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

Primary Purpose

Crohn's Disease

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Upadacitinib
Placebo for Upadacitinib
Sponsored by
AbbVie
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Crohn's Disease focused on measuring Upadacitinib, ABT-494, Efficacy, Safety, Crohn's Disease

Eligibility Criteria

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

Inclusion Criteria:

  • Confirmed diagnosis of CD for at least 3 months prior to Baseline.
  • Confirmed diagnosis of moderate to severe CD as assessed by stool frequency (SF), abdominal pain (AP) score.
  • Evidence of mucosal inflammation based on the Simplified Endoscopic Score for Crohn's disease (SES-CD) on an endoscopy confirmed by a central reader.
  • Demonstrated an inadequate response or intolerance to one or more conventional and/or biologic therapies (Oral locally acting steroids, Intravenous or oral corticosteroids, Immunosuppressants), in the opinion of the investigator.

Note: Participants who have had inadequate response or intolerance to conventional therapy who have received prior biologic may be enrolled; however, participants must have discontinued the biologic for reasons other than inadequate response or intolerance (e.g., change of insurance, well controlled disease).

- If female, participant must meet the contraception recommendations.

Exclusion Criteria:

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

Sites / Locations

  • East View Medical Research, LLC /ID# 171176
  • CB Flock Research Corporation /ID# 166185
  • Delsol Research Management, Ll /Id# 170145
  • HonorHealth Research Institute - Shea /ID# 164821
  • Arizona Arthritis & Rheumatology Research, PLLC /ID# 164803
  • Southern California Res. Ctr. /ID# 169655
  • Citrus Valley Gastroenterology /ID# 166173
  • Hoag Memorial Hosp Presbyterian /ID# 222540
  • United Medical Doctors /ID# 207449
  • Gastrointestinal Biosciences Clinical Trials, LLC /ID# 164762
  • Facey Medical Foundation /ID# 203136
  • United Medical Doctors - Murrieta /ID# 164945
  • Ucsd /Id# 164910
  • Medical Assoc Research Grp /ID# 169706
  • Univ of California San Francis /ID# 164944
  • Care Access Research /ID# 167767
  • Peak Gastroenterology Associates, PC /ID# 170143
  • Delta Waves, Inc. /ID# 164776
  • Western States Clinical Res /ID# 164760
  • Medical Research Center of CT /ID# 164926
  • Clinical Research of West Florida, Inc /ID# 205827
  • Clinical Research of West Florida, Inc /ID# 208118
  • Advanced Research - Coral Springs /ID# 218021
  • Encore Borland-Groover Clinical Research /Id# 203499
  • Ctr for Advanced Gastroenterol /ID# 165353
  • Crystal Pharmacology Research /ID# 166081
  • Coral Research Clinic /ID# 164890
  • Advanced Research Institute, Inc /ID# 164921
  • Endoscopic Research, Inc. /ID# 206136
  • Omega Research Maitland, LLC /ID# 203481
  • Clinical Research Trials of Florida, Inc. /ID# 203485
  • AdventHealth Tampa /ID# 171167
  • Gastroenterology Associates of Central Georgia, LLC /ID# 165478
  • Gastroenterology Consultants PC - Roswell /ID# 218220
  • Atlanta Gastroenterology Spec /ID# 164799
  • Treasure Valley Medical Research /ID# 215032
  • Rush University Medical Center /ID# 165497
  • University of Chicago Medicine /ID# 165503
  • DuPage Medical Group /ID# 205328
  • MediSphere Medical Research Center /ID# 166175
  • Indianapolis Gastroenterology /ID# 164938
  • University of Iowa Hospitals and Clinics /ID# 165436
  • Tri-State Gastroenterology /ID# 165496
  • University of Louisville /ID# 165366
  • University of Louisville /ID# 168572
  • CroNOLA, LLC /ID# 164823
  • Nola Research Works, LLC /ID# 164759
  • Louisana Research Center, LLC /ID# 164894
  • Johns Hopkins University School of Medicine /ID# 211941
  • MGG Group Co, Inc.Chevy Chase Clinical Research /ID# 164935
  • Gastro Center of Maryland /ID# 171161
  • Lahey Hospital and Medical Center /ID# 214726
  • University of Michigan Comprehensive Cancer Center Michigan Medicine /ID# 164943
  • Digestive Health Associates (DHA) - Farmington Hills /ID# 205793
  • Center for Digestive Health /ID# 164822
  • Clin Res Inst of Michigan, LLC /ID# 170133
  • Mayo Clinic - Rochester /ID# 164783
  • Southern Therapy and Advanced Research (STAR) LLC /ID# 165343
  • Quality Clinical Research Inc. /ID# 170137
  • Duplicate_CHI Nebraska d/b/a CHI Health /ID# 168578
  • Las Vegas Medical Research /ID# 168588
  • AGA Clinical Research Associates, LLC /ID# 164769
  • Rutgers Robert Wood Johnson /ID# 166073
  • Montefiore Medical Center - Moses Campus /ID# 166193
  • Advantage Clinical Trials /ID# 168546
  • NY Scientific /ID# 164931
  • United Health Services Hospitals, Inc /ID# 217485
  • NYU Langone Long Island Clinical Research Associates /ID# 164927
  • The Mount Sinai Hospital /ID# 170257
  • Columbia Univ Medical Center /ID# 164782
  • Gastoenterology Group of Rochester /ID# 166177
  • Richmond University Medical Center /ID# 201857
  • Atrium Health Carolinas Medical Center /ID# 164932
  • PMG Research of Charlotte /ID# 171160
  • Wake Radiology UNC REX Healthcare - Raleigh Office /ID# 164904
  • Wake Forest Baptist Medical Center /ID# 164908
  • Plains Clinical Research Center, LLC /ID# 170140
  • Gastro Health Research /ID# 164791
  • University of Cincinnati /ID# 164825
  • Cleveland Clinic Main Campus /ID# 209231
  • The Ohio State University /ID# 170141
  • Optimed Research, Ltd. /ID# 205624
  • Hometown Urgent Care and Resea /ID# 201291
  • Dayton Gastroenterology, Inc. /ID# 167627
  • Great Lakes Medical Research, LLC /ID# 202010
  • Digestive Disease Specialists /ID# 201064
  • Options Health Research, LLC /ID# 164820
  • Healthcare Research Consultant /ID# 166195
  • University of Pennsylvania /ID# 168430
  • Pharmacorp Clinical Trials /ID# 164916
  • Gastroenterology Associates, P.A. of Greenville /ID# 164771
  • Rapid City Medical Center - GI Research /ID# 201735
  • Gastro One /ID# 164826
  • East Tennessee Research Institute /ID# 203613
  • Quality Medical Research /ID# 205263
  • Vanderbilt University Medical Center /ID# 164946
  • TX Clinical Research Institute /ID# 164896
  • Inquest Clinical Research /ID# 164785
  • Texas Digestive Disease Consultants /ID# 209953
  • Texas Digestive Disease Consultants /ID# 209801
  • Baylor Scott & White Center for Inflammatory Bowel Diseases /ID# 170144
  • CliniCore International, LLC /ID# 164902
  • Baylor College of Medicine - Baylor Medical Center /ID# 164947
  • Centex Studies, Inc. - Houston /ID# 201214
  • GI Specialists of Houston /ID# 202339
  • Caprock Gastro Research, LLC /ID# 215438
  • Clinical Associates in Research Therapeutics of America, LLC /ID# 164786
  • Southern Star Research Institute, LLC /ID# 169755
  • Carl R. Meisner Medical Clinic /ID# 201061
  • Tyler Research Institute, LLC /ID# 168687
  • Gastro Health & Nutrition - Victoria /ID# 167812
  • HP Clinical Research /ID# 164933
  • Advanced Research Institute /ID# 164784
  • Duplicate_Care Access Research /ID# 164794
  • Velocity Clinical Research - Salt Lake City /ID# 166076
  • Washington Gastroenterology /ID# 164824
  • Virginia Mason Medical Center /ID# 164913
  • The Vancouver Clinic, INC. PS /ID# 164918
  • Allegiance Research Specialists /ID# 165346
  • Cardio Alem /ID# 211285
  • Hospital Italiano de Buenos Aires /ID# 215541
  • Gedyt /ID# 210020
  • Cemic /Id# 169182
  • Hospital Provincial del Centenario /ID# 171252
  • Hospital Privado Univesitario /ID# 169230
  • Concord Repatriation General Hospital /ID# 171512
  • Coral Sea Clinical Research institute /ID# 212988
  • Mater Misericordiae Limited /ID# 204909
  • Royal Adelaide Hospital /ID# 171514
  • Box Hill Hospital /ID# 203736
  • Fiona Stanley Hospital /ID# 171513
  • Medizinische Universitaet Wien /ID# 169465
  • Landeskrankenhaus Salzburg-Universitätsklinikum der PMU (LKH) /ID# 214470
  • UCL Saint-Luc /ID# 200303
  • CHU de Liege Sart Tilman /ID# 217534
  • AZ Sint-Lucas /ID# 200302
  • University Clinical Centre of the Republic of Srpska /ID# 208051
  • University Clinical Center Tuzla /ID# 210325
  • Clinical Center University of Sarajevo /ID# 203887
  • Polyclinic and Daily Hospital Dr. Al-Tawil /ID# 217842
  • Instituto Goiano de Gastroenterologia e Endoscopia Digestiva /ID# 166852
  • Hospital Nossa Senhora das Graças /ID# 166863
  • Hospital de Clinicas de Porto Alegre /ID# 166862
  • Upeclin Fmb - Unesp /Id# 166867
  • Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto - USP /ID# 166866
  • Faculdade de Medicina do ABC /ID# 208323
  • Kaiser Clinica e Hospital Dia /ID# 166865
  • UMHAT Kaspela EOOD /ID# 167613
  • Duplicate_Second MHAT Sofia /ID# 167614
  • MHAT Trakia /ID# 201679
  • University of Calgary /ID# 166974
  • Allen Whey Khye Lim Professional Corporation /ID# 168044
  • University of Alberta - Zeidler Ledcor Centre /ID# 166971
  • South Edmonton Gastroenterology Research Clinic /ID# 166978
  • Fraser Clinical Trials Inc /ID# 166968
  • GIRI Gastrointestinal Research Institute /ID# 166975
  • QEII - Health Sciences Centre /ID# 169307
  • London Health Sciences Center /ID# 221038
  • Scott Shulman Medicine Professional Corporation /ID# 169066
  • Taunton Surgical Centre /ID# 168043
  • Ottawa Hospital Research Institute /ID# 212414
  • Medicor Research Inc /ID# 166979
  • Toronto Digestive Disease Asso /ID# 166972
  • CISSS de Chaudière-Appalaches, Hôpital Hotel-Dieu de Lévis /ID# 166969
  • Centre Hospitalier de l'Universite de Montreal - CRCHUM /ID# 170120
  • Royal Victoria Hospital / McGill University Health Centre /ID# 170119
  • CIUSSS de l'Estrie - CHUS /ID# 170940
  • Research Group /ID# 203179
  • M y F Estudios Clínicos /ID# 169984
  • Hospital Guillermo Grant Benavente de Concepción /ID# 212423
  • CTR Estudios Clinicos /ID# 203941
  • Hospital Clinico Universidad De Los Andes /ID# 207466
  • Zhongshan Hospital Xiamen University /ID# 204984
  • The First Affiliated Hospital, Sun Yat-sen University /ID# 205228
  • Nanfang Hospital of Southern Medical University /ID# 204083
  • The Sixth Affiliated Hosp Sun /ID# 204077
  • Union Hospital Tongji Medical College Huazhong University of Science and Technol /ID# 204081
  • Nanjing Drum Tower Hospital /ID# 204900
  • The First Affiliated Hospital of Nanchang University /ID# 204092
  • The First Hospital of Jilin University /ID# 206868
  • Ruijin Hospital, Shanghai Jiaotong University School of Medicine /ID# 204091
  • The second Affiliated hospital of Zhejiang University school of Medicine /ID# 204073
  • Sir Run Run Shaw Hospital,Meical School Zhejiang University /ID# 204076
  • Beijing Friendship Hospital /ID# 204173
  • The Second Xiangya Hospital of Central South University /ID# 204082
  • Duplicate_Tianjin Med Univ General Hosp /ID# 206994
  • Tongji Hospital Tongji Medical College of HUST /ID# 204088
  • Hospital Pablo Tobon Uribe /ID# 202404
  • Hospital Universitario San Vic /ID# 200029
  • Clinical Hospital Dubrava /ID# 171185
  • Klinicki bolnicki centar Sestre milosrdnice /ID# 205535
  • Klinicki bolnicki centar Zagreb /ID# 171203
  • Poliklinika Solmed /ID# 211519
  • UHC Split /ID# 171191
  • Zadar General Hospital /ID# 205536
  • Nemocnice Ceske Budejovice a.s. /ID# 224389
  • Hepato-Gastroenterologie HK, s.r.o. /ID# 171401
  • ARTROSCAN s.r.o. /ID# 200790
  • ResTrial s.r.o. /ID# 208653
  • Herlev Hospital /ID# 202423
  • Nordsjaellands Hospital /ID# 202424
  • Kobenhavns Universitet - Hvidovre Hospital (HH) /ID# 202425
  • Duplicate_Sjaellands Universitets Hospital /ID# 209445
  • Clinical Research Center, Faculty of Medicine, Alexandria university. /ID# 171012
  • Clinical Research Center, Faculty of Medicine, Alexandria university. /ID# 171013
  • Clinical Research Center, Faculty of Medicine, Alexandria university. /ID# 209564
  • National Hepatology and Tropical Medicine Research Institute /ID# 170989
  • Air Force Specialized Hospital /ID# 170996
  • National Liver Institute /ID# 170988
  • West Tallinn Central Hospital /ID# 202785
  • CHU Grenoble - Hopital Michallon /ID# 219034
  • Clinique Jules Verne /ID# 219073
  • CH Valenciennes /ID# 219035
  • Universitatsklinikum Mannheim /ID# 168759
  • Universitaetsklinikum Ulm /ID# 203560
  • Universitaetsklinikum Erlangen /ID# 203552
  • Universitaetsklinikum Frankfurt /ID# 203566
  • Zentrum für Gastroenterologie Saar MVZ GmbH /ID# 206741
  • Universitaetsklinikum Schleswig-Holstein Campus Kiel /ID# 168757
  • Gastroenterologie am Mexikoplatz /ID# 203575
  • Universitaetsmedizin Essen St. Josef Krankenhaus Werden /ID# 203570
  • Agaplesion Markus Krankenhaus /ID# 168758
  • Universitaetsklinikum Halle (Saale) /ID# 207455
  • Medizinisches Versorgungszentrum Portal 10 /ID# 200214
  • General Hospital of Athens Ippokratio /ID# 167045
  • General Hospital of Chest Diseases of Athens SOTIRIA /ID# 202104
  • Tzaneio general hospital of Piraeus /ID# 206433
  • University General Hospital of Heraklion PA.G.N.I /ID# 167044
  • General Hospital of Thessaloniki Hippokrateio /ID# 208825
  • Tuen Mun Hospital /ID# 171218
  • Mohacsi Korhaz /ID# 209441
  • CRU Hungary Egeszsegugyi és Szolgaltato Kft. /ID# 205547
  • Debreceni Egyetem Klinikai Kozpont /ID# 216419
  • Bugat Pal Korhaz /ID# 201893
  • Szent Borbala Korhaz /ID# 209897
  • Obudai Egeszsegugyi Centrum Kft. /ID# 201892
  • Semmelweis Egyetem /ID# 210167
  • Magyar Honvedseg Egeszsegugyi Kozpont /ID# 201724
  • Debreceni Egyetem Kenezy Gyula Egyetemi Korhaz /ID# 201723
  • Pest Megyei Flor Ferenc Korhaz /ID# 206154
  • Mentahaz Maganorvosi Kozpont /ID# 201895
  • Mercy University Hospital /ID# 206511
  • Soroka University Medical Center /ID# 169913
  • Tel Aviv Sourasky Medical Center /ID# 204877
  • Assaf Harofeh Medical Center /ID# 204872
  • Hadassah Medical Center-Hebrew University /ID# 169928
  • Rabin Medical Center /ID# 202636
  • Kaplan Medical Center /ID# 170276
  • Policlinico Universitario Campus Bio-Medico /ID# 168183
  • Azienda Ospedaliera San Camillo Forlanini /ID# 168184
  • Istituto Clinico Humanitas /ID# 168185
  • Fondazione PTV Policlinico Tor Vergata /ID# 168188
  • Presidio Columbus-Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Un /ID# 168182
  • IRCCS Ospedale Sacro Cuore Don Calabria /ID# 168186
  • IRCCS Azienda Ospedaliero-Universitaria di Bologna /ID# 168187
  • A.O. Per L'Emergenza Cannizzaro /ID# 168190
  • Policlinico San Martino/Univer /ID# 168191
  • ASST Fatebenefratelli Sacco - Ospedale Fatebenefratelli e Oftalmico /ID# 168181
  • ASST Grande Ospedale Metropolitano Niguarda /ID# 170849
  • Azienda Ospedaliero-Universitaria di Modena /ID# 201897
  • A.O. Ospedali Riuniti Villa Sofia - Cervello /ID# 168189
  • Azienda Ospedaliero Universitaria Pisana-Stabilimento di Cisanello /ID# 202421
  • Aichi Medical University Hospital /ID# 165971
  • Nagoya City University Hospital /ID# 165970
  • Nagoya University Hospital /ID# 165969
  • Toyohashi Municipal Hospital /ID# 200175
  • National Hospital Organization Hirosaki General Medical Center /ID# 165961
  • Toho University Sakura Medical Center /ID# 165963
  • Fukuoka University Chikushi Hospital /ID# 214404
  • Kurume University Hospital /ID# 166012
  • National Hospital Organization Takasaki General Medical Center /ID# 167127
  • NHO Fukuyama Medical Center /ID# 167131
  • Hiroshima University Hospital /ID# 166014
  • Asahikawa Medical University Hospital /ID# 167120
  • Hokkaido P.W.F.A.C. Sapporo-Kosei General Hospital /ID# 165960
  • Sapporo Medical University Hospital /ID# 167124
  • Sapporo IBD Clinic /ID# 223561
  • Aoyama Clinic /ID# 166009
  • Hyogo College of Medicine College Hospital /Id# 165973
  • Kanazawa University Hospital /ID# 169218
  • Iwate Medical University Uchimaru Medical Center /ID# 202464
  • Imamura General Hospital /ID# 227137
  • Idzuro Imamura Hospital /ID# 206654
  • Sameshima Hospital /ID# 206675
  • Yokohama City University Medical Center /ID# 167128
  • Japanese Red Cross Kyoto Daiichi Hosital /ID# 165972
  • Kyoto University Hospital /ID# 169889
  • Yokkaichi Hazu Medical Center /ID# 167196
  • Tohoku University Hospital /ID# 167122
  • Nara Medical University Hospital /ID# 169219
  • Kenseikai Dongo Hospital /ID# 208104
  • Niigata University Medical & Dental Hospital /ID# 170045
  • Ishida Clinic of IBD and Gastroenterology /ID# 167121
  • Chikuba Hospital for Proctological and Gastrointestinal Diseases /ID# 166010
  • Okayama University Hospital /ID# 167356
  • Kinshukai Infusion Clinic /ID# 218872
  • Osaka Metropolitan University Hospital /ID# 166015
  • Osaka University Hospital /ID# 169663
  • Osaka Medical and Pharmaceutical University Hospital /ID# 206326
  • Tokitokai Tokito clinic /ID# 165962
  • Shiga University of Medical Science Hospital /ID# 167129
  • Hamamatsu University Hospital /ID# 224352
  • NHO Shizuoka Medical Center /ID# 167125
  • Tokyo Medical And Dental University Hospital /ID# 165965
  • Tokai University Hachioji Hospital /ID# 165967
  • The Jikei University Hospital /ID# 167130
  • Kyorin University Hospital /ID# 165966
  • Tokyo Women's Medical University Hospital /ID# 205980
  • Toyama Prefectural Central Hospital /ID# 217834
  • Japanese Red Cross Wakayama Medical Center /ID# 200643
  • Wakayama Medical University Hospital /ID# 169482
  • Yamagata University Hospital /ID# 200157
  • Hayang University GuriHospital /ID# 167587
  • CHA University Bundang Medical Center /ID# 167592
  • Kangbuk Samsung Hospital /ID# 167586
  • Yonsei University Health System Severance Hospital /ID# 167590
  • Inje University Haeundae Hospital /ID# 202630
  • Dong-A University Hospital /ID# 167591
  • Pusan National University Hospital /ID# 167589
  • Kyungpook National University Hospital /ID# 207019
  • Samsung Medical Center /ID# 167588
  • Chung-Ang University Hostipal /ID# 207018
  • VCA Polyclinic Aura /ID# 169498
  • Pauls Stradins Clinical University Hospital /ID# 169519
  • Digestive Disease Center Gastro /ID# 169508
  • Hospital of Lithuanian University of Health Sciences Kaunas Clinics /ID# 206936
  • Vilnius University Hospital Santaros Klinikos /ID# 203286
  • Hospital Sultanah Bahiyah /ID# 202626
  • Universiti Kebangsaan Malaysia (UKM) Medical Centre /ID# 170773
  • Universiti Sains Malaysia /ID# 200102
  • Instituto de Investigaciones Aplicadas a la Neurociencias A.C. /ID# 207579
  • Morales Vargas Centro de Investigacion S.C. /ID# 203494
  • Clinica de Investigacion en Reumatologia y Obesidad S.C. /ID# 207238
  • Radboud Universitair Medisch Centrum /ID# 166928
  • Zuyderland Medisch Centrum /ID# 169700
  • Onze Lieve Vrouwe Gasthuis /ID# 166929
  • Academisch Medisch Centrum /ID# 166927
  • Medisch Spectrum Twente /ID# 170298
  • Vistamed /ID# 208572
  • Malopolskie Centrum Kliniczne /ID# 202167
  • WIP Warsaw IBD Point Profesor Kierkus /ID# 224301
  • Centrum Zdrowia MDM /ID# 200491
  • Centrum Medyczne Reuma Park /ID# 200490
  • Hospital da Senhora da Oliveira Guimaraes, EPE /ID# 170245
  • Hospital Egas Moniz /ID# 170253
  • Unidade Local de Saúde do Alto Minho, EPE - Hospital Conde de Bertiandos /ID# 200607
  • Hospital Garcia de Orta, EPE /ID# 170241
  • Centro Hospitalar Universitario de Sao Joao, EPE /ID# 170248
  • Mindful Medical Research /ID# 203358
  • School of Medicine University of Puerto Rico-Medical Science Campus /ID# 166771
  • Institutul Clinic Fundeni /ID# 167817
  • Clinica GASTRO MED SRL /ID# 206369
  • Cabinet Particular Policlinic Algomed /ID# 167818
  • Immanuel Kant Baltic Federal University /ID# 203811
  • LLC Medical Center /ID# 209236
  • Perm Clinical Center of the Federal Medical and Biological Agency /ID# 202990
  • LLC Novaya Klinika /ID# 206616
  • Professor Pasechnikov Gastroenterology and Pankreatology clinic /ID# 202997
  • Kazan State Medical University /ID# 169638
  • Olla-Med Clinic /ID# 208720
  • P.A. Bayandin Murmansk Regiona /ID# 169639
  • Republican hospital named after V.A. Baranov /ID# 206488
  • Euromedservice /ID# 206610
  • X7 Clinical Research Center /ID# 216350
  • City Clinical Hospital No. 31 /ID# 208868
  • Clinical Hosp Center Zvezdara /ID# 168214
  • Military Medical Academy /ID# 168783
  • University Clinical Center Serbia /ID# 168215
  • Clin Hosp Ctr Bezanijska Kosa /ID# 168750
  • University Clinical Center Kragujevac /ID# 205859
  • Clinical Center Vojvodina /ID# 168213
  • KL Ling Gastroenterology and Liver Clinic /ID# 217962
  • Gleneagles Medical Centre /ID# 206531
  • Tan Tock Seng Hospital /ID# 203160
  • Fakultna nemocnica s poliklinikou F.D. Roosevelta Banska Bystrica /ID# 169958
  • KM Management, spol. s.r.o. /ID# 170201
  • Univ Medical Ctr Ljubljana /ID# 217795
  • Farmovs (Pty) Ltd /Id# 207535
  • Lenasia Clinical Trial Centre /ID# 205145
  • Wits Clinical Research Site /ID# 170852
  • Allergy & Immunology (AIU) /ID# 171431
  • Dr JP Wright /ID# 170887
  • Private Practice Dr MN Rajabally /ID# 169853
  • Hospital Universitari Son Espases /ID# 201998
  • Hospital Universitario de Navarra /ID# 202355
  • Hospital Universitario A Coruna - CHUAC /ID# 203910
  • Hospital Clinic de Barcelona /ID# 201990
  • Hospital Universitario de Girona Doctor Josep Trueta /ID# 202645
  • Hospital Juan Ramon Jimenez /ID# 201995
  • Hospital Universitario La Paz /ID# 201994
  • Hospital Universitario de Salamanca /ID# 206358
  • Hospital Universitario Virgen Macarena /ID# 201993
  • Hospital Clinico Universitario de Valencia /ID# 209657
  • Hospital Universitario y Politecnico La Fe /ID# 201992
  • Hallands Hospital Halmstad /ID# 170828
  • Karolinska University Hospital Solna /ID# 224488
  • Alingsas lasarett /ID# 170826
  • Sodra Alvsborgs sjukhus /ID# 203077
  • Sahlgrenska University Hospital /ID# 169171
  • Universitätsspital Zürich /ID# 170998
  • Inselspital, Universitätsspital Bern /ID# 170997
  • China Medical University Hospital /ID# 169791
  • Taichung Veterans General Hospital /ID# 169790
  • National Taiwan University Hospital /ID# 169792
  • Acibadem Kozyatagi Hospital /ID# 209406
  • Erciyes University Medical Fac /ID# 171331
  • Ankara Univ Medical Faculty /ID# 206409
  • Inonu Universitesi Turgut Ozal /ID# 201268
  • Mustafa Kemal University Medic /ID# 171336
  • Istanbul University Istanbul Medical Faculty /ID# 171364
  • Marmara Universitesi Pendik Egitim ve Arastirma Hastanesi /ID# 171332
  • Mersin University Medical /ID# 171338
  • Sisli Etfal Train & Res Hosp /ID# 171334
  • Gazi Universitesi Tip Fakultes /ID# 217444
  • Medical Centre of "Ukrainian German Antiulcer Gastroenterology Centre BYK-KYIV" /ID# 203738
  • Kharkiv City Clinical Hospital No.2 n.a. Prof. O.O. Shalimov /ID# 167907
  • Kyiv Municipal Clinical Hospital #18 /ID# 207889
  • MNI KRC Kyiv Regional Clinical Hospital /ID# 202454
  • Lviv Railway Clinical Hospital of branch Healthcare Centers of Public Joint Stoc /ID# 167908
  • CNE Vinnytsya Regional Clinical Hospital named after N.I.Pirogov /ID# 222110
  • South Eastern Health and Social Care Trust /ID# 205323
  • Warrington and Halton Hospitals NHS Foundation Trust /ID# 171383
  • Warrington and Halton Hospitals NHS Foundation Trust /ID# 209086
  • Royal United Hospitals Bath /ID# 169074
  • University Hospitals Birmingham NHS Foundation Trust /ID# 169070
  • The Dudley Group NHS Foundation Trust /ID# 169069
  • King's College Hospital NHS Foundation Trust /ID# 169072
  • The Newcastle Upon Tyne Hospitals NHS Foundation Trust /ID# 169075
  • Stockport NHS foundation trust /ID# 208719
  • Taunton and Somerset NHS Foundation Trust /ID# 209665
  • St George's University Hospitals NHS Foundation Trust /ID# 205552
  • The Royal Wolverhampton NHS Trust /ID# 171382

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

Upadacitinib

Arm Description

Participants will receive placebo once daily for 12 weeks in Part 1. Clinical non-responders will receive 45 mg upadacitinib once daily for 12 weeks in Part 2.

Participants will receive 45 mg upadacitinib once daily for 12 weeks in Part 1. Clinical non-responders will receive 30 mg upadacitinib once daily for 12 weeks in Part 2.

Outcomes

Primary Outcome Measures

Percentage of Participants With Clinical Remission Per Crohn's Disease Activity Index (CDAI) at Week 12
The co-primary endpoint for United States (US)/Food and Drug Administration (FDA) regulatory purposes was clinical remission based on CDAI at Week 12. CDAI is a composite instrument that includes participant symptoms evaluated over 7 days (abdominal pain, stool frequency and general well-being), as well as presence of complications (arthritis/arthralgia, iritis/uveitis, erythema nodosum/pyoderma gangrenosum/aphthous stomatitis, anal fissure/fistula/abscess, other fistula, and fever), the use of antidiarrheal medicines, presence of an abdominal mass, hematocrit, and body weight. These items are scored individually, weighted, and do not contribute equally to the overall score. The CDAI is derived from summing up the weighted individual scores of eight items. CDAI approximately ranges from 0 to 600 with higher scores indicating more severe disease. Clinical remission is defined as a CDAI score less than 150.
Percentage of Participants With Clinical Remission Per Patient-Reported Outcomes (PROs) at Week 12
The co-primary endpoint for European Union (EU)/European Medicines Agency (EMA) regulatory purposes was clinical remission defined based on two patient reported outcomes, average daily stool frequency (SF) and average daily abdominal pain score (APS). Clinical remission per PROs was defined as average daily very soft or liquid SF ≤ 2.8 and average daily APS ≤ 1.0 and neither worse than Baseline. Participants recorded APS and the number of very soft or liquid SF daily in an electronic diary. Abdominal pain was rated on a scale from 0 (none) to 3 (severe). The average daily very soft or liquid SF and APS were calculated using the 4-7 most recent useable days of patient-report outcomes (i.e., excluding days with missing entries or associated with endoscopy procedures) out of the last 14 days prior to the Week 12 visit.
Percentage of Participants With Endoscopic Response at Week 12
Endoscopic response at Week 12 was a co-primary endpoint for both the US/FDA and EU/EMA regulatory purposes. Endoscopic response was defined as greater than 50% decrease in Simple Endoscopic Score for Crohn's Disease (SES-CD) from Baseline of the induction study (or for participants with an SES-CD of 4 at Baseline, at least a 2-point reduction from Baseline), as scored by independent external and blinded central readers. The SES-CD evaluates 4 endoscopic variables (ulcer size, ulcerated surface, affected surface, and narrowing, each on a scale from 0 (none) to 3 in 5 segments assessed during ileocolonoscopy (ileum, right colon, transverse colon, sigmoid and left colon, and rectum). The total score is the sum of the 4 endoscopic variable scores and ranges from 0 to 56, where higher scores indicate more severe disease.

Secondary Outcome Measures

Percentage of Participants With Endoscopic Remission at Week 12
Endoscopic remission is defined as an SES-CD ≤ 4 and at least 2 point reduction from Baseline and no subscore > 1 in any individual variable,as scored by independent external and blinded central readers. The SES-CD evaluates 4 endoscopic variables (ulcer size, ulcerated surface, affected surface, and narrowing, each on a scale from 0 (none) to 3 in 5 segments assessed during ileocolonoscopy (ileum, right colon, transverse colon, sigmoid and left colon, and rectum). The total score is the sum of the 4 endoscopic variable scores and ranges from 0 to 56, where higher scores indicate more severe disease.
Percentage of Participants Who Discontinued Corticosteroid Use for Crohn's Disease and Achieved Clinical Remission Per CDAI at Week 12
Corticosteroid-free clinical remission is defined as participants who discontinued corticosteroid use for CD and achieved clinical remission per CDAI at Week 12, assessed for participants taking corticosteroids for CD at Baseline. CDAI is a composite instrument that includes participant symptoms evaluated over 7 days (abdominal pain, stool frequency and general well-being), as well as presence of complications (arthritis/arthralgia, iritis/uveitis, erythema nodosum/pyoderma gangrenosum/aphthous stomatitis, anal fissure/fistula/abscess, other fistula, and fever), the use of antidiarrheal medicines, presence of an abdominal mass, hematocrit, and body weight. These items are scored individually, weighted, and do not contribute equally to the overall score. The CDAI is derived from summing up the weighted individual scores of eight items. CDAI approximately ranges from 0 to 600 with higher scores indicating more severe disease. Clinical remission is defined as CDAI score less than 150.
Change From Baseline in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue) at Week 12
The FACIT-Fatigue questionnaire is a self-administered patient questionnaire that consists of 13 questions designed to measure the degree of fatigue experienced by participants in the previous 7 days, including physical fatigue (e.g., I feel tired), functional fatigue (e.g., trouble finishing things), emotional fatigue (e.g., frustration), and social consequences of fatigue (e.g., limits social activity). Participants respond to the questions on a scale from 0 (not at all) to 4 (very much). The FACIT-Fatigue score is computed by summing the item scores, after reversing those items that are worded in the negative direction. The FACIT-Fatigue score ranges from 0 to 52, where higher scores represent less fatigue. A positive change from Baseline indicates improvement.
Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score at Week 12
The Inflammatory Bowel Disease Questionnaire (IBDQ) is used to assess health-related quality of life (HRQoL) in patients with inflammatory bowel disease. It consists of 32 questions evaluating bowel and systemic symptoms, as well as emotional and social functions. Each question is answered on a scale from 1 (worst) to 7 (best). The total score ranges from 32 to 224 with higher scores indicating better health-related quality of life. A positive change from Baseline indicates improvement.
Percentage of Participants Achieving Clinical Response 100 (CR-100) at Week 2
Clinical response 100 (CR-100) is defined as a decrease of at least 100 points in CDAI from Baseline. CDAI is a composite instrument that includes participant symptoms evaluated over 7 days (abdominal pain, stool frequency and general well-being), as well as presence of complications (arthritis/arthralgia, iritis/uveitis, erythema nodosum/pyoderma gangrenosum/aphthous stomatitis, anal fissure/fistula/abscess, other fistula, and fever), the use of antidiarrheal medicines, presence of an abdominal mass, hematocrit, and body weight. These items are scored individually, weighted, and do not contribute equally to the overall score. The CDAI is derived from summing up the weighted individual scores of eight items. CDAI approximately ranges from 0 to 600 with higher scores indicating more severe disease.
Percentage of Participants Achieving Clinical Response 100 (CR-100) at Week 12
Clinical response 100 (CR-100) is defined as a decrease of at least 100 points in CDAI from Baseline. CDAI is a composite instrument that includes participant symptoms evaluated over 7 days (abdominal pain, stool frequency and general well-being), as well as presence of complications (arthritis/arthralgia, iritis/uveitis, erythema nodosum/pyoderma gangrenosum/aphthous stomatitis, anal fissure/fistula/abscess, other fistula, and fever), the use of antidiarrheal medicines, presence of an abdominal mass, hematocrit, and body weight. These items are scored individually, weighted, and do not contribute equally to the overall score. The CDAI is derived from summing up the weighted individual scores of eight items. CDAI approximately ranges from 0 to 600 with higher scores indicating more severe disease.
Percentage of Participants With Clinical Remission Per CDAI at Week 4
CDAI is a composite instrument that includes participant symptoms evaluated over 7 days (abdominal pain, stool frequency and general well-being), as well as presence of complications (arthritis/arthralgia, iritis/uveitis, erythema nodosum/pyoderma gangrenosum/aphthous stomatitis, anal fissure/fistula/abscess, other fistula, and fever), the use of antidiarrheal medicines, presence of an abdominal mass, hematocrit, and body weight. These items are scored individually, weighted, and do not contribute equally to the overall score. The CDAI is derived from summing up the weighted individual scores of eight items. CDAI approximately ranges from 0 to 600 with higher scores indicating more severe disease. Clinical remission is defined as CDAI score less than 150.
Percentage of Participants With Hospitalizations Due to Crohn's Disease (CD) During the 12-Week Induction Period
This was assessed by reviewing participant's hospitalization data.
Percentage of Participants With Resolution of Extra-Intestinal Manifestation (EIMs) at Week 12
EIMs are defined as manifestations of Crohn's disease in areas of the body other than the digestive tract, including eyes, skin, joints, mouth, and liver. Only participants with any EIM present at Baseline were included in the analysis of resolution of EIMs. Resolution of EIMs was defined as absence of all EIMs at the Week 12 visit.
Percentage of Participants With Clinical Remission Per PROs at Week 4
Clinical remission per PROs was defined as average daily very soft or liquid SF ≤ 2.8 and average daily APS ≤ 1.0 and neither worse than Baseline. Participants recorded APS and the number of liquid or very soft SF daily in an electronic diary. Abdominal pain was rated on a scale from 0 (none) to 3 (severe). The average daily very soft or liquid SF and APS were calculated using the 4-7 most recent useable days of patient-reported outcomes (i.e., excluding days with missing entries or associated with endoscopy procedures) out of the last 14 days prior to the Week 4 visit.
Percentage of Participants Who Discontinued Corticosteroid Use for Crohn's Disease and Achieved Clinical Remission Per PROs at Week 12
Corticosteroid-free clinical remission is defined as participants who discontinued corticosteroid use for CD and achieved clinical remission per PROs at Week 12, assessed for participants taking corticosteroids for CD at Baseline. Clinical remission per PROs was defined as average daily very soft or liquid stool frequency (SF) ≤ 2.8 and average daily APS ≤ 1.0 and neither worse than Baseline. Participants recorded APS and the number of liquid or very soft SF daily in an electronic diary. Abdominal pain was rated on a scale from 0 (none) to 3 (severe). The average daily liquid or very soft SF and APS were calculated using the 4-7 most recent useable days of patient-reported outcomes (i.e., excluding days with missing entries or associated with endoscopy procedures) out of the last 14 days prior to the Week 12 visit.

Full Information

First Posted
November 15, 2017
Last Updated
October 31, 2022
Sponsor
AbbVie
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1. Study Identification

Unique Protocol Identification Number
NCT03345849
Brief Title
A Study of the Efficacy and Safety of Upadacitinib in Participants With Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or Are Intolerant to Conventional and/or Biologic Therapies
Acronym
U-EXCEL
Official Title
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects With Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or Are Intolerant to Conventional and/or Biologic Therapies
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
December 7, 2017 (Actual)
Primary Completion Date
October 15, 2021 (Actual)
Study Completion Date
January 13, 2022 (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
The objective of this study is to evaluate the efficacy and safety of upadacitinib compared to placebo as induction therapy in adults with moderately and severely active Crohn's disease (CD).
Detailed Description
This study includes two parts: Part 1: a randomized double-blind placebo-controlled induction period and Part 2: an extended treatment period for non-responders from Part 1. In Part 1, participants will be randomized in a 2:1 ratio to upadacitinib 45 mg once daily (QD) or matching placebo for 12 weeks. The randomization will be stratified by baseline corticosteroid use (yes or no), endoscopic disease severity (Simplified Endoscopic Score for Crohn's disease [SES-CD] < 15 and ≥ 15), and number of prior biologics with prior inadequate response or intolerance (0, 1, > 1). Participants who do not achieve clinical response at Week 12 will be able to enroll in Part 2 to receive a double-blind extended treatment with upadacitinib until Week 24. Clinical response is defined as a ≥ 30% decrease in average daily very soft or liquid stool frequency (SF) and/or ≥ 30% decrease in average daily abdominal pain (AP) score (both not worse than Baseline). Participants who achieve clinical response at Week 12 may be eligible to enter the 52-week, double-blind, maintenance portion of Study M14-430 (NCT03345823).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Crohn's Disease
Keywords
Upadacitinib, ABT-494, Efficacy, Safety, Crohn's Disease

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants will receive placebo once daily for 12 weeks in Part 1. Clinical non-responders will receive 45 mg upadacitinib once daily for 12 weeks in Part 2.
Arm Title
Upadacitinib
Arm Type
Experimental
Arm Description
Participants will receive 45 mg upadacitinib once daily for 12 weeks in Part 1. Clinical non-responders will receive 30 mg upadacitinib once daily for 12 weeks in Part 2.
Intervention Type
Drug
Intervention Name(s)
Upadacitinib
Other Intervention Name(s)
ABT-494, RINVOQ
Intervention Description
Oral; Tablet
Intervention Type
Drug
Intervention Name(s)
Placebo for Upadacitinib
Intervention Description
Oral; Tablet
Primary Outcome Measure Information:
Title
Percentage of Participants With Clinical Remission Per Crohn's Disease Activity Index (CDAI) at Week 12
Description
The co-primary endpoint for United States (US)/Food and Drug Administration (FDA) regulatory purposes was clinical remission based on CDAI at Week 12. CDAI is a composite instrument that includes participant symptoms evaluated over 7 days (abdominal pain, stool frequency and general well-being), as well as presence of complications (arthritis/arthralgia, iritis/uveitis, erythema nodosum/pyoderma gangrenosum/aphthous stomatitis, anal fissure/fistula/abscess, other fistula, and fever), the use of antidiarrheal medicines, presence of an abdominal mass, hematocrit, and body weight. These items are scored individually, weighted, and do not contribute equally to the overall score. The CDAI is derived from summing up the weighted individual scores of eight items. CDAI approximately ranges from 0 to 600 with higher scores indicating more severe disease. Clinical remission is defined as a CDAI score less than 150.
Time Frame
Week 12
Title
Percentage of Participants With Clinical Remission Per Patient-Reported Outcomes (PROs) at Week 12
Description
The co-primary endpoint for European Union (EU)/European Medicines Agency (EMA) regulatory purposes was clinical remission defined based on two patient reported outcomes, average daily stool frequency (SF) and average daily abdominal pain score (APS). Clinical remission per PROs was defined as average daily very soft or liquid SF ≤ 2.8 and average daily APS ≤ 1.0 and neither worse than Baseline. Participants recorded APS and the number of very soft or liquid SF daily in an electronic diary. Abdominal pain was rated on a scale from 0 (none) to 3 (severe). The average daily very soft or liquid SF and APS were calculated using the 4-7 most recent useable days of patient-report outcomes (i.e., excluding days with missing entries or associated with endoscopy procedures) out of the last 14 days prior to the Week 12 visit.
Time Frame
Week 12
Title
Percentage of Participants With Endoscopic Response at Week 12
Description
Endoscopic response at Week 12 was a co-primary endpoint for both the US/FDA and EU/EMA regulatory purposes. Endoscopic response was defined as greater than 50% decrease in Simple Endoscopic Score for Crohn's Disease (SES-CD) from Baseline of the induction study (or for participants with an SES-CD of 4 at Baseline, at least a 2-point reduction from Baseline), as scored by independent external and blinded central readers. The SES-CD evaluates 4 endoscopic variables (ulcer size, ulcerated surface, affected surface, and narrowing, each on a scale from 0 (none) to 3 in 5 segments assessed during ileocolonoscopy (ileum, right colon, transverse colon, sigmoid and left colon, and rectum). The total score is the sum of the 4 endoscopic variable scores and ranges from 0 to 56, where higher scores indicate more severe disease.
Time Frame
Baseline and Week 12
Secondary Outcome Measure Information:
Title
Percentage of Participants With Endoscopic Remission at Week 12
Description
Endoscopic remission is defined as an SES-CD ≤ 4 and at least 2 point reduction from Baseline and no subscore > 1 in any individual variable,as scored by independent external and blinded central readers. The SES-CD evaluates 4 endoscopic variables (ulcer size, ulcerated surface, affected surface, and narrowing, each on a scale from 0 (none) to 3 in 5 segments assessed during ileocolonoscopy (ileum, right colon, transverse colon, sigmoid and left colon, and rectum). The total score is the sum of the 4 endoscopic variable scores and ranges from 0 to 56, where higher scores indicate more severe disease.
Time Frame
Baseline and Week 12
Title
Percentage of Participants Who Discontinued Corticosteroid Use for Crohn's Disease and Achieved Clinical Remission Per CDAI at Week 12
Description
Corticosteroid-free clinical remission is defined as participants who discontinued corticosteroid use for CD and achieved clinical remission per CDAI at Week 12, assessed for participants taking corticosteroids for CD at Baseline. CDAI is a composite instrument that includes participant symptoms evaluated over 7 days (abdominal pain, stool frequency and general well-being), as well as presence of complications (arthritis/arthralgia, iritis/uveitis, erythema nodosum/pyoderma gangrenosum/aphthous stomatitis, anal fissure/fistula/abscess, other fistula, and fever), the use of antidiarrheal medicines, presence of an abdominal mass, hematocrit, and body weight. These items are scored individually, weighted, and do not contribute equally to the overall score. The CDAI is derived from summing up the weighted individual scores of eight items. CDAI approximately ranges from 0 to 600 with higher scores indicating more severe disease. Clinical remission is defined as CDAI score less than 150.
Time Frame
Week 12
Title
Change From Baseline in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue) at Week 12
Description
The FACIT-Fatigue questionnaire is a self-administered patient questionnaire that consists of 13 questions designed to measure the degree of fatigue experienced by participants in the previous 7 days, including physical fatigue (e.g., I feel tired), functional fatigue (e.g., trouble finishing things), emotional fatigue (e.g., frustration), and social consequences of fatigue (e.g., limits social activity). Participants respond to the questions on a scale from 0 (not at all) to 4 (very much). The FACIT-Fatigue score is computed by summing the item scores, after reversing those items that are worded in the negative direction. The FACIT-Fatigue score ranges from 0 to 52, where higher scores represent less fatigue. A positive change from Baseline indicates improvement.
Time Frame
Baseline and Week 12
Title
Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score at Week 12
Description
The Inflammatory Bowel Disease Questionnaire (IBDQ) is used to assess health-related quality of life (HRQoL) in patients with inflammatory bowel disease. It consists of 32 questions evaluating bowel and systemic symptoms, as well as emotional and social functions. Each question is answered on a scale from 1 (worst) to 7 (best). The total score ranges from 32 to 224 with higher scores indicating better health-related quality of life. A positive change from Baseline indicates improvement.
Time Frame
Baseline and Week 12
Title
Percentage of Participants Achieving Clinical Response 100 (CR-100) at Week 2
Description
Clinical response 100 (CR-100) is defined as a decrease of at least 100 points in CDAI from Baseline. CDAI is a composite instrument that includes participant symptoms evaluated over 7 days (abdominal pain, stool frequency and general well-being), as well as presence of complications (arthritis/arthralgia, iritis/uveitis, erythema nodosum/pyoderma gangrenosum/aphthous stomatitis, anal fissure/fistula/abscess, other fistula, and fever), the use of antidiarrheal medicines, presence of an abdominal mass, hematocrit, and body weight. These items are scored individually, weighted, and do not contribute equally to the overall score. The CDAI is derived from summing up the weighted individual scores of eight items. CDAI approximately ranges from 0 to 600 with higher scores indicating more severe disease.
Time Frame
Baseline and Week 2
Title
Percentage of Participants Achieving Clinical Response 100 (CR-100) at Week 12
Description
Clinical response 100 (CR-100) is defined as a decrease of at least 100 points in CDAI from Baseline. CDAI is a composite instrument that includes participant symptoms evaluated over 7 days (abdominal pain, stool frequency and general well-being), as well as presence of complications (arthritis/arthralgia, iritis/uveitis, erythema nodosum/pyoderma gangrenosum/aphthous stomatitis, anal fissure/fistula/abscess, other fistula, and fever), the use of antidiarrheal medicines, presence of an abdominal mass, hematocrit, and body weight. These items are scored individually, weighted, and do not contribute equally to the overall score. The CDAI is derived from summing up the weighted individual scores of eight items. CDAI approximately ranges from 0 to 600 with higher scores indicating more severe disease.
Time Frame
Baseline and Week 12
Title
Percentage of Participants With Clinical Remission Per CDAI at Week 4
Description
CDAI is a composite instrument that includes participant symptoms evaluated over 7 days (abdominal pain, stool frequency and general well-being), as well as presence of complications (arthritis/arthralgia, iritis/uveitis, erythema nodosum/pyoderma gangrenosum/aphthous stomatitis, anal fissure/fistula/abscess, other fistula, and fever), the use of antidiarrheal medicines, presence of an abdominal mass, hematocrit, and body weight. These items are scored individually, weighted, and do not contribute equally to the overall score. The CDAI is derived from summing up the weighted individual scores of eight items. CDAI approximately ranges from 0 to 600 with higher scores indicating more severe disease. Clinical remission is defined as CDAI score less than 150.
Time Frame
Week 4
Title
Percentage of Participants With Hospitalizations Due to Crohn's Disease (CD) During the 12-Week Induction Period
Description
This was assessed by reviewing participant's hospitalization data.
Time Frame
12 weeks
Title
Percentage of Participants With Resolution of Extra-Intestinal Manifestation (EIMs) at Week 12
Description
EIMs are defined as manifestations of Crohn's disease in areas of the body other than the digestive tract, including eyes, skin, joints, mouth, and liver. Only participants with any EIM present at Baseline were included in the analysis of resolution of EIMs. Resolution of EIMs was defined as absence of all EIMs at the Week 12 visit.
Time Frame
Week 12
Title
Percentage of Participants With Clinical Remission Per PROs at Week 4
Description
Clinical remission per PROs was defined as average daily very soft or liquid SF ≤ 2.8 and average daily APS ≤ 1.0 and neither worse than Baseline. Participants recorded APS and the number of liquid or very soft SF daily in an electronic diary. Abdominal pain was rated on a scale from 0 (none) to 3 (severe). The average daily very soft or liquid SF and APS were calculated using the 4-7 most recent useable days of patient-reported outcomes (i.e., excluding days with missing entries or associated with endoscopy procedures) out of the last 14 days prior to the Week 4 visit.
Time Frame
Week 4
Title
Percentage of Participants Who Discontinued Corticosteroid Use for Crohn's Disease and Achieved Clinical Remission Per PROs at Week 12
Description
Corticosteroid-free clinical remission is defined as participants who discontinued corticosteroid use for CD and achieved clinical remission per PROs at Week 12, assessed for participants taking corticosteroids for CD at Baseline. Clinical remission per PROs was defined as average daily very soft or liquid stool frequency (SF) ≤ 2.8 and average daily APS ≤ 1.0 and neither worse than Baseline. Participants recorded APS and the number of liquid or very soft SF daily in an electronic diary. Abdominal pain was rated on a scale from 0 (none) to 3 (severe). The average daily liquid or very soft SF and APS were calculated using the 4-7 most recent useable days of patient-reported outcomes (i.e., excluding days with missing entries or associated with endoscopy procedures) out of the last 14 days prior to the Week 12 visit.
Time Frame
Week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Confirmed diagnosis of CD for at least 3 months prior to Baseline. Confirmed diagnosis of moderate to severe CD as assessed by stool frequency (SF), abdominal pain (AP) score. Evidence of mucosal inflammation based on the Simplified Endoscopic Score for Crohn's disease (SES-CD) on an endoscopy confirmed by a central reader. Demonstrated an inadequate response or intolerance to one or more conventional and/or biologic therapies (oral locally acting steroids, intravenous or oral corticosteroids, immunosuppressants or biologic therapies for CD), in the opinion of the investigator. Note: Participants who have had inadequate response or intolerance to conventional therapy who have received prior biologic may be enrolled; however, participants must have discontinued the biologic for reasons other than inadequate response or intolerance (e.g., change of insurance, well controlled disease). If female, participant must meet the contraception recommendations. Exclusion Criteria: Participant with a current diagnosis of ulcerative colitis or indeterminate colitis. Participant not on stable doses of CD related antibiotics, oral aminosalicylates, corticosteroids or methotrexate (MTX). Participant with the following ongoing known complications of CD: abscess (abdominal or peri-anal), symptomatic bowel strictures, fulminant colitis, toxic megacolon, > 2 entire missing segments of the following 5 segments: terminal ileum, right colon, transverse colon, sigmoid and left colon, and rectum, or any other manifestation that might require surgery while enrolled in the study. Participant with ostomy or ileoanal pouch. Participant diagnosed with conditions that could interfere with drug absorption including but not limited to short gut or short bowel syndrome. Screening laboratory and other analyses show abnormal results.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ABBVIE INC.
Organizational Affiliation
AbbVie
Official's Role
Study Director
Facility Information:
Facility Name
East View Medical Research, LLC /ID# 171176
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36606
Country
United States
Facility Name
CB Flock Research Corporation /ID# 166185
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36608
Country
United States
Facility Name
Delsol Research Management, Ll /Id# 170145
City
Chandler
State/Province
Arizona
ZIP/Postal Code
85224
Country
United States
Facility Name
HonorHealth Research Institute - Shea /ID# 164821
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85258
Country
United States
Facility Name
Arizona Arthritis & Rheumatology Research, PLLC /ID# 164803
City
Sun City
State/Province
Arizona
ZIP/Postal Code
85306
Country
United States
Facility Name
Southern California Res. Ctr. /ID# 169655
City
Coronado
State/Province
California
ZIP/Postal Code
92118-1408
Country
United States
Facility Name
Citrus Valley Gastroenterology /ID# 166173
City
Covina
State/Province
California
ZIP/Postal Code
91722-3797
Country
United States
Facility Name
Hoag Memorial Hosp Presbyterian /ID# 222540
City
Irvine
State/Province
California
ZIP/Postal Code
92618
Country
United States
Facility Name
United Medical Doctors /ID# 207449
City
Los Alamitos
State/Province
California
ZIP/Postal Code
90720-3309
Country
United States
Facility Name
Gastrointestinal Biosciences Clinical Trials, LLC /ID# 164762
City
Los Angeles
State/Province
California
ZIP/Postal Code
90067-2001
Country
United States
Facility Name
Facey Medical Foundation /ID# 203136
City
Mission Hills
State/Province
California
ZIP/Postal Code
91345
Country
United States
Facility Name
United Medical Doctors - Murrieta /ID# 164945
City
Murrieta
State/Province
California
ZIP/Postal Code
92563
Country
United States
Facility Name
Ucsd /Id# 164910
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
Medical Assoc Research Grp /ID# 169706
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Univ of California San Francis /ID# 164944
City
San Francisco
State/Province
California
ZIP/Postal Code
94158
Country
United States
Facility Name
Care Access Research /ID# 167767
City
San Pablo
State/Province
California
ZIP/Postal Code
94806
Country
United States
Facility Name
Peak Gastroenterology Associates, PC /ID# 170143
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80907
Country
United States
Facility Name
Delta Waves, Inc. /ID# 164776
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80918
Country
United States
Facility Name
Western States Clinical Res /ID# 164760
City
Wheat Ridge
State/Province
Colorado
ZIP/Postal Code
80033-2896
Country
United States
Facility Name
Medical Research Center of CT /ID# 164926
City
Hamden
State/Province
Connecticut
ZIP/Postal Code
06518
Country
United States
Facility Name
Clinical Research of West Florida, Inc /ID# 205827
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33765
Country
United States
Facility Name
Clinical Research of West Florida, Inc /ID# 208118
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33765
Country
United States
Facility Name
Advanced Research - Coral Springs /ID# 218021
City
Coral Springs
State/Province
Florida
ZIP/Postal Code
33067-3173
Country
United States
Facility Name
Encore Borland-Groover Clinical Research /Id# 203499
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32256
Country
United States
Facility Name
Ctr for Advanced Gastroenterol /ID# 165353
City
Maitland
State/Province
Florida
ZIP/Postal Code
32751-6108
Country
United States
Facility Name
Crystal Pharmacology Research /ID# 166081
City
Miami
State/Province
Florida
ZIP/Postal Code
33165
Country
United States
Facility Name
Coral Research Clinic /ID# 164890
City
Miami
State/Province
Florida
ZIP/Postal Code
33186-4643
Country
United States
Facility Name
Advanced Research Institute, Inc /ID# 164921
City
New Port Richey
State/Province
Florida
ZIP/Postal Code
34653
Country
United States
Facility Name
Endoscopic Research, Inc. /ID# 206136
City
Orlando
State/Province
Florida
ZIP/Postal Code
32803
Country
United States
Facility Name
Omega Research Maitland, LLC /ID# 203481
City
Orlando
State/Province
Florida
ZIP/Postal Code
32808
Country
United States
Facility Name
Clinical Research Trials of Florida, Inc. /ID# 203485
City
Tampa
State/Province
Florida
ZIP/Postal Code
33607
Country
United States
Facility Name
AdventHealth Tampa /ID# 171167
City
Tampa
State/Province
Florida
ZIP/Postal Code
33613-4680
Country
United States
Facility Name
Gastroenterology Associates of Central Georgia, LLC /ID# 165478
City
Macon
State/Province
Georgia
ZIP/Postal Code
31201
Country
United States
Facility Name
Gastroenterology Consultants PC - Roswell /ID# 218220
City
Roswell
State/Province
Georgia
ZIP/Postal Code
30076-4913
Country
United States
Facility Name
Atlanta Gastroenterology Spec /ID# 164799
City
Suwanee
State/Province
Georgia
ZIP/Postal Code
30024
Country
United States
Facility Name
Treasure Valley Medical Research /ID# 215032
City
Boise
State/Province
Idaho
ZIP/Postal Code
83706
Country
United States
Facility Name
Rush University Medical Center /ID# 165497
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
University of Chicago Medicine /ID# 165503
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637-1426
Country
United States
Facility Name
DuPage Medical Group /ID# 205328
City
Downers Grove
State/Province
Illinois
ZIP/Postal Code
60515-5509
Country
United States
Facility Name
MediSphere Medical Research Center /ID# 166175
City
Evansville
State/Province
Indiana
ZIP/Postal Code
47714-8011
Country
United States
Facility Name
Indianapolis Gastroenterology /ID# 164938
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46237
Country
United States
Facility Name
University of Iowa Hospitals and Clinics /ID# 165436
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
Tri-State Gastroenterology /ID# 165496
City
Crestview Hills
State/Province
Kentucky
ZIP/Postal Code
41017
Country
United States
Facility Name
University of Louisville /ID# 165366
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
University of Louisville /ID# 168572
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
CroNOLA, LLC /ID# 164823
City
Houma
State/Province
Louisiana
ZIP/Postal Code
70360
Country
United States
Facility Name
Nola Research Works, LLC /ID# 164759
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70115
Country
United States
Facility Name
Louisana Research Center, LLC /ID# 164894
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71105-6800
Country
United States
Facility Name
Johns Hopkins University School of Medicine /ID# 211941
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287-0010
Country
United States
Facility Name
MGG Group Co, Inc.Chevy Chase Clinical Research /ID# 164935
City
Chevy Chase
State/Province
Maryland
ZIP/Postal Code
20815
Country
United States
Facility Name
Gastro Center of Maryland /ID# 171161
City
Columbia
State/Province
Maryland
ZIP/Postal Code
21045
Country
United States
Facility Name
Lahey Hospital and Medical Center /ID# 214726
City
Burlington
State/Province
Massachusetts
ZIP/Postal Code
01805
Country
United States
Facility Name
University of Michigan Comprehensive Cancer Center Michigan Medicine /ID# 164943
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
Digestive Health Associates (DHA) - Farmington Hills /ID# 205793
City
Farmington Hills
State/Province
Michigan
ZIP/Postal Code
48334-3230
Country
United States
Facility Name
Center for Digestive Health /ID# 164822
City
Troy
State/Province
Michigan
ZIP/Postal Code
48098-6363
Country
United States
Facility Name
Clin Res Inst of Michigan, LLC /ID# 170133
City
Troy
State/Province
Michigan
ZIP/Postal Code
48098
Country
United States
Facility Name
Mayo Clinic - Rochester /ID# 164783
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905-0001
Country
United States
Facility Name
Southern Therapy and Advanced Research (STAR) LLC /ID# 165343
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39216
Country
United States
Facility Name
Quality Clinical Research Inc. /ID# 170137
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68114-3723
Country
United States
Facility Name
Duplicate_CHI Nebraska d/b/a CHI Health /ID# 168578
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68124
Country
United States
Facility Name
Las Vegas Medical Research /ID# 168588
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89113
Country
United States
Facility Name
AGA Clinical Research Associates, LLC /ID# 164769
City
Egg Harbor Township
State/Province
New Jersey
ZIP/Postal Code
08234
Country
United States
Facility Name
Rutgers Robert Wood Johnson /ID# 166073
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08901
Country
United States
Facility Name
Montefiore Medical Center - Moses Campus /ID# 166193
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
Facility Name
Advantage Clinical Trials /ID# 168546
City
Bronx
State/Province
New York
ZIP/Postal Code
10468
Country
United States
Facility Name
NY Scientific /ID# 164931
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11235
Country
United States
Facility Name
United Health Services Hospitals, Inc /ID# 217485
City
Johnson City
State/Province
New York
ZIP/Postal Code
13790-2107
Country
United States
Facility Name
NYU Langone Long Island Clinical Research Associates /ID# 164927
City
Lake Success
State/Province
New York
ZIP/Postal Code
11042
Country
United States
Facility Name
The Mount Sinai Hospital /ID# 170257
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Columbia Univ Medical Center /ID# 164782
City
New York
State/Province
New York
ZIP/Postal Code
10032-3725
Country
United States
Facility Name
Gastoenterology Group of Rochester /ID# 166177
City
Rochester
State/Province
New York
ZIP/Postal Code
14618-5703
Country
United States
Facility Name
Richmond University Medical Center /ID# 201857
City
Staten Island
State/Province
New York
ZIP/Postal Code
10310-1664
Country
United States
Facility Name
Atrium Health Carolinas Medical Center /ID# 164932
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28203
Country
United States
Facility Name
PMG Research of Charlotte /ID# 171160
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28209
Country
United States
Facility Name
Wake Radiology UNC REX Healthcare - Raleigh Office /ID# 164904
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27612
Country
United States
Facility Name
Wake Forest Baptist Medical Center /ID# 164908
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157-0001
Country
United States
Facility Name
Plains Clinical Research Center, LLC /ID# 170140
City
Fargo
State/Province
North Dakota
ZIP/Postal Code
58104-5925
Country
United States
Facility Name
Gastro Health Research /ID# 164791
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
University of Cincinnati /ID# 164825
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267-0585
Country
United States
Facility Name
Cleveland Clinic Main Campus /ID# 209231
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
The Ohio State University /ID# 170141
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Optimed Research, Ltd. /ID# 205624
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43235
Country
United States
Facility Name
Hometown Urgent Care and Resea /ID# 201291
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45424
Country
United States
Facility Name
Dayton Gastroenterology, Inc. /ID# 167627
City
Englewood
State/Province
Ohio
ZIP/Postal Code
45415
Country
United States
Facility Name
Great Lakes Medical Research, LLC /ID# 202010
City
Mentor
State/Province
Ohio
ZIP/Postal Code
44060-6211
Country
United States
Facility Name
Digestive Disease Specialists /ID# 201064
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73112
Country
United States
Facility Name
Options Health Research, LLC /ID# 164820
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74104
Country
United States
Facility Name
Healthcare Research Consultant /ID# 166195
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74135
Country
United States
Facility Name
University of Pennsylvania /ID# 168430
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104-5502
Country
United States
Facility Name
Pharmacorp Clinical Trials /ID# 164916
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29412
Country
United States
Facility Name
Gastroenterology Associates, P.A. of Greenville /ID# 164771
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29615-3593
Country
United States
Facility Name
Rapid City Medical Center - GI Research /ID# 201735
City
Rapid City
State/Province
South Dakota
ZIP/Postal Code
57701
Country
United States
Facility Name
Gastro One /ID# 164826
City
Germantown
State/Province
Tennessee
ZIP/Postal Code
38138
Country
United States
Facility Name
East Tennessee Research Institute /ID# 203613
City
Johnson City
State/Province
Tennessee
ZIP/Postal Code
37604
Country
United States
Facility Name
Quality Medical Research /ID# 205263
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37211
Country
United States
Facility Name
Vanderbilt University Medical Center /ID# 164946
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232-0011
Country
United States
Facility Name
TX Clinical Research Institute /ID# 164896
City
Arlington
State/Province
Texas
ZIP/Postal Code
76012
Country
United States
Facility Name
Inquest Clinical Research /ID# 164785
City
Baytown
State/Province
Texas
ZIP/Postal Code
77521-2415
Country
United States
Facility Name
Texas Digestive Disease Consultants /ID# 209953
City
Cedar Park
State/Province
Texas
ZIP/Postal Code
78613-5028
Country
United States
Facility Name
Texas Digestive Disease Consultants /ID# 209801
City
Cedar Park
State/Province
Texas
ZIP/Postal Code
78613
Country
United States
Facility Name
Baylor Scott & White Center for Inflammatory Bowel Diseases /ID# 170144
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
CliniCore International, LLC /ID# 164902
City
Houston
State/Province
Texas
ZIP/Postal Code
77027-6812
Country
United States
Facility Name
Baylor College of Medicine - Baylor Medical Center /ID# 164947
City
Houston
State/Province
Texas
ZIP/Postal Code
77030-3411
Country
United States
Facility Name
Centex Studies, Inc. - Houston /ID# 201214
City
Houston
State/Province
Texas
ZIP/Postal Code
77058
Country
United States
Facility Name
GI Specialists of Houston /ID# 202339
City
Houston
State/Province
Texas
ZIP/Postal Code
77070-4347
Country
United States
Facility Name
Caprock Gastro Research, LLC /ID# 215438
City
Lubbock
State/Province
Texas
ZIP/Postal Code
79424-3017
Country
United States
Facility Name
Clinical Associates in Research Therapeutics of America, LLC /ID# 164786
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78212
Country
United States
Facility Name
Southern Star Research Institute, LLC /ID# 169755
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229-5390
Country
United States
Facility Name
Carl R. Meisner Medical Clinic /ID# 201061
City
Sugar Land
State/Province
Texas
ZIP/Postal Code
77478
Country
United States
Facility Name
Tyler Research Institute, LLC /ID# 168687
City
Tyler
State/Province
Texas
ZIP/Postal Code
75701-4464
Country
United States
Facility Name
Gastro Health & Nutrition - Victoria /ID# 167812
City
Victoria
State/Province
Texas
ZIP/Postal Code
77904
Country
United States
Facility Name
HP Clinical Research /ID# 164933
City
Bountiful
State/Province
Utah
ZIP/Postal Code
84010
Country
United States
Facility Name
Advanced Research Institute /ID# 164784
City
Ogden
State/Province
Utah
ZIP/Postal Code
84403
Country
United States
Facility Name
Duplicate_Care Access Research /ID# 164794
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84124-1377
Country
United States
Facility Name
Velocity Clinical Research - Salt Lake City /ID# 166076
City
West Jordan
State/Province
Utah
ZIP/Postal Code
84088
Country
United States
Facility Name
Washington Gastroenterology /ID# 164824
City
Bellevue
State/Province
Washington
ZIP/Postal Code
98004
Country
United States
Facility Name
Virginia Mason Medical Center /ID# 164913
City
Seattle
State/Province
Washington
ZIP/Postal Code
98101
Country
United States
Facility Name
The Vancouver Clinic, INC. PS /ID# 164918
City
Vancouver
State/Province
Washington
ZIP/Postal Code
98664
Country
United States
Facility Name
Allegiance Research Specialists /ID# 165346
City
Wauwatosa
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Facility Name
Cardio Alem /ID# 211285
City
San Isidro
State/Province
Buenos Aires
ZIP/Postal Code
1642
Country
Argentina
Facility Name
Hospital Italiano de Buenos Aires /ID# 215541
City
Ciudad Autonoma Buenos Aires
State/Province
Ciuadad Autonoma De Buenos Aires
ZIP/Postal Code
1199
Country
Argentina
Facility Name
Gedyt /ID# 210020
City
Ciudad Autonoma de Buenos Aire
State/Province
Ciuadad Autonoma De Buenos Aires
ZIP/Postal Code
1115
Country
Argentina
Facility Name
Cemic /Id# 169182
City
Ciudad Autonoma de Buenos Aire
State/Province
Ciuadad Autonoma De Buenos Aires
ZIP/Postal Code
1431
Country
Argentina
Facility Name
Hospital Provincial del Centenario /ID# 171252
City
Rosario
State/Province
Santa Fe
ZIP/Postal Code
2000
Country
Argentina
Facility Name
Hospital Privado Univesitario /ID# 169230
City
Cordoba
ZIP/Postal Code
5016
Country
Argentina
Facility Name
Concord Repatriation General Hospital /ID# 171512
City
Concord
State/Province
New South Wales
ZIP/Postal Code
2139
Country
Australia
Facility Name
Coral Sea Clinical Research institute /ID# 212988
City
North Mackay
State/Province
Queensland
ZIP/Postal Code
4740
Country
Australia
Facility Name
Mater Misericordiae Limited /ID# 204909
City
South Brisbane
State/Province
Queensland
ZIP/Postal Code
4101
Country
Australia
Facility Name
Royal Adelaide Hospital /ID# 171514
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5000
Country
Australia
Facility Name
Box Hill Hospital /ID# 203736
City
Box Hill
State/Province
Victoria
ZIP/Postal Code
3128
Country
Australia
Facility Name
Fiona Stanley Hospital /ID# 171513
City
Murdoch
State/Province
Western Australia
ZIP/Postal Code
6150
Country
Australia
Facility Name
Medizinische Universitaet Wien /ID# 169465
City
Vienna
State/Province
Wien
ZIP/Postal Code
1090
Country
Austria
Facility Name
Landeskrankenhaus Salzburg-Universitätsklinikum der PMU (LKH) /ID# 214470
City
Salzburg
ZIP/Postal Code
5020
Country
Austria
Facility Name
UCL Saint-Luc /ID# 200303
City
Woluwe-Saint-Lambert
State/Province
Bruxelles-Capitale
ZIP/Postal Code
1200
Country
Belgium
Facility Name
CHU de Liege Sart Tilman /ID# 217534
City
Liège
State/Province
Liege
ZIP/Postal Code
4000
Country
Belgium
Facility Name
AZ Sint-Lucas /ID# 200302
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
University Clinical Centre of the Republic of Srpska /ID# 208051
City
Banja Luka
State/Province
Republika Srpska
ZIP/Postal Code
78000
Country
Bosnia and Herzegovina
Facility Name
University Clinical Center Tuzla /ID# 210325
City
Tuzla
State/Province
Tuzlanski
ZIP/Postal Code
75000
Country
Bosnia and Herzegovina
Facility Name
Clinical Center University of Sarajevo /ID# 203887
City
Sarajevo
ZIP/Postal Code
71000
Country
Bosnia and Herzegovina
Facility Name
Polyclinic and Daily Hospital Dr. Al-Tawil /ID# 217842
City
Sarajevo
ZIP/Postal Code
71000
Country
Bosnia and Herzegovina
Facility Name
Instituto Goiano de Gastroenterologia e Endoscopia Digestiva /ID# 166852
City
Goiânia
State/Province
Goias
ZIP/Postal Code
74535-170
Country
Brazil
Facility Name
Hospital Nossa Senhora das Graças /ID# 166863
City
Curitiba
State/Province
Parana
ZIP/Postal Code
80810-040
Country
Brazil
Facility Name
Hospital de Clinicas de Porto Alegre /ID# 166862
City
Porto Alegre
State/Province
Rio Grande Do Sul
ZIP/Postal Code
90035-903
Country
Brazil
Facility Name
Upeclin Fmb - Unesp /Id# 166867
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# 166866
City
Ribeirão Preto
State/Province
Sao Paulo
ZIP/Postal Code
14051-140
Country
Brazil
Facility Name
Faculdade de Medicina do ABC /ID# 208323
City
Santo André
State/Province
Sao Paulo
ZIP/Postal Code
09060-870
Country
Brazil
Facility Name
Kaiser Clinica e Hospital Dia /ID# 166865
City
Sao Jose Do Rio Preto
State/Province
Sao Paulo
ZIP/Postal Code
15015-110
Country
Brazil
Facility Name
UMHAT Kaspela EOOD /ID# 167613
City
Plovdiv
ZIP/Postal Code
4001
Country
Bulgaria
Facility Name
Duplicate_Second MHAT Sofia /ID# 167614
City
Sofia
ZIP/Postal Code
1202
Country
Bulgaria
Facility Name
MHAT Trakia /ID# 201679
City
Stara Zagora
ZIP/Postal Code
6004
Country
Bulgaria
Facility Name
University of Calgary /ID# 166974
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4Z6
Country
Canada
Facility Name
Allen Whey Khye Lim Professional Corporation /ID# 168044
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T5R 1W2
Country
Canada
Facility Name
University of Alberta - Zeidler Ledcor Centre /ID# 166971
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2X8
Country
Canada
Facility Name
South Edmonton Gastroenterology Research Clinic /ID# 166978
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6K 4B2
Country
Canada
Facility Name
Fraser Clinical Trials Inc /ID# 166968
City
New Westminster
State/Province
British Columbia
ZIP/Postal Code
V3L 3W4
Country
Canada
Facility Name
GIRI Gastrointestinal Research Institute /ID# 166975
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6Z 2K5
Country
Canada
Facility Name
QEII - Health Sciences Centre /ID# 169307
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 2Y9
Country
Canada
Facility Name
London Health Sciences Center /ID# 221038
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5W9
Country
Canada
Facility Name
Scott Shulman Medicine Professional Corporation /ID# 169066
City
North Bay
State/Province
Ontario
ZIP/Postal Code
P1B 2H3
Country
Canada
Facility Name
Taunton Surgical Centre /ID# 168043
City
Oshawa
State/Province
Ontario
ZIP/Postal Code
L1H 7K4
Country
Canada
Facility Name
Ottawa Hospital Research Institute /ID# 212414
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 8L6
Country
Canada
Facility Name
Medicor Research Inc /ID# 166979
City
Sudbury
State/Province
Ontario
ZIP/Postal Code
P3A 1W8
Country
Canada
Facility Name
Toronto Digestive Disease Asso /ID# 166972
City
Vaughan
State/Province
Ontario
ZIP/Postal Code
L4L 4Y7
Country
Canada
Facility Name
CISSS de Chaudière-Appalaches, Hôpital Hotel-Dieu de Lévis /ID# 166969
City
Levis
State/Province
Quebec
ZIP/Postal Code
G6V 3Z1
Country
Canada
Facility Name
Centre Hospitalier de l'Universite de Montreal - CRCHUM /ID# 170120
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2X 0A9
Country
Canada
Facility Name
Royal Victoria Hospital / McGill University Health Centre /ID# 170119
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H4A 3J1
Country
Canada
Facility Name
CIUSSS de l'Estrie - CHUS /ID# 170940
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1G 2E8
Country
Canada
Facility Name
Research Group /ID# 203179
City
Santiago
State/Province
Region Metropolitana De Santiago
ZIP/Postal Code
2540364
Country
Chile
Facility Name
M y F Estudios Clínicos /ID# 169984
City
Santiago
State/Province
Region Metropolitana Santiago
ZIP/Postal Code
7750495
Country
Chile
Facility Name
Hospital Guillermo Grant Benavente de Concepción /ID# 212423
City
Concepción
ZIP/Postal Code
4070038
Country
Chile
Facility Name
CTR Estudios Clinicos /ID# 203941
City
Providencia
ZIP/Postal Code
7500571
Country
Chile
Facility Name
Hospital Clinico Universidad De Los Andes /ID# 207466
City
Santiago
ZIP/Postal Code
7501504
Country
Chile
Facility Name
Zhongshan Hospital Xiamen University /ID# 204984
City
Xiamen
State/Province
Fujian
ZIP/Postal Code
361004
Country
China
Facility Name
The First Affiliated Hospital, Sun Yat-sen University /ID# 205228
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510080
Country
China
Facility Name
Nanfang Hospital of Southern Medical University /ID# 204083
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510515
Country
China
Facility Name
The Sixth Affiliated Hosp Sun /ID# 204077
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510655
Country
China
Facility Name
Union Hospital Tongji Medical College Huazhong University of Science and Technol /ID# 204081
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430022
Country
China
Facility Name
Nanjing Drum Tower Hospital /ID# 204900
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210008
Country
China
Facility Name
The First Affiliated Hospital of Nanchang University /ID# 204092
City
Nanchang
State/Province
Jiangxi
ZIP/Postal Code
330006
Country
China
Facility Name
The First Hospital of Jilin University /ID# 206868
City
Changchun
State/Province
Jilin
ZIP/Postal Code
130021
Country
China
Facility Name
Ruijin Hospital, Shanghai Jiaotong University School of Medicine /ID# 204091
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200065
Country
China
Facility Name
The second Affiliated hospital of Zhejiang University school of Medicine /ID# 204073
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310009
Country
China
Facility Name
Sir Run Run Shaw Hospital,Meical School Zhejiang University /ID# 204076
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310018
Country
China
Facility Name
Beijing Friendship Hospital /ID# 204173
City
Beijing
ZIP/Postal Code
100032
Country
China
Facility Name
The Second Xiangya Hospital of Central South University /ID# 204082
City
Changsha
ZIP/Postal Code
410011
Country
China
Facility Name
Duplicate_Tianjin Med Univ General Hosp /ID# 206994
City
Tianjin
ZIP/Postal Code
300052
Country
China
Facility Name
Tongji Hospital Tongji Medical College of HUST /ID# 204088
City
Wuhan
ZIP/Postal Code
430030
Country
China
Facility Name
Hospital Pablo Tobon Uribe /ID# 202404
City
Medellín
State/Province
Antioquia
ZIP/Postal Code
50034
Country
Colombia
Facility Name
Hospital Universitario San Vic /ID# 200029
City
Medellin
ZIP/Postal Code
50010
Country
Colombia
Facility Name
Clinical Hospital Dubrava /ID# 171185
City
Zagreb
State/Province
Grad Zagreb
ZIP/Postal Code
10000
Country
Croatia
Facility Name
Klinicki bolnicki centar Sestre milosrdnice /ID# 205535
City
Zagreb
State/Province
Grad Zagreb
ZIP/Postal Code
10000
Country
Croatia
Facility Name
Klinicki bolnicki centar Zagreb /ID# 171203
City
Zagreb
State/Province
Grad Zagreb
ZIP/Postal Code
10000
Country
Croatia
Facility Name
Poliklinika Solmed /ID# 211519
City
Zagreb
State/Province
Grad Zagreb
ZIP/Postal Code
10000
Country
Croatia
Facility Name
UHC Split /ID# 171191
City
Split
ZIP/Postal Code
21000
Country
Croatia
Facility Name
Zadar General Hospital /ID# 205536
City
Zadar
ZIP/Postal Code
23000
Country
Croatia
Facility Name
Nemocnice Ceske Budejovice a.s. /ID# 224389
City
Ceske Budejovice
ZIP/Postal Code
370 01
Country
Czechia
Facility Name
Hepato-Gastroenterologie HK, s.r.o. /ID# 171401
City
Hradec Kralove
ZIP/Postal Code
500 12
Country
Czechia
Facility Name
ARTROSCAN s.r.o. /ID# 200790
City
Ostrava
ZIP/Postal Code
722 00
Country
Czechia
Facility Name
ResTrial s.r.o. /ID# 208653
City
Praha
ZIP/Postal Code
143 00
Country
Czechia
Facility Name
Herlev Hospital /ID# 202423
City
Herlev
State/Province
Hovedstaden
ZIP/Postal Code
2730
Country
Denmark
Facility Name
Nordsjaellands Hospital /ID# 202424
City
Hilleroed
State/Province
Hovedstaden
ZIP/Postal Code
3600
Country
Denmark
Facility Name
Kobenhavns Universitet - Hvidovre Hospital (HH) /ID# 202425
City
Hvidovre
State/Province
Hovedstaden
ZIP/Postal Code
2650
Country
Denmark
Facility Name
Duplicate_Sjaellands Universitets Hospital /ID# 209445
City
Roskilde
State/Province
Sjælland
ZIP/Postal Code
4000
Country
Denmark
Facility Name
Clinical Research Center, Faculty of Medicine, Alexandria university. /ID# 171012
City
Alexandria
ZIP/Postal Code
21131
Country
Egypt
Facility Name
Clinical Research Center, Faculty of Medicine, Alexandria university. /ID# 171013
City
Alexandria
ZIP/Postal Code
21131
Country
Egypt
Facility Name
Clinical Research Center, Faculty of Medicine, Alexandria university. /ID# 209564
City
Alexandria
ZIP/Postal Code
21131
Country
Egypt
Facility Name
National Hepatology and Tropical Medicine Research Institute /ID# 170989
City
Cairo
ZIP/Postal Code
11559
Country
Egypt
Facility Name
Air Force Specialized Hospital /ID# 170996
City
Cairo
Country
Egypt
Facility Name
National Liver Institute /ID# 170988
City
Menoufiya
ZIP/Postal Code
35111
Country
Egypt
Facility Name
West Tallinn Central Hospital /ID# 202785
City
Tallinn
ZIP/Postal Code
10617
Country
Estonia
Facility Name
CHU Grenoble - Hopital Michallon /ID# 219034
City
La Tronche
ZIP/Postal Code
38700
Country
France
Facility Name
Clinique Jules Verne /ID# 219073
City
Nantes
ZIP/Postal Code
44300
Country
France
Facility Name
CH Valenciennes /ID# 219035
City
Valenciennes
ZIP/Postal Code
59300
Country
France
Facility Name
Universitatsklinikum Mannheim /ID# 168759
City
Mannheim
State/Province
Baden-Wuerttemberg
ZIP/Postal Code
68167
Country
Germany
Facility Name
Universitaetsklinikum Ulm /ID# 203560
City
Ulm
State/Province
Baden-Wuerttemberg
ZIP/Postal Code
89081
Country
Germany
Facility Name
Universitaetsklinikum Erlangen /ID# 203552
City
Erlangen
State/Province
Bayern
ZIP/Postal Code
91054
Country
Germany
Facility Name
Universitaetsklinikum Frankfurt /ID# 203566
City
Frankfurt am Main
State/Province
Hessen
ZIP/Postal Code
60590
Country
Germany
Facility Name
Zentrum für Gastroenterologie Saar MVZ GmbH /ID# 206741
City
Saarbrücken
State/Province
Saarland
ZIP/Postal Code
66111
Country
Germany
Facility Name
Universitaetsklinikum Schleswig-Holstein Campus Kiel /ID# 168757
City
Kiel
State/Province
Schleswig-Holstein
ZIP/Postal Code
24105
Country
Germany
Facility Name
Gastroenterologie am Mexikoplatz /ID# 203575
City
Berlin
ZIP/Postal Code
14163
Country
Germany
Facility Name
Universitaetsmedizin Essen St. Josef Krankenhaus Werden /ID# 203570
City
Essen
ZIP/Postal Code
45239
Country
Germany
Facility Name
Agaplesion Markus Krankenhaus /ID# 168758
City
Frankfurt am Main
ZIP/Postal Code
60431
Country
Germany
Facility Name
Universitaetsklinikum Halle (Saale) /ID# 207455
City
Halle (Saale)
ZIP/Postal Code
06120
Country
Germany
Facility Name
Medizinisches Versorgungszentrum Portal 10 /ID# 200214
City
Muenster
ZIP/Postal Code
48155
Country
Germany
Facility Name
General Hospital of Athens Ippokratio /ID# 167045
City
Athens
State/Province
Attiki
ZIP/Postal Code
11527
Country
Greece
Facility Name
General Hospital of Chest Diseases of Athens SOTIRIA /ID# 202104
City
Athens
State/Province
Attiki
ZIP/Postal Code
11527
Country
Greece
Facility Name
Tzaneio general hospital of Piraeus /ID# 206433
City
Piraeus
State/Province
Attiki
ZIP/Postal Code
18536
Country
Greece
Facility Name
University General Hospital of Heraklion PA.G.N.I /ID# 167044
City
Heraklion
State/Province
Kriti
ZIP/Postal Code
71500
Country
Greece
Facility Name
General Hospital of Thessaloniki Hippokrateio /ID# 208825
City
Thessaloniki
ZIP/Postal Code
54642
Country
Greece
Facility Name
Tuen Mun Hospital /ID# 171218
City
Hong Kong
Country
Hong Kong
Facility Name
Mohacsi Korhaz /ID# 209441
City
Mohacs
State/Province
Baranya
ZIP/Postal Code
7700
Country
Hungary
Facility Name
CRU Hungary Egeszsegugyi és Szolgaltato Kft. /ID# 205547
City
Encs
State/Province
Borsod-Abauj-Zemplen
ZIP/Postal Code
3860
Country
Hungary
Facility Name
Debreceni Egyetem Klinikai Kozpont /ID# 216419
City
Debrecen
State/Province
Hajdu-Bihar
ZIP/Postal Code
4032
Country
Hungary
Facility Name
Bugat Pal Korhaz /ID# 201893
City
Gyöngyös
State/Province
Heves
ZIP/Postal Code
3200
Country
Hungary
Facility Name
Szent Borbala Korhaz /ID# 209897
City
Tatabanya
State/Province
Komarom-Esztergom
ZIP/Postal Code
2800
Country
Hungary
Facility Name
Obudai Egeszsegugyi Centrum Kft. /ID# 201892
City
Budapest
State/Province
Pest
ZIP/Postal Code
1036
Country
Hungary
Facility Name
Semmelweis Egyetem /ID# 210167
City
Budapest
ZIP/Postal Code
1085
Country
Hungary
Facility Name
Magyar Honvedseg Egeszsegugyi Kozpont /ID# 201724
City
Budapest
ZIP/Postal Code
1134
Country
Hungary
Facility Name
Debreceni Egyetem Kenezy Gyula Egyetemi Korhaz /ID# 201723
City
Debrecen
ZIP/Postal Code
4031
Country
Hungary
Facility Name
Pest Megyei Flor Ferenc Korhaz /ID# 206154
City
Kistarcsa
ZIP/Postal Code
2143
Country
Hungary
Facility Name
Mentahaz Maganorvosi Kozpont /ID# 201895
City
Szekesfehervar
ZIP/Postal Code
8000
Country
Hungary
Facility Name
Mercy University Hospital /ID# 206511
City
Cork
ZIP/Postal Code
T12 WE28
Country
Ireland
Facility Name
Soroka University Medical Center /ID# 169913
City
Be'er Sheva
State/Province
HaDarom
ZIP/Postal Code
8443901
Country
Israel
Facility Name
Tel Aviv Sourasky Medical Center /ID# 204877
City
Tel Aviv-Yafo
State/Province
Tel-Aviv
ZIP/Postal Code
6423906
Country
Israel
Facility Name
Assaf Harofeh Medical Center /ID# 204872
City
Be'Er Ya'Akov
ZIP/Postal Code
70300
Country
Israel
Facility Name
Hadassah Medical Center-Hebrew University /ID# 169928
City
Jerusalem
ZIP/Postal Code
91120
Country
Israel
Facility Name
Rabin Medical Center /ID# 202636
City
Petakh Tikva
ZIP/Postal Code
4941492
Country
Israel
Facility Name
Kaplan Medical Center /ID# 170276
City
Rehovot
ZIP/Postal Code
7661041
Country
Israel
Facility Name
Policlinico Universitario Campus Bio-Medico /ID# 168183
City
Rome
State/Province
Lazio
ZIP/Postal Code
00128
Country
Italy
Facility Name
Azienda Ospedaliera San Camillo Forlanini /ID# 168184
City
Rome
State/Province
Lazio
ZIP/Postal Code
00152
Country
Italy
Facility Name
Istituto Clinico Humanitas /ID# 168185
City
Rozzano
State/Province
Milano
ZIP/Postal Code
20089
Country
Italy
Facility Name
Fondazione PTV Policlinico Tor Vergata /ID# 168188
City
Rome
State/Province
Roma
ZIP/Postal Code
00133
Country
Italy
Facility Name
Presidio Columbus-Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Un /ID# 168182
City
Rome
State/Province
Roma
ZIP/Postal Code
00168
Country
Italy
Facility Name
IRCCS Ospedale Sacro Cuore Don Calabria /ID# 168186
City
Negrar
State/Province
Verona
ZIP/Postal Code
37024
Country
Italy
Facility Name
IRCCS Azienda Ospedaliero-Universitaria di Bologna /ID# 168187
City
Bologna
ZIP/Postal Code
40138
Country
Italy
Facility Name
A.O. Per L'Emergenza Cannizzaro /ID# 168190
City
Catania
ZIP/Postal Code
95126
Country
Italy
Facility Name
Policlinico San Martino/Univer /ID# 168191
City
Genova
ZIP/Postal Code
16132
Country
Italy
Facility Name
ASST Fatebenefratelli Sacco - Ospedale Fatebenefratelli e Oftalmico /ID# 168181
City
Milano
ZIP/Postal Code
20121
Country
Italy
Facility Name
ASST Grande Ospedale Metropolitano Niguarda /ID# 170849
City
Milano
ZIP/Postal Code
20162
Country
Italy
Facility Name
Azienda Ospedaliero-Universitaria di Modena /ID# 201897
City
Modena
ZIP/Postal Code
41124
Country
Italy
Facility Name
A.O. Ospedali Riuniti Villa Sofia - Cervello /ID# 168189
City
Palermo
ZIP/Postal Code
90146
Country
Italy
Facility Name
Azienda Ospedaliero Universitaria Pisana-Stabilimento di Cisanello /ID# 202421
City
Pisa
ZIP/Postal Code
56125
Country
Italy
Facility Name
Aichi Medical University Hospital /ID# 165971
City
Nagakute-shi
State/Province
Aichi
ZIP/Postal Code
480-1195
Country
Japan
Facility Name
Nagoya City University Hospital /ID# 165970
City
Nagoya shi
State/Province
Aichi
ZIP/Postal Code
467-8602
Country
Japan
Facility Name
Nagoya University Hospital /ID# 165969
City
Nagoya-shi
State/Province
Aichi
ZIP/Postal Code
4668560
Country
Japan
Facility Name
Toyohashi Municipal Hospital /ID# 200175
City
Toyohashi-shi
State/Province
Aichi
ZIP/Postal Code
441-8570
Country
Japan
Facility Name
National Hospital Organization Hirosaki General Medical Center /ID# 165961
City
Hirosaki-shi
State/Province
Aomori
ZIP/Postal Code
036-8545
Country
Japan
Facility Name
Toho University Sakura Medical Center /ID# 165963
City
Sakura-shi
State/Province
Chiba
ZIP/Postal Code
285-8741
Country
Japan
Facility Name
Fukuoka University Chikushi Hospital /ID# 214404
City
Chikushino-shi
State/Province
Fukuoka
ZIP/Postal Code
818-8502
Country
Japan
Facility Name
Kurume University Hospital /ID# 166012
City
Kurume-shi
State/Province
Fukuoka
ZIP/Postal Code
830-0011
Country
Japan
Facility Name
National Hospital Organization Takasaki General Medical Center /ID# 167127
City
Takasaki-shi
State/Province
Gunma
ZIP/Postal Code
370-0829
Country
Japan
Facility Name
NHO Fukuyama Medical Center /ID# 167131
City
Fukuyama-shi
State/Province
Hiroshima
ZIP/Postal Code
720-8520
Country
Japan
Facility Name
Hiroshima University Hospital /ID# 166014
City
Hiroshima-shi
State/Province
Hiroshima
ZIP/Postal Code
734-8551
Country
Japan
Facility Name
Asahikawa Medical University Hospital /ID# 167120
City
Asahikawa-shi
State/Province
Hokkaido
ZIP/Postal Code
078-8510
Country
Japan
Facility Name
Hokkaido P.W.F.A.C. Sapporo-Kosei General Hospital /ID# 165960
City
Sapporo-shi
State/Province
Hokkaido
ZIP/Postal Code
060-0033
Country
Japan
Facility Name
Sapporo Medical University Hospital /ID# 167124
City
Sapporo-shi
State/Province
Hokkaido
ZIP/Postal Code
060-8543
Country
Japan
Facility Name
Sapporo IBD Clinic /ID# 223561
City
Sapporo-shi
State/Province
Hokkaido
ZIP/Postal Code
064-0919
Country
Japan
Facility Name
Aoyama Clinic /ID# 166009
City
Kobe-shi
State/Province
Hyogo
ZIP/Postal Code
650-0015
Country
Japan
Facility Name
Hyogo College of Medicine College Hospital /Id# 165973
City
Nishinomiya-shi
State/Province
Hyogo
ZIP/Postal Code
663-8501
Country
Japan
Facility Name
Kanazawa University Hospital /ID# 169218
City
Kanazawa-shi
State/Province
Ishikawa
ZIP/Postal Code
920-8641
Country
Japan
Facility Name
Iwate Medical University Uchimaru Medical Center /ID# 202464
City
Morioka-shi
State/Province
Iwate
ZIP/Postal Code
020-8505
Country
Japan
Facility Name
Imamura General Hospital /ID# 227137
City
Kagoshima-shi
State/Province
Kagoshima
ZIP/Postal Code
890-0064
Country
Japan
Facility Name
Idzuro Imamura Hospital /ID# 206654
City
Kagoshima-shi
State/Province
Kagoshima
ZIP/Postal Code
892-0824
Country
Japan
Facility Name
Sameshima Hospital /ID# 206675
City
Kagoshima-shi
State/Province
Kagoshima
ZIP/Postal Code
892-0846
Country
Japan
Facility Name
Yokohama City University Medical Center /ID# 167128
City
Yokohama shi
State/Province
Kanagawa
ZIP/Postal Code
232-0024
Country
Japan
Facility Name
Japanese Red Cross Kyoto Daiichi Hosital /ID# 165972
City
Kyoto-shi
State/Province
Kyoto
ZIP/Postal Code
605-0981
Country
Japan
Facility Name
Kyoto University Hospital /ID# 169889
City
Kyoto-shi
State/Province
Kyoto
ZIP/Postal Code
606-8507
Country
Japan
Facility Name
Yokkaichi Hazu Medical Center /ID# 167196
City
Yokkaichi-shi
State/Province
Mie
ZIP/Postal Code
510-0016
Country
Japan
Facility Name
Tohoku University Hospital /ID# 167122
City
Sendai-shi
State/Province
Miyagi
ZIP/Postal Code
9808574
Country
Japan
Facility Name
Nara Medical University Hospital /ID# 169219
City
Kashihara-shi
State/Province
Nara
ZIP/Postal Code
634-8522
Country
Japan
Facility Name
Kenseikai Dongo Hospital /ID# 208104
City
Yamatotakada-shi
State/Province
Nara
ZIP/Postal Code
635-0022
Country
Japan
Facility Name
Niigata University Medical & Dental Hospital /ID# 170045
City
Niigata-shi
State/Province
Niigata
ZIP/Postal Code
951-8520
Country
Japan
Facility Name
Ishida Clinic of IBD and Gastroenterology /ID# 167121
City
Oita-shi
State/Province
Oita
ZIP/Postal Code
870-0823
Country
Japan
Facility Name
Chikuba Hospital for Proctological and Gastrointestinal Diseases /ID# 166010
City
Kurashiki-shi
State/Province
Okayama
ZIP/Postal Code
710-0142
Country
Japan
Facility Name
Okayama University Hospital /ID# 167356
City
Okayama-shi
State/Province
Okayama
ZIP/Postal Code
700-8558
Country
Japan
Facility Name
Kinshukai Infusion Clinic /ID# 218872
City
Osaka-shi
State/Province
Osaka
ZIP/Postal Code
530-0011
Country
Japan
Facility Name
Osaka Metropolitan University Hospital /ID# 166015
City
Osaka-shi
State/Province
Osaka
ZIP/Postal Code
545-8586
Country
Japan
Facility Name
Osaka University Hospital /ID# 169663
City
Suita-shi
State/Province
Osaka
ZIP/Postal Code
565-0871
Country
Japan
Facility Name
Osaka Medical and Pharmaceutical University Hospital /ID# 206326
City
Takatsuki-shi
State/Province
Osaka
ZIP/Postal Code
569-8686
Country
Japan
Facility Name
Tokitokai Tokito clinic /ID# 165962
City
Saitama-shi
State/Province
Saitama
ZIP/Postal Code
336-0963
Country
Japan
Facility Name
Shiga University of Medical Science Hospital /ID# 167129
City
Otsu-shi
State/Province
Shiga
ZIP/Postal Code
520-2192
Country
Japan
Facility Name
Hamamatsu University Hospital /ID# 224352
City
Hamamatsu-shi
State/Province
Shizuoka
ZIP/Postal Code
431-3192
Country
Japan
Facility Name
NHO Shizuoka Medical Center /ID# 167125
City
Sunto-gun
State/Province
Shizuoka
ZIP/Postal Code
411-8611
Country
Japan
Facility Name
Tokyo Medical And Dental University Hospital /ID# 165965
City
Bunkyo-ku
State/Province
Tokyo
ZIP/Postal Code
113-8519
Country
Japan
Facility Name
Tokai University Hachioji Hospital /ID# 165967
City
Hachioji-shi
State/Province
Tokyo
ZIP/Postal Code
192-0032
Country
Japan
Facility Name
The Jikei University Hospital /ID# 167130
City
Minato-ku
State/Province
Tokyo
ZIP/Postal Code
105-8471
Country
Japan
Facility Name
Kyorin University Hospital /ID# 165966
City
Mitaka-shi
State/Province
Tokyo
ZIP/Postal Code
181-8611
Country
Japan
Facility Name
Tokyo Women's Medical University Hospital /ID# 205980
City
Shinjuku-ku
State/Province
Tokyo
ZIP/Postal Code
162-8666
Country
Japan
Facility Name
Toyama Prefectural Central Hospital /ID# 217834
City
Toyama-shi
State/Province
Toyama
ZIP/Postal Code
930-8550
Country
Japan
Facility Name
Japanese Red Cross Wakayama Medical Center /ID# 200643
City
Wakayama-shi
State/Province
Wakayama
ZIP/Postal Code
640-8558
Country
Japan
Facility Name
Wakayama Medical University Hospital /ID# 169482
City
Wakayama-shi
State/Province
Wakayama
ZIP/Postal Code
641-8510
Country
Japan
Facility Name
Yamagata University Hospital /ID# 200157
City
Yamagata-shi
State/Province
Yamagata
ZIP/Postal Code
990-9585
Country
Japan
Facility Name
Hayang University GuriHospital /ID# 167587
City
Guri
State/Province
Gyeonggido
ZIP/Postal Code
11923
Country
Korea, Republic of
Facility Name
CHA University Bundang Medical Center /ID# 167592
City
Seongnam si
State/Province
Gyeonggido
ZIP/Postal Code
13496
Country
Korea, Republic of
Facility Name
Kangbuk Samsung Hospital /ID# 167586
City
Seoul
State/Province
Seoul Teugbyeolsi
ZIP/Postal Code
03181
Country
Korea, Republic of
Facility Name
Yonsei University Health System Severance Hospital /ID# 167590
City
Seoul
State/Province
Seoul Teugbyeolsi
ZIP/Postal Code
03722
Country
Korea, Republic of
Facility Name
Inje University Haeundae Hospital /ID# 202630
City
Busan
ZIP/Postal Code
48108
Country
Korea, Republic of
Facility Name
Dong-A University Hospital /ID# 167591
City
Busan
ZIP/Postal Code
49201
Country
Korea, Republic of
Facility Name
Pusan National University Hospital /ID# 167589
City
Busan
ZIP/Postal Code
49241
Country
Korea, Republic of
Facility Name
Kyungpook National University Hospital /ID# 207019
City
Daegu
ZIP/Postal Code
41944
Country
Korea, Republic of
Facility Name
Samsung Medical Center /ID# 167588
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
Facility Name
Chung-Ang University Hostipal /ID# 207018
City
Seoul
ZIP/Postal Code
06973
Country
Korea, Republic of
Facility Name
VCA Polyclinic Aura /ID# 169498
City
Riga
ZIP/Postal Code
1035
Country
Latvia
Facility Name
Pauls Stradins Clinical University Hospital /ID# 169519
City
Riga
ZIP/Postal Code
LV- 1002
Country
Latvia
Facility Name
Digestive Disease Center Gastro /ID# 169508
City
Riga
ZIP/Postal Code
LV-1079
Country
Latvia
Facility Name
Hospital of Lithuanian University of Health Sciences Kaunas Clinics /ID# 206936
City
Kaunas
ZIP/Postal Code
50161
Country
Lithuania
Facility Name
Vilnius University Hospital Santaros Klinikos /ID# 203286
City
Vilnius
ZIP/Postal Code
08661
Country
Lithuania
Facility Name
Hospital Sultanah Bahiyah /ID# 202626
City
Alor Setar
State/Province
Kedah
ZIP/Postal Code
05460
Country
Malaysia
Facility Name
Universiti Kebangsaan Malaysia (UKM) Medical Centre /ID# 170773
City
Kuala Lumpur
State/Province
Selangor
ZIP/Postal Code
56000
Country
Malaysia
Facility Name
Universiti Sains Malaysia /ID# 200102
City
Kelantan
ZIP/Postal Code
16150
Country
Malaysia
Facility Name
Instituto de Investigaciones Aplicadas a la Neurociencias A.C. /ID# 207579
City
Victoria de Durango
State/Province
Durango
ZIP/Postal Code
34000
Country
Mexico
Facility Name
Morales Vargas Centro de Investigacion S.C. /ID# 203494
City
Leon
State/Province
Guanajuato
ZIP/Postal Code
37000
Country
Mexico
Facility Name
Clinica de Investigacion en Reumatologia y Obesidad S.C. /ID# 207238
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
44650
Country
Mexico
Facility Name
Radboud Universitair Medisch Centrum /ID# 166928
City
Nijmegen
State/Province
Gelderland
ZIP/Postal Code
6525 GA
Country
Netherlands
Facility Name
Zuyderland Medisch Centrum /ID# 169700
City
Heerlen
State/Province
Limburg
ZIP/Postal Code
6419 PC
Country
Netherlands
Facility Name
Onze Lieve Vrouwe Gasthuis /ID# 166929
City
Amsterdam
ZIP/Postal Code
1091 AC
Country
Netherlands
Facility Name
Academisch Medisch Centrum /ID# 166927
City
Amsterdam
ZIP/Postal Code
1105 AZ
Country
Netherlands
Facility Name
Medisch Spectrum Twente /ID# 170298
City
Enschede
ZIP/Postal Code
7512 KZ
Country
Netherlands
Facility Name
Vistamed /ID# 208572
City
Wroclaw
State/Province
Dolnoslaskie
ZIP/Postal Code
53-149
Country
Poland
Facility Name
Malopolskie Centrum Kliniczne /ID# 202167
City
Krakow
State/Province
Malopolskie
ZIP/Postal Code
30-149
Country
Poland
Facility Name
WIP Warsaw IBD Point Profesor Kierkus /ID# 224301
City
Warsaw
State/Province
Mazowieckie
ZIP/Postal Code
00-728
Country
Poland
Facility Name
Centrum Zdrowia MDM /ID# 200491
City
Warszawa
State/Province
Mazowieckie
ZIP/Postal Code
00-635
Country
Poland
Facility Name
Centrum Medyczne Reuma Park /ID# 200490
City
Warszawa
State/Province
Mazowieckie
ZIP/Postal Code
02-665
Country
Poland
Facility Name
Hospital da Senhora da Oliveira Guimaraes, EPE /ID# 170245
City
Guimaraes
State/Province
Braga
ZIP/Postal Code
4835-044
Country
Portugal
Facility Name
Hospital Egas Moniz /ID# 170253
City
Lisbon
State/Province
Porto
ZIP/Postal Code
1349-019
Country
Portugal
Facility Name
Unidade Local de Saúde do Alto Minho, EPE - Hospital Conde de Bertiandos /ID# 200607
City
Ponte de Lima
State/Province
Viana Do Castelo
ZIP/Postal Code
4990-041
Country
Portugal
Facility Name
Hospital Garcia de Orta, EPE /ID# 170241
City
Almada
ZIP/Postal Code
2805-267
Country
Portugal
Facility Name
Centro Hospitalar Universitario de Sao Joao, EPE /ID# 170248
City
Porto
ZIP/Postal Code
4200-319
Country
Portugal
Facility Name
Mindful Medical Research /ID# 203358
City
San Juan
ZIP/Postal Code
00918-3756
Country
Puerto Rico
Facility Name
School of Medicine University of Puerto Rico-Medical Science Campus /ID# 166771
City
San Juan
ZIP/Postal Code
00935
Country
Puerto Rico
Facility Name
Institutul Clinic Fundeni /ID# 167817
City
Sector 2
State/Province
Bucuresti
ZIP/Postal Code
022328
Country
Romania
Facility Name
Clinica GASTRO MED SRL /ID# 206369
City
Cluj-Napoca
State/Province
Cluj
ZIP/Postal Code
400380
Country
Romania
Facility Name
Cabinet Particular Policlinic Algomed /ID# 167818
City
Timișoara
ZIP/Postal Code
300002
Country
Romania
Facility Name
Immanuel Kant Baltic Federal University /ID# 203811
City
Kaliningrad
State/Province
Kaliningradskaya Oblast
ZIP/Postal Code
236016
Country
Russian Federation
Facility Name
LLC Medical Center /ID# 209236
City
Novosibirsk
State/Province
Novosibirskaya Oblast
ZIP/Postal Code
630099
Country
Russian Federation
Facility Name
Perm Clinical Center of the Federal Medical and Biological Agency /ID# 202990
City
Perm
State/Province
Permskiy Kray
ZIP/Postal Code
614109
Country
Russian Federation
Facility Name
LLC Novaya Klinika /ID# 206616
City
Pyatigorsk
State/Province
Stavropol Skiy Kray
ZIP/Postal Code
357500
Country
Russian Federation
Facility Name
Professor Pasechnikov Gastroenterology and Pankreatology clinic /ID# 202997
City
Stavropol
State/Province
Stavropol Skiy Kray
ZIP/Postal Code
355012
Country
Russian Federation
Facility Name
Kazan State Medical University /ID# 169638
City
Kazan
State/Province
Tatarstan, Respublika
ZIP/Postal Code
420012
Country
Russian Federation
Facility Name
Olla-Med Clinic /ID# 208720
City
Moscow
ZIP/Postal Code
105554
Country
Russian Federation
Facility Name
P.A. Bayandin Murmansk Regiona /ID# 169639
City
Murmansk
ZIP/Postal Code
183047
Country
Russian Federation
Facility Name
Republican hospital named after V.A. Baranov /ID# 206488
City
Petrozavodsk
ZIP/Postal Code
185019
Country
Russian Federation
Facility Name
Euromedservice /ID# 206610
City
Pushkin
ZIP/Postal Code
196603
Country
Russian Federation
Facility Name
X7 Clinical Research Center /ID# 216350
City
Saint Petersburg
ZIP/Postal Code
194156
Country
Russian Federation
Facility Name
City Clinical Hospital No. 31 /ID# 208868
City
St. Petersburg
ZIP/Postal Code
197110
Country
Russian Federation
Facility Name
Clinical Hosp Center Zvezdara /ID# 168214
City
Belgrade
State/Province
Beograd
ZIP/Postal Code
11000
Country
Serbia
Facility Name
Military Medical Academy /ID# 168783
City
Belgrade
State/Province
Beograd
ZIP/Postal Code
11000
Country
Serbia
Facility Name
University Clinical Center Serbia /ID# 168215
City
Belgrade
State/Province
Beograd
ZIP/Postal Code
11000
Country
Serbia
Facility Name
Clin Hosp Ctr Bezanijska Kosa /ID# 168750
City
Belgrade
State/Province
Beograd
ZIP/Postal Code
11080
Country
Serbia
Facility Name
University Clinical Center Kragujevac /ID# 205859
City
Kragujevac
State/Province
Sumadijski Okrug
ZIP/Postal Code
34000
Country
Serbia
Facility Name
Clinical Center Vojvodina /ID# 168213
City
Novi Sad
State/Province
Vojvodina
ZIP/Postal Code
21000
Country
Serbia
Facility Name
KL Ling Gastroenterology and Liver Clinic /ID# 217962
City
Singapore
ZIP/Postal Code
228510
Country
Singapore
Facility Name
Gleneagles Medical Centre /ID# 206531
City
Singapore
ZIP/Postal Code
258499
Country
Singapore
Facility Name
Tan Tock Seng Hospital /ID# 203160
City
Singapore
ZIP/Postal Code
308433
Country
Singapore
Facility Name
Fakultna nemocnica s poliklinikou F.D. Roosevelta Banska Bystrica /ID# 169958
City
Banska Bystrica
ZIP/Postal Code
975 17
Country
Slovakia
Facility Name
KM Management, spol. s.r.o. /ID# 170201
City
Nitra
ZIP/Postal Code
949 01
Country
Slovakia
Facility Name
Univ Medical Ctr Ljubljana /ID# 217795
City
Ljubljana
ZIP/Postal Code
1000
Country
Slovenia
Facility Name
Farmovs (Pty) Ltd /Id# 207535
City
Bloemfontein
State/Province
Free State
ZIP/Postal Code
9301
Country
South Africa
Facility Name
Lenasia Clinical Trial Centre /ID# 205145
City
Johannesburg
State/Province
Gauteng
ZIP/Postal Code
1820
Country
South Africa
Facility Name
Wits Clinical Research Site /ID# 170852
City
Johannesburg
State/Province
Gauteng
ZIP/Postal Code
2193
Country
South Africa
Facility Name
Allergy & Immunology (AIU) /ID# 171431
City
Cape Town
State/Province
Western Cape
ZIP/Postal Code
7700
Country
South Africa
Facility Name
Dr JP Wright /ID# 170887
City
Cape Town
State/Province
Western Cape
ZIP/Postal Code
7708
Country
South Africa
Facility Name
Private Practice Dr MN Rajabally /ID# 169853
City
Cape Town
State/Province
Western Cape
ZIP/Postal Code
7800
Country
South Africa
Facility Name
Hospital Universitari Son Espases /ID# 201998
City
Palma de Mallorca
State/Province
Illes Balears
ZIP/Postal Code
07120
Country
Spain
Facility Name
Hospital Universitario de Navarra /ID# 202355
City
Pamplona
State/Province
Navarra
ZIP/Postal Code
31008
Country
Spain
Facility Name
Hospital Universitario A Coruna - CHUAC /ID# 203910
City
A Coruna
ZIP/Postal Code
15006
Country
Spain
Facility Name
Hospital Clinic de Barcelona /ID# 201990
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Hospital Universitario de Girona Doctor Josep Trueta /ID# 202645
City
Girona
ZIP/Postal Code
17007
Country
Spain
Facility Name
Hospital Juan Ramon Jimenez /ID# 201995
City
Huelva
ZIP/Postal Code
21005
Country
Spain
Facility Name
Hospital Universitario La Paz /ID# 201994
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Facility Name
Hospital Universitario de Salamanca /ID# 206358
City
Salamanca
ZIP/Postal Code
37711
Country
Spain
Facility Name
Hospital Universitario Virgen Macarena /ID# 201993
City
Sevilla
ZIP/Postal Code
41009
Country
Spain
Facility Name
Hospital Clinico Universitario de Valencia /ID# 209657
City
Valencia
ZIP/Postal Code
46010
Country
Spain
Facility Name
Hospital Universitario y Politecnico La Fe /ID# 201992
City
Valencia
ZIP/Postal Code
46026
Country
Spain
Facility Name
Hallands Hospital Halmstad /ID# 170828
City
Halmstad
State/Province
Hallands Lan
ZIP/Postal Code
302 33
Country
Sweden
Facility Name
Karolinska University Hospital Solna /ID# 224488
City
Solna
State/Province
Stockholms Lan
ZIP/Postal Code
171 64
Country
Sweden
Facility Name
Alingsas lasarett /ID# 170826
City
Alingsas
State/Province
Vastra Gotalands Lan
ZIP/Postal Code
441 33
Country
Sweden
Facility Name
Sodra Alvsborgs sjukhus /ID# 203077
City
Boras
State/Province
Vastra Gotalands Lan
ZIP/Postal Code
501 82
Country
Sweden
Facility Name
Sahlgrenska University Hospital /ID# 169171
City
Gothenburg
State/Province
Vastra Gotalands Lan
ZIP/Postal Code
413 46
Country
Sweden
Facility Name
Universitätsspital Zürich /ID# 170998
City
Zürich
State/Province
Zuerich
ZIP/Postal Code
8091
Country
Switzerland
Facility Name
Inselspital, Universitätsspital Bern /ID# 170997
City
Bern
ZIP/Postal Code
3010
Country
Switzerland
Facility Name
China Medical University Hospital /ID# 169791
City
Taichung City
ZIP/Postal Code
40447
Country
Taiwan
Facility Name
Taichung Veterans General Hospital /ID# 169790
City
Taichung
ZIP/Postal Code
40705
Country
Taiwan
Facility Name
National Taiwan University Hospital /ID# 169792
City
Taipei City
ZIP/Postal Code
100
Country
Taiwan
Facility Name
Acibadem Kozyatagi Hospital /ID# 209406
City
Kadikoy
State/Province
Istanbul
ZIP/Postal Code
34742
Country
Turkey
Facility Name
Erciyes University Medical Fac /ID# 171331
City
Melikgazi
State/Province
Kayseri
ZIP/Postal Code
38030
Country
Turkey
Facility Name
Ankara Univ Medical Faculty /ID# 206409
City
Ankara
ZIP/Postal Code
06590
Country
Turkey
Facility Name
Inonu Universitesi Turgut Ozal /ID# 201268
City
Battalgazi/malatya
ZIP/Postal Code
44280
Country
Turkey
Facility Name
Mustafa Kemal University Medic /ID# 171336
City
Hatay
ZIP/Postal Code
31001
Country
Turkey
Facility Name
Istanbul University Istanbul Medical Faculty /ID# 171364
City
Istanbul
ZIP/Postal Code
34093
Country
Turkey
Facility Name
Marmara Universitesi Pendik Egitim ve Arastirma Hastanesi /ID# 171332
City
Istanbul
ZIP/Postal Code
34899
Country
Turkey
Facility Name
Mersin University Medical /ID# 171338
City
Mersin
ZIP/Postal Code
33343
Country
Turkey
Facility Name
Sisli Etfal Train & Res Hosp /ID# 171334
City
Sisli
ZIP/Postal Code
34371
Country
Turkey
Facility Name
Gazi Universitesi Tip Fakultes /ID# 217444
City
Yenimahalle
ZIP/Postal Code
06560
Country
Turkey
Facility Name
Medical Centre of "Ukrainian German Antiulcer Gastroenterology Centre BYK-KYIV" /ID# 203738
City
Kyiv
State/Province
Kyivska Oblast
ZIP/Postal Code
01030
Country
Ukraine
Facility Name
Kharkiv City Clinical Hospital No.2 n.a. Prof. O.O. Shalimov /ID# 167907
City
Kharkiv
ZIP/Postal Code
61037
Country
Ukraine
Facility Name
Kyiv Municipal Clinical Hospital #18 /ID# 207889
City
Kyiv
ZIP/Postal Code
01030
Country
Ukraine
Facility Name
MNI KRC Kyiv Regional Clinical Hospital /ID# 202454
City
Kyiv
ZIP/Postal Code
04107
Country
Ukraine
Facility Name
Lviv Railway Clinical Hospital of branch Healthcare Centers of Public Joint Stoc /ID# 167908
City
Lviv
ZIP/Postal Code
79000
Country
Ukraine
Facility Name
CNE Vinnytsya Regional Clinical Hospital named after N.I.Pirogov /ID# 222110
City
Vinnytsia
ZIP/Postal Code
21028
Country
Ukraine
Facility Name
South Eastern Health and Social Care Trust /ID# 205323
City
Belfast
State/Province
Antrim
ZIP/Postal Code
BT16 1RH
Country
United Kingdom
Facility Name
Warrington and Halton Hospitals NHS Foundation Trust /ID# 171383
City
Warrington
State/Province
Cheshire West And Chester
ZIP/Postal Code
WA5 1QG
Country
United Kingdom
Facility Name
Warrington and Halton Hospitals NHS Foundation Trust /ID# 209086
City
Warrington
State/Province
Cheshire West And Chester
ZIP/Postal Code
WA5 1QG
Country
United Kingdom
Facility Name
Royal United Hospitals Bath /ID# 169074
City
Bath
ZIP/Postal Code
BA1 3NG
Country
United Kingdom
Facility Name
University Hospitals Birmingham NHS Foundation Trust /ID# 169070
City
Birmingham
ZIP/Postal Code
B15 2TH
Country
United Kingdom
Facility Name
The Dudley Group NHS Foundation Trust /ID# 169069
City
Dudley
ZIP/Postal Code
DY1 2HQ
Country
United Kingdom
Facility Name
King's College Hospital NHS Foundation Trust /ID# 169072
City
London
ZIP/Postal Code
SE5 9RS
Country
United Kingdom
Facility Name
The Newcastle Upon Tyne Hospitals NHS Foundation Trust /ID# 169075
City
Newcastle Upon Tyne
ZIP/Postal Code
NE7 7DN
Country
United Kingdom
Facility Name
Stockport NHS foundation trust /ID# 208719
City
Stockport
ZIP/Postal Code
SK2 7JE
Country
United Kingdom
Facility Name
Taunton and Somerset NHS Foundation Trust /ID# 209665
City
Taunton
ZIP/Postal Code
TA1 5DA
Country
United Kingdom
Facility Name
St George's University Hospitals NHS Foundation Trust /ID# 205552
City
Tooting
ZIP/Postal Code
SW17 0QT
Country
United Kingdom
Facility Name
The Royal Wolverhampton NHS Trust /ID# 171382
City
Wolverhampton
ZIP/Postal Code
WV10 0QP
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, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
IPD Sharing Time Frame
For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
IPD Sharing Access Criteria
Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
IPD Sharing URL
https://vivli.org/ourmember/abbvie/
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 of the Efficacy and Safety of Upadacitinib in Participants With Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or Are Intolerant to Conventional and/or Biologic Therapies

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