Filgotinib in Long-Term Extension Study of Adults With Crohn's Disease (DIVERSITYLTE)

August 10, 2023 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

  • Argentina
      • Rosario, Argentina, S2000DEF
        • Fundacion Estudios Clinicos CiRec
  • Australia
    • New South Wales
      • Camperdown, New South Wales, Australia, 2050
        • Royal Prince Alfred Hospital
      • Darlinghurst, New South Wales, Australia, 2010
        • St. Vincent's Hospital Sydney
      • Kingswood, New South Wales, Australia, 2747
        • Nepean Hospital
      • Wollongong, New South Wales, Australia, 2500
        • Wollongong Hospital
    • Queensland
      • Mountain Creek, Queensland, Australia, 4557
        • Coastal Digestive Health
      • North Mackay, Queensland, Australia, 4740
        • Coral Sea Clinical Research Institute (Mackay)
      • South Brisbane, Queensland, Australia, 4101
        • Mater Misericordiae Ltd
      • Woolloongabba, Queensland, Australia, 4102
        • Princess Alexandra Hospital
    • South Australia
      • Woodville South, South Australia, Australia, 5011
        • The Queen Elizabeth Hospital
    • Victoria
      • Camberwell, Victoria, Australia, 3124
        • Emeritus Research
      • Clayton, Victoria, Australia, 3168
        • Monash Medical Centre
      • Footscray, Victoria, Australia, 3011
        • Footscray Hospital
      • Heidelberg, Victoria, Australia, 3084
        • Austin Health
      • Malvern, Victoria, Australia, 3144
        • Cabrini Hospital
      • Melbourne, Victoria, Australia, 3004
        • Alfred Hospital
      • Parkville, Victoria, Australia, 3050
        • Royal Melbourne Hospital
  • Austria
      • Innsbruck, Austria, 6020
        • Universitätsklinik Innsbruck
      • Klagenfurt am Wörthersee, Austria, 9020
        • Klinikum Klagenfurt am Wörthersee, Abt. Für Inn. Med. & Gastroenterol, (IMuG), Hepatol., Endokrinol., Rheumatol., & Nephrol.
      • Wien, Austria, 1090
        • AKH-Medizinische Universitat Wien
  • Belgium
      • Antwerpen, Belgium, 2018
        • GZA Ziekenhuizen, campus Sint-Vincentius
      • Bonheiden, Belgium, 2820
        • Imelda General Hospital
      • Brussel, Belgium, 1070
        • CUB Hôpital Erasme
      • Edegem, Belgium, 2650
        • Universitair Ziekenhuis Antwerpen
      • Gent, Belgium, 9000
        • Universitair Ziekenhuis Gent
      • Leuven, Belgium, 3000
        • Universitair Ziekenhuis Leuven
      • Liege, Belgium, 4000
        • CHR Citadelle
      • Liège, Belgium, 4000
        • Centre Hospitalier Chretien (CHC) - Clinique Saint-Joseph
      • Roeselare, Belgium, 8800
        • AZ Delta
  • Bulgaria
      • Samokov, Bulgaria, 2000
        • Medical Center - Complete Medical Solutions OOD
      • Sliven, Bulgaria, 8800
        • Medical Center - "Tsaritsa Yoanna" EOOD
      • Veliko Tarnovo, Bulgaria, 5000
        • "MDHAT Dr. St.Cherkezov" AD
      • Vidin, Bulgaria, 3700
        • MHAT "Sveta Petka" AD
  • Canada
      • Barrie, Canada, L4M 7G1
        • Barrie GI Associates
      • Calgary, Canada, T2N 4Z6
        • University of Calgary, Heritage Medical Research Clinic
      • Hamilton, Canada, L8S 4K1
        • Hamilton Health Sciences Corporation, McMaster University Medical Centre
      • London, Canada, N6A 5A5
        • London Health Sciences Centre - University Hospital
      • North York, Canada, M6A 3B4
        • TIDHI Innovation, Inc.
      • Oakville, Canada, L6L 5L7
        • ABP Research Services
      • Saskatoon, Canada, S7N 0W8
        • Royal University Hospital
      • Toronto, Canada, M5T 3L9
        • Mount Sinai Hospital
      • Vancouver, Canada, V5Z 1M9
        • The Gordon and Leslie Diamond Health Care Centre
      • Vaughan, Canada, L4L 4Y7
        • Toronto Digestive Disease Associates Inc.
      • Victoria, Canada, V8V 3P9
        • PerCuro Clinical Research Ltd.
  • Croatia
      • Osijek, Croatia, 31 000
        • University Hospital Center Osijek
      • Zagreb, Croatia, 10000
        • University Hospital Center Zagreb
      • Zagreb, Croatia, 10000
        • Clinical Hospital Dubrava
  • Czechia
      • Hradec Kralove, Czechia, 500 12
        • Hepato-Gastroenterology HK, s.r.o.
      • Mlada Boleslav, Czechia, 293 01
        • Oblastni nemocnice Mlada Boleslav, a.s., nemocnice Stredoceskeho kraje, Gastroenterologicke oddeleni
      • Praha 3, Czechia, 130 00
        • G.E.P. Clinic, s r.o.
      • Praha 4, Czechia, 140 00
        • Thomayerova nemocnice, Interni klinika 3. LF UK a TN
      • Praha 9, Czechia, 190 00
        • ISCARE a.s. (Klinicke centrum ISCARE), Klinicke a vyzkumne centrum pro strevni zancty
  • France
      • Amiens Cedex 1, France, 80054
        • CHU Amiens Picardie
      • Caen Cedex 9, France, 14033
        • CHU de Caen
      • Clermont-Ferrand, France, 63003
        • CHU de Clermont-Ferrand - Hôpital d'Estaing
      • Clichy, France, 92110
        • APHP - Hopital Beaujon - Clichy - Universite Paris VII
      • Créteil Cedex, France, 94010
        • Centre hospitalier intercommunal de Créteil
      • Dijon, France, 21079
        • CHU de Dijon Bourgogne - Hopital Francois Mitterand
      • La Tronche, France, 38700
        • Chu Grenoble Alpes
      • Le Kremlin Bicetre, France, 94270
        • Hopital Universitaire de Bicetre
      • Lille, France, 59000
        • Centre Hospitalier Régional Universitaire de Lille
      • Marseille, France, 13015
        • Hopital Nord
      • Marseille, France, 13285
        • Hopital Saint Joseph
      • Montpellier, France, 34295
        • CHU de Montpellier-Hopital Saint Eloi
      • Nantes, France, 44093
        • CHU Hôtel-Dieu
      • Nice, France, 06202
        • Hopital de l'archet 2
      • Pessac, France, 33600
        • CHU de Bordeaux - Hôpital Haut Leveque
      • Pierre-Benite, France, 69495
        • Centre Hospitalier Universitaire de Lyon Sud
      • Pringy Cedex, France, 74374
        • CH Annecy Genevois - Site d'Annecy
      • Rennes Cedex 9, France, 35033
        • Centre Hospitalier Universitaire de Rennes - Hopital Pontchaillou
      • Saint Priest en Jarez, France, 42055
        • CHU de Saint Etienne - Hôpital Nord
      • Strasbourg, France, 67091
        • Nouvel Hopital Civil
      • Strasbourg, France, 67098
        • Hôpitaux Universitaires de Strasbourg - Hôpital de Hautepierre
      • Toulouse, France, 31059
        • CHU de Toulouse - Hôpital Rangueil
      • Toulouse Cedex 9, France, 31059
        • CHU de Toulouse - Hôpital Rangueil
      • Vandoeuvre-les-Nancy Cedex, France, 54511
        • CHU de Nancy - Hopital Brabois Adultes
  • Georgia
      • Batumi, Georgia, 6010
        • Unimed Ajara LLC - Batumi Referral Hospital
      • Tbilisi, Georgia, 0160
        • Medi Club Georgia LLC
      • Telavi, Georgia, 2200
        • Ltd. Unimed Kakheti - Telavi Referral Hospital
  • Germany
      • Berlin, Germany, 13353
        • Charité - Universitätsmedizin Berlin
      • Berlin, Germany, 10117
        • Charite Universitaetsmedizin Berlin
      • Berlin, Germany, 14050
        • DRK Kliniken Berlin - Westend - Klinik fuer Innere Medizin
      • Berlin, Germany, 10825
        • Medizinisches Versorgungszentrum Delitzsch
      • Braunschweig, Germany, 38126
        • Städtisches Klinikum Braunschweig gGmbH
      • Dresden, Germany, 01307
        • Universitätsklinikum Dresden
      • Frankfurt am Main, Germany, 60431
        • Agaplesion Markus Krankenhaus
      • Frankfurt am Main, Germany, 60594
        • CED Studien UG, Interdisciplinary Crohn Colitis Center (iCCC)
      • Freiburg, Germany, 79106
        • Universitätsklinikum Freiburg
      • Hamburg, Germany, 22559
        • Asklepios Westklinikum Hamburg
      • Hannover, Germany, 30625
        • Medizinische Hochschule Hannover
      • Heidelberg, Germany, 69120
        • Universitätsklinikum Heidelberg
      • Heidelberg, Germany, 69121
        • Praxis fur Gastroenterologie
      • Herne, Germany, 44623
        • Gastroenterologische Gemeinschaftspraxis Herne
      • Jena, Germany, 07747
        • Universitätsklinikum Jena
      • Kiel, Germany, 24105
        • Universitätsklinikum Schleswig-Holstein
      • Koln, Germany, 50937
        • Universitaetsklinik Koln
      • Leipzig, Germany, 04103
        • Universitatsklinikum Leipzig
      • Leipzig, Germany, 04103
        • Eugastro GmbH
      • Lüneburg, Germany, 21339
        • Klinikum Luneburg
      • Minden, Germany, 32423
        • Gastroenterologische Gemeinschaftspraxis Minden
      • Muenchen, Germany, 81377
        • Klinikum der Universität München - Großhadern
      • Rostock, Germany, 18057
        • Universitaetsmedizin Rostock, Zentrum fuer Innere Medizin
      • Tuebingen, Germany, 72074
        • Universitaetsklinikum Tuebingen
      • Ulm, Germany, 89081
        • Universitatsklinikum Ulm, Zentrum Fur Innere Medizin
  • Greece
      • Athens, Greece, 12462
        • University General Hospital "Attikon", 2nd Propaedeutic Internal Medicine Dept. and Research Unit, Hepatogastroenterology Unit
      • Athens, Greece, 11527
        • Hippokration Hospital of Athens
      • Ioannina, Greece, 45332
        • University General Hospital of Ioannina, Gastroenterology Department, Internal Medicine Division
      • Patra, Greece, 26504
        • University General Hospital of Patras "Panagia I Voithia", Gastroenterology Department, Internal Medicine Division
      • Thessaloniki, Greece, 54642
        • Hippokratio General Hospital of Thessaloniki "Hippokratio" 4th Internal Medicine Department of Aristotle University of Thessaloniki
  • Hong Kong
      • Hong Kong, Hong Kong
        • Queen Mary Hospital
      • Hong Kong, Hong Kong
        • Princess Margaret Hospital
      • Shatin, Hong Kong
        • Department of Medicine & Therapeutics, The Chinese University of Hong Kong, Prince of Wales Hospital
      • Tuen Mun, Hong Kong
        • Tuen Mun Hospital
  • Hungary
      • Bekescsaba, Hungary, 5600
        • Bekes Megyei Kosponti Korhaz, Dr. Rethy Pal Tagkorhaz, IV. Belgyogyaszat - 2. Gasztroenterologia
      • Budapest, Hungary, 1032
        • Szent Margit Korhaz, Gasztroenterológiai Osztály
      • Budapest, Hungary, 1033
        • Clinexpert Egeszsegugyi Szolgaltato Es Kereskedelmi Kft.
      • Budapest, Hungary, 1097
        • Del-pesti Centrumkorhaz - Orszagos Hematologiai es Infektologiai Intezet, Kozponti Felnott Szakrendelo
      • Budapest, Hungary, 1125
        • Szent Janos Korhaz es Eszak-budai Egitett Korhazak, I. Belgyogyaszati - Gasztroenterologiai Osztaly
      • Debrecen, Hungary, 4032
        • Debreceni Egyetem Klinikai Kozpont, II. sz. Belgyogyaszati Klinika, Gasztroenterologia
      • Gyöngyös, Hungary, 3200
        • Bugat Pal Korhaz, Belgyogyaszat
      • Mosonmagyarovar, Hungary, 9200
        • Karolina Korhaz es Rendelointezet, Altalanos Belgyogyaszat-Gasztroenterologia
  • Iceland
      • Reykjavik, Iceland, 101
        • Landspitali University Hospital
  • India
      • Ahmedabad, India, 380052
        • Kaizen Hospital
      • Bangalore, India, 560054
        • M S Ramaiah Medical College and Hospital
      • Bangalore, India, 560002
        • Victoria Hospital, Bangalore Medical College and Research Institute (BMCRI)
      • Chennai, India, 600035
        • Apollo Speciality Hospital
      • Coimbatore, India, 641005
        • VGM Hospital Institute of Gastroenterology
      • Ernakulam, India, 682012
        • Lourdes Hospital
      • Gurgaon, India, 122002
        • Fortis Memorial Research Institute
      • Hyderabad, India, 500004
        • Gleneagles Global Hospital
      • Hyderabad, India, 500019
        • Citizens Specialty Hospital
      • Hyderabad, India, 500058
        • Centre for Liver Research & Diagnostics
      • Jaipur, India, 302001
        • SR Kalla Memorial Gastro And General Hospital
      • Jaipur, India, 302004
        • S.M.S Hospital
      • Kolkata, India, 700020
        • School of Digestive & Liver Diseases
      • Lucknow, India, 226003
        • King George's Medical University
      • Ludhiana, India, 141001
        • Dayanand Medical College & Hospital
      • Mangaluru, India, 575001
        • Kasturba Medical College (KMC) Hospital
      • Mumbai, India, 400022
        • Lokmanya Tilak Municipal General Hospital
      • Mumbai, India, 400012
        • Seth G.S. Medical College & KEM Hospital
      • Mumbai, India, 400016
        • S.L. Raheja Hospital (A Fortis Associate)
      • Nagpur, India, 440010
        • Midas Multispeciality Hospital Pvt. Ltd
      • Nagpur, India, 440012
        • Suretech Hospital & Research Centre Ltd
      • New Delhi, India, 110029
        • All India Institute of medical Sciences
      • Pune, India, 411001
        • Department of Surgery, B.J. Government Medical College & Sassoon General Hospital
      • Pune, India, 411001
        • Grant Medical Foundation Ruby Hall Clinic
      • Pune, India, 411011
        • Universal Hospital
      • Rajkot, India, 360002
        • Shree Giriraj Multispeciality Hospital
      • Secunderabad, India, 500003
        • Gandhi Hospital
      • Secunderabad, India, 500003
        • Institute of Gastroenterology & Liver Disease. Sunshine Hospitals
      • Surat, India, 395002
        • Surat Institute of Digestive Sciences
      • Udupi, India, 576104
        • Kasturba Hospital Medical College
      • Vadodara, India, 390007
        • Sterling Hospital
      • Varanasi, India, 221005
        • Samvedna Hospital
    • Kerala
      • Kochi, Kerala, India, 682040
        • Lakeshore Hospital and Research Centre Ltd
  • Ireland
      • Dublin, Ireland, 9
        • Beaumont Hospital
      • Dublin, Ireland, 4
        • St. Vincent'S University Hospital
      • Dublin, Ireland, DUBLIN 8
        • Wellcome Trust HRB Clinical Research Facility
      • Galway, Ireland, H91 YR71
        • University Hospital Galway
  • Israel
      • Afula, Israel, 18101
        • Emek Medical Center
      • Beer-Sheva, Israel, 8410101
        • Soroka Medical Center
      • Haifa, Israel, 31048
        • Bnai Zion Medical Center
      • Haifa, Israel, 3109601
        • Rambam Medical Health Care Campus
      • Holon, Israel, 5822012
        • The Edith Wolfson Medical Center
      • Jerusalem, Israel, 9103102
        • Shaare Zedek Medical Center
      • Jerusalem, Israel, 9112001
        • Hadassah Medical Center
      • Kefar Sava, Israel, 4428164
        • Meir MC
      • Petah Tikva, Israel, 4941492
        • Rabin Medical Center
      • Ramat Gan, Israel, 5265601
        • The Chaim Sheba Medical Center
      • Tel Aviv-Yafo, Israel, 64239
        • Tel Aviv Sourasky Medical Center
  • Italy
      • Castellana Grotte, Italy, 70013
        • UOC Gastroenterologia II
      • Catanzaro, Italy, 88100
        • U.O. Fisiopatologia Digestiva
      • Cento, Italy, 44042
        • UOC Medicina Interna
      • Chieti, Italy, 66100
        • Ospedale Clinicizzato SS. Annunziata - Dipartimento di Medicina
      • Firenze, Italy, 50134
        • Gastroenterologia clinica - Azienda Ospedaliero-Universitaria Careggi
      • Milano, Italy, 20121
        • Endocsopia Digestiva Centralizzata
      • Modena, Italy, 40124
        • UO Gastroenterologia
      • Padova, Italy, 35128
        • UOC Gastroenterologia
      • Pisa, Italy, 56124
        • Azienda Ospedaliero-Universitaria Pisana - Presidio Ospedaliero Cisanello
      • Roma, Italy, 00133
        • UOC di Gastroenterologia ed Endoscopia Digestiva
      • Roma, Italy, 00128
        • UOC Gastroenterologia ed Endoscopia Digestiva
      • Roma, Italy, 00168
        • UOC Medicina Interna a Gastroenterologia
      • Rozzano, Italy, 20089
        • Istituto Clinico Humanitas
      • Torino, Italy, 10122
        • A.S.O. Ordine Mauriziano Di Torino S.C.
  • Japan
      • Ageo-shi, Japan, 362-0075
        • Ohmori Toshihide gastro-intestinal Clinic
      • Bunkyo-ku, Japan, 113-8519
        • Tokyo Medical And Dental University Hospital
      • Chuo-ku, Japan, 060-0033
        • Hokkaido P.W.F.A.C Sapporo-Kosei General Hospital
      • Fukuoka-shi, Japan, 815-8555
        • Japanese Red Cross Fukuoka Hospital
      • Hachioji, Japan, 192-0032
        • Tokai university hachioji hospital
      • Hiroshima-shi, Japan, 734-8530
        • Hiroshima Prefectural Hospital
      • Jonan-ku, Japan, 814-0180
        • Fukuoka University Hospital
      • Kawagoe, Japan, 350-8550
        • Saitama Medical Center, Saitama Medical University
      • Kitakyushu-shi, Japan, 802-0077
        • Kitakyushu City Hospital Organization Kitakyushu Municipal Medical Center
      • Kofu-shi, Japan, 400-8506
        • Yamanashi Prefectural Central Hospital
      • Kurume-shi, Japan, 839-0809
        • Hidaka Coloproctology Clinic
      • Kurume-shi, Japan, 830-0011
        • Kurume University Hospital
      • Kyoto-shi, Japan, 602-8566
        • University Hospital, Kyoto Prefectural University of Medicine
      • Minato-ku, Japan, 108-8642
        • Kitasato University Kitasato Institute Hospital
      • Minato-ku, Japan, 105-8471
        • The Jikei University Hospital
      • Mitaka-shi, Japan, 181-8611
        • Kyorin University Hospital
      • Morioka-shi, Japan, 020-8505
        • Iwate Medical University Hospital
      • Nagakute-shi, Japan, 480-1195
        • Aichi Medical University Hospital
      • Nagasaki-shi, Japan, 8528501
        • Nagasaki University Hospital
      • Nagoya, Japan, 467-8602
        • Nagoya City University Hospital
      • Nishi-ku, Japan, 950-1104
        • Saiseikai Niigata Daini Hospital
      • Nishinomiya, Japan, 663-8501
        • Hyogo College of Medicine College Hospital
      • Oita-shi, Japan, 870-0823
        • Ishida IBD Clinic
      • Okayama-city, Japan, 700-8558
        • Okayama University Hospital
      • Osaka, Japan, 545-8586
        • Osaka City University Hospital
      • Osaka, Japan, 579-8056
        • Wakakusa-Daiichi Hospital
      • Osaka-City, Japan, 530-0011
        • Kinshukai Infusion Clinic
      • Otsu, Japan, 520-2192
        • Shiga University of Medical Science Hospital
      • Saga, Japan, 849-8501
        • Saga University Hospital
      • Saga-shi, Japan, 840-8571
        • Saga-ken Medical Centre Koseikan
      • Saitama, Japan, 336-0963
        • Tokito Clinic
      • Sakura, Japan, 285-8741
        • Toho University Sakura Medical Center
      • Sapporo-shi, Japan, 065-0033
        • Sapporo Higashi Tokushukai Hospital
      • Sendai, Japan, 983-8520
        • National Hospital Organization Sendai Medical Center
      • Suita, Japan, 565-0871
        • Osaka University Hospital
      • Takamatsu-shi, Japan, 760-8557
        • Kagawa Prefectural Central Hospital
      • Takasaki-shi, Japan, 3700829
        • National Hospital Organization Takasaki General Medical Center
      • Toyota-shi, Japan, 470-1219
        • Ieda Hospital
      • Wakayama-shi, Japan, 641-8509
        • Wakayama Medical University Hospital
      • Yokohama-shi, Japan, 231-0012
        • Yokohama Health Medicine Association Kannai Suzuki Clinic
  • Korea, Republic of
      • Busan, Korea, Republic of, 49241
        • Pusan National University Hospital
      • Daegu, Korea, Republic of, 42415
        • Yeungnam University Hospital
      • Guri-Si, Korea, Republic of, 471-701
        • Kyung Hee University Hospital
      • Gyeonggi-do, Korea, Republic of, 11923
        • Hanyang University Guri Hospital
      • Seongnam-si, Korea, Republic of, 463-712
        • CHA Bundang Medical Center, CHA University
      • Seoul, Korea, Republic of, 03080
        • Seoul National University Hospital
      • Seoul, Korea, Republic of, 05505
        • Asan Medical Center
      • Seoul, Korea, Republic of, 03181
        • Kangbuk Samsung Hospital
      • Seoul, Korea, Republic of, 03722
        • Yonsei University Health System, Severance Hospital
      • Seoul, Korea, Republic of, 06351
        • Division of Gastroenterology, Department of Medicine, Samsung Medical Center
      • Suwon-si, Korea, Republic of, 16247
        • The Catholic University of Korea, St. Vincent's Hospital
      • Wonju, Korea, Republic of, 220-701
        • Yonsei University Wonju Severance Christian Hospital
  • Malaysia
      • Cheras, Malaysia, 56000
        • Universiti Kebangsaan Malaysia Medical Center
      • George Town, Malaysia, 10990
        • Hospital Pulau Pinang
      • Kota Kinabalu, Malaysia, 88586
        • Hospital Queen Elizabeth
      • Kuala Lumpur, Malaysia, 59100
        • University Malaya Medical Centre
      • Kuantan, Malaysia, 25100
        • Hospital Tengku Ampuan Afzan
  • Netherlands
      • Alkmaar, Netherlands, 1815 JD
        • NZW Alkmaar (Noordwest Ziekenhuisgroep)
      • Amsterdam, Netherlands, 1081 HV
        • VU medisch centrum
      • Amsterdam, Netherlands, 1105 AZ
        • Academic Medical Center (AMC)
      • Apeldoorn, Netherlands, 7334
        • Gelre Hospital
      • Groningen, Netherlands, 9700 RB
        • Universitair Medisch Centrum Groningen
      • Maastricht, Netherlands, 6229 HX
        • Maastricht University Medical Centre
      • Rotterdam, Netherlands, 3015 CE
        • Erasmus University Medical Center
      • Tilburg, Netherlands, 5022
        • Elisabeth-TweeSteden hospital
      • Utrecht, Netherlands, 3584 CX
        • University Medical Center Utrecht
  • New Zealand
      • Christchurch, New Zealand, 8011
        • ChristChurch Hospital
      • Dunedin, New Zealand, 9016
        • Southern District Health Board - Dunedin Hospital
      • Grafton, New Zealand, 1023
        • Auckland City Hospital
      • Hamilton, New Zealand, 3240
        • Waikato Hospital
      • Newtown, New Zealand, 6021
        • Wellington Hospital
      • Tauranga, New Zealand, 3112
        • Bay of Plenty District Health Board - Tauranga Hospital
      • Wellington, New Zealand, 5010
        • Hutt Valley District Health Board - Hutt Valley Hospital
  • Poland
      • Bialystok, Poland, 15-276
        • Uniwersytecki Szpital Kliniczny w Bialymstoku, Klinika Gastroenterologii i Chorob Wewnetrznych
      • Bydgoszcz, Poland, 85-681
        • Gabinet Lekarski Janusz Rudzinski
      • Bydgoszcz, Poland, 85-079
        • VITAMED Galaj i Cichomski spolka jawna
      • Bydgoszcz, Poland, 85-168
        • Szpital Uniwersytecki nr 2 im. Dr. Jana Biziela w Bydgoszczy, Centrum Endoskopii Zabiegowej, Poradnia Chorob Jelitowych
      • Czestochowa, Poland, 42-217
        • NZOZ INTER-MED, Centrum Endoskopowe
      • Katowice, Poland, 40-659
        • Niepubliczny Zaklad Opieki Zdrowotnej All-Medicus
      • Krakow, Poland, 31-009
        • Gabinet Endoskopii Przewodu Pokarmowego
      • Kraków, Poland, 31-501
        • KRAKOWSKIE CENTRUM MEDYCZNE Sp. z o.o
      • Lodz, Poland, 90-153
        • Samodzielny Publiczny Zaklad Opieki Zdrowotnej Uniwerstyeckiego Szpitala Klinicznego nr 1 im. Norberta Barlickiego
      • Piotrków Trybunalski, Poland, 97-300
        • Trialmed CRS
      • Poznan, Poland, 60-848
        • Clinical Research Center Sp. z o.o. Medic-R Sp.k.
      • Rzeszów, Poland, 35-301
        • Gabinet Lekarski Dr. Hab. N. Med. Bartosz Korczowski
      • Sopot, Poland, 81-756
        • ENDOSKOPIA Sp. z o.o.
      • Szczecin, Poland, 71-434
        • Twoja Przychodnia-Szczecinskie Centrum Medyczne
      • Torun, Poland, 87-100
        • GASTROMED Kopon, Zmudzkinski i Wspolnicy Sp. j. Specjalistyczne Centrum Gastrologii i Endoskopii
      • Tychy, Poland, 43-100
        • H-T.Centrum Medyczne Spolka z Ograniczona Odpowiedzialnoscia Sp.K.
      • 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
  • Portugal
      • 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 Angelo
      • Porto, Portugal, 4200-319
        • Centro Hospitalar de Sao Joao, EPE
      • Viana do Castelo, Portugal, 4904-858
        • Unidade Local de Saúde do Alto Minho
  • Romania
      • 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
  • Russian Federation
      • 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"
  • Serbia
      • 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, Singapore, 169608
        • Singapore General Hospital
      • Singapore, Singapore, 119074
        • National University Hospital
      • Singapore, Singapore, 308433
        • Tan Tock Seng Hospital
      • Singapore, Singapore, 529889
        • Changi General Hospital
  • Slovakia
      • 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.
  • South Africa
      • 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
  • Spain
      • 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 Maranon
      • 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 Rocio
      • Usansolo, Spain, 48960
        • Hospital de Galdakao-Usandolo
  • Sri Lanka
      • 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
  • Sweden
      • Danderyd, Sweden, SE-18288
        • Danderyds sjukhus AB
      • Uppsala, Sweden, 75185
        • Akademiska Sjukhuset
  • Switzerland
      • Bern, Switzerland, 3012
        • Intesto Gastroenterologische Praxis & Crohn-Colitis-Zentrum Bern
      • Zurich, Switzerland, 8091
        • UniversitätsSpital Zürich
  • Taiwan
      • 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
  • Ukraine
      • 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
  • United Kingdom
      • 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
  • United States
    • 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
  • Female subjects of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception for the duration described in the protocol
  • Willingness to refrain from live or attenuated vaccines during the study and for 12 weeks after last dose of study drug
  • Must have completed all required procedures or met protocol specified efficacy discontinuation criteria in a prior filgotinib treatment study for CD

Key Exclusion Criteria:

  • Known hypersensitivity to the study drug
  • Any chronic medical condition (including, but not limited to, cardiac or pulmonary disease, alcohol or drug abuse) that, in the opinion of the Investigator or sponsor, would make the individual unsuitable for the study or would prevent compliance with the study protocol
  • Females of reproductive potential who are unwilling to abide by protocol-specified contraceptive methods as defined in the protocol
  • Use of prohibited medications as outlined in the study protocol

NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.

Study 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 (blinded dosing)
Filgotinib 200 mg + placebo to match filgotinib 100 mg for up to 390 weeks
Drug: Filgotinib
Tablet(s) administered orally once daily
Other Names:
  • GS-6034
  • GLPG0634
Drug: Placebo
Tablet(s) administered orally once daily
Experimental: Filgotinib 100 mg (blinded dosing)
Filgotinib 100 mg + placebo to match filgotinib 200 mg for up to 390 weeks
Drug: Filgotinib
Tablet(s) administered orally once daily
Other Names:
  • GS-6034
  • GLPG0634
Drug: Placebo
Tablet(s) administered orally once daily
Placebo Comparator: Placebo (blinded dosing)
Placebo to match filgotinib 200 mg for up to 390 weeks
Drug: Placebo
Tablet(s) administered orally once daily
Experimental: Filgotinib 200 mg (open-label)
Filgotinib 200 mg for up to 390 weeks
Drug: Filgotinib
Tablet(s) administered orally once daily
Other Names:
  • GS-6034
  • GLPG0634
Experimental: Filgotinib 100 mg (open-label)
Filgotinib 100 mg for up to 390 weeks
Drug: Filgotinib
Tablet(s) administered orally once daily
Other Names:
  • GS-6034
  • GLPG0634

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Overall Safety Profile of Filgotinib Evaluated by the Percentage of Participants Experiencing Adverse Events and Abnormal Clinical Laboratory Tests
Time Frame: Up to 390 weeks plus 30 days
Up to 390 weeks plus 30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline in PRO2 Scores
Time Frame: Baseline and up to 390 weeks
PRO2 are patient reported outcomes consisting of 2 items: abdominal pain severity and liquid stool frequency.
Baseline and up to 390 weeks
Change from Baseline in Crohn's Disease Activity Index (CDAI) Scores
Time Frame: Baseline and up to 390 weeks
Baseline and up to 390 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Galapagos NV

Collaborators

Gilead Sciences

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)

August 14, 2023

Last Update Submitted That Met QC Criteria

August 10, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GS-US-419-3896
  • 2016-002763-34 (EudraCT Number)

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.

Clinical Trials on Crohn's Disease

Clinical Trials on Filgotinib

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Papua New Guinea

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe