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A Study to Evaluate the Safety and Efficacy of Upadacitinib (ABT-494) for Induction and Maintenance Therapy in Participants With Moderately to Severely Active Ulcerative Colitis (UC)

Primary Purpose

Ulcerative Colitis (UC)

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Placebo
Upadacitinib
Sponsored by
AbbVie
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ulcerative Colitis (UC) focused on measuring Upadacitinib (ABT-494), Moderately to Severely Active UC, RINVOQ

Eligibility Criteria

16 Years - 75 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Note: Adolescent participants who are 16 or 17 years old will be eligible to participate if approved by the country or regulatory/health authority. If approval has not been granted, only participants ≥18 years old will be enrolled. Adolescents must weigh ≥ 40 kilograms and meet the definition of Tanner Stage 5 at Screening Visit.

  • Diagnosis of ulcerative colitis 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 ulcerative colitis with an Adapted Mayo score of 5 to 9 points and endoscopic sub score of 2 to 3 (confirmed by central reader).
  • Demonstrated an inadequate response to, loss of response to, or intolerance to at least one of the following treatments including: oral aminosalicylates, corticosteroids, immunosuppressants, and/or biologic therapies in the opinion of the investigator.

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 to aminosalicylates, corticosteroids, and/or immunosuppressants as defined above.

  • If female, participant must meet the criteria for Contraception Recommendations
  • 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 prior to study drug dosing.

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 on azathioprine or 6-mercaptopurine 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 abnormal results meeting the exclusion criteria

Sites / Locations

  • Birmingham Gastroenterology Associates P.C /ID# 151276
  • East View Medical Research, LLC /ID# 171183
  • CB Flock Research Corporation /ID# 165980
  • Delsol Research Management, Ll /Id# 170131
  • Digestive Disease Consultants, A Division of Arizona Digestive Health, P.C /ID# 211885
  • Arizona Arthritis & Rheumatology Research, PLLC /ID# 169822
  • Adobe Clinical Research LLC /ID# 155250
  • University of Arizona /ID# 150553
  • Citrus Valley Gastroenterology /ID# 151914
  • Newport Huntington Medical Group /ID# 217005
  • UC San Diego Health System /ID# 155185
  • United Medical Doctors /ID# 207464
  • TLC Clinical Research Inc /ID# 216829
  • Gastrointestinal Biosciences Clinical Trials, LLC /ID# 157080
  • Facey Medical Foundation /ID# 203133
  • United Medical Doctors - Murrieta /ID# 151211
  • InSite Digestive Health Care - Oxnard /ID# 163414
  • Inland Empire Clinical Trials, LLC /ID# 216038
  • San Diego Clinical Trials /ID# 212120
  • Medical Assoc Research Grp /ID# 169148
  • Univ of California San Francis /ID# 164581
  • Delta Waves, Inc. /ID# 151721
  • South Denver Gastroenterology /ID# 151223
  • Western States Clinical Res /ID# 158076
  • Western Connecticut Medical Group /ID# 169210
  • Medical Research Center of CT /ID# 150482
  • Gastro Florida /ID# 155245
  • Moonshine Research Center, Inc /ID# 152533
  • Universal Axon Clinical Research /ID# 213461
  • Palmetto Research, LLC /ID# 151716
  • Nature Coast Clinical Research - Inverness /ID# 154064
  • Encore Borland-Groover Clinical Research /Id# 170912
  • SIH Research Mumtaz, Inc /ID# 163319
  • Cfagi Llc /Id# 202017
  • University of Miami /ID# 215441
  • Advanced Pharma /ID# 151719
  • New Horizon Research Center /ID# 152474
  • Crystal Pharmacology Research /ID# 151841
  • Coral Research Clinic /ID# 150444
  • Advanced Research Institute, Inc /ID# 163098
  • Endoscopic Research, Inc. /ID# 151720
  • Omega Research Maitland, LLC /ID# 200269
  • Clinical Research Trials of Florida, Inc. /ID# 201790
  • University of South Florida /ID# 214493
  • AdventHealth Tampa /ID# 200272
  • Gastroenterology Associates of Central Georgia, LLC /ID# 165782
  • Infinite Clinical Trials /ID# 215340
  • Atlanta Gastroenterology Spec /ID# 150548
  • Next Innovative Clinical Research - Chicago /ID# 216060
  • The University of Chicago DCAM /ID# 150547
  • NorthShore University HealthSystem /ID# 150555
  • Northwest Health Care Associates /ID# 151590
  • Carle Foundation Hospital /ID# 151137
  • MediSphere Medical Research Center /ID# 152064
  • Indianapolis Gastroenterology /ID# 162901
  • University of Iowa Hospitals and Clinics /ID# 157058
  • Cotton-O'Neil Clinical Res Ctr /ID# 167182
  • Tri-State Gastroenterology /ID# 169811
  • Houma Digestive Health Special /ID# 151844
  • Nola Research Works, LLC /ID# 153356
  • Louisana Research Center, LLC /ID# 150446
  • University of Maryland Med Ctr /ID# 150449
  • Gastro Center of Maryland /ID# 200022
  • Massachusetts General Hospital /ID# 165676
  • University of Michigan Comprehensive Cancer Center Michigan Medicine /ID# 151140
  • Huron Gastroenterology Assoc /ID# 152710
  • Clin Res Inst of Michigan, LLC /ID# 153027
  • Revival Research Institute, LLC /ID# 207280
  • Center for Digestive Health /ID# 161984
  • Gastroenterology Associates of Western Michigan, PLC d.b.a. West Michigan Clinic /ID# 157484
  • Mayo Clinic - Rochester /ID# 151677
  • Minnesota Gastroenterology PA /ID# 151678
  • University of Mississippi Medical Center /ID# 213139
  • Southern Therapy and Advanced Research (STAR) LLC /ID# 170712
  • Washington University-School of Medicine /ID# 150485
  • Las Vegas Medical Research /ID# 153044
  • Dartmouth-Hitchcock Medical Center /ID# 150549
  • AGA Clinical Research Associates, LLC /ID# 153040
  • Atlantic Digestive Health Inst /ID# 150447
  • Rutgers Robert Wood Johnson /ID# 155248
  • Duplicate_University of New Mexico Department of Internal Medicine /ID# 214396
  • Montefiore Medical Center - Moses Campus /ID# 150543
  • Advantage Clinical Trials /ID# 163938
  • NY Scientific /ID# 152707
  • NYU Langone Long Island Clinical Research Association /ID# 155272
  • Columbia Univ Medical Center /ID# 163410
  • DiGiovanna Institute for Medical Education & Research /ID# 201533
  • Premier Medical Group - GI Division /ID# 153357
  • Gastoenterology Group of Rochester /ID# 151079
  • Richmond University Medical Center /ID# 201859
  • Digestive Health Partners, P.A /ID# 167237
  • Atrium Health Carolinas Medical Center /ID# 156971
  • Charlotte Gastroenterology and Hepatology, PLLC /ID# 150545
  • Atlantic Gastroenterology Clinical Research /ID# 151899
  • Clinical Trials of America /ID# 153448
  • Wake Forest Baptist Medical Center /ID# 150448
  • Plains Clinical Research Center, LLC /ID# 170290
  • Consultants for Clinical Research /ID# 151679
  • University of Cincinnati /ID# 164582
  • The Ohio State University /ID# 169416
  • Optimed Research, Ltd. /ID# 169696
  • Hometown Urgent Care and Resea /ID# 200065
  • Dayton Gastroenterology, Inc. /ID# 167631
  • Great Lakes Medical Research, LLC /ID# 201772
  • Ohio Clinical Research Partner /ID# 154068
  • Hightower Clinical /ID# 216337
  • Digestive Disease Specialists /ID# 201056
  • Options Health Research, LLC /ID# 150554
  • Healthcare Research Consultant /ID# 163100
  • Northwest Gastroenterology Clinic /ID# 152527
  • Guthrie Medical Group, PC /ID# 150481
  • Penn State Health Colonnade /ID# 150259
  • Pharmacorp Clinical Trials /ID# 153354
  • Gastroenterology Associates, P.A. of Greenville /ID# 150541
  • Gastro One /ID# 151144
  • East Tennessee Research Institute /ID# 203610
  • Quality Medical Research /ID# 203426
  • Vanderbilt University Medical Center /ID# 153355
  • TX Clinical Research Institute /ID# 151526
  • Inquest Clinical Research /ID# 164635
  • Texas Digestive Disease Consultants /ID# 209947
  • Texas Digestive Disease Consultants /ID# 209804
  • Baylor Scott & White Center for Inflammatory Bowel Diseases /ID# 200770
  • DHAT Research Institute /ID# 151218
  • Vilo Research Group Inc /ID# 212624
  • CliniCore International, LLC /ID# 152062
  • Baylor College of Medicine - Baylor Medical Center /ID# 150486
  • Centex Studies, Inc. - Houston /ID# 201216
  • GI Specialists of Houston /ID# 202327
  • Caprock Gastro Research, LLC /ID# 214754
  • Clinical Associates in Research Therapeutics of America, LLC /ID# 201260
  • Southern Star Research Institute, LLC /ID# 169396
  • Carl R. Meisner Medical Clinic /ID# 171061
  • Baylor Scott & White Center for Diagnostic Medicine /ID# 204499
  • Tyler Research Institute, LLC /ID# 169146
  • Gastro Health & Nutrition - Victoria /ID# 167761
  • HP Clinical Research /ID# 163939
  • Advanced Research Institute /ID# 162624
  • Utah Gastroenternology - St. Mark's Office /ID# 163101
  • Velocity Clinical Research - Salt Lake City /ID# 163181
  • Ctr for Gastrointestinal Healt /ID# 153360
  • Emeritas Research Group, LLC /ID# 150258
  • Washington Gastroenterology /ID# 163629
  • Virginia Mason Medical Center /ID# 153026
  • The Polyclinic /ID# 164369
  • The Vancouver Clinic, INC. PS /ID# 162333
  • Aurora Medical Center - Grafto /ID# 151717
  • Wisconsin Center for Advanced Research, a division of GI Associates, LLC /ID# 151838
  • Medical College of Wisconsin /ID# 151843
  • Cardio Alem /ID# 211280
  • Gedyt /ID# 210015
  • Mautalen Salud e Investigacion /ID# 171173
  • Hospital Britanico de Buenos Aires /ID# 209495
  • Sanatorio 9 de Julio /ID# 150189
  • Hospital Privado Univesitario /ID# 164185
  • Macquarie University Hospital /ID# 211951
  • Mater Misericordiae Limited /ID# 212685
  • Griffith University /ID# 211952
  • Monash Medical Centre /ID# 150206
  • St Vincent's Hospital Melbourne /ID# 152472
  • Fiona Stanley Hospital /ID# 211640
  • Ordensklinikum Linz GmbH Barmherzige Schwestern /ID# 150305
  • Klinik Landstrasse /ID# 162866
  • Medizinische Universitaet Wien /ID# 150614
  • Landeskrankenhaus Salzburg-Universitätsklinikum der PMU (LKH) /ID# 150306
  • Vitebsk Regional Advanced Clin /ID# 169612
  • Universitair Ziekenhuis Leuven /ID# 150332
  • AZ Maria Middelares /ID# 150331
  • AZ-Delta /ID# 150330
  • University Clinical Centre of the Republic of Srpska /ID# 150209
  • University Clinical Centre of the Republic of Srpska /ID# 150706
  • University Clinical Center Tuzla /ID# 150211
  • University Clinical Hospital Mostar /ID# 150705
  • Clinical Center University of Sarajevo /ID# 150208
  • Instituto Goiano de Gastroenterologia e Endoscopia Digestiva /ID# 153742
  • Hospital Nossa Senhora das Graças /ID# 152480
  • Hospital de Clinicas de Porto Alegre /ID# 153743
  • Upeclin Fmb - Unesp /Id# 152485
  • Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto - USP /ID# 152484
  • Faculdade de Medicina do ABC /ID# 152481
  • Kaiser Clinica e Hospital Dia /ID# 152483
  • University of Calgary /ID# 151821
  • Allen Whey Khye Lim Professional Corporation /ID# 211168
  • University of Alberta - Zeidler Ledcor Centre /ID# 151100
  • Covenant Health /ID# 158930
  • Okanagan Clinical Trials /ID# 153178
  • Percuro Clinical Research, Ltd /ID# 150367
  • Hamilton Health Sciences - McMaster University Medical Centre /ID# 150365
  • Ottawa Hospital Research Institute /ID# 151820
  • Medicor Research Inc /ID# 151101
  • Toronto Digestive Disease Asso /ID# 150363
  • CISSS de la Monteregie /ID# 159215
  • CISSS de Chaudière-Appalaches, Hôpital Hotel-Dieu de Lévis /ID# 150361
  • Recherche GCP Research /ID# 151822
  • Centre Hospitalier de l'Universite de Montreal - CRCHUM /ID# 167169
  • Montreal General Hospital - McGill University Health Centre /ID# 170012
  • CIUSSS de l'Estrie - CHUS /ID# 150366
  • Research Group /ID# 203176
  • M y F Estudios Clínicos /ID# 200107
  • Centro de Investigaciones Clínicas Viña del Mar /ID# 150212
  • Hospital Guillermo Grant Benavente de Concepción /ID# 212424
  • CTR Estudios Clinicos /ID# 200110
  • Hospital Clinico Universidad De Los Andes /ID# 207422
  • The First Affiliated Hospital, Sun Yat-sen University /ID# 150455
  • The Sixth Affiliated Hosp Sun /ID# 150456
  • Affiliated Taihe Hospital of Hubei University of Medicine /ID# 216405
  • Tongji Hospital Tongji Medical College Huazhong University of Science and Techno /ID# 167088
  • Union Hospital Tongji Medical College Huazhong University of Science and Technol /ID# 167078
  • The First Affiliated Hospital of Nanchang University /ID# 211750
  • The First Hospital of Jilin University /ID# 209986
  • Ruijin Hospital, Shanghai Jiaotong University School of Medicine /ID# 150461
  • Shanghai Tenth People's Hospital /ID# 150460
  • Renji Hospital, Shanghai Jiaotong University School of Medicine /ID# 165815
  • The second Affiliated hospital of Zhejiang University school of Medicine /ID# 165807
  • Sir Run Run Shaw Hospital,Meical School Zhejiang University /ID# 150454
  • Xiangya Hospital Central South University /ID# 167229
  • West China Hospital, Sichuan University /ID# 167040
  • Shengjing Hospital of China Medical University /ID# 166920
  • Tianjin Medical University General Hospital /ID# 170604
  • Instituto Medico de Alta Tecnologia Oncomédica S.A /ID# 207042
  • Corporacion Hospitalaria Juan Cuidad Sede Denominada Hospital Universitario Mayo /ID# 151564
  • Hospital Universitario de San /ID# 155387
  • Clinical Hospital Dubrava /ID# 150213
  • Klinicki bolnicki centar Zagreb /ID# 150225
  • Klinicki bolnicki centar Zagreb /ID# 150709
  • Poliklinika Solmed /ID# 211483
  • Duplicate_Klinicki bolnicki centar Osijek /ID# 150216
  • Klinicki bolnicki centar Rijeka /ID# 150708
  • Klinicki bolnicki centar Split /ID# 213988
  • Zadar General Hospital /ID# 150221
  • Hepato-Gastroenterologie HK, s.r.o. /ID# 150912
  • CTCenter MaVe s.r.o. /ID# 150904
  • ARTROSCAN s.r.o. /ID# 150401
  • Nemocnice Pardubickeho kraje, a.s. /ID# 213539
  • Nemocnice Milosrdnych sester sv. Karla Boromejskeho v Praze /ID# 216221
  • Axon Clinical, s.r.o. /ID# 152479
  • ISCARE a.s. /ID# 209278
  • East Tallinn Central Hospital /ID# 150417
  • North Estonia Medical Centre /ID# 160870
  • Tartu University Hospital /ID# 150418
  • West Tallinn Central Hospital /ID# 150419
  • Tampere University Hospital /ID# 150114
  • Duplicate_Helsinki Univ Central Hospital /ID# 150407
  • Keski-Suomen Sairaala Nova /ID# 155666
  • Laakarikeskus Ikioma /ID# 150121
  • Turku University Hospital /ID# 168301
  • Chu de Nice-Hopital L'Archet Ii /Id# 152606
  • HCL - Hôpital Lyon Sud /ID# 152539
  • CHU Hopital Nord /ID# 163508
  • CHRU Lille - Hopital Claude Huriez /ID# 152607
  • CHU Montpellier - Hôpital Saint Eloi /ID# 200006
  • CHU Amiens-Picardie Site Sud /ID# 163456
  • CHD Vendée- La Roche-sur-Yon - Les Oudairies /ID# 154452
  • CHU de Saint-Etienne, Hopital Nord /ID# 154453
  • Universitatsklinikum Mannheim /ID# 150173
  • Universitaetsklinimum Tuebingen /ID# 150767
  • Universitatsklinikum Munster /ID# 150158
  • Gastroenterologische Gemeinschaftspraxis Herne /ID# 214574
  • Zentrum für Gastroenterologie Saar MVZ GmbH /ID# 215811
  • Universitaetsklinikum Schleswig-Holstein Campus Kiel /ID# 161981
  • MVZ fuer Gastroenterlogie am Bayerischen Platz /ID# 150766
  • Agaplesion Markus Krankenhaus /ID# 161982
  • Medizinisches Versorgungszentrum Portal 10 /ID# 207135
  • Praxis medicum /ID# 150166
  • General Hospital of Athens Laiko /ID# 208669
  • General Hospital of Chest Diseases of Athens SOTIRIA /ID# 202100
  • University General Hospital of Heraklion PA.G.N.I /ID# 150250
  • General Hospital of Athens Evaggelismos and Ophthalmiatrio of Athens Polyclinic /ID# 150309
  • University General Hospital of Ioannina /ID# 164248
  • Theageneio Anticancer Hospital /ID# 163896
  • General Hospital of Thessaloniki Hippokrateio /ID# 209521
  • Markusovszky Egyetemi Oktatokorhaz /ID# 150313
  • Bekes Megyei Kozponti Korhaz /ID# 151572
  • Semmelweis Egyetem /ID# 150312
  • Meditres Kft. /ID# 151521
  • Soproni Erzsebet Oktato Korhaz es Rehabilitacios Intezet /ID# 151523
  • Mentahaz Maganorvosi Kozpont /ID# 205884
  • Beaumont Hospital /ID# 150321
  • St James Hospital /ID# 150320
  • St Vincent's University Hospital /ID# 150318
  • Mercy University Hospital /ID# 151529
  • University Hospital Galway /ID# 150319
  • Soroka University Medical Center /ID# 156561
  • Rambam Health Care Campus /ID# 150325
  • Shaare Zedek Medical Center /ID# 161677
  • Hadassah Medical Center-Hebrew University /ID# 165118
  • Azienda Ospedaliera San Camillo Forlanini /ID# 151360
  • ASST Rhodense/Presidio Ospedaliero di Rho /ID# 216610
  • Istituto Clinico Humanitas /ID# 151361
  • Fondazione PTV Policlinico Tor Vergata /ID# 150338
  • Presidio Columbus-Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Un /ID# 150333
  • IRCCS Ospedale Sacro Cuore Don Calabria /ID# 201725
  • IRCCS Azienda Ospedaliero-Universitaria di Bologna /ID# 150337
  • ASST Fatebenefratelli Sacco - Ospedale Fatebenefratelli e Oftalmico /ID# 150602
  • Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico /ID# 150334
  • A.O. Ospedali Riuniti Villa Sofia - Cervello /ID# 150253
  • Aichi Medical University Hospital /ID# 151993
  • Nagoya City University Hospital /ID# 151950
  • Nagoya University Hospital /ID# 152709
  • Toyohashi Municipal Hospital /ID# 171457
  • Ieda Hospital /ID# 157781
  • Hirosaki National Hospital /ID# 152763
  • Tokatsu Tsujinaka Hospital /ID# 214962
  • Tsujinaka Hospital Kashiwanoha /ID# 209130
  • Toho University Sakura Medical Center /ID# 151936
  • Juntendo University Urayasu Hospital /ID# 208781
  • Fukui Prefectural Hospital /ID# 210448
  • Fukuoka University Chikushi Hospital /ID# 152628
  • Saiseikai Fukuoka Genaral Hospital /ID# 209479
  • Kyushu University Hospital /ID# 152526
  • Kitakyushu Municipal Med Ctr /ID# 152588
  • Kurume University Hospital /ID# 151976
  • Ogaki Municipal Hospital /ID# 208225
  • NHO Fukuyama Medical Center /ID# 206293
  • Hiroshima University Hospital /ID# 151951
  • Asahikawa Medical University Hospital /ID# 170289
  • Obihiro kosei Hospital /ID# 210412
  • Sapporo Tokushukai Hospital /ID# 209397
  • Hokkaido P.W.F.A.C. Sapporo-Kosei General Hospital /ID# 151506
  • Sapporo Medical University Hospital /ID# 206492
  • Sapporo Higashi Tokushukai Hospital /ID# 208487
  • Aoyama Clinic /ID# 152049
  • Hyogo College of Medicine College Hospital /Id# 152434
  • National Hospital Organization Mito Medical Center /ID# 152631
  • Kanazawa University Hospital /ID# 205099
  • Iwate Medical University Uchimaru Medical Center /ID# 203411
  • Imamura General Hospital /ID# 227134
  • Idzuro Imamura Hospital /ID# 206024
  • Sameshima Hospital /ID# 206672
  • St. Marianna University School of Medicine Hospital /ID# 208654
  • Yokohama City University Medical Center /ID# 169899
  • Showa University Fujigaoka Hospital /ID# 208222
  • Japanese Red Cross Kyoto Daiichi Hosital /ID# 152359
  • Kyoto University Hospital /ID# 211758
  • Mie University Hospital /ID# 205362
  • Yokkaichi Hazu Medical Center /ID# 214347
  • National Hospital Organization Sendai Medical Center /ID# 209527
  • NHO Nagasaki Medical Center /ID# 209531
  • Kenseikai Dongo Hospital /ID# 208100
  • Saiseikai Niigata Hospital /ID# 209916
  • Niigata University Medical & Dental Hospital /ID# 218048
  • Ishida Clinic of IBD and Gastroenterology /ID# 210117
  • Chikuba Hospital for Proctological and Gastrointestinal Diseases /ID# 157821
  • Okayama University Hospital /ID# 217923
  • Kinshukai Infusion Clinic /ID# 207864
  • Kitano Hospital /ID# 210395
  • Osaka City General Hospital /ID# 152704
  • Japanese Red Cross Osaka Hospital /ID# 209476
  • Osaka City University Hospital /ID# 152682
  • Toyonaka Municipal Hospital /ID# 217079
  • Saga University Hospital /ID# 209268
  • Saitama Medical Center /ID# 152031
  • Tokitokai Tokito clinic /ID# 152677
  • National Hospital Organization Higashi-Ohmi General Medical Center /ID# 210709
  • Shimane University Hospital /ID# 208899
  • Hamamatsu University Hospital /ID# 205708
  • NHO Shizuoka Medical Center /ID# 163572
  • Tokyo Medical And Dental University Hospital /ID# 152016
  • St.Luke's International Hospital /ID# 208074
  • Tokai University Hachioji Hospital /ID# 152587
  • Teikyo University Hospital /ID# 208897
  • Kitasato University Kitasato Institute Hospital /ID# 152686
  • Kyorin University Hospital /ID# 153194
  • Center Hospital of the National Center for Global Health and Medicine /ID# 209267
  • Tokyo Women's Medical University Hospital /ID# 205977
  • Yamagata University Hospital /ID# 171454
  • Tokuyama Central Hospital /ID# 216993
  • Yamanashi Prefectural Central Hospital /ID# 151908
  • Shoyukai Fujita Gastroenterological Hospital /ID# 216492
  • Hayang University GuriHospital /ID# 150344
  • CHA University Bundang Medical Center /ID# 159479
  • The Catholic University of Korea, ST. Vincent's Hospital /ID# 150347
  • Kangbuk Samsung Hospital /ID# 150348
  • Yonsei University Health System Severance Hospital /ID# 159478
  • Dong-A University Hospital /ID# 159480
  • Pusan National University Hospital /ID# 159481
  • Yeungnam University Medical Center /ID# 150345
  • Asan Medical Center /ID# 150900
  • Samsung Medical Center /ID# 150346
  • Pauls Stradins Clinical University Hospital /ID# 151409
  • Riga East Clinical University Hospital /ID# 150354
  • Hospital of Lithuanian University of Health Sciences Kaunas Clinics /ID# 150357
  • Klaipeda Seamens Hospital /ID# 154319
  • Klaipeda University Hospital /ID# 158862
  • Vilnius University Hospital /ID# 154318
  • Hospital Sultanah Bahiyah /ID# 151687
  • Universiti Kebangsaan Malaysia (UKM) Medical Centre /ID# 151689
  • Hospital Ampang /ID# 151298
  • Uni Malaya MC /ID# 150359
  • Morales Vargas Centro de Investigacion S.C. /ID# 211325
  • Clinica de Investigacion en Reumatologia y Obesidad S.C. /ID# 150710
  • Centro Regiomontano de Estudios Clínicos ROMA S.C /ID# 150256
  • Radboud Universitair Medisch Centrum /ID# 151700
  • Erasmus Medisch Centrum /ID# 150308
  • Academisch Medisch Centrum /ID# 150647
  • Leids Universitair Medisch Centrum /ID# 152624
  • Universitair Medisch Centrum Utrecht /ID# 152775
  • Akershus universitetssykehus /ID# 150317
  • Universitetssykehuset Nord-Norge /ID# 152835
  • Gastromed /Id# 216197
  • Centrum Zdrowia MDM /ID# 150351
  • Centralny Szpital Kliniczny MSWiA w Warszawie /ID# 150580
  • Centrum Medyczne Reuma Park /ID# 150349
  • NZOZ Vivamed /ID# 216742
  • Instytut Pomnik - Centrum Zdrowia Dziecka /ID# 215732
  • Endoskopia Sp. z o.o. /ID# 150765
  • Hospital da Senhora da Oliveira Guimaraes, EPE /ID# 151607
  • Centro Hospitalar de Entre Douro e Vouga /ID# 152335
  • Unidade Local de Saúde do Alto Minho, EPE - Hospital Conde de Bertiandos /ID# 151609
  • Hospital Garcia de Orta, EPE /ID# 151613
  • CCA Braga - Hospital de Braga /ID# 151608
  • Centro Hospitalar Universitario Lisboa Central, EPE - Hospital dos Capuchos /ID# 151611
  • Centro Hospitalar Universitário de Lisboa Norte, EPE - Hospital de Santa Maria /ID# 151606
  • Centro Hospitalar Universitario de Sao Joao, EPE /ID# 151610
  • School of Medicine University of Puerto Rico-Medical Science Campus /ID# 150358
  • Immanuel Kant Baltic Federal University /ID# 200719
  • NW State Medical Univ na Mechn /ID# 169322
  • Perm Clinical Center of the Federal Medical and Biological Agency /ID# 150386
  • Medical Company Hepatolog /ID# 200197
  • LLC Novaya Klinika /ID# 208107
  • Kazan State Medical University /ID# 166042
  • Olla-Med Clinic /ID# 215332
  • City Clinical Hospital #24 /ID# 150395
  • Republican hospital named after V.A. Baranov /ID# 206506
  • Euromedservice /ID# 203800
  • Duplicate_Stavropol State Medical Univ /ID# 150387
  • Clinical Hosp Center Zvezdara /ID# 150427
  • Military Medical Academy /ID# 150429
  • University Clinical Center Serbia /ID# 150428
  • Clin Hosp Ctr Bezanijska Kosa /ID# 150426
  • University Clinical Center of Nis /ID# 151903
  • University Clinical Center Kragujevac /ID# 150430
  • Clinical Center Vojvodina /ID# 150764
  • General Hospital Leskovac /ID# 217880
  • National University Hospital /ID# 150453
  • Gleneagles Medical Centre /ID# 206018
  • Tan Tock Seng Hospital /ID# 150443
  • Fakultna nemocnica s poliklinikou F.D. Roosevelta Banska Bystrica /ID# 150868
  • Medak s.r.o. /ID# 150480
  • Slovak Research Center Team Me /ID# 150257
  • B+B MED, s.r.o. /ID# 150471
  • Fakultna nemocnica s poliklinikou Nove Zamky /ID# 211370
  • GASTRO I., s.r.o. /ID# 150472
  • MD Search /ID# 167293
  • Clinresco Centers /ID# 163622
  • Lenasia Clinical Trial Centre /ID# 214344
  • Wits Clinical Research , Wits Health Consortium (PTY) Ltd /ID# 150785
  • Wits Clinical Research Site /ID# 150496
  • Spoke Research Inc /ID# 162202
  • Kingsbury Hospital /ID# 150497
  • Private Practice Dr MN Rajabally /ID# 155144
  • Hospital Clínico Universitario de Santiago-CHUS /ID# 151065
  • Hospital Unversitario Marques de Valdecilla /ID# 216620
  • Hospital Universitario Dr. Negrin /ID# 203937
  • Hospital Universitario A Coruna - CHUAC /ID# 203911
  • Hospital Clinic de Barcelona /ID# 150612
  • Hospital Universitario Reina Sofia /ID# 151066
  • Hospital Universitario Ramon y Cajal /ID# 151067
  • Hospital Universitario La Paz /ID# 214539
  • Hospital Universitario de Salamanca /ID# 150509
  • Hospital Universitario y Politecnico La Fe /ID# 150611
  • Sahlgrenska University Hospital /ID# 151496
  • Universitätsspital Basel /ID# 161731
  • Kantonsspital St. Gallen /ID# 152599
  • Universitätsspital Zürich /ID# 152591
  • Inselspital, Universitätsspital Bern /ID# 152590
  • Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 150575
  • China Medical University Hospital /ID# 150571
  • Chung Shan Medical University Hospital /ID# 150573
  • National Cheng Kung University Hospital /ID# 151749
  • National Taiwan University Hospital /ID# 150574
  • Taipei Veterans General Hosp /ID# 151748
  • Erciyes University Medical Fac /ID# 150129
  • Istanbul University-Cerrahpasa, Cerrahpasa Medical Faculty /ID# 150125
  • Umraniye Training and Res Hosp /ID# 162659
  • Marmara University Medical Fac /ID# 213969
  • Mersin University Medical /ID# 157849
  • Gazi Universitesi Tip Fakultes /ID# 150127
  • Medical Center of the "Health /ID# 151274
  • Municipal Enterprise "I.I. Mechnikov Dnipropetrovsk Regional Clinical Hospital" /ID# 207723
  • CNCE of Kharkiv Regional Council Regional Clinical Hospital /ID# 206940
  • PE PMC Acinus, Medical and Diagnostic Center /ID# 217216
  • Kyiv Municipal Clinical Hospital #18 /ID# 150372
  • Medical Center CONSILIUM MEDICAL /ID# 217446
  • CNPE of Kyiv Regional Council Kyiv Regional Hospital /ID# 217372
  • Lviv Regional Clinical Hospital /ID# 150375
  • Municipal Non-Commercial Enterprise Odesa Regional Clinical Hospital of the Od /ID# 151275
  • CNE Vinnytsya Regional Clinical Hospital named after N.I.Pirogov /ID# 216297
  • Royal Devon and Exeter NHS Trust Hospital /ID# 150379
  • Hampshire Hospitals NHS Foundation Trust /ID# 150380
  • Barts Health NHS Trust /ID# 150384
  • NHS Greater Glasgow and Clyde /ID# 163787
  • Royal United Hospitals Bath /ID# 151532
  • University Hospitals Birmingham NHS Foundation Trust /ID# 150382
  • Calderdale and Huddersfield NHS Foundation Trust /ID# 217658
  • St George's University Hospitals NHS Foundation Trust /ID# 208374

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm Type

Placebo Comparator

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

SS1: Placebo

SS1: Upadacitinib 7.5 mg

SS1: Upadacitinib 15 mg

SS1: Upadacitinib 30 mg

SS1: Upadacitinib 45 mg

SS2: Placebo/Upadacitinib 45 mg

SS2: Upadacitinib 45 mg/Upadacitinib 45 mg

SS3: M14-675 clinical responders

Arm Description

During the 8-week induction phase in Substudy 1, participants received placebo for upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks.

During the 8-week induction phase in Substudy 1, participants received 7.5 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks.

During the 8-week induction phase in Substudy 1, participants received 15 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks.

During the 8-week induction phase in Substudy 1, participants received 30 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks. Additional participants were enrolled during the Substudy 1 analysis period and received 30 mg upadacitinib film-coated tablets once daily by mouth (QD) for 4 weeks.

During the 8-week induction phase in Substudy 1, participants received 45 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks. Additional participants were enrolled during the Substudy 1 analysis period and received 45 mg upadacitinib film-coated tablets once daily by mouth (QD) for 4 weeks.

During the Substudy 2 Part 1 induction period, participants received placebo for upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks. Participants who did not achieve clinical response at Week 8 of Part 1 were enrolled in an open-label extended treatment period and received 45 mg upadacitinib film-coated tablets once daily by mouth (QD) for an additional 8 weeks.

During the Substudy 2 Part 1 induction period, participants received 45 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks. Participants who did not achieve clinical response at Week 8 of Part 1 were enrolled in an open-label expended treatment period and received 45 mg upadacitinib film-coated tablets once daily by mouth (QD) for an additional 8 weeks.

Participants in Study M14-675 (NCT03653026) who achieved clinical response defined by Adapted Mayo Score at Week 8 or Week 16 in that study and did not meet any study discontinuation criteria were eligible to enroll into Substudy 3. Participants were re-randomized and treated with a blinded treatment assignment (15 mg upadacitinib film-coated tablets once daily by mouth [QD], or 30 mg upadacitinib film-coated tablets QD, or placebo for upadacitinib film-coated tablets QD) for up to 52 weeks.

Outcomes

Primary Outcome Measures

Substudy 1: Percentage Of Participants Who Achieved Clinical Remission Per Adapted Mayo Score at Week 8
The Adapted Mayo Score is a composite score of UC disease activity based on the following 3 subscores: Stool frequency subscore (SFS), scored from 0 (normal number of stools) to 3 (5 or more stools more than normal) Rectal bleeding subscore (RBS), scored from 0 (no blood seen) to 3 (blood alone passed) 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. For Substudy 1, clinical remission is defined as SFS ≤ 1, RBS of 0, and endoscopic subscore ≤ 1.
Substudy 2: Percentage Of Participants Who Achieved Clinical Remission Per Adapted Mayo Score at Week 8
The Adapted Mayo Score is a composite score of UC disease activity based on the following 3 subscores: Stool frequency subscore (SFS), scored from 0 (normal number of stools) to 3 (5 or more stools more than normal) Rectal bleeding subscore (RBS), scored from 0 (no blood seen) to 3 (blood alone passed) 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. For Substudy 2, clinical remission is defined as SFS ≤ 1 and not greater than Baseline, RBS of 0, and endoscopic subscore ≤ 1. In Substudy 2, evidence of friability during endoscopy in participants with otherwise "mild" endoscopic activity conferred an endoscopic subscore of 2.
Substudy 3: Percentage Of Participants Who Achieved Clinical Remission Per Adapted Mayo Score at Week 52
The Adapted Mayo Score is a composite score of UC disease activity based on the following 3 subscores: Stool frequency subscore (SFS), scored from 0 (normal number of stools) to 3 (5 or more stools more than normal). Rectal bleeding subscore (RBS), scored from 0 (no blood seen) to 3 (blood alone passed). 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. For Substudy 3, clinical remission is defined as SFS ≤ 1 and not greater than Baseline, RBS of 0, and endoscopic subscore ≤ 1. In addition, evidence of friability during endoscopy in participants with otherwise "mild" endoscopic activity conferred an endoscopic subscore of 2.

Secondary Outcome Measures

Substudy 1: Percentage Of Participants With Endoscopic Improvement at 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).
Substudy 1: Percentage Of Participants Achieving Clinical Remission Per Full Mayo Score at Week 8
The Mayo score is a tool designed to measure disease activity for ulcerative colitis. The Full Mayo score (FMS) ranges from 0 (normal or inactive disease) to 12 (severe disease) and is calculated as the sum of 4 subscores (stool frequency, rectal bleeding, endoscopy [confirmed by a central reader], and physician's global assessment), each of which ranges from 0 (normal) to 3 (severe disease). Negative changes indicate improvement. Clinical remission per FMS is defined as Mayo Score ≤ 2 and no individual subscore > 1.
Substudy 1: Percentage Of Participants Achieving Clinical Response Per Adapted Mayo Score at Week 8
The Adapted Mayo Score is a composite score of UC disease activity based on the following 3 subscores: Stool frequency subscore (SFS), scored from 0 (normal number of stools) to 3 (5 or more stools more than normal). Rectal bleeding subscore (RBS), scored from 0 (no blood seen) to 3 (blood alone passed). 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 response is defined as a decrease from baseline in the Adapted Mayo score ≥ 2 points and ≥ 30% from baseline, and a decrease in RBS ≥ 1 or an absolute RBS ≤ 1).
Substudy 1: Percentage Of Participants Achieving Clinical Response Per Partial Mayo Score at Week 2
The Partial Mayo Score is a composite score of UC disease activity based on the following 2 subscores: Stool frequency subscore (SFS), scored from 0 (normal number of stools) to 3 (5 or more stools more than normal). Rectal bleeding subscore (RBS), scored from 0 (no blood seen) to 3 (blood alone passed). The overall Partial Mayo score ranges from 0 to 6 with higher scores representing more severe disease. Clinical response per Partial Mayo Score is defined as a decrease in Partial Adapted Mayo score ≥ 2 points and ≥ 30% from Baseline, plus a decrease in RBS ≥ 1 or an absolute RBS ≤ 1.
Substudy 1: Change in Full Mayo Score From Baseline to Week 8
The Mayo score is a tool designed to measure disease activity for ulcerative colitis. The Full Mayo score (FMS) ranges from 0 (normal or inactive disease) to 12 (severe disease) and is calculated as the sum of 4 subscores (stool frequency, rectal bleeding, endoscopy [confirmed by a central reader], and physician's global assessment), each of which ranges from 0 (normal) to 3 (severe disease). Negative changes indicate improvement. Clinical remission per FMS is defined as Mayo Score ≤ 2 and no individual subscore > 1.
Substudy 1: Percentage Of Participants With Endoscopic Remission at 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).
Substudy 1: Percentage Of Participants Who Achieved Histologic Improvement at Week 8
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. Histologic improvement was defined as decrease from baseline in Geboes score.
Substudy 2: Percentage Of Participants With Endoscopic Improvement at 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).
Substudy 2: Percentage Of Participants With Endoscopic Remission at 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).
Substudy 2: Percentage Of Participants Achieving Clinical Response Per Adapted Mayo Score at Week 8
The Adapted Mayo Score is a composite score of UC disease activity based on the following 3 subscores: Stool frequency subscore (SFS), scored from 0 (normal number of stools) to 3 (5 or more stools more than normal). Rectal bleeding subscore (RBS), scored from 0 (no blood seen) to 3 (blood alone passed). 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 response is defined as a decrease from baseline in the Adapted Mayo score ≥ 2 points and ≥ 30% from baseline, and a decrease in RBS ≥ 1 or an absolute RBS ≤ 1).
Substudy 2: Percentage Of Participants Achieving Clinical Response Per Partial Mayo Score at Week 2
The Partial Mayo Score is a composite score of UC disease activity based on the following 2 subscores: Stool frequency subscore (SFS), scored from 0 (normal number of stools) to 3 (5 or more stools more than normal). Rectal bleeding subscore (RBS), scored from 0 (no blood seen) to 3 (blood alone passed). The overall Partial Mayo score ranges from 0 to 6 with higher scores representing more severe disease. Clinical response per Partial Mayo Score is defined as a decrease from Baseline ≥ 1 point and ≥ 30% from Baseline, plus a decrease in RBS ≥ 1 or an absolute RBS ≤ 1.
Substudy 2: Percentage Of Participants Who Achieved Histologic-Endoscopic Mucosal Improvement at 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.
Substudy 2: Percentage Of Participants Who Report No Bowel Urgency at Week 8
Bowel urgency was assessed by participants in a subject diary completed once a day.
Substudy 2: Percentage Of Participants Who Reported No Abdominal Pain at Week 8
Abdominal pain was assessed by participants in a subject diary completed once a day.
Substudy 2: Percentage Of Participants Who Achieved Histologic Improvement at Week 8
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. Histologic improvement was defined as decrease from baseline in Geboes score.
Substudy 2: Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score at 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.
Substudy 2: Percentage Of Participants With Mucosal Healing at 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.
Substudy 2: Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Score at 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.
Substudy 3: Percentage Of Participants With Endoscopic Improvement at Week 52
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).
Substudy 3: Percentage of Participants With Clinical Remission Per Adapted Mayo Score at Week 52 Among Those Who Achieved Clinical Remission at the End of the Induction Treatment
The Adapted Mayo Score is a composite score of UC disease activity based on the following 3 subscores: Stool frequency subscore (SFS), scored from 0 (normal number of stools) to 3 (5 or more stools more than normal). Rectal bleeding subscore (RBS), scored from 0 (no blood seen) to 3 (blood alone passed). 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. For Substudy 3, clinical remission is defined as SFS ≤ 1 and not greater than Baseline, RBS of 0, and endoscopic subscore ≤ 1. In addition, evidence of friability during endoscopy in participants with otherwise "mild" endoscopic activity conferred an endoscopic subscore of 2.
Substudy 3: Percentage of Participants Who Achieved Clinical Remission Per Adapted Mayo Score at Wk 52 and Were Corticosteroid Free for ≥ 90 Days Immediately Preceding Wk 52 Among Those Who Achieved Clinical Remission at the End of the Induction Treatment
The Adapted Mayo Score is a composite score of UC disease activity based on the following 3 subscores: Stool frequency subscore (SFS), scored from 0 (normal number of stools) to 3 (5 or more stools more than normal). Rectal bleeding subscore (RBS), scored from 0 (no blood seen) to 3 (blood alone passed). 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. For Substudy 3, clinical remission is defined as SFS ≤ 1 and not greater than Baseline, RBS of 0, and endoscopic subscore ≤ 1. In addition, evidence of friability during endoscopy in participants with otherwise "mild" endoscopic activity conferred an endoscopic subscore of 2.
Substudy 3: Percentage of Participants With Endoscopic Improvement at Wk 52 Among Those Who Achieved Endoscopic Improvement at the End of the Induction Treatment
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).
Substudy 3: Percentage Of Participants With Endoscopic Remission At Week 52
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).
Substudy 3: Percentage Of Participants Who Maintained Clinical Response Per Adapted Mayo Score at Wk 52 Among Those Who Achieved Clinical Response at the End of the Induction Treatment
The Adapted Mayo Score is a composite score of UC disease activity based on the following 3 subscores: Stool frequency subscore (SFS), scored from 0 (normal number of stools) to 3 (5 or more stools more than normal). Rectal bleeding subscore (RBS), scored from 0 (no blood seen) to 3 (blood alone passed). 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 response is defined as a decrease from baseline in the Adapted Mayo score ≥ 2 points and ≥ 30% from baseline, and a decrease in RBS ≥ 1 or an absolute RBS ≤ 1).
Substudy 3: Percentage Of Participants Who Achieved Histologic-Endoscopic Mucosal Improvement at Week 52
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.
Substudy 3: Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score at Week 52
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.
Substudy 3: Percentage Of Participants With Mucosal Healing at Week 52
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.
Substudy 3: Percentage Of Participants Who Reported No Bowel Urgency at Week 52
Bowel urgency was assessed by participants in a subject diary completed once a day.
Substudy 3: Percentage Of Participants Who Reported No Abdominal Pain at Week 52
Abdominal pain was assessed by participants in a subject diary completed once a day.
Substudy 3: Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Score at Week 52
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.

Full Information

First Posted
June 28, 2016
Last Updated
June 3, 2022
Sponsor
AbbVie
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1. Study Identification

Unique Protocol Identification Number
NCT02819635
Brief Title
A Study to Evaluate the Safety and Efficacy of Upadacitinib (ABT-494) for Induction and Maintenance Therapy in Participants With Moderately to Severely Active Ulcerative Colitis (UC)
Official Title
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Upadacitinib (ABT-494) for Induction and Maintenance Therapy in Subjects With Moderately to Severely Active Ulcerative Colitis
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
September 26, 2016 (Actual)
Primary Completion Date
December 13, 2021 (Actual)
Study Completion Date
December 13, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AbbVie

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study was comprised of three substudies. The objective of Substudy 1 was to characterize the dose-response, efficacy, and safety of upadacitinib compared to placebo in inducing clinical remission to identify the induction dose of upadacitinib for further evaluation in Substudy 2. The objective of Substudy 2 was to evaluate the efficacy and safety of upadacitinib compared to placebo in inducing clinical remission in participants. The objective of Substudy 3 was to evaluate the efficacy and safety of upadacitinib compared to placebo in achieving clinical remission in participants who had a response following induction with upadacitinib.
Detailed Description
Substudy 1 was a Phase 2b dose-ranging study designed to evaluate the efficacy and safety of different oral doses of upadacitinib compared to placebo as 8-week induction therapy in participants with moderately to severely active UC. Approximately 250 participants were planned to be randomized 1:1:1:1:1 to the placebo group and 4 upadacitinib doses (7.5, 15, 30, and 45 mg). Randomization was stratified by previous biologic therapy use (yes/no), Baseline corticosteroid use (yes/no), and Baseline Adapted Mayo score (≤ 7 or > 7). The study duration included a Screening Period of up to 5 weeks and an 8-week double-blind (DB) Induction Period. After all randomized participants completed the 8-week induction, a dose-selection analysis of efficacy and safety (selected laboratory parameters) of upadacitinib versus placebo was performed. Based on this dose-selection analysis, one induction dose (upadacitinib 45 mg) was identified for further evaluation in two Phase 3 induction studies, M14-234 Substudy 2 and M14-675 (NCT03653026). During the analysis period, 132 additional participants were randomized into Groups 3 and 4 of Substudy 1 (upadacitinib 30 mg and 45 mg dose groups; approximately 66 participants per dose group). The objectives of enrolling these additional participants were to avoid interrupting the study activities during the analysis period and to support a sufficient number of participants with clinical response to be re-randomized into the maintenance portion in Substudy 3. Substudy 1 main participants are defined as those first 250 randomized 250, and additional participants are defined as those who were randomized after the main participants. Substudy 2 was a two-part Phase 3 dose-confirming study designed to evaluate the efficacy and safety of oral administration of upadacitinib 45 mg compared to placebo as induction therapy for up to 16 weeks in participants with moderately to severely active UC. Substudy 2 included a Screening Period of up to 5 weeks, Part 1, and Part 2. Part 1 was a randomized, DB, placebo-controlled 8-week induction period. Part 2 was an open-label, 8-week extended treatment period for clinical non-responders from Part 1 of Substudy 2. Part 1 was planned to enroll 462 subjects; actual enrollment was 474 subjects. Eligible participants were randomized in a 2:1 ratio to one of the two treatment groups (DB upadacitinib 45 mg or matching placebo) for 8 weeks. The randomization was stratified by bio-IR status (Biologic inadequate responders [bio-IR] vs Non-biologic-inadequate responders [non-bio-IR], corticosteroid use (yes or no), and Adapted Mayo score (≤ 7 or > 7) at Baseline. Within bio-IR, the randomization was further stratified by number of prior biologic treatments (≤ 1 or > 1). Within non-bio-IR, the randomization was further stratified by previous biologic use (yes or no). Part 2 was an open label, 8-week Extended Treatment Period for those who did not achieve clinical response per Adapted Mayo score at Week 8 in Part 1. All participants received upadacitinib 45 mg. Substudy 3 was a Phase 3 maintenance study designed to evaluate the efficacy and safety of upadacitinib 15 and 30 mg once daily (QD) compared to placebo in achieving clinical remission per Adapted Mayo score in participants with moderately to severely active UC who achieved clinical response per Adapted Mayo score following induction therapy from Substudy 1, Substudy 2, or Study M14-675. A total of 1,046 subjects who achieved clinical response per Adapted Mayo score after completion of induction treatment or Extended Treatment Period in Study M14-234 Substudy 1, Substudy 2, or Study M14-675 entered Substudy 3, and 1,044 were treated with a blinded treatment assignment for up to 52 weeks. Substudy 3 included 4 cohorts. Cohort 1: 847 participants who achieved clinical response in Substudy 1, Substudy 2, or Study M14-675 at either Week 8 or Week 16, and received upadacitinib 15, 30, or 45 mg QD. The treatment groups in Cohort 1 were Group 1: upadacitinib 15 mg QD; Group 2: upadacitinib 30 mg QD; and Group 3: placebo QD. Those who achieved clinical response and received upadacitinib 15 mg QD in Substudy 1 were re-randomized 1:1 to only receive upadacitinib 15 mg QD or placebo QD (treatment Group 1 or 3). Cohort 2: 104 participants who received double-blind placebo QD treatment for 8 weeks during Substudy 1, Substudy 2 Part 1, or Study M14-675 Part 1 and achieved clinical response at Week 8 continued to receive blinded placebo QD in Substudy 3. Cohort 3: 75 participants who received upadacitinib 45 mg QD in Induction Phase and did not achieve clinical response and received upadacitinib 45 mg QD in Extended Treatment in Substudy 2 Part 2 or in Study M14-675 Part 2 and achieved clinical response at Week 16 were re-randomized 1:1 and received blinded upadacitinib 30 mg QD or upadacitinib 15 mg QD in Substudy 3. Cohort 4: 20 participants who received double-blinded treatment of upadacitinib 7.5 mg QD for 8 weeks during Substudy 1 and achieved clinical response at Week 8 continued to receive blinded treatment of upadacitinib 7.5 mg QD in Substudy 3.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ulcerative Colitis (UC)
Keywords
Upadacitinib (ABT-494), Moderately to Severely Active UC, RINVOQ

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1302 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SS1: Placebo
Arm Type
Placebo Comparator
Arm Description
During the 8-week induction phase in Substudy 1, participants received placebo for upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks.
Arm Title
SS1: Upadacitinib 7.5 mg
Arm Type
Experimental
Arm Description
During the 8-week induction phase in Substudy 1, participants received 7.5 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks.
Arm Title
SS1: Upadacitinib 15 mg
Arm Type
Experimental
Arm Description
During the 8-week induction phase in Substudy 1, participants received 15 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks.
Arm Title
SS1: Upadacitinib 30 mg
Arm Type
Experimental
Arm Description
During the 8-week induction phase in Substudy 1, participants received 30 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks. Additional participants were enrolled during the Substudy 1 analysis period and received 30 mg upadacitinib film-coated tablets once daily by mouth (QD) for 4 weeks.
Arm Title
SS1: Upadacitinib 45 mg
Arm Type
Experimental
Arm Description
During the 8-week induction phase in Substudy 1, participants received 45 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks. Additional participants were enrolled during the Substudy 1 analysis period and received 45 mg upadacitinib film-coated tablets once daily by mouth (QD) for 4 weeks.
Arm Title
SS2: Placebo/Upadacitinib 45 mg
Arm Type
Experimental
Arm Description
During the Substudy 2 Part 1 induction period, participants received placebo for upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks. Participants who did not achieve clinical response at Week 8 of Part 1 were enrolled in an open-label extended treatment period and received 45 mg upadacitinib film-coated tablets once daily by mouth (QD) for an additional 8 weeks.
Arm Title
SS2: Upadacitinib 45 mg/Upadacitinib 45 mg
Arm Type
Experimental
Arm Description
During the Substudy 2 Part 1 induction period, participants received 45 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks. Participants who did not achieve clinical response at Week 8 of Part 1 were enrolled in an open-label expended treatment period and received 45 mg upadacitinib film-coated tablets once daily by mouth (QD) for an additional 8 weeks.
Arm Title
SS3: M14-675 clinical responders
Arm Type
Experimental
Arm Description
Participants in Study M14-675 (NCT03653026) who achieved clinical response defined by Adapted Mayo Score at Week 8 or Week 16 in that study and did not meet any study discontinuation criteria were eligible to enroll into Substudy 3. Participants were re-randomized and treated with a blinded treatment assignment (15 mg upadacitinib film-coated tablets once daily by mouth [QD], or 30 mg upadacitinib film-coated tablets QD, or placebo for upadacitinib film-coated tablets QD) for up to 52 weeks.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Film-coated tablet for oral administration
Intervention Type
Drug
Intervention Name(s)
Upadacitinib
Other Intervention Name(s)
ABT-494, RINVOQ
Intervention Description
Film-coated tablet for oral administration
Primary Outcome Measure Information:
Title
Substudy 1: Percentage Of Participants Who Achieved Clinical Remission Per Adapted Mayo Score at Week 8
Description
The Adapted Mayo Score is a composite score of UC disease activity based on the following 3 subscores: Stool frequency subscore (SFS), scored from 0 (normal number of stools) to 3 (5 or more stools more than normal) Rectal bleeding subscore (RBS), scored from 0 (no blood seen) to 3 (blood alone passed) 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. For Substudy 1, clinical remission is defined as SFS ≤ 1, RBS of 0, and endoscopic subscore ≤ 1.
Time Frame
At Week 8
Title
Substudy 2: Percentage Of Participants Who Achieved Clinical Remission Per Adapted Mayo Score at Week 8
Description
The Adapted Mayo Score is a composite score of UC disease activity based on the following 3 subscores: Stool frequency subscore (SFS), scored from 0 (normal number of stools) to 3 (5 or more stools more than normal) Rectal bleeding subscore (RBS), scored from 0 (no blood seen) to 3 (blood alone passed) 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. For Substudy 2, clinical remission is defined as SFS ≤ 1 and not greater than Baseline, RBS of 0, and endoscopic subscore ≤ 1. In Substudy 2, evidence of friability during endoscopy in participants with otherwise "mild" endoscopic activity conferred an endoscopic subscore of 2.
Time Frame
At Week 8
Title
Substudy 3: Percentage Of Participants Who Achieved Clinical Remission Per Adapted Mayo Score at Week 52
Description
The Adapted Mayo Score is a composite score of UC disease activity based on the following 3 subscores: Stool frequency subscore (SFS), scored from 0 (normal number of stools) to 3 (5 or more stools more than normal). Rectal bleeding subscore (RBS), scored from 0 (no blood seen) to 3 (blood alone passed). 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. For Substudy 3, clinical remission is defined as SFS ≤ 1 and not greater than Baseline, RBS of 0, and endoscopic subscore ≤ 1. In addition, evidence of friability during endoscopy in participants with otherwise "mild" endoscopic activity conferred an endoscopic subscore of 2.
Time Frame
At Week 52
Secondary Outcome Measure Information:
Title
Substudy 1: Percentage Of Participants With Endoscopic Improvement at Week 8
Description
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).
Time Frame
At Week 8
Title
Substudy 1: Percentage Of Participants Achieving Clinical Remission Per Full Mayo Score at Week 8
Description
The Mayo score is a tool designed to measure disease activity for ulcerative colitis. The Full Mayo score (FMS) ranges from 0 (normal or inactive disease) to 12 (severe disease) and is calculated as the sum of 4 subscores (stool frequency, rectal bleeding, endoscopy [confirmed by a central reader], and physician's global assessment), each of which ranges from 0 (normal) to 3 (severe disease). Negative changes indicate improvement. Clinical remission per FMS is defined as Mayo Score ≤ 2 and no individual subscore > 1.
Time Frame
At Week 8
Title
Substudy 1: Percentage Of Participants Achieving Clinical Response Per Adapted Mayo Score at Week 8
Description
The Adapted Mayo Score is a composite score of UC disease activity based on the following 3 subscores: Stool frequency subscore (SFS), scored from 0 (normal number of stools) to 3 (5 or more stools more than normal). Rectal bleeding subscore (RBS), scored from 0 (no blood seen) to 3 (blood alone passed). 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 response is defined as a decrease from baseline in the Adapted Mayo score ≥ 2 points and ≥ 30% from baseline, and a decrease in RBS ≥ 1 or an absolute RBS ≤ 1).
Time Frame
At Week 8
Title
Substudy 1: Percentage Of Participants Achieving Clinical Response Per Partial Mayo Score at Week 2
Description
The Partial Mayo Score is a composite score of UC disease activity based on the following 2 subscores: Stool frequency subscore (SFS), scored from 0 (normal number of stools) to 3 (5 or more stools more than normal). Rectal bleeding subscore (RBS), scored from 0 (no blood seen) to 3 (blood alone passed). The overall Partial Mayo score ranges from 0 to 6 with higher scores representing more severe disease. Clinical response per Partial Mayo Score is defined as a decrease in Partial Adapted Mayo score ≥ 2 points and ≥ 30% from Baseline, plus a decrease in RBS ≥ 1 or an absolute RBS ≤ 1.
Time Frame
At Week 2
Title
Substudy 1: Change in Full Mayo Score From Baseline to Week 8
Description
The Mayo score is a tool designed to measure disease activity for ulcerative colitis. The Full Mayo score (FMS) ranges from 0 (normal or inactive disease) to 12 (severe disease) and is calculated as the sum of 4 subscores (stool frequency, rectal bleeding, endoscopy [confirmed by a central reader], and physician's global assessment), each of which ranges from 0 (normal) to 3 (severe disease). Negative changes indicate improvement. Clinical remission per FMS is defined as Mayo Score ≤ 2 and no individual subscore > 1.
Time Frame
Baseline (Week 0), Week 8
Title
Substudy 1: Percentage Of Participants With Endoscopic Remission at Week 8
Description
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).
Time Frame
At Week 8
Title
Substudy 1: Percentage Of Participants Who Achieved Histologic Improvement at Week 8
Description
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. Histologic improvement was defined as decrease from baseline in Geboes score.
Time Frame
At Week 8
Title
Substudy 2: Percentage Of Participants With Endoscopic Improvement at Week 8
Description
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).
Time Frame
At Week 8
Title
Substudy 2: Percentage Of Participants With Endoscopic Remission at Week 8
Description
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).
Time Frame
At Week 8
Title
Substudy 2: Percentage Of Participants Achieving Clinical Response Per Adapted Mayo Score at Week 8
Description
The Adapted Mayo Score is a composite score of UC disease activity based on the following 3 subscores: Stool frequency subscore (SFS), scored from 0 (normal number of stools) to 3 (5 or more stools more than normal). Rectal bleeding subscore (RBS), scored from 0 (no blood seen) to 3 (blood alone passed). 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 response is defined as a decrease from baseline in the Adapted Mayo score ≥ 2 points and ≥ 30% from baseline, and a decrease in RBS ≥ 1 or an absolute RBS ≤ 1).
Time Frame
At Week 8
Title
Substudy 2: Percentage Of Participants Achieving Clinical Response Per Partial Mayo Score at Week 2
Description
The Partial Mayo Score is a composite score of UC disease activity based on the following 2 subscores: Stool frequency subscore (SFS), scored from 0 (normal number of stools) to 3 (5 or more stools more than normal). Rectal bleeding subscore (RBS), scored from 0 (no blood seen) to 3 (blood alone passed). The overall Partial Mayo score ranges from 0 to 6 with higher scores representing more severe disease. Clinical response per Partial Mayo Score is defined as a decrease from Baseline ≥ 1 point and ≥ 30% from Baseline, plus a decrease in RBS ≥ 1 or an absolute RBS ≤ 1.
Time Frame
At Week 2
Title
Substudy 2: Percentage Of Participants Who Achieved Histologic-Endoscopic Mucosal Improvement at Week 8
Description
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.
Time Frame
At Week 8
Title
Substudy 2: Percentage Of Participants Who Report No Bowel Urgency at Week 8
Description
Bowel urgency was assessed by participants in a subject diary completed once a day.
Time Frame
At Week 8
Title
Substudy 2: Percentage Of Participants Who Reported No Abdominal Pain at Week 8
Description
Abdominal pain was assessed by participants in a subject diary completed once a day.
Time Frame
At Week 8
Title
Substudy 2: Percentage Of Participants Who Achieved Histologic Improvement at Week 8
Description
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. Histologic improvement was defined as decrease from baseline in Geboes score.
Time Frame
At Week 8
Title
Substudy 2: Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score at Week 8
Description
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.
Time Frame
Baseline (Week 0), Week 8
Title
Substudy 2: Percentage Of Participants With Mucosal Healing at Week 8
Description
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.
Time Frame
At Week 8
Title
Substudy 2: Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Score at Week 8
Description
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.
Time Frame
Baseline (Week 0), Week 8
Title
Substudy 3: Percentage Of Participants With Endoscopic Improvement at Week 52
Description
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).
Time Frame
At Week 52
Title
Substudy 3: Percentage of Participants With Clinical Remission Per Adapted Mayo Score at Week 52 Among Those Who Achieved Clinical Remission at the End of the Induction Treatment
Description
The Adapted Mayo Score is a composite score of UC disease activity based on the following 3 subscores: Stool frequency subscore (SFS), scored from 0 (normal number of stools) to 3 (5 or more stools more than normal). Rectal bleeding subscore (RBS), scored from 0 (no blood seen) to 3 (blood alone passed). 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. For Substudy 3, clinical remission is defined as SFS ≤ 1 and not greater than Baseline, RBS of 0, and endoscopic subscore ≤ 1. In addition, evidence of friability during endoscopy in participants with otherwise "mild" endoscopic activity conferred an endoscopic subscore of 2.
Time Frame
At Week 52
Title
Substudy 3: Percentage of Participants Who Achieved Clinical Remission Per Adapted Mayo Score at Wk 52 and Were Corticosteroid Free for ≥ 90 Days Immediately Preceding Wk 52 Among Those Who Achieved Clinical Remission at the End of the Induction Treatment
Description
The Adapted Mayo Score is a composite score of UC disease activity based on the following 3 subscores: Stool frequency subscore (SFS), scored from 0 (normal number of stools) to 3 (5 or more stools more than normal). Rectal bleeding subscore (RBS), scored from 0 (no blood seen) to 3 (blood alone passed). 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. For Substudy 3, clinical remission is defined as SFS ≤ 1 and not greater than Baseline, RBS of 0, and endoscopic subscore ≤ 1. In addition, evidence of friability during endoscopy in participants with otherwise "mild" endoscopic activity conferred an endoscopic subscore of 2.
Time Frame
At Week 52
Title
Substudy 3: Percentage of Participants With Endoscopic Improvement at Wk 52 Among Those Who Achieved Endoscopic Improvement at the End of the Induction Treatment
Description
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).
Time Frame
At Week 52
Title
Substudy 3: Percentage Of Participants With Endoscopic Remission At Week 52
Description
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).
Time Frame
At Week 52
Title
Substudy 3: Percentage Of Participants Who Maintained Clinical Response Per Adapted Mayo Score at Wk 52 Among Those Who Achieved Clinical Response at the End of the Induction Treatment
Description
The Adapted Mayo Score is a composite score of UC disease activity based on the following 3 subscores: Stool frequency subscore (SFS), scored from 0 (normal number of stools) to 3 (5 or more stools more than normal). Rectal bleeding subscore (RBS), scored from 0 (no blood seen) to 3 (blood alone passed). 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 response is defined as a decrease from baseline in the Adapted Mayo score ≥ 2 points and ≥ 30% from baseline, and a decrease in RBS ≥ 1 or an absolute RBS ≤ 1).
Time Frame
At Week 52
Title
Substudy 3: Percentage Of Participants Who Achieved Histologic-Endoscopic Mucosal Improvement at Week 52
Description
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.
Time Frame
At Week 52
Title
Substudy 3: Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score at Week 52
Description
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.
Time Frame
Baseline (Week 0), Week 52
Title
Substudy 3: Percentage Of Participants With Mucosal Healing at Week 52
Description
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.
Time Frame
At Week 52
Title
Substudy 3: Percentage Of Participants Who Reported No Bowel Urgency at Week 52
Description
Bowel urgency was assessed by participants in a subject diary completed once a day.
Time Frame
At Week 52
Title
Substudy 3: Percentage Of Participants Who Reported No Abdominal Pain at Week 52
Description
Abdominal pain was assessed by participants in a subject diary completed once a day.
Time Frame
At Week 52
Title
Substudy 3: Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Score at Week 52
Description
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.
Time Frame
Baseline (Week 0), Week 52

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Note: Adolescent participants who are 16 or 17 years old will be eligible to participate if approved by the country or regulatory/health authority. If approval has not been granted, only participants ≥18 years old will be enrolled. Adolescents must weigh ≥ 40 kilograms and meet the definition of Tanner Stage 5 at Screening Visit. Diagnosis of ulcerative colitis 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 ulcerative colitis with an Adapted Mayo score of 5 to 9 points and endoscopic sub score of 2 to 3 (confirmed by central reader). Demonstrated an inadequate response to, loss of response to, or intolerance to at least one of the following treatments including: oral aminosalicylates, corticosteroids, immunosuppressants, and/or biologic therapies in the opinion of the investigator. 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 to aminosalicylates, corticosteroids, and/or immunosuppressants as defined above. If female, participant must meet the criteria for Contraception Recommendations 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 prior to study drug dosing. 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 on azathioprine or 6-mercaptopurine 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 abnormal results meeting the exclusion criteria
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ABBVIE INC.
Organizational Affiliation
AbbVie
Official's Role
Study Director
Facility Information:
Facility Name
Birmingham Gastroenterology Associates P.C /ID# 151276
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35209
Country
United States
Facility Name
East View Medical Research, LLC /ID# 171183
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36606
Country
United States
Facility Name
CB Flock Research Corporation /ID# 165980
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36608
Country
United States
Facility Name
Delsol Research Management, Ll /Id# 170131
City
Chandler
State/Province
Arizona
ZIP/Postal Code
85224
Country
United States
Facility Name
Digestive Disease Consultants, A Division of Arizona Digestive Health, P.C /ID# 211885
City
Mesa
State/Province
Arizona
ZIP/Postal Code
85206
Country
United States
Facility Name
Arizona Arthritis & Rheumatology Research, PLLC /ID# 169822
City
Sun City
State/Province
Arizona
ZIP/Postal Code
85306
Country
United States
Facility Name
Adobe Clinical Research LLC /ID# 155250
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85712
Country
United States
Facility Name
University of Arizona /ID# 150553
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724
Country
United States
Facility Name
Citrus Valley Gastroenterology /ID# 151914
City
Covina
State/Province
California
ZIP/Postal Code
91722-3797
Country
United States
Facility Name
Newport Huntington Medical Group /ID# 217005
City
Huntington Beach
State/Province
California
ZIP/Postal Code
92648-5994
Country
United States
Facility Name
UC San Diego Health System /ID# 155185
City
La Jolla
State/Province
California
ZIP/Postal Code
92093
Country
United States
Facility Name
United Medical Doctors /ID# 207464
City
Los Alamitos
State/Province
California
ZIP/Postal Code
90720-3309
Country
United States
Facility Name
TLC Clinical Research Inc /ID# 216829
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
Gastrointestinal Biosciences Clinical Trials, LLC /ID# 157080
City
Los Angeles
State/Province
California
ZIP/Postal Code
90067-2001
Country
United States
Facility Name
Facey Medical Foundation /ID# 203133
City
Mission Hills
State/Province
California
ZIP/Postal Code
91345
Country
United States
Facility Name
United Medical Doctors - Murrieta /ID# 151211
City
Murrieta
State/Province
California
ZIP/Postal Code
92563
Country
United States
Facility Name
InSite Digestive Health Care - Oxnard /ID# 163414
City
Oxnard
State/Province
California
ZIP/Postal Code
93030
Country
United States
Facility Name
Inland Empire Clinical Trials, LLC /ID# 216038
City
Rialto
State/Province
California
ZIP/Postal Code
92377
Country
United States
Facility Name
San Diego Clinical Trials /ID# 212120
City
San Diego
State/Province
California
ZIP/Postal Code
92120
Country
United States
Facility Name
Medical Assoc Research Grp /ID# 169148
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Univ of California San Francis /ID# 164581
City
San Francisco
State/Province
California
ZIP/Postal Code
94158
Country
United States
Facility Name
Delta Waves, Inc. /ID# 151721
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80918
Country
United States
Facility Name
South Denver Gastroenterology /ID# 151223
City
Lone Tree
State/Province
Colorado
ZIP/Postal Code
80124
Country
United States
Facility Name
Western States Clinical Res /ID# 158076
City
Wheat Ridge
State/Province
Colorado
ZIP/Postal Code
80033-2896
Country
United States
Facility Name
Western Connecticut Medical Group /ID# 169210
City
Danbury
State/Province
Connecticut
ZIP/Postal Code
06810
Country
United States
Facility Name
Medical Research Center of CT /ID# 150482
City
Hamden
State/Province
Connecticut
ZIP/Postal Code
06518
Country
United States
Facility Name
Gastro Florida /ID# 155245
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33756
Country
United States
Facility Name
Moonshine Research Center, Inc /ID# 152533
City
Doral
State/Province
Florida
ZIP/Postal Code
33166
Country
United States
Facility Name
Universal Axon Clinical Research /ID# 213461
City
Doral
State/Province
Florida
ZIP/Postal Code
33166
Country
United States
Facility Name
Palmetto Research, LLC /ID# 151716
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33016
Country
United States
Facility Name
Nature Coast Clinical Research - Inverness /ID# 154064
City
Inverness
State/Province
Florida
ZIP/Postal Code
34452-4717
Country
United States
Facility Name
Encore Borland-Groover Clinical Research /Id# 170912
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32256
Country
United States
Facility Name
SIH Research Mumtaz, Inc /ID# 163319
City
Kissimmee
State/Province
Florida
ZIP/Postal Code
34741-4161
Country
United States
Facility Name
Cfagi Llc /Id# 202017
City
Maitland
State/Province
Florida
ZIP/Postal Code
32751-6108
Country
United States
Facility Name
University of Miami /ID# 215441
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Advanced Pharma /ID# 151719
City
Miami
State/Province
Florida
ZIP/Postal Code
33147
Country
United States
Facility Name
New Horizon Research Center /ID# 152474
City
Miami
State/Province
Florida
ZIP/Postal Code
33165-3372
Country
United States
Facility Name
Crystal Pharmacology Research /ID# 151841
City
Miami
State/Province
Florida
ZIP/Postal Code
33165
Country
United States
Facility Name
Coral Research Clinic /ID# 150444
City
Miami
State/Province
Florida
ZIP/Postal Code
33186-4643
Country
United States
Facility Name
Advanced Research Institute, Inc /ID# 163098
City
New Port Richey
State/Province
Florida
ZIP/Postal Code
34653
Country
United States
Facility Name
Endoscopic Research, Inc. /ID# 151720
City
Orlando
State/Province
Florida
ZIP/Postal Code
32803
Country
United States
Facility Name
Omega Research Maitland, LLC /ID# 200269
City
Orlando
State/Province
Florida
ZIP/Postal Code
32808
Country
United States
Facility Name
Clinical Research Trials of Florida, Inc. /ID# 201790
City
Tampa
State/Province
Florida
ZIP/Postal Code
33607
Country
United States
Facility Name
University of South Florida /ID# 214493
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
AdventHealth Tampa /ID# 200272
City
Tampa
State/Province
Florida
ZIP/Postal Code
33613-4680
Country
United States
Facility Name
Gastroenterology Associates of Central Georgia, LLC /ID# 165782
City
Macon
State/Province
Georgia
ZIP/Postal Code
31201
Country
United States
Facility Name
Infinite Clinical Trials /ID# 215340
City
Riverdale
State/Province
Georgia
ZIP/Postal Code
30274
Country
United States
Facility Name
Atlanta Gastroenterology Spec /ID# 150548
City
Suwanee
State/Province
Georgia
ZIP/Postal Code
30024
Country
United States
Facility Name
Next Innovative Clinical Research - Chicago /ID# 216060
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60605-2168
Country
United States
Facility Name
The University of Chicago DCAM /ID# 150547
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
NorthShore University HealthSystem /ID# 150555
City
Evanston
State/Province
Illinois
ZIP/Postal Code
60201
Country
United States
Facility Name
Northwest Health Care Associates /ID# 151590
City
Hoffman Estates
State/Province
Illinois
ZIP/Postal Code
60169
Country
United States
Facility Name
Carle Foundation Hospital /ID# 151137
City
Urbana
State/Province
Illinois
ZIP/Postal Code
61801
Country
United States
Facility Name
MediSphere Medical Research Center /ID# 152064
City
Evansville
State/Province
Indiana
ZIP/Postal Code
47714-8011
Country
United States
Facility Name
Indianapolis Gastroenterology /ID# 162901
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46237
Country
United States
Facility Name
University of Iowa Hospitals and Clinics /ID# 157058
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
Cotton-O'Neil Clinical Res Ctr /ID# 167182
City
Topeka
State/Province
Kansas
ZIP/Postal Code
66606
Country
United States
Facility Name
Tri-State Gastroenterology /ID# 169811
City
Crestview Hills
State/Province
Kentucky
ZIP/Postal Code
41017
Country
United States
Facility Name
Houma Digestive Health Special /ID# 151844
City
Houma
State/Province
Louisiana
ZIP/Postal Code
70360
Country
United States
Facility Name
Nola Research Works, LLC /ID# 153356
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70115
Country
United States
Facility Name
Louisana Research Center, LLC /ID# 150446
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71105-6800
Country
United States
Facility Name
University of Maryland Med Ctr /ID# 150449
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
Gastro Center of Maryland /ID# 200022
City
Columbia
State/Province
Maryland
ZIP/Postal Code
21045
Country
United States
Facility Name
Massachusetts General Hospital /ID# 165676
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
University of Michigan Comprehensive Cancer Center Michigan Medicine /ID# 151140
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
Huron Gastroenterology Assoc /ID# 152710
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48197
Country
United States
Facility Name
Clin Res Inst of Michigan, LLC /ID# 153027
City
Chesterfield
State/Province
Michigan
ZIP/Postal Code
48047
Country
United States
Facility Name
Revival Research Institute, LLC /ID# 207280
City
Southfield
State/Province
Michigan
ZIP/Postal Code
48034-1659
Country
United States
Facility Name
Center for Digestive Health /ID# 161984
City
Troy
State/Province
Michigan
ZIP/Postal Code
48098-6363
Country
United States
Facility Name
Gastroenterology Associates of Western Michigan, PLC d.b.a. West Michigan Clinic /ID# 157484
City
Wyoming
State/Province
Michigan
ZIP/Postal Code
49519
Country
United States
Facility Name
Mayo Clinic - Rochester /ID# 151677
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905-0001
Country
United States
Facility Name
Minnesota Gastroenterology PA /ID# 151678
City
Saint Paul
State/Province
Minnesota
ZIP/Postal Code
55114
Country
United States
Facility Name
University of Mississippi Medical Center /ID# 213139
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39216-4500
Country
United States
Facility Name
Southern Therapy and Advanced Research (STAR) LLC /ID# 170712
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39216
Country
United States
Facility Name
Washington University-School of Medicine /ID# 150485
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Las Vegas Medical Research /ID# 153044
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89113
Country
United States
Facility Name
Dartmouth-Hitchcock Medical Center /ID# 150549
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States
Facility Name
AGA Clinical Research Associates, LLC /ID# 153040
City
Egg Harbor Township
State/Province
New Jersey
ZIP/Postal Code
08234
Country
United States
Facility Name
Atlantic Digestive Health Inst /ID# 150447
City
Morristown
State/Province
New Jersey
ZIP/Postal Code
07960
Country
United States
Facility Name
Rutgers Robert Wood Johnson /ID# 155248
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08901
Country
United States
Facility Name
Duplicate_University of New Mexico Department of Internal Medicine /ID# 214396
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87131
Country
United States
Facility Name
Montefiore Medical Center - Moses Campus /ID# 150543
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
Facility Name
Advantage Clinical Trials /ID# 163938
City
Bronx
State/Province
New York
ZIP/Postal Code
10468
Country
United States
Facility Name
NY Scientific /ID# 152707
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11235
Country
United States
Facility Name
NYU Langone Long Island Clinical Research Association /ID# 155272
City
Great Neck
State/Province
New York
ZIP/Postal Code
11021
Country
United States
Facility Name
Columbia Univ Medical Center /ID# 163410
City
New York
State/Province
New York
ZIP/Postal Code
10032-3725
Country
United States
Facility Name
DiGiovanna Institute for Medical Education & Research /ID# 201533
City
North Massapequa
State/Province
New York
ZIP/Postal Code
11758
Country
United States
Facility Name
Premier Medical Group - GI Division /ID# 153357
City
Poughkeepsie
State/Province
New York
ZIP/Postal Code
12601
Country
United States
Facility Name
Gastoenterology Group of Rochester /ID# 151079
City
Rochester
State/Province
New York
ZIP/Postal Code
14618-5703
Country
United States
Facility Name
Richmond University Medical Center /ID# 201859
City
Staten Island
State/Province
New York
ZIP/Postal Code
10310-1664
Country
United States
Facility Name
Digestive Health Partners, P.A /ID# 167237
City
Asheville
State/Province
North Carolina
ZIP/Postal Code
28801
Country
United States
Facility Name
Atrium Health Carolinas Medical Center /ID# 156971
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28203
Country
United States
Facility Name
Charlotte Gastroenterology and Hepatology, PLLC /ID# 150545
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28207
Country
United States
Facility Name
Atlantic Gastroenterology Clinical Research /ID# 151899
City
Greenville
State/Province
North Carolina
ZIP/Postal Code
27834
Country
United States
Facility Name
Clinical Trials of America /ID# 153448
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Wake Forest Baptist Medical Center /ID# 150448
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157-0001
Country
United States
Facility Name
Plains Clinical Research Center, LLC /ID# 170290
City
Fargo
State/Province
North Dakota
ZIP/Postal Code
58104-5925
Country
United States
Facility Name
Consultants for Clinical Research /ID# 151679
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
University of Cincinnati /ID# 164582
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267-0585
Country
United States
Facility Name
The Ohio State University /ID# 169416
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Optimed Research, Ltd. /ID# 169696
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43235
Country
United States
Facility Name
Hometown Urgent Care and Resea /ID# 200065
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45424
Country
United States
Facility Name
Dayton Gastroenterology, Inc. /ID# 167631
City
Englewood
State/Province
Ohio
ZIP/Postal Code
45415
Country
United States
Facility Name
Great Lakes Medical Research, LLC /ID# 201772
City
Mentor
State/Province
Ohio
ZIP/Postal Code
44060-6211
Country
United States
Facility Name
Ohio Clinical Research Partner /ID# 154068
City
Mentor
State/Province
Ohio
ZIP/Postal Code
44060
Country
United States
Facility Name
Hightower Clinical /ID# 216337
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73102
Country
United States
Facility Name
Digestive Disease Specialists /ID# 201056
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73112
Country
United States
Facility Name
Options Health Research, LLC /ID# 150554
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74104
Country
United States
Facility Name
Healthcare Research Consultant /ID# 163100
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74135
Country
United States
Facility Name
Northwest Gastroenterology Clinic /ID# 152527
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States
Facility Name
Guthrie Medical Group, PC /ID# 150481
City
Sayre
State/Province
Pennsylvania
ZIP/Postal Code
18840
Country
United States
Facility Name
Penn State Health Colonnade /ID# 150259
City
State College
State/Province
Pennsylvania
ZIP/Postal Code
16803-2309
Country
United States
Facility Name
Pharmacorp Clinical Trials /ID# 153354
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29412
Country
United States
Facility Name
Gastroenterology Associates, P.A. of Greenville /ID# 150541
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29615-3593
Country
United States
Facility Name
Gastro One /ID# 151144
City
Germantown
State/Province
Tennessee
ZIP/Postal Code
38138
Country
United States
Facility Name
East Tennessee Research Institute /ID# 203610
City
Johnson City
State/Province
Tennessee
ZIP/Postal Code
37604
Country
United States
Facility Name
Quality Medical Research /ID# 203426
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37211
Country
United States
Facility Name
Vanderbilt University Medical Center /ID# 153355
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232-0011
Country
United States
Facility Name
TX Clinical Research Institute /ID# 151526
City
Arlington
State/Province
Texas
ZIP/Postal Code
76012
Country
United States
Facility Name
Inquest Clinical Research /ID# 164635
City
Baytown
State/Province
Texas
ZIP/Postal Code
77521-2415
Country
United States
Facility Name
Texas Digestive Disease Consultants /ID# 209947
City
Cedar Park
State/Province
Texas
ZIP/Postal Code
78613-5028
Country
United States
Facility Name
Texas Digestive Disease Consultants /ID# 209804
City
Cedar Park
State/Province
Texas
ZIP/Postal Code
78613
Country
United States
Facility Name
Baylor Scott & White Center for Inflammatory Bowel Diseases /ID# 200770
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
DHAT Research Institute /ID# 151218
City
Garland
State/Province
Texas
ZIP/Postal Code
75044-2208
Country
United States
Facility Name
Vilo Research Group Inc /ID# 212624
City
Houston
State/Province
Texas
ZIP/Postal Code
77017-2337
Country
United States
Facility Name
CliniCore International, LLC /ID# 152062
City
Houston
State/Province
Texas
ZIP/Postal Code
77027-6812
Country
United States
Facility Name
Baylor College of Medicine - Baylor Medical Center /ID# 150486
City
Houston
State/Province
Texas
ZIP/Postal Code
77030-3411
Country
United States
Facility Name
Centex Studies, Inc. - Houston /ID# 201216
City
Houston
State/Province
Texas
ZIP/Postal Code
77058
Country
United States
Facility Name
GI Specialists of Houston /ID# 202327
City
Houston
State/Province
Texas
ZIP/Postal Code
77070-4347
Country
United States
Facility Name
Caprock Gastro Research, LLC /ID# 214754
City
Lubbock
State/Province
Texas
ZIP/Postal Code
79424-3017
Country
United States
Facility Name
Clinical Associates in Research Therapeutics of America, LLC /ID# 201260
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78212
Country
United States
Facility Name
Southern Star Research Institute, LLC /ID# 169396
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229-5390
Country
United States
Facility Name
Carl R. Meisner Medical Clinic /ID# 171061
City
Sugar Land
State/Province
Texas
ZIP/Postal Code
77478
Country
United States
Facility Name
Baylor Scott & White Center for Diagnostic Medicine /ID# 204499
City
Temple
State/Province
Texas
ZIP/Postal Code
76508
Country
United States
Facility Name
Tyler Research Institute, LLC /ID# 169146
City
Tyler
State/Province
Texas
ZIP/Postal Code
75701-4464
Country
United States
Facility Name
Gastro Health & Nutrition - Victoria /ID# 167761
City
Victoria
State/Province
Texas
ZIP/Postal Code
77904
Country
United States
Facility Name
HP Clinical Research /ID# 163939
City
Bountiful
State/Province
Utah
ZIP/Postal Code
84010
Country
United States
Facility Name
Advanced Research Institute /ID# 162624
City
Ogden
State/Province
Utah
ZIP/Postal Code
84403
Country
United States
Facility Name
Utah Gastroenternology - St. Mark's Office /ID# 163101
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84124
Country
United States
Facility Name
Velocity Clinical Research - Salt Lake City /ID# 163181
City
West Jordan
State/Province
Utah
ZIP/Postal Code
84088
Country
United States
Facility Name
Ctr for Gastrointestinal Healt /ID# 153360
City
Franklin
State/Province
Virginia
ZIP/Postal Code
23851
Country
United States
Facility Name
Emeritas Research Group, LLC /ID# 150258
City
Leesburg
State/Province
Virginia
ZIP/Postal Code
20176
Country
United States
Facility Name
Washington Gastroenterology /ID# 163629
City
Bellevue
State/Province
Washington
ZIP/Postal Code
98004
Country
United States
Facility Name
Virginia Mason Medical Center /ID# 153026
City
Seattle
State/Province
Washington
ZIP/Postal Code
98101
Country
United States
Facility Name
The Polyclinic /ID# 164369
City
Seattle
State/Province
Washington
ZIP/Postal Code
98122-4201
Country
United States
Facility Name
The Vancouver Clinic, INC. PS /ID# 162333
City
Vancouver
State/Province
Washington
ZIP/Postal Code
98664
Country
United States
Facility Name
Aurora Medical Center - Grafto /ID# 151717
City
Grafton
State/Province
Wisconsin
ZIP/Postal Code
53024
Country
United States
Facility Name
Wisconsin Center for Advanced Research, a division of GI Associates, LLC /ID# 151838
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53215
Country
United States
Facility Name
Medical College of Wisconsin /ID# 151843
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226-3522
Country
United States
Facility Name
Cardio Alem /ID# 211280
City
San Isidro
State/Province
Buenos Aires
ZIP/Postal Code
1642
Country
Argentina
Facility Name
Gedyt /ID# 210015
City
Ciudad Autonoma de Buenos Aire
State/Province
Ciuadad Autonoma De Buenos Aires
ZIP/Postal Code
1115
Country
Argentina
Facility Name
Mautalen Salud e Investigacion /ID# 171173
City
Ciudad Autonoma de Buenos Aire
State/Province
Ciuadad Autonoma De Buenos Aires
ZIP/Postal Code
1128
Country
Argentina
Facility Name
Hospital Britanico de Buenos Aires /ID# 209495
City
Ciudad Autonoma de Buenos Aire
State/Province
Ciuadad Autonoma De Buenos Aires
ZIP/Postal Code
1280
Country
Argentina
Facility Name
Sanatorio 9 de Julio /ID# 150189
City
San Miguel de Tucuman
State/Province
Tucuman
ZIP/Postal Code
4000
Country
Argentina
Facility Name
Hospital Privado Univesitario /ID# 164185
City
Cordoba
ZIP/Postal Code
5016
Country
Argentina
Facility Name
Macquarie University Hospital /ID# 211951
City
Macquarie University
State/Province
New South Wales
ZIP/Postal Code
2109
Country
Australia
Facility Name
Mater Misericordiae Limited /ID# 212685
City
South Brisbane
State/Province
Queensland
ZIP/Postal Code
4101
Country
Australia
Facility Name
Griffith University /ID# 211952
City
Southport
State/Province
Queensland
ZIP/Postal Code
4222
Country
Australia
Facility Name
Monash Medical Centre /ID# 150206
City
Clayton
State/Province
Victoria
ZIP/Postal Code
3168
Country
Australia
Facility Name
St Vincent's Hospital Melbourne /ID# 152472
City
Fitzroy Melbourne
State/Province
Victoria
ZIP/Postal Code
3065
Country
Australia
Facility Name
Fiona Stanley Hospital /ID# 211640
City
Murdoch
State/Province
Western Australia
ZIP/Postal Code
6150
Country
Australia
Facility Name
Ordensklinikum Linz GmbH Barmherzige Schwestern /ID# 150305
City
Linz
State/Province
Oberoesterreich
ZIP/Postal Code
4010
Country
Austria
Facility Name
Klinik Landstrasse /ID# 162866
City
Vienna
State/Province
Wien
ZIP/Postal Code
1030
Country
Austria
Facility Name
Medizinische Universitaet Wien /ID# 150614
City
Vienna
State/Province
Wien
ZIP/Postal Code
1090
Country
Austria
Facility Name
Landeskrankenhaus Salzburg-Universitätsklinikum der PMU (LKH) /ID# 150306
City
Salzburg
ZIP/Postal Code
5020
Country
Austria
Facility Name
Vitebsk Regional Advanced Clin /ID# 169612
City
Витебск
ZIP/Postal Code
210001
Country
Belarus
Facility Name
Universitair Ziekenhuis Leuven /ID# 150332
City
Leuven
State/Province
Vlaams-Brabant
ZIP/Postal Code
3000
Country
Belgium
Facility Name
AZ Maria Middelares /ID# 150331
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
AZ-Delta /ID# 150330
City
Roeselare
ZIP/Postal Code
8800
Country
Belgium
Facility Name
University Clinical Centre of the Republic of Srpska /ID# 150209
City
Banja Luka
State/Province
Republika Srpska
ZIP/Postal Code
78000
Country
Bosnia and Herzegovina
Facility Name
University Clinical Centre of the Republic of Srpska /ID# 150706
City
Banja Luka
State/Province
Republika Srpska
ZIP/Postal Code
78000
Country
Bosnia and Herzegovina
Facility Name
University Clinical Center Tuzla /ID# 150211
City
Tuzla
State/Province
Tuzlanski
ZIP/Postal Code
75000
Country
Bosnia and Herzegovina
Facility Name
University Clinical Hospital Mostar /ID# 150705
City
Mostar
ZIP/Postal Code
88000
Country
Bosnia and Herzegovina
Facility Name
Clinical Center University of Sarajevo /ID# 150208
City
Sarajevo
ZIP/Postal Code
71000
Country
Bosnia and Herzegovina
Facility Name
Instituto Goiano de Gastroenterologia e Endoscopia Digestiva /ID# 153742
City
Goiânia
State/Province
Goias
ZIP/Postal Code
74535-170
Country
Brazil
Facility Name
Hospital Nossa Senhora das Graças /ID# 152480
City
Curitiba
State/Province
Parana
ZIP/Postal Code
80810-040
Country
Brazil
Facility Name
Hospital de Clinicas de Porto Alegre /ID# 153743
City
Porto Alegre
State/Province
Rio Grande Do Sul
ZIP/Postal Code
90035-903
Country
Brazil
Facility Name
Upeclin Fmb - Unesp /Id# 152485
City
Botucatu
State/Province
Sao Paulo
ZIP/Postal Code
18618-686
Country
Brazil
Facility Name
Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto - USP /ID# 152484
City
Ribeirão Preto
State/Province
Sao Paulo
ZIP/Postal Code
14051-140
Country
Brazil
Facility Name
Faculdade de Medicina do ABC /ID# 152481
City
Santo André
State/Province
Sao Paulo
ZIP/Postal Code
09060-870
Country
Brazil
Facility Name
Kaiser Clinica e Hospital Dia /ID# 152483
City
Sao Jose Do Rio Preto
State/Province
Sao Paulo
ZIP/Postal Code
15015-110
Country
Brazil
Facility Name
University of Calgary /ID# 151821
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4Z6
Country
Canada
Facility Name
Allen Whey Khye Lim Professional Corporation /ID# 211168
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T5R 1W2
Country
Canada
Facility Name
University of Alberta - Zeidler Ledcor Centre /ID# 151100
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2X8
Country
Canada
Facility Name
Covenant Health /ID# 158930
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6K 4B2
Country
Canada
Facility Name
Okanagan Clinical Trials /ID# 153178
City
Kelowna
State/Province
British Columbia
ZIP/Postal Code
V1Y 1Z9
Country
Canada
Facility Name
Percuro Clinical Research, Ltd /ID# 150367
City
Victoria
State/Province
British Columbia
ZIP/Postal Code
V8V 3M9
Country
Canada
Facility Name
Hamilton Health Sciences - McMaster University Medical Centre /ID# 150365
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8S 4K1
Country
Canada
Facility Name
Ottawa Hospital Research Institute /ID# 151820
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 8L6
Country
Canada
Facility Name
Medicor Research Inc /ID# 151101
City
Sudbury
State/Province
Ontario
ZIP/Postal Code
P3A 1W8
Country
Canada
Facility Name
Toronto Digestive Disease Asso /ID# 150363
City
Vaughan
State/Province
Ontario
ZIP/Postal Code
L4L 4Y7
Country
Canada
Facility Name
CISSS de la Monteregie /ID# 159215
City
Greenfield Park
State/Province
Quebec
ZIP/Postal Code
J4V 2H1
Country
Canada
Facility Name
CISSS de Chaudière-Appalaches, Hôpital Hotel-Dieu de Lévis /ID# 150361
City
Levis
State/Province
Quebec
ZIP/Postal Code
G6V 3Z1
Country
Canada
Facility Name
Recherche GCP Research /ID# 151822
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H1M 1B1
Country
Canada
Facility Name
Centre Hospitalier de l'Universite de Montreal - CRCHUM /ID# 167169
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2X 0A9
Country
Canada
Facility Name
Montreal General Hospital - McGill University Health Centre /ID# 170012
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H3G 1A4
Country
Canada
Facility Name
CIUSSS de l'Estrie - CHUS /ID# 150366
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1G 2E8
Country
Canada
Facility Name
Research Group /ID# 203176
City
Santiago
State/Province
Region Metropolitana De Santiago
ZIP/Postal Code
2540364
Country
Chile
Facility Name
M y F Estudios Clínicos /ID# 200107
City
Santiago
State/Province
Region Metropolitana Santiago
ZIP/Postal Code
7750495
Country
Chile
Facility Name
Centro de Investigaciones Clínicas Viña del Mar /ID# 150212
City
Viña del Mar
State/Province
Valparaíso
ZIP/Postal Code
2540488
Country
Chile
Facility Name
Hospital Guillermo Grant Benavente de Concepción /ID# 212424
City
Concepción
ZIP/Postal Code
4070038
Country
Chile
Facility Name
CTR Estudios Clinicos /ID# 200110
City
Providencia
ZIP/Postal Code
7500571
Country
Chile
Facility Name
Hospital Clinico Universidad De Los Andes /ID# 207422
City
Santiago
ZIP/Postal Code
7501504
Country
Chile
Facility Name
The First Affiliated Hospital, Sun Yat-sen University /ID# 150455
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510080
Country
China
Facility Name
The Sixth Affiliated Hosp Sun /ID# 150456
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510655
Country
China
Facility Name
Affiliated Taihe Hospital of Hubei University of Medicine /ID# 216405
City
Shiyan
State/Province
Hubei
ZIP/Postal Code
442700
Country
China
Facility Name
Tongji Hospital Tongji Medical College Huazhong University of Science and Techno /ID# 167088
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430022
Country
China
Facility Name
Union Hospital Tongji Medical College Huazhong University of Science and Technol /ID# 167078
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430022
Country
China
Facility Name
The First Affiliated Hospital of Nanchang University /ID# 211750
City
Nanchang
State/Province
Jiangxi
ZIP/Postal Code
330006
Country
China
Facility Name
The First Hospital of Jilin University /ID# 209986
City
Changchun
State/Province
Jilin
ZIP/Postal Code
130021
Country
China
Facility Name
Ruijin Hospital, Shanghai Jiaotong University School of Medicine /ID# 150461
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200065
Country
China
Facility Name
Shanghai Tenth People's Hospital /ID# 150460
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200072
Country
China
Facility Name
Renji Hospital, Shanghai Jiaotong University School of Medicine /ID# 165815
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200127
Country
China
Facility Name
The second Affiliated hospital of Zhejiang University school of Medicine /ID# 165807
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310009
Country
China
Facility Name
Sir Run Run Shaw Hospital,Meical School Zhejiang University /ID# 150454
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310018
Country
China
Facility Name
Xiangya Hospital Central South University /ID# 167229
City
Changsha
ZIP/Postal Code
410008
Country
China
Facility Name
West China Hospital, Sichuan University /ID# 167040
City
Chengdu
ZIP/Postal Code
610041
Country
China
Facility Name
Shengjing Hospital of China Medical University /ID# 166920
City
Shenyang
ZIP/Postal Code
110022
Country
China
Facility Name
Tianjin Medical University General Hospital /ID# 170604
City
Tianjin
ZIP/Postal Code
300052
Country
China
Facility Name
Instituto Medico de Alta Tecnologia Oncomédica S.A /ID# 207042
City
Monteria
State/Province
Cordoba
ZIP/Postal Code
230002
Country
Colombia
Facility Name
Corporacion Hospitalaria Juan Cuidad Sede Denominada Hospital Universitario Mayo /ID# 151564
City
Bogota DC
State/Province
Cundinamarca
ZIP/Postal Code
111221
Country
Colombia
Facility Name
Hospital Universitario de San /ID# 155387
City
Medellin
Country
Colombia
Facility Name
Clinical Hospital Dubrava /ID# 150213
City
Zagreb
State/Province
Grad Zagreb
ZIP/Postal Code
10000
Country
Croatia
Facility Name
Klinicki bolnicki centar Zagreb /ID# 150225
City
Zagreb
State/Province
Grad Zagreb
ZIP/Postal Code
10000
Country
Croatia
Facility Name
Klinicki bolnicki centar Zagreb /ID# 150709
City
Zagreb
State/Province
Grad Zagreb
ZIP/Postal Code
10000
Country
Croatia
Facility Name
Poliklinika Solmed /ID# 211483
City
Zagreb
State/Province
Grad Zagreb
ZIP/Postal Code
10000
Country
Croatia
Facility Name
Duplicate_Klinicki bolnicki centar Osijek /ID# 150216
City
Osijek
State/Province
Osjecko-baranjska Zupanija
ZIP/Postal Code
31000
Country
Croatia
Facility Name
Klinicki bolnicki centar Rijeka /ID# 150708
City
Rijeka
State/Province
Primorsko-goranska Zupanija
ZIP/Postal Code
51000
Country
Croatia
Facility Name
Klinicki bolnicki centar Split /ID# 213988
City
Split
State/Province
Splitsko-dalmatinska Zupanija
ZIP/Postal Code
21000
Country
Croatia
Facility Name
Zadar General Hospital /ID# 150221
City
Zadar
ZIP/Postal Code
23000
Country
Croatia
Facility Name
Hepato-Gastroenterologie HK, s.r.o. /ID# 150912
City
Hradec Kralove
ZIP/Postal Code
500 12
Country
Czechia
Facility Name
CTCenter MaVe s.r.o. /ID# 150904
City
Olomouc
ZIP/Postal Code
779 00
Country
Czechia
Facility Name
ARTROSCAN s.r.o. /ID# 150401
City
Ostrava
ZIP/Postal Code
722 00
Country
Czechia
Facility Name
Nemocnice Pardubickeho kraje, a.s. /ID# 213539
City
Pardubice
ZIP/Postal Code
530 03
Country
Czechia
Facility Name
Nemocnice Milosrdnych sester sv. Karla Boromejskeho v Praze /ID# 216221
City
Praha
ZIP/Postal Code
118 33
Country
Czechia
Facility Name
Axon Clinical, s.r.o. /ID# 152479
City
Praha
ZIP/Postal Code
140 00
Country
Czechia
Facility Name
ISCARE a.s. /ID# 209278
City
Praha
ZIP/Postal Code
190 00
Country
Czechia
Facility Name
East Tallinn Central Hospital /ID# 150417
City
Kesklinna Linnaosa
State/Province
Harjumaa
ZIP/Postal Code
10138
Country
Estonia
Facility Name
North Estonia Medical Centre /ID# 160870
City
Mustamäe Linnaosa
State/Province
Harjumaa
ZIP/Postal Code
13419
Country
Estonia
Facility Name
Tartu University Hospital /ID# 150418
City
Tartu Linn
State/Province
Tartumaa
ZIP/Postal Code
50406
Country
Estonia
Facility Name
West Tallinn Central Hospital /ID# 150419
City
Tallinn
ZIP/Postal Code
10617
Country
Estonia
Facility Name
Tampere University Hospital /ID# 150114
City
Tampere
State/Province
Pirkanmaa
ZIP/Postal Code
33520
Country
Finland
Facility Name
Duplicate_Helsinki Univ Central Hospital /ID# 150407
City
Helsinki
ZIP/Postal Code
00290
Country
Finland
Facility Name
Keski-Suomen Sairaala Nova /ID# 155666
City
Jyvaskyla
ZIP/Postal Code
40620
Country
Finland
Facility Name
Laakarikeskus Ikioma /ID# 150121
City
Mikkeli
ZIP/Postal Code
50100
Country
Finland
Facility Name
Turku University Hospital /ID# 168301
City
Turku
ZIP/Postal Code
20520
Country
Finland
Facility Name
Chu de Nice-Hopital L'Archet Ii /Id# 152606
City
Nice
State/Province
Alpes-Maritimes
ZIP/Postal Code
06200
Country
France
Facility Name
HCL - Hôpital Lyon Sud /ID# 152539
City
Pierre Benite CEDEX
State/Province
Auvergne-Rhone-Alpes
ZIP/Postal Code
69495
Country
France
Facility Name
CHU Hopital Nord /ID# 163508
City
Marseille
State/Province
Bouches-du-Rhone
ZIP/Postal Code
13915
Country
France
Facility Name
CHRU Lille - Hopital Claude Huriez /ID# 152607
City
Lille
State/Province
Hauts-de-France
ZIP/Postal Code
59037
Country
France
Facility Name
CHU Montpellier - Hôpital Saint Eloi /ID# 200006
City
Montpellier Cedex 5
State/Province
Herault
ZIP/Postal Code
34295
Country
France
Facility Name
CHU Amiens-Picardie Site Sud /ID# 163456
City
Amiens CEDEX 1
State/Province
Somme
ZIP/Postal Code
80054
Country
France
Facility Name
CHD Vendée- La Roche-sur-Yon - Les Oudairies /ID# 154452
City
La Roche Sur Yon
ZIP/Postal Code
85000
Country
France
Facility Name
CHU de Saint-Etienne, Hopital Nord /ID# 154453
City
SAINT-ETIENNE Cedex 1
ZIP/Postal Code
42270
Country
France
Facility Name
Universitatsklinikum Mannheim /ID# 150173
City
Mannheim
State/Province
Baden-Wuerttemberg
ZIP/Postal Code
68167
Country
Germany
Facility Name
Universitaetsklinimum Tuebingen /ID# 150767
City
Tubingen
State/Province
Baden-Wuerttemberg
ZIP/Postal Code
72076
Country
Germany
Facility Name
Universitatsklinikum Munster /ID# 150158
City
Munster
State/Province
Niedersachsen
ZIP/Postal Code
48149
Country
Germany
Facility Name
Gastroenterologische Gemeinschaftspraxis Herne /ID# 214574
City
Herne
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
44623
Country
Germany
Facility Name
Zentrum für Gastroenterologie Saar MVZ GmbH /ID# 215811
City
Saarbrücken
State/Province
Saarland
ZIP/Postal Code
66111
Country
Germany
Facility Name
Universitaetsklinikum Schleswig-Holstein Campus Kiel /ID# 161981
City
Kiel
State/Province
Schleswig-Holstein
ZIP/Postal Code
24105
Country
Germany
Facility Name
MVZ fuer Gastroenterlogie am Bayerischen Platz /ID# 150766
City
Berlin
ZIP/Postal Code
10825
Country
Germany
Facility Name
Agaplesion Markus Krankenhaus /ID# 161982
City
Frankfurt am Main
ZIP/Postal Code
60431
Country
Germany
Facility Name
Medizinisches Versorgungszentrum Portal 10 /ID# 207135
City
Muenster
ZIP/Postal Code
48155
Country
Germany
Facility Name
Praxis medicum /ID# 150166
City
Wiesbaden
ZIP/Postal Code
65189
Country
Germany
Facility Name
General Hospital of Athens Laiko /ID# 208669
City
Athens
State/Province
Attiki
ZIP/Postal Code
11527
Country
Greece
Facility Name
General Hospital of Chest Diseases of Athens SOTIRIA /ID# 202100
City
Athens
State/Province
Attiki
ZIP/Postal Code
11527
Country
Greece
Facility Name
University General Hospital of Heraklion PA.G.N.I /ID# 150250
City
Heraklion
State/Province
Kriti
ZIP/Postal Code
71500
Country
Greece
Facility Name
General Hospital of Athens Evaggelismos and Ophthalmiatrio of Athens Polyclinic /ID# 150309
City
Athens
ZIP/Postal Code
10676
Country
Greece
Facility Name
University General Hospital of Ioannina /ID# 164248
City
Ioannina
ZIP/Postal Code
45500
Country
Greece
Facility Name
Theageneio Anticancer Hospital /ID# 163896
City
Thessaloniki
ZIP/Postal Code
54639
Country
Greece
Facility Name
General Hospital of Thessaloniki Hippokrateio /ID# 209521
City
Thessaloniki
ZIP/Postal Code
54642
Country
Greece
Facility Name
Markusovszky Egyetemi Oktatokorhaz /ID# 150313
City
Szombathely
State/Province
Vas
ZIP/Postal Code
9700
Country
Hungary
Facility Name
Bekes Megyei Kozponti Korhaz /ID# 151572
City
Bekescsaba
ZIP/Postal Code
5600
Country
Hungary
Facility Name
Semmelweis Egyetem /ID# 150312
City
Budapest
ZIP/Postal Code
1085
Country
Hungary
Facility Name
Meditres Kft. /ID# 151521
City
Kecskemet
ZIP/Postal Code
6000
Country
Hungary
Facility Name
Soproni Erzsebet Oktato Korhaz es Rehabilitacios Intezet /ID# 151523
City
Sopron
ZIP/Postal Code
9400
Country
Hungary
Facility Name
Mentahaz Maganorvosi Kozpont /ID# 205884
City
Szekesfehervar
ZIP/Postal Code
8000
Country
Hungary
Facility Name
Beaumont Hospital /ID# 150321
City
Beaumont
State/Province
Dublin
ZIP/Postal Code
D09 XR63
Country
Ireland
Facility Name
St James Hospital /ID# 150320
City
Dublin 8
State/Province
Dublin
ZIP/Postal Code
D08 NHY1
Country
Ireland
Facility Name
St Vincent's University Hospital /ID# 150318
City
Elm Park
State/Province
Dublin
ZIP/Postal Code
D04 T6F4
Country
Ireland
Facility Name
Mercy University Hospital /ID# 151529
City
Cork
ZIP/Postal Code
T12 WE28
Country
Ireland
Facility Name
University Hospital Galway /ID# 150319
City
Galway
ZIP/Postal Code
H91 YR71
Country
Ireland
Facility Name
Soroka University Medical Center /ID# 156561
City
Be'er Sheva
State/Province
HaDarom
ZIP/Postal Code
8443901
Country
Israel
Facility Name
Rambam Health Care Campus /ID# 150325
City
Haifa
ZIP/Postal Code
3109601
Country
Israel
Facility Name
Shaare Zedek Medical Center /ID# 161677
City
Jerusalem
ZIP/Postal Code
91031
Country
Israel
Facility Name
Hadassah Medical Center-Hebrew University /ID# 165118
City
Jerusalem
ZIP/Postal Code
91120
Country
Israel
Facility Name
Azienda Ospedaliera San Camillo Forlanini /ID# 151360
City
Rome
State/Province
Lazio
ZIP/Postal Code
00152
Country
Italy
Facility Name
ASST Rhodense/Presidio Ospedaliero di Rho /ID# 216610
City
Rho
State/Province
Milano
ZIP/Postal Code
20017
Country
Italy
Facility Name
Istituto Clinico Humanitas /ID# 151361
City
Rozzano
State/Province
Milano
ZIP/Postal Code
20089
Country
Italy
Facility Name
Fondazione PTV Policlinico Tor Vergata /ID# 150338
City
Rome
State/Province
Roma
ZIP/Postal Code
00133
Country
Italy
Facility Name
Presidio Columbus-Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Un /ID# 150333
City
Rome
State/Province
Roma
ZIP/Postal Code
00168
Country
Italy
Facility Name
IRCCS Ospedale Sacro Cuore Don Calabria /ID# 201725
City
Negrar
State/Province
Verona
ZIP/Postal Code
37024
Country
Italy
Facility Name
IRCCS Azienda Ospedaliero-Universitaria di Bologna /ID# 150337
City
Bologna
ZIP/Postal Code
40138
Country
Italy
Facility Name
ASST Fatebenefratelli Sacco - Ospedale Fatebenefratelli e Oftalmico /ID# 150602
City
Milano
ZIP/Postal Code
20121
Country
Italy
Facility Name
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico /ID# 150334
City
Milan
ZIP/Postal Code
20122
Country
Italy
Facility Name
A.O. Ospedali Riuniti Villa Sofia - Cervello /ID# 150253
City
Palermo
ZIP/Postal Code
90146
Country
Italy
Facility Name
Aichi Medical University Hospital /ID# 151993
City
Nagakute-shi
State/Province
Aichi
ZIP/Postal Code
480-1195
Country
Japan
Facility Name
Nagoya City University Hospital /ID# 151950
City
Nagoya shi
State/Province
Aichi
ZIP/Postal Code
467-8602
Country
Japan
Facility Name
Nagoya University Hospital /ID# 152709
City
Nagoyashi
State/Province
Aichi
ZIP/Postal Code
4668560
Country
Japan
Facility Name
Toyohashi Municipal Hospital /ID# 171457
City
Toyohashi-shi
State/Province
Aichi
ZIP/Postal Code
441-8570
Country
Japan
Facility Name
Ieda Hospital /ID# 157781
City
Toyota-shi
State/Province
Aichi
ZIP/Postal Code
470-1219
Country
Japan
Facility Name
Hirosaki National Hospital /ID# 152763
City
Hirosaki-shi
State/Province
Aomori
ZIP/Postal Code
036-8545
Country
Japan
Facility Name
Tokatsu Tsujinaka Hospital /ID# 214962
City
Abiko-shi
State/Province
Chiba
ZIP/Postal Code
270-1168
Country
Japan
Facility Name
Tsujinaka Hospital Kashiwanoha /ID# 209130
City
Kashiwa-shi
State/Province
Chiba
ZIP/Postal Code
277-0871
Country
Japan
Facility Name
Toho University Sakura Medical Center /ID# 151936
City
Sakura-shi
State/Province
Chiba
ZIP/Postal Code
285-8741
Country
Japan
Facility Name
Juntendo University Urayasu Hospital /ID# 208781
City
Urayasu-shi
State/Province
Chiba
ZIP/Postal Code
279-0021
Country
Japan
Facility Name
Fukui Prefectural Hospital /ID# 210448
City
Fukui-shi
State/Province
Fukui
ZIP/Postal Code
910-8526
Country
Japan
Facility Name
Fukuoka University Chikushi Hospital /ID# 152628
City
Chikushino-shi
State/Province
Fukuoka
ZIP/Postal Code
818-8502
Country
Japan
Facility Name
Saiseikai Fukuoka Genaral Hospital /ID# 209479
City
Fukuoka-shi
State/Province
Fukuoka
ZIP/Postal Code
810-0001
Country
Japan
Facility Name
Kyushu University Hospital /ID# 152526
City
Fukuoka-shi
State/Province
Fukuoka
ZIP/Postal Code
812-8582
Country
Japan
Facility Name
Kitakyushu Municipal Med Ctr /ID# 152588
City
Kitakyushu
State/Province
Fukuoka
ZIP/Postal Code
8020077
Country
Japan
Facility Name
Kurume University Hospital /ID# 151976
City
Kurume-shi
State/Province
Fukuoka
ZIP/Postal Code
830-0011
Country
Japan
Facility Name
Ogaki Municipal Hospital /ID# 208225
City
Ogaki-shi
State/Province
Gifu
ZIP/Postal Code
503-8502
Country
Japan
Facility Name
NHO Fukuyama Medical Center /ID# 206293
City
Fukuyama-shi
State/Province
Hiroshima
ZIP/Postal Code
720-8520
Country
Japan
Facility Name
Hiroshima University Hospital /ID# 151951
City
Hiroshima-shi
State/Province
Hiroshima
ZIP/Postal Code
734-8551
Country
Japan
Facility Name
Asahikawa Medical University Hospital /ID# 170289
City
Asahikawa-shi
State/Province
Hokkaido
ZIP/Postal Code
078-8510
Country
Japan
Facility Name
Obihiro kosei Hospital /ID# 210412
City
Obihiro-shi
State/Province
Hokkaido
ZIP/Postal Code
080-0024
Country
Japan
Facility Name
Sapporo Tokushukai Hospital /ID# 209397
City
Sapporo-shi
State/Province
Hokkaido
ZIP/Postal Code
004-0041
Country
Japan
Facility Name
Hokkaido P.W.F.A.C. Sapporo-Kosei General Hospital /ID# 151506
City
Sapporo-shi
State/Province
Hokkaido
ZIP/Postal Code
060-0033
Country
Japan
Facility Name
Sapporo Medical University Hospital /ID# 206492
City
Sapporo-shi
State/Province
Hokkaido
ZIP/Postal Code
060-8543
Country
Japan
Facility Name
Sapporo Higashi Tokushukai Hospital /ID# 208487
City
Sapporo-shi
State/Province
Hokkaido
ZIP/Postal Code
065-0033
Country
Japan
Facility Name
Aoyama Clinic /ID# 152049
City
Kobe-shi
State/Province
Hyogo
ZIP/Postal Code
650-0015
Country
Japan
Facility Name
Hyogo College of Medicine College Hospital /Id# 152434
City
Nishinomiya-shi
State/Province
Hyogo
ZIP/Postal Code
663-8501
Country
Japan
Facility Name
National Hospital Organization Mito Medical Center /ID# 152631
City
Higashi Ibaraki-gun
State/Province
Ibaraki
ZIP/Postal Code
311-3193
Country
Japan
Facility Name
Kanazawa University Hospital /ID# 205099
City
Kanazawa-shi
State/Province
Ishikawa
ZIP/Postal Code
920-8641
Country
Japan
Facility Name
Iwate Medical University Uchimaru Medical Center /ID# 203411
City
Morioka-shi
State/Province
Iwate
ZIP/Postal Code
020-8505
Country
Japan
Facility Name
Imamura General Hospital /ID# 227134
City
Kagoshima-shi
State/Province
Kagoshima
ZIP/Postal Code
890-0064
Country
Japan
Facility Name
Idzuro Imamura Hospital /ID# 206024
City
Kagoshima-shi
State/Province
Kagoshima
ZIP/Postal Code
892-0824
Country
Japan
Facility Name
Sameshima Hospital /ID# 206672
City
Kagoshima-shi
State/Province
Kagoshima
ZIP/Postal Code
892-0846
Country
Japan
Facility Name
St. Marianna University School of Medicine Hospital /ID# 208654
City
Kawasaki-shi
State/Province
Kanagawa
ZIP/Postal Code
216-8511
Country
Japan
Facility Name
Yokohama City University Medical Center /ID# 169899
City
Yokohama shi
State/Province
Kanagawa
ZIP/Postal Code
232-0024
Country
Japan
Facility Name
Showa University Fujigaoka Hospital /ID# 208222
City
Yokohama-shi
State/Province
Kanagawa
ZIP/Postal Code
227-8501
Country
Japan
Facility Name
Japanese Red Cross Kyoto Daiichi Hosital /ID# 152359
City
Kyoto-shi
State/Province
Kyoto
ZIP/Postal Code
605-0981
Country
Japan
Facility Name
Kyoto University Hospital /ID# 211758
City
Kyoto-shi
State/Province
Kyoto
ZIP/Postal Code
606-8507
Country
Japan
Facility Name
Mie University Hospital /ID# 205362
City
Tsu-shi
State/Province
Mie
ZIP/Postal Code
514-8507
Country
Japan
Facility Name
Yokkaichi Hazu Medical Center /ID# 214347
City
Yokkaichi-shi
State/Province
Mie
ZIP/Postal Code
510-0016
Country
Japan
Facility Name
National Hospital Organization Sendai Medical Center /ID# 209527
City
Sendai-shi
State/Province
Miyagi
ZIP/Postal Code
983-8520
Country
Japan
Facility Name
NHO Nagasaki Medical Center /ID# 209531
City
Omura-shi
State/Province
Nagasaki
ZIP/Postal Code
856-8562
Country
Japan
Facility Name
Kenseikai Dongo Hospital /ID# 208100
City
Yamatotakada-shi
State/Province
Nara
ZIP/Postal Code
635-0022
Country
Japan
Facility Name
Saiseikai Niigata Hospital /ID# 209916
City
Niigata-shi
State/Province
Niigata
ZIP/Postal Code
950-1104
Country
Japan
Facility Name
Niigata University Medical & Dental Hospital /ID# 218048
City
Niigata-shi
State/Province
Niigata
ZIP/Postal Code
951-8520
Country
Japan
Facility Name
Ishida Clinic of IBD and Gastroenterology /ID# 210117
City
Oita-shi
State/Province
Oita
ZIP/Postal Code
870-0823
Country
Japan
Facility Name
Chikuba Hospital for Proctological and Gastrointestinal Diseases /ID# 157821
City
Kurashiki-shi
State/Province
Okayama
ZIP/Postal Code
710-0142
Country
Japan
Facility Name
Okayama University Hospital /ID# 217923
City
Okayama-shi
State/Province
Okayama
ZIP/Postal Code
700-8558
Country
Japan
Facility Name
Kinshukai Infusion Clinic /ID# 207864
City
Osaka-shi
State/Province
Osaka
ZIP/Postal Code
530-0011
Country
Japan
Facility Name
Kitano Hospital /ID# 210395
City
Osaka-shi
State/Province
Osaka
ZIP/Postal Code
530-8480
Country
Japan
Facility Name
Osaka City General Hospital /ID# 152704
City
Osaka-shi
State/Province
Osaka
ZIP/Postal Code
534-0021
Country
Japan
Facility Name
Japanese Red Cross Osaka Hospital /ID# 209476
City
Osaka-shi
State/Province
Osaka
ZIP/Postal Code
543-8555
Country
Japan
Facility Name
Osaka City University Hospital /ID# 152682
City
Osaka-shi
State/Province
Osaka
ZIP/Postal Code
545-8586
Country
Japan
Facility Name
Toyonaka Municipal Hospital /ID# 217079
City
Toyonaka-shi
State/Province
Osaka
ZIP/Postal Code
560-0055
Country
Japan
Facility Name
Saga University Hospital /ID# 209268
City
Saga-shi
State/Province
Saga
ZIP/Postal Code
849-8501
Country
Japan
Facility Name
Saitama Medical Center /ID# 152031
City
Kawagoe-shi
State/Province
Saitama
ZIP/Postal Code
350-8550
Country
Japan
Facility Name
Tokitokai Tokito clinic /ID# 152677
City
Saitama-shi
State/Province
Saitama
ZIP/Postal Code
336-0963
Country
Japan
Facility Name
National Hospital Organization Higashi-Ohmi General Medical Center /ID# 210709
City
Higashi-ohmi-shi
State/Province
Shiga
ZIP/Postal Code
527-8505
Country
Japan
Facility Name
Shimane University Hospital /ID# 208899
City
Izumo-shi
State/Province
Shimane
ZIP/Postal Code
693-8501
Country
Japan
Facility Name
Hamamatsu University Hospital /ID# 205708
City
Hamamatsu-shi
State/Province
Shizuoka
ZIP/Postal Code
431-3192
Country
Japan
Facility Name
NHO Shizuoka Medical Center /ID# 163572
City
Sunto-gun
State/Province
Shizuoka
ZIP/Postal Code
411-8611
Country
Japan
Facility Name
Tokyo Medical And Dental University Hospital /ID# 152016
City
Bunkyo-ku
State/Province
Tokyo
ZIP/Postal Code
113-8519
Country
Japan
Facility Name
St.Luke's International Hospital /ID# 208074
City
Chuo-ku
State/Province
Tokyo
ZIP/Postal Code
104-8560
Country
Japan
Facility Name
Tokai University Hachioji Hospital /ID# 152587
City
Hachioji-shi
State/Province
Tokyo
ZIP/Postal Code
192-0032
Country
Japan
Facility Name
Teikyo University Hospital /ID# 208897
City
Itabashi-ku
State/Province
Tokyo
ZIP/Postal Code
173-8606
Country
Japan
Facility Name
Kitasato University Kitasato Institute Hospital /ID# 152686
City
Minato-ku
State/Province
Tokyo
ZIP/Postal Code
108-8642
Country
Japan
Facility Name
Kyorin University Hospital /ID# 153194
City
Mitaka-shi
State/Province
Tokyo
ZIP/Postal Code
181-8611
Country
Japan
Facility Name
Center Hospital of the National Center for Global Health and Medicine /ID# 209267
City
Shinjuku-ku
State/Province
Tokyo
ZIP/Postal Code
162-8655
Country
Japan
Facility Name
Tokyo Women's Medical University Hospital /ID# 205977
City
Shinjuku-ku
State/Province
Tokyo
ZIP/Postal Code
162-8666
Country
Japan
Facility Name
Yamagata University Hospital /ID# 171454
City
Yamagata-shi
State/Province
Yamagata
ZIP/Postal Code
990-9585
Country
Japan
Facility Name
Tokuyama Central Hospital /ID# 216993
City
Shunan-shi
State/Province
Yamaguchi
ZIP/Postal Code
745-8522
Country
Japan
Facility Name
Yamanashi Prefectural Central Hospital /ID# 151908
City
Kofu-shi
State/Province
Yamanashi
ZIP/Postal Code
400-8506
Country
Japan
Facility Name
Shoyukai Fujita Gastroenterological Hospital /ID# 216492
City
Takatsuki-shi
ZIP/Postal Code
569-0086
Country
Japan
Facility Name
Hayang University GuriHospital /ID# 150344
City
Guri
State/Province
Gyeonggido
ZIP/Postal Code
11923
Country
Korea, Republic of
Facility Name
CHA University Bundang Medical Center /ID# 159479
City
Seongnam si
State/Province
Gyeonggido
ZIP/Postal Code
13496
Country
Korea, Republic of
Facility Name
The Catholic University of Korea, ST. Vincent's Hospital /ID# 150347
City
Suwon
State/Province
Gyeonggido
ZIP/Postal Code
16247
Country
Korea, Republic of
Facility Name
Kangbuk Samsung Hospital /ID# 150348
City
Seoul
State/Province
Seoul Teugbyeolsi
ZIP/Postal Code
03181
Country
Korea, Republic of
Facility Name
Yonsei University Health System Severance Hospital /ID# 159478
City
Seoul
State/Province
Seoul Teugbyeolsi
ZIP/Postal Code
03722
Country
Korea, Republic of
Facility Name
Dong-A University Hospital /ID# 159480
City
Busan
ZIP/Postal Code
49201
Country
Korea, Republic of
Facility Name
Pusan National University Hospital /ID# 159481
City
Busan
ZIP/Postal Code
49241
Country
Korea, Republic of
Facility Name
Yeungnam University Medical Center /ID# 150345
City
Daegu
ZIP/Postal Code
42415
Country
Korea, Republic of
Facility Name
Asan Medical Center /ID# 150900
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Facility Name
Samsung Medical Center /ID# 150346
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
Facility Name
Pauls Stradins Clinical University Hospital /ID# 151409
City
Riga
ZIP/Postal Code
1002
Country
Latvia
Facility Name
Riga East Clinical University Hospital /ID# 150354
City
Riga
ZIP/Postal Code
LV-1079
Country
Latvia
Facility Name
Hospital of Lithuanian University of Health Sciences Kaunas Clinics /ID# 150357
City
Kaunas
ZIP/Postal Code
50161
Country
Lithuania
Facility Name
Klaipeda Seamens Hospital /ID# 154319
City
Klaipeda
ZIP/Postal Code
92288
Country
Lithuania
Facility Name
Klaipeda University Hospital /ID# 158862
City
Klaipeda
ZIP/Postal Code
92288
Country
Lithuania
Facility Name
Vilnius University Hospital /ID# 154318
City
Vilnius
ZIP/Postal Code
LT-08661
Country
Lithuania
Facility Name
Hospital Sultanah Bahiyah /ID# 151687
City
Alor Setar
State/Province
Kedah
ZIP/Postal Code
05460
Country
Malaysia
Facility Name
Universiti Kebangsaan Malaysia (UKM) Medical Centre /ID# 151689
City
Kuala Lumpur
State/Province
Selangor
ZIP/Postal Code
56000
Country
Malaysia
Facility Name
Hospital Ampang /ID# 151298
City
Ampang
ZIP/Postal Code
68000
Country
Malaysia
Facility Name
Uni Malaya MC /ID# 150359
City
Kuala Lumpur
ZIP/Postal Code
59100
Country
Malaysia
Facility Name
Morales Vargas Centro de Investigacion S.C. /ID# 211325
City
Leon
State/Province
Guanajuato
ZIP/Postal Code
37000
Country
Mexico
Facility Name
Clinica de Investigacion en Reumatologia y Obesidad S.C. /ID# 150710
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
44650
Country
Mexico
Facility Name
Centro Regiomontano de Estudios Clínicos ROMA S.C /ID# 150256
City
Monterrey
State/Province
Nuevo Leon
ZIP/Postal Code
64610
Country
Mexico
Facility Name
Radboud Universitair Medisch Centrum /ID# 151700
City
Nijmegen
State/Province
Gelderland
ZIP/Postal Code
6525 GA
Country
Netherlands
Facility Name
Erasmus Medisch Centrum /ID# 150308
City
Rotterdam
State/Province
Zuid-Holland
ZIP/Postal Code
3015 GD
Country
Netherlands
Facility Name
Academisch Medisch Centrum /ID# 150647
City
Amsterdam
ZIP/Postal Code
1105 AZ
Country
Netherlands
Facility Name
Leids Universitair Medisch Centrum /ID# 152624
City
Leiden
ZIP/Postal Code
2333 ZA
Country
Netherlands
Facility Name
Universitair Medisch Centrum Utrecht /ID# 152775
City
Utrecht
ZIP/Postal Code
3584 CX
Country
Netherlands
Facility Name
Akershus universitetssykehus /ID# 150317
City
Nordbyhagen
State/Province
Akershus
ZIP/Postal Code
1474
Country
Norway
Facility Name
Universitetssykehuset Nord-Norge /ID# 152835
City
Tromsø
State/Province
Troms
ZIP/Postal Code
9019
Country
Norway
Facility Name
Gastromed /Id# 216197
City
Torun
State/Province
Kujawsko-pomorskie
ZIP/Postal Code
87-100
Country
Poland
Facility Name
Centrum Zdrowia MDM /ID# 150351
City
Warszawa
State/Province
Mazowieckie
ZIP/Postal Code
00-635
Country
Poland
Facility Name
Centralny Szpital Kliniczny MSWiA w Warszawie /ID# 150580
City
Warszawa
State/Province
Mazowieckie
ZIP/Postal Code
02-507
Country
Poland
Facility Name
Centrum Medyczne Reuma Park /ID# 150349
City
Warszawa
State/Province
Mazowieckie
ZIP/Postal Code
02-665
Country
Poland
Facility Name
NZOZ Vivamed /ID# 216742
City
Warszawa
State/Province
Mazowieckie
ZIP/Postal Code
03-580
Country
Poland
Facility Name
Instytut Pomnik - Centrum Zdrowia Dziecka /ID# 215732
City
Warszawa
State/Province
Mazowieckie
ZIP/Postal Code
04-730
Country
Poland
Facility Name
Endoskopia Sp. z o.o. /ID# 150765
City
Sopot
State/Province
Pomorskie
ZIP/Postal Code
81-756
Country
Poland
Facility Name
Hospital da Senhora da Oliveira Guimaraes, EPE /ID# 151607
City
Guimaraes
State/Province
Braga
ZIP/Postal Code
4835-044
Country
Portugal
Facility Name
Centro Hospitalar de Entre Douro e Vouga /ID# 152335
City
Santa Maria Da Feira
State/Province
Porto
ZIP/Postal Code
4520-211
Country
Portugal
Facility Name
Unidade Local de Saúde do Alto Minho, EPE - Hospital Conde de Bertiandos /ID# 151609
City
Ponte de Lima
State/Province
Viana Do Castelo
ZIP/Postal Code
4990-041
Country
Portugal
Facility Name
Hospital Garcia de Orta, EPE /ID# 151613
City
Almada
ZIP/Postal Code
2805-267
Country
Portugal
Facility Name
CCA Braga - Hospital de Braga /ID# 151608
City
Braga
ZIP/Postal Code
4710-243
Country
Portugal
Facility Name
Centro Hospitalar Universitario Lisboa Central, EPE - Hospital dos Capuchos /ID# 151611
City
Lisboa
ZIP/Postal Code
1169-050
Country
Portugal
Facility Name
Centro Hospitalar Universitário de Lisboa Norte, EPE - Hospital de Santa Maria /ID# 151606
City
Lisboa
ZIP/Postal Code
1649-035
Country
Portugal
Facility Name
Centro Hospitalar Universitario de Sao Joao, EPE /ID# 151610
City
Porto
ZIP/Postal Code
4200-319
Country
Portugal
Facility Name
School of Medicine University of Puerto Rico-Medical Science Campus /ID# 150358
City
San Juan
ZIP/Postal Code
00935
Country
Puerto Rico
Facility Name
Immanuel Kant Baltic Federal University /ID# 200719
City
Kaliningrad
State/Province
Kaliningradskaya Oblast
ZIP/Postal Code
236016
Country
Russian Federation
Facility Name
NW State Medical Univ na Mechn /ID# 169322
City
St. Petersburg
State/Province
Leningradskaya Oblast
ZIP/Postal Code
191015
Country
Russian Federation
Facility Name
Perm Clinical Center of the Federal Medical and Biological Agency /ID# 150386
City
Perm
State/Province
Permskiy Kray
ZIP/Postal Code
614109
Country
Russian Federation
Facility Name
Medical Company Hepatolog /ID# 200197
City
Samara
State/Province
Samarskaya Oblast
ZIP/Postal Code
443063
Country
Russian Federation
Facility Name
LLC Novaya Klinika /ID# 208107
City
Pyatigorsk
State/Province
Stavropol Skiy Kray
ZIP/Postal Code
357500
Country
Russian Federation
Facility Name
Kazan State Medical University /ID# 166042
City
Kazan
State/Province
Tatarstan, Respublika
ZIP/Postal Code
420012
Country
Russian Federation
Facility Name
Olla-Med Clinic /ID# 215332
City
Moscow
ZIP/Postal Code
105554
Country
Russian Federation
Facility Name
City Clinical Hospital #24 /ID# 150395
City
Moscow
ZIP/Postal Code
127015
Country
Russian Federation
Facility Name
Republican hospital named after V.A. Baranov /ID# 206506
City
Petrozavodsk
ZIP/Postal Code
185019
Country
Russian Federation
Facility Name
Euromedservice /ID# 203800
City
Pushkin
ZIP/Postal Code
196603
Country
Russian Federation
Facility Name
Duplicate_Stavropol State Medical Univ /ID# 150387
City
Stavropol
ZIP/Postal Code
355017
Country
Russian Federation
Facility Name
Clinical Hosp Center Zvezdara /ID# 150427
City
Belgrade
State/Province
Beograd
ZIP/Postal Code
11000
Country
Serbia
Facility Name
Military Medical Academy /ID# 150429
City
Belgrade
State/Province
Beograd
ZIP/Postal Code
11000
Country
Serbia
Facility Name
University Clinical Center Serbia /ID# 150428
City
Belgrade
State/Province
Beograd
ZIP/Postal Code
11000
Country
Serbia
Facility Name
Clin Hosp Ctr Bezanijska Kosa /ID# 150426
City
Belgrade
State/Province
Beograd
ZIP/Postal Code
11080
Country
Serbia
Facility Name
University Clinical Center of Nis /ID# 151903
City
NIS
State/Province
Nisavski Okrug
ZIP/Postal Code
18000
Country
Serbia
Facility Name
University Clinical Center Kragujevac /ID# 150430
City
Kragujevac
State/Province
Sumadijski Okrug
ZIP/Postal Code
34000
Country
Serbia
Facility Name
Clinical Center Vojvodina /ID# 150764
City
Novi Sad
State/Province
Vojvodina
ZIP/Postal Code
21000
Country
Serbia
Facility Name
General Hospital Leskovac /ID# 217880
City
Leskovac
ZIP/Postal Code
16000
Country
Serbia
Facility Name
National University Hospital /ID# 150453
City
Singapore
ZIP/Postal Code
119074
Country
Singapore
Facility Name
Gleneagles Medical Centre /ID# 206018
City
Singapore
ZIP/Postal Code
258499
Country
Singapore
Facility Name
Tan Tock Seng Hospital /ID# 150443
City
Singapore
ZIP/Postal Code
308433
Country
Singapore
Facility Name
Fakultna nemocnica s poliklinikou F.D. Roosevelta Banska Bystrica /ID# 150868
City
Banska Bystrica
ZIP/Postal Code
975 17
Country
Slovakia
Facility Name
Medak s.r.o. /ID# 150480
City
Bratislava
ZIP/Postal Code
851 01
Country
Slovakia
Facility Name
Slovak Research Center Team Me /ID# 150257
City
Ilava
ZIP/Postal Code
019 01
Country
Slovakia
Facility Name
B+B MED, s.r.o. /ID# 150471
City
Kosice
ZIP/Postal Code
040 01
Country
Slovakia
Facility Name
Fakultna nemocnica s poliklinikou Nove Zamky /ID# 211370
City
Nove Zamky
ZIP/Postal Code
940 34
Country
Slovakia
Facility Name
GASTRO I., s.r.o. /ID# 150472
City
Presov
ZIP/Postal Code
080 01
Country
Slovakia
Facility Name
MD Search /ID# 167293
City
Boksburg North
State/Province
Gauteng
ZIP/Postal Code
1460
Country
South Africa
Facility Name
Clinresco Centers /ID# 163622
City
Johannesburg
State/Province
Gauteng
ZIP/Postal Code
1619
Country
South Africa
Facility Name
Lenasia Clinical Trial Centre /ID# 214344
City
Johannesburg
State/Province
Gauteng
ZIP/Postal Code
1820
Country
South Africa
Facility Name
Wits Clinical Research , Wits Health Consortium (PTY) Ltd /ID# 150785
City
Johannesburg
State/Province
Gauteng
ZIP/Postal Code
2193
Country
South Africa
Facility Name
Wits Clinical Research Site /ID# 150496
City
Johannesburg
State/Province
Gauteng
ZIP/Postal Code
2193
Country
South Africa
Facility Name
Spoke Research Inc /ID# 162202
City
CAPE TOWN Milnerton
State/Province
Western Cape
ZIP/Postal Code
7441
Country
South Africa
Facility Name
Kingsbury Hospital /ID# 150497
City
Cape Town
State/Province
Western Cape
ZIP/Postal Code
7708
Country
South Africa
Facility Name
Private Practice Dr MN Rajabally /ID# 155144
City
Cape Town
State/Province
Western Cape
ZIP/Postal Code
7800
Country
South Africa
Facility Name
Hospital Clínico Universitario de Santiago-CHUS /ID# 151065
City
Santiago de Compostela
State/Province
A Coruna
ZIP/Postal Code
15706
Country
Spain
Facility Name
Hospital Unversitario Marques de Valdecilla /ID# 216620
City
Santander
State/Province
Cantabria
ZIP/Postal Code
39008
Country
Spain
Facility Name
Hospital Universitario Dr. Negrin /ID# 203937
City
Las Palmas de Gran Canaria
State/Province
Las Palmas
ZIP/Postal Code
35019
Country
Spain
Facility Name
Hospital Universitario A Coruna - CHUAC /ID# 203911
City
A Coruna
ZIP/Postal Code
15006
Country
Spain
Facility Name
Hospital Clinic de Barcelona /ID# 150612
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Hospital Universitario Reina Sofia /ID# 151066
City
Cordoba
ZIP/Postal Code
14004
Country
Spain
Facility Name
Hospital Universitario Ramon y Cajal /ID# 151067
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Facility Name
Hospital Universitario La Paz /ID# 214539
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Facility Name
Hospital Universitario de Salamanca /ID# 150509
City
Salamanca
ZIP/Postal Code
37711
Country
Spain
Facility Name
Hospital Universitario y Politecnico La Fe /ID# 150611
City
Valencia
ZIP/Postal Code
46026
Country
Spain
Facility Name
Sahlgrenska University Hospital /ID# 151496
City
Gothenburg
State/Province
Vastra Gotalands Lan
ZIP/Postal Code
413 45
Country
Sweden
Facility Name
Universitätsspital Basel /ID# 161731
City
Basel
State/Province
Basel-Stadt
ZIP/Postal Code
4031
Country
Switzerland
Facility Name
Kantonsspital St. Gallen /ID# 152599
City
St. Gallen
State/Province
Sankt Gallen
ZIP/Postal Code
9007
Country
Switzerland
Facility Name
Universitätsspital Zürich /ID# 152591
City
Zürich
State/Province
Zuerich
ZIP/Postal Code
8091
Country
Switzerland
Facility Name
Inselspital, Universitätsspital Bern /ID# 152590
City
Bern
ZIP/Postal Code
3010
Country
Switzerland
Facility Name
Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 150575
City
Kaohsiung
ZIP/Postal Code
807
Country
Taiwan
Facility Name
China Medical University Hospital /ID# 150571
City
Taichung City
ZIP/Postal Code
40447
Country
Taiwan
Facility Name
Chung Shan Medical University Hospital /ID# 150573
City
Taichung
ZIP/Postal Code
40201
Country
Taiwan
Facility Name
National Cheng Kung University Hospital /ID# 151749
City
Tainan
ZIP/Postal Code
704
Country
Taiwan
Facility Name
National Taiwan University Hospital /ID# 150574
City
Taipei City
ZIP/Postal Code
100
Country
Taiwan
Facility Name
Taipei Veterans General Hosp /ID# 151748
City
Taipei City
ZIP/Postal Code
11217
Country
Taiwan
Facility Name
Erciyes University Medical Fac /ID# 150129
City
Melikgazi
State/Province
Kayseri
ZIP/Postal Code
38030
Country
Turkey
Facility Name
Istanbul University-Cerrahpasa, Cerrahpasa Medical Faculty /ID# 150125
City
Istanbul
ZIP/Postal Code
34098
Country
Turkey
Facility Name
Umraniye Training and Res Hosp /ID# 162659
City
Istanbul
ZIP/Postal Code
34764
Country
Turkey
Facility Name
Marmara University Medical Fac /ID# 213969
City
Istanbul
ZIP/Postal Code
34899
Country
Turkey
Facility Name
Mersin University Medical /ID# 157849
City
Mersin
ZIP/Postal Code
33343
Country
Turkey
Facility Name
Gazi Universitesi Tip Fakultes /ID# 150127
City
Yenimahalle
ZIP/Postal Code
06560
Country
Turkey
Facility Name
Medical Center of the "Health /ID# 151274
City
Vinnytsya
State/Province
Vinnytska Oblast
ZIP/Postal Code
21009
Country
Ukraine
Facility Name
Municipal Enterprise "I.I. Mechnikov Dnipropetrovsk Regional Clinical Hospital" /ID# 207723
City
Dnipro
ZIP/Postal Code
49005
Country
Ukraine
Facility Name
CNCE of Kharkiv Regional Council Regional Clinical Hospital /ID# 206940
City
Kharkiv
ZIP/Postal Code
61058
Country
Ukraine
Facility Name
PE PMC Acinus, Medical and Diagnostic Center /ID# 217216
City
Kropyvnytskyi
ZIP/Postal Code
25006
Country
Ukraine
Facility Name
Kyiv Municipal Clinical Hospital #18 /ID# 150372
City
Kyiv
ZIP/Postal Code
01030
Country
Ukraine
Facility Name
Medical Center CONSILIUM MEDICAL /ID# 217446
City
Kyiv
ZIP/Postal Code
04050
Country
Ukraine
Facility Name
CNPE of Kyiv Regional Council Kyiv Regional Hospital /ID# 217372
City
Kyiv
ZIP/Postal Code
04073
Country
Ukraine
Facility Name
Lviv Regional Clinical Hospital /ID# 150375
City
Lviv
ZIP/Postal Code
79010
Country
Ukraine
Facility Name
Municipal Non-Commercial Enterprise Odesa Regional Clinical Hospital of the Od /ID# 151275
City
Odesa
ZIP/Postal Code
65025
Country
Ukraine
Facility Name
CNE Vinnytsya Regional Clinical Hospital named after N.I.Pirogov /ID# 216297
City
Vinnytsia
ZIP/Postal Code
21028
Country
Ukraine
Facility Name
Royal Devon and Exeter NHS Trust Hospital /ID# 150379
City
Exeter
State/Province
Devon
ZIP/Postal Code
EX2 5DW
Country
United Kingdom
Facility Name
Hampshire Hospitals NHS Foundation Trust /ID# 150380
City
Basingstoke
State/Province
Essex
ZIP/Postal Code
RG24 9NA
Country
United Kingdom
Facility Name
Barts Health NHS Trust /ID# 150384
City
London
State/Province
London, City Of
ZIP/Postal Code
E1 2ES
Country
United Kingdom
Facility Name
NHS Greater Glasgow and Clyde /ID# 163787
City
Glasgow
State/Province
Scotland
ZIP/Postal Code
G12 0XH
Country
United Kingdom
Facility Name
Royal United Hospitals Bath /ID# 151532
City
Bath
ZIP/Postal Code
BA1 3NG
Country
United Kingdom
Facility Name
University Hospitals Birmingham NHS Foundation Trust /ID# 150382
City
Birmingham
ZIP/Postal Code
B15 2TH
Country
United Kingdom
Facility Name
Calderdale and Huddersfield NHS Foundation Trust /ID# 217658
City
Huddersfield
ZIP/Postal Code
HX3 0PW
Country
United Kingdom
Facility Name
St George's University Hospitals NHS Foundation Trust /ID# 208374
City
Tooting
ZIP/Postal Code
SW17 0QT
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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 URL
https://vivli.org/ourmember/abbvie/
Citations:
PubMed Identifier
35644166
Citation
Danese S, Vermeire S, Zhou W, Pangan AL, Siffledeen J, Greenbloom S, Hebuterne X, D'Haens G, Nakase H, Panes J, Higgins PDR, Juillerat P, Lindsay JO, Loftus EV Jr, Sandborn WJ, Reinisch W, Chen MH, Sanchez Gonzalez Y, Huang B, Xie W, Liu J, Weinreich MA, Panaccione R. Upadacitinib as induction and maintenance therapy for moderately to severely active ulcerative colitis: results from three phase 3, multicentre, double-blind, randomised trials. Lancet. 2022 Jun 4;399(10341):2113-2128. doi: 10.1016/S0140-6736(22)00581-5. Epub 2022 May 26. Erratum In: Lancet. 2022 Sep 24;400(10357):996.
Results Reference
derived
PubMed Identifier
32092309
Citation
Sandborn WJ, Ghosh S, Panes J, Schreiber S, D'Haens G, Tanida S, Siffledeen J, Enejosa J, Zhou W, Othman AA, Huang B, Higgins PDR. Efficacy of Upadacitinib in a Randomized Trial of Patients With Active Ulcerative Colitis. Gastroenterology. 2020 Jun;158(8):2139-2149.e14. doi: 10.1053/j.gastro.2020.02.030. Epub 2020 Feb 22. Erratum In: Gastroenterology. 2020 Sep;159(3):1192.
Results Reference
derived
Links:
URL
https://www.rxabbvie.com
Description
This clinical study may be evaluating a usage that is not currently FDA approved. Please see US Prescribing Information for approved uses.

Learn more about this trial

A Study to Evaluate the Safety and Efficacy of Upadacitinib (ABT-494) for Induction and Maintenance Therapy in Participants With Moderately to Severely Active Ulcerative Colitis (UC)

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