A Study of the Efficacy and Safety of Upadacitinib in Participants With Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or Are Intolerant to Conventional and/or Biologic Therapies (U-EXCEL)

October 31, 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 Conventional and/or Biologic Therapies

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study includes two parts:

  • Part 1: a randomized double-blind placebo-controlled induction period and
  • Part 2: an extended treatment period for non-responders from Part 1.

In Part 1, participants will be randomized in a 2:1 ratio to upadacitinib 45 mg once daily (QD) or matching placebo for 12 weeks. The randomization will be stratified by baseline corticosteroid use (yes or no), endoscopic disease severity (Simplified Endoscopic Score for Crohn's disease [SES-CD] < 15 and ≥ 15), and number of prior biologics with prior inadequate response or intolerance (0, 1, > 1).

Participants who do not achieve clinical response at Week 12 will be able to enroll in Part 2 to receive a double-blind extended treatment with upadacitinib until Week 24. Clinical response is defined as a ≥ 30% decrease in average daily very soft or liquid stool frequency (SF) and/or ≥ 30% decrease in average daily abdominal pain (AP) score (both not worse than Baseline).

Participants who achieve clinical response at Week 12 may be eligible to enter the 52-week, double-blind, maintenance portion of Study M14-430 (NCT03345823).

Study Type

Interventional

Enrollment (Actual)

526

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# 169230
    • Buenos Aires
      • San Isidro, Buenos Aires, Argentina, 1642
        • Cardio Alem /ID# 211285
    • Ciuadad Autonoma De Buenos Aires
      • Ciudad Autonoma Buenos Aires, Ciuadad Autonoma De Buenos Aires, Argentina, 1199
        • Hospital Italiano de Buenos Aires /ID# 215541
      • Ciudad Autonoma de Buenos Aire, Ciuadad Autonoma De Buenos Aires, Argentina, 1115
        • Gedyt /ID# 210020
      • Ciudad Autonoma de Buenos Aire, Ciuadad Autonoma De Buenos Aires, Argentina, 1431
        • Cemic /Id# 169182
    • Santa Fe
      • Rosario, Santa Fe, Argentina, 2000
        • Hospital Provincial del Centenario /ID# 171252
  • Australia
    • New South Wales
      • Concord, New South Wales, Australia, 2139
        • Concord Repatriation General Hospital /ID# 171512
    • Queensland
      • North Mackay, Queensland, Australia, 4740
        • Coral Sea Clinical Research institute /ID# 212988
      • South Brisbane, Queensland, Australia, 4101
        • Mater Misericordiae Limited /ID# 204909
    • South Australia
      • Adelaide, South Australia, Australia, 5000
        • Royal Adelaide Hospital /ID# 171514
    • Victoria
      • Box Hill, Victoria, Australia, 3128
        • Box Hill Hospital /ID# 203736
    • Western Australia
      • Murdoch, Western Australia, Australia, 6150
        • Fiona Stanley Hospital /ID# 171513
  • Austria
      • Salzburg, Austria, 5020
        • Landeskrankenhaus Salzburg-Universitätsklinikum der PMU (LKH) /ID# 214470
    • Wien
      • Vienna, Wien, Austria, 1090
        • Medizinische Universitaet Wien /ID# 169465
  • Belgium
      • Gent, Belgium, 9000
        • AZ Sint-Lucas /ID# 200302
    • Bruxelles-Capitale
      • Woluwe-Saint-Lambert, Bruxelles-Capitale, Belgium, 1200
        • UCL Saint-Luc /ID# 200303
    • Liege
      • Liège, Liege, Belgium, 4000
        • CHU de Liege Sart Tilman /ID# 217534
  • Bosnia and Herzegovina
      • Sarajevo, Bosnia and Herzegovina, 71000
        • Clinical Center University of Sarajevo /ID# 203887
      • Sarajevo, Bosnia and Herzegovina, 71000
        • Polyclinic and Daily Hospital Dr. Al-Tawil /ID# 217842
    • Republika Srpska
      • Banja Luka, Republika Srpska, Bosnia and Herzegovina, 78000
        • University Clinical Centre of the Republic of Srpska /ID# 208051
    • Tuzlanski
      • Tuzla, Tuzlanski, Bosnia and Herzegovina, 75000
        • University Clinical Center Tuzla /ID# 210325
  • Brazil
    • Goias
      • Goiânia, Goias, Brazil, 74535-170
        • Instituto Goiano de Gastroenterologia e Endoscopia Digestiva /ID# 166852
    • Parana
      • Curitiba, Parana, Brazil, 80810-040
        • Hospital Nossa Senhora das Graças /ID# 166863
    • Rio Grande Do Sul
      • Porto Alegre, Rio Grande Do Sul, Brazil, 90035-903
        • Hospital de Clinicas de Porto Alegre /ID# 166862
    • Sao Paulo
      • Botucatu, Sao Paulo, Brazil, 18618-686
        • Upeclin Fmb - Unesp /Id# 166867
      • Ribeirão Preto, Sao Paulo, Brazil, 14051-140
        • Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto - USP /ID# 166866
      • Santo André, Sao Paulo, Brazil, 09060-870
        • Faculdade de Medicina do ABC /ID# 208323
      • Sao Jose Do Rio Preto, Sao Paulo, Brazil, 15015-110
        • Kaiser Clinica e Hospital Dia /ID# 166865
  • Bulgaria
      • Plovdiv, Bulgaria, 4001
        • UMHAT Kaspela EOOD /ID# 167613
      • Sofia, Bulgaria, 1202
        • Duplicate_Second MHAT Sofia /ID# 167614
      • Stara Zagora, Bulgaria, 6004
        • MHAT Trakia /ID# 201679
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 4Z6
        • University of Calgary /ID# 166974
      • Edmonton, Alberta, Canada, T5R 1W2
        • Allen Whey Khye Lim Professional Corporation /ID# 168044
      • Edmonton, Alberta, Canada, T6G 2X8
        • University of Alberta - Zeidler Ledcor Centre /ID# 166971
      • Edmonton, Alberta, Canada, T6K 4B2
        • South Edmonton Gastroenterology Research Clinic /ID# 166978
    • British Columbia
      • New Westminster, British Columbia, Canada, V3L 3W4
        • Fraser Clinical Trials Inc /ID# 166968
      • Vancouver, British Columbia, Canada, V6Z 2K5
        • GIRI Gastrointestinal Research Institute /ID# 166975
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 2Y9
        • QEII - Health Sciences Centre /ID# 169307
    • Ontario
      • London, Ontario, Canada, N6A 5W9
        • London Health Sciences Center /ID# 221038
      • North Bay, Ontario, Canada, P1B 2H3
        • Scott Shulman Medicine Professional Corporation /ID# 169066
      • Oshawa, Ontario, Canada, L1H 7K4
        • Taunton Surgical Centre /ID# 168043
      • Ottawa, Ontario, Canada, K1H 8L6
        • Ottawa Hospital Research Institute /ID# 212414
      • Sudbury, Ontario, Canada, P3A 1W8
        • Medicor Research Inc /ID# 166979
      • Vaughan, Ontario, Canada, L4L 4Y7
        • Toronto Digestive Disease Asso /ID# 166972
    • Quebec
      • Levis, Quebec, Canada, G6V 3Z1
        • CISSS de Chaudière-Appalaches, Hôpital Hotel-Dieu de Lévis /ID# 166969
      • Montreal, Quebec, Canada, H2X 0A9
        • Centre Hospitalier de l'Universite de Montreal - CRCHUM /ID# 170120
      • Montreal, Quebec, Canada, H4A 3J1
        • Royal Victoria Hospital / McGill University Health Centre /ID# 170119
      • Sherbrooke, Quebec, Canada, J1G 2E8
        • CIUSSS de l'Estrie - CHUS /ID# 170940
  • Chile
      • Concepción, Chile, 4070038
        • Hospital Guillermo Grant Benavente de Concepción /ID# 212423
      • Providencia, Chile, 7500571
        • CTR Estudios Clinicos /ID# 203941
      • Santiago, Chile, 7501504
        • Hospital Clinico Universidad De Los Andes /ID# 207466
    • Region Metropolitana De Santiago
      • Santiago, Region Metropolitana De Santiago, Chile, 2540364
        • Research Group /ID# 203179
    • Region Metropolitana Santiago
      • Santiago, Region Metropolitana Santiago, Chile, 7750495
        • M y F Estudios Clínicos /ID# 169984
  • China
      • Beijing, China, 100032
        • Beijing Friendship Hospital /ID# 204173
      • Changsha, China, 410011
        • The Second Xiangya Hospital of Central South University /ID# 204082
      • Tianjin, China, 300052
        • Duplicate_Tianjin Med Univ General Hosp /ID# 206994
      • Wuhan, China, 430030
        • Tongji Hospital Tongji Medical College of HUST /ID# 204088
    • Fujian
      • Xiamen, Fujian, China, 361004
        • Zhongshan Hospital Xiamen University /ID# 204984
    • Guangdong
      • Guangzhou, Guangdong, China, 510080
        • The First Affiliated Hospital, Sun Yat-sen University /ID# 205228
      • Guangzhou, Guangdong, China, 510515
        • Nanfang Hospital of Southern Medical University /ID# 204083
      • Guangzhou, Guangdong, China, 510655
        • The Sixth Affiliated Hosp Sun /ID# 204077
    • Hubei
      • Wuhan, Hubei, China, 430022
        • Union Hospital Tongji Medical College Huazhong University of Science and Technol /ID# 204081
    • Jiangsu
      • Nanjing, Jiangsu, China, 210008
        • Nanjing Drum Tower Hospital /ID# 204900
    • Jiangxi
      • Nanchang, Jiangxi, China, 330006
        • The First Affiliated Hospital of Nanchang University /ID# 204092
    • Jilin
      • Changchun, Jilin, China, 130021
        • The First Hospital of Jilin University /ID# 206868
    • Shanghai
      • Shanghai, Shanghai, China, 200065
        • Ruijin Hospital, Shanghai Jiaotong University School of Medicine /ID# 204091
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310009
        • The second Affiliated hospital of Zhejiang University school of Medicine /ID# 204073
      • Hangzhou, Zhejiang, China, 310018
        • Sir Run Run Shaw Hospital,Meical School Zhejiang University /ID# 204076
  • Colombia
      • Medellin, Colombia, 50010
        • Hospital Universitario San Vic /ID# 200029
    • Antioquia
      • Medellín, Antioquia, Colombia, 50034
        • Hospital Pablo Tobon Uribe /ID# 202404
  • Croatia
      • Split, Croatia, 21000
        • UHC Split /ID# 171191
      • Zadar, Croatia, 23000
        • Zadar General Hospital /ID# 205536
    • Grad Zagreb
      • Zagreb, Grad Zagreb, Croatia, 10000
        • Clinical Hospital Dubrava /ID# 171185
      • Zagreb, Grad Zagreb, Croatia, 10000
        • Klinicki bolnicki centar Sestre milosrdnice /ID# 205535
      • Zagreb, Grad Zagreb, Croatia, 10000
        • Klinicki bolnicki centar Zagreb /ID# 171203
      • Zagreb, Grad Zagreb, Croatia, 10000
        • Poliklinika Solmed /ID# 211519
  • Czechia
      • Ceske Budejovice, Czechia, 370 01
        • Nemocnice Ceske Budejovice a.s. /ID# 224389
      • Hradec Kralove, Czechia, 500 12
        • Hepato-Gastroenterologie HK, s.r.o. /ID# 171401
      • Ostrava, Czechia, 722 00
        • ARTROSCAN s.r.o. /ID# 200790
      • Praha, Czechia, 143 00
        • ResTrial s.r.o. /ID# 208653
  • Denmark
    • Hovedstaden
      • Herlev, Hovedstaden, Denmark, 2730
        • Herlev Hospital /ID# 202423
      • Hilleroed, Hovedstaden, Denmark, 3600
        • Nordsjaellands Hospital /ID# 202424
      • Hvidovre, Hovedstaden, Denmark, 2650
        • Kobenhavns Universitet - Hvidovre Hospital (HH) /ID# 202425
    • Sjælland
      • Roskilde, Sjælland, Denmark, 4000
        • Duplicate_Sjaellands Universitets Hospital /ID# 209445
  • Egypt
      • Alexandria, Egypt, 21131
        • Clinical Research Center, Faculty of Medicine, Alexandria university. /ID# 171012
      • Alexandria, Egypt, 21131
        • Clinical Research Center, Faculty of Medicine, Alexandria university. /ID# 171013
      • Alexandria, Egypt, 21131
        • Clinical Research Center, Faculty of Medicine, Alexandria university. /ID# 209564
      • Cairo, Egypt, 11559
        • National Hepatology and Tropical Medicine Research Institute /ID# 170989
      • Cairo, Egypt
        • Air Force Specialized Hospital /ID# 170996
      • Menoufiya, Egypt, 35111
        • National Liver Institute /ID# 170988
  • Estonia
      • Tallinn, Estonia, 10617
        • West Tallinn Central Hospital /ID# 202785
  • France
      • La Tronche, France, 38700
        • CHU Grenoble - Hopital Michallon /ID# 219034
      • Nantes, France, 44300
        • Clinique Jules Verne /ID# 219073
      • Valenciennes, France, 59300
        • CH Valenciennes /ID# 219035
  • Germany
      • Berlin, Germany, 14163
        • Gastroenterologie am Mexikoplatz /ID# 203575
      • Essen, Germany, 45239
        • Universitaetsmedizin Essen St. Josef Krankenhaus Werden /ID# 203570
      • Frankfurt am Main, Germany, 60431
        • Agaplesion Markus Krankenhaus /ID# 168758
      • Halle (Saale), Germany, 06120
        • Universitaetsklinikum Halle (Saale) /ID# 207455
      • Muenster, Germany, 48155
        • Medizinisches Versorgungszentrum Portal 10 /ID# 200214
    • Baden-Wuerttemberg
      • Mannheim, Baden-Wuerttemberg, Germany, 68167
        • Universitatsklinikum Mannheim /ID# 168759
      • Ulm, Baden-Wuerttemberg, Germany, 89081
        • Universitaetsklinikum Ulm /ID# 203560
    • Bayern
      • Erlangen, Bayern, Germany, 91054
        • Universitaetsklinikum Erlangen /ID# 203552
    • Hessen
      • Frankfurt am Main, Hessen, Germany, 60590
        • Universitaetsklinikum Frankfurt /ID# 203566
    • Saarland
      • Saarbrücken, Saarland, Germany, 66111
        • Zentrum für Gastroenterologie Saar MVZ GmbH /ID# 206741
    • Schleswig-Holstein
      • Kiel, Schleswig-Holstein, Germany, 24105
        • Universitaetsklinikum Schleswig-Holstein Campus Kiel /ID# 168757
  • Greece
      • Thessaloniki, Greece, 54642
        • General Hospital of Thessaloniki Hippokrateio /ID# 208825
    • Attiki
      • Athens, Attiki, Greece, 11527
        • General Hospital of Athens Ippokratio /ID# 167045
      • Athens, Attiki, Greece, 11527
        • General Hospital of Chest Diseases of Athens SOTIRIA /ID# 202104
      • Piraeus, Attiki, Greece, 18536
        • Tzaneio general hospital of Piraeus /ID# 206433
    • Kriti
      • Heraklion, Kriti, Greece, 71500
        • University General Hospital of Heraklion PA.G.N.I /ID# 167044
  • Hong Kong
      • Hong Kong, Hong Kong
        • Tuen Mun Hospital /ID# 171218
  • Hungary
      • Budapest, Hungary, 1085
        • Semmelweis Egyetem /ID# 210167
      • Budapest, Hungary, 1134
        • Magyar Honvedseg Egeszsegugyi Kozpont /ID# 201724
      • Debrecen, Hungary, 4031
        • Debreceni Egyetem Kenezy Gyula Egyetemi Korhaz /ID# 201723
      • Kistarcsa, Hungary, 2143
        • Pest Megyei Flor Ferenc Korhaz /ID# 206154
      • Szekesfehervar, Hungary, 8000
        • Mentahaz Maganorvosi Kozpont /ID# 201895
    • Baranya
      • Mohacs, Baranya, Hungary, 7700
        • Mohacsi Korhaz /ID# 209441
    • Borsod-Abauj-Zemplen
      • Encs, Borsod-Abauj-Zemplen, Hungary, 3860
        • CRU Hungary Egeszsegugyi és Szolgaltato Kft. /ID# 205547
    • Hajdu-Bihar
      • Debrecen, Hajdu-Bihar, Hungary, 4032
        • Debreceni Egyetem Klinikai Kozpont /ID# 216419
    • Heves
      • Gyöngyös, Heves, Hungary, 3200
        • Bugat Pal Korhaz /ID# 201893
    • Komarom-Esztergom
      • Tatabanya, Komarom-Esztergom, Hungary, 2800
        • Szent Borbala Korhaz /ID# 209897
    • Pest
      • Budapest, Pest, Hungary, 1036
        • Obudai Egeszsegugyi Centrum Kft. /ID# 201892
  • Ireland
      • Cork, Ireland, T12 WE28
        • Mercy University Hospital /ID# 206511
  • Israel
      • Be'Er Ya'Akov, Israel, 70300
        • Assaf Harofeh Medical Center /ID# 204872
      • Jerusalem, Israel, 91120
        • Hadassah Medical Center-Hebrew University /ID# 169928
      • Petakh Tikva, Israel, 4941492
        • Rabin Medical Center /ID# 202636
      • Rehovot, Israel, 7661041
        • Kaplan Medical Center /ID# 170276
    • HaDarom
      • Be'er Sheva, HaDarom, Israel, 8443901
        • Soroka University Medical Center /ID# 169913
    • Tel-Aviv
      • Tel Aviv-Yafo, Tel-Aviv, Israel, 6423906
        • Tel Aviv Sourasky Medical Center /ID# 204877
  • Italy
      • Bologna, Italy, 40138
        • IRCCS Azienda Ospedaliero-Universitaria di Bologna /ID# 168187
      • Catania, Italy, 95126
        • A.O. Per L'Emergenza Cannizzaro /ID# 168190
      • Genova, Italy, 16132
        • Policlinico San Martino/Univer /ID# 168191
      • Milano, Italy, 20121
        • ASST Fatebenefratelli Sacco - Ospedale Fatebenefratelli e Oftalmico /ID# 168181
      • Milano, Italy, 20162
        • ASST Grande Ospedale Metropolitano Niguarda /ID# 170849
      • Modena, Italy, 41124
        • Azienda Ospedaliero-Universitaria di Modena /ID# 201897
      • Palermo, Italy, 90146
        • A.O. Ospedali Riuniti Villa Sofia - Cervello /ID# 168189
      • Pisa, Italy, 56125
        • Azienda Ospedaliero Universitaria Pisana-Stabilimento di Cisanello /ID# 202421
    • Lazio
      • Rome, Lazio, Italy, 00128
        • Policlinico Universitario Campus Bio-Medico /ID# 168183
      • Rome, Lazio, Italy, 00152
        • Azienda Ospedaliera San Camillo Forlanini /ID# 168184
    • Milano
      • Rozzano, Milano, Italy, 20089
        • Istituto Clinico Humanitas /ID# 168185
    • Roma
      • Rome, Roma, Italy, 00133
        • Fondazione PTV Policlinico Tor Vergata /ID# 168188
      • Rome, Roma, Italy, 00168
        • Presidio Columbus-Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Un /ID# 168182
    • Verona
      • Negrar, Verona, Italy, 37024
        • IRCCS Ospedale Sacro Cuore Don Calabria /ID# 168186
  • Japan
    • Aichi
      • Nagakute-shi, Aichi, Japan, 480-1195
        • Aichi Medical University Hospital /ID# 165971
      • Nagoya shi, Aichi, Japan, 467-8602
        • Nagoya City University Hospital /ID# 165970
      • Nagoya-shi, Aichi, Japan, 4668560
        • Nagoya University Hospital /ID# 165969
      • Toyohashi-shi, Aichi, Japan, 441-8570
        • Toyohashi Municipal Hospital /ID# 200175
    • Aomori
      • Hirosaki-shi, Aomori, Japan, 036-8545
        • National Hospital Organization Hirosaki General Medical Center /ID# 165961
    • Chiba
      • Sakura-shi, Chiba, Japan, 285-8741
        • Toho University Sakura Medical Center /ID# 165963
    • Fukuoka
      • Chikushino-shi, Fukuoka, Japan, 818-8502
        • Fukuoka University Chikushi Hospital /ID# 214404
      • Kurume-shi, Fukuoka, Japan, 830-0011
        • Kurume University Hospital /ID# 166012
    • Gunma
      • Takasaki-shi, Gunma, Japan, 370-0829
        • National Hospital Organization Takasaki General Medical Center /ID# 167127
    • Hiroshima
      • Fukuyama-shi, Hiroshima, Japan, 720-8520
        • NHO Fukuyama Medical Center /ID# 167131
      • Hiroshima-shi, Hiroshima, Japan, 734-8551
        • Hiroshima University Hospital /ID# 166014
    • Hokkaido
      • Asahikawa-shi, Hokkaido, Japan, 078-8510
        • Asahikawa Medical University Hospital /ID# 167120
      • Sapporo-shi, Hokkaido, Japan, 060-0033
        • Hokkaido P.W.F.A.C. Sapporo-Kosei General Hospital /ID# 165960
      • Sapporo-shi, Hokkaido, Japan, 060-8543
        • Sapporo Medical University Hospital /ID# 167124
      • Sapporo-shi, Hokkaido, Japan, 064-0919
        • Sapporo IBD Clinic /ID# 223561
    • Hyogo
      • Kobe-shi, Hyogo, Japan, 650-0015
        • Aoyama Clinic /ID# 166009
      • Nishinomiya-shi, Hyogo, Japan, 663-8501
        • Hyogo College of Medicine College Hospital /Id# 165973
    • Ishikawa
      • Kanazawa-shi, Ishikawa, Japan, 920-8641
        • Kanazawa University Hospital /ID# 169218
    • Iwate
      • Morioka-shi, Iwate, Japan, 020-8505
        • Iwate Medical University Uchimaru Medical Center /ID# 202464
    • Kagoshima
      • Kagoshima-shi, Kagoshima, Japan, 890-0064
        • Imamura General Hospital /ID# 227137
      • Kagoshima-shi, Kagoshima, Japan, 892-0824
        • Idzuro Imamura Hospital /ID# 206654
      • Kagoshima-shi, Kagoshima, Japan, 892-0846
        • Sameshima Hospital /ID# 206675
    • Kanagawa
      • Yokohama shi, Kanagawa, Japan, 232-0024
        • Yokohama City University Medical Center /ID# 167128
    • Kyoto
      • Kyoto-shi, Kyoto, Japan, 605-0981
        • Japanese Red Cross Kyoto Daiichi Hosital /ID# 165972
      • Kyoto-shi, Kyoto, Japan, 606-8507
        • Kyoto University Hospital /ID# 169889
    • Mie
      • Yokkaichi-shi, Mie, Japan, 510-0016
        • Yokkaichi Hazu Medical Center /ID# 167196
    • Miyagi
      • Sendai-shi, Miyagi, Japan, 9808574
        • Tohoku University Hospital /ID# 167122
    • Nara
      • Kashihara-shi, Nara, Japan, 634-8522
        • Nara Medical University Hospital /ID# 169219
      • Yamatotakada-shi, Nara, Japan, 635-0022
        • Kenseikai Dongo Hospital /ID# 208104
    • Niigata
      • Niigata-shi, Niigata, Japan, 951-8520
        • Niigata University Medical & Dental Hospital /ID# 170045
    • Oita
      • Oita-shi, Oita, Japan, 870-0823
        • Ishida Clinic of IBD and Gastroenterology /ID# 167121
    • Okayama
      • Kurashiki-shi, Okayama, Japan, 710-0142
        • Chikuba Hospital for Proctological and Gastrointestinal Diseases /ID# 166010
      • Okayama-shi, Okayama, Japan, 700-8558
        • Okayama University Hospital /ID# 167356
    • Osaka
      • Osaka-shi, Osaka, Japan, 530-0011
        • Kinshukai Infusion Clinic /ID# 218872
      • Osaka-shi, Osaka, Japan, 545-8586
        • Osaka Metropolitan University Hospital /ID# 166015
      • Suita-shi, Osaka, Japan, 565-0871
        • Osaka University Hospital /ID# 169663
      • Takatsuki-shi, Osaka, Japan, 569-8686
        • Osaka Medical and Pharmaceutical University Hospital /ID# 206326
    • Saitama
      • Saitama-shi, Saitama, Japan, 336-0963
        • Tokitokai Tokito clinic /ID# 165962
    • Shiga
      • Otsu-shi, Shiga, Japan, 520-2192
        • Shiga University of Medical Science Hospital /ID# 167129
    • Shizuoka
      • Hamamatsu-shi, Shizuoka, Japan, 431-3192
        • Hamamatsu University Hospital /ID# 224352
      • Sunto-gun, Shizuoka, Japan, 411-8611
        • NHO Shizuoka Medical Center /ID# 167125
    • Tokyo
      • Bunkyo-ku, Tokyo, Japan, 113-8519
        • Tokyo Medical And Dental University Hospital /ID# 165965
      • Hachioji-shi, Tokyo, Japan, 192-0032
        • Tokai University Hachioji Hospital /ID# 165967
      • Minato-ku, Tokyo, Japan, 105-8471
        • The Jikei University Hospital /ID# 167130
      • Mitaka-shi, Tokyo, Japan, 181-8611
        • Kyorin University Hospital /ID# 165966
      • Shinjuku-ku, Tokyo, Japan, 162-8666
        • Tokyo Women's Medical University Hospital /ID# 205980
    • Toyama
      • Toyama-shi, Toyama, Japan, 930-8550
        • Toyama Prefectural Central Hospital /ID# 217834
    • Wakayama
      • Wakayama-shi, Wakayama, Japan, 640-8558
        • Japanese Red Cross Wakayama Medical Center /ID# 200643
      • Wakayama-shi, Wakayama, Japan, 641-8510
        • Wakayama Medical University Hospital /ID# 169482
    • Yamagata
      • Yamagata-shi, Yamagata, Japan, 990-9585
        • Yamagata University Hospital /ID# 200157
  • Korea, Republic of
      • Busan, Korea, Republic of, 48108
        • Inje University Haeundae Hospital /ID# 202630
      • Busan, Korea, Republic of, 49201
        • Dong-A University Hospital /ID# 167591
      • Busan, Korea, Republic of, 49241
        • Pusan National University Hospital /ID# 167589
      • Daegu, Korea, Republic of, 41944
        • Kyungpook National University Hospital /ID# 207019
      • Seoul, Korea, Republic of, 06351
        • Samsung Medical Center /ID# 167588
      • Seoul, Korea, Republic of, 06973
        • Chung-Ang University Hostipal /ID# 207018
    • Gyeonggido
      • Guri, Gyeonggido, Korea, Republic of, 11923
        • Hayang University GuriHospital /ID# 167587
      • Seongnam si, Gyeonggido, Korea, Republic of, 13496
        • CHA University Bundang Medical Center /ID# 167592
    • Seoul Teugbyeolsi
      • Seoul, Seoul Teugbyeolsi, Korea, Republic of, 03181
        • Kangbuk Samsung Hospital /ID# 167586
      • Seoul, Seoul Teugbyeolsi, Korea, Republic of, 03722
        • Yonsei University Health System Severance Hospital /ID# 167590
  • Latvia
      • Riga, Latvia, 1035
        • VCA Polyclinic Aura /ID# 169498
      • Riga, Latvia, LV- 1002
        • Pauls Stradins Clinical University Hospital /ID# 169519
      • Riga, Latvia, LV-1079
        • Digestive Disease Center Gastro /ID# 169508
  • Lithuania
      • Kaunas, Lithuania, 50161
        • Hospital of Lithuanian University of Health Sciences Kaunas Clinics /ID# 206936
      • Vilnius, Lithuania, 08661
        • Vilnius University Hospital Santaros Klinikos /ID# 203286
  • Malaysia
      • Kelantan, Malaysia, 16150
        • Universiti Sains Malaysia /ID# 200102
    • Kedah
      • Alor Setar, Kedah, Malaysia, 05460
        • Hospital Sultanah Bahiyah /ID# 202626
    • Selangor
      • Kuala Lumpur, Selangor, Malaysia, 56000
        • Universiti Kebangsaan Malaysia (UKM) Medical Centre /ID# 170773
  • Mexico
    • Durango
      • Victoria de Durango, Durango, Mexico, 34000
        • Instituto de Investigaciones Aplicadas a la Neurociencias A.C. /ID# 207579
    • Guanajuato
      • Leon, Guanajuato, Mexico, 37000
        • Morales Vargas Centro de Investigacion S.C. /ID# 203494
    • Jalisco
      • Guadalajara, Jalisco, Mexico, 44650
        • Clinica de Investigacion en Reumatologia y Obesidad S.C. /ID# 207238
  • Netherlands
      • Amsterdam, Netherlands, 1091 AC
        • Onze Lieve Vrouwe Gasthuis /ID# 166929
      • Amsterdam, Netherlands, 1105 AZ
        • Academisch Medisch Centrum /ID# 166927
      • Enschede, Netherlands, 7512 KZ
        • Medisch Spectrum Twente /ID# 170298
    • Gelderland
      • Nijmegen, Gelderland, Netherlands, 6525 GA
        • Radboud Universitair Medisch Centrum /ID# 166928
    • Limburg
      • Heerlen, Limburg, Netherlands, 6419 PC
        • Zuyderland Medisch Centrum /ID# 169700
  • Poland
    • Dolnoslaskie
      • Wroclaw, Dolnoslaskie, Poland, 53-149
        • Vistamed /ID# 208572
    • Malopolskie
      • Krakow, Malopolskie, Poland, 30-149
        • Malopolskie Centrum Kliniczne /ID# 202167
    • Mazowieckie
      • Warsaw, Mazowieckie, Poland, 00-728
        • WIP Warsaw IBD Point Profesor Kierkus /ID# 224301
      • Warszawa, Mazowieckie, Poland, 00-635
        • Centrum Zdrowia MDM /ID# 200491
      • Warszawa, Mazowieckie, Poland, 02-665
        • Centrum Medyczne Reuma Park /ID# 200490
  • Portugal
      • Almada, Portugal, 2805-267
        • Hospital Garcia de Orta, EPE /ID# 170241
      • Porto, Portugal, 4200-319
        • Centro Hospitalar Universitario de Sao Joao, EPE /ID# 170248
    • Braga
      • Guimaraes, Braga, Portugal, 4835-044
        • Hospital da Senhora da Oliveira Guimaraes, EPE /ID# 170245
    • Porto
      • Lisbon, Porto, Portugal, 1349-019
        • Hospital Egas Moniz /ID# 170253
    • 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# 200607
  • Puerto Rico
      • San Juan, Puerto Rico, 00918-3756
        • Mindful Medical Research /ID# 203358
      • San Juan, Puerto Rico, 00935
        • School of Medicine University of Puerto Rico-Medical Science Campus /ID# 166771
  • Romania
      • Timișoara, Romania, 300002
        • Cabinet Particular Policlinic Algomed /ID# 167818
    • Bucuresti
      • Sector 2, Bucuresti, Romania, 022328
        • Institutul Clinic Fundeni /ID# 167817
    • Cluj
      • Cluj-Napoca, Cluj, Romania, 400380
        • Clinica GASTRO MED SRL /ID# 206369
  • Russian Federation
      • Moscow, Russian Federation, 105554
        • Olla-Med Clinic /ID# 208720
      • Murmansk, Russian Federation, 183047
        • P.A. Bayandin Murmansk Regiona /ID# 169639
      • Petrozavodsk, Russian Federation, 185019
        • Republican hospital named after V.A. Baranov /ID# 206488
      • Pushkin, Russian Federation, 196603
        • Euromedservice /ID# 206610
      • Saint Petersburg, Russian Federation, 194156
        • X7 Clinical Research Center /ID# 216350
      • St. Petersburg, Russian Federation, 197110
        • City Clinical Hospital No. 31 /ID# 208868
    • Kaliningradskaya Oblast
      • Kaliningrad, Kaliningradskaya Oblast, Russian Federation, 236016
        • Immanuel Kant Baltic Federal University /ID# 203811
    • Novosibirskaya Oblast
      • Novosibirsk, Novosibirskaya Oblast, Russian Federation, 630099
        • LLC Medical Center /ID# 209236
    • Permskiy Kray
      • Perm, Permskiy Kray, Russian Federation, 614109
        • Perm Clinical Center of the Federal Medical and Biological Agency /ID# 202990
    • Stavropol Skiy Kray
      • Pyatigorsk, Stavropol Skiy Kray, Russian Federation, 357500
        • LLC Novaya Klinika /ID# 206616
      • Stavropol, Stavropol Skiy Kray, Russian Federation, 355012
        • Professor Pasechnikov Gastroenterology and Pankreatology clinic /ID# 202997
    • Tatarstan, Respublika
      • Kazan, Tatarstan, Respublika, Russian Federation, 420012
        • Kazan State Medical University /ID# 169638
  • Serbia
    • Beograd
      • Belgrade, Beograd, Serbia, 11000
        • Clinical Hosp Center Zvezdara /ID# 168214
      • Belgrade, Beograd, Serbia, 11000
        • Military Medical Academy /ID# 168783
      • Belgrade, Beograd, Serbia, 11000
        • University Clinical Center Serbia /ID# 168215
      • Belgrade, Beograd, Serbia, 11080
        • Clin Hosp Ctr Bezanijska Kosa /ID# 168750
    • Sumadijski Okrug
      • Kragujevac, Sumadijski Okrug, Serbia, 34000
        • University Clinical Center Kragujevac /ID# 205859
    • Vojvodina
      • Novi Sad, Vojvodina, Serbia, 21000
        • Clinical Center Vojvodina /ID# 168213
  • Singapore
      • Singapore, Singapore, 228510
        • KL Ling Gastroenterology and Liver Clinic /ID# 217962
      • Singapore, Singapore, 258499
        • Gleneagles Medical Centre /ID# 206531
      • Singapore, Singapore, 308433
        • Tan Tock Seng Hospital /ID# 203160
  • Slovakia
      • Banska Bystrica, Slovakia, 975 17
        • Fakultna nemocnica s poliklinikou F.D. Roosevelta Banska Bystrica /ID# 169958
      • Nitra, Slovakia, 949 01
        • KM Management, spol. s.r.o. /ID# 170201
  • Slovenia
      • Ljubljana, Slovenia, 1000
        • Univ Medical Ctr Ljubljana /ID# 217795
  • South Africa
    • Free State
      • Bloemfontein, Free State, South Africa, 9301
        • Farmovs (Pty) Ltd /Id# 207535
    • Gauteng
      • Johannesburg, Gauteng, South Africa, 1820
        • Lenasia Clinical Trial Centre /ID# 205145
      • Johannesburg, Gauteng, South Africa, 2193
        • Wits Clinical Research Site /ID# 170852
    • Western Cape
      • Cape Town, Western Cape, South Africa, 7700
        • Allergy & Immunology (AIU) /ID# 171431
      • Cape Town, Western Cape, South Africa, 7708
        • Dr JP Wright /ID# 170887
      • Cape Town, Western Cape, South Africa, 7800
        • Private Practice Dr MN Rajabally /ID# 169853
  • Spain
      • A Coruna, Spain, 15006
        • Hospital Universitario A Coruna - CHUAC /ID# 203910
      • Barcelona, Spain, 08036
        • Hospital Clinic de Barcelona /ID# 201990
      • Girona, Spain, 17007
        • Hospital Universitario de Girona Doctor Josep Trueta /ID# 202645
      • Huelva, Spain, 21005
        • Hospital Juan Ramon Jimenez /ID# 201995
      • Madrid, Spain, 28046
        • Hospital Universitario La Paz /ID# 201994
      • Salamanca, Spain, 37711
        • Hospital Universitario de Salamanca /ID# 206358
      • Sevilla, Spain, 41009
        • Hospital Universitario Virgen Macarena /ID# 201993
      • Valencia, Spain, 46010
        • Hospital Clinico Universitario de Valencia /ID# 209657
      • Valencia, Spain, 46026
        • Hospital Universitario y Politecnico La Fe /ID# 201992
    • Illes Balears
      • Palma de Mallorca, Illes Balears, Spain, 07120
        • Hospital Universitari Son Espases /ID# 201998
    • Navarra
      • Pamplona, Navarra, Spain, 31008
        • Hospital Universitario de Navarra /ID# 202355
  • Sweden
    • Hallands Lan
      • Halmstad, Hallands Lan, Sweden, 302 33
        • Hallands Hospital Halmstad /ID# 170828
    • Stockholms Lan
      • Solna, Stockholms Lan, Sweden, 171 64
        • Karolinska University Hospital Solna /ID# 224488
    • Vastra Gotalands Lan
      • Alingsas, Vastra Gotalands Lan, Sweden, 441 33
        • Alingsas lasarett /ID# 170826
      • Boras, Vastra Gotalands Lan, Sweden, 501 82
        • Sodra Alvsborgs sjukhus /ID# 203077
      • Gothenburg, Vastra Gotalands Lan, Sweden, 413 46
        • Sahlgrenska University Hospital /ID# 169171
  • Switzerland
      • Bern, Switzerland, 3010
        • Inselspital, Universitätsspital Bern /ID# 170997
    • Zuerich
      • Zürich, Zuerich, Switzerland, 8091
        • Universitätsspital Zürich /ID# 170998
  • Taiwan
      • Taichung, Taiwan, 40705
        • Taichung Veterans General Hospital /ID# 169790
      • Taichung City, Taiwan, 40447
        • China Medical University Hospital /ID# 169791
      • Taipei City, Taiwan, 100
        • National Taiwan University Hospital /ID# 169792
  • Turkey
      • Ankara, Turkey, 06590
        • Ankara Univ Medical Faculty /ID# 206409
      • Battalgazi/malatya, Turkey, 44280
        • Inonu Universitesi Turgut Ozal /ID# 201268
      • Hatay, Turkey, 31001
        • Mustafa Kemal University Medic /ID# 171336
      • Istanbul, Turkey, 34093
        • Istanbul University Istanbul Medical Faculty /ID# 171364
      • Istanbul, Turkey, 34899
        • Marmara Universitesi Pendik Egitim ve Arastirma Hastanesi /ID# 171332
      • Mersin, Turkey, 33343
        • Mersin University Medical /ID# 171338
      • Sisli, Turkey, 34371
        • Sisli Etfal Train & Res Hosp /ID# 171334
      • Yenimahalle, Turkey, 06560
        • Gazi Universitesi Tip Fakultes /ID# 217444
    • Istanbul
      • Kadikoy, Istanbul, Turkey, 34742
        • Acibadem Kozyatagi Hospital /ID# 209406
    • Kayseri
      • Melikgazi, Kayseri, Turkey, 38030
        • Erciyes University Medical Fac /ID# 171331
  • Ukraine
      • Kharkiv, Ukraine, 61037
        • Kharkiv City Clinical Hospital No.2 n.a. Prof. O.O. Shalimov /ID# 167907
      • Kyiv, Ukraine, 01030
        • Kyiv Municipal Clinical Hospital #18 /ID# 207889
      • Kyiv, Ukraine, 04107
        • MNI KRC Kyiv Regional Clinical Hospital /ID# 202454
      • Lviv, Ukraine, 79000
        • Lviv Railway Clinical Hospital of branch Healthcare Centers of Public Joint Stoc /ID# 167908
      • Vinnytsia, Ukraine, 21028
        • CNE Vinnytsya Regional Clinical Hospital named after N.I.Pirogov /ID# 222110
    • Kyivska Oblast
      • Kyiv, Kyivska Oblast, Ukraine, 01030
        • Medical Centre of "Ukrainian German Antiulcer Gastroenterology Centre BYK-KYIV" /ID# 203738
  • United Kingdom
      • Bath, United Kingdom, BA1 3NG
        • Royal United Hospitals Bath /ID# 169074
      • Birmingham, United Kingdom, B15 2TH
        • University Hospitals Birmingham NHS Foundation Trust /ID# 169070
      • Dudley, United Kingdom, DY1 2HQ
        • The Dudley Group NHS Foundation Trust /ID# 169069
      • London, United Kingdom, SE5 9RS
        • King's College Hospital NHS Foundation Trust /ID# 169072
      • Newcastle Upon Tyne, United Kingdom, NE7 7DN
        • The Newcastle Upon Tyne Hospitals NHS Foundation Trust /ID# 169075
      • Stockport, United Kingdom, SK2 7JE
        • Stockport NHS foundation trust /ID# 208719
      • Taunton, United Kingdom, TA1 5DA
        • Taunton and Somerset NHS Foundation Trust /ID# 209665
      • Tooting, United Kingdom, SW17 0QT
        • St George's University Hospitals NHS Foundation Trust /ID# 205552
      • Wolverhampton, United Kingdom, WV10 0QP
        • The Royal Wolverhampton NHS Trust /ID# 171382
    • Antrim
      • Belfast, Antrim, United Kingdom, BT16 1RH
        • South Eastern Health and Social Care Trust /ID# 205323
    • Cheshire West And Chester
      • Warrington, Cheshire West And Chester, United Kingdom, WA5 1QG
        • Warrington and Halton Hospitals NHS Foundation Trust /ID# 171383
      • Warrington, Cheshire West And Chester, United Kingdom, WA5 1QG
        • Warrington and Halton Hospitals NHS Foundation Trust /ID# 209086
  • United States
    • Alabama
      • Mobile, Alabama, United States, 36606
        • East View Medical Research, LLC /ID# 171176
      • Mobile, Alabama, United States, 36608
        • CB Flock Research Corporation /ID# 166185
    • Arizona
      • Chandler, Arizona, United States, 85224
        • Delsol Research Management, Ll /Id# 170145
      • Scottsdale, Arizona, United States, 85258
        • HonorHealth Research Institute - Shea /ID# 164821
      • Sun City, Arizona, United States, 85306
        • Arizona Arthritis & Rheumatology Research, PLLC /ID# 164803
    • California
      • Coronado, California, United States, 92118-1408
        • Southern California Res. Ctr. /ID# 169655
      • Covina, California, United States, 91722-3797
        • Citrus Valley Gastroenterology /ID# 166173
      • Irvine, California, United States, 92618
        • Hoag Memorial Hosp Presbyterian /ID# 222540
      • Los Alamitos, California, United States, 90720-3309
        • United Medical Doctors /ID# 207449
      • Los Angeles, California, United States, 90067-2001
        • Gastrointestinal Biosciences Clinical Trials, LLC /ID# 164762
      • Mission Hills, California, United States, 91345
        • Facey Medical Foundation /ID# 203136
      • Murrieta, California, United States, 92563
        • United Medical Doctors - Murrieta /ID# 164945
      • San Diego, California, United States, 92103
        • Ucsd /Id# 164910
      • San Diego, California, United States, 92123
        • Medical Assoc Research Grp /ID# 169706
      • San Francisco, California, United States, 94158
        • Univ of California San Francis /ID# 164944
      • San Pablo, California, United States, 94806
        • Care Access Research /ID# 167767
    • Colorado
      • Colorado Springs, Colorado, United States, 80907
        • Peak Gastroenterology Associates, PC /ID# 170143
      • Colorado Springs, Colorado, United States, 80918
        • Delta Waves, Inc. /ID# 164776
      • Wheat Ridge, Colorado, United States, 80033-2896
        • Western States Clinical Res /ID# 164760
    • Connecticut
      • Hamden, Connecticut, United States, 06518
        • Medical Research Center of CT /ID# 164926
    • Florida
      • Clearwater, Florida, United States, 33765
        • Clinical Research of West Florida, Inc /ID# 205827
      • Clearwater, Florida, United States, 33765
        • Clinical Research of West Florida, Inc /ID# 208118
      • Coral Springs, Florida, United States, 33067-3173
        • Advanced Research - Coral Springs /ID# 218021
      • Jacksonville, Florida, United States, 32256
        • Encore Borland-Groover Clinical Research /Id# 203499
      • Maitland, Florida, United States, 32751-6108
        • Ctr for Advanced Gastroenterol /ID# 165353
      • Miami, Florida, United States, 33165
        • Crystal Pharmacology Research /ID# 166081
      • Miami, Florida, United States, 33186-4643
        • Coral Research Clinic /ID# 164890
      • New Port Richey, Florida, United States, 34653
        • Advanced Research Institute, Inc /ID# 164921
      • Orlando, Florida, United States, 32803
        • Endoscopic Research, Inc. /ID# 206136
      • Orlando, Florida, United States, 32808
        • Omega Research Maitland, LLC /ID# 203481
      • Tampa, Florida, United States, 33607
        • Clinical Research Trials of Florida, Inc. /ID# 203485
      • Tampa, Florida, United States, 33613-4680
        • AdventHealth Tampa /ID# 171167
    • Georgia
      • Macon, Georgia, United States, 31201
        • Gastroenterology Associates of Central Georgia, LLC /ID# 165478
      • Roswell, Georgia, United States, 30076-4913
        • Gastroenterology Consultants PC - Roswell /ID# 218220
      • Suwanee, Georgia, United States, 30024
        • Atlanta Gastroenterology Spec /ID# 164799
    • Idaho
      • Boise, Idaho, United States, 83706
        • Treasure Valley Medical Research /ID# 215032
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Rush University Medical Center /ID# 165497
      • Chicago, Illinois, United States, 60637-1426
        • University of Chicago Medicine /ID# 165503
      • Downers Grove, Illinois, United States, 60515-5509
        • DuPage Medical Group /ID# 205328
    • Indiana
      • Evansville, Indiana, United States, 47714-8011
        • MediSphere Medical Research Center /ID# 166175
      • Indianapolis, Indiana, United States, 46237
        • Indianapolis Gastroenterology /ID# 164938
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • University of Iowa Hospitals and Clinics /ID# 165436
    • Kentucky
      • Crestview Hills, Kentucky, United States, 41017
        • Tri-State Gastroenterology /ID# 165496
      • Louisville, Kentucky, United States, 40202
        • University of Louisville /ID# 165366
      • Louisville, Kentucky, United States, 40202
        • University of Louisville /ID# 168572
    • Louisiana
      • Houma, Louisiana, United States, 70360
        • CroNOLA, LLC /ID# 164823
      • New Orleans, Louisiana, United States, 70115
        • Nola Research Works, LLC /ID# 164759
      • Shreveport, Louisiana, United States, 71105-6800
        • Louisana Research Center, LLC /ID# 164894
    • Maryland
      • Baltimore, Maryland, United States, 21287-0010
        • Johns Hopkins University School of Medicine /ID# 211941
      • Chevy Chase, Maryland, United States, 20815
        • MGG Group Co, Inc.Chevy Chase Clinical Research /ID# 164935
      • Columbia, Maryland, United States, 21045
        • Gastro Center of Maryland /ID# 171161
    • Massachusetts
      • Burlington, Massachusetts, United States, 01805
        • Lahey Hospital and Medical Center /ID# 214726
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan Comprehensive Cancer Center Michigan Medicine /ID# 164943
      • Farmington Hills, Michigan, United States, 48334-3230
        • Digestive Health Associates (DHA) - Farmington Hills /ID# 205793
      • Troy, Michigan, United States, 48098-6363
        • Center for Digestive Health /ID# 164822
      • Troy, Michigan, United States, 48098
        • Clin Res Inst of Michigan, LLC /ID# 170133
    • Minnesota
      • Rochester, Minnesota, United States, 55905-0001
        • Mayo Clinic - Rochester /ID# 164783
    • Mississippi
      • Jackson, Mississippi, United States, 39216
        • Southern Therapy and Advanced Research (STAR) LLC /ID# 165343
    • Nebraska
      • Omaha, Nebraska, United States, 68114-3723
        • Quality Clinical Research Inc. /ID# 170137
      • Omaha, Nebraska, United States, 68124
        • Duplicate_CHI Nebraska d/b/a CHI Health /ID# 168578
    • Nevada
      • Las Vegas, Nevada, United States, 89113
        • Las Vegas Medical Research /ID# 168588
    • New Jersey
      • Egg Harbor Township, New Jersey, United States, 08234
        • AGA Clinical Research Associates, LLC /ID# 164769
      • New Brunswick, New Jersey, United States, 08901
        • Rutgers Robert Wood Johnson /ID# 166073
    • New York
      • Bronx, New York, United States, 10467
        • Montefiore Medical Center - Moses Campus /ID# 166193
      • Bronx, New York, United States, 10468
        • Advantage Clinical Trials /ID# 168546
      • Brooklyn, New York, United States, 11235
        • NY Scientific /ID# 164931
      • Johnson City, New York, United States, 13790-2107
        • United Health Services Hospitals, Inc /ID# 217485
      • Lake Success, New York, United States, 11042
        • NYU Langone Long Island Clinical Research Associates /ID# 164927
      • New York, New York, United States, 10029
        • The Mount Sinai Hospital /ID# 170257
      • New York, New York, United States, 10032-3725
        • Columbia Univ Medical Center /ID# 164782
      • Rochester, New York, United States, 14618-5703
        • Gastoenterology Group of Rochester /ID# 166177
      • Staten Island, New York, United States, 10310-1664
        • Richmond University Medical Center /ID# 201857
    • North Carolina
      • Charlotte, North Carolina, United States, 28203
        • Atrium Health Carolinas Medical Center /ID# 164932
      • Charlotte, North Carolina, United States, 28209
        • PMG Research of Charlotte /ID# 171160
      • Raleigh, North Carolina, United States, 27612
        • Wake Radiology UNC REX Healthcare - Raleigh Office /ID# 164904
      • Winston-Salem, North Carolina, United States, 27157-0001
        • Wake Forest Baptist Medical Center /ID# 164908
    • North Dakota
      • Fargo, North Dakota, United States, 58104-5925
        • Plains Clinical Research Center, LLC /ID# 170140
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • Gastro Health Research /ID# 164791
      • Cincinnati, Ohio, United States, 45267-0585
        • University of Cincinnati /ID# 164825
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic Main Campus /ID# 209231
      • Columbus, Ohio, United States, 43210
        • The Ohio State University /ID# 170141
      • Columbus, Ohio, United States, 43235
        • Optimed Research, Ltd. /ID# 205624
      • Dayton, Ohio, United States, 45424
        • Hometown Urgent Care and Resea /ID# 201291
      • Englewood, Ohio, United States, 45415
        • Dayton Gastroenterology, Inc. /ID# 167627
      • Mentor, Ohio, United States, 44060-6211
        • Great Lakes Medical Research, LLC /ID# 202010
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73112
        • Digestive Disease Specialists /ID# 201064
      • Tulsa, Oklahoma, United States, 74104
        • Options Health Research, LLC /ID# 164820
      • Tulsa, Oklahoma, United States, 74135
        • Healthcare Research Consultant /ID# 166195
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104-5502
        • University of Pennsylvania /ID# 168430
    • South Carolina
      • Charleston, South Carolina, United States, 29412
        • Pharmacorp Clinical Trials /ID# 164916
      • Greenville, South Carolina, United States, 29615-3593
        • Gastroenterology Associates, P.A. of Greenville /ID# 164771
    • South Dakota
      • Rapid City, South Dakota, United States, 57701
        • Rapid City Medical Center - GI Research /ID# 201735
    • Tennessee
      • Germantown, Tennessee, United States, 38138
        • Gastro One /ID# 164826
      • Johnson City, Tennessee, United States, 37604
        • East Tennessee Research Institute /ID# 203613
      • Nashville, Tennessee, United States, 37211
        • Quality Medical Research /ID# 205263
      • Nashville, Tennessee, United States, 37232-0011
        • Vanderbilt University Medical Center /ID# 164946
    • Texas
      • Arlington, Texas, United States, 76012
        • TX Clinical Research Institute /ID# 164896
      • Baytown, Texas, United States, 77521-2415
        • Inquest Clinical Research /ID# 164785
      • Cedar Park, Texas, United States, 78613-5028
        • Texas Digestive Disease Consultants /ID# 209953
      • Cedar Park, Texas, United States, 78613
        • Texas Digestive Disease Consultants /ID# 209801
      • Dallas, Texas, United States, 75246
        • Baylor Scott & White Center for Inflammatory Bowel Diseases /ID# 170144
      • Houston, Texas, United States, 77027-6812
        • CliniCore International, LLC /ID# 164902
      • Houston, Texas, United States, 77030-3411
        • Baylor College of Medicine - Baylor Medical Center /ID# 164947
      • Houston, Texas, United States, 77058
        • Centex Studies, Inc. - Houston /ID# 201214
      • Houston, Texas, United States, 77070-4347
        • GI Specialists of Houston /ID# 202339
      • Lubbock, Texas, United States, 79424-3017
        • Caprock Gastro Research, LLC /ID# 215438
      • San Antonio, Texas, United States, 78212
        • Clinical Associates in Research Therapeutics of America, LLC /ID# 164786
      • San Antonio, Texas, United States, 78229-5390
        • Southern Star Research Institute, LLC /ID# 169755
      • Sugar Land, Texas, United States, 77478
        • Carl R. Meisner Medical Clinic /ID# 201061
      • Tyler, Texas, United States, 75701-4464
        • Tyler Research Institute, LLC /ID# 168687
      • Victoria, Texas, United States, 77904
        • Gastro Health & Nutrition - Victoria /ID# 167812
    • Utah
      • Bountiful, Utah, United States, 84010
        • HP Clinical Research /ID# 164933
      • Ogden, Utah, United States, 84403
        • Advanced Research Institute /ID# 164784
      • Salt Lake City, Utah, United States, 84124-1377
        • Duplicate_Care Access Research /ID# 164794
      • West Jordan, Utah, United States, 84088
        • Velocity Clinical Research - Salt Lake City /ID# 166076
    • Washington
      • Bellevue, Washington, United States, 98004
        • Washington Gastroenterology /ID# 164824
      • Seattle, Washington, United States, 98101
        • Virginia Mason Medical Center /ID# 164913
      • Vancouver, Washington, United States, 98664
        • The Vancouver Clinic, INC. PS /ID# 164918
    • Wisconsin
      • Wauwatosa, Wisconsin, United States, 53226
        • Allegiance Research Specialists /ID# 165346

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 one or more conventional and/or biologic therapies (oral locally acting steroids, intravenous or oral corticosteroids, immunosuppressants or biologic therapies for CD), in the opinion of the investigator.

    • Note: Participants who have had inadequate response or intolerance to conventional therapy who have received prior biologic may be enrolled; however, participants must have discontinued the biologic for reasons other than inadequate response or intolerance (e.g., change of insurance, well controlled disease).
  • 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, > 2 entire missing segments of the following 5 segments: terminal ileum, right colon, transverse colon, sigmoid and left colon, and rectum, 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 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 Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Participants will receive placebo once daily for 12 weeks in Part 1. Clinical non-responders will receive 45 mg upadacitinib once daily for 12 weeks in Part 2.
Drug: Upadacitinib
Oral; Tablet
Other Names:
  • RINVOQ
  • ABT-494
Drug: Placebo for Upadacitinib
Oral; Tablet
Experimental: Upadacitinib
Participants will receive 45 mg upadacitinib once daily for 12 weeks in Part 1. Clinical non-responders will receive 30 mg upadacitinib once daily for 12 weeks in Part 2.
Drug: Upadacitinib
Oral; Tablet
Other Names:
  • RINVOQ
  • ABT-494

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 co-primary endpoint for United States (US)/Food and Drug Administration (FDA) regulatory purposes was clinical remission based on CDAI at Week 12.

CDAI is a composite instrument that includes participant symptoms evaluated over 7 days (abdominal pain, stool frequency and general well-being), as well as presence of complications (arthritis/arthralgia, iritis/uveitis, erythema nodosum/pyoderma gangrenosum/aphthous stomatitis, anal fissure/fistula/abscess, other fistula, and fever), the use of antidiarrheal medicines, presence of an abdominal mass, hematocrit, and body weight. These items are scored individually, weighted, and do not contribute equally to the overall score. The CDAI is derived from summing up the weighted individual scores of eight items. CDAI approximately ranges from 0 to 600 with higher scores indicating more severe disease. Clinical remission is defined as a CDAI score less than 150.
Week 12
Percentage of Participants With Clinical Remission Per Patient-Reported Outcomes (PROs) at Week 12
Time Frame: Week 12

The co-primary endpoint for European Union (EU)/European Medicines Agency (EMA) regulatory purposes was clinical remission defined based on two patient reported outcomes, average daily stool frequency (SF) and average daily abdominal pain score (APS). Clinical remission per PROs was defined as average daily very soft or liquid SF ≤ 2.8 and average daily APS ≤ 1.0 and neither worse than Baseline.

Participants recorded APS and the number of very soft or liquid SF daily in an electronic diary. Abdominal pain was rated on a scale from 0 (none) to 3 (severe).

The average daily very soft or liquid SF and APS were calculated using the 4-7 most recent useable days of patient-report outcomes (i.e., excluding days with missing entries or associated with endoscopy procedures) out of the last 14 days prior to the Week 12 visit.
Week 12
Percentage of Participants With Endoscopic Response at Week 12
Time Frame: Baseline and Week 12

Endoscopic response at Week 12 was a co-primary endpoint for both the US/FDA and EU/EMA regulatory purposes. 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, at least a 2-point reduction from Baseline), as scored by independent external and blinded central readers.

The SES-CD evaluates 4 endoscopic variables (ulcer size, ulcerated surface, affected surface, and narrowing, each on a scale from 0 (none) to 3 in 5 segments assessed during ileocolonoscopy (ileum, right colon, transverse colon, sigmoid and left colon, and rectum). The total score is the sum of the 4 endoscopic variable scores and ranges from 0 to 56, where higher scores indicate more severe disease.
Baseline and Week 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants With Endoscopic Remission at Week 12
Time Frame: Baseline and Week 12

Endoscopic remission is defined as an SES-CD ≤ 4 and at least 2 point reduction from Baseline and no subscore > 1 in any individual variable,as scored by independent external and blinded central readers.

The SES-CD evaluates 4 endoscopic variables (ulcer size, ulcerated surface, affected surface, and narrowing, each on a scale from 0 (none) to 3 in 5 segments assessed during ileocolonoscopy (ileum, right colon, transverse colon, sigmoid and left colon, and rectum). The total score is the sum of the 4 endoscopic variable scores and ranges from 0 to 56, where higher scores indicate more severe disease.
Baseline and Week 12
Percentage of Participants Who Discontinued Corticosteroid Use for Crohn's Disease and Achieved Clinical Remission Per CDAI at Week 12
Time Frame: Week 12

Corticosteroid-free clinical remission is defined as participants who discontinued corticosteroid use for CD and achieved clinical remission per CDAI at Week 12, assessed for participants taking corticosteroids for CD at Baseline.

CDAI is a composite instrument that includes participant symptoms evaluated over 7 days (abdominal pain, stool frequency and general well-being), as well as presence of complications (arthritis/arthralgia, iritis/uveitis, erythema nodosum/pyoderma gangrenosum/aphthous stomatitis, anal fissure/fistula/abscess, other fistula, and fever), the use of antidiarrheal medicines, presence of an abdominal mass, hematocrit, and body weight. These items are scored individually, weighted, and do not contribute equally to the overall score. The CDAI is derived from summing up the weighted individual scores of eight items. CDAI approximately ranges from 0 to 600 with higher scores indicating more severe disease. Clinical remission is defined as CDAI score less than 150.
Week 12
Change From Baseline in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue) at Week 12
Time Frame: Baseline and Week 12
The FACIT-Fatigue questionnaire is a self-administered patient questionnaire that consists of 13 questions designed to measure the degree of fatigue experienced by participants in the previous 7 days, including physical fatigue (e.g., I feel tired), functional fatigue (e.g., trouble finishing things), emotional fatigue (e.g., frustration), and social consequences of fatigue (e.g., limits social activity). Participants respond to the questions on a scale from 0 (not at all) to 4 (very much). The FACIT-Fatigue score is computed by summing the item scores, after reversing those items that are worded in the negative direction. The FACIT-Fatigue score ranges from 0 to 52, where higher 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 Inflammatory Bowel Disease Questionnaire (IBDQ) is used to assess health-related quality of life (HRQoL) in patients with inflammatory bowel disease. It consists of 32 questions evaluating bowel and systemic symptoms, as well as emotional and social functions. Each question is answered on a scale from 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 and Week 2

Clinical response 100 (CR-100) is defined as a decrease of at least 100 points in CDAI from Baseline.

CDAI is a composite instrument that includes participant symptoms evaluated over 7 days (abdominal pain, stool frequency and general well-being), as well as presence of complications (arthritis/arthralgia, iritis/uveitis, erythema nodosum/pyoderma gangrenosum/aphthous stomatitis, anal fissure/fistula/abscess, other fistula, and fever), the use of antidiarrheal medicines, presence of an abdominal mass, hematocrit, and body weight. These items are scored individually, weighted, and do not contribute equally to the overall score. The CDAI is derived from summing up the weighted individual scores of eight items. CDAI approximately ranges from 0 to 600 with higher scores indicating more severe disease.
Baseline and Week 2
Percentage of Participants Achieving Clinical Response 100 (CR-100) at Week 12
Time Frame: Baseline and Week 12

Clinical response 100 (CR-100) is defined as a decrease of at least 100 points in CDAI from Baseline.

CDAI is a composite instrument that includes participant symptoms evaluated over 7 days (abdominal pain, stool frequency and general well-being), as well as presence of complications (arthritis/arthralgia, iritis/uveitis, erythema nodosum/pyoderma gangrenosum/aphthous stomatitis, anal fissure/fistula/abscess, other fistula, and fever), the use of antidiarrheal medicines, presence of an abdominal mass, hematocrit, and body weight. These items are scored individually, weighted, and do not contribute equally to the overall score. The CDAI is derived from summing up the weighted individual scores of eight items. CDAI approximately ranges from 0 to 600 with higher scores indicating more severe disease.
Baseline and Week 12
Percentage of Participants With Clinical Remission Per CDAI at Week 4
Time Frame: Week 4
CDAI is a composite instrument that includes participant symptoms evaluated over 7 days (abdominal pain, stool frequency and general well-being), as well as presence of complications (arthritis/arthralgia, iritis/uveitis, erythema nodosum/pyoderma gangrenosum/aphthous stomatitis, anal fissure/fistula/abscess, other fistula, and fever), the use of antidiarrheal medicines, presence of an abdominal mass, hematocrit, and body weight. These items are scored individually, weighted, and do not contribute equally to the overall score. The CDAI is derived from summing up the weighted individual scores of eight items. CDAI approximately ranges from 0 to 600 with higher scores indicating more severe disease. Clinical remission is defined as CDAI score less than 150.
Week 4
Percentage of Participants With Hospitalizations Due to Crohn's Disease (CD) During the 12-Week Induction Period
Time Frame: 12 weeks
This was assessed by reviewing participant's hospitalization data.
12 weeks
Percentage of Participants With Resolution of Extra-Intestinal Manifestation (EIMs) at Week 12
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.

Only participants with any EIM present at Baseline were included in the analysis of resolution of EIMs. Resolution of EIMs was defined as absence of all EIMs at the Week 12 visit.
Week 12
Percentage of Participants With Clinical Remission Per PROs at Week 4
Time Frame: Week 4

Clinical remission per PROs was defined as average daily very soft or liquid SF ≤ 2.8 and average daily APS ≤ 1.0 and neither worse than Baseline.

Participants recorded APS and the number of liquid or very soft SF daily in an electronic diary. Abdominal pain was rated on a scale from 0 (none) to 3 (severe).

The average daily very soft or liquid SF and APS were calculated using the 4-7 most recent useable days of patient-reported outcomes (i.e., excluding days with missing entries or associated with endoscopy procedures) out of the last 14 days prior to the Week 4 visit.
Week 4
Percentage of Participants Who Discontinued Corticosteroid Use for Crohn's Disease and Achieved Clinical Remission Per PROs at Week 12
Time Frame: Week 12

Corticosteroid-free clinical remission is defined as participants who discontinued corticosteroid use for CD and achieved clinical remission per PROs at Week 12, assessed for participants taking corticosteroids for CD at Baseline.

Clinical remission per PROs was defined as average daily very soft or liquid stool frequency (SF) ≤ 2.8 and average daily APS ≤ 1.0 and neither worse than Baseline.

Participants recorded APS and the number of liquid or very soft SF daily in an electronic diary. Abdominal pain was rated on a scale from 0 (none) to 3 (severe).

The average daily liquid or very soft SF and APS were calculated using the 4-7 most recent useable days of patient-reported outcomes (i.e., excluding days with missing entries or associated with endoscopy procedures) out of the last 14 days prior to the Week 12 visit.
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)

December 7, 2017

Primary Completion (Actual)

October 15, 2021

Study Completion (Actual)

January 13, 2022

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)

November 23, 2022

Last Update Submitted That Met QC Criteria

October 31, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M14-433
  • 2017-001240-35 (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, 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
  • Statistical Analysis Plan (SAP)
  • Clinical Study Report (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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