clinical Research Associates
-
New York, New York, United States, 10029
- Icahn School of Medicine at Mount Sinai
-
New York, New York, United States, 10028
- Lenox Hill Hospital
-
New York, New York, United States, 10016
- New York University School of Medicine / NYU Gastroenterology Associates
-
Poughkeepsie, New York, United States, 12601
- Premier Medical Group of the Hudson Valley
-
-
North Carolina
-
Charlotte, North Carolina, United States, 28207
- Charlotte Gastroenterology & Hepatology, PLLC
-
Raleigh, North Carolina, United States, 27607
- Carolina's GI Research LLC
-
-
North Dakota
-
Fargo, North Dakota, United States, 58103
- Fargo Gastroenterology and Hepatology Clinic
-
-
Ohio
-
Cincinnati, Ohio, United States, 45219
- Consultants for Clinical Research
-
Cincinnati, Ohio, United States, 45219
- UC Health Physicians Clifton
-
Mentor, Ohio, United States, 44060
- Great Lakes Gastroenterology Research, LLC
-
Middleburg Heights, Ohio, United States, 44130
- Paramount Medical Research & Consulting, LLC
-
-
Oklahoma
-
Tulsa, Oklahoma, United States, 74104
- Options Health Research LLC
-
-
Pennsylvania
-
Harrisburg, Pennsylvania, United States, 17110
- Great Lakes Medical Research, LLC
-
-
South Carolina
-
Orangeburg, South Carolina, United States, 29118
- Gastroenterology Associates of Orangeburg
-
-
Tennessee
-
Chattanooga, Tennessee, United States, 37421
- WR-ClinSearch, LLC
-
Germantown, Tennessee, United States, 38138
- Gastro One
-
Nashville, Tennessee, United States, 37211
- Quality Medical Research
-
Nashville, Tennessee, United States, 37212
- Vanderbilt University Medical Center - IBD Clinic
-
-
Texas
-
Arlington, Texas, United States, 76012
- Texas Clinical Research Institute
-
Austin, Texas, United States, 78757
- Pinnacle Clinical Research
-
Baytown, Texas, United States, 77521
- Inquest Clinical Research
-
Fort Sam Houston, Texas, United States, 78219
- San Antonio Military Medical Center,
-
Garland, Texas, United States, 75044
- DHAT Research Institute
-
Houston, Texas, United States, 77030
- The Methodist Hospital
-
Houston, Texas, United States, 77030
- The University of Texas Health Science Center at Houston
-
Houston, Texas, United States, 77025
- Kelsey-Seybold Clinic
-
Houston, Texas, United States, 77058
- Centex Studies, Inc.
-
Houston, Texas, United States, 77098
- Gulf Coast Research Group
-
Houston, Texas, United States, 77030
- Baylor College of Medicine - McNair Campus
-
San Antonio, Texas, United States, 78212
- Clinical Associates in Research Therapeutics of America, LLC
-
San Antonio, Texas, United States, 78229
- Pinnacle Clinical Research
-
San Antonio, Texas, United States, 78229
- Gastroenterology Research of San Antonio
-
San Marcos, Texas, United States, 78666
- TDDC San Marcos
-
Southlake, Texas, United States, 76092
- Texas Digestive Disease Consultants
-
The Woodlands, Texas, United States, 77380
- Spring Gastroenterology
-
Tyler, Texas, United States, 75701
- Tyler Research Institute, LLC
-
-
Utah
-
Bountiful, Utah, United States, 84010
- HP Clinical Research
-
-
Virginia
-
Charlottesville, Virginia, United States, 22908
- University of Virginia Health System
-
Charlottesville, Virginia, United States, 22911
- Charlottesville Medical Research Center, LLC
-
Chesapeake, Virginia, United States, 23320
- Gastroenterology Associates of Tidewater
-
Richmond, Virginia, United States, 23249
- McGuire DVAMC
-
Richmond, Virginia, United States, 23298
- Virginia Commonwealth University
-
-
Wisconsin
-
Madison, Wisconsin, United States, 53705
- University of Wisconsin Hospital & Clinics
-
Milwaukee, Wisconsin, United States, 53215
- Wisconsin Center for Advanced Research, a division of GI Associates, LLC
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Key Inclusion Criteria:
- Must have the ability to understand and sign a written informed consent form (ICF), which must be obtained prior to initiation of study procedures associated with this trial
- Must have enrolled in a CD parent protocol, GS-US-419-4015, GS-US-419-4016 or GS-US-419-3895 or any other Gilead/Galapagos sponsored filgotinib treatment study for CD
- Females of childbearing potential must have a negative pregnancy test at Day 1 and must agree to continued monthly pregnancy testing during use of filgotinib treatment
- Female participants of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception for the duration described in the protocol
- Willingness to refrain from live or attenuated vaccines during the study and for 12 weeks after last dose of study drug
- Must have completed all required procedures or met protocol specified efficacy discontinuation criteria in a prior filgotinib treatment study for CD
Key Exclusion Criteria:
- Known hypersensitivity to the study drug
- Any chronic medical condition (including, but not limited to, cardiac or pulmonary disease, alcohol or drug abuse) that, in the opinion of the Investigator or sponsor, would make the individual unsuitable for the study or would prevent compliance with the study protocol
- Females of reproductive potential who are unwilling to abide by protocol-specified contraceptive methods as defined in the protocol
- Use of prohibited concomitant medications as outlined in the study protocol
NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Filgotinib 200 mg
Participants who received filgotinib 200 milligrams (mg) blinded and completed the parent study, continued to receive filgotinib 200 mg blinded in this study. After unblinding of the parent study, participants continued open-label on filgotinib 200 mg. Participants who exited the parent study due to disease worsening or failure to meet response or remission criteria, with the exception of US and Korean males who were not considered dual-biologic refractory, received filgotinib 200 mg open-label in this study. Treatment was administered orally once a day until filgotinib becomes commercially available or until the early termination (up to 308 weeks). |
Tablet administered orally once a day
Other Names:
|
|
Experimental: Filgotinib 100 mg
Participants who received filgotinib 100 mg blinded and completed the parent study, continued to receive filgotinib 100 mg blinded in this study. After unblinding of the parent study, participants continued open-label on filgotinib 100 mg. Male participants from the US & Korea who were not considered dual biologic refractory, and who exited the parent study due to disease worsening or failure to meet response or remission criteria, received filgotinib 100 mg open-label in this study. Treatment was administered orally once a day until filgotinib becomes commercially available or until the early termination (up to 308 weeks). |
Tablet administered orally once a day
Other Names:
|
|
Placebo Comparator: Placebo
Participants who received placebo and completed the parent study, continued to receive placebo in this extension study. After unblinding of the parent study, participants on placebo treatment discontinued study drug and study participation. Treatment was administered orally once a day until unblinding of the parent study (up to 308 weeks). |
Tablet administered orally once a day
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Time Frame: From the First Dose to Week 312
|
An AE was defined as any untoward medical occurrence in a participant administered a study drug, and which did not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study drug whether or not considered related to the study drug. Treatment-emergent adverse events (TEAEs) were defined as 1 or both of the following:
|
From the First Dose to Week 312
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change From Baseline in Patient Reported Outcomes 2 (PRO2) Scores for Liquid or Very Soft Stools
Time Frame: Baseline, Week 12, Week 24, Week 48, Week 96, Week 156, Week 216, Week 264, and Week 300
|
The PRO2 was a composite score based on 2 components of CDAI, the number of liquid or soft stools/day for 7 days, stool frequency and abdominal pain (rated on a scale of 0-3, higher values mean greater abdominal pain) assessed for 7 days.
The CDAI system was a composite index of 8 disease activity variables: severity of abdominal pain, general well-being, very soft/liquid stool frequency, extra-intestinal symptoms, need for antidiarrheal drugs, presence of abdominal mass, body weight and hematocrit.
Participants reported information regarding symptoms using a diary.
The sub scores of abdominal pain (0-3), general well-being (0-4, higher values mean worse well-being), and number of liquid or very soft stools were summed over the 7 days prior to each visit.
The remaining predictors were also weighted to create the total CDAI score which ranged from 0-600 with a higher score indicating a worse outcome.
Change from baseline for number of liquid or very soft stool per day was reported.
|
Baseline, Week 12, Week 24, Week 48, Week 96, Week 156, Week 216, Week 264, and Week 300
|
|
Change From Baseline in Patient Reported Outcomes (PRO2) Scores for Abdominal Pain
Time Frame: Baseline, Week 12, Week 24, Week 48, Week 96, Week 156, Week 216, Week 264, and Week 300
|
The PRO2 was a composite score based on 2 components of CDAI, the number of liquid or soft stools/day for 7 days, stool frequency and abdominal pain (rated on a scale of 0-3, higher values mean greater abdominal pain) assessed for 7 days.
The CDAI system was a composite index of 8 disease activity variables: severity of abdominal pain, general well-being, very soft/liquid stool frequency, extra-intestinal symptoms, need for antidiarrheal drugs, presence of an abdominal mass, body weight and hematocrit.
Participants reported information regarding symptoms using a diary.
The sub scores of abdominal pain (0-3), general well-being (0-4, higher values mean worse well-being), and number of very soft or liquid stools were then summed over the 7 days prior to each visit.
Additionally, the remaining predictors were also noted and weighted to create the total CDAI score which ranged from 0-600 with a higher score indicating a worse outcome.
Change from baseline in abdominal pain was reported.
|
Baseline, Week 12, Week 24, Week 48, Week 96, Week 156, Week 216, Week 264, and Week 300
|
|
Change From Baseline in CDAI Scores
Time Frame: Baseline, Week 12, Week 24, Week 48, Week 96, Week 156, Week 216, Week 264, and Week 300
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The CDAI system was a composite index of 8 disease activity variables: severity of abdominal pain, general well-being, very soft/liquid stool frequency, extra-intestinal symptoms, need for antidiarrheal drugs, presence of an abdominal mass, body weight and hematocrit.
Participants reported information regarding symptoms using a diary.
The sub scores of abdominal pain (rated on a scale of 0-3, higher values mean greater abdominal pain), general well-being (0-4, higher values mean worse well-being), and number of very soft or liquid stools were then summed over the 7 days prior to each visit.
Additionally, the remaining predictors were also noted and weighted to create the total CDAI score which ranged from 0-600 with a higher score indicating a worse outcome.
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Baseline, Week 12, Week 24, Week 48, Week 96, Week 156, Week 216, Week 264, and Week 300
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Director: Galapagos Study Director, Galapagos NV
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 17, 2017
Primary Completion (Actual)
August 1, 2023
Study Completion (Actual)
August 1, 2023
Study Registration Dates
First Submitted
September 22, 2016
First Submitted That Met QC Criteria
September 22, 2016
First Posted (Estimated)
September 26, 2016
Study Record Updates
Last Update Posted (Actual)
July 10, 2024
Last Update Submitted That Met QC Criteria
July 4, 2024
Last Verified
May 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- GS-US-419-3896
- 2016-002763-34 (EudraCT Number)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.