A Maintenance and Long-Term Extension Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Participants With Crohn's Disease Who Completed the Studies M14-431 or M14-433 (U-ENDURE)

June 13, 2024 updated by: AbbVie

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Maintenance and Long-Term Extension Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects With Crohn's Disease Who Completed the Studies M14-431 or M14-433

A multicenter study to evaluate the efficacy and safety of maintenance and long-term treatment administration of upadacitinib, an orally administered Janus kinase 1 inhibitor, in adult participants with Crohn's Disease.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

747

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
      • Cordoba, Argentina, 5016
        • Hospital Privado Universitario - Hospital Privado Centro Medico de Cordoba S.A. /ID# 169229
    • Buenos Aires
      • San Isidro, Buenos Aires, Argentina, 1642
        • Cardio Alem /ID# 211283
    • Ciudad Autonoma De Buenos Aires
      • Ciudad Autonoma Buenos Aires, Ciudad Autonoma De Buenos Aires, Argentina, 1199
        • Hospital Italiano de Buenos Aires /ID# 215542
      • Ciudad Autonoma de Buenos Aire, Ciudad Autonoma De Buenos Aires, Argentina, 1115
        • Gedyt /ID# 210018
      • Ciudad Autonoma de Buenos Aire, Ciudad Autonoma De Buenos Aires, Argentina, 1431
        • Cemic /Id# 169183
    • Santa Fe
      • Rosario, Santa Fe, Argentina, 2000
        • Hospital Provincial del Centenario /ID# 171251
  • Australia
    • New South Wales
      • Concord, New South Wales, Australia, 2139
        • Concord Repatriation General Hospital /ID# 171506
    • Queensland
      • North Mackay, Queensland, Australia, 4740
        • Coral Sea Clinical Research institute /ID# 212989
      • South Brisbane, Queensland, Australia, 4101
        • Mater Misericordiae Limited /ID# 204910
    • South Australia
      • Adelaide, South Australia, Australia, 5000
        • Royal Adelaide Hospital /ID# 171508
    • Victoria
      • Box Hill, Victoria, Australia, 3128
        • Box Hill Hospital /ID# 203735
    • Western Australia
      • Murdoch, Western Australia, Australia, 6150
        • Fiona Stanley Hospital /ID# 171507
  • Austria
      • Salzburg, Austria, 5020
        • Landeskrankenhaus Salzburg-Universitaetsklinikum der PMU (LKH) /ID# 214468
    • Wien
      • Vienna, Wien, Austria, 1030
        • Klinik Landstrasse /ID# 203438
      • Vienna, Wien, Austria, 1090
        • Medizinische Universitaet Wien /ID# 169459
  • Belgium
    • Bruxelles-Capitale
      • Woluwe-Saint-Lambert, Bruxelles-Capitale, Belgium, 1200
        • Cliniques Universitaires UCL Saint-Luc /ID# 200293
    • Liege
      • Liège, Liege, Belgium, 4000
        • CHU de Liège /ID# 200294
    • Namur
      • Yvoir, Namur, Belgium, 5530
        • Université Catholique de Louvain-Namur - Centre Hospitalier Universitaire Dinant /ID# 200295
    • Oost-Vlaanderen
      • Gent, Oost-Vlaanderen, Belgium, 9000
        • Duplicate_AZ Sint-Lucas /ID# 200296
    • Vlaams-Brabant
      • Leuven, Vlaams-Brabant, Belgium, 3000
        • Universitair Ziekenhuis Leuven /ID# 200031
  • Bosnia and Herzegovina
      • Sarajevo, Bosnia and Herzegovina, 71000
        • Clinical Center University of Sarajevo /ID# 201346
      • Sarajevo, Bosnia and Herzegovina, 71000
        • Polyclinic and Daily Hospital Dr. Al-Tawil /ID# 217843
    • Republika Srpska
      • Banja Luka, Republika Srpska, Bosnia and Herzegovina, 78000
        • Duplicate_University Clinical Centre of the Republic of Srpska /ID# 200743
    • Tuzlanski
      • Tuzla, Tuzlanski, Bosnia and Herzegovina, 75000
        • University Clinical Center Tuzla /ID# 210323
  • Brazil
    • Goias
      • Goiânia, Goias, Brazil, 74535-170
        • Instituto Goiano de Gastroenterologia e Endoscopia Digestiva /ID# 166853
    • La Spezia
      • Santo André, La Spezia, Brazil, 09060-870
        • Faculdade de Medicina do ABC /ID# 166854
    • Parana
      • Curitiba, Parana, Brazil, 80810-040
        • Hospital Nossa Senhora das Graças /ID# 166856
    • Rio Grande Do Sul
      • Porto Alegre, Rio Grande Do Sul, Brazil, 90035-903
        • Hospital de Clinicas de Porto Alegre /ID# 166855
    • Sao Paulo
      • Botucatu, Sao Paulo, Brazil, 18618-686
        • Upeclin Fmb - Unesp /Id# 166860
      • Ribeirão Preto, Sao Paulo, Brazil, 14049-900
        • Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto /ID# 166859
      • Sao Jose Do Rio Preto, Sao Paulo, Brazil, 15015-110
        • Kaiser Clinica e Hospital Dia /ID# 166858
  • Bulgaria
      • Plovdiv, Bulgaria, 4001
        • UMHAT Kaspela EOOD /ID# 167615
      • Sofia, Bulgaria, 1202
        • Duplicate_Second MHAT Sofia /ID# 167616
      • Stara Zagora, Bulgaria, 6004
        • MHAT Trakia /ID# 201677
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 4Z6
        • University of Calgary /ID# 166990
      • Edmonton, Alberta, Canada, T5R 1W2
        • Allen Whey Khye Lim Professional Corporation /ID# 168047
      • Edmonton, Alberta, Canada, T6K 4B2
        • Covenant Health /ID# 166996
      • Edmonton, Alberta, Canada, T6G 2B7
        • University of Alberta Hospital /ID# 166987
    • British Columbia
      • New Westminster, British Columbia, Canada, V3L 3W4
        • Fraser Clinical Trials Inc /ID# 166984
      • Vancouver, British Columbia, Canada, V6Z 2K5
        • GIRI Gastrointestinal Research Institute /ID# 166994
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 2Y9
        • QEII - Health Sciences Centre /ID# 169308
    • Ontario
      • London, Ontario, Canada, N6A 5W9
        • London Health Sciences Center- University Hospital /ID# 221039
      • North Bay, Ontario, Canada, P1B 2H3
        • Scott Shulman Medicine Professional Corporation /ID# 169065
      • Oshawa, Ontario, Canada, L1H 7K4
        • Taunton surgical centre /ID# 168045
      • Ottawa, Ontario, Canada, K1H 8L6
        • Ottawa Hospital Research Institute /ID# 212412
      • Sudbury, Ontario, Canada, P3A 1W8
        • Medicor Research Inc /ID# 166997
      • Vaughan, Ontario, Canada, L4L 4Y7
        • Toronto Digestive Disease Associates, Inc. /ID# 166988
    • Quebec
      • Lévis, Quebec, Canada, G6V 3Z1
        • Hotel Dieu de Levis /ID# 166985
      • Montreal, Quebec, Canada, H4A 3J1
        • Royal Victoria Hospital / McGill University Health Centre /ID# 170011
      • Montreal, Quebec, Canada, H2X 0A9
        • Centre Hospitalier de l'Universite de Montreal - CRCHUM /ID# 170122
      • Sherbrooke, Quebec, Canada, J1G 2E8
        • CIUSSS de l'Estrie - CHUS /ID# 170936
  • Chile
      • Concepción, Chile, 4070038
        • Hospital Guillermo Grant Benavente de Concepción /ID# 212421
      • Providencia, Chile, 7500571
        • CTR Estudios Clinicos /ID# 203940
      • Santiago, Chile, 7501504
        • Hospital Clinico Universidad De Los Andes /ID# 207463
      • Ñuñoa, Chile, 7750495
        • CEC SpA /ID# 169872
    • Region Metropolitana De Santiago
      • Santiago, Region Metropolitana De Santiago, Chile, 2540364
        • Research Group /ID# 203178
  • China
      • Changsha, China, 410011
        • The Second Xiangya Hospital of Central South University /ID# 204057
      • Tianjin, China, 300052
        • Duplicate_Tianjin Med Univ General Hosp /ID# 206979
    • Beijing
      • Beijing, Beijing, China, 100032
        • Beijing Friendship Hospital /ID# 204175
    • Fujian
      • Xiamen, Fujian, China, 361004
        • Zhongshan Hospital Xiamen University /ID# 204986
    • Guangdong
      • Guangzhou, Guangdong, China, 510080
        • The First Affiliated Hospital, Sun Yat-sen University /ID# 205227
      • Guangzhou, Guangdong, China, 510655
        • The Sixth Affiliated Hosp Sun /ID# 204054
      • Guangzhou, Guangdong, China, 510515
        • Nanfang Hospital of Southern Medical University /ID# 204056
    • Hubei
      • Wuhan, Hubei, China, 430022
        • Union Hospital Tongji Medical College Huazhong University of Science and Technol /ID# 204065
      • Wuhan, Hubei, China, 430030
        • Tongji Hospital Tongji Medical College of HUST /ID# 204051
    • Jiangsu
      • Nanjing, Jiangsu, China, 210008
        • Nanjing Drum Tower Hospital /ID# 204899
    • Jiangxi
      • Nanchang, Jiangxi, China, 330006
        • The First Affiliated Hospital of Nanchang University /ID# 204052
    • Jilin
      • Changchun, Jilin, China, 130021
        • The First Hospital of Jilin University /ID# 206865
    • Shanghai
      • Shanghai, Shanghai, China, 200065
        • Ruijin Hospital, Shanghai Jiaotong University School of Medicine /ID# 204055
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310009
        • The second affiliated hospital of Zhejiang University school of medicine /ID# 204058
      • Hangzhou, Zhejiang, China, 310018
        • Sir Run Run Shaw Hospital,Meical School Zhejiang University /ID# 204050
  • Colombia
    • Antioquia
      • Medellin, Antioquia, Colombia, 50034
        • Hospital San Vicente de Paul /ID# 200020
      • Medellín, Antioquia, Colombia, 50034
        • Duplicate_Hospital Pablo Tobon Uribe /ID# 202403
  • Croatia
      • Grad Zagreb, Croatia, 10000
        • Poliklinika Solmed /ID# 211517
      • Split, Croatia, 21000
        • UHC Split /ID# 171205
      • Zadar, Croatia, 23000
        • Zadar General Hospital /ID# 205533
    • Grad Zagreb
      • Zagreb, Grad Zagreb, Croatia, 10000
        • Clinical Hospital Dubrava /ID# 171165
      • Zagreb, Grad Zagreb, Croatia, 10000
        • Klinicki bolnicki centar Sestre milosrdnice /ID# 171194
      • Zagreb, Grad Zagreb, Croatia, 10000
        • Klinicki bolnicki centar Zagreb /ID# 171168
  • Czechia
      • Ceske Budejovice, Czechia, 370 01
        • Nemocnice Ceske Budejovice a.s. /ID# 224390
      • Hradec Kralove, Czechia, 500 12
        • Hepato-Gastroenterologie HK, s.r.o. /ID# 171564
      • Ostrava, Czechia, 722 00
        • ARTROSCAN s.r.o. /ID# 171575
      • Praha, Czechia, 143 00
        • ResTrial s.r.o. /ID# 208651
  • Denmark
    • Hovedstaden
      • Herlev, Hovedstaden, Denmark, 2730
        • Herlev Hospital /ID# 200785
      • Hilleroed, Hovedstaden, Denmark, 3600
        • Nordsjaellands Hospital /ID# 200788
      • Hvidovre, Hovedstaden, Denmark, 2650
        • Kobenhavns Universitet - Hvidovre Hospital (HH) /ID# 200787
    • Sjælland
      • Roskilde, Sjælland, Denmark, 4000
        • Duplicate_Sjaellands Universitets Hospital /ID# 200786
  • Egypt
      • Alexandria, Egypt, 21131
        • Alexandria University /ID# 171008
      • Alexandria, Egypt, 21131
        • Alexandria University /ID# 171017
      • Alexandria, Egypt, 21131
        • Duplicate_Clinical Research Center, Faculty of Medicine, Alexandria university. /ID# 209561
      • Cairo, Egypt, 11559
        • National Hepatology and Tropical Medicine Research Institute /ID# 170991
      • Cairo, Egypt
        • Air Force Specialized Hospital /ID# 170993
      • Cairo, Egypt, 11566
        • Ain Shams University Faculty of Medicine /ID# 209566
      • Menoufiya, Egypt, 35111
        • National Liver Institute /ID# 170987
  • Estonia
      • Tallinn, Estonia, 10617
        • West Tallinn Central Hospital /ID# 202787
    • Tartumaa
      • Tartu Linn, Tartumaa, Estonia, 50406
        • Tartu University Hospital /ID# 203141
  • France
      • Chambray Les Tours, France, 37170
        • CHRU Tours - Hopital Trousseau /ID# 169783
      • Creteil, France, 94000
        • Duplicate_CHU Henri Mondor /ID# 169782
      • Nantes, France, 44300
        • Clinique Jules Verne /ID# 222240
      • Nimes Cedex, France, 30932
        • Polyclinique Grand Sud /ID# 170037
      • St-Priest-en-Jarez, France, 42270
        • Centre Hospitalier Universitaire de Saint Étienne - Hôpital Nord /ID# 171027
    • Alpes-Maritimes
      • Nice, Alpes-Maritimes, France, 06200
        • Chu de Nice-Hopital Larchet Ii /Id# 171004
    • Gironde
      • Pessac, Gironde, France, 33604
        • Duplicate_CHU Bordeaux - Hopital Haut Leveque /ID# 207812
    • Haute-Garonne
      • Toulouse, Haute-Garonne, France, 31400
        • CHU Toulouse - Hopital Rangueil /ID# 169784
    • Herault
      • Montpellier CEDEX 5, Herault, France, 34295
        • Duplicate_Hopital Saint Eloi /ID# 170039
    • Ile-de-France
      • Clichy, Ile-de-France, France, 92110
        • Hopital Beaujon /ID# 171007
    • Isere
      • La Tronche, Isere, France, 38700
        • Duplicate_CHU Grenoble - Hopital Michallon /ID# 222403
    • Meurthe-et-Moselle
      • Vandoeuvre-les-Nancy, Meurthe-et-Moselle, France, 54500
        • CHRU Nancy - Hopitaux de Brabois /ID# 170970
    • Nord
      • Lille, Nord, France, 59037
        • CHRU Lille - Hopital Claude Huriez /ID# 206653
      • Valenciennes, Nord, France, 59300
        • CH Valenciennes /ID# 222399
    • Rhone
      • Pierre Benite CEDEX, Rhone, France, 69495
        • HCL - Hopital Lyon Sud /ID# 171030
    • Somme
      • Amiens CEDEX 1, Somme, France, 80054
        • CHU Amiens-Picardie Site Sud /ID# 171023
  • Germany
      • Berlin, Germany, 12203
        • Charite Universitaetsklinikum Berlin - Campus Benjamin Franklin /ID# 169271
      • Berlin, Germany, 14163
        • Gastroenterologie am Mexikoplatz /ID# 203574
      • Essen, Germany, 45239
        • Universitaetsmedizin Essen St. Josef Krankenhaus Werden /ID# 203569
      • Halle (Saale), Germany, 06120
        • Universitaetsklinikum Halle (Saale) /ID# 207453
      • Muenster, Germany, 48155
        • Medizinisches Versorgungszentrum Portal 10 /ID# 200212
    • Baden-Wuerttemberg
      • Mannheim, Baden-Wuerttemberg, Germany, 68167
        • Universitatsklinikum Mannheim /ID# 168754
      • Ulm, Baden-Wuerttemberg, Germany, 89081
        • Universitaetsklinikum Ulm /ID# 203554
    • Bayern
      • Erlangen, Bayern, Germany, 91054
        • Universitaetsklinikum Erlangen /ID# 203550
    • Hessen
      • Frankfurt am Main, Hessen, Germany, 60590
        • Universitaetsklinikum Frankfurt /ID# 203567
      • Frankfurt am Main, Hessen, Germany, 60431
        • Duplicate_Agaplesion Markus Krankenhaus /ID# 168753
    • Saarland
      • Saarbrücken, Saarland, Germany, 66111
        • Zentrum für Gastroenterologie Saar MVZ GmbH /ID# 206739
    • Schleswig-Holstein
      • Kiel, Schleswig-Holstein, Germany, 24105
        • Universitaetsklinikum Schleswig-Holstein Campus Kiel /ID# 168755
  • Greece
      • Athens, Greece, 10676
        • General Hospital of Athens Evaggelismos and Ophthalmiatrio of Athens Polyclinic /ID# 167033
      • Thessaloniki, Greece, 54642
        • General Hospital of Thessaloniki Hippokrateio /ID# 208823
    • Attiki
      • Athens, Attiki, Greece, 11527
        • General Hospital of Athens Ippokratio /ID# 167032
      • Athens, Attiki, Greece, 11527
        • General Hospital of Chest Diseases of Athens SOTIRIA /ID# 202102
      • Piraeus, Attiki, Greece, 18536
        • Tzaneio general hospital of Piraeus /ID# 206435
    • Kriti
      • Heraklion, Kriti, Greece, 71500
        • University General Hospital of Heraklion PA.G.N.I /ID# 167031
  • Hong Kong
      • Hong Kong, Hong Kong, 999077
        • Queen Mary Hospital /ID# 171214
      • Hong Kong, Hong Kong
        • Tuen Mun Hospital /ID# 171213
  • Hungary
      • Budapest, Hungary, 1085
        • Semmelweis Egyetem /ID# 210166
      • Budapest, Hungary, 1134
        • Magyar Honvedseg Egeszsegugyi Kozpont /ID# 200888
      • Budapest, Hungary, 1036
        • Obudai Egeszsegugyi Centrum Kft. /ID# 201886
      • Debrecen, Hungary, 4031
        • Debreceni Egyetem Kenezy Gyula Egyetemi Korhaz /ID# 200887
      • Kistarcsa, Hungary, 2143
        • Kistarcsai Flor Ferenc Korhaz /ID# 206153
      • Szekesfehervar, Hungary, 8000
        • Mentahaz Maganorvosi Kozpont /ID# 201888
    • Baranya
      • Mohacs, Baranya, Hungary, 7700
        • Pecsi Tudomanyegyetem Klinikai Kozpont Mohacsi Korhaz /ID# 209440
    • Borsod-Abauj-Zemplen
      • Encs, Borsod-Abauj-Zemplen, Hungary, 3860
        • CRU Hungary Egeszsegugyi és Szolgaltato Kft. /ID# 205549
    • Hajdu-Bihar
      • Debrecen, Hajdu-Bihar, Hungary, 4032
        • Duplicate_Debreceni Egyetem Klinikai Kozpont /ID# 216420
    • Heves
      • Gyongyos, Heves, Hungary, 3200
        • Gyongyosi Bugat Pal Korhaz /ID# 201885
    • Komarom-Esztergom
      • Tatabanya, Komarom-Esztergom, Hungary, 2800
        • Komarom-Esztergom Varmegyei Szent Borbala Korhaz (Clinexpert Tatabanya Kft.) /ID# 209896
  • Ireland
      • Cork, Ireland, T12 WE28
        • Mercy University Hospital /ID# 206512
  • Israel
      • Haifa, Israel, 4941492
        • Rabin Medical Center /ID# 202634
    • HaDarom
      • Ashkelon, HaDarom, Israel, 7830604
        • Barzilai Medical Center /ID# 223374
      • Be'er Sheva, HaDarom, Israel, 8443901
        • Soroka University Medical Center /ID# 169911
    • HaMerkaz
      • Rehovot, HaMerkaz, Israel, 7661041
        • Duplicate_Kaplan Medical Center /ID# 170275
      • Zerifin, HaMerkaz, Israel, 70300
        • Yitzhak Shamir Medical Center /ID# 206449
    • Tel-Aviv
      • Tel Aviv, Tel-Aviv, Israel, 6423906
        • Tel Aviv Sourasky Medical Center /ID# 206450
    • Yerushalayim
      • Jerusalem, Yerushalayim, Israel, 91120
        • Hadassah Medical Center-Hebrew University /ID# 169926
  • Italy
      • Bologna, Italy, 40138
        • IRCCS Azienda Ospedaliero-Universitaria di Bologna /ID# 168155
      • Catania, Italy, 95126
        • A.O. Per L'Emergenza Cannizzaro /ID# 168161
      • Genova, Italy, 16132
        • Policlinico San Martino/Univer /ID# 168162
      • Milano, Italy, 20121
        • ASST Fatebenefratelli Sacco - Ospedale Fatebenefratelli e Oftalmico /ID# 168149
      • Modena, Italy, 41124
        • Azienda Ospedaliero-Universitaria di Modena /ID# 200009
      • Palermo, Italy, 90146
        • A.O. Ospedali Riuniti Villa Sofia - Cervello /ID# 168157
      • Pisa, Italy, 56125
        • Duplicate_Azienda Ospedaliero Universitaria Pisana-Stabilimento di Cisanello /ID# 202419
    • Calabria
      • Catanzaro, Calabria, Italy, 88100
        • University of Catanzaro /ID# 201986
    • Lazio
      • Rome, Lazio, Italy, 00168
        • Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Universita Cattolica /ID# 168150
    • Milano
      • Milan, Milano, Italy, 20162
        • ASST Grande Ospedale Metropolitano Niguarda /ID# 170906
      • Rozzano, Milano, Italy, 20089
        • Istituto Clinico Humanitas /ID# 168153
    • Roma
      • Rome, Roma, Italy, 00133
        • Fondazione PTV Policlinico Tor Vergata /ID# 168156
      • Rome, Roma, Italy, 00128
        • Fondazione Policlinico Universitario Campus Bio-Medico di Roma /ID# 168151
      • Rome, Roma, Italy, 00152
        • Azienda Ospedaliera San Camillo Forlanini /ID# 168152
    • Verona
      • Negrar, Verona, Italy, 37024
        • IRCCS Ospedale Sacro Cuore Don Calabria /ID# 168154
  • Japan
      • Mitaka, Japan, 181-8611
        • Kyorin University - Mitaka Campus /ID# 165983
    • Aichi
      • Nagakute, Aichi, Japan, 480-1195
        • Aichi Medical University /ID# 165989
      • Nagoya shi, Aichi, Japan, 467-8602
        • Nagoya City University Hospital /ID# 165988
      • Nagoya-shi, Aichi, Japan, 4668560
        • Nagoya University Hospital /ID# 165987
      • Toyohashi-shi, Aichi, Japan, 441-8570
        • Toyohashi Municipal Hospital /ID# 200176
    • Aomori
      • Hirosaki-shi, Aomori, Japan, 036-8545
        • National Hospital Organization Hirosaki General Medical Center /ID# 165976
    • Chiba
      • Sakura-shi, Chiba, Japan, 285-8741
        • Toho University Sakura Medical Center /ID# 165978
    • Fukuoka
      • Chikushino-shi, Fukuoka, Japan, 818-8502
        • Fukuoka University Chikushi Hospital /ID# 214402
      • Kurume-shi, Fukuoka, Japan, 830-0011
        • Kurume University Hospital /ID# 165996
    • Gunma
      • Takasaki-shi, Gunma, Japan, 370-0829
        • National Hospital Organization Takasaki General Medical Center /ID# 167151
    • Hiroshima
      • Fukuyama-shi, Hiroshima, Japan, 720-8520
        • NHO Fukuyama Medical Center /ID# 167155
      • Hiroshima-shi, Hiroshima, Japan, 734-8551
        • Hiroshima University Hospital /ID# 165998
    • Hokkaido
      • Asahikawa-shi, Hokkaido, Japan, 078-8510
        • Asahikawa Medical University Hospital /ID# 167148
      • Sapporo-shi, Hokkaido, Japan, 060-0033
        • Hokkaido P.W.F.A.C. Sapporo-Kosei General Hospital /ID# 165975
      • Sapporo-shi, Hokkaido, Japan, 060-8543
        • Sapporo Medical University Hospital /ID# 167152
      • Sapporo-shi, Hokkaido, Japan, 064-0919
        • Sapporo IBD Clinic /ID# 223559
    • Hyogo
      • Kobe-shi, Hyogo, Japan, 650-0015
        • Aoyama Clinic /ID# 165993
      • Nishinomiya-shi, Hyogo, Japan, 663-8501
        • Hyogo Medical University Hospital /ID# 165991
    • Ishikawa
      • Kanazawa-shi, Ishikawa, Japan, 920-8641
        • Kanazawa University Hospital /ID# 169212
    • Iwate
      • Morioka-shi, Iwate, Japan, 020-8505
        • Iwate Medical University Uchimaru Medical Center /ID# 202465
    • Kagoshima
      • Kagoshima-shi, Kagoshima, Japan, 890-0064
        • Imamura General Hospital /ID# 227135
      • Kagoshima-shi, Kagoshima, Japan, 892-0824
        • Idzuro Imamura Hospital /ID# 206655
      • Kagoshima-shi, Kagoshima, Japan, 892-0846
        • Sameshima Hospital /ID# 206677
    • Kanagawa
      • Yokohama shi, Kanagawa, Japan, 232-0024
        • Yokohama City University Medical Center /ID# 167156
    • Kyoto
      • Kyoto-shi, Kyoto, Japan, 605-0981
        • Japanese Red Cross Kyoto Daiichi Hosital /ID# 165990
      • Kyoto-shi, Kyoto, Japan, 606-8507
        • Kyoto University Hospital /ID# 169887
    • Mie
      • Yokkaichi-shi, Mie, Japan, 510-0016
        • Yokkaichi Hazu Medical Center /ID# 167201
    • Miyagi
      • Sendai-shi, Miyagi, Japan, 9808574
        • Tohoku University Hospital /ID# 167150
    • Nara
      • Kashihara-shi, Nara, Japan, 634-8522
        • Nara Medical University Hospital /ID# 169213
      • Yamatotakada-shi, Nara, Japan, 635-0022
        • Kenseikai Dongo Hospital /ID# 208105
    • Niigata
      • Niigata-shi, Niigata, Japan, 951-8520
        • Niigata University Medical & Dental Hospital /ID# 170042
    • Oita
      • Oita-shi, Oita, Japan, 870-0823
        • Ishida Clinic of IBD and Gastroenterology /ID# 167149
    • Okayama
      • Kurashiki-shi, Okayama, Japan, 710-0142
        • Chikuba Hospital for Proctological and Gastrointestinal Diseases /ID# 165994
      • Okayama-shi, Okayama, Japan, 700-8558
        • Duplicate_Okayama University Hospital /ID# 167354
    • Osaka
      • Osaka-shi, Osaka, Japan, 530-0011
        • Kinshukai Infusion Clinic /ID# 218873
      • Osaka-shi, Osaka, Japan, 545-8586
        • Osaka Metropolitan University Hospital /ID# 165999
      • Suita-shi, Osaka, Japan, 565-0871
        • Osaka University Hospital /ID# 169661
      • Takatsuki-shi, Osaka, Japan, 569-8686
        • Osaka Medical and Pharmaceutical University Hospital /ID# 206323
    • Saitama
      • Saitama-shi, Saitama, Japan, 336-0963
        • Tokitokai Tokito clinic /ID# 165977
    • Shiga
      • Otsu-shi, Shiga, Japan, 520-2192
        • Shiga University of Medical Science Hospital /ID# 167157
    • Shizuoka
      • Hamamatsu-shi, Shizuoka, Japan, 431-3192
        • Hamamatsu University Hospital /ID# 224402
      • Sunto-gun, Shizuoka, Japan, 411-8611
        • NHO Shizuoka Medical Center /ID# 167153
    • Tokyo
      • Bunkyo-ku, Tokyo, Japan, 113-8519
        • Tokyo Medical And Dental University Hospital /ID# 165982
      • Hachioji-shi, Tokyo, Japan, 192-0032
        • Tokai University Hachioji Hospital /ID# 165984
      • Minato-ku, Tokyo, Japan, 105-8471
        • The Jikei University Hospital /ID# 167154
      • Shinjuku-ku, Tokyo, Japan, 162-8666
        • Tokyo Women's Medical University Hospital /ID# 205979
    • Toyama
      • Toyama-shi, Toyama, Japan, 930-8550
        • Toyama Prefectural Central Hospital /ID# 217836
    • Wakayama
      • Wakayama-shi, Wakayama, Japan, 640-8558
        • Japanese Red Cross Wakayama Medical Center /ID# 200641
      • Wakayama-shi, Wakayama, Japan, 641-8510
        • Wakayama Medical University Hospital /ID# 169480
    • Yamagata
      • Yamagata-shi, Yamagata, Japan, 990-9585
        • Yamagata University Hospital /ID# 200158
  • Korea, Republic of
      • Busan, Korea, Republic of, 48108
        • Inje University Haeundae Hospital /ID# 202631
      • Busan, Korea, Republic of, 49241
        • Pusan National University Hospital /ID# 167565
      • Seoul, Korea, Republic of, 06351
        • Samsung Medical Center /ID# 167564
    • Daegu Gwang Yeogsi
      • 중구, Daegu Gwang Yeogsi, Korea, Republic of, 41944
        • Kyungpook National University Hospital /ID# 207020
    • Gyeonggido
      • Dongjak-gu, Gyeonggido, Korea, Republic of, 06973
        • Chungang University Hospital /ID# 207021
      • Guri, Gyeonggido, Korea, Republic of, 11923
        • Duplicate_Hanyang University Gurihospital /ID# 167563
      • Seongnam si, Gyeonggido, Korea, Republic of, 13496
        • Duplicate_CHA University Bundang Medical Center /ID# 167569
    • Gyeongsangnamdo
      • Busan, Gyeongsangnamdo, Korea, Republic of, 49201
        • Dong-A University Medical Center /ID# 167568
    • Seoul Teugbyeolsi
      • Seoul, Seoul Teugbyeolsi, Korea, Republic of, 03181
        • Kangbuk Samsung Hospital /ID# 167562
      • Seoul, Seoul Teugbyeolsi, Korea, Republic of, 03722
        • Yonsei University Health System Severance Hospital /ID# 167567
  • Latvia
      • Riga, Latvia, 1035
        • VCA Polyclinic Aura /ID# 169499
      • Riga, Latvia, LV-1079
        • Duplicate_Digestive Disease Center Gastro /ID# 169518
    • Riga
      • Rīga, Riga, Latvia, 1002
        • Pauls Stradins Clinical University Hospital /ID# 169494
  • Lithuania
      • Kaunas, Lithuania, 50161
        • Hospital of Lithuanian University of Health Sciences Kaunas Clinics /ID# 207030
      • Vilnius, Lithuania, 08661
        • Vilnius University Hospital Santaros Klinikos /ID# 203269
  • Malaysia
      • Kelantan, Malaysia, 16150
        • Universiti Sains Malaysia /ID# 200101
    • Kedah
      • Alor Setar, Kedah, Malaysia, 05460
        • Hospital Sultanah Bahiyah /ID# 201317
    • Selangor
      • Kuala Lumpur, Selangor, Malaysia, 56000
        • Universiti Kebangsaan Malaysia (UKM) Medical Centre /ID# 170780
  • Mexico
    • Durango
      • Victoria de Durango, Durango, Mexico, 34000
        • Instituto de Investigaciones Aplicadas a la Neurociencias A.C. /ID# 207681
    • Guanajuato
      • Leon, Guanajuato, Mexico, 37000
        • Morales Vargas Centro de Investigacion S.C. /ID# 203496
    • Jalisco
      • Guadalajara, Jalisco, Mexico, 44650
        • Clinica de Investigacion en Reumatologia y Obesidad S.C. /ID# 206843
  • Netherlands
      • Amsterdam, Netherlands, 1091 AC
        • Onze Lieve Vrouwe Gasthuis /ID# 166932
      • Amsterdam, Netherlands, 1081 HV
        • Amsterdam UMC, locatie VUmc /ID# 166930
      • Enschede, Netherlands, 7512 KZ
        • Medisch Spectrum Twente /ID# 170299
    • Gelderland
      • Nijmegen, Gelderland, Netherlands, 6525 GA
        • Radboud Universitair Medisch Centrum /ID# 166931
    • Limburg
      • Heerlen, Limburg, Netherlands, 6419 PC
        • Zuyderland Medisch Centrum /ID# 169699
  • Poland
    • Dolnoslaskie
      • Wroclaw, Dolnoslaskie, Poland, 53-149
        • Vistamed /ID# 208571
    • Malopolskie
      • Krakow, Malopolskie, Poland, 30-149
        • Malopolskie Centrum Kliniczne /ID# 202169
    • Mazowieckie
      • Warsaw, Mazowieckie, Poland, 00-728
        • Duplicate_WIP Warsaw IBD Point Profesor Kierkus /ID# 224302
      • Warszawa, Mazowieckie, Poland, 02-665
        • Centrum Medyczne Reuma Park /ID# 200489
      • Warszawa, Mazowieckie, Poland, 00-189
        • Centrum Zdrowia MDM /ID# 200493
  • Portugal
      • Porto, Portugal, 4200-319
        • Centro Hospitalar Universitario de Sao Joao, EPE /ID# 170211
    • Braga
      • Guimaraes, Braga, Portugal, 4835-044
        • Duplicate_Hospital da Senhora da Oliveira Guimaraes, EPE /ID# 170204
    • Porto
      • Lisbon, Porto, Portugal, 1349-019
        • Hospital Egas Moniz /ID# 170232
    • Setubal
      • Almada, Setubal, Portugal, 2805-267
        • Duplicate_Hospital Garcia de Orta, EPE /ID# 170209
    • Viana Do Castelo
      • Ponte de Lima, Viana Do Castelo, Portugal, 4990-041
        • Unidade Local de Saúde do Alto Minho, EPE - Hospital Conde de Bertiandos /ID# 200608
  • Puerto Rico
      • San Juan, Puerto Rico, 00918-3756
        • Mindful Medical Research /ID# 203356
      • San Juan, Puerto Rico, 00935
        • School of Medicine University of Puerto Rico-Medical Science Campus /ID# 166769
  • Romania
      • Timișoara, Romania, 300002
        • Cabinet Particular Policlinic Algomed /ID# 167832
    • Bucuresti
      • Bucharest, Bucuresti, Romania, 022328
        • Fundeni Clinical Institute /ID# 167831
    • Cluj
      • Cluj-Napoca, Cluj, Romania, 400380
        • Duplicate_Clinica GASTRO MED SRL /ID# 206363
  • Russian Federation
      • Moscow, Russian Federation, 105554
        • Olla-Med Clinic /ID# 208723
      • Murmansk, Russian Federation, 183047
        • P.A. Bayandin Murmansk Regiona /ID# 169590
      • Petrozavodsk, Russian Federation, 185019
        • Republican hospital named after V.A. Baranov /ID# 206497
      • Pushkin, Russian Federation, 196603
        • Euromedservice /ID# 206608
      • Saint Petersburg, Russian Federation, 194156
        • X7 Clinical Research Center /ID# 216348
      • St. Petersburg, Russian Federation, 197110
        • City Clinical Hospital No. 31 /ID# 208871
    • Kaliningradskaya Oblast
      • Kaliningrad, Kaliningradskaya Oblast, Russian Federation, 236016
        • Immanuel Kant Baltic Federal University /ID# 203810
    • Novosibirskaya Oblast
      • Novosibirsk, Novosibirskaya Oblast, Russian Federation, 630099
        • LLC Medical Center /ID# 209234
    • Permskiy Kray
      • Perm, Permskiy Kray, Russian Federation, 614109
        • Perm Clinical Center of the Federal Medical and Biological Agency /ID# 202989
    • Stavropol Skiy Kray
      • Pyatigorsk, Stavropol Skiy Kray, Russian Federation, 357500
        • LLC Novaya Klinika /ID# 206613
      • Stavropol, Stavropol Skiy Kray, Russian Federation, 355012
        • Professor Pasechnikov Gastroenterology and Pankreatology clinic /ID# 202996
    • Tatarstan, Respublika
      • Kazan, Tatarstan, Respublika, Russian Federation, 420012
        • Kazan State Medical University /ID# 169589
  • Serbia
    • Beograd
      • Belgrade, Beograd, Serbia, 11000
        • Clinical Hosp Center Zvezdara /ID# 168216
      • Belgrade, Beograd, Serbia, 11000
        • Military Medical Academy /ID# 168785
      • Belgrade, Beograd, Serbia, 11000
        • University Clinical Center Serbia /ID# 168217
      • Belgrade, Beograd, Serbia, 11080
        • Clin Hosp Ctr Bezanijska Kosa /ID# 168787
    • Sumadijski Okrug
      • Kragujevac, Sumadijski Okrug, Serbia, 34000
        • Duplicate_University Clinical Center Kragujevac /ID# 205856
    • Vojvodina
      • Novi Sad, Vojvodina, Serbia, 21000
        • Duplicate_Clinical Center Vojvodina /ID# 168196
  • Singapore
      • Singapore, Singapore, 228510
        • KL Ling Gastroenterology and Liver Clinic /ID# 205739
      • Singapore, Singapore, 258499
        • Gleneagles Medical Centre /ID# 206019
      • Singapore, Singapore, 308433
        • Tan Tock Seng Hospital /ID# 203158
  • Slovakia
      • Banska Bystrica, Slovakia, 975 17
        • Fakultna nemocnica s poliklinikou F.D. Roosevelta Banska Bystrica /ID# 169960
    • Nitriansky Kraj
      • Nitra, Nitriansky Kraj, Slovakia, 949 01
        • KM Management, spol. s.r.o. /ID# 170202
  • Slovenia
      • Ljubljana, Slovenia, 1000
        • Univ Medical Ctr Ljubljana /ID# 211041
  • South Africa
    • Free State
      • Bloemfontein, Free State, South Africa, 9301
        • Farmovs (Pty) Ltd /Id# 207534
    • Gauteng
      • Johannesburg, Gauteng, South Africa, 1820
        • Lenasia Clinical Trial Centre /ID# 205143
      • Johannesburg, Gauteng, South Africa, 1864
        • Wits Clinical Research /ID# 170850
    • Western Cape
      • Cape Town, Western Cape, South Africa, 7700
        • Allergy & Immunology (AIU) /ID# 171427
      • Cape Town, Western Cape, South Africa, 7708
        • Dr JP Wright /ID# 170882
      • Cape Town, Western Cape, South Africa, 7800
        • Private Practice Dr MN Rajabally /ID# 169851
  • Spain
      • A Coruna, Spain, 15006
        • Duplicate_Hospital Universitario A Coruna - CHUAC /ID# 203909
      • Barcelona, Spain, 08035
        • Hospital Universitario Vall d'Hebron /ID# 202721
      • Barcelona, Spain, 08036
        • Hospital Clinic de Barcelona /ID# 202726
      • Girona, Spain, 17007
        • Hospital Universitario de Girona Doctor Josep Trueta /ID# 202644
      • Huelva, Spain, 21005
        • Hospital Juan Ramon Jimenez /ID# 202727
      • Madrid, Spain, 28046
        • Hospital Universitario La Paz /ID# 202725
      • Salamanca, Spain, 37711
        • Hospital Universitario de Salamanca /ID# 206359
      • Sevilla, Spain, 41009
        • Hospital Universitario Virgen Macarena /ID# 202722
      • Valencia, Spain, 46010
        • Hospital Clinico Universitario de Valencia /ID# 209658
      • Valencia, Spain, 46026
        • Hospital Universitario y Politecnico La Fe /ID# 202720
    • Cantabria
      • Santander, Cantabria, Spain, 39008
        • Hospital Universitario Marques de Valdecilla /ID# 202495
    • Illes Balears
      • Palma de Mallorca, Illes Balears, Spain, 07120
        • Hospital Universitari Son Espases /ID# 201969
    • Las Palmas
      • Las Palmas de Gran Canaria, Las Palmas, Spain, 35019
        • Hospital Universitario Dr. Negrin /ID# 202723
    • Navarra
      • Pamplona, Navarra, Spain, 31008
        • Hospital Universitario de Navarra /ID# 202354
  • Sweden
    • Hallands Lan
      • Halmstad, Hallands Lan, Sweden, 302 33
        • Hallands Hospital Halmstad /ID# 170815
    • Stockholms Lan
      • Solna, Stockholms Lan, Sweden, 171 64
        • Karolinska University Hospital Solna /ID# 224489
    • Vastra Gotalands Lan
      • Alingsas, Vastra Gotalands Lan, Sweden, 441 33
        • Alingsas lasarett /ID# 170814
      • Boras, Vastra Gotalands Lan, Sweden, 501 82
        • Sodra Alvsborgs sjukhus /ID# 203078
      • Gothenburg, Vastra Gotalands Lan, Sweden, 413 46
        • Duplicate_Sahlgrenska University Hospital /ID# 169032
      • Gothenburg, Vastra Gotalands Lan, Sweden, 413 46
        • Duplicate_Sahlgrenska University Hospital /ID# 169170
  • Switzerland
      • Bern, Switzerland, 3010
        • Inselspital, Universitaetsspital Bern /ID# 170994
    • Zuerich
      • Zurich, Zuerich, Switzerland, 8091
        • Duplicate_Universitatsspital Zurich /ID# 171000
  • Taiwan
      • Taichung, Taiwan, 40705
        • Taichung Veterans General Hospital /ID# 169802
      • Taichung, Taiwan, 40447
        • China Medical University Hospital /ID# 169803
      • Taoyuan City, Taiwan, 333
        • Linkou Chang Gung Memorial Hospital /ID# 169804
    • Taipei
      • Taipei City, Taipei, Taiwan, 100
        • National Taiwan University Hospital /ID# 169805
  • Turkey
      • Ankara, Turkey, 06590
        • Ankara Univ Medical Faculty /ID# 206408
      • Battalgazi/malatya, Turkey, 44280
        • Inonu Universitesi Turgut Ozal /ID# 201266
      • Hatay, Turkey, 31001
        • Mustafa Kemal University Medic /ID# 171328
      • Istanbul, Turkey, 34899
        • Marmara Universitesi Pendik Egitim ve Arastirma Hastanesi /ID# 171326
      • Istanbul, Turkey, 34093
        • Duplicate_Istanbul University Istanbul Medical Faculty /ID# 171365
      • Mersin, Turkey, 33343
        • Mersin University Medical /ID# 171330
    • Ankara
      • Yenimahalle, Ankara, Turkey, 06560
        • Gazi Universitesi Tip Fakultes /ID# 217445
    • Istanbul
      • Kadikoy, Istanbul, Turkey, 34742
        • Acibadem Kozyatagi Hospital /ID# 209404
      • Sisli, Istanbul, Turkey, 34371
        • Sisli Etfal Train & Res Hosp /ID# 171327
    • Kayseri
      • Melikgazi, Kayseri, Turkey, 38030
        • Duplicate_Erciyes University Medical Fac /ID# 171325
  • Ukraine
      • Kharkiv, Ukraine, 61037
        • Kharkiv City Clinical Hospital No.2 n.a. Prof. O.O. Shalimov /ID# 167918
      • Kyiv, Ukraine, 01030
        • Kyiv City Clinical Hospital No.18 /ID# 207890
      • Kyiv, Ukraine, 01030
        • Medical Centre of "Ukrainian German Antiulcer Gastroenterology Centre BYK-KYIV" /ID# 203739
      • Kyiv, Ukraine, 04106
        • MNE KRC Kyiv Regional Clinical Hospital /ID# 202456
      • Lviv, Ukraine, 79000
        • Lviv Railway Clinical Hospital of branch Healthcare Centers of Public Joint Stoc /ID# 167917
    • Vinnytska Oblast
      • Vinnytsia, Vinnytska Oblast, Ukraine, 21018
        • CNE Vinnytsya Regional Clinical Hospital named after N.I.Pirogov /ID# 222111
  • United Kingdom
      • Bath, United Kingdom, BA1 3NG
        • Royal United Hospitals Bath /ID# 169062
      • Belfast, United Kingdom, BT16 1RH
        • Ulster Hospital - South Eastern Health & Social Care Trust /ID# 205324
      • Birmingham, United Kingdom, B15 2TH
        • University Hospitals Birmingham NHS Foundation Trust /ID# 169058
      • Dudley, United Kingdom, DY1 2HQ
        • The Dudley Group NHS Foundation Trust /ID# 169057
      • Harrow, United Kingdom, HA1 3UJ
        • London North West University Healthcare NHS Trust /ID# 169056
      • London, United Kingdom, SE5 9RS
        • King's College Hospital NHS Foundation Trust /ID# 169060
      • Newcastle upon Tyne, United Kingdom, NE3 3HD
        • The Newcastle Upon Tyne Hospitals NHS Foundation Trust /ID# 169063
      • Stockport, United Kingdom, SK2 7JE
        • Stockport NHS foundation trust /ID# 208717
      • Taunton, United Kingdom, TA1 5DA
        • Taunton and Somerset NHS Foundation Trust /ID# 209666
      • Tooting, United Kingdom, SW17 0QT
        • St George's University Hospitals NHS Foundation Trust /ID# 205550
      • Wolverhampton, United Kingdom, WV10 0QP
        • The Royal Wolverhampton NHS Trust /ID# 171395
    • Cheshire West And Chester
      • Warrington, Cheshire West And Chester, United Kingdom, WA5 1QG
        • Warrington and Halton Hospitals NHS Foundation Trust /ID# 171396
    • London, City Of
      • London, London, City Of, United Kingdom, E1 2ES
        • Barts Health NHS Trust /ID# 218830
    • Warrington
      • Prescot, Warrington, United Kingdom, L35 5DR
        • Mersey and West Lancashire NHS teaching hospitals trust /ID# 209087
  • United States
    • Alabama
      • Mobile, Alabama, United States, 36606
        • East View Medical Research, LLC /ID# 171132
      • Mobile, Alabama, United States, 36608
        • CB Flock Research Corporation /ID# 166239
    • Arizona
      • Chandler, Arizona, United States, 85224
        • Delsol Research Management, Ll /Id# 170164
      • Scottsdale, Arizona, United States, 85258
        • HonorHealth Research Institute - Shea /ID# 164725
      • Sun City, Arizona, United States, 85306
        • Arizona Arthritis & Rheumatology Research, PLLC /ID# 164702
    • California
      • Coronado, California, United States, 92118-1408
        • Southern California Res. Ctr. /ID# 169653
      • Covina, California, United States, 91722-3797
        • Citrus Valley Gastroenterology /ID# 166230
      • Irvine, California, United States, 92618
        • Hoag Memorial Hosp Presbyterian /ID# 222538
      • La Jolla, California, United States, 92037
        • UC San Diego Health System /ID# 164763
      • Los Alamitos, California, United States, 90720-3309
        • United Medical Doctors /ID# 207458
      • Los Angeles, California, United States, 90067-2001
        • Gastrointestinal Biosciences Clinical Trials, LLC /ID# 164640
      • Mission Hills, California, United States, 91345
        • Facey Medical Foundation /ID# 203138
      • Murrieta, California, United States, 92563
        • United Medical Doctors - Murrieta /ID# 164602
      • San Diego, California, United States, 92123
        • Medical Assoc Research Grp /ID# 169704
      • San Francisco, California, United States, 94158
        • Univ of California San Francis /ID# 164653
      • San Francisco, California, United States, 94115
        • UCSF Medical Center - Mount Zion /ID# 202372
      • San Pablo, California, United States, 94806
        • Care Access Research /ID# 167765
    • Colorado
      • Colorado Springs, Colorado, United States, 80907
        • Peak Gastroenterology Associates, PC /ID# 170166
      • Colorado Springs, Colorado, United States, 80918
        • Delta Waves, Inc. /ID# 164656
      • Wheat Ridge, Colorado, United States, 80033-2896
        • Western States Clinical Res /ID# 164625
    • Connecticut
      • Hamden, Connecticut, United States, 06518
        • Gastroenterology Center of Connecticut /ID# 164614
    • Florida
      • Coral Springs, Florida, United States, 33067-3173
        • Advanced Research - Coral Springs /ID# 218019
      • Jacksonville, Florida, United States, 32256
        • Encore Borland-Groover Clinical Research /Id# 203500
      • Maitland, Florida, United States, 32751-6108
        • Ctr for Advanced Gastroenterol /ID# 165306
      • Miami, Florida, United States, 33165
        • Crystal Pharmacology Research /ID# 166118
      • Miami, Florida, United States, 33186-4643
        • Coral Research Clinic /ID# 164604
      • New Port Richey, Florida, United States, 34653
        • Advanced Research Institute, Inc /ID# 164601
      • Orlando, Florida, United States, 32803
        • Endoscopic Research, Inc. /ID# 206139
      • Orlando, Florida, United States, 32808
        • Omega Research Group /ID# 203482
      • Tampa, Florida, United States, 33607
        • Clinical Research Trials of Florida, Inc. /ID# 203486
      • Tampa, Florida, United States, 33606-1246
        • Clinical Research of West Florida, Inc /ID# 205828
      • Tampa, Florida, United States, 33606-1246
        • Clinical Research of West Florida, Inc /ID# 208119
      • Tampa, Florida, United States, 33613-4680
        • Duplicate_AdventHealth Tampa /ID# 171181
    • Georgia
      • Macon, Georgia, United States, 31201
        • Gastroenterology Associates of Central Georgia, LLC /ID# 165492
      • Roswell, Georgia, United States, 30076-4913
        • Gastroenterology Consultants, P.C /ID# 218218
      • Suwanee, Georgia, United States, 30024
        • Atlanta Gastroenterology Spec /ID# 164698
    • Idaho
      • Boise, Idaho, United States, 83706
        • Treasure Valley Medical Research /ID# 215030
    • Illinois
      • Chicago, Illinois, United States, 60637-1426
        • University of Chicago Medicine /ID# 165509
      • Chicago, Illinois, United States, 60612
        • Duplicate_Rush University Medical Center /ID# 165470
      • Downers Grove, Illinois, United States, 60515-5509
        • DuPage Medical Group /ID# 205320
    • Indiana
      • Evansville, Indiana, United States, 47714-8011
        • MediSphere Medical Research Center /ID# 166233
      • Indianapolis, Indiana, United States, 46237
        • Indianapolis Gastroenterology /ID# 164649
      • New Albany, Indiana, United States, 47150-4053
        • Aquiant Research /ID# 205505
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • University of Iowa Hospitals and Clinics /ID# 165405
    • Kentucky
      • Crestview Hills, Kentucky, United States, 41017
        • Tri-State Gastroenterology /ID# 165469
      • Louisville, Kentucky, United States, 40202
        • Duplicate_University of Louisville /ID# 165391
      • Louisville, Kentucky, United States, 40202
        • University of Louisville Hospital /ID# 168520
    • Louisiana
      • Houma, Louisiana, United States, 70360
        • Houma Digestive Health Special /ID# 164727
      • New Orleans, Louisiana, United States, 70115
        • Nola Research Works, LLC /ID# 164612
      • Shreveport, Louisiana, United States, 71105-6800
        • Louisiana Research Center, LLC /ID# 164694
    • Maryland
      • Baltimore, Maryland, United States, 21287-0010
        • Duplicate_Johns Hopkins University School of Medicine /ID# 211939
      • Chevy Chase, Maryland, United States, 20815
        • Metropolitan Gastroenterology Group - Chevy Chase /ID# 164647
      • Columbia, Maryland, United States, 21045
        • Gastro Center of Maryland /ID# 171180
    • Massachusetts
      • Burlington, Massachusetts, United States, 01805
        • Duplicate_Lahey Hospital and Medical Center /ID# 214724
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan Comprehensive Cancer Center Michigan Medicine /ID# 164654
      • Chesterfield, Michigan, United States, 48047
        • Clin Res Inst of Michigan, LLC /ID# 170163
      • Farmington Hills, Michigan, United States, 48334-3230
        • Digestive Health Associates (DHA) - Farmington Hills /ID# 206101
      • Troy, Michigan, United States, 48098-6363
        • Center for Digestive Health /ID# 164726
    • Minnesota
      • Rochester, Minnesota, United States, 55905-0001
        • Mayo Clinic - Rochester /ID# 164691
    • Mississippi
      • Jackson, Mississippi, United States, 39216
        • Southern Therapy and Advanced Research (STAR) LLC /ID# 165295
    • Nebraska
      • Omaha, Nebraska, United States, 68114-3723
        • Quality Clinical Research Inc. /ID# 170162
      • Omaha, Nebraska, United States, 68124
        • CHI Health Research Center /ID# 168513
    • Nevada
      • Las Vegas, Nevada, United States, 89113
        • Las Vegas Medical Research /ID# 168551
    • New Jersey
      • Egg Harbor Township, New Jersey, United States, 08234
        • Cooper Gastroenterology at Fire Road /ID# 164641
      • New Brunswick, New Jersey, United States, 08901
        • Rutgers Robert Wood Johnson /ID# 166110
    • New York
      • Bronx, New York, United States, 10467
        • Montefiore Medical Center - Moses Campus /ID# 166242
      • Bronx, New York, United States, 10468
        • Advantage Clinical Trials /ID# 168582
      • Brooklyn, New York, United States, 11235
        • NY Scientific /ID# 164630
      • Johnson City, New York, United States, 13790-2107
        • United Health Services Hospitals, Inc /ID# 217483
      • Lake Success, New York, United States, 11042
        • NYU Langone Long Island Clinical Research Associates /ID# 164627
      • New York, New York, United States, 10029
        • The Mount Sinai Hospital /ID# 170256
      • New York, New York, United States, 10032-3725
        • Columbia Univ Medical Center /ID# 164692
      • Rochester, New York, United States, 14618-5703
        • Gastoenterology Group of Rochester /ID# 166235
      • Staten Island, New York, United States, 10310-1664
        • Richmond University Medical Center /ID# 201858
    • North Carolina
      • Charlotte, North Carolina, United States, 28203
        • Atrium Health Carolinas Medical Center /ID# 164632
      • Charlotte, North Carolina, United States, 28209
        • PMG Research of Charlotte /ID# 171178
      • Raleigh, North Carolina, United States, 27612
        • Wake Radiology UNC REX Healthcare - Raleigh Office /ID# 164752
      • Winston-Salem, North Carolina, United States, 27157-0001
        • Atrium Health Wake Forest Baptist Medical Center /ID# 164755
    • North Dakota
      • Fargo, North Dakota, United States, 58104-5925
        • Plains Clinical Research Center, LLC /ID# 170169
    • Ohio
      • Cincinnati, Ohio, United States, 45267-0585
        • University of Cincinnati /ID# 164729
      • Cincinnati, Ohio, United States, 45219
        • Gastro Health Research /ID# 164668
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic Main Campus /ID# 209230
      • Columbus, Ohio, United States, 43210
        • Ohio State University/ Gastroe /ID# 170159
      • Columbus, Ohio, United States, 43235
        • Optimed Research, Ltd. /ID# 205625
      • Dayton, Ohio, United States, 45424
        • Hometown Urgent Care and Resea /ID# 201289
      • Englewood, Ohio, United States, 45415
        • Dayton Gastroenterology, Inc. /ID# 167623
      • Mentor, Ohio, United States, 44060-6211
        • Great Lakes Gastroenterology Research, LLC /ID# 202006
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73112
        • Digestive Disease Specialists /ID# 201063
      • Tulsa, Oklahoma, United States, 74104
        • Options Health Research, LLC /ID# 164704
      • Tulsa, Oklahoma, United States, 74135
        • Healthcare Research Consultant /ID# 166244
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104-5502
        • University of Pennsylvania /ID# 168406
      • Philadelphia, Pennsylvania, United States, 19107-4414
        • Duplicate_Thomas Jefferson University /ID# 168003
    • South Carolina
      • Charleston, South Carolina, United States, 29412
        • Pharmacorp Clinical Trials /ID# 165008
      • Greenville, South Carolina, United States, 29607
        • Gastroenterology Associates, P.A. of Greenville /ID# 164643
    • South Dakota
      • Rapid City, South Dakota, United States, 57701
        • Rapid City Medical Center - GI Research /ID# 201733
    • Tennessee
      • Cordova, Tennessee, United States, 38018
        • Gastro One /ID# 164730
      • Johnson City, Tennessee, United States, 37604
        • East Tennessee Research Institute /ID# 203614
      • Nashville, Tennessee, United States, 37211
        • Quality Medical Research /ID# 205264
      • Nashville, Tennessee, United States, 37232-0011
        • Vanderbilt University Medical Center /ID# 164607
    • Texas
      • Arlington, Texas, United States, 76012
        • TX Clinical Research Institute /ID# 164719
      • Baytown, Texas, United States, 77521-2415
        • Inquest Clinical Research /ID# 164676
      • Cedar Park, Texas, United States, 78613-5028
        • Texas Digestive Disease Consultants /ID# 209954
      • Cedar Park, Texas, United States, 78613
        • GI Alliance /ID# 209803
      • Dallas, Texas, United States, 75246
        • Baylor Scott & White Center for Inflammatory Bowel Diseases /ID# 170161
      • Houston, Texas, United States, 77058
        • Centex Studies, Inc. - Houston /ID# 201212
      • Houston, Texas, United States, 77070-4347
        • GI Specialists of Houston /ID# 202340
      • Houston, Texas, United States, 77030
        • Baylor College of Medicine /ID# 164609
      • Lubbock, Texas, United States, 79424
        • Caprock Gastro Research - Lubbock - 80th Street /ID# 215436
      • San Antonio, Texas, United States, 78212
        • Clinical Associates in Research Therapeutics of America, LLC /ID# 164675
      • San Antonio, Texas, United States, 78229-5390
        • Southern Star Research Institute, LLC /ID# 169756
      • Sugar Land, Texas, United States, 77478
        • Carl R. Meisner Medical Clinic /ID# 171057
      • Tyler, Texas, United States, 75701
        • Tyler Research Institute, LLC /ID# 168679
      • Victoria, Texas, United States, 77904
        • Gastro Health & Nutrition - Victoria /ID# 167810
    • Utah
      • Bountiful, Utah, United States, 84010
        • HP Clinical Research /ID# 164631
      • Ogden, Utah, United States, 84405
        • Advanced Research Institute /ID# 164689
      • Salt Lake City, Utah, United States, 84124-1377
        • Duplicate_Care Access Research /ID# 164685
      • West Jordan, Utah, United States, 84088
        • Velocity Clinical Research - Salt Lake City /ID# 166113
    • Washington
      • Bellevue, Washington, United States, 98004
        • Texas Digestive Disease Consultants, PLLC dba GI Alliance /ID# 164728
      • Seattle, Washington, United States, 98109
        • University of Washington /ID# 164646
      • Seattle, Washington, United States, 98101
        • Virginia Mason Hospital & Medical Center /ID# 164862
      • Vancouver, Washington, United States, 98664
        • The Vancouver Clinic, INC. PS /ID# 164874
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226-3522
        • Froedtert Memorial Lutheran Hospital /ID# 202285
      • Wauwatosa, Wisconsin, United States, 53226
        • Allegiance Research Specialists /ID# 165298

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

16 years to 73 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

For Substudy 1:

  • Participant who achieve clinical response in Study M14-431 or Study M14-433.
  • Participant completes study procedures in the parent study. The final endoscopy for Studies M14-431 or M14-433 may be missing, if the endoscopy cannot be performed during the COVID-19 pandemic.

For Substudy 2:

  • Participant completes Substudy 1. The Week 52 endoscopy may be missing, if the endoscopy cannot be performed during the COVID-19 pandemic.
  • Participant who achieved clinical response at the time described in the protocol and completes study procedures in the parent study/ substudy.

Exclusion Criteria:

For Substudies 1 and 2:

  • Participant is considered by the investigator, for any reason, to be an unsuitable candidate for the study.
  • Participant who has a known hypersensitivity to upadacitinib or its excipients, or had an adverse event during Studies M14-431 and M14-433 or Substudy 1 or 2 of Study M14-430 that in the investigator's judgment makes the participant unsuitable for this study.
  • Participant at the final visit of M14-431 or M14-433 with any active or chronic recurring infections based on the investigator's assessment that makes the participant an unsuitable candidate for the study. Participants with serious infections undergoing treatment may be enrolled BUT NOT dosed until the infection treatment has been completed and the infection is resolved, based on the investigator's assessment.
  • Participants with high grade colonic dysplasia or malignancy diagnosed at the endoscopy performed at the final visit of Studies M14-431, M14-433 or Substudy 1 of Study M14-430 (Week 52).

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: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Substudy 1: Cohort 1 Upadacitinib Dose A
This is a maintenance group which includes participants who achieved clinical response to upadacitinib in studies M14-431 and M14-433 and will receive upadacitinib dose A for 52 weeks.
Drug: Upadacitinib
Oral; Tablet
Other Names:
  • RINVOQ
  • ABT-494
Experimental: Substudy 1: Cohort 1 Upadacitinib Dose B
This is a maintenance group which includes participants who achieved clinical response to upadacitinib in studies M14-431 and M14-433 and will receive upadacitinib dose B for 52 weeks.
Drug: Upadacitinib
Oral; Tablet
Other Names:
  • RINVOQ
  • ABT-494
Experimental: Substudy 1: Cohort 1 Placebo
This is a maintenance group which includes participants who achieved clinical response to upadacitinib in studies M14-431 and M14-433 and will receive placebo for 52 weeks.
Drug: Placebo for Upadacitinib
Oral; Tablet
Experimental: Substudy 1: Cohort 2 Placebo
This is a maintenance group which includes participants who received double-blind placebo in studies M14-431 and M14-433 and achieved clinical response will continue to receive blinded placebo for 52 Weeks.
Drug: Placebo for Upadacitinib
Oral; Tablet
Experimental: Substudy 1: Cohort 3 Upadacitinib Dose B
This is a maintenance group which includes participants who achieved clinical response to upadacitinib from the extended treatment period of studies M14-431 and M14-433 and will receive upadacitinib Dose B for 52 Weeks.
Drug: Upadacitinib
Oral; Tablet
Other Names:
  • RINVOQ
  • ABT-494
Experimental: Substudy 2: Cohort 4 Upadacitinib Dose B
This is a long-term extension group which includes participants who achieved clinical response in the open-label extended treatment period of study M14-431 and will receive upadacitinib dose B for 240 weeks.
Drug: Upadacitinib
Oral; Tablet
Other Names:
  • RINVOQ
  • ABT-494
Experimental: Substudy 2: Cohort 5 Upadacitinib Dose A
This is a long-term extension group which includes participants who complete Substudy 1 and will receive upadacitinib dose A for 240 weeks.
Drug: Upadacitinib
Oral; Tablet
Other Names:
  • RINVOQ
  • ABT-494
Experimental: Substudy 2: Cohort 5 Upadacitinib Dose B
This is a long-term extension group which includes participants who complete Substudy 1 and will receive upadacitinib dose B for 240 weeks.
Drug: Upadacitinib
Oral; Tablet
Other Names:
  • RINVOQ
  • ABT-494
Experimental: Substudy 2: Cohort 5 Placebo
This is a long-term extension group which includes participants who complete Substudy 1 and will receive placebo for 240 weeks.
Drug: Placebo for Upadacitinib
Oral; Tablet

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sub-Study 1: Percentage of Participants with Clinical Remission per Crohn's Disease Activity Index (CDAI)
Time Frame: Week 52
Clinical remission per CDAI is defined as CDAI <150.
Week 52
Sub-Study 1: Percentage of Participants with Endoscopic Response
Time Frame: Week 52
Endoscopic response is defined as decrease in Simple Endoscopic Score for Crohn's Disease (SES-CD) from Baseline.
Week 52
Number of Participants with Adverse Events
Time Frame: Through Week 240
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The investigator assessed the relationship of each event to the use of study drug as either probably related, possibly related, probably not related or not related. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above. For more details on adverse events please see the Adverse Event section.
Through Week 240

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sub-Study 1: Percentage of Participants with Clinical Remission per Patient-Reported Outcomes (PROs)
Time Frame: Week 52
Clinical remission is defined based on average daily stool frequency (SF) AND average daily abdominal pain (AP) score.
Week 52
Sub-Study 1: Percentage of Participants Achieving Clinical Response 100 (CR-100)
Time Frame: Week 52
Decrease of at least 100 points in CDAI from Baseline.
Week 52
Sub-Study 1: Percentage of Participants with Endoscopic Remission
Time Frame: Week 52
Endoscopic remission is defined per Simplified Endoscopic Score for Crohn's Disease (SES-CD).
Week 52
Sub-Study 1: Percentage of Participants without Corticosteroid use for Crohn's Disease Among All Participants
Time Frame: Week 52
This is assessed in participants not taking corticosteroids at least 90 days prior to Week 52 and achieved clinical remission per CDAI. Clinical remission is defined as CDAI <150.
Week 52
Sub-Study 1: Percentage of Participants with Clinical Remission per CDAI and Endoscopic Remission
Time Frame: Week 52
Clinical remission per CDAI is defined as CDAI <150. Endoscopic remission is defined per SES-CD.
Week 52
Sub-Study 1: Percentage of Participants who Discontinue Corticosteroid Use for Crohn's Disease at Least 90 Days Prior to Week 52 and Achieve Clinical Remission, in Participants Taking Corticosteroids at Baseline.
Time Frame: Week 52
This is assessed in participants taking corticosteroids at Baseline. Clinical remission is defined based on average daily stool frequency (SF) AND average daily abdominal pain (AP) score.
Week 52
Sub-Study 1: Change in Inflammatory Bowel Disease Questionnaire (IBDQ)
Time Frame: Baseline (Week 0) to Week 52
The IBDQ is used to assess the quality of life of patients with inflammatory bowel disease.
Baseline (Week 0) to Week 52
Sub-Study 1: Change in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F)
Time Frame: Baseline (Week 0) to Week 52
The FACIT-F questionnaire was developed to assess fatigue.
Baseline (Week 0) to Week 52
Sub-Study 1: Percentage of Participants with Hospitalizations due to Crohn's Disease (CD)
Time Frame: Up to Week 52
This is assessed by reviewing participant's hospitalization data.
Up to Week 52
Sub-Study 1: Percentage of Participants with Resolution of Extra-Intestinal Manifestation (EIMs) , in Participants with EIMs at Baseline
Time Frame: Week 52
EIMs are defined as manifestations of Crohn's disease in areas of the body other than the digestive tract, including eyes, skin, joints, mouth, and liver.
Week 52
Sub-Study 1: Percentage of Participants with Clinical Remission per CDAI
Time Frame: Through Week 52
Clinical remission per CDAI is defined as CDAI <150 (as measured by the percentage of participants with clinical remission at Week 52 among those with clinical remission at Week 0).
Through Week 52

Collaborators and Investigators

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

Sponsor

AbbVie

Investigators

  • Study Director: ABBVIE INC., AbbVie

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

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 21, 2018

Primary Completion (Estimated)

September 3, 2027

Study Completion (Estimated)

September 3, 2027

Study Registration Dates

First Submitted

November 15, 2017

First Submitted That Met QC Criteria

November 15, 2017

First Posted (Actual)

November 17, 2017

Study Record Updates

Last Update Posted (Actual)

June 17, 2024

Last Update Submitted That Met QC Criteria

June 13, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M14-430
  • 2023-504951-29 (Other Identifier: EU CT)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.

IPD Sharing Time Frame

For details on when studies are available for sharing visit https://vivli.org/ ourmember/abbvie/

IPD Sharing Access Criteria

Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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.

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