A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Participants With Moderately to Severely Active Ulcerative Colitis (U-Accomplish)

February 17, 2022 updated by: AbbVie

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study to Evaluate the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects With Moderately to Severely Active Ulcerative Colitis

The objective of this study is to evaluate the efficacy and safety of upadacitinib compared to placebo in inducing clinical remission (per Adapted Mayo score) in participants with moderately to severely active ulcerative colitis (UC).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Study M14-675 consists of 2 parts, Part 1 and Part 2. Part 1 is a randomized, double-blind, placebo-controlled 8-week induction period. Part 2 is an open-label, 8-week extended treatment period for participants who did not achieve clinical response at Week 8 in Part 1.

Eligible participants are randomized in a 2:1 ratio to one of the two treatment groups (upadacitinib 45 mg or matching placebo) for 8 weeks. The randomization is stratified by biologic inadequate responder (bio-IR) status (bio-IR vs non-bio-IR), corticosteroid use (yes or no), and Adapted Mayo score (≤ 7 or > 7) at Baseline. Within bio-IR, the randomization is further stratified by number of prior biologic treatments (≤ 1 or > 1). Within non-bio-IR, the randomization is further stratified by previous biologic use (yes or no).

Participants who achieve clinical response defined by Adapted Mayo Score at Week 8 or Week 16 and do not meet any study discontinuation criteria are eligible to enroll into Study M14-234 Substudy 3 (NCT02819635; 52-week maintenance study) or Study M14-533 Cohort 1 (NCT03006068; long-term follow-up study).

Study Type

Interventional

Enrollment (Actual)

522

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# 206030
    • Buenos Aires
      • San Isidro, Buenos Aires, Argentina, 1642
        • Cardio Alem /ID# 211282
    • Ciuadad Autonoma De Buenos Aires
      • Ciudad Autonoma de Buenos Aire, Ciuadad Autonoma De Buenos Aires, Argentina, 1128
        • Mautalen Salud e Investigacion /ID# 206033
      • Ciudad Autonoma de Buenos Aire, Ciuadad Autonoma De Buenos Aires, Argentina, 1280
        • Hospital Britanico de Buenos Aires /ID# 209497
      • Ciudad Autonoma de Buenos Aire, Ciuadad Autonoma De Buenos Aires, Argentina, 1426
        • Gedyt /ID# 210017
  • Australia
    • New South Wales
      • Macquarie University, New South Wales, Australia, 2109
        • Macquarie University Hospital /ID# 211955
    • Queensland
      • South Brisbane, Queensland, Australia, 4101
        • Duplicate_Mater Misericordiae /ID# 212687
      • Southport, Queensland, Australia, 4222
        • Griffith University /ID# 211956
    • Victoria
      • Fitzroy, Victoria, Australia, 3065
        • St Vincent's Hospital Melbourne /ID# 205758
      • Melbourne, Victoria, Australia, 3168
        • Monash Medical Centre /ID# 206486
    • Western Australia
      • Murdoch, Western Australia, Australia, 6150
        • Fiona Stanley Hospital /ID# 211642
  • Austria
      • Salzburg, Austria, 5020
        • LKH Salzburg and Paracelsus /ID# 208788
    • Wien
      • Vienna, Wien, Austria, 1030
        • Klinik Landstrasse /ID# 205764
      • Vienna, Wien, Austria, 1090
        • Medical University of Vienna /ID# 205763
  • Belgium
      • Gent, Belgium, 9000
        • AZ Maria Middelares /ID# 210928
    • Vlaams-Brabant
      • Leuven, Vlaams-Brabant, Belgium, 3000
        • Universitair Ziekenhuis Leuven /ID# 205988
  • Bosnia and Herzegovina
      • Mostar, Bosnia and Herzegovina, 88000
        • University Clinical Hospital Mostar /ID# 208054
      • Sarajevo, Bosnia and Herzegovina, 71000
        • Clinical Center University of Sarajevo /ID# 208058
    • Republika Srpska
      • Banja Luka, Republika Srpska, Bosnia and Herzegovina, 78000
        • University Clinical Centre of the Republic of Srpska /ID# 208053
      • Banja Luka, Republika Srpska, Bosnia and Herzegovina, 78000
        • University Clinical Centre of the Republic of Srpska /ID# 208055
    • Tuzlanski
      • Tuzla, Tuzlanski, Bosnia and Herzegovina, 75000
        • University Clinical Center Tuzla /ID# 208057
  • Brazil
    • Parana
      • Curitiba, Parana, Brazil, 80810-040
        • Hospital Nossa Senhora das Graças /ID# 206981
    • Rio Grande Do Sul
      • Porto Alegre, Rio Grande Do Sul, Brazil, 90035-903
        • Hospital de Clinicas de Porto Alegre /ID# 206985
    • Sao Paulo
      • Botucatu, Sao Paulo, Brazil, 18618-686
        • Upeclin Fmb - Unesp /Id# 206986
      • Ribeirão Preto, Sao Paulo, Brazil, 14051-140
        • Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto - USP /ID# 206504
      • Santo André, Sao Paulo, Brazil, 09060-870
        • Faculdade de Medicina do ABC /ID# 206984
      • Sao Jose Do Rio Preto, Sao Paulo, Brazil, 15015-110
        • Kaiser Clinica e Hospital Dia /ID# 206982
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 4Z6
        • University of Calgary - Cumming School of Medicine - Adult Cystic Fibrosis Clini /ID# 205755
      • Edmonton, Alberta, Canada, T5R 1W2
        • Allen Whey Khye Lim Professional Corporation /ID# 211167
      • Edmonton, Alberta, Canada, T6K 4B2
        • Covenant Health /ID# 205500
    • British Columbia
      • Victoria, British Columbia, Canada, V8V 3M9
        • Percuro Clinical Research, Ltd /ID# 205501
    • Ontario
      • Vaughan, Ontario, Canada, L4L 4Y7
        • Duplicate_Toronto Digestive Disease Asso /ID# 205498
    • Quebec
      • Montreal, Quebec, Canada, H2X 0A9
        • Crchum /Id# 207387
      • Sherbrooke, Quebec, Canada, J1G 2E8
        • CIUSSS de l'Estrie - CHUS /ID# 205499
  • Chile
      • Concepción, Chile, 4070038
        • Hospital Guillermo Grant Benavente de Concepción /ID# 212426
      • Providencia, Chile, 7500571
        • CTR Estudios Clinicos /ID# 208036
      • Santiago, Chile, 7501504
        • Hospital Clinico Universidad De Los Andes /ID# 207426
    • Region Metropolitana De Santiago
      • Santiago, Region Metropolitana De Santiago, Chile, 2540364
        • Research Group /ID# 208037
      • Santiago, Region Metropolitana De Santiago, Chile, 7750495
        • M y F Estudios Clínicos Ltda. /ID# 208035
  • China
      • Chengdu, China, 610041
        • West China Hospital, Sichuan University /ID# 205332
      • Tianjin, China, 300052
        • Duplicate_Tianjin Med Univ General Hosp /ID# 205246
      • Wuhan, China, 430030
        • Tongji Hospital Tongji Medical College Huazhong University of Science and Techno /ID# 205265
    • Guangdong
      • Guangzhou, Guangdong, China, 510120
        • Sun Yat-sen Memorial Hospital of Sun Yat-sen University /ID# 205267
      • Guangzhou, Guangdong, China, 510655
        • The Sixth Affiliated Hosp Sun /ID# 205268
    • Hubei
      • Shiyan, Hubei, China, 442700
        • Affiliated Taihe Hospital of Hubei University of Medicine /ID# 216406
      • Wuhan, Hubei, China, 430022
        • Union Hospital Tongji Medical College Huazhong University of Science and Technol /ID# 205266
    • Jiangxi
      • Nanchang, Jiangxi, China, 330006
        • The First Affiliated Hospital of Nanchang University /ID# 212186
    • Jilin
      • Changchun, Jilin, China, 130021
        • The First Hospital of Jilin University /ID# 210088
    • Shanghai
      • Shanghai, Shanghai, China, 200025
        • Ruijin Hospital, Shanghai Jiaotong University School of Medicine /ID# 205333
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310009
        • The second Affiliated hospital of Zhejiang University school of Medicine /ID# 205271
  • Colombia
      • Medellin, Colombia, 50010
        • Hospital Universitario San Vic /ID# 208888
    • Cordoba
      • Monteria, Cordoba, Colombia, 230002
        • Instituto Medico de Alta Tecnologia Oncomédica S.A /ID# 208887
    • Cundinamarca
      • Bogota DC, Cundinamarca, Colombia, 111221
        • Corporacion Hospitalaria Juan Cuidad Sede Denominada Hospital Universitario Mayo /ID# 208886
  • Croatia
      • Split, Croatia, 21000
        • Klinicki bolnicki centar Split /ID# 217027
    • Grad Zagreb
      • Zagreb, Grad Zagreb, Croatia, 10000
        • Klinicka bolnica Dubrava Zagreb /ID# 208460
      • Zagreb, Grad Zagreb, Croatia, 10000
        • Poliklinika Solmed /ID# 211568
    • Primorsko-goranska Zupanija
      • Rijeka, Primorsko-goranska Zupanija, Croatia, 51000
        • Klinicki bolnicki centar Rijeka /ID# 208650
  • Czechia
      • Hradec Kralove, Czechia, 500 12
        • Hepato-Gastroenterologie HK, s.r.o. /ID# 205672
      • Olomouc, Czechia, 779 00
        • CTCenter MaVe s.r.o. /ID# 205671
      • Ostrava, Czechia, 722 00
        • Artroscan s.r.o. /ID# 205668
      • Pardubice, Czechia, 530 03
        • Nemocnice Pardubickeho kraje, a.s. /ID# 213540
      • Praha, Czechia, 118 33
        • Nemocnice Milosrdnych sester sv. Karla Boromejskeho v Praze /ID# 216223
      • Praha, Czechia, 140 00
        • Axon Clinical, s.r.o. /ID# 205670
      • Praha, Czechia, 190 00
        • ISCARE a.s. /ID# 209240
  • Estonia
      • Tallinn, Estonia, 10617
        • West Tallinn Central Hospital /ID# 207356
      • Tallinn, Estonia, 13419
        • North Estonia Medical Centre /ID# 207357
      • Tartu, Estonia, 51014
        • Tartu University Hospital /ID# 212282
    • Harjumaa
      • Tallinn, Harjumaa, Estonia, 10138
        • East Tallinn Central Hospital /ID# 207564
  • Finland
      • Jyvaskyla, Finland, 40620
        • Keski-Suomen Sairaala Nova /ID# 206159
      • Mikkeli, Finland, 50100
        • Laakarikeskus Ikioma /ID# 205814
      • Turku, Finland, 20521
        • Tyks /Id# 205813
    • Pirkanmaa
      • Tampere, Pirkanmaa, Finland, 33520
        • Tampere University Hospital /ID# 206161
  • France
    • Alpes-Maritimes
      • Nice CEDEX 3, Alpes-Maritimes, France, 06202
        • Chu de Nice-Hopital L'Archet Ii /Id# 209118
    • Rhone
      • Pierre Benite CEDEX, Rhone, France, 69495
        • Centre Hospitalier Lyon Sud /ID# 209121
  • Germany
      • Berlin, Germany, 10825
        • Duplicate_Praxis am Bayrischen Platz /ID# 206733
      • Frankfurt am Main, Germany, 60431
        • Agaplesion Markus Krankenhaus /ID# 206731
      • Kiel, Germany, 24105
        • Duplicate_Univ Hosp Schleswig-Holstein /ID# 206791
      • Muenster, Germany, 48155
        • Medizinisches Versorgungszentrum Portal 10 /ID# 207137
    • Baden-Wuerttemberg
      • Mannheim, Baden-Wuerttemberg, Germany, 68167
        • Universitatsklinikum Mannheim /ID# 206811
      • Tübingen, Baden-Wuerttemberg, Germany, 72076
        • Duplicate_Universitaetsklinikum Tuebingen /ID# 206737
    • Nordrhein-Westfalen
      • Herne, Nordrhein-Westfalen, Germany, 44623
        • Gastroenterologische Gemeinschaftspraxis Herne /ID# 214576
    • Saarland
      • Saarbrücken, Saarland, Germany, 66111
        • Zentrum für Gastroenterologie Saar MVZ GmbH /ID# 215813
  • Greece
      • Athens, Greece, 10676
        • General Hospital of Athens Evaggelismos and Ophthalmiatrio of Athens Polyclinic /ID# 206332
      • Thessaloniki, Greece, 54642
        • Duplicate_General Hospital of Thessaloniki Hippokrateio /ID# 208822
    • Attiki
      • Athens, Attiki, Greece, 11527
        • General Hospital of Athens Laiko /ID# 208671
    • Kriti
      • Heraklion, Kriti, Greece, 711 10
        • University General Hospital of Heraklion PA.G.N.I /ID# 207061
  • Hungary
      • Bekescsaba, Hungary, 5600
        • Bekes Megyei Kozponti Korhaz /ID# 205885
      • Budapest, Hungary, 1085
        • Semmelweis Egyetem /ID# 205883
      • Sopron, Hungary, 9400
        • Soproni Erzsebet Oktato Korhaz es Rehabilitacios Intezet /ID# 207992
      • Szekesfehervar, Hungary, 8000
        • Mentahaz Maganorvosi Kozpont /ID# 205882
  • Ireland
      • Dublin, Ireland, D09 XR63
        • Beaumont Hospital /ID# 206509
      • Galway, Ireland, H91 YR71
        • University Hospital Galway /ID# 218035
  • Israel
      • Haifa, Israel, 3109601
        • Rambam Health Care Campus /ID# 206362
      • Jerusalem, Israel, 91031
        • Shaare Zedek Medical Center /ID# 206365
  • Italy
      • Milan, Italy, 20122
        • Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico /ID# 206349
      • Palermo, Italy, 90146
        • A.O. Ospedali Riuniti Villa Sofia - Cervello /ID# 206350
    • Emilia-Romagna
      • Bologna, Emilia-Romagna, Italy, 40138
        • A.O.U. Policlinico S.Orsola-Malpighi /ID# 206351
    • Milano
      • Rho, Milano, Italy, 20017
        • ASST Rhodense/Presidio Ospedaliero di Rho /ID# 216611
      • Rozzano, Milano, Italy, 20089
        • Istituto Clinico Humanitas /ID# 206346
    • Roma
      • Rome, Roma, Italy, 00168
        • Presidio Columbus-Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Un /ID# 206347
    • Verona
      • Negrar, Verona, Italy, 37024
        • IRCCS Ospedale Sacro Cuore Don Calabria /ID# 206354
  • Japan
      • Takatsuki-shi, Japan, 569-0086
        • Shoyukai Fujita Gastroenterological Hospital /ID# 216493
    • Aichi
      • Nagoya shi, Aichi, Japan, 467-8602
        • Nagoya City University Hospital /ID# 206058
      • Nagoyashi, Aichi, Japan, 4668560
        • Nagoya University Hospital /ID# 206355
      • Toyohashi-shi, Aichi, Japan, 441-8570
        • Toyohashi Municipal Hospital /ID# 207625
      • Toyota-shi, Aichi, Japan, 470-1219
        • Ieda Hospital /ID# 207479
    • Aomori
      • Hirosaki-shi, Aomori, Japan, 036-8545
        • Hirosaki National Hospital /ID# 206387
    • Chiba
      • Abiko-shi, Chiba, Japan, 270-1168
        • Tokatsu Tsujinaka Hospital /ID# 214963
      • Kashiwa-shi, Chiba, Japan, 277-0871
        • Tsujinaka Hospital Kashiwanoha /ID# 209573
      • Sakura-shi, Chiba, Japan, 285-8741
        • Toho University Medical Center Sakura Hospital /ID# 207705
      • Urayasu-shi, Chiba, Japan, 279-0021
        • Juntendo University Urayasu Hospital /ID# 208784
    • Fukui
      • Fukui-shi, Fukui, Japan, 910-8526
        • Fukui Prefectural Hospital /ID# 210449
    • Fukuoka
      • Chikushino-shi, Fukuoka, Japan, 818-8502
        • Fukuoka University Chikushi Hospital /ID# 214405
      • Fukuoka-shi, Fukuoka, Japan, 810-0001
        • Saiseikai Fukuoka Genaral Hospital /ID# 209482
      • Kurume-shi, Fukuoka, Japan, 830-0011
        • Kurume University Hospital /ID# 206385
    • Gifu
      • Ogaki-shi, Gifu, Japan, 503-8502
        • Ogaki Municipal Hospital /ID# 208227
    • Hiroshima
      • Fukuyama-shi, Hiroshima, Japan, 720-8520
        • NHO Fukuyama Medical Center /ID# 206295
      • Hiroshima-shi, Hiroshima, Japan, 734-8551
        • Hiroshima University Hospital /ID# 206464
    • Hokkaido
      • Midorigaokahiga-shi, Hokkaido, Japan, 078-8510
        • Asahikawa Medical University Hospital /ID# 206404
      • Obihiro-shi, Hokkaido, Japan, 080-0024
        • Obihiro kosei Hospital /ID# 210424
      • Sapporo-shi, Hokkaido, Japan, 004-0041
        • Sapporo Tokushukai Hospital /ID# 209448
      • Sapporo-shi, Hokkaido, Japan, 060-0033
        • Hokkaido P.W.F.A.C. Sapporo-Kosei General Hospital /ID# 206059
      • Sapporo-shi, Hokkaido, Japan, 060-8543
        • Sapporo Medical University Hospital /ID# 206314
      • Sapporo-shi, Hokkaido, Japan, 065-0033
        • Sapporo Higashi Tokushukai Hospital /ID# 208494
    • Hyogo
      • Kobe-shi, Hyogo, Japan, 650-0015
        • Aoyama Clinic /ID# 206452
      • Nishinomiya-shi, Hyogo, Japan, 663-8501
        • Hyogo College of Medicine Hospital /ID# 206455
    • Ishikawa
      • Kanazawa-shi, Ishikawa, Japan, 920-8641
        • Kanazawa University Hospital /ID# 206316
    • Iwate
      • Morioka-shi, Iwate, Japan, 020-8505
        • Iwate Medical University Uchimaru Medical Center /ID# 207051
    • Kagoshima
      • Kagoshima-shi, Kagoshima, Japan, 892-0824
        • Idzuro Imamura Hospital /ID# 207639
      • Kagoshima-shi, Kagoshima, Japan, 892-0846
        • Sameshima Hospital /ID# 207935
    • Kanagawa
      • Kawasaki-shi, Kanagawa, Japan, 216-8511
        • St. Marianna University School of Medicine Hospital /ID# 209451
      • Yokohama-shi, Kanagawa, Japan, 227-8501
        • Showa University Fujigaoka Hospital /ID# 208224
    • Kyoto
      • Kyoto-shi, Kyoto, Japan, 606-8507
        • Kyoto University Hospital /ID# 211809
    • Mie
      • Tsu-shi, Mie, Japan, 514-8507
        • Mie University Hospital /ID# 206803
      • Yokkaichi-shi, Mie, Japan, 510-0016
        • Yokkaichi Hazu Medical Center /ID# 214348
    • Miyagi
      • Sendai-shi, Miyagi, Japan, 983-8520
        • National Hospital Organization Sendai Medical Center /ID# 209528
    • Nagasaki
      • Omura-shi, Nagasaki, Japan, 856-8562
        • NHO Nagasaki Medical Center /ID# 210822
    • Nara
      • Yamatotakada-shi, Nara, Japan, 635-0022
        • Kenseikai Dongo Hospital /ID# 208101
    • Niigata
      • Niigata-shi, Niigata, Japan, 950-1104
        • Saiseikai Niigata Hospital /ID# 209921
      • Niigata-shi, Niigata, Japan, 951-8520
        • Niigata University Medical & Dental Hospital /ID# 218049
    • Oita
      • Oita-shi, Oita, Japan, 870-0823
        • Ishida Clinic of IBD and Gastroenterology /ID# 210119
    • Okayama
      • Kurashiki-shi, Okayama, Japan, 710-0142
        • Chikuba Hospital for Proctological and Gastrointestinal Diseases /ID# 206646
      • Okayama-shi, Okayama, Japan, 700-8558
        • Okayama University Hospital /ID# 217925
    • Osaka
      • Osaka-shi, Osaka, Japan, 530-0011
        • Kinshukai Infusion Clinic /ID# 207865
      • Osaka-shi, Osaka, Japan, 530-8480
        • Kitano Hospital /ID# 210397
      • Osaka-shi, Osaka, Japan, 543-8555
        • Japanese Red Cross Osaka Hospital /ID# 209478
      • Osaka-shi, Osaka, Japan, 545-8586
        • Osaka City University Hospital /ID# 206457
      • Toyonaka-shi, Osaka, Japan, 560-0055
        • Toyonaka Municipal Hospital /ID# 217082
    • Saga
      • Saga-shi, Saga, Japan, 849-8501
        • Saga University Hospital /ID# 209270
    • Saitama
      • Kawagoe-shi, Saitama, Japan, 350-8550
        • Saitama Medical Center /ID# 206393
      • Saitama-shi, Saitama, Japan, 336-0963
        • Tokitokai Tokito clinic /ID# 206313
    • Shiga
      • Higashi-ohmi-shi, Shiga, Japan, 527-8505
        • National Hospital Organization Higashi-Ohmi General Medical Center /ID# 210710
    • Shimane
      • Izumo-shi, Shimane, Japan, 693-0021
        • Shimane University School of Medicine /ID# 208905
    • Shizuoka
      • Hamamatsu-shi, Shizuoka, Japan, 431-3192
        • Hamamatsu University Hospital /ID# 206459
      • Sunto-gun, Shizuoka, Japan, 411-8611
        • NHO Shizuoka Medical Center /ID# 208785
    • Tokyo
      • Bunkyo-ku, Tokyo, Japan, 113-8519
        • Tokyo Medical And Dental University, Medical Hospital /ID# 206453
      • Chuo-ku, Tokyo, Japan, 104-8560
        • St.Luke's International Hospital /ID# 208076
      • Hachioji-shi, Tokyo, Japan, 192-0032
        • Tokai University Hachioji Hospital /ID# 208903
      • Itabashi-ku, Tokyo, Japan, 173-8606
        • Teikyo University Hospital /ID# 209866
      • Shinjuku-ku, Tokyo, Japan, 162-8655
        • Center Hospital of the National Center for Global Health and Medicine /ID# 209532
      • Shinjuku-ku, Tokyo, Japan, 162-8666
        • Tokyo Women's Medical University Hospital /ID# 206460
    • Yamagata
      • Yamagata-shi, Yamagata, Japan, 990-9585
        • Yamagata University Hospital /ID# 206465
    • Yamaguchi
      • Shunan-shi, Yamaguchi, Japan, 745-8522
        • Tokuyama Central Hospital /ID# 216994
  • Korea, Republic of
      • Busan, Korea, Republic of, 49201
        • Dong-A University Hospital /ID# 206955
      • Busan, Korea, Republic of, 49241
        • Pusan National University Hospital /ID# 206956
      • Daegu, Korea, Republic of, 42415
        • Yeungnam University Medical Center /ID# 206959
      • Seongnam-si, Gyeonggi-do, Korea, Republic of, 13496
        • Duplicate_CHA Bundang Medical Center /ID# 207432
      • Seoul, Korea, Republic of, 03722
        • Yonsei University Health System, Severance hospital /ID# 206958
    • Seoul Teugbyeolsi
      • Seoul, Seoul Teugbyeolsi, Korea, Republic of, 03181
        • Kangbuk Samsung Hospital /ID# 206960
  • Latvia
      • Riga, Latvia, 1038
        • Riga East Clinical Univ Hosp /ID# 206828
      • Riga, Latvia, LV-1002
        • P. Stradins Clinical Univ Hosp /ID# 206827
  • Lithuania
      • Kaunas, Lithuania, 50161
        • Hospital of Lithuanian University of Health Sciences Kaunas Clinics /ID# 209052
      • Klaipeda, Lithuania, 92288
        • Klaipeda Seamens Hospital /ID# 208791
      • Klaipeda, Lithuania, 92288
        • Klaipeda University Hospital /ID# 208790
      • Vilnius, Lithuania, LT-08661
        • Vilnius University Hospital /ID# 209051
  • Malaysia
      • Kuala Lumpur, Malaysia, 59100
        • Duplicate_Uni Malaya MC /ID# 208936
    • Selangor
      • Kuala Lumpur, Selangor, Malaysia, 56000
        • Universiti Kebangsaan Malaysia (UKM) Medical Centre /ID# 207662
  • Mexico
    • Guanajuato
      • Leon, Guanajuato, Mexico, 37000
        • Morales Vargas Centro de Investigacion S.C. /ID# 211326
    • Jalisco
      • Guadalajara, Jalisco, Mexico, 44650
        • Clinica de Investigacion en Reumatologia y Obesidad S.C. /ID# 208068
    • Nuevo Leon
      • Monterrey, Nuevo Leon, Mexico, 64610
        • Centro Regiomontano de Estudios Clínicos ROMA S.C /ID# 208067
  • Netherlands
      • Rotterdam, Netherlands, 3015 GD
        • Erasmus Medisch Centrum /ID# 205280
  • Norway
    • Akershus
      • Lorenskog, Akershus, Norway, 1478
        • Akershus Universitetssykehus_MAIN /ID# 205293
    • Troms
      • Tromsø, Troms, Norway, 9019
        • Universitetssykehuset Nord-Norge /ID# 205691
  • Poland
    • Kujawsko-pomorskie
      • Torun, Kujawsko-pomorskie, Poland, 87-100
        • Gastromed /Id# 216108
    • Mazowieckie
      • Warsaw, Mazowieckie, Poland, 02-691
        • Centrum Medyczne Reuma Park w Warszawie /ID# 212913
      • Warszawa, Mazowieckie, Poland, 00-635
        • Centrum Zdrowia MDM /ID# 205874
      • Warszawa, Mazowieckie, Poland, 03-580
        • NZOZ Vivamed /ID# 216697
      • Warszawa, Mazowieckie, Poland, 04-730
        • Instytut Pomnik - Centrum Zdrowia Dziecka /ID# 215070
    • Pomorskie
      • Sopot, Pomorskie, Poland, 81-756
        • Endoskopia Sp. z o.o. /ID# 212964
  • Portugal
      • Almada, Portugal, 2805-267
        • Hospital Garcia de Orta, EPE /ID# 206143
      • Braga, Portugal, 4710-243
        • CCA Braga - Hospital de Braga /ID# 206144
      • Lisboa, Portugal, 1649-035
        • Centro Hospitalar Universitário de Lisboa Norte, EPE - Hospital de Santa Maria /ID# 206117
      • Lisbon, Portugal, 1150-069
        • Hospital Santo Antonio dos Cap /ID# 206145
      • Porto, Portugal, 4200-319
        • Centro Hospitalar Universitario de Sao Joao, EPE /ID# 206142
    • Braga
      • Guimaraes, Braga, Portugal, 4835-044
        • Hospital da Senhora da Oliveira Guimaraes, EPE /ID# 205554
    • Porto
      • Santa Maria Da Feira, Porto, Portugal, 4520-211
        • Centro Hospitalar de Entre Douro e Vouga /ID# 205563
    • 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# 205556
  • Puerto Rico
      • San Juan, Puerto Rico, 00935
        • School of Medicine University of Puerto Rico-Medical Science Campus /ID# 209626
  • Russian Federation
      • Moscow, Russian Federation, 105554
        • Olla-Med Clinic /ID# 215335
      • Petrozavodsk, Russian Federation, 185019
        • Republican hospital named after V.A. Baranov /ID# 206507
      • Pushkin, Russian Federation, 196603
        • Euromedservice /ID# 208265
      • Pyatigorsk, Russian Federation, 357532
        • LLC Novaya Clinica /ID# 208260
    • Kaliningradskaya Oblast
      • Kaliningrad, Kaliningradskaya Oblast, Russian Federation, 236016
        • Immanuel Kant Baltic Federal University /ID# 208264
    • Leningradskaya Oblast
      • St. Petersburg, Leningradskaya Oblast, Russian Federation, 191015
        • NW State Medical Univ na Mechn /ID# 208258
    • Permskiy Kray
      • Perm, Permskiy Kray, Russian Federation, 614109
        • Perm Clinical Center of the Federal Medical and Biological Agency /ID# 211653
    • Samarskaya Oblast
      • Samara, Samarskaya Oblast, Russian Federation, 443063
        • Medical Company Hepatolog /ID# 208261
    • Stavropol Skiy Kray
      • Stavropol, Stavropol Skiy Kray, Russian Federation, 355012
        • Professor Pasechnikov Gastroenterology and Pankreatology clinic /ID# 211652
    • Tatarstan, Respublika
      • Kazan, Tatarstan, Respublika, Russian Federation, 420012
        • Kazan State Medical University /ID# 208256
  • Serbia
      • Leskovac, Serbia, 16000
        • General Hospital Leskovac /ID# 217881
    • Beograd
      • Belgrade, Beograd, Serbia, 11000
        • Clinical Hosp Center Zvezdara /ID# 205258
      • Belgrade, Beograd, Serbia, 11000
        • Military Medical Academy /ID# 205257
      • Belgrade, Beograd, Serbia, 11000
        • University Clinical Center Serbia /ID# 205256
      • Belgrade, Beograd, Serbia, 11080
        • Clin Hosp Ctr Bezanijska Kosa /ID# 206413
    • Nisavski Okrug
      • NIS, Nisavski Okrug, Serbia, 18000
        • University Clinical Center of Nis /ID# 206411
    • Sumadijski Okrug
      • Kragujevac, Sumadijski Okrug, Serbia, 34000
        • University Clinical Center Kragujevac /ID# 206410
    • Vojvodina
      • Novi Sad, Vojvodina, Serbia, 21000
        • Clinical Center Vojvodina /ID# 205259
  • Singapore
      • Singapore, Singapore, 119074
        • National University Hospital /ID# 209099
      • Singapore, Singapore, 258499
        • Gleneagles Medical Centre /ID# 206954
      • Singapore, Singapore, 308433
        • Tan Tock Seng Hospital /ID# 207663
  • Slovakia
      • Banska Bystrica, Slovakia, 975 17
        • Fakultna nemocnica s poliklinikou F.D. Roosevelta Banska Bystrica /ID# 205147
      • Kosice, Slovakia, 040 01
        • B+B MED, s.r.o. /ID# 205213
      • Nove Zamky, Slovakia, 940 34
        • Fakultna nemocnica s poliklini /ID# 211372
      • Presov, Slovakia, 080 01
        • GASTRO I., s.r.o. /ID# 205148
    • Bratislavsky Kraj
      • Bratislava, Bratislavsky Kraj, Slovakia, 851 01
        • Medak s.r.o. /ID# 205191
  • South Africa
    • Gauteng
      • Boksburg North, Gauteng, South Africa, 1460
        • MD Search /ID# 208084
      • Johannesburg, Gauteng, South Africa, 1619
        • Clinresco Centers /ID# 208083
      • Johannesburg, Gauteng, South Africa, 1820
        • Lenasia Clinical Trial Centre /ID# 214359
      • Johannesburg, Gauteng, South Africa, 2193
        • Wits Clinical Research , Wits Health Consortium (PTY) Ltd /ID# 208082
      • Johannesburg, Gauteng, South Africa, 2193
        • Wits Clinical Research Site /ID# 208949
    • Western Cape
      • CAPE TOWN Milnerton, Western Cape, South Africa, 7441
        • Mediclinic Milnerton /ID# 207979
      • Cape Town, Western Cape, South Africa, 7708
        • Kingsbury Hospital /ID# 205281
      • Cape Town, Western Cape, South Africa, 7800
        • Private Practice Dr MN Rajabally /ID# 205273
  • Spain
      • A Coruna, Spain, 15006
        • Hospital Universitario A Coruna - CHUAC /ID# 206907
      • Barcelona, Spain, 08036
        • Hospital Clinic de Barcelona /ID# 206906
      • Cordoba, Spain, 14004
        • Hospital Universitario Reina Sofia /ID# 204412
      • Madrid, Spain, 28034
        • Hospital Universitario Ramon y Cajal /ID# 204410
      • Madrid, Spain, 28046
        • Hospital Universitario La Paz /ID# 214540
      • Salamanca, Spain, 37007
        • Hospital Clinico Universitario de Salamanca /ID# 205013
      • Valencia, Spain, 46026
        • Hospital Universitario y Politecnico La Fe /ID# 206904
    • A Coruna
      • Santiago de Compostela, A Coruna, Spain, 15706
        • Hospital Clínico Universitario de Santiago-CHUS /ID# 204411
    • Cantabria
      • Santander, Cantabria, Spain, 39008
        • Hospital Unversitario Marques de Valdecilla /ID# 216622
    • Las Palmas
      • Las Palmas de Gran Canaria, Las Palmas, Spain, 35010
        • Hospital Universitario Dr. Negrin /ID# 206905
  • Switzerland
      • Basel, Switzerland, 4031
        • Universitaetsspital Basel /ID# 211381
      • Bern, Switzerland, 3010
        • Inselspital, Universitaetsklinik /ID# 211312
      • Zurich, Switzerland, 8091
        • Universitaetsspital Zuerich /ID# 211308
    • Sankt Gallen
      • St. Gallen, Sankt Gallen, Switzerland, 9007
        • Kantonsspital St. Gallen /ID# 211310
  • Taiwan
      • Kaohsiung, Taiwan, 80708
        • Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 207848
      • Taipei City, Taiwan, 11217
        • Taipei Veterans General Hosp /ID# 207849
    • Taichung
      • Taichung City, Taichung, Taiwan, 40447
        • China Medical University Hosp /ID# 207845
    • Taipei
      • Taipei City, Taipei, Taiwan, 100
        • National Taiwan University Hospital /ID# 207847
  • Turkey
      • Ankara GAZI, Turkey, 06500
        • Gazi University Med. Faculty /ID# 208040
      • Istanbul, Turkey, 34098
        • Istanbul University-Cerrahpasa, Cerrahpasa Medical Faculty /ID# 207507
      • Istanbul, Turkey, 34764
        • Umraniye Training and Res Hosp /ID# 208206
      • Mersin, Turkey, 33343
        • Mersin University Medical /ID# 208039
    • Kayseri
      • Melikgazi, Kayseri, Turkey, 38030
        • Erciyes University Medical Fac /ID# 207506
  • Ukraine
      • Kropyvnytskyi, Ukraine, 25006
        • PE PMC Acinus, Medical and Diagnostic Center /ID# 217218
      • Kyiv, Ukraine, 04050
        • Medical centre of CONSILIUM MEDICAL LLC /ID# 217447
      • Vinnytsia, Ukraine, 21018
        • Vinnytsia Regional Clinical Hospital n.a. M.I.Pyrogov /ID# 216300
    • Kharkivska Oblast
      • Kharkiv, Kharkivska Oblast, Ukraine, 61204
        • Communal Non-Commercial Enterprize of Kharkiv Regional Council Regional Clinical /ID# 206939
    • Kyivska Oblast
      • Kyiv, Kyivska Oblast, Ukraine, 04073
        • Kyiv Regional Hospital /ID# 217373
  • United Kingdom
      • Basingstoke, United Kingdom, RG24 9NA
        • Basingstoke & North Hampshire /ID# 207985
      • Glasgow, United Kingdom, G514TF
        • Queen Elizabeth University Hos /ID# 205154
      • Huddersfield, United Kingdom, HD3 3EA
        • Huddersfield Royal Infirmary /ID# 217660
      • London, United Kingdom, SW17 0QT
        • St. George's Healthcare NHS /ID# 208375
      • Whitechapel, United Kingdom, E1 1 BB
        • Barts and the London NHS Trust /ID# 205153
  • United States
    • Alabama
      • Mobile, Alabama, United States, 36606
        • East View Medical Research, LLC /ID# 216933
      • Mobile, Alabama, United States, 36608
        • CB Flock Research Corporation /ID# 206094
    • Arizona
      • Sun City, Arizona, United States, 85306
        • Arizona Arthritis & Rheumatology Research, PLLC /ID# 211030
      • Tempe, Arizona, United States, 85284-2604
        • Digestive Disease Consultants, A Division of Arizona Digestive Health, P.C /ID# 211887
      • Tucson, Arizona, United States, 85724
        • University of Arizona /ID# 208856
    • California
      • Covina, California, United States, 91722-3797
        • Citrus Valley Gastroenterology /ID# 205627
      • Huntington Beach, California, United States, 92648-5994
        • Care Access Research /ID# 217003
      • La Jolla, California, United States, 92093
        • Moore UC San Diego Cancer Center /ID# 204919
      • Los Alamitos, California, United States, 90720-3309
        • United Medical Doctors /ID# 207867
      • Los Angeles, California, United States, 90048
        • TLC Clinical Research Inc /ID# 216831
      • Los Angeles, California, United States, 90067-2001
        • Gastrointestinal Biosciences Clinical Trials, LLC /ID# 205314
      • Mission Hills, California, United States, 91345
        • Facey Medical Foundation /ID# 205301
      • Murrieta, California, United States, 92563
        • United Medical Doctors - Murrieta /ID# 205313
      • Oxnard, California, United States, 93030
        • InSite Digestive Health Care - Oxnard /ID# 205628
      • Rialto, California, United States, 92377
        • Inland Empire Clinical Trials, LLC /ID# 216164
      • San Diego, California, United States, 92120
        • San Diego Clinical Trials /ID# 212122
      • San Diego, California, United States, 92123
        • Medical Assoc Research Grp /ID# 205626
    • Colorado
      • Colorado Springs, Colorado, United States, 80918
        • Delta Waves, Inc. /ID# 206170
      • Wheat Ridge, Colorado, United States, 80033-2896
        • Western States Clinical Res /ID# 206091
    • Connecticut
      • Danbury, Connecticut, United States, 06810-6000
        • Western Connecticut Medical Group /ID# 208290
      • Hamden, Connecticut, United States, 06518
        • Gastroenterology Center of CT /ID# 208291
    • Florida
      • Clearwater, Florida, United States, 33756
        • Gastro Florida /ID# 206174
      • Doral, Florida, United States, 33166
        • Universal Axon Clinical Research /ID# 213462
      • Hialeah, Florida, United States, 33016
        • Palmetto Research, LLC /ID# 208293
      • Inverness, Florida, United States, 34452-4717
        • Nature Coast Clinical Research - Inverness /ID# 206087
      • Jacksonville, Florida, United States, 32256
        • Encore Borland-Groover Clinical Research /Id# 208128
      • Maitland, Florida, United States, 32751-6108
        • Cfagi Llc /Id# 207995
      • Miami, Florida, United States, 33136
        • University of Miami /ID# 215445
      • Miami, Florida, United States, 33186-4643
        • Coral Research Clinic /ID# 208292
      • New Port Richey, Florida, United States, 34653
        • Advanced Research Institute, Inc /ID# 206077
      • Orlando, Florida, United States, 32803
        • Endoscopic Research, Inc. /ID# 207360
      • Orlando, Florida, United States, 32810
        • Omega Research Consultants /ID# 206066
      • Tampa, Florida, United States, 33607
        • Clinical Research Trials of Florida, Inc. /ID# 206068
      • Tampa, Florida, United States, 33612
        • University of South Florida /ID# 214495
      • Tampa, Florida, United States, 33613-4680
        • AdventHealth Tampa /ID# 207363
    • Georgia
      • Macon, Georgia, United States, 31201
        • Gastroenterology Associates of Central Georgia, LLC /ID# 216940
      • Riverdale, Georgia, United States, 30274
        • Infinite Clinical Trials /ID# 215343
      • Suwanee, Georgia, United States, 30024
        • Atlanta Gastroenterology Spec /ID# 206173
    • Illinois
      • Chicago, Illinois, United States, 60605-2168
        • Next Innovative Clinical Research - Chicago /ID# 217324
      • Chicago, Illinois, United States, 60637-1443
        • The University of Chicago Medical Center /ID# 206172
      • Effingham, Illinois, United States, 62401
        • Carle Foundation Hospital /ID# 207397
    • Indiana
      • Evansville, Indiana, United States, 47714-8011
        • MediSphere Medical Research Center /ID# 206073
      • Indianapolis, Indiana, United States, 46237
        • Indianapolis Gastroenterology /ID# 206381
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • University of Iowa Hospitals and Clinics /ID# 206167
    • Kansas
      • Topeka, Kansas, United States, 66606
        • Cotton-O'Neil Clinical Res Ctr /ID# 206175
    • Kentucky
      • Crestview Hills, Kentucky, United States, 41017
        • Tri-State Gastroenterology /ID# 206124
    • Louisiana
      • Houma, Louisiana, United States, 70360
        • Houma Digestive Health Special /ID# 206176
      • Shreveport, Louisiana, United States, 71105-6800
        • Louisana Research Center, LLC /ID# 206064
    • Maryland
      • Columbia, Maryland, United States, 21045
        • Gastro Center of Maryland /ID# 206883
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan Health Systems /ID# 206918
      • Ann Arbor, Michigan, United States, 48197
        • Huron Gastroenterology Assoc /ID# 205109
      • Chesterfield, Michigan, United States, 48047
        • Clin Res Inst of Michigan, LLC /ID# 207078
      • Southfield, Michigan, United States, 48034-1659
        • Revival Research Institute, LLC /ID# 207282
      • Troy, Michigan, United States, 48098-6363
        • Center for Digestive Health /ID# 207080
    • Minnesota
      • Rochester, Minnesota, United States, 55905-0001
        • Mayo Clinic /ID# 205645
    • Mississippi
      • Jackson, Mississippi, United States, 39216-4500
        • University of Mississippi Medical Center /ID# 213116
      • Jackson, Mississippi, United States, 39216
        • Southern Therapy and Advanced Research (STAR) LLC /ID# 206069
    • Nevada
      • Las Vegas, Nevada, United States, 89113
        • Las Vegas Medical Research /ID# 206814
    • New Jersey
      • Egg Harbor Township, New Jersey, United States, 08234
        • AGA Clinical Research Associates, LLC /ID# 206880
      • Morristown, New Jersey, United States, 07960
        • Atlantic Digestive Health Inst /ID# 208748
      • New Brunswick, New Jersey, United States, 08901
        • Rutgers Robert Wood Johnson /ID# 207382
    • New Mexico
      • Albuquerque, New Mexico, United States, 87131-0001
        • University of New Mexico Department of Internal Medicine /ID# 214397
    • New York
      • Bronx, New York, United States, 10468
        • Advantage Clinical Trials /ID# 206082
      • Brooklyn, New York, United States, 11235
        • NY Scientific /ID# 206080
      • Lake Success, New York, United States, 11042
        • NYU Langone Long Island Clinical Research Associates /ID# 206079
      • North Massapequa, New York, United States, 11758
        • DiGiovanna Institute for Medical Education & Research /ID# 206885
      • Poughkeepsie, New York, United States, 12601
        • Premier Medical Group - GI Division /ID# 206097
      • Rochester, New York, United States, 14618-5703
        • Gastro Group of Rochester /ID# 206881
      • Staten Island, New York, United States, 10310-1664
        • Richmond University Medical Center /ID# 213185
    • North Carolina
      • Asheville, North Carolina, United States, 28801
        • Digestive Health Partners, P.A /ID# 206842
      • Charlotte, North Carolina, United States, 28203
        • Atrium Health Carolinas Medical Center /ID# 206085
      • Charlotte, North Carolina, United States, 28207
        • Charlotte Gastroenterology and Hepatology, PLLC /ID# 206138
      • Winston-Salem, North Carolina, United States, 27157-0001
        • Wake Forest Baptist Medical Center /ID# 206067
    • North Dakota
      • Fargo, North Dakota, United States, 58104
        • Duplicate_Plains Clinical Research Center, LLC /ID# 205111
    • Ohio
      • Cincinnati, Ohio, United States, 45267-0585
        • University of Cincinnati /ID# 205633
      • Columbus, Ohio, United States, 43210
        • The Ohio State University /ID# 205637
      • Columbus, Ohio, United States, 43235
        • Optimed Research, Ltd. /ID# 205638
      • Dayton, Ohio, United States, 45424
        • Hometown Urgent Care and Resea /ID# 205630
      • Englewood, Ohio, United States, 45415
        • Dayton Gastroenterology, Inc. /ID# 205639
      • Mentor, Ohio, United States, 44060-6211
        • Great Lakes Gastroenterology Research LLC /ID# 205631
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73102
        • Hightower Clinical /ID# 216336
      • Oklahoma City, Oklahoma, United States, 73112
        • Digestive Disease Specialists /ID# 206076
      • Tulsa, Oklahoma, United States, 74104
        • Options Health Research, LLC /ID# 206707
      • Tulsa, Oklahoma, United States, 74135
        • Healthcare Research Consultant /ID# 206706
    • Pennsylvania
      • Sayre, Pennsylvania, United States, 18840
        • Guthrie Medical Group, PC /ID# 206078
    • South Carolina
      • Charleston, South Carolina, United States, 29412
        • Pharmacorp Clinical Trials /ID# 206074
      • Greenville, South Carolina, United States, 29615-3593
        • Gastroenterology Associates, P.A. of Greenville /ID# 206098
    • Tennessee
      • Germantown, Tennessee, United States, 38138
        • Gastro One /ID# 206178
      • Johnson City, Tennessee, United States, 37604
        • East Tennessee Research Institute /ID# 206169
      • Nashville, Tennessee, United States, 37211
        • Quality Medical Research /ID# 206088
      • Nashville, Tennessee, United States, 37232-0011
        • Vanderbilt University Medical Center /ID# 210405
    • Texas
      • Arlington, Texas, United States, 76012
        • TX Clinical Research Institute /ID# 206718
      • Baytown, Texas, United States, 77521
        • Inquest Clinical Research /ID# 206132
      • Cedar Park, Texas, United States, 78613-5028
        • Texas Digestive Disease Consultants /ID# 209805
      • Cedar Park, Texas, United States, 78613-5028
        • Texas Digestive Disease Consultants /ID# 209948
      • Dallas, Texas, United States, 75246
        • Baylor Scott & White Center for Inflammatory Bowel Diseases /ID# 207484
      • Garland, Texas, United States, 75044-2208
        • DHAT Research Institute /ID# 206716
      • Houston, Texas, United States, 77017-2337
        • Vilo Research Group Inc /ID# 212625
      • Houston, Texas, United States, 77030-3411
        • Baylor College of Medicine - Baylor Medical Center /ID# 206717
      • Houston, Texas, United States, 77058
        • Centex Studies, Inc. - Houston /ID# 206168
      • Houston, Texas, United States, 77070-4347
        • GI Specialists of Houston /ID# 206090
      • Lubbock, Texas, United States, 79424-3017
        • Caprock Gastro Research /ID# 215115
      • San Antonio, Texas, United States, 78212
        • Clinical Associates in Research Therapeutics of America, LLC /ID# 206710
      • San Antonio, Texas, United States, 78229-5390
        • Southern Star Research Institute, LLC /ID# 205379
      • Temple, Texas, United States, 76508
        • Baylor Scott & White Center for Diagnostic Medicine /ID# 206096
      • Tyler, Texas, United States, 75701
        • Duplicate_Tyler Research Institue /ID# 206075
      • Victoria, Texas, United States, 77904
        • Gastro Health & Nutrition - Victoria /ID# 205378
    • Utah
      • Ogden, Utah, United States, 84403
        • Advanced Research Institute /ID# 206133
    • Virginia
      • Franklin, Virginia, United States, 23851
        • Ctr for Gastrointestinal Healt /ID# 208475
    • Washington
      • Bellevue, Washington, United States, 98004
        • Washington Gastroenterology Associates /ID# 206177
      • Seattle, Washington, United States, 98101
        • Virginia Mason - Seattle Orthapedics /ID# 206070
      • Vancouver, Washington, United States, 98664
        • The Vancouver Clinic, INC. PS /ID# 204973
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53215
        • Wisconsin Center for Advanced Research, a division of GI Associates, LLC /ID# 206917
      • Milwaukee, Wisconsin, United States, 53226-3522
        • Froedtert Memorial Lutheran Hospital /ID# 206945

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 75 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

- Male or female participants ≥ 16 and ≤ 75 years of age at Baseline Note: Adolescent participants at the age of 16 or 17 years old will be eligible to participate if approved by the country or regulatory/health authorities.

Note: Adolescent participants at the age of 16 or 17 years old must weigh ≥ 40 kilograms and meet the definition of Tanner Stage 5 at the Screening Visit.

  • Diagnosis of Ulcerative Colitis (UC) for 90 days or greater prior to Baseline, confirmed by colonoscopy during the Screening Period, with exclusion of current infection, colonic dysplasia and/or malignancy. Appropriate documentation of biopsy results consistent with the diagnosis of UC, in the assessment of the Investigator, must be available.
  • Active UC with an Adapted Mayo score of 5 to 9 points and endoscopic subscore of 2 to 3.
  • Demonstrated an inadequate response, loss of response, or intolerance to at lease one of the following treatments including, oral aminosalicylates, corticosteroids, immunosuppressants, and/or biologic therapies.

Note: Participants who have had inadequate response, loss of response to conventional therapy but have not failed biologic therapy (Non-bio-IR) and have received a prior biologic for up to 1 year may be enrolled, however they must have discontinued the biologic for reasons other than inadequate response or intolerance (e.g., change of insurance, well controlled disease), and must meet criteria for inadequate response, loss of response, or intolerance as defined above.

  • Female Participants of childbearing potential must have a negative serum pregnancy test at the Screening Visit and a negative urine pregnancy test at the Baseline Visit.
  • If female, participant must meet the contraception recommendation criteria.

Exclusion Criteria:

  • Participant with current diagnosis of Crohn's disease (CD) or diagnosis of indeterminate colitis (IC).
  • Current diagnosis of fulminant colitis and/or toxic megacolon.
  • Participant with disease limited to the rectum (ulcerative proctitis) during the Screening endoscopy.
  • Received cyclosporine, tacrolimus, mycophenolate mofetil, or thalidomide within 30 days prior to Baseline.
  • Participant who received azathioprine or 6-mercaptopurine (6-MP) within 10 days of Baseline.
  • Received intravenous corticosteroids within 14 days prior to Screening or during the Screening Period.
  • Participant with previous exposure to Janus Activated Kinase (JAK) inhibitor (e.g., tofacitinib, baricitinib, filgotinib, upadacitinib).
  • Screening laboratory and other analyses show any prespecified abnormal hematologic 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
Experimental: Upadacitinib 45 mg
Participants received 45 mg upadacitinib once daily (QD) for 8 weeks. Participants who did not achieve clinical response per Adapted Mayo score at Week 8 received upadacitinib 45 mg once daily for 8 additional weeks in the open-label extension period.
Drug: Upadacitinib
Tablet for oral administration
Other Names:
  • ABT-494
  • RINVOQ®
Placebo Comparator: Placebo
Participants received placebo matching to upadacitinib once daily for 8 weeks. Participants who did not achieve clinical response per Adapted Mayo score at Week 8 received upadacitinib 45 mg once daily for 8 weeks in the open-label extension period.
Drug: Upadacitinib
Tablet for oral administration
Other Names:
  • ABT-494
  • RINVOQ®
Drug: Placebo
Tablet for oral administration

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants Who Achieved Clinical Remission Per Adapted Mayo Score at Week 8
Time Frame: Week 8

The Adapted Mayo Score is a composite score of UC disease activity based on the following 3 subscores:

  1. Stool frequency subscore (SFS), scored from 0 (normal number of stools) to 3 (5 or more stools more than normal).
  2. Rectal bleeding subscore (RBS), scored from 0 (no blood seen) to 3 (blood alone passed).
  3. Endoscopic subscore, scored from 0 (normal or inactive disease) to 3 (severe disease, spontaneous bleeding, ulceration).

The overall Adapted Mayo score ranges from 0 to 9 where higher scores represent more severe disease.

Clinical remission is defined as an Adapted Mayo score ≤ 2, with SFS ≤ 1 and not higher than Baseline, RBS of 0, and endoscopic subscore ≤ 1.
Week 8

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants With Endoscopic Improvement at Week 8
Time Frame: Week 8
Endoscopic improvement is defined as an endoscopic subscore of 0 or 1. Endoscopies were assessed by a blinded central reader and scored according to the following scale: 0 = Normal or inactive disease; 1 = Mild disease (erythema, decreased vascular pattern); 2 = Moderate disease (marked erythema, lack of vascular pattern, any friability, erosions); 3 = Severe disease (spontaneous bleeding, ulceration).
Week 8
Percentage of Participants With Endoscopic Remission at Week 8
Time Frame: Week 8
Endoscopic remission is defined as an endoscopic subscore of 0. Endoscopies were assessed by a blinded central reader and scored according to the following scale: 0 = Normal or inactive disease; 1 = Mild disease (erythema, decreased vascular pattern); 2 = Moderate disease (marked erythema, lack of vascular pattern, any friability, erosions); 3 = Severe disease (spontaneous bleeding, ulceration).
Week 8
Percentage of Participants Who Achieved Clinical Response Per Adapted Mayo Score at Week 8
Time Frame: Week 8

The Adapted Mayo Score is a composite score of UC disease activity based on the following 3 subscores:

  1. Stool frequency subscore (SFS), scored from 0 (normal number of stools) to 3 (5 or more stools more than normal).
  2. Rectal bleeding subscore (RBS), scored from 0 (no blood seen) to 3 (blood alone passed).
  3. Endoscopic subscore, scored from 0 (normal or inactive disease) to 3 (severe disease with spontaneous bleeding, ulceration).

The overall Adapted Mayo score ranges from 0 to 9 with higher scores representing more severe disease.

Clinical response per the Adapted Mayo Score is defined as a decrease in Adapted Mayo score ≥ 2 points and ≥ 30% from Baseline, plus a decrease in RBS ≥ 1 or an absolute RBS ≤ 1.
Week 8
Percentage of Participants Who Achieved Clinical Response Per Partial Adapted Mayo Score at Week 2
Time Frame: Week 2

The Partial Adapted Mayo Score is a composite score of UC disease activity based on the following 2 subscores:

  1. Stool frequency subscore (SFS), scored from 0 (normal number of stools) to 3 (5 or more stools more than normal).
  2. Rectal bleeding subscore (RBS), scored from 0 (no blood seen) to 3 (blood alone passed).

The overall Partial Adapted Mayo score ranges from 0 to 6 with higher scores representing more severe disease.

Clinical response per Partial Adapted Mayo Score is defined as a decrease in Partial Adapted Mayo score ≥ 1 point and ≥ 30% from Baseline, plus a decrease in RBS ≥ 1 or an absolute RBS ≤ 1.
Week 2
Percentage Of Participants Who Achieved Histologic-Endoscopic Mucosal Improvement at Week 8
Time Frame: Week 8

Histologic endoscopic mucosal improvement is defined as an endoscopic subscore of 0 or 1 and a Geboes score ≤ 3.1.

The endoscopic subscore ranges from 0 (normal or inactive disease) to 3 (severe disease with spontaneous bleeding, ulceration).

The Geboes histologic index includes seven histological features (architectural change, chronic inflammatory infiltrate, lamina propria neutrophils and eosinophils, neutrophils in epithelium, crypt destruction and erosion or ulcers). The Geboes score has 6 grades, each with 3-5 subgrades: Grade 0, structural change only; Grade 1, chronic inflammation; Grade 2, lamina propria neutrophils and eosinophils; Grade 3, neutrophils in epithelium; Grade 4, crypt destruction; and Grade 5, erosions or ulceration.
Week 8
Percentage of Participants Who Reported No Bowel Urgency at Week 8
Time Frame: Week 8
Bowel urgency was assessed by participants in a subject diary completed once a day.
Week 8
Percentage of Participants Who Reported No Abdominal Pain at Week 8
Time Frame: Week 8
Abdominal pain was assessed by participants in a subject diary completed once a day.
Week 8
Percentage of Participants Who Achieved Histologic Improvement at Week 8
Time Frame: Week 8
Histologic improvement is defined as a decrease from Baseline in Geboes score. The Geboes histologic index includes seven histological features (architectural change, chronic inflammatory infiltrate, lamina propria neutrophils and eosinophils, neutrophils in epithelium, crypt destruction and erosion or ulcers). The Geboes score has 6 grades, each with 3-5 subgrades: Grade 0, structural change only; Grade 1, chronic inflammation; Grade 2, lamina propria neutrophils and eosinophils; Grade 3, neutrophils in epithelium; Grade 4, crypt destruction; and Grade 5, erosions or ulceration.
Week 8
Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score at Week 8
Time Frame: Baseline (Week 0) to Week 8
The Inflammatory Bowel Disease Questionnaire (IBDQ) is used to assess health-related quality of life (HRQoL) in patients with ulcerative colitis. 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 (Week 0) to Week 8
Percentage of Participants Who Achieved Mucosal Healing at Week 8
Time Frame: Week 8

Mucosal healing is defined as an endoscopic score of 0 and Geboes score < 2.0. The endoscopic subscore ranges from 0 (normal or inactive disease) to 3 (severe disease with spontaneous bleeding, ulceration).

The Geboes histologic index includes seven histological features (architectural change, chronic inflammatory infiltrate, lamina propria neutrophils and eosinophils, neutrophils in epithelium, crypt destruction and erosion or ulcers). The Geboes score has 6 grades, each with 3-5 subgrades: Grade 0, structural change only; Grade 1, chronic inflammation; Grade 2, lamina propria neutrophils and eosinophils; Grade 3, neutrophils in epithelium; Grade 4, crypt destruction; and Grade 5, erosions or ulceration.
Week 8
Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Score at Week 8
Time Frame: Baseline (Week 0) to Week 8
The FACIT fatigue questionnaire was developed to assess fatigue associated with anemia. It consists of 13 fatigue-related questions. Each question is answered on a 5-point Likert scale: 0 (not at all); 1 (a little bit); 2 (somewhat); 3 (quite a bit); and 4 (very much). The total score ranges from 0 to 52, where higher scores represent less fatigue, and a positive change from Baseline indicates improvement.
Baseline (Week 0) to Week 8

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.

General Publications

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 6, 2018

Primary Completion (Actual)

January 14, 2021

Study Completion (Actual)

January 14, 2021

Study Registration Dates

First Submitted

August 28, 2018

First Submitted That Met QC Criteria

August 28, 2018

First Posted (Actual)

August 31, 2018

Study Record Updates

Last Update Posted (Actual)

March 2, 2022

Last Update Submitted That Met QC Criteria

February 17, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M14-675
  • 2016-000642-62 (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
  • 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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