A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Participants With Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or Are Intolerant to Biologic Therapy

July 18, 2022 updated by: AbbVie

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects With Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or Are Intolerant to Biologic Therapy

The objective of this study is to evaluate the efficacy and safety of upadacitinib compared to placebo as induction therapy in participants with moderately and severely active Crohn's disease (CD).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

624

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 Univesitario /ID# 169228
    • Buenos Aires
      • San Isidro, Buenos Aires, Argentina, 1642
        • Cardio Alem /ID# 211284
    • Ciuadad Autonoma De Buenos Aires
      • Ciudad Autonoma Buenos Aires, Ciuadad Autonoma De Buenos Aires, Argentina, 1199
        • Hospital Italiano de Buenos Aires /ID# 215543
      • Ciudad Autonoma de Buenos Aire, Ciuadad Autonoma De Buenos Aires, Argentina, 1115
        • Gedyt /ID# 210019
      • Ciudad Autonoma de Buenos Aire, Ciuadad Autonoma De Buenos Aires, Argentina, 1431
        • Cemic /Id# 169184
    • Santa Fe
      • Rosario, Santa Fe, Argentina, 2000
        • Hospital Provincial del Centenario /ID# 171254
  • Australia
    • New South Wales
      • Concord, New South Wales, Australia, 2139
        • Concord Repatriation General Hospital /ID# 171509
    • Queensland
      • North Mackay, Queensland, Australia, 4740
        • Coral Sea Clinical Research institute /ID# 212987
      • South Brisbane, Queensland, Australia, 4101
        • Mater Misericordiae Limited /ID# 204908
    • South Australia
      • Adelaide, South Australia, Australia, 5000
        • Royal Adelaide Hospital /ID# 171511
    • Victoria
      • Box Hill, Victoria, Australia, 3128
        • Box Hill Hospital /ID# 203734
    • Western Australia
      • Murdoch, Western Australia, Australia, 6150
        • Fiona Stanley Hospital /ID# 171510
  • Austria
      • Salzburg, Austria, 5020
        • Landeskrankenhaus Salzburg-Universitätsklinikum der PMU (LKH) /ID# 214467
    • Wien
      • Vienna, Wien, Austria, 1030
        • Klinik Landstrasse /ID# 203437
      • Vienna, Wien, Austria, 1090
        • Medizinische Universitaet Wien /ID# 169462
  • Belgium
      • Gent, Belgium, 9000
        • AZ Sint-Lucas /ID# 200301
    • Bruxelles-Capitale
      • Woluwe-Saint-Lambert, Bruxelles-Capitale, Belgium, 1200
        • UCL Saint-Luc /ID# 200297
    • Liege
      • Liège, Liege, Belgium, 4000
        • CHU de Liege Sart Tilman /ID# 200299
    • Namur
      • Godinne, Namur, Belgium, 5530
        • CHU UCL Namur - site Godinne /ID# 200300
    • Vlaams-Brabant
      • Leuven, Vlaams-Brabant, Belgium, 3000
        • Universitair Ziekenhuis Leuven /ID# 200298
  • Bosnia and Herzegovina
      • Sarajevo, Bosnia and Herzegovina, 71000
        • Clinical Center University of Sarajevo /ID# 203885
      • Sarajevo, Bosnia and Herzegovina, 71000
        • Polyclinic and Daily Hospital Dr. Al-Tawil /ID# 217841
    • Republika Srpska
      • Banja Luka, Republika Srpska, Bosnia and Herzegovina, 78000
        • University Clinical Centre of the Republic of Srpska /ID# 208050
    • Tuzlanski
      • Tuzla, Tuzlanski, Bosnia and Herzegovina, 75000
        • University Clinical Center Tuzla /ID# 210324
  • Brazil
    • Goias
      • Goiânia, Goias, Brazil, 74535-170
        • Instituto Goiano de Gastroenterologia e Endoscopia Digestiva /ID# 166870
    • Parana
      • Curitiba, Parana, Brazil, 80810-040
        • Hospital Nossa Senhora das Graças /ID# 166869
    • Rio Grande Do Sul
      • Porto Alegre, Rio Grande Do Sul, Brazil, 90035-903
        • Hospital de Clinicas de Porto Alegre /ID# 166872
    • Sao Paulo
      • Botucatu, Sao Paulo, Brazil, 18618-686
        • Upeclin Fmb - Unesp /Id# 166876
      • Ribeirão Preto, Sao Paulo, Brazil, 14051-140
        • Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto - USP /ID# 166874
      • Santo André, Sao Paulo, Brazil, 09060-870
        • Faculdade de Medicina do ABC /ID# 208327
      • Sao Jose Do Rio Preto, Sao Paulo, Brazil, 15015-110
        • Kaiser Clinica e Hospital Dia /ID# 166873
  • Bulgaria
      • Plovdiv, Bulgaria, 4001
        • UMHAT Kaspela EOOD /ID# 167617
      • Sofia, Bulgaria, 1202
        • Duplicate_Second MHAT Sofia /ID# 167618
      • Stara Zagora, Bulgaria, 6004
        • MHAT Trakia /ID# 201678
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 4Z6
        • University of Calgary - Cumming School of Medicine - Adult Cystic Fibrosis Clini /ID# 166963
      • Edmonton, Alberta, Canada, T5R 1W2
        • Allen Whey Khye Lim Professional Corporation /ID# 168041
      • Edmonton, Alberta, Canada, T6K 4B2
        • Covenant Health /ID# 166966
    • British Columbia
      • New Westminster, British Columbia, Canada, V3L 3W4
        • Fraser Clinical Trials Inc /ID# 166957
      • Vancouver, British Columbia, Canada, V6Z 2K5
        • GIRI Gastrointestinal Research Institute /ID# 166964
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 2Y9
        • QEII - Health Sciences Centre /ID# 169306
    • Ontario
      • North Bay, Ontario, Canada, P1B 2H3
        • Scott Shulman Medicine Professional Corporation /ID# 169064
      • Oshawa, Ontario, Canada, L1H 7K4
        • Taunton Surgical Centre /ID# 168039
      • Ottawa, Ontario, Canada, K1H 8L6
        • The Ottawa Hospital /ID# 212413
      • Sudbury, Ontario, Canada, P3A 1W8
        • Medicor Research Inc /ID# 166967
      • Vaughan, Ontario, Canada, L4L 4Y7
        • Toronto Digestive Disease Asso /ID# 166961
    • Quebec
      • Levis, Quebec, Canada, G6V 3Z1
        • CHAU- Hotel-Dieu de Levis /ID# 166958
      • Montreal, Quebec, Canada, H2X 0A9
        • Crchum /Id# 170121
      • Montreal, Quebec, Canada, H3G 1A4
        • Montreal General Hospital - McGill University Health Center /ID# 170010
      • Sherbrooke, Quebec, Canada, J1G 2E8
        • CIUSSS de l'Estrie - CHUS /ID# 170935
  • Chile
      • Concepción, Chile, 4070038
        • Hospital Guillermo Grant Benavente de Concepción /ID# 212422
      • Providencia, Chile, 7500571
        • CTR Estudios Clinicos /ID# 200650
      • Santiago, Chile, 7501504
        • Hospital Clinico Universidad De Los Andes /ID# 207465
    • Region Metropolitana De Santiago
      • Santiago, Region Metropolitana De Santiago, Chile, 2540364
        • Research Group /ID# 203180
    • Region Metropolitana Santiago
      • Santiago, Region Metropolitana Santiago, Chile, 7750495
        • M y F Estudios Clínicos /ID# 169995
  • China
      • Beijing, China, 100032
        • Beijing Friendship Hospital /ID# 204536
      • Changsha, China, 410011
        • The Second Hospital Central South University /ID# 204075
      • Guangzhou, China, 510080
        • Nanfang Hospital of Southern Medical University /ID# 204074
      • Tianjin, China, 300052
        • Duplicate_Tianjin Med Univ General Hosp /ID# 206993
      • Wuhan, China, 430030
        • Tongji Hospital Tongji Medical College Huazhong University of Science and Techno /ID# 204069
    • Anhui
      • Fujian, Anhui, China, 361004
        • Zhongshan Hospital Xiamen University /ID# 204985
    • Guangdong
      • Guangzhou, Guangdong, China, 510120
        • Sun Yat-sen Memorial Hospital of Sun Yat-sen University /ID# 205226
      • Guangzhou, Guangdong, China, 510655
        • The Sixth Affiliated Hosp Sun /ID# 204049
    • Hubei
      • Wuhan, Hubei, China, 430022
        • Union Hospital Tongji Medical College Huazhong University of Science and Technol /ID# 204096
    • Jiangsu
      • Nanjing, Jiangsu, China, 210008
        • Nanjing Drum Tower Hospital /ID# 204869
    • Jiangxi
      • Nanchang, Jiangxi, China, 330006
        • The First Affiliated Hospital of Nanchang University /ID# 204070
    • Jilin
      • Changchun, Jilin, China, 130021
        • The First Hospital of Jilin University /ID# 206867
    • Shanghai
      • Shanghai, Shanghai, China, 200065
        • Ruijin Hospital, Shanghai Jiaotong University School of Medicine /ID# 204072
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310009
        • The second Affiliated hospital of Zhejiang University school of Medicine /ID# 204078
      • Hangzhou, Zhejiang, China, 310018
        • Sir Run Run Shaw Hospital,Meical School Zhejiang University /ID# 204068
  • Colombia
    • Antioquia
      • Medellin, Antioquia, Colombia, 50034
        • Hospital San Vicente de Paul /ID# 200028
      • Medellín, Antioquia, Colombia, 50034
        • Hospital Pablo Tobon Uribe /ID# 202405
  • Croatia
      • Split, Croatia, 21000
        • UHC Split /ID# 171206
      • Zadar, Croatia, 23000
        • Zadar General Hospital /ID# 205534
    • Grad Zagreb
      • Zagreb, Grad Zagreb, Croatia, 10000
        • Clinical Hospital Dubrava /ID# 171186
      • Zagreb, Grad Zagreb, Croatia, 10000
        • Klinicki bolnicki centar Sestre milosrdnice /ID# 171190
      • Zagreb, Grad Zagreb, Croatia, 10000
        • Klinicki bolnicki centar Zagreb /ID# 171201
      • Zagreb, Grad Zagreb, Croatia, 10000
        • Poliklinika Solmed /ID# 211518
  • Czechia
      • Hradec Kralove, Czechia, 500 12
        • Hepato-Gastroenterologie HK, s.r.o. /ID# 171566
      • Praha, Czechia, 143 00
        • ResTrial s.r.o. /ID# 208652
      • Třebovice, Czechia, 722 00
        • ARTROSCAN s.r.o. /ID# 171592
  • Denmark
    • Hovedstaden
      • Frederikssund, Hovedstaden, Denmark, 3600
        • Nordsjaellands Hospital /ID# 200613
      • Herlev, Hovedstaden, Denmark, 2730
        • Herlev Hospital /ID# 200782
      • Hvidovre, Hovedstaden, Denmark, 2650
        • Kobenhavns Universitet - Hvidovre Hospital (HH) /ID# 200611
    • Sjælland
      • Roskilde, Sjælland, Denmark, 4000
        • Duplicate_Sjaellands Universitets Hospital /ID# 200783
  • Egypt
      • Alexandria, Egypt, 21131
        • Clinical Research Center, Faculty of Medicine, Alexandria university. /ID# 171010
      • Alexandria, Egypt, 21131
        • Clinical Research Center, Faculty of Medicine, Alexandria university. /ID# 171015
      • Cairo, Egypt, 11559
        • Clinical Research Center, Faculty of Medicine, Cairo university /ID# 209557
      • Cairo, Egypt, 11559
        • National Hepatology and Tropical Medicine Research Institute /ID# 170990
      • Cairo, Egypt, 11566
        • Faculty of Medicine Ain Shams Research Institute- Clinical Research Centre /ID# 209565
      • Cairo, Egypt
        • Air Force Specialized Hospital /ID# 170995
  • Estonia
    • Tartumaa
      • Tartu Linn, Tartumaa, Estonia, 50406
        • Tartu University Hospital /ID# 203140
  • France
      • Chambray Les Tours, France, 37170
        • CHRU Tours - Hopital Trousseau /ID# 169786
      • Creteil, France, 94000
        • Duplicate_CHU Henri Mondor /ID# 169787
      • Nimes Cedex, France, 30932
        • Polyclinique Grand Sud /ID# 170649
      • Toulouse, France, 31400
        • CHU Toulouse - Hopital Rangueil /ID# 169785
    • Alpes-Maritimes
      • Nice, Alpes-Maritimes, France, 06200
        • Chu de Nice-Hopital L'Archet Ii /Id# 171009
    • Auvergne-Rhone-Alpes
      • Pierre Benite CEDEX, Auvergne-Rhone-Alpes, France, 69495
        • HCL - Hôpital Lyon Sud /ID# 171014
    • Gironde
      • Pessac CEDEX, Gironde, France, 33604
        • CHU Bordeaux - Hopital Haut Lévêque /ID# 207414
    • Hauts-de-France
      • Lille, Hauts-de-France, France, 59037
        • CHRU Lille - Hopital Claude Huriez /ID# 206539
    • Herault
      • Montpellier CEDEX 5, Herault, France, 34295
        • Duplicate_Hopital Saint Eloi /ID# 170646
    • Ile-de-France
      • Clichy, Ile-de-France, France, 92110
        • Hopital Beaujon /ID# 171011
    • Loire
      • St. Priest En Jarez, Loire, France, 42270
        • CHU de SAINT ETIENNE - Hopital Nord /ID# 171018
    • Meurthe-et-Moselle
      • Vandœuvre-lès-Nancy, Meurthe-et-Moselle, France, 54500
        • CHRU Nancy - Hôpitaux de Brabois /ID# 170985
    • Somme
      • Amiens CEDEX 1, Somme, France, 80054
        • CHU Amiens-Picardie Site Sud /ID# 171016
  • Germany
      • Berlin, Germany, 12203
        • Charite Universitaetsklinikum Berlin - Campus Benjamin Franklin /ID# 169067
      • Berlin, Germany, 14163
        • Gastroenterologie am Mexikoplatz /ID# 203573
      • Essen, Germany, 45239
        • Universitaetsmedizin Essen St. Josef Krankenhaus Werden /ID# 203571
      • Frankfurt am Main, Germany, 60431
        • Agaplesion Markus Krankenhaus /ID# 168777
      • Halle (Saale), Germany, 06120
        • Universitaetsklinikum Halle (Saale) /ID# 207454
      • Muenster, Germany, 48155
        • Medizinisches Versorgungszentrum Portal 10 /ID# 200213
    • Baden-Wuerttemberg
      • Mannheim, Baden-Wuerttemberg, Germany, 68167
        • Universitatsklinikum Mannheim /ID# 168778
      • Ulm, Baden-Wuerttemberg, Germany, 89081
        • Universitaetsklinikum Ulm /ID# 203563
    • Bayern
      • Erlangen, Bayern, Germany, 91054
        • Universitaetsklinikum Erlangen /ID# 203551
    • Hessen
      • Frankfurt am Main, Hessen, Germany, 60590
        • Universitaetsklinikum Frankfurt /ID# 203565
    • Saarland
      • Saarbrücken, Saarland, Germany, 66111
        • Zentrum für Gastroenterologie Saar MVZ GmbH /ID# 206740
    • Schleswig-Holstein
      • Kiel, Schleswig-Holstein, Germany, 24105
        • Universitaetsklinikum Schleswig-Holstein Campus Kiel /ID# 168779
  • Greece
      • Athens, Greece, 10676
        • General Hospital of Athens Evaggelismos and Ophthalmiatrio of Athens Polyclinic /ID# 167037
      • Thessaloniki, Greece, 54642
        • Genl Hosp Thess Ippokrateio /ID# 208824
    • Attiki
      • Athens, Attiki, Greece, 11527
        • General Hospital of Athens Ippokratio /ID# 167036
      • Athens, Attiki, Greece, 11527
        • General Hospital of Chest Diseases of Athens SOTIRIA /ID# 202103
      • Piraeus, Attiki, Greece, 18536
        • Tzaneio general hospital of Piraeus /ID# 206432
    • Kriti
      • Heraklion, Kriti, Greece, 71500
        • University General Hospital of Heraklion PA.G.N.I /ID# 167035
  • Hong Kong
      • Hong Kong, Hong Kong, 999077
        • Queen Mary Hospital /ID# 171217
  • Hungary
      • Budapest, Hungary, 1134
        • Magyar Honvedseg Egeszsegugyi Kozpont /ID# 201719
      • Debrecen, Hungary, 4031
        • Debreceni Egyetem Kenezy Gyula Egyetemi Korhaz /ID# 201720
      • Szekesfehervar, Hungary, 8000
        • Mentahaz Maganorvosi Kozpont /ID# 201890
    • Borsod-Abauj-Zemplen
      • Miskolc, Borsod-Abauj-Zemplen, Hungary, 3529
        • CRU Hungary Egeszsegugyi és Szolgaltato Kft. /ID# 205546
    • Heves
      • Gyöngyös, Heves, Hungary, 3200
        • Bugat Pal Korhaz /ID# 201889
    • Pest
      • Budapest, Pest, Hungary, 1036
        • Obudai Egeszsegugyi Centrum Kft. /ID# 201891
  • Ireland
      • Cork, Ireland, T12 WE28
        • Mercy University Hospital /ID# 206510
  • Israel
      • Ashkelon, Israel, 7830604
        • Barzilai Medical Center /ID# 223372
      • Be'Er Ya'Akov, Israel, 70300
        • Assaf Harofeh Medical Center /ID# 204870
      • Jerusalem, Israel, 91120
        • Hadassah Medical Center-Hebrew University /ID# 169927
      • Petakh Tikva, Israel, 4941492
        • Rabin Medical Center /ID# 202635
      • Rehovot, Israel, 7661041
        • Kaplan Medical Center /ID# 170277
    • HaDarom
      • Be'er Sheva, HaDarom, Israel, 8443901
        • Soroka University Medical Center /ID# 169912
    • Tel-Aviv
      • Tel Aviv-Yafo, Tel-Aviv, Israel, 6423906
        • Tel Aviv Sourasky Medical Center /ID# 204876
  • Italy
      • Bologna, Italy, 40138
        • A.O.U. di Bologna Policlinico S.Orsola-Malpighi /ID# 168173
      • Catania, Italy, 95126
        • A.O. Per L'Emergenza Cannizzaro /ID# 168176
      • Genova, Italy, 16132
        • Policlinico San Martino/Univer /ID# 168177
      • Milano, Italy, 20121
        • ASST Fatebenefratelli Sacco - Ospedale Fatebenefratelli e Oftalmico /ID# 168167
      • Modena, Italy, 41124
        • Azienda Ospedaliero-Universitaria di Modena /ID# 200008
      • Palermo, Italy, 90146
        • A.O. Ospedali Riuniti Villa Sofia - Cervello /ID# 168175
      • Pisa, Italy, 56125
        • Azienda Ospedaliero Universitaria Pisana-Stabilimento di Cisanello /ID# 202420
    • Calabria
      • Catanzaro, Calabria, Italy, 88100
        • University of Catanzaro /ID# 201920
    • Lazio
      • Rome, Lazio, Italy, 00128
        • Policlinico Universitario Campus Bio-Medico /ID# 168169
      • Rome, Lazio, Italy, 00152
        • Azienda Ospedaliera San Camillo Forlanini /ID# 168170
    • Milano
      • Rozzano, Milano, Italy, 20089
        • Istituto Clinico Humanitas /ID# 168171
    • Roma
      • Rome, Roma, Italy, 00133
        • Fondazione PTV Policlinico Tor Vergata /ID# 168174
      • Rome, Roma, Italy, 00168
        • Presidio Columbus-Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Un /ID# 168168
    • Verona
      • Negrar, Verona, Italy, 37024
        • IRCCS Ospedale Sacro Cuore Don Calabria /ID# 168172
  • Japan
    • Aichi
      • Nagakute-shi, Aichi, Japan, 480-1195
        • Aichi Medical University Hospital /ID# 165957
      • Nagoya shi, Aichi, Japan, 467-8602
        • Nagoya City University Hospital /ID# 165956
      • Nagoyashi, Aichi, Japan, 4668560
        • Nagoya University Hospital /ID# 165955
      • Toyohashi-shi, Aichi, Japan, 441-8570
        • Toyohashi Municipal Hospital /ID# 200174
    • Aomori
      • Hirosaki-shi, Aomori, Japan, 036-8545
        • Hirosaki National Hospital /ID# 165944
    • Chiba
      • Sakura-shi, Chiba, Japan, 285-8741
        • Toho University Sakura Medical Center /ID# 165949
    • Fukuoka
      • Kurume-shi, Fukuoka, Japan, 830-0011
        • Kurume University Hospital /ID# 166004
    • Gunma
      • Takasaki-shi, Gunma, Japan, 370-0829
        • National Hospital Organization Takasaki General Medical Center /ID# 167136
    • Hiroshima
      • Fukuyama-shi, Hiroshima, Japan, 720-8520
        • NHO Fukuyama Medical Center /ID# 167139
      • Hiroshima-shi, Hiroshima, Japan, 734-8551
        • Hiroshima University Hospital /ID# 166006
    • Hokkaido
      • Asahikawa-shi, Hokkaido, Japan, 078-8510
        • Asahikawa Medical University Hospital /ID# 167133
      • Sapporo-shi, Hokkaido, Japan, 060-0033
        • Hokkaido P.W.F.A.C. Sapporo-Kosei General Hospital /ID# 165943
      • Sapporo-shi, Hokkaido, Japan, 060-8543
        • Sapporo Medical University Hospital /ID# 167137
    • Hyogo
      • Kobe-shi, Hyogo, Japan, 650-0015
        • Aoyama Clinic /ID# 166001
      • Nishinomiya-shi, Hyogo, Japan, 663-8501
        • Hyogo College of Medicine College Hospital /Id# 200173
    • Ishikawa
      • Kanazawa-shi, Ishikawa, Japan, 920-8641
        • Kanazawa University Hospital /ID# 169215
    • Iwate
      • Morioka-shi, Iwate, Japan, 020-8505
        • Iwate Medical University Uchimaru Medical Center /ID# 202407
    • Kagoshima
      • Kagoshima-shi, Kagoshima, Japan, 890-0064
        • Imamura General Hospital /ID# 227136
      • Kagoshima-shi, Kagoshima, Japan, 892-0824
        • Idzuro Imamura Hospital /ID# 206651
      • Kagoshima-shi, Kagoshima, Japan, 892-0846
        • Sameshima Hospital /ID# 206674
    • Kyoto
      • Kyoto-shi, Kyoto, Japan, 605-0981
        • Japanese Red Cross Kyoto Daiichi Hosital /ID# 165958
      • Kyoto-shi, Kyoto, Japan, 606-8507
        • Kyoto University Hospital /ID# 169888
    • Mie
      • Yokkaichi-shi, Mie, Japan, 510-0016
        • Yokkaichi Hazu Medical Center /ID# 167191
    • Miyagi
      • Sendai-shi, Miyagi, Japan, 9808574
        • Tohoku University Hospital /ID# 167135
    • Nara
      • Kashihara-shi, Nara, Japan, 634-8522
        • Nara Medical University Hospital /ID# 169216
      • Yamatotakada-shi, Nara, Japan, 635-0022
        • Kenseikai Dongo Hospital /ID# 208103
    • Niigata
      • Niigata-shi, Niigata, Japan, 951-8520
        • Niigata University Medical & Dental Hospital /ID# 170044
    • Oita
      • Oita-shi, Oita, Japan, 870-0823
        • Ishida Clinic of IBD and Gastroenterology /ID# 167134
    • Okayama
      • Kurashiki-shi, Okayama, Japan, 710-0142
        • Chikuba Hospital for Proctological and Gastrointestinal Diseases /ID# 166002
      • Okayama-shi, Okayama, Japan, 700-8558
        • Okayama University Hospital /ID# 167355
    • Osaka
      • Osaka-shi, Osaka, Japan, 530-0011
        • Kinshukai Infusion Clinic /ID# 218871
      • Osaka-shi, Osaka, Japan, 545-8586
        • Osaka City University Hospital /ID# 166007
      • Suita-shi, Osaka, Japan, 565-0871
        • Osaka University Hospital /ID# 169662
      • Takatsuki-shi, Osaka, Japan, 569-8686
        • Osaka Medical and Pharmaceutical University Hospital /ID# 206324
    • Saitama
      • Saitama-shi, Saitama, Japan, 336-0963
        • Tokitokai Tokito clinic /ID# 165945
    • Shiga
      • Otsu-shi, Shiga, Japan, 520-2192
        • Shiga University of Medical Science Hospital /ID# 167141
    • Shizuoka
      • Sunto-gun, Shizuoka, Japan, 411-8611
        • NHO Shizuoka Medical Center /ID# 167138
    • Tokyo
      • Bunkyo-ku, Tokyo, Japan, 113-8519
        • Tokyo Medical And Dental University, Medical Hospital /ID# 165948
      • Hachioji-shi, Tokyo, Japan, 192-0032
        • Duplicate_Tokai University Hachioji Hospital /ID# 165951
      • Minato-ku, Tokyo, Japan, 105-8471
        • The Jikei University Hospital /ID# 167142
      • Mitaka-shi, Tokyo, Japan, 181-8611
        • Kyorin University Hospital /ID# 165950
      • Shinjuku-ku, Tokyo, Japan, 162-8666
        • Tokyo Women's Medical University Hospital /ID# 205981
    • Toyama
      • Toyama-shi, Toyama, Japan, 930-8550
        • Toyama Prefectural Central Hospital /ID# 217833
    • Wakayama
      • Wakayama-shi, Wakayama, Japan, 640-8558
        • Japanese Red Cross Wakayama Medical Center /ID# 200638
      • Wakayama-shi, Wakayama, Japan, 641-8510
        • Wakayama Medical University Hospital /ID# 169481
    • Yamagata
      • Yamagata-shi, Yamagata, Japan, 990-9585
        • Yamagata University Hospital /ID# 200156
  • Korea, Republic of
      • Busan, Korea, Republic of, 48108
        • Inje University Haeundae Hospital /ID# 202629
      • Busan, Korea, Republic of, 49201
        • Dong-A University Hospital /ID# 167582
      • Busan, Korea, Republic of, 49241
        • Pusan National University Hospital /ID# 167580
      • Daegu, Korea, Republic of, 41944
        • Kyungpook National Univ Hosp /ID# 207015
      • Seoul, Korea, Republic of, 06351
        • Samsung Medical Center /ID# 167579
      • Seoul, Korea, Republic of, 06973
        • Chung-Ang University Hostipal /ID# 207017
    • Gyeonggido
      • Guri, Gyeonggido, Korea, Republic of, 11923
        • Hayang University GuriHospital /ID# 167578
      • Seongnam si, Gyeonggido, Korea, Republic of, 13496
        • CHA University Bundang Medical Center /ID# 167583
    • Seoul Teugbyeolsi
      • Seoul, Seoul Teugbyeolsi, Korea, Republic of, 03181
        • Kangbuk Samsung Hospital /ID# 167577
      • Seoul, Seoul Teugbyeolsi, Korea, Republic of, 03722
        • Yonsei University Health System Severance Hospital /ID# 167581
  • Latvia
      • Riga, Latvia, 1002
        • Pauls Stradins Clinical University Hospital /ID# 169493
      • Riga, Latvia, LV-1079
        • Digestive Disease Center Gastro /ID# 169517
      • Riga, Latvia, LV-1079
        • Riga East Clinical University Hospital /ID# 169496
  • Lithuania
      • Kaunas, Lithuania, 50161
        • Hospital of Lithuanian University of Health Sciences Kaunas Clinics /ID# 207263
      • Vilnius, Lithuania, 08661
        • Vilnius University Hospital Santaros Klinikos /ID# 203285
  • Malaysia
    • Kedah
      • Alor Setar, Kedah, Malaysia, 05460
        • Hospital Sultanah Bahiyah /ID# 202627
    • Selangor
      • Kuala Lumpur, Selangor, Malaysia, 56000
        • Universiti Kebangsaan Malaysia (UKM) Medical Centre /ID# 170778
  • Mexico
    • Durango
      • Victoria de Durango, Durango, Mexico, 34000
        • Instituto de Investigaciones Aplicadas a la Neurociencias A.C. /ID# 207143
    • Guanajuato
      • Leon, Guanajuato, Mexico, 37000
        • Morales Vargas Centro de Investigacion S.C. /ID# 203495
    • Jalisco
      • Guadalajara, Jalisco, Mexico, 44650
        • Clinica de Investigacion en Reumatologia y Obesidad S.C. /ID# 206779
  • Netherlands
      • Amsterdam, Netherlands, 1105 AZ
        • Academisch Medisch Centrum /ID# 166924
      • Enschede, Netherlands, 7512 KZ
        • Medisch Spectrum Twente /ID# 170297
    • Gelderland
      • Nijmegen, Gelderland, Netherlands, 6525 GA
        • Radboud Universitair Medisch Centrum /ID# 166925
    • Limburg
      • Heerlen, Limburg, Netherlands, 6419 PC
        • Zuyderland Medisch Centrum /ID# 169698
  • Poland
    • Dolnoslaskie
      • Wroclaw, Dolnoslaskie, Poland, 53-149
        • Vistamed /ID# 208570
    • Malopolskie
      • Krakow, Malopolskie, Poland, 30-149
        • Malopolskie Centrum Kliniczne /ID# 202166
    • Mazowieckie
      • Warsaw, Mazowieckie, Poland, 00-728
        • WIP Warsaw IBD Point Profesor Kierkus /ID# 224300
      • Warsaw, Mazowieckie, Poland, 02-691
        • Centrum Medyczne Reuma Park w Warszawie /ID# 200488
      • Warszawa, Mazowieckie, Poland, 00-635
        • Centrum Zdrowia MDM /ID# 200486
  • Portugal
      • Almada, Portugal, 2805-267
        • Hospital Garcia de Orta, EPE /ID# 170234
      • Porto, Portugal, 4200-319
        • Centro Hospitalar Universitario de Sao Joao, EPE /ID# 170231
    • Braga
      • Guimaraes, Braga, Portugal, 4835-044
        • Hospital da Senhora da Oliveira Guimaraes, EPE /ID# 170225
    • Porto
      • Lisbon, Porto, Portugal, 1349-019
        • Hospital Egas Moniz /ID# 170249
    • 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# 200606
  • Puerto Rico
      • San Juan, Puerto Rico, 00918-3756
        • Mindful Medical Research /ID# 203357
      • San Juan, Puerto Rico, 00935
        • School of Medicine University of Puerto Rico-Medical Science Campus /ID# 166770
  • Romania
      • Timișoara, Romania, 300002
        • Cabinet Particular Policlinic Algomed /ID# 167827
    • Bucuresti
      • Sector 2, Bucuresti, Romania, 022328
        • Institutul Clinic Fundeni /ID# 167826
    • Cluj
      • Cluj-Napoca, Cluj, Romania, 400380
        • Clinica GASTRO MED SRL /ID# 206367
  • Russian Federation
      • Moscow, Russian Federation, 105554
        • Olla-Med Clinic /ID# 208721
      • Murmansk, Russian Federation, 183047
        • P.A. Bayandin Murmansk Regiona /ID# 169575
      • Petrozavodsk, Russian Federation, 185019
        • Republican hospital named after V.A. Baranov /ID# 206487
      • Pushkin, Russian Federation, 196603
        • Euromedservice /ID# 206609
      • Saint Petersburg, Russian Federation, 194156
        • X7 Clinical Research Center /ID# 216349
      • St. Petersburg, Russian Federation, 197110
        • City Clinical Hospital No. 31 /ID# 208870
    • Kaliningradskaya Oblast
      • Kaliningrad, Kaliningradskaya Oblast, Russian Federation, 236016
        • Immanuel Kant Baltic Federal University /ID# 202128
    • Novosibirskaya Oblast
      • Novosibirsk, Novosibirskaya Oblast, Russian Federation, 630099
        • LLC Medical Center /ID# 209233
    • Permskiy Kray
      • Perm, Permskiy Kray, Russian Federation, 614109
        • Perm Clinical Center of the Federal Medical and Biological Agency /ID# 202988
    • Stavropol Skiy Kray
      • Pyatigorsk, Stavropol Skiy Kray, Russian Federation, 357500
        • LLC Novaya Klinika /ID# 206615
      • Stavropol, Stavropol Skiy Kray, Russian Federation, 355012
        • Professor Pasechnikov Gastroenterology and Pankreatology clinic /ID# 202995
    • Tatarstan, Respublika
      • Kazan, Tatarstan, Respublika, Russian Federation, 420012
        • Kazan State Medical University /ID# 169574
  • Serbia
    • Beograd
      • Belgrade, Beograd, Serbia, 11000
        • Clinical Hosp Center Zvezdara /ID# 168221
      • Belgrade, Beograd, Serbia, 11000
        • Military Medical Academy /ID# 168784
      • Belgrade, Beograd, Serbia, 11000
        • University Clinical Center Serbia /ID# 168220
      • Belgrade, Beograd, Serbia, 11080
        • Clin Hosp Ctr Bezanijska Kosa /ID# 168799
    • Sumadijski Okrug
      • Kragujevac, Sumadijski Okrug, Serbia, 34000
        • University Clinical Center Kragujevac /ID# 205858
    • Vojvodina
      • Novi Sad, Vojvodina, Serbia, 21000
        • Clinical Center Vojvodina /ID# 168222
  • Singapore
      • Singapore, Singapore, 228510
        • KL Ling Gastroenterology and Liver Clinic /ID# 217963
      • Singapore, Singapore, 258499
        • Gleneagles Medical Centre /ID# 206530
      • Singapore, Singapore, 308433
        • Tan Tock Seng Hospital /ID# 203159
  • Slovakia
      • Banska Bystrica, Slovakia, 975 17
        • Fakultna nemocnica s poliklinikou F.D. Roosevelta Banska Bystrica /ID# 169952
      • Nitra, Slovakia, 949 01
        • KM Management, spol. s.r.o. /ID# 170199
  • Slovenia
      • Ljubljana, Slovenia, 1000
        • Univ Medical Ctr Ljubljana /ID# 211042
  • South Africa
    • Free State
      • Bloemfontein, Free State, South Africa, 9301
        • Farmovs (Pty) Ltd /Id# 207536
    • Gauteng
      • Johannesburg, Gauteng, South Africa, 1820
        • Lenasia Clinical Trial Centre /ID# 205144
      • Johannesburg, Gauteng, South Africa, 2193
        • Wits Clinical Research Site /ID# 170851
    • Western Cape
      • Cape Town, Western Cape, South Africa, 7708
        • Dr JP Wright /ID# 170885
      • Cape Town, Western Cape, South Africa, 7800
        • Private Practice Dr MN Rajabally /ID# 169852
  • Spain
      • A Coruna, Spain, 15006
        • Hospital Universitario A Coruna - CHUAC /ID# 203908
      • Barcelona, Spain, 08035
        • Hospital Universitario Vall d'Hebron /ID# 171237
      • Barcelona, Spain, 08036
        • Hospital Clinic de Barcelona /ID# 171242
      • Girona, Spain, 17007
        • Hospital Universitario de Girona Doctor Josep Trueta /ID# 202040
      • Huelva, Spain, 21005
        • Hospital Juan Ramon Jimenez /ID# 171243
      • Madrid, Spain, 28046
        • Hospital Universitario La Paz /ID# 171241
      • Sevilla, Spain, 41009
        • Hospital Universitario Virgen Macarena /ID# 171240
      • Valencia, Spain, 46026
        • Hospital Universitario y Politecnico La Fe /ID# 201988
    • Cantabria
      • Santander, Cantabria, Spain, 39008
        • Hospital Unversitario Marques de Valdecilla /ID# 202039
    • Illes Balears
      • Palma de Mallorca, Illes Balears, Spain, 07120
        • Hospital Universitari Son Espases /ID# 201997
    • Las Palmas
      • Las Palmas de Gran Canaria, Las Palmas, Spain, 35010
        • Hospital Universitario Dr. Negrin /ID# 171238
    • Navarra
      • Pamplona, Navarra, Spain, 31008
        • Complejo Hospitalario de Navarra /ID# 202038
  • Sweden
    • Hallands Lan
      • Halmstad, Hallands Lan, Sweden, 302 33
        • Hallands Hospital Halmstad /ID# 170840
    • Vastra Gotalands Lan
      • Alingsas, Vastra Gotalands Lan, Sweden, 441 33
        • Alingsas lasarett /ID# 170838
      • Boras, Vastra Gotalands Lan, Sweden, 501 82
        • Sodra Alvsborgs sjukhus /ID# 202889
      • Gothenburg, Vastra Gotalands Lan, Sweden, 413 46
        • Sahlgrenska University Hospital /ID# 169031
  • Switzerland
      • Bern, Switzerland, 3010
        • Inselspital, Universitätsspital Bern /ID# 171006
    • Zuerich
      • Zürich, Zuerich, Switzerland, 8091
        • Universitätsspital Zürich /ID# 170999
  • Taiwan
      • Taipei City, Taiwan, 100
        • National Taiwan University Hospital /ID# 169789
      • Taoyuan City, Taiwan, 333
        • Linkou Chang Gung Memorial Ho /ID# 169788
  • Turkey
      • Ankara, Turkey, 06590
        • Ankara Univ Medical Faculty /ID# 206412
      • Battalgazi/malatya, Turkey, 44280
        • Inonu Universitesi Turgut Ozal /ID# 201267
      • Hatay, Turkey, 31001
        • Mustafa Kemal University Medic /ID# 171318
      • Istanbul, Turkey, 34098
        • Istanbul University-Cerrahpasa, Cerrahpasa Medical Faculty /ID# 200280
      • Istanbul, Turkey, 34899
        • Marmara Universitesi Pendik Egitim ve Arastirma Hastanesi /ID# 171316
      • Mersin, Turkey, 33343
        • Mersin University Medical /ID# 171320
      • Sisli, Turkey, 34371
        • Sisli Etfal Train & Res Hosp /ID# 171317
      • Yenimahalle, Turkey, 06560
        • Gazi Universitesi Tip Fakultes /ID# 217443
    • Istanbul
      • Kadikoy, Istanbul, Turkey, 34742
        • Acibadem Kozyatagi Hospital /ID# 209405
    • Kayseri
      • Melikgazi, Kayseri, Turkey, 38030
        • Erciyes University Medical Fac /ID# 171321
  • United Kingdom
      • Bath, United Kingdom, BA1 3NG
        • Royal United Hospitals Bath /ID# 169084
      • Birmingham, United Kingdom, B15 2TH
        • University Hospitals Birmingham NHS Foundation Trust /ID# 169080
      • Dudley, United Kingdom, DY1 2HQ
        • The Dudley Group NHS Foundation Trust /ID# 169079
      • Harrow, United Kingdom, HA1 3UJ
        • London North West University Healthcare NHS Trust /ID# 169078
      • London, United Kingdom, SE5 9RS
        • King's College Hospital NHS Foundation Trusts /ID# 169082
      • Newcastle Upon Tyne, United Kingdom, NE7 7DN
        • The Newcastle Upon Tyne Hospitals NHS Foundation Trust /ID# 169085
      • Stockport, United Kingdom, SK2 7JE
        • Stockport NHS foundation trust /ID# 208718
      • Taunton, United Kingdom, TA1 5DA
        • Taunton and Somerset NHS Foundation Trust /ID# 209664
      • Tooting, United Kingdom, SW17 0QT
        • St George's University Hospitals NHS Foundation Trust /ID# 205551
      • Wolverhampton, United Kingdom, WV10 0QP
        • The Royal Wolverhampton NHS Trust /ID# 171387
    • Antrim
      • Belfast, Antrim, United Kingdom, BT16 1RH
        • South Eastern Health and Social Care Trust /ID# 205322
    • Cheshire West And Chester
      • Warrington, Cheshire West And Chester, United Kingdom, WA5 1QG
        • Warrington and Halton Hospitals NHS Foundation Trust /ID# 171388
      • Warrington, Cheshire West And Chester, United Kingdom, WA5 1QG
        • Warrington and Halton Hospitals NHS Foundation Trust /ID# 209085
    • London, City Of
      • London, London, City Of, United Kingdom, E1 2ES
        • Barts Health NHS Trust /ID# 218829
  • United States
    • Alabama
      • Mobile, Alabama, United States, 36606
        • East View Medical Research, LLC /ID# 171133
      • Mobile, Alabama, United States, 36608
        • CB Flock Research Corporation /ID# 166220
    • Arizona
      • Chandler, Arizona, United States, 85224
        • Delsol Research Management, Ll /Id# 170179
      • Scottsdale, Arizona, United States, 85258
        • HonorHealth Research Institute - Shea /ID# 164734
      • Sun City, Arizona, United States, 85306
        • Arizona Arthritis & Rheumatology Research, PLLC /ID# 203891
    • California
      • Coronado, California, United States, 92118-1408
        • Southern California Res. Ctr. /ID# 169654
      • Covina, California, United States, 91722-3797
        • Citrus Valley Gastroenterology /ID# 166201
      • Los Alamitos, California, United States, 90720-3309
        • United Medical Doctors /ID# 207452
      • Los Angeles, California, United States, 90067-2001
        • Gastrointestinal Biosciences Clinical Trials, LLC /ID# 164887
      • Mission Hills, California, United States, 91345
        • Facey Medical Foundation /ID# 203137
      • Murrieta, California, United States, 92563
        • United Medical Doctors - Murrieta /ID# 164845
      • San Diego, California, United States, 92103
        • Ucsd /Id# 164679
      • San Diego, California, United States, 92123
        • Medical Assoc Research Grp /ID# 169705
      • San Francisco, California, United States, 94115-3011
        • UCSF Center for Colitis and Crohn's Disease /ID# 202373
      • San Francisco, California, United States, 94158
        • Univ of California San Francis /ID# 164843
      • San Pablo, California, United States, 94806
        • Care Access Research /ID# 167766
    • Colorado
      • Colorado Springs, Colorado, United States, 80907
        • Peak Gastroenterology Associates, PC /ID# 170181
      • Colorado Springs, Colorado, United States, 80918
        • Delta Waves, Inc. /ID# 164872
      • Wheat Ridge, Colorado, United States, 80033-2896
        • Duplicate_Western States Clinical Research, Inc. /ID# 164895
    • Connecticut
      • Hamden, Connecticut, United States, 06518
        • Medical Research Center of CT /ID# 164829
    • Florida
      • Clearwater, Florida, United States, 33765
        • Clinical Research of West Florida, Inc /ID# 205825
      • Clearwater, Florida, United States, 33765
        • Clinical Research of West Florida, Inc /ID# 208117
      • Coral Springs, Florida, United States, 33067-3173
        • Advanced Research - Coral Springs /ID# 218020
      • Jacksonville, Florida, United States, 32256
        • Encore Borland-Groover Clinical Research /Id# 203498
      • Maitland, Florida, United States, 32751-6108
        • Ctr for Advanced Gastroenterol /ID# 165332
      • Miami, Florida, United States, 33165
        • Crystal Pharmacology Research /ID# 166101
      • Miami, Florida, United States, 33186-4643
        • Coral Research Clinic /ID# 164657
      • New Port Richey, Florida, United States, 34653
        • Advanced Research Institute, Inc /ID# 164814
      • Orlando, Florida, United States, 32803
        • Endoscopic Research, Inc. /ID# 205893
      • Orlando, Florida, United States, 32810-2907
        • Omega Research Maitland, LLC /ID# 203480
      • Tampa, Florida, United States, 33607
        • Clinical Research Trials of Florida, Inc. /ID# 203484
      • Tampa, Florida, United States, 33613-4680
        • AdventHealth Tampa /ID# 171175
    • Georgia
      • Macon, Georgia, United States, 31201
        • Gastroenterology Associates of Central Georgia, LLC /ID# 165460
      • Roswell, Georgia, United States, 30076-4913
        • Gastroenterology Consultants PC - Roswell /ID# 218219
      • Suwanee, Georgia, United States, 30024
        • Atlanta Gastroenterology Spec /ID# 164780
    • Illinois
      • Chicago, Illinois, United States, 60637-1426
        • University of Chicago Medicine /ID# 165472
      • Downers Grove, Illinois, United States, 60515-5509
        • DuPage Medical Group /ID# 205303
    • Indiana
      • Evansville, Indiana, United States, 47714-8011
        • MediSphere Medical Research Center /ID# 166209
      • Indianapolis, Indiana, United States, 46237
        • Indianapolis Gastroenterology /ID# 164837
      • New Albany, Indiana, United States, 47150-4053
        • Aquiant Research /ID# 205504
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • University of Iowa Hospitals and Clinics /ID# 165330
    • Kentucky
      • Crestview Hills, Kentucky, United States, 41017
        • Tri-State Gastroenterology /ID# 165484
      • Louisville, Kentucky, United States, 40202
        • University of Louisville /ID# 168536
      • Louisville, Kentucky, United States, 40202
        • University of Louisville /ID# 208093
    • Louisiana
      • Houma, Louisiana, United States, 70360
        • CroNOLA, LLC /ID# 164722
      • New Orleans, Louisiana, United States, 70115
        • Nola Research Works, LLC /ID# 164897
      • Shreveport, Louisiana, United States, 71105-6800
        • Louisana Research Center, LLC /ID# 164659
    • Maryland
      • Baltimore, Maryland, United States, 21287-0010
        • Johns Hopkins University School of Medicine /ID# 211940
      • Chevy Chase, Maryland, United States, 20815
        • MGG Group Co, Inc.Chevy Chase Clinical Research /ID# 164835
      • Columbia, Maryland, United States, 21045
        • Gastro Center of Maryland /ID# 171171
    • Massachusetts
      • Burlington, Massachusetts, United States, 01805
        • Lahey Hospital and Medical Center /ID# 214725
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan Health Systems /ID# 164844
      • Chesterfield, Michigan, United States, 48047
        • Clin Res Inst of Michigan, LLC /ID# 170178
      • Farmington Hills, Michigan, United States, 48334-3230
        • Digestive Health Associates (DHA) - Farmington Hills /ID# 206099
      • Troy, Michigan, United States, 48098-6363
        • Center for Digestive Health /ID# 164733
    • Minnesota
      • Rochester, Minnesota, United States, 55905-0001
        • Mayo Clinic - Rochester /ID# 164868
    • Mississippi
      • Jackson, Mississippi, United States, 39216
        • Southern Therapy and Advanced Research (STAR) LLC /ID# 165318
    • Nebraska
      • Omaha, Nebraska, United States, 68114-3723
        • Quality Clinical Research Inc. /ID# 170177
      • Omaha, Nebraska, United States, 68124
        • CHI Health Research Center /ID# 168545
    • Nevada
      • Las Vegas, Nevada, United States, 89113
        • Las Vegas Medical Research /ID# 168562
    • New Jersey
      • Egg Harbor Township, New Jersey, United States, 08234
        • AGA Clinical Research Associates, LLC /ID# 164883
      • New Brunswick, New Jersey, United States, 08901
        • Rutgers Robert Wood Johnson /ID# 166092
    • New York
      • Bronx, New York, United States, 10467
        • Montefiore Medical Center - Moses Campus /ID# 166226
      • Bronx, New York, United States, 10468
        • Advantage Clinical Trials /ID# 168557
      • Brooklyn, New York, United States, 11235
        • NY Scientific /ID# 164833
      • Lake Success, New York, United States, 11042
        • NYU Langone Long Island Clinical Research Associates /ID# 164830
      • New York, New York, United States, 10029
        • The Mount Sinai Hospital /ID# 170172
      • New York, New York, United States, 10032-3725
        • Columbia Univ Medical Center /ID# 164870
      • Rochester, New York, United States, 14618-5703
        • Gastro Group of Rochester /ID# 166216
      • Staten Island, New York, United States, 10310-1664
        • Richmond University Medical Center /ID# 201855
    • North Carolina
      • Charlotte, North Carolina, United States, 28203
        • Atrium Health Carolinas Medical Center /ID# 164834
      • Charlotte, North Carolina, United States, 28209
        • PMG Research of Charlotte /ID# 171170
      • Raleigh, North Carolina, United States, 27612
        • Wake Radiology UNC REX Healthcare - Raleigh Office /ID# 164663
      • Winston-Salem, North Carolina, United States, 27157-0001
        • Wake Forest Baptist Medical Center /ID# 201225
    • North Dakota
      • Fargo, North Dakota, United States, 58104-5925
        • Plains Clinical Research Center, LLC /ID# 170184
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • Consultants for Clinical Research /ID# 164855
      • Cincinnati, Ohio, United States, 45267-0585
        • University of Cincinnati /ID# 164720
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic Main Campus /ID# 208220
      • Columbus, Ohio, United States, 43210
        • The Ohio State University /ID# 170174
      • Columbus, Ohio, United States, 43235
        • Optimed Research, Ltd. /ID# 205618
      • Dayton, Ohio, United States, 45424
        • Hometown Urgent Care and Resea /ID# 201290
      • Englewood, Ohio, United States, 45415
        • Dayton Gastroenterology, Inc. /ID# 167624
      • Mentor, Ohio, United States, 44060-6211
        • Great Lakes Medical Research, LLC /ID# 202007
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73112
        • Digestive Disease Specialists /ID# 201062
      • Tulsa, Oklahoma, United States, 74104
        • Options Health Research, LLC /ID# 164737
      • Tulsa, Oklahoma, United States, 74135
        • Healthcare Research Consultant /ID# 166228
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104-5502
        • University of Pennsylvania /ID# 168402
      • Philadelphia, Pennsylvania, United States, 19107-4414
        • Thomas Jefferson University /ID# 168014
    • South Carolina
      • Charleston, South Carolina, United States, 29412
        • Pharmacorp Clinical Trials /ID# 164809
      • Greenville, South Carolina, United States, 29615-3593
        • Gastroenterology Associates, P.A. of Greenville /ID# 164880
    • South Dakota
      • Rapid City, South Dakota, United States, 57701
        • Rapid City Medical Center - GI Research /ID# 201734
    • Tennessee
      • Germantown, Tennessee, United States, 38138
        • Gastro One /ID# 164718
      • Johnson City, Tennessee, United States, 37604
        • East Tennessee Research Institute /ID# 203612
      • Nashville, Tennessee, United States, 37211
        • Quality Medical Research /ID# 205262
      • Nashville, Tennessee, United States, 37232-0011
        • Vanderbilt University Medical Center /ID# 164846
    • Texas
      • Arlington, Texas, United States, 76012
        • TX Clinical Research Institute /ID# 164848
      • Baytown, Texas, United States, 77521-2415
        • Inquest Clinical Research /ID# 164865
      • Cedar Park, Texas, United States, 78613-5028
        • Texas Digestive Disease Consultants /ID# 209952
      • Cedar Park, Texas, United States, 78613
        • Texas Digestive Disease Consultants /ID# 209802
      • Houston, Texas, United States, 77027-6812
        • CliniCore International, LLC /ID# 164662
      • Houston, Texas, United States, 77030-3411
        • Baylor College of Medicine - Baylor Medical Center /ID# 164847
      • Houston, Texas, United States, 77058
        • Centex Studies, Inc. - Houston /ID# 201213
      • Houston, Texas, United States, 77070-4347
        • GI Specialists of Houston /ID# 202338
      • Lubbock, Texas, United States, 79424-3017
        • Caprock Gastro Research /ID# 215437
      • San Antonio, Texas, United States, 78212
        • Clinical Associates in Research Therapeutics of America, LLC /ID# 164863
      • San Antonio, Texas, United States, 78229-5390
        • Southern Star Research Institute, LLC /ID# 169754
      • Sugar Land, Texas, United States, 77478
        • Carl R. Meisner Medical Clinic /ID# 201060
      • Tyler, Texas, United States, 75701-4464
        • Tyler Research Institute, LLC /ID# 168681
      • Victoria, Texas, United States, 77904
        • Gastro Health & Nutrition - Victoria /ID# 167813
    • Utah
      • Bountiful, Utah, United States, 84010
        • HP Clinical Research /ID# 164929
      • Ogden, Utah, United States, 84403
        • Advanced Research Institute /ID# 164866
      • Salt Lake City, Utah, United States, 84124-1377
        • Duplicate_Care Access Research /ID# 164853
      • West Jordan, Utah, United States, 84088
        • Velocity Clinical Research - Salt Lake City /ID# 166095
    • Washington
      • Bellevue, Washington, United States, 98004
        • Washington Gastroenterology Associates /ID# 164721
      • Seattle, Washington, United States, 98101
        • Virginia Mason - Seattle Orthapedics /ID# 164680
      • Seattle, Washington, United States, 98109
        • University of Washington /ID# 164875
      • Vancouver, Washington, United States, 98664
        • The Vancouver Clinic, INC. PS /ID# 164811
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226-3522
        • Froedtert Memorial Lutheran Hospital /ID# 202286
      • Wauwatosa, Wisconsin, United States, 53226
        • Allegiance Research Specialists /ID# 165321

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 to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Confirmed diagnosis of CD for at least 3 months prior to Baseline.
  • Confirmed diagnosis of moderate to severe CD as assessed by stool frequency (SF), abdominal pain (AP) score.
  • Evidence of mucosal inflammation based on the Simplified Endoscopic Score for Crohn's disease (SES-CD) on an endoscopy confirmed by a central reader.
  • Demonstrated an inadequate response or intolerance to any biologic therapy for infliximab, adalimumab, certolizumab pegol, vedolizumab, and ustekinumab.
  • If female, participant must meet the contraception recommendations.

Exclusion Criteria:

  • Participant with a current diagnosis of ulcerative colitis or indeterminate colitis.
  • Participant not on stable doses of CD related antibiotics, oral aminosalicylates, corticosteroids or methotrexate (MTX).
  • Participant with the following ongoing known complications of CD: abscess (abdominal or peri-anal), symptomatic bowel strictures, fulminant colitis, toxic megacolon, or any other manifestation that might require surgery while enrolled in the study.
  • Participant with ostomy or ileoanal pouch.
  • Participant diagnosed with conditions that could interfere with drug absorption including but not limited to short gut or short bowel syndrome.
  • Screening laboratory and other protocol pre-specified analyses show abnormal results.

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: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: Part 1 (Double-blind): Placebo
Participants received upadacitinib matching placebo tablets, orally, once daily (QD) for 12 weeks during the Double-blind (DB) Induction Period.
Drug: Matching Placebo for Upadacitinib
Matching placebo tablets
EXPERIMENTAL: Part 1 (Double-blind): Upadacitinib 45 mg
Participants received upadacitinib 45 mg tablets, orally, QD for 12 weeks during the DB Induction Period.
Drug: Upadacitinib
Upadacitinib tablets
Other Names:
  • ABT-494
  • RINVOQ®
EXPERIMENTAL: Part 2 (Open-label): Upadacitinib 45 mg
Participants received upadacitinib 45 mg tablets, orally, QD for 12 weeks during the Open-label (OL) Induction Period.
Drug: Upadacitinib
Upadacitinib tablets
Other Names:
  • ABT-494
  • RINVOQ®
EXPERIMENTAL: Part 3 (Extended Treatment DB): Upadacitinib 45 mg From Part 1 DB Placebo
Participants received upadacitinib 45 mg tablets, orally, QD for 12 weeks (until Week 24) during the Extended Treatment (ET) Period. Participants who received placebo in Part 1 and did not achieve clinical response at Week 12 were included in this group.
Drug: Upadacitinib
Upadacitinib tablets
Other Names:
  • ABT-494
  • RINVOQ®
EXPERIMENTAL: Part 3 (Extended Treatment DB): Upadacitinib 30 mg From Part 1 DB Upadacitinib 45 mg
Participants received upadacitinib 30 mg tablets, orally, QD for 12 weeks (until Week 24) during the ET Period. Participants who received DB upadacitinib 45 mg in Part 1 and did not achieve clinical response at Week 12 were included in this group.
Drug: Upadacitinib
Upadacitinib tablets
Other Names:
  • ABT-494
  • RINVOQ®
EXPERIMENTAL: Part 3 (Extended Treatment OL): Upadacitinib 30 mg From Part 2 OL Upadacitinib 45 mg
Participants received upadacitinib 30 mg tablets, orally, QD for 12 weeks (until Week 24) during the ET Period. Participants who received OL upadacitinib 45 mg during Part 2 and did not achieve clinical response at Week 12 were included in this group.
Drug: Upadacitinib
Upadacitinib tablets
Other Names:
  • ABT-494
  • RINVOQ®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants With Clinical Remission Per Crohn's Disease Activity Index (CDAI) at Week 12
Time Frame: Week 12
The CDAI was used to evaluate the activity of Crohn's disease. Clinical remission per CDAI is defined as CDAI <150. The CDAI is calculated on the basis of a one-week evaluation of 8 items: frequency of liquid or very soft stool, abdominal pain, complications of Crohn's disease (e.g., uveitis, arthritis, fistula, and abscess), abdominal mass, hematocrit, body weight, use of antidiarrheals, and general condition. Total score ranges from 0 to about 600. Higher CDAI scores indicate more severe disease. CDAI scores below 150 represent remission and scores over 450 represent very severe Crohn's disease. Results were based on non-responder imputation incorporating multiple imputation to handle missing data due to COVID-19 (NRI-C).
Week 12
Percentage of Participants With Endoscopic Response at Week 12
Time Frame: Baseline to Week 12
Endoscopic response was defined as greater than 50% decrease in Simple Endoscopic Score for Crohn's Disease (SES-CD) from Baseline of the induction study (or for participants with an SES-CD of 4 at Baseline of the induction study, at least a 2-point reduction from Baseline), as scored by Central Reviewer. SES-CD is calculated based on the sum of individual segment values for four endoscopic variables (presence and size of ulcers, ulcerated surface, affected surface and presence of narrowing). Each variable in each segment is scored 0 to 3 resulting in SES-CD values ranging from 0 to 56 with higher scores indicating more severe disease. Results were based on NRI-C.
Baseline to Week 12
Number of Participants With Adverse Events
Time Frame: From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
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. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not the event is considered causally related to the use of the product.
From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants With Clinical Remission Per Patient-Reported Outcomes (PROs) at Week 12
Time Frame: Baseline to Week 12
Clinical remission per PROs was defined as average daily very soft or liquid stool frequency (SF) ≤2.8 and average daily abdominal pain (AP) score ≤1.0 and both not greater than Baseline. The number of soft or liquid stools and abdominal pain rated on a scale of 0=none to 3=severe were recorded in an electronic diary. Results were based on NRI-C.
Baseline to Week 12
Percentage of Participants With Endoscopic Remission at Week 12
Time Frame: Baseline to Week 12
Endoscopic remission was defined per SES-CD. SES-CD ≤4 and at least 2-point reduction from Baseline and no subscore >1 in any individual variable, as scored by Central Reviewer. SES-CD is calculated based on the sum of individual segment values for four endoscopic variables (presence and size of ulcers, ulcerated surface, affected surface and presence of narrowing). Each variable in each segment is scored 0 to 3 resulting in SES-CD values ranging from 0 to 56 with higher scores indicating more severe disease. Results were based on NRI-C.
Baseline to Week 12
Percentage of Participants Who Discontinued Corticosteroid Use for Crohn's Disease (CD) and Achieved Clinical Remission Per CDAI at Week 12, in Participants Taking Corticosteroids at Baseline
Time Frame: Week 12
As prespecified in the protocol, this outcome measure was planned to be assessed in participants taking corticosteroids at Baseline. Clinical remission per CDAI: CDAI <150. The CDAI is used to evaluate the activity of Crohn's disease. The CDAI is calculated on the basis of a one-week evaluation of 8 items: frequency of liquid or very soft stool, abdominal pain, complications of Crohn's disease (e.g., uveitis, arthritis, fistula, and abscess), abdominal mass, hematocrit, body weight, use of antidiarrheals, and general condition. Total score ranges from 0 to about 600. Higher CDAI scores indicate more severe disease. CDAI scores below 150 represent remission and scores over 450 represent very severe Crohn's disease. Results were based on NRI-C.
Week 12
Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Total Score at Week 12
Time Frame: Baseline and Week 12
The FACIT-F questionnaire was developed to assess fatigue associated with anemia. It consists of 13 fatigue-related questions. The responses to the 13 items on the FACIT-F questionnaire are each measured on a 5-point Likert scale. The responses to the answers are the following: 0= not at all; 1= a little bit; 2= somewhat; 3= quite a bit; 4=very much. Thus, the total score ranges from 0 to 52. High scores represent less fatigue. A positive change from Baseline indicates improvement.
Baseline and Week 12
Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score at Week 12
Time Frame: Baseline and Week 12
The IBDQ is a disease-specific instrument composed of 32 Likert-scaled items. The IBDQ scale contains 4 component subscales: bowel symptoms (10 items), systemic symptoms (5 items), emotional function (12 items), and social function(5 items). Each item is scored on a 7-point scale where: 1=worst to 7= best. The total score ranges from 32 to 224, with higher scores indicating better health-related quality of life. A positive change from Baseline indicates improvement.
Baseline and Week 12
Percentage of Participants Achieving Clinical Response 100 (CR-100) at Week 2
Time Frame: Baseline to Week 2
CR-100 is defined as a decrease of at least 100 points in CDAI from Baseline at Week 2. The CDAI is used to evaluate the activity of Crohn's disease. The CDAI is calculated on the basis of a one-week evaluation of 8 items: frequency of liquid or very soft stool, abdominal pain, complications of Crohn's disease (e.g., uveitis, arthritis, fistula, and abscess), abdominal mass, hematocrit, body weight, use of antidiarrheals, and general condition. Total score ranges from 0 to about 600. Higher CDAI scores indicate more severe disease. CDAI scores below 150 represent remission and scores over 450 represent very severe Crohn's disease. Results were based on NRI-C.
Baseline to Week 2
Percentage of Participants Achieving Clinical Response 100 (CR-100) at Week 12
Time Frame: Baseline to Week 12
CR-100 is defined as a decrease of at least 100 points in CDAI from Baseline at Week 12. The CDAI is used to evaluate the activity of Crohn's disease. The CDAI is calculated on the basis of a one-week evaluation of 8 items: frequency of liquid or very soft stool, abdominal pain, complications of Crohn's disease (e.g., uveitis, arthritis, fistula, and abscess), abdominal mass, hematocrit, body weight, use of antidiarrheals, and general condition. Total score ranges from 0 to about 600. Higher CDAI scores indicate more severe disease. CDAI scores below 150 represent remission and scores over 450 represent very severe Crohn's disease. Results were based on NRI-C.
Baseline to Week 12
Percentage of Participants With Clinical Remission Per Crohn's Disease Activity Index (CDAI) at Week 4
Time Frame: Week 4
The CDAI was used to evaluate the activity of Crohn's disease. Clinical remission per CDAI is defined as CDAI <150. The CDAI is calculated on the basis of a one-week evaluation of 8 items: frequency of liquid or very soft stool, abdominal pain, complications of Crohn's disease (e.g., uveitis, arthritis, fistula, and abscess), abdominal mass, hematocrit, body weight, use of antidiarrheals, and general condition. Total score ranges from 0 to 600. Higher CDAI scores indicate more severe disease. CDAI scores below 150 represent remission and scores over 450 represent very severe Crohn's disease. Results were based on NRI-C.
Week 4
Percentage of Participants With Hospitalizations Due to Crohn's Disease (CD) During Part 1 (12-week Double-blind Induction Period)
Time Frame: Up to Week 12 in Part 1: Double-blind Induction Period
Up to Week 12 in Part 1: Double-blind Induction Period
Percentage of Participants With Resolution of Extra-Intestinal Manifestations (EIMs) at Week 12, in Participants With EIMs at Baseline
Time Frame: Week 12
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. Results were based on NRI-C.
Week 12

Collaborators and Investigators

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

Sponsor

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)

November 29, 2017

Primary Completion (ACTUAL)

August 11, 2021

Study Completion (ACTUAL)

August 11, 2021

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)

August 15, 2022

Last Update Submitted That Met QC Criteria

July 18, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M14-431
  • 2017-001226-18 (EUDRACT_NUMBER)

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 and 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, please refer to the link below.

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 (SAP) and execution of a Data Use Agreement (DUA). For more information on the process, or to submit a request, visit the following link.

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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