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

Primary Purpose

Crohn's Disease

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Matching Placebo for Upadacitinib
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, Crohn's Disease, Efficacy, Safety

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 any biologic therapy for infliximab, adalimumab, certolizumab pegol, vedolizumab, and ustekinumab.
  • If female, participant must meet the contraception recommendations.

Exclusion Criteria:

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

Sites / Locations

  • East View Medical Research, LLC /ID# 171133
  • CB Flock Research Corporation /ID# 166220
  • Delsol Research Management, Ll /Id# 170179
  • HonorHealth Research Institute - Shea /ID# 164734
  • Arizona Arthritis & Rheumatology Research, PLLC /ID# 203891
  • Southern California Res. Ctr. /ID# 169654
  • Citrus Valley Gastroenterology /ID# 166201
  • United Medical Doctors /ID# 207452
  • Gastrointestinal Biosciences Clinical Trials, LLC /ID# 164887
  • Facey Medical Foundation /ID# 203137
  • United Medical Doctors - Murrieta /ID# 164845
  • Ucsd /Id# 164679
  • Medical Assoc Research Grp /ID# 169705
  • UCSF Center for Colitis and Crohn's Disease /ID# 202373
  • Univ of California San Francis /ID# 164843
  • Care Access Research /ID# 167766
  • Peak Gastroenterology Associates, PC /ID# 170181
  • Delta Waves, Inc. /ID# 164872
  • Duplicate_Western States Clinical Research, Inc. /ID# 164895
  • Medical Research Center of CT /ID# 164829
  • Clinical Research of West Florida, Inc /ID# 205825
  • Clinical Research of West Florida, Inc /ID# 208117
  • Advanced Research - Coral Springs /ID# 218020
  • Encore Borland-Groover Clinical Research /Id# 203498
  • Ctr for Advanced Gastroenterol /ID# 165332
  • Crystal Pharmacology Research /ID# 166101
  • Coral Research Clinic /ID# 164657
  • Advanced Research Institute, Inc /ID# 164814
  • Endoscopic Research, Inc. /ID# 205893
  • Omega Research Maitland, LLC /ID# 203480
  • Clinical Research Trials of Florida, Inc. /ID# 203484
  • AdventHealth Tampa /ID# 171175
  • Gastroenterology Associates of Central Georgia, LLC /ID# 165460
  • Gastroenterology Consultants PC - Roswell /ID# 218219
  • Atlanta Gastroenterology Spec /ID# 164780
  • University of Chicago Medicine /ID# 165472
  • DuPage Medical Group /ID# 205303
  • MediSphere Medical Research Center /ID# 166209
  • Indianapolis Gastroenterology /ID# 164837
  • Aquiant Research /ID# 205504
  • University of Iowa Hospitals and Clinics /ID# 165330
  • Tri-State Gastroenterology /ID# 165484
  • University of Louisville /ID# 168536
  • University of Louisville /ID# 208093
  • CroNOLA, LLC /ID# 164722
  • Nola Research Works, LLC /ID# 164897
  • Louisana Research Center, LLC /ID# 164659
  • Johns Hopkins University School of Medicine /ID# 211940
  • MGG Group Co, Inc.Chevy Chase Clinical Research /ID# 164835
  • Gastro Center of Maryland /ID# 171171
  • Lahey Hospital and Medical Center /ID# 214725
  • University of Michigan Health Systems /ID# 164844
  • Clin Res Inst of Michigan, LLC /ID# 170178
  • Digestive Health Associates (DHA) - Farmington Hills /ID# 206099
  • Center for Digestive Health /ID# 164733
  • Mayo Clinic - Rochester /ID# 164868
  • Southern Therapy and Advanced Research (STAR) LLC /ID# 165318
  • Quality Clinical Research Inc. /ID# 170177
  • CHI Health Research Center /ID# 168545
  • Las Vegas Medical Research /ID# 168562
  • AGA Clinical Research Associates, LLC /ID# 164883
  • Rutgers Robert Wood Johnson /ID# 166092
  • Montefiore Medical Center - Moses Campus /ID# 166226
  • Advantage Clinical Trials /ID# 168557
  • NY Scientific /ID# 164833
  • NYU Langone Long Island Clinical Research Associates /ID# 164830
  • The Mount Sinai Hospital /ID# 170172
  • Columbia Univ Medical Center /ID# 164870
  • Gastro Group of Rochester /ID# 166216
  • Richmond University Medical Center /ID# 201855
  • Atrium Health Carolinas Medical Center /ID# 164834
  • PMG Research of Charlotte /ID# 171170
  • Wake Radiology UNC REX Healthcare - Raleigh Office /ID# 164663
  • Wake Forest Baptist Medical Center /ID# 201225
  • Plains Clinical Research Center, LLC /ID# 170184
  • Consultants for Clinical Research /ID# 164855
  • University of Cincinnati /ID# 164720
  • Cleveland Clinic Main Campus /ID# 208220
  • The Ohio State University /ID# 170174
  • Optimed Research, Ltd. /ID# 205618
  • Hometown Urgent Care and Resea /ID# 201290
  • Dayton Gastroenterology, Inc. /ID# 167624
  • Great Lakes Medical Research, LLC /ID# 202007
  • Digestive Disease Specialists /ID# 201062
  • Options Health Research, LLC /ID# 164737
  • Healthcare Research Consultant /ID# 166228
  • University of Pennsylvania /ID# 168402
  • Thomas Jefferson University /ID# 168014
  • Pharmacorp Clinical Trials /ID# 164809
  • Gastroenterology Associates, P.A. of Greenville /ID# 164880
  • Rapid City Medical Center - GI Research /ID# 201734
  • Gastro One /ID# 164718
  • East Tennessee Research Institute /ID# 203612
  • Quality Medical Research /ID# 205262
  • Vanderbilt University Medical Center /ID# 164846
  • TX Clinical Research Institute /ID# 164848
  • Inquest Clinical Research /ID# 164865
  • Texas Digestive Disease Consultants /ID# 209952
  • Texas Digestive Disease Consultants /ID# 209802
  • CliniCore International, LLC /ID# 164662
  • Baylor College of Medicine - Baylor Medical Center /ID# 164847
  • Centex Studies, Inc. - Houston /ID# 201213
  • GI Specialists of Houston /ID# 202338
  • Caprock Gastro Research /ID# 215437
  • Clinical Associates in Research Therapeutics of America, LLC /ID# 164863
  • Southern Star Research Institute, LLC /ID# 169754
  • Carl R. Meisner Medical Clinic /ID# 201060
  • Tyler Research Institute, LLC /ID# 168681
  • Gastro Health & Nutrition - Victoria /ID# 167813
  • HP Clinical Research /ID# 164929
  • Advanced Research Institute /ID# 164866
  • Duplicate_Care Access Research /ID# 164853
  • Velocity Clinical Research - Salt Lake City /ID# 166095
  • Washington Gastroenterology Associates /ID# 164721
  • Virginia Mason - Seattle Orthapedics /ID# 164680
  • University of Washington /ID# 164875
  • The Vancouver Clinic, INC. PS /ID# 164811
  • Froedtert Memorial Lutheran Hospital /ID# 202286
  • Allegiance Research Specialists /ID# 165321
  • Cardio Alem /ID# 211284
  • Hospital Italiano de Buenos Aires /ID# 215543
  • Gedyt /ID# 210019
  • Cemic /Id# 169184
  • Hospital Provincial del Centenario /ID# 171254
  • Hospital Privado Univesitario /ID# 169228
  • Concord Repatriation General Hospital /ID# 171509
  • Coral Sea Clinical Research institute /ID# 212987
  • Mater Misericordiae Limited /ID# 204908
  • Royal Adelaide Hospital /ID# 171511
  • Box Hill Hospital /ID# 203734
  • Fiona Stanley Hospital /ID# 171510
  • Klinik Landstrasse /ID# 203437
  • Medizinische Universitaet Wien /ID# 169462
  • Landeskrankenhaus Salzburg-Universitätsklinikum der PMU (LKH) /ID# 214467
  • UCL Saint-Luc /ID# 200297
  • CHU de Liege Sart Tilman /ID# 200299
  • CHU UCL Namur - site Godinne /ID# 200300
  • Universitair Ziekenhuis Leuven /ID# 200298
  • AZ Sint-Lucas /ID# 200301
  • University Clinical Centre of the Republic of Srpska /ID# 208050
  • University Clinical Center Tuzla /ID# 210324
  • Clinical Center University of Sarajevo /ID# 203885
  • Polyclinic and Daily Hospital Dr. Al-Tawil /ID# 217841
  • Instituto Goiano de Gastroenterologia e Endoscopia Digestiva /ID# 166870
  • Hospital Nossa Senhora das Graças /ID# 166869
  • Hospital de Clinicas de Porto Alegre /ID# 166872
  • Upeclin Fmb - Unesp /Id# 166876
  • Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto - USP /ID# 166874
  • Faculdade de Medicina do ABC /ID# 208327
  • Kaiser Clinica e Hospital Dia /ID# 166873
  • UMHAT Kaspela EOOD /ID# 167617
  • Duplicate_Second MHAT Sofia /ID# 167618
  • MHAT Trakia /ID# 201678
  • University of Calgary - Cumming School of Medicine - Adult Cystic Fibrosis Clini /ID# 166963
  • Allen Whey Khye Lim Professional Corporation /ID# 168041
  • Covenant Health /ID# 166966
  • Fraser Clinical Trials Inc /ID# 166957
  • GIRI Gastrointestinal Research Institute /ID# 166964
  • QEII - Health Sciences Centre /ID# 169306
  • Scott Shulman Medicine Professional Corporation /ID# 169064
  • Taunton Surgical Centre /ID# 168039
  • The Ottawa Hospital /ID# 212413
  • Medicor Research Inc /ID# 166967
  • Toronto Digestive Disease Asso /ID# 166961
  • CHAU- Hotel-Dieu de Levis /ID# 166958
  • Crchum /Id# 170121
  • Montreal General Hospital - McGill University Health Center /ID# 170010
  • CIUSSS de l'Estrie - CHUS /ID# 170935
  • Research Group /ID# 203180
  • M y F Estudios Clínicos /ID# 169995
  • Hospital Guillermo Grant Benavente de Concepción /ID# 212422
  • CTR Estudios Clinicos /ID# 200650
  • Hospital Clinico Universidad De Los Andes /ID# 207465
  • Zhongshan Hospital Xiamen University /ID# 204985
  • Sun Yat-sen Memorial Hospital of Sun Yat-sen University /ID# 205226
  • The Sixth Affiliated Hosp Sun /ID# 204049
  • Union Hospital Tongji Medical College Huazhong University of Science and Technol /ID# 204096
  • Nanjing Drum Tower Hospital /ID# 204869
  • The First Affiliated Hospital of Nanchang University /ID# 204070
  • The First Hospital of Jilin University /ID# 206867
  • Ruijin Hospital, Shanghai Jiaotong University School of Medicine /ID# 204072
  • The second Affiliated hospital of Zhejiang University school of Medicine /ID# 204078
  • Sir Run Run Shaw Hospital,Meical School Zhejiang University /ID# 204068
  • Beijing Friendship Hospital /ID# 204536
  • The Second Hospital Central South University /ID# 204075
  • Nanfang Hospital of Southern Medical University /ID# 204074
  • Duplicate_Tianjin Med Univ General Hosp /ID# 206993
  • Tongji Hospital Tongji Medical College Huazhong University of Science and Techno /ID# 204069
  • Hospital San Vicente de Paul /ID# 200028
  • Hospital Pablo Tobon Uribe /ID# 202405
  • Clinical Hospital Dubrava /ID# 171186
  • Klinicki bolnicki centar Sestre milosrdnice /ID# 171190
  • Klinicki bolnicki centar Zagreb /ID# 171201
  • Poliklinika Solmed /ID# 211518
  • UHC Split /ID# 171206
  • Zadar General Hospital /ID# 205534
  • Hepato-Gastroenterologie HK, s.r.o. /ID# 171566
  • ResTrial s.r.o. /ID# 208652
  • ARTROSCAN s.r.o. /ID# 171592
  • Nordsjaellands Hospital /ID# 200613
  • Herlev Hospital /ID# 200782
  • Kobenhavns Universitet - Hvidovre Hospital (HH) /ID# 200611
  • Duplicate_Sjaellands Universitets Hospital /ID# 200783
  • Clinical Research Center, Faculty of Medicine, Alexandria university. /ID# 171010
  • Clinical Research Center, Faculty of Medicine, Alexandria university. /ID# 171015
  • Clinical Research Center, Faculty of Medicine, Cairo university /ID# 209557
  • National Hepatology and Tropical Medicine Research Institute /ID# 170990
  • Faculty of Medicine Ain Shams Research Institute- Clinical Research Centre /ID# 209565
  • Air Force Specialized Hospital /ID# 170995
  • Tartu University Hospital /ID# 203140
  • Chu de Nice-Hopital L'Archet Ii /Id# 171009
  • HCL - Hôpital Lyon Sud /ID# 171014
  • CHU Bordeaux - Hopital Haut Lévêque /ID# 207414
  • CHRU Lille - Hopital Claude Huriez /ID# 206539
  • Duplicate_Hopital Saint Eloi /ID# 170646
  • Hopital Beaujon /ID# 171011
  • CHU de SAINT ETIENNE - Hopital Nord /ID# 171018
  • CHRU Nancy - Hôpitaux de Brabois /ID# 170985
  • CHU Amiens-Picardie Site Sud /ID# 171016
  • CHRU Tours - Hopital Trousseau /ID# 169786
  • Duplicate_CHU Henri Mondor /ID# 169787
  • Polyclinique Grand Sud /ID# 170649
  • CHU Toulouse - Hopital Rangueil /ID# 169785
  • Universitatsklinikum Mannheim /ID# 168778
  • Universitaetsklinikum Ulm /ID# 203563
  • Universitaetsklinikum Erlangen /ID# 203551
  • Universitaetsklinikum Frankfurt /ID# 203565
  • Zentrum für Gastroenterologie Saar MVZ GmbH /ID# 206740
  • Universitaetsklinikum Schleswig-Holstein Campus Kiel /ID# 168779
  • Charite Universitaetsklinikum Berlin - Campus Benjamin Franklin /ID# 169067
  • Gastroenterologie am Mexikoplatz /ID# 203573
  • Universitaetsmedizin Essen St. Josef Krankenhaus Werden /ID# 203571
  • Agaplesion Markus Krankenhaus /ID# 168777
  • Universitaetsklinikum Halle (Saale) /ID# 207454
  • Medizinisches Versorgungszentrum Portal 10 /ID# 200213
  • General Hospital of Athens Ippokratio /ID# 167036
  • General Hospital of Chest Diseases of Athens SOTIRIA /ID# 202103
  • Tzaneio general hospital of Piraeus /ID# 206432
  • University General Hospital of Heraklion PA.G.N.I /ID# 167035
  • General Hospital of Athens Evaggelismos and Ophthalmiatrio of Athens Polyclinic /ID# 167037
  • Genl Hosp Thess Ippokrateio /ID# 208824
  • Queen Mary Hospital /ID# 171217
  • CRU Hungary Egeszsegugyi és Szolgaltato Kft. /ID# 205546
  • Bugat Pal Korhaz /ID# 201889
  • Obudai Egeszsegugyi Centrum Kft. /ID# 201891
  • Magyar Honvedseg Egeszsegugyi Kozpont /ID# 201719
  • Debreceni Egyetem Kenezy Gyula Egyetemi Korhaz /ID# 201720
  • Mentahaz Maganorvosi Kozpont /ID# 201890
  • Mercy University Hospital /ID# 206510
  • Soroka University Medical Center /ID# 169912
  • Tel Aviv Sourasky Medical Center /ID# 204876
  • Barzilai Medical Center /ID# 223372
  • Assaf Harofeh Medical Center /ID# 204870
  • Hadassah Medical Center-Hebrew University /ID# 169927
  • Rabin Medical Center /ID# 202635
  • Kaplan Medical Center /ID# 170277
  • University of Catanzaro /ID# 201920
  • Policlinico Universitario Campus Bio-Medico /ID# 168169
  • Azienda Ospedaliera San Camillo Forlanini /ID# 168170
  • Istituto Clinico Humanitas /ID# 168171
  • Fondazione PTV Policlinico Tor Vergata /ID# 168174
  • Presidio Columbus-Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Un /ID# 168168
  • IRCCS Ospedale Sacro Cuore Don Calabria /ID# 168172
  • A.O.U. di Bologna Policlinico S.Orsola-Malpighi /ID# 168173
  • A.O. Per L'Emergenza Cannizzaro /ID# 168176
  • Policlinico San Martino/Univer /ID# 168177
  • ASST Fatebenefratelli Sacco - Ospedale Fatebenefratelli e Oftalmico /ID# 168167
  • Azienda Ospedaliero-Universitaria di Modena /ID# 200008
  • A.O. Ospedali Riuniti Villa Sofia - Cervello /ID# 168175
  • Azienda Ospedaliero Universitaria Pisana-Stabilimento di Cisanello /ID# 202420
  • Aichi Medical University Hospital /ID# 165957
  • Nagoya City University Hospital /ID# 165956
  • Nagoya University Hospital /ID# 165955
  • Toyohashi Municipal Hospital /ID# 200174
  • Hirosaki National Hospital /ID# 165944
  • Toho University Sakura Medical Center /ID# 165949
  • Kurume University Hospital /ID# 166004
  • National Hospital Organization Takasaki General Medical Center /ID# 167136
  • NHO Fukuyama Medical Center /ID# 167139
  • Hiroshima University Hospital /ID# 166006
  • Asahikawa Medical University Hospital /ID# 167133
  • Hokkaido P.W.F.A.C. Sapporo-Kosei General Hospital /ID# 165943
  • Sapporo Medical University Hospital /ID# 167137
  • Aoyama Clinic /ID# 166001
  • Hyogo College of Medicine College Hospital /Id# 200173
  • Kanazawa University Hospital /ID# 169215
  • Iwate Medical University Uchimaru Medical Center /ID# 202407
  • Imamura General Hospital /ID# 227136
  • Idzuro Imamura Hospital /ID# 206651
  • Sameshima Hospital /ID# 206674
  • Japanese Red Cross Kyoto Daiichi Hosital /ID# 165958
  • Kyoto University Hospital /ID# 169888
  • Yokkaichi Hazu Medical Center /ID# 167191
  • Tohoku University Hospital /ID# 167135
  • Nara Medical University Hospital /ID# 169216
  • Kenseikai Dongo Hospital /ID# 208103
  • Niigata University Medical & Dental Hospital /ID# 170044
  • Ishida Clinic of IBD and Gastroenterology /ID# 167134
  • Chikuba Hospital for Proctological and Gastrointestinal Diseases /ID# 166002
  • Okayama University Hospital /ID# 167355
  • Kinshukai Infusion Clinic /ID# 218871
  • Osaka City University Hospital /ID# 166007
  • Osaka University Hospital /ID# 169662
  • Osaka Medical and Pharmaceutical University Hospital /ID# 206324
  • Tokitokai Tokito clinic /ID# 165945
  • Shiga University of Medical Science Hospital /ID# 167141
  • NHO Shizuoka Medical Center /ID# 167138
  • Tokyo Medical And Dental University, Medical Hospital /ID# 165948
  • Duplicate_Tokai University Hachioji Hospital /ID# 165951
  • The Jikei University Hospital /ID# 167142
  • Kyorin University Hospital /ID# 165950
  • Tokyo Women's Medical University Hospital /ID# 205981
  • Toyama Prefectural Central Hospital /ID# 217833
  • Japanese Red Cross Wakayama Medical Center /ID# 200638
  • Wakayama Medical University Hospital /ID# 169481
  • Yamagata University Hospital /ID# 200156
  • Hayang University GuriHospital /ID# 167578
  • CHA University Bundang Medical Center /ID# 167583
  • Kangbuk Samsung Hospital /ID# 167577
  • Yonsei University Health System Severance Hospital /ID# 167581
  • Inje University Haeundae Hospital /ID# 202629
  • Dong-A University Hospital /ID# 167582
  • Pusan National University Hospital /ID# 167580
  • Kyungpook National Univ Hosp /ID# 207015
  • Samsung Medical Center /ID# 167579
  • Chung-Ang University Hostipal /ID# 207017
  • Pauls Stradins Clinical University Hospital /ID# 169493
  • Digestive Disease Center Gastro /ID# 169517
  • Riga East Clinical University Hospital /ID# 169496
  • Hospital of Lithuanian University of Health Sciences Kaunas Clinics /ID# 207263
  • Vilnius University Hospital Santaros Klinikos /ID# 203285
  • Hospital Sultanah Bahiyah /ID# 202627
  • Universiti Kebangsaan Malaysia (UKM) Medical Centre /ID# 170778
  • Instituto de Investigaciones Aplicadas a la Neurociencias A.C. /ID# 207143
  • Morales Vargas Centro de Investigacion S.C. /ID# 203495
  • Clinica de Investigacion en Reumatologia y Obesidad S.C. /ID# 206779
  • Radboud Universitair Medisch Centrum /ID# 166925
  • Zuyderland Medisch Centrum /ID# 169698
  • Academisch Medisch Centrum /ID# 166924
  • Medisch Spectrum Twente /ID# 170297
  • Vistamed /ID# 208570
  • Malopolskie Centrum Kliniczne /ID# 202166
  • WIP Warsaw IBD Point Profesor Kierkus /ID# 224300
  • Centrum Medyczne Reuma Park w Warszawie /ID# 200488
  • Centrum Zdrowia MDM /ID# 200486
  • Hospital da Senhora da Oliveira Guimaraes, EPE /ID# 170225
  • Hospital Egas Moniz /ID# 170249
  • Unidade Local de Saúde do Alto Minho, EPE - Hospital Conde de Bertiandos /ID# 200606
  • Hospital Garcia de Orta, EPE /ID# 170234
  • Centro Hospitalar Universitario de Sao Joao, EPE /ID# 170231
  • Mindful Medical Research /ID# 203357
  • School of Medicine University of Puerto Rico-Medical Science Campus /ID# 166770
  • Institutul Clinic Fundeni /ID# 167826
  • Clinica GASTRO MED SRL /ID# 206367
  • Cabinet Particular Policlinic Algomed /ID# 167827
  • Immanuel Kant Baltic Federal University /ID# 202128
  • LLC Medical Center /ID# 209233
  • Perm Clinical Center of the Federal Medical and Biological Agency /ID# 202988
  • LLC Novaya Klinika /ID# 206615
  • Professor Pasechnikov Gastroenterology and Pankreatology clinic /ID# 202995
  • Kazan State Medical University /ID# 169574
  • Olla-Med Clinic /ID# 208721
  • P.A. Bayandin Murmansk Regiona /ID# 169575
  • Republican hospital named after V.A. Baranov /ID# 206487
  • Euromedservice /ID# 206609
  • X7 Clinical Research Center /ID# 216349
  • City Clinical Hospital No. 31 /ID# 208870
  • Clinical Hosp Center Zvezdara /ID# 168221
  • Military Medical Academy /ID# 168784
  • University Clinical Center Serbia /ID# 168220
  • Clin Hosp Ctr Bezanijska Kosa /ID# 168799
  • University Clinical Center Kragujevac /ID# 205858
  • Clinical Center Vojvodina /ID# 168222
  • KL Ling Gastroenterology and Liver Clinic /ID# 217963
  • Gleneagles Medical Centre /ID# 206530
  • Tan Tock Seng Hospital /ID# 203159
  • Fakultna nemocnica s poliklinikou F.D. Roosevelta Banska Bystrica /ID# 169952
  • KM Management, spol. s.r.o. /ID# 170199
  • Univ Medical Ctr Ljubljana /ID# 211042
  • Farmovs (Pty) Ltd /Id# 207536
  • Lenasia Clinical Trial Centre /ID# 205144
  • Wits Clinical Research Site /ID# 170851
  • Dr JP Wright /ID# 170885
  • Private Practice Dr MN Rajabally /ID# 169852
  • Hospital Unversitario Marques de Valdecilla /ID# 202039
  • Hospital Universitari Son Espases /ID# 201997
  • Hospital Universitario Dr. Negrin /ID# 171238
  • Complejo Hospitalario de Navarra /ID# 202038
  • Hospital Universitario A Coruna - CHUAC /ID# 203908
  • Hospital Universitario Vall d'Hebron /ID# 171237
  • Hospital Clinic de Barcelona /ID# 171242
  • Hospital Universitario de Girona Doctor Josep Trueta /ID# 202040
  • Hospital Juan Ramon Jimenez /ID# 171243
  • Hospital Universitario La Paz /ID# 171241
  • Hospital Universitario Virgen Macarena /ID# 171240
  • Hospital Universitario y Politecnico La Fe /ID# 201988
  • Hallands Hospital Halmstad /ID# 170840
  • Alingsas lasarett /ID# 170838
  • Sodra Alvsborgs sjukhus /ID# 202889
  • Sahlgrenska University Hospital /ID# 169031
  • Universitätsspital Zürich /ID# 170999
  • Inselspital, Universitätsspital Bern /ID# 171006
  • National Taiwan University Hospital /ID# 169789
  • Linkou Chang Gung Memorial Ho /ID# 169788
  • Acibadem Kozyatagi Hospital /ID# 209405
  • Erciyes University Medical Fac /ID# 171321
  • Ankara Univ Medical Faculty /ID# 206412
  • Inonu Universitesi Turgut Ozal /ID# 201267
  • Mustafa Kemal University Medic /ID# 171318
  • Istanbul University-Cerrahpasa, Cerrahpasa Medical Faculty /ID# 200280
  • Marmara Universitesi Pendik Egitim ve Arastirma Hastanesi /ID# 171316
  • Mersin University Medical /ID# 171320
  • Sisli Etfal Train & Res Hosp /ID# 171317
  • Gazi Universitesi Tip Fakultes /ID# 217443
  • South Eastern Health and Social Care Trust /ID# 205322
  • Warrington and Halton Hospitals NHS Foundation Trust /ID# 171388
  • Warrington and Halton Hospitals NHS Foundation Trust /ID# 209085
  • Barts Health NHS Trust /ID# 218829
  • Royal United Hospitals Bath /ID# 169084
  • University Hospitals Birmingham NHS Foundation Trust /ID# 169080
  • The Dudley Group NHS Foundation Trust /ID# 169079
  • London North West University Healthcare NHS Trust /ID# 169078
  • King's College Hospital NHS Foundation Trusts /ID# 169082
  • The Newcastle Upon Tyne Hospitals NHS Foundation Trust /ID# 169085
  • Stockport NHS foundation trust /ID# 208718
  • Taunton and Somerset NHS Foundation Trust /ID# 209664
  • St George's University Hospitals NHS Foundation Trust /ID# 205551
  • The Royal Wolverhampton NHS Trust /ID# 171387

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Placebo Comparator

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Part 1 (Double-blind): Placebo

Part 1 (Double-blind): Upadacitinib 45 mg

Part 2 (Open-label): Upadacitinib 45 mg

Part 3 (Extended Treatment DB): Upadacitinib 45 mg From Part 1 DB Placebo

Part 3 (Extended Treatment DB): Upadacitinib 30 mg From Part 1 DB Upadacitinib 45 mg

Part 3 (Extended Treatment OL): Upadacitinib 30 mg From Part 2 OL Upadacitinib 45 mg

Arm Description

Participants received upadacitinib matching placebo tablets, orally, once daily (QD) for 12 weeks during the Double-blind (DB) Induction Period.

Participants received upadacitinib 45 mg tablets, orally, QD for 12 weeks during the DB Induction Period.

Participants received upadacitinib 45 mg tablets, orally, QD for 12 weeks during the Open-label (OL) Induction Period.

Participants received upadacitinib 45 mg tablets, orally, QD for 12 weeks (until Week 24) during the Extended Treatment (ET) Period. Participants who received placebo in Part 1 and did not achieve clinical response at Week 12 were included in this group.

Participants received upadacitinib 30 mg tablets, orally, QD for 12 weeks (until Week 24) during the ET Period. Participants who received DB upadacitinib 45 mg in Part 1 and did not achieve clinical response at Week 12 were included in this group.

Participants received upadacitinib 30 mg tablets, orally, QD for 12 weeks (until Week 24) during the ET Period. Participants who received OL upadacitinib 45 mg during Part 2 and did not achieve clinical response at Week 12 were included in this group.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
November 15, 2017
Last Updated
July 18, 2022
Sponsor
AbbVie
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1. Study Identification

Unique Protocol Identification Number
NCT03345836
Brief Title
A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Participants With Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or Are Intolerant to Biologic Therapy
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 Biologic Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
November 29, 2017 (Actual)
Primary Completion Date
August 11, 2021 (Actual)
Study Completion Date
August 11, 2021 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

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

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Part 1 (Double-blind): Placebo
Arm Type
Placebo Comparator
Arm Description
Participants received upadacitinib matching placebo tablets, orally, once daily (QD) for 12 weeks during the Double-blind (DB) Induction Period.
Arm Title
Part 1 (Double-blind): Upadacitinib 45 mg
Arm Type
Experimental
Arm Description
Participants received upadacitinib 45 mg tablets, orally, QD for 12 weeks during the DB Induction Period.
Arm Title
Part 2 (Open-label): Upadacitinib 45 mg
Arm Type
Experimental
Arm Description
Participants received upadacitinib 45 mg tablets, orally, QD for 12 weeks during the Open-label (OL) Induction Period.
Arm Title
Part 3 (Extended Treatment DB): Upadacitinib 45 mg From Part 1 DB Placebo
Arm Type
Experimental
Arm Description
Participants received upadacitinib 45 mg tablets, orally, QD for 12 weeks (until Week 24) during the Extended Treatment (ET) Period. Participants who received placebo in Part 1 and did not achieve clinical response at Week 12 were included in this group.
Arm Title
Part 3 (Extended Treatment DB): Upadacitinib 30 mg From Part 1 DB Upadacitinib 45 mg
Arm Type
Experimental
Arm Description
Participants received upadacitinib 30 mg tablets, orally, QD for 12 weeks (until Week 24) during the ET Period. Participants who received DB upadacitinib 45 mg in Part 1 and did not achieve clinical response at Week 12 were included in this group.
Arm Title
Part 3 (Extended Treatment OL): Upadacitinib 30 mg From Part 2 OL Upadacitinib 45 mg
Arm Type
Experimental
Arm Description
Participants received upadacitinib 30 mg tablets, orally, QD for 12 weeks (until Week 24) during the ET Period. Participants who received OL upadacitinib 45 mg during Part 2 and did not achieve clinical response at Week 12 were included in this group.
Intervention Type
Drug
Intervention Name(s)
Matching Placebo for Upadacitinib
Intervention Description
Matching placebo tablets
Intervention Type
Drug
Intervention Name(s)
Upadacitinib
Other Intervention Name(s)
ABT-494, RINVOQ®
Intervention Description
Upadacitinib tablets
Primary Outcome Measure Information:
Title
Percentage of Participants With Clinical Remission Per Crohn's Disease Activity Index (CDAI) at Week 12
Description
The CDAI was used to evaluate the activity of Crohn's disease. Clinical remission per CDAI is defined as CDAI <150. The CDAI is calculated on the basis of a one-week evaluation of 8 items: frequency of liquid or very soft stool, abdominal pain, complications of Crohn's disease (e.g., uveitis, arthritis, fistula, and abscess), abdominal mass, hematocrit, body weight, use of antidiarrheals, and general condition. Total score ranges from 0 to about 600. Higher CDAI scores indicate more severe disease. CDAI scores below 150 represent remission and scores over 450 represent very severe Crohn's disease. Results were based on non-responder imputation incorporating multiple imputation to handle missing data due to COVID-19 (NRI-C).
Time Frame
Week 12
Title
Percentage of Participants With Endoscopic Response at Week 12
Description
Endoscopic response was defined as greater than 50% decrease in Simple Endoscopic Score for Crohn's Disease (SES-CD) from Baseline of the induction study (or for participants with an SES-CD of 4 at Baseline of the induction study, at least a 2-point reduction from Baseline), as scored by Central Reviewer. SES-CD is calculated based on the sum of individual segment values for four endoscopic variables (presence and size of ulcers, ulcerated surface, affected surface and presence of narrowing). Each variable in each segment is scored 0 to 3 resulting in SES-CD values ranging from 0 to 56 with higher scores indicating more severe disease. Results were based on NRI-C.
Time Frame
Baseline to Week 12
Title
Number of Participants With Adverse Events
Description
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not the event is considered causally related to the use of the product.
Time Frame
From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Secondary Outcome Measure Information:
Title
Percentage of Participants With Clinical Remission Per Patient-Reported Outcomes (PROs) at Week 12
Description
Clinical remission per PROs was defined as average daily very soft or liquid stool frequency (SF) ≤2.8 and average daily abdominal pain (AP) score ≤1.0 and both not greater than Baseline. The number of soft or liquid stools and abdominal pain rated on a scale of 0=none to 3=severe were recorded in an electronic diary. Results were based on NRI-C.
Time Frame
Baseline to Week 12
Title
Percentage of Participants With Endoscopic Remission at Week 12
Description
Endoscopic remission was defined per SES-CD. SES-CD ≤4 and at least 2-point reduction from Baseline and no subscore >1 in any individual variable, as scored by Central Reviewer. SES-CD is calculated based on the sum of individual segment values for four endoscopic variables (presence and size of ulcers, ulcerated surface, affected surface and presence of narrowing). Each variable in each segment is scored 0 to 3 resulting in SES-CD values ranging from 0 to 56 with higher scores indicating more severe disease. Results were based on NRI-C.
Time Frame
Baseline to Week 12
Title
Percentage of Participants Who Discontinued Corticosteroid Use for Crohn's Disease (CD) and Achieved Clinical Remission Per CDAI at Week 12, in Participants Taking Corticosteroids at Baseline
Description
As prespecified in the protocol, this outcome measure was planned to be assessed in participants taking corticosteroids at Baseline. Clinical remission per CDAI: CDAI <150. The CDAI is used to evaluate the activity of Crohn's disease. The CDAI is calculated on the basis of a one-week evaluation of 8 items: frequency of liquid or very soft stool, abdominal pain, complications of Crohn's disease (e.g., uveitis, arthritis, fistula, and abscess), abdominal mass, hematocrit, body weight, use of antidiarrheals, and general condition. Total score ranges from 0 to about 600. Higher CDAI scores indicate more severe disease. CDAI scores below 150 represent remission and scores over 450 represent very severe Crohn's disease. Results were based on NRI-C.
Time Frame
Week 12
Title
Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Total Score at Week 12
Description
The FACIT-F questionnaire was developed to assess fatigue associated with anemia. It consists of 13 fatigue-related questions. The responses to the 13 items on the FACIT-F questionnaire are each measured on a 5-point Likert scale. The responses to the answers are the following: 0= not at all; 1= a little bit; 2= somewhat; 3= quite a bit; 4=very much. Thus, the total score ranges from 0 to 52. High scores represent less fatigue. A positive change from Baseline indicates improvement.
Time Frame
Baseline and Week 12
Title
Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score at Week 12
Description
The IBDQ is a disease-specific instrument composed of 32 Likert-scaled items. The IBDQ scale contains 4 component subscales: bowel symptoms (10 items), systemic symptoms (5 items), emotional function (12 items), and social function(5 items). Each item is scored on a 7-point scale where: 1=worst to 7= best. The total score ranges from 32 to 224, with higher scores indicating better health-related quality of life. A positive change from Baseline indicates improvement.
Time Frame
Baseline and Week 12
Title
Percentage of Participants Achieving Clinical Response 100 (CR-100) at Week 2
Description
CR-100 is defined as a decrease of at least 100 points in CDAI from Baseline at Week 2. The CDAI is used to evaluate the activity of Crohn's disease. The CDAI is calculated on the basis of a one-week evaluation of 8 items: frequency of liquid or very soft stool, abdominal pain, complications of Crohn's disease (e.g., uveitis, arthritis, fistula, and abscess), abdominal mass, hematocrit, body weight, use of antidiarrheals, and general condition. Total score ranges from 0 to about 600. Higher CDAI scores indicate more severe disease. CDAI scores below 150 represent remission and scores over 450 represent very severe Crohn's disease. Results were based on NRI-C.
Time Frame
Baseline to Week 2
Title
Percentage of Participants Achieving Clinical Response 100 (CR-100) at Week 12
Description
CR-100 is defined as a decrease of at least 100 points in CDAI from Baseline at Week 12. The CDAI is used to evaluate the activity of Crohn's disease. The CDAI is calculated on the basis of a one-week evaluation of 8 items: frequency of liquid or very soft stool, abdominal pain, complications of Crohn's disease (e.g., uveitis, arthritis, fistula, and abscess), abdominal mass, hematocrit, body weight, use of antidiarrheals, and general condition. Total score ranges from 0 to about 600. Higher CDAI scores indicate more severe disease. CDAI scores below 150 represent remission and scores over 450 represent very severe Crohn's disease. Results were based on NRI-C.
Time Frame
Baseline to Week 12
Title
Percentage of Participants With Clinical Remission Per Crohn's Disease Activity Index (CDAI) at Week 4
Description
The CDAI was used to evaluate the activity of Crohn's disease. Clinical remission per CDAI is defined as CDAI <150. The CDAI is calculated on the basis of a one-week evaluation of 8 items: frequency of liquid or very soft stool, abdominal pain, complications of Crohn's disease (e.g., uveitis, arthritis, fistula, and abscess), abdominal mass, hematocrit, body weight, use of antidiarrheals, and general condition. Total score ranges from 0 to 600. Higher CDAI scores indicate more severe disease. CDAI scores below 150 represent remission and scores over 450 represent very severe Crohn's disease. Results were based on NRI-C.
Time Frame
Week 4
Title
Percentage of Participants With Hospitalizations Due to Crohn's Disease (CD) During Part 1 (12-week Double-blind Induction Period)
Time Frame
Up to Week 12 in Part 1: Double-blind Induction Period
Title
Percentage of Participants With Resolution of Extra-Intestinal Manifestations (EIMs) at Week 12, in Participants With EIMs at Baseline
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. Results were based on NRI-C.
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 any biologic therapy for infliximab, adalimumab, certolizumab pegol, vedolizumab, and ustekinumab. If female, participant must meet the contraception recommendations. Exclusion Criteria: Participant with a current diagnosis of ulcerative colitis or indeterminate colitis. Participant not on stable doses of CD related antibiotics, oral aminosalicylates, corticosteroids or methotrexate (MTX). Participant with the following ongoing known complications of CD: abscess (abdominal or peri-anal), symptomatic bowel strictures, fulminant colitis, toxic megacolon, or any other manifestation that might require surgery while enrolled in the study. Participant with ostomy or ileoanal pouch. Participant diagnosed with conditions that could interfere with drug absorption including but not limited to short gut or short bowel syndrome. Screening laboratory and other protocol pre-specified analyses show abnormal results.
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# 171133
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36606
Country
United States
Facility Name
CB Flock Research Corporation /ID# 166220
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36608
Country
United States
Facility Name
Delsol Research Management, Ll /Id# 170179
City
Chandler
State/Province
Arizona
ZIP/Postal Code
85224
Country
United States
Facility Name
HonorHealth Research Institute - Shea /ID# 164734
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85258
Country
United States
Facility Name
Arizona Arthritis & Rheumatology Research, PLLC /ID# 203891
City
Sun City
State/Province
Arizona
ZIP/Postal Code
85306
Country
United States
Facility Name
Southern California Res. Ctr. /ID# 169654
City
Coronado
State/Province
California
ZIP/Postal Code
92118-1408
Country
United States
Facility Name
Citrus Valley Gastroenterology /ID# 166201
City
Covina
State/Province
California
ZIP/Postal Code
91722-3797
Country
United States
Facility Name
United Medical Doctors /ID# 207452
City
Los Alamitos
State/Province
California
ZIP/Postal Code
90720-3309
Country
United States
Facility Name
Gastrointestinal Biosciences Clinical Trials, LLC /ID# 164887
City
Los Angeles
State/Province
California
ZIP/Postal Code
90067-2001
Country
United States
Facility Name
Facey Medical Foundation /ID# 203137
City
Mission Hills
State/Province
California
ZIP/Postal Code
91345
Country
United States
Facility Name
United Medical Doctors - Murrieta /ID# 164845
City
Murrieta
State/Province
California
ZIP/Postal Code
92563
Country
United States
Facility Name
Ucsd /Id# 164679
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
Medical Assoc Research Grp /ID# 169705
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
UCSF Center for Colitis and Crohn's Disease /ID# 202373
City
San Francisco
State/Province
California
ZIP/Postal Code
94115-3011
Country
United States
Facility Name
Univ of California San Francis /ID# 164843
City
San Francisco
State/Province
California
ZIP/Postal Code
94158
Country
United States
Facility Name
Care Access Research /ID# 167766
City
San Pablo
State/Province
California
ZIP/Postal Code
94806
Country
United States
Facility Name
Peak Gastroenterology Associates, PC /ID# 170181
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80907
Country
United States
Facility Name
Delta Waves, Inc. /ID# 164872
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80918
Country
United States
Facility Name
Duplicate_Western States Clinical Research, Inc. /ID# 164895
City
Wheat Ridge
State/Province
Colorado
ZIP/Postal Code
80033-2896
Country
United States
Facility Name
Medical Research Center of CT /ID# 164829
City
Hamden
State/Province
Connecticut
ZIP/Postal Code
06518
Country
United States
Facility Name
Clinical Research of West Florida, Inc /ID# 205825
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33765
Country
United States
Facility Name
Clinical Research of West Florida, Inc /ID# 208117
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33765
Country
United States
Facility Name
Advanced Research - Coral Springs /ID# 218020
City
Coral Springs
State/Province
Florida
ZIP/Postal Code
33067-3173
Country
United States
Facility Name
Encore Borland-Groover Clinical Research /Id# 203498
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32256
Country
United States
Facility Name
Ctr for Advanced Gastroenterol /ID# 165332
City
Maitland
State/Province
Florida
ZIP/Postal Code
32751-6108
Country
United States
Facility Name
Crystal Pharmacology Research /ID# 166101
City
Miami
State/Province
Florida
ZIP/Postal Code
33165
Country
United States
Facility Name
Coral Research Clinic /ID# 164657
City
Miami
State/Province
Florida
ZIP/Postal Code
33186-4643
Country
United States
Facility Name
Advanced Research Institute, Inc /ID# 164814
City
New Port Richey
State/Province
Florida
ZIP/Postal Code
34653
Country
United States
Facility Name
Endoscopic Research, Inc. /ID# 205893
City
Orlando
State/Province
Florida
ZIP/Postal Code
32803
Country
United States
Facility Name
Omega Research Maitland, LLC /ID# 203480
City
Orlando
State/Province
Florida
ZIP/Postal Code
32810-2907
Country
United States
Facility Name
Clinical Research Trials of Florida, Inc. /ID# 203484
City
Tampa
State/Province
Florida
ZIP/Postal Code
33607
Country
United States
Facility Name
AdventHealth Tampa /ID# 171175
City
Tampa
State/Province
Florida
ZIP/Postal Code
33613-4680
Country
United States
Facility Name
Gastroenterology Associates of Central Georgia, LLC /ID# 165460
City
Macon
State/Province
Georgia
ZIP/Postal Code
31201
Country
United States
Facility Name
Gastroenterology Consultants PC - Roswell /ID# 218219
City
Roswell
State/Province
Georgia
ZIP/Postal Code
30076-4913
Country
United States
Facility Name
Atlanta Gastroenterology Spec /ID# 164780
City
Suwanee
State/Province
Georgia
ZIP/Postal Code
30024
Country
United States
Facility Name
University of Chicago Medicine /ID# 165472
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637-1426
Country
United States
Facility Name
DuPage Medical Group /ID# 205303
City
Downers Grove
State/Province
Illinois
ZIP/Postal Code
60515-5509
Country
United States
Facility Name
MediSphere Medical Research Center /ID# 166209
City
Evansville
State/Province
Indiana
ZIP/Postal Code
47714-8011
Country
United States
Facility Name
Indianapolis Gastroenterology /ID# 164837
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46237
Country
United States
Facility Name
Aquiant Research /ID# 205504
City
New Albany
State/Province
Indiana
ZIP/Postal Code
47150-4053
Country
United States
Facility Name
University of Iowa Hospitals and Clinics /ID# 165330
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
Tri-State Gastroenterology /ID# 165484
City
Crestview Hills
State/Province
Kentucky
ZIP/Postal Code
41017
Country
United States
Facility Name
University of Louisville /ID# 168536
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
University of Louisville /ID# 208093
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
CroNOLA, LLC /ID# 164722
City
Houma
State/Province
Louisiana
ZIP/Postal Code
70360
Country
United States
Facility Name
Nola Research Works, LLC /ID# 164897
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70115
Country
United States
Facility Name
Louisana Research Center, LLC /ID# 164659
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71105-6800
Country
United States
Facility Name
Johns Hopkins University School of Medicine /ID# 211940
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287-0010
Country
United States
Facility Name
MGG Group Co, Inc.Chevy Chase Clinical Research /ID# 164835
City
Chevy Chase
State/Province
Maryland
ZIP/Postal Code
20815
Country
United States
Facility Name
Gastro Center of Maryland /ID# 171171
City
Columbia
State/Province
Maryland
ZIP/Postal Code
21045
Country
United States
Facility Name
Lahey Hospital and Medical Center /ID# 214725
City
Burlington
State/Province
Massachusetts
ZIP/Postal Code
01805
Country
United States
Facility Name
University of Michigan Health Systems /ID# 164844
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
Clin Res Inst of Michigan, LLC /ID# 170178
City
Chesterfield
State/Province
Michigan
ZIP/Postal Code
48047
Country
United States
Facility Name
Digestive Health Associates (DHA) - Farmington Hills /ID# 206099
City
Farmington Hills
State/Province
Michigan
ZIP/Postal Code
48334-3230
Country
United States
Facility Name
Center for Digestive Health /ID# 164733
City
Troy
State/Province
Michigan
ZIP/Postal Code
48098-6363
Country
United States
Facility Name
Mayo Clinic - Rochester /ID# 164868
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905-0001
Country
United States
Facility Name
Southern Therapy and Advanced Research (STAR) LLC /ID# 165318
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39216
Country
United States
Facility Name
Quality Clinical Research Inc. /ID# 170177
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68114-3723
Country
United States
Facility Name
CHI Health Research Center /ID# 168545
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68124
Country
United States
Facility Name
Las Vegas Medical Research /ID# 168562
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89113
Country
United States
Facility Name
AGA Clinical Research Associates, LLC /ID# 164883
City
Egg Harbor Township
State/Province
New Jersey
ZIP/Postal Code
08234
Country
United States
Facility Name
Rutgers Robert Wood Johnson /ID# 166092
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08901
Country
United States
Facility Name
Montefiore Medical Center - Moses Campus /ID# 166226
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
Facility Name
Advantage Clinical Trials /ID# 168557
City
Bronx
State/Province
New York
ZIP/Postal Code
10468
Country
United States
Facility Name
NY Scientific /ID# 164833
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11235
Country
United States
Facility Name
NYU Langone Long Island Clinical Research Associates /ID# 164830
City
Lake Success
State/Province
New York
ZIP/Postal Code
11042
Country
United States
Facility Name
The Mount Sinai Hospital /ID# 170172
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Columbia Univ Medical Center /ID# 164870
City
New York
State/Province
New York
ZIP/Postal Code
10032-3725
Country
United States
Facility Name
Gastro Group of Rochester /ID# 166216
City
Rochester
State/Province
New York
ZIP/Postal Code
14618-5703
Country
United States
Facility Name
Richmond University Medical Center /ID# 201855
City
Staten Island
State/Province
New York
ZIP/Postal Code
10310-1664
Country
United States
Facility Name
Atrium Health Carolinas Medical Center /ID# 164834
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28203
Country
United States
Facility Name
PMG Research of Charlotte /ID# 171170
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28209
Country
United States
Facility Name
Wake Radiology UNC REX Healthcare - Raleigh Office /ID# 164663
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27612
Country
United States
Facility Name
Wake Forest Baptist Medical Center /ID# 201225
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157-0001
Country
United States
Facility Name
Plains Clinical Research Center, LLC /ID# 170184
City
Fargo
State/Province
North Dakota
ZIP/Postal Code
58104-5925
Country
United States
Facility Name
Consultants for Clinical Research /ID# 164855
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
University of Cincinnati /ID# 164720
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267-0585
Country
United States
Facility Name
Cleveland Clinic Main Campus /ID# 208220
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
The Ohio State University /ID# 170174
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Optimed Research, Ltd. /ID# 205618
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43235
Country
United States
Facility Name
Hometown Urgent Care and Resea /ID# 201290
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45424
Country
United States
Facility Name
Dayton Gastroenterology, Inc. /ID# 167624
City
Englewood
State/Province
Ohio
ZIP/Postal Code
45415
Country
United States
Facility Name
Great Lakes Medical Research, LLC /ID# 202007
City
Mentor
State/Province
Ohio
ZIP/Postal Code
44060-6211
Country
United States
Facility Name
Digestive Disease Specialists /ID# 201062
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73112
Country
United States
Facility Name
Options Health Research, LLC /ID# 164737
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74104
Country
United States
Facility Name
Healthcare Research Consultant /ID# 166228
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74135
Country
United States
Facility Name
University of Pennsylvania /ID# 168402
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104-5502
Country
United States
Facility Name
Thomas Jefferson University /ID# 168014
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107-4414
Country
United States
Facility Name
Pharmacorp Clinical Trials /ID# 164809
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29412
Country
United States
Facility Name
Gastroenterology Associates, P.A. of Greenville /ID# 164880
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29615-3593
Country
United States
Facility Name
Rapid City Medical Center - GI Research /ID# 201734
City
Rapid City
State/Province
South Dakota
ZIP/Postal Code
57701
Country
United States
Facility Name
Gastro One /ID# 164718
City
Germantown
State/Province
Tennessee
ZIP/Postal Code
38138
Country
United States
Facility Name
East Tennessee Research Institute /ID# 203612
City
Johnson City
State/Province
Tennessee
ZIP/Postal Code
37604
Country
United States
Facility Name
Quality Medical Research /ID# 205262
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37211
Country
United States
Facility Name
Vanderbilt University Medical Center /ID# 164846
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232-0011
Country
United States
Facility Name
TX Clinical Research Institute /ID# 164848
City
Arlington
State/Province
Texas
ZIP/Postal Code
76012
Country
United States
Facility Name
Inquest Clinical Research /ID# 164865
City
Baytown
State/Province
Texas
ZIP/Postal Code
77521-2415
Country
United States
Facility Name
Texas Digestive Disease Consultants /ID# 209952
City
Cedar Park
State/Province
Texas
ZIP/Postal Code
78613-5028
Country
United States
Facility Name
Texas Digestive Disease Consultants /ID# 209802
City
Cedar Park
State/Province
Texas
ZIP/Postal Code
78613
Country
United States
Facility Name
CliniCore International, LLC /ID# 164662
City
Houston
State/Province
Texas
ZIP/Postal Code
77027-6812
Country
United States
Facility Name
Baylor College of Medicine - Baylor Medical Center /ID# 164847
City
Houston
State/Province
Texas
ZIP/Postal Code
77030-3411
Country
United States
Facility Name
Centex Studies, Inc. - Houston /ID# 201213
City
Houston
State/Province
Texas
ZIP/Postal Code
77058
Country
United States
Facility Name
GI Specialists of Houston /ID# 202338
City
Houston
State/Province
Texas
ZIP/Postal Code
77070-4347
Country
United States
Facility Name
Caprock Gastro Research /ID# 215437
City
Lubbock
State/Province
Texas
ZIP/Postal Code
79424-3017
Country
United States
Facility Name
Clinical Associates in Research Therapeutics of America, LLC /ID# 164863
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78212
Country
United States
Facility Name
Southern Star Research Institute, LLC /ID# 169754
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229-5390
Country
United States
Facility Name
Carl R. Meisner Medical Clinic /ID# 201060
City
Sugar Land
State/Province
Texas
ZIP/Postal Code
77478
Country
United States
Facility Name
Tyler Research Institute, LLC /ID# 168681
City
Tyler
State/Province
Texas
ZIP/Postal Code
75701-4464
Country
United States
Facility Name
Gastro Health & Nutrition - Victoria /ID# 167813
City
Victoria
State/Province
Texas
ZIP/Postal Code
77904
Country
United States
Facility Name
HP Clinical Research /ID# 164929
City
Bountiful
State/Province
Utah
ZIP/Postal Code
84010
Country
United States
Facility Name
Advanced Research Institute /ID# 164866
City
Ogden
State/Province
Utah
ZIP/Postal Code
84403
Country
United States
Facility Name
Duplicate_Care Access Research /ID# 164853
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84124-1377
Country
United States
Facility Name
Velocity Clinical Research - Salt Lake City /ID# 166095
City
West Jordan
State/Province
Utah
ZIP/Postal Code
84088
Country
United States
Facility Name
Washington Gastroenterology Associates /ID# 164721
City
Bellevue
State/Province
Washington
ZIP/Postal Code
98004
Country
United States
Facility Name
Virginia Mason - Seattle Orthapedics /ID# 164680
City
Seattle
State/Province
Washington
ZIP/Postal Code
98101
Country
United States
Facility Name
University of Washington /ID# 164875
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States
Facility Name
The Vancouver Clinic, INC. PS /ID# 164811
City
Vancouver
State/Province
Washington
ZIP/Postal Code
98664
Country
United States
Facility Name
Froedtert Memorial Lutheran Hospital /ID# 202286
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226-3522
Country
United States
Facility Name
Allegiance Research Specialists /ID# 165321
City
Wauwatosa
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Facility Name
Cardio Alem /ID# 211284
City
San Isidro
State/Province
Buenos Aires
ZIP/Postal Code
1642
Country
Argentina
Facility Name
Hospital Italiano de Buenos Aires /ID# 215543
City
Ciudad Autonoma Buenos Aires
State/Province
Ciuadad Autonoma De Buenos Aires
ZIP/Postal Code
1199
Country
Argentina
Facility Name
Gedyt /ID# 210019
City
Ciudad Autonoma de Buenos Aire
State/Province
Ciuadad Autonoma De Buenos Aires
ZIP/Postal Code
1115
Country
Argentina
Facility Name
Cemic /Id# 169184
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# 171254
City
Rosario
State/Province
Santa Fe
ZIP/Postal Code
2000
Country
Argentina
Facility Name
Hospital Privado Univesitario /ID# 169228
City
Cordoba
ZIP/Postal Code
5016
Country
Argentina
Facility Name
Concord Repatriation General Hospital /ID# 171509
City
Concord
State/Province
New South Wales
ZIP/Postal Code
2139
Country
Australia
Facility Name
Coral Sea Clinical Research institute /ID# 212987
City
North Mackay
State/Province
Queensland
ZIP/Postal Code
4740
Country
Australia
Facility Name
Mater Misericordiae Limited /ID# 204908
City
South Brisbane
State/Province
Queensland
ZIP/Postal Code
4101
Country
Australia
Facility Name
Royal Adelaide Hospital /ID# 171511
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5000
Country
Australia
Facility Name
Box Hill Hospital /ID# 203734
City
Box Hill
State/Province
Victoria
ZIP/Postal Code
3128
Country
Australia
Facility Name
Fiona Stanley Hospital /ID# 171510
City
Murdoch
State/Province
Western Australia
ZIP/Postal Code
6150
Country
Australia
Facility Name
Klinik Landstrasse /ID# 203437
City
Vienna
State/Province
Wien
ZIP/Postal Code
1030
Country
Austria
Facility Name
Medizinische Universitaet Wien /ID# 169462
City
Vienna
State/Province
Wien
ZIP/Postal Code
1090
Country
Austria
Facility Name
Landeskrankenhaus Salzburg-Universitätsklinikum der PMU (LKH) /ID# 214467
City
Salzburg
ZIP/Postal Code
5020
Country
Austria
Facility Name
UCL Saint-Luc /ID# 200297
City
Woluwe-Saint-Lambert
State/Province
Bruxelles-Capitale
ZIP/Postal Code
1200
Country
Belgium
Facility Name
CHU de Liege Sart Tilman /ID# 200299
City
Liège
State/Province
Liege
ZIP/Postal Code
4000
Country
Belgium
Facility Name
CHU UCL Namur - site Godinne /ID# 200300
City
Godinne
State/Province
Namur
ZIP/Postal Code
5530
Country
Belgium
Facility Name
Universitair Ziekenhuis Leuven /ID# 200298
City
Leuven
State/Province
Vlaams-Brabant
ZIP/Postal Code
3000
Country
Belgium
Facility Name
AZ Sint-Lucas /ID# 200301
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
University Clinical Centre of the Republic of Srpska /ID# 208050
City
Banja Luka
State/Province
Republika Srpska
ZIP/Postal Code
78000
Country
Bosnia and Herzegovina
Facility Name
University Clinical Center Tuzla /ID# 210324
City
Tuzla
State/Province
Tuzlanski
ZIP/Postal Code
75000
Country
Bosnia and Herzegovina
Facility Name
Clinical Center University of Sarajevo /ID# 203885
City
Sarajevo
ZIP/Postal Code
71000
Country
Bosnia and Herzegovina
Facility Name
Polyclinic and Daily Hospital Dr. Al-Tawil /ID# 217841
City
Sarajevo
ZIP/Postal Code
71000
Country
Bosnia and Herzegovina
Facility Name
Instituto Goiano de Gastroenterologia e Endoscopia Digestiva /ID# 166870
City
Goiânia
State/Province
Goias
ZIP/Postal Code
74535-170
Country
Brazil
Facility Name
Hospital Nossa Senhora das Graças /ID# 166869
City
Curitiba
State/Province
Parana
ZIP/Postal Code
80810-040
Country
Brazil
Facility Name
Hospital de Clinicas de Porto Alegre /ID# 166872
City
Porto Alegre
State/Province
Rio Grande Do Sul
ZIP/Postal Code
90035-903
Country
Brazil
Facility Name
Upeclin Fmb - Unesp /Id# 166876
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# 166874
City
Ribeirão Preto
State/Province
Sao Paulo
ZIP/Postal Code
14051-140
Country
Brazil
Facility Name
Faculdade de Medicina do ABC /ID# 208327
City
Santo André
State/Province
Sao Paulo
ZIP/Postal Code
09060-870
Country
Brazil
Facility Name
Kaiser Clinica e Hospital Dia /ID# 166873
City
Sao Jose Do Rio Preto
State/Province
Sao Paulo
ZIP/Postal Code
15015-110
Country
Brazil
Facility Name
UMHAT Kaspela EOOD /ID# 167617
City
Plovdiv
ZIP/Postal Code
4001
Country
Bulgaria
Facility Name
Duplicate_Second MHAT Sofia /ID# 167618
City
Sofia
ZIP/Postal Code
1202
Country
Bulgaria
Facility Name
MHAT Trakia /ID# 201678
City
Stara Zagora
ZIP/Postal Code
6004
Country
Bulgaria
Facility Name
University of Calgary - Cumming School of Medicine - Adult Cystic Fibrosis Clini /ID# 166963
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4Z6
Country
Canada
Facility Name
Allen Whey Khye Lim Professional Corporation /ID# 168041
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T5R 1W2
Country
Canada
Facility Name
Covenant Health /ID# 166966
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6K 4B2
Country
Canada
Facility Name
Fraser Clinical Trials Inc /ID# 166957
City
New Westminster
State/Province
British Columbia
ZIP/Postal Code
V3L 3W4
Country
Canada
Facility Name
GIRI Gastrointestinal Research Institute /ID# 166964
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6Z 2K5
Country
Canada
Facility Name
QEII - Health Sciences Centre /ID# 169306
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 2Y9
Country
Canada
Facility Name
Scott Shulman Medicine Professional Corporation /ID# 169064
City
North Bay
State/Province
Ontario
ZIP/Postal Code
P1B 2H3
Country
Canada
Facility Name
Taunton Surgical Centre /ID# 168039
City
Oshawa
State/Province
Ontario
ZIP/Postal Code
L1H 7K4
Country
Canada
Facility Name
The Ottawa Hospital /ID# 212413
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 8L6
Country
Canada
Facility Name
Medicor Research Inc /ID# 166967
City
Sudbury
State/Province
Ontario
ZIP/Postal Code
P3A 1W8
Country
Canada
Facility Name
Toronto Digestive Disease Asso /ID# 166961
City
Vaughan
State/Province
Ontario
ZIP/Postal Code
L4L 4Y7
Country
Canada
Facility Name
CHAU- Hotel-Dieu de Levis /ID# 166958
City
Levis
State/Province
Quebec
ZIP/Postal Code
G6V 3Z1
Country
Canada
Facility Name
Crchum /Id# 170121
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2X 0A9
Country
Canada
Facility Name
Montreal General Hospital - McGill University Health Center /ID# 170010
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3G 1A4
Country
Canada
Facility Name
CIUSSS de l'Estrie - CHUS /ID# 170935
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1G 2E8
Country
Canada
Facility Name
Research Group /ID# 203180
City
Santiago
State/Province
Region Metropolitana De Santiago
ZIP/Postal Code
2540364
Country
Chile
Facility Name
M y F Estudios Clínicos /ID# 169995
City
Santiago
State/Province
Region Metropolitana Santiago
ZIP/Postal Code
7750495
Country
Chile
Facility Name
Hospital Guillermo Grant Benavente de Concepción /ID# 212422
City
Concepción
ZIP/Postal Code
4070038
Country
Chile
Facility Name
CTR Estudios Clinicos /ID# 200650
City
Providencia
ZIP/Postal Code
7500571
Country
Chile
Facility Name
Hospital Clinico Universidad De Los Andes /ID# 207465
City
Santiago
ZIP/Postal Code
7501504
Country
Chile
Facility Name
Zhongshan Hospital Xiamen University /ID# 204985
City
Fujian
State/Province
Anhui
ZIP/Postal Code
361004
Country
China
Facility Name
Sun Yat-sen Memorial Hospital of Sun Yat-sen University /ID# 205226
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510120
Country
China
Facility Name
The Sixth Affiliated Hosp Sun /ID# 204049
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# 204096
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430022
Country
China
Facility Name
Nanjing Drum Tower Hospital /ID# 204869
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210008
Country
China
Facility Name
The First Affiliated Hospital of Nanchang University /ID# 204070
City
Nanchang
State/Province
Jiangxi
ZIP/Postal Code
330006
Country
China
Facility Name
The First Hospital of Jilin University /ID# 206867
City
Changchun
State/Province
Jilin
ZIP/Postal Code
130021
Country
China
Facility Name
Ruijin Hospital, Shanghai Jiaotong University School of Medicine /ID# 204072
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200065
Country
China
Facility Name
The second Affiliated hospital of Zhejiang University school of Medicine /ID# 204078
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310009
Country
China
Facility Name
Sir Run Run Shaw Hospital,Meical School Zhejiang University /ID# 204068
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310018
Country
China
Facility Name
Beijing Friendship Hospital /ID# 204536
City
Beijing
ZIP/Postal Code
100032
Country
China
Facility Name
The Second Hospital Central South University /ID# 204075
City
Changsha
ZIP/Postal Code
410011
Country
China
Facility Name
Nanfang Hospital of Southern Medical University /ID# 204074
City
Guangzhou
ZIP/Postal Code
510080
Country
China
Facility Name
Duplicate_Tianjin Med Univ General Hosp /ID# 206993
City
Tianjin
ZIP/Postal Code
300052
Country
China
Facility Name
Tongji Hospital Tongji Medical College Huazhong University of Science and Techno /ID# 204069
City
Wuhan
ZIP/Postal Code
430030
Country
China
Facility Name
Hospital San Vicente de Paul /ID# 200028
City
Medellin
State/Province
Antioquia
ZIP/Postal Code
50034
Country
Colombia
Facility Name
Hospital Pablo Tobon Uribe /ID# 202405
City
Medellín
State/Province
Antioquia
ZIP/Postal Code
50034
Country
Colombia
Facility Name
Clinical Hospital Dubrava /ID# 171186
City
Zagreb
State/Province
Grad Zagreb
ZIP/Postal Code
10000
Country
Croatia
Facility Name
Klinicki bolnicki centar Sestre milosrdnice /ID# 171190
City
Zagreb
State/Province
Grad Zagreb
ZIP/Postal Code
10000
Country
Croatia
Facility Name
Klinicki bolnicki centar Zagreb /ID# 171201
City
Zagreb
State/Province
Grad Zagreb
ZIP/Postal Code
10000
Country
Croatia
Facility Name
Poliklinika Solmed /ID# 211518
City
Zagreb
State/Province
Grad Zagreb
ZIP/Postal Code
10000
Country
Croatia
Facility Name
UHC Split /ID# 171206
City
Split
ZIP/Postal Code
21000
Country
Croatia
Facility Name
Zadar General Hospital /ID# 205534
City
Zadar
ZIP/Postal Code
23000
Country
Croatia
Facility Name
Hepato-Gastroenterologie HK, s.r.o. /ID# 171566
City
Hradec Kralove
ZIP/Postal Code
500 12
Country
Czechia
Facility Name
ResTrial s.r.o. /ID# 208652
City
Praha
ZIP/Postal Code
143 00
Country
Czechia
Facility Name
ARTROSCAN s.r.o. /ID# 171592
City
Třebovice
ZIP/Postal Code
722 00
Country
Czechia
Facility Name
Nordsjaellands Hospital /ID# 200613
City
Frederikssund
State/Province
Hovedstaden
ZIP/Postal Code
3600
Country
Denmark
Facility Name
Herlev Hospital /ID# 200782
City
Herlev
State/Province
Hovedstaden
ZIP/Postal Code
2730
Country
Denmark
Facility Name
Kobenhavns Universitet - Hvidovre Hospital (HH) /ID# 200611
City
Hvidovre
State/Province
Hovedstaden
ZIP/Postal Code
2650
Country
Denmark
Facility Name
Duplicate_Sjaellands Universitets Hospital /ID# 200783
City
Roskilde
State/Province
Sjælland
ZIP/Postal Code
4000
Country
Denmark
Facility Name
Clinical Research Center, Faculty of Medicine, Alexandria university. /ID# 171010
City
Alexandria
ZIP/Postal Code
21131
Country
Egypt
Facility Name
Clinical Research Center, Faculty of Medicine, Alexandria university. /ID# 171015
City
Alexandria
ZIP/Postal Code
21131
Country
Egypt
Facility Name
Clinical Research Center, Faculty of Medicine, Cairo university /ID# 209557
City
Cairo
ZIP/Postal Code
11559
Country
Egypt
Facility Name
National Hepatology and Tropical Medicine Research Institute /ID# 170990
City
Cairo
ZIP/Postal Code
11559
Country
Egypt
Facility Name
Faculty of Medicine Ain Shams Research Institute- Clinical Research Centre /ID# 209565
City
Cairo
ZIP/Postal Code
11566
Country
Egypt
Facility Name
Air Force Specialized Hospital /ID# 170995
City
Cairo
Country
Egypt
Facility Name
Tartu University Hospital /ID# 203140
City
Tartu Linn
State/Province
Tartumaa
ZIP/Postal Code
50406
Country
Estonia
Facility Name
Chu de Nice-Hopital L'Archet Ii /Id# 171009
City
Nice
State/Province
Alpes-Maritimes
ZIP/Postal Code
06200
Country
France
Facility Name
HCL - Hôpital Lyon Sud /ID# 171014
City
Pierre Benite CEDEX
State/Province
Auvergne-Rhone-Alpes
ZIP/Postal Code
69495
Country
France
Facility Name
CHU Bordeaux - Hopital Haut Lévêque /ID# 207414
City
Pessac CEDEX
State/Province
Gironde
ZIP/Postal Code
33604
Country
France
Facility Name
CHRU Lille - Hopital Claude Huriez /ID# 206539
City
Lille
State/Province
Hauts-de-France
ZIP/Postal Code
59037
Country
France
Facility Name
Duplicate_Hopital Saint Eloi /ID# 170646
City
Montpellier CEDEX 5
State/Province
Herault
ZIP/Postal Code
34295
Country
France
Facility Name
Hopital Beaujon /ID# 171011
City
Clichy
State/Province
Ile-de-France
ZIP/Postal Code
92110
Country
France
Facility Name
CHU de SAINT ETIENNE - Hopital Nord /ID# 171018
City
St. Priest En Jarez
State/Province
Loire
ZIP/Postal Code
42270
Country
France
Facility Name
CHRU Nancy - Hôpitaux de Brabois /ID# 170985
City
Vandœuvre-lès-Nancy
State/Province
Meurthe-et-Moselle
ZIP/Postal Code
54500
Country
France
Facility Name
CHU Amiens-Picardie Site Sud /ID# 171016
City
Amiens CEDEX 1
State/Province
Somme
ZIP/Postal Code
80054
Country
France
Facility Name
CHRU Tours - Hopital Trousseau /ID# 169786
City
Chambray Les Tours
ZIP/Postal Code
37170
Country
France
Facility Name
Duplicate_CHU Henri Mondor /ID# 169787
City
Creteil
ZIP/Postal Code
94000
Country
France
Facility Name
Polyclinique Grand Sud /ID# 170649
City
Nimes Cedex
ZIP/Postal Code
30932
Country
France
Facility Name
CHU Toulouse - Hopital Rangueil /ID# 169785
City
Toulouse
ZIP/Postal Code
31400
Country
France
Facility Name
Universitatsklinikum Mannheim /ID# 168778
City
Mannheim
State/Province
Baden-Wuerttemberg
ZIP/Postal Code
68167
Country
Germany
Facility Name
Universitaetsklinikum Ulm /ID# 203563
City
Ulm
State/Province
Baden-Wuerttemberg
ZIP/Postal Code
89081
Country
Germany
Facility Name
Universitaetsklinikum Erlangen /ID# 203551
City
Erlangen
State/Province
Bayern
ZIP/Postal Code
91054
Country
Germany
Facility Name
Universitaetsklinikum Frankfurt /ID# 203565
City
Frankfurt am Main
State/Province
Hessen
ZIP/Postal Code
60590
Country
Germany
Facility Name
Zentrum für Gastroenterologie Saar MVZ GmbH /ID# 206740
City
Saarbrücken
State/Province
Saarland
ZIP/Postal Code
66111
Country
Germany
Facility Name
Universitaetsklinikum Schleswig-Holstein Campus Kiel /ID# 168779
City
Kiel
State/Province
Schleswig-Holstein
ZIP/Postal Code
24105
Country
Germany
Facility Name
Charite Universitaetsklinikum Berlin - Campus Benjamin Franklin /ID# 169067
City
Berlin
ZIP/Postal Code
12203
Country
Germany
Facility Name
Gastroenterologie am Mexikoplatz /ID# 203573
City
Berlin
ZIP/Postal Code
14163
Country
Germany
Facility Name
Universitaetsmedizin Essen St. Josef Krankenhaus Werden /ID# 203571
City
Essen
ZIP/Postal Code
45239
Country
Germany
Facility Name
Agaplesion Markus Krankenhaus /ID# 168777
City
Frankfurt am Main
ZIP/Postal Code
60431
Country
Germany
Facility Name
Universitaetsklinikum Halle (Saale) /ID# 207454
City
Halle (Saale)
ZIP/Postal Code
06120
Country
Germany
Facility Name
Medizinisches Versorgungszentrum Portal 10 /ID# 200213
City
Muenster
ZIP/Postal Code
48155
Country
Germany
Facility Name
General Hospital of Athens Ippokratio /ID# 167036
City
Athens
State/Province
Attiki
ZIP/Postal Code
11527
Country
Greece
Facility Name
General Hospital of Chest Diseases of Athens SOTIRIA /ID# 202103
City
Athens
State/Province
Attiki
ZIP/Postal Code
11527
Country
Greece
Facility Name
Tzaneio general hospital of Piraeus /ID# 206432
City
Piraeus
State/Province
Attiki
ZIP/Postal Code
18536
Country
Greece
Facility Name
University General Hospital of Heraklion PA.G.N.I /ID# 167035
City
Heraklion
State/Province
Kriti
ZIP/Postal Code
71500
Country
Greece
Facility Name
General Hospital of Athens Evaggelismos and Ophthalmiatrio of Athens Polyclinic /ID# 167037
City
Athens
ZIP/Postal Code
10676
Country
Greece
Facility Name
Genl Hosp Thess Ippokrateio /ID# 208824
City
Thessaloniki
ZIP/Postal Code
54642
Country
Greece
Facility Name
Queen Mary Hospital /ID# 171217
City
Hong Kong
ZIP/Postal Code
999077
Country
Hong Kong
Facility Name
CRU Hungary Egeszsegugyi és Szolgaltato Kft. /ID# 205546
City
Miskolc
State/Province
Borsod-Abauj-Zemplen
ZIP/Postal Code
3529
Country
Hungary
Facility Name
Bugat Pal Korhaz /ID# 201889
City
Gyöngyös
State/Province
Heves
ZIP/Postal Code
3200
Country
Hungary
Facility Name
Obudai Egeszsegugyi Centrum Kft. /ID# 201891
City
Budapest
State/Province
Pest
ZIP/Postal Code
1036
Country
Hungary
Facility Name
Magyar Honvedseg Egeszsegugyi Kozpont /ID# 201719
City
Budapest
ZIP/Postal Code
1134
Country
Hungary
Facility Name
Debreceni Egyetem Kenezy Gyula Egyetemi Korhaz /ID# 201720
City
Debrecen
ZIP/Postal Code
4031
Country
Hungary
Facility Name
Mentahaz Maganorvosi Kozpont /ID# 201890
City
Szekesfehervar
ZIP/Postal Code
8000
Country
Hungary
Facility Name
Mercy University Hospital /ID# 206510
City
Cork
ZIP/Postal Code
T12 WE28
Country
Ireland
Facility Name
Soroka University Medical Center /ID# 169912
City
Be'er Sheva
State/Province
HaDarom
ZIP/Postal Code
8443901
Country
Israel
Facility Name
Tel Aviv Sourasky Medical Center /ID# 204876
City
Tel Aviv-Yafo
State/Province
Tel-Aviv
ZIP/Postal Code
6423906
Country
Israel
Facility Name
Barzilai Medical Center /ID# 223372
City
Ashkelon
ZIP/Postal Code
7830604
Country
Israel
Facility Name
Assaf Harofeh Medical Center /ID# 204870
City
Be'Er Ya'Akov
ZIP/Postal Code
70300
Country
Israel
Facility Name
Hadassah Medical Center-Hebrew University /ID# 169927
City
Jerusalem
ZIP/Postal Code
91120
Country
Israel
Facility Name
Rabin Medical Center /ID# 202635
City
Petakh Tikva
ZIP/Postal Code
4941492
Country
Israel
Facility Name
Kaplan Medical Center /ID# 170277
City
Rehovot
ZIP/Postal Code
7661041
Country
Israel
Facility Name
University of Catanzaro /ID# 201920
City
Catanzaro
State/Province
Calabria
ZIP/Postal Code
88100
Country
Italy
Facility Name
Policlinico Universitario Campus Bio-Medico /ID# 168169
City
Rome
State/Province
Lazio
ZIP/Postal Code
00128
Country
Italy
Facility Name
Azienda Ospedaliera San Camillo Forlanini /ID# 168170
City
Rome
State/Province
Lazio
ZIP/Postal Code
00152
Country
Italy
Facility Name
Istituto Clinico Humanitas /ID# 168171
City
Rozzano
State/Province
Milano
ZIP/Postal Code
20089
Country
Italy
Facility Name
Fondazione PTV Policlinico Tor Vergata /ID# 168174
City
Rome
State/Province
Roma
ZIP/Postal Code
00133
Country
Italy
Facility Name
Presidio Columbus-Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Un /ID# 168168
City
Rome
State/Province
Roma
ZIP/Postal Code
00168
Country
Italy
Facility Name
IRCCS Ospedale Sacro Cuore Don Calabria /ID# 168172
City
Negrar
State/Province
Verona
ZIP/Postal Code
37024
Country
Italy
Facility Name
A.O.U. di Bologna Policlinico S.Orsola-Malpighi /ID# 168173
City
Bologna
ZIP/Postal Code
40138
Country
Italy
Facility Name
A.O. Per L'Emergenza Cannizzaro /ID# 168176
City
Catania
ZIP/Postal Code
95126
Country
Italy
Facility Name
Policlinico San Martino/Univer /ID# 168177
City
Genova
ZIP/Postal Code
16132
Country
Italy
Facility Name
ASST Fatebenefratelli Sacco - Ospedale Fatebenefratelli e Oftalmico /ID# 168167
City
Milano
ZIP/Postal Code
20121
Country
Italy
Facility Name
Azienda Ospedaliero-Universitaria di Modena /ID# 200008
City
Modena
ZIP/Postal Code
41124
Country
Italy
Facility Name
A.O. Ospedali Riuniti Villa Sofia - Cervello /ID# 168175
City
Palermo
ZIP/Postal Code
90146
Country
Italy
Facility Name
Azienda Ospedaliero Universitaria Pisana-Stabilimento di Cisanello /ID# 202420
City
Pisa
ZIP/Postal Code
56125
Country
Italy
Facility Name
Aichi Medical University Hospital /ID# 165957
City
Nagakute-shi
State/Province
Aichi
ZIP/Postal Code
480-1195
Country
Japan
Facility Name
Nagoya City University Hospital /ID# 165956
City
Nagoya shi
State/Province
Aichi
ZIP/Postal Code
467-8602
Country
Japan
Facility Name
Nagoya University Hospital /ID# 165955
City
Nagoyashi
State/Province
Aichi
ZIP/Postal Code
4668560
Country
Japan
Facility Name
Toyohashi Municipal Hospital /ID# 200174
City
Toyohashi-shi
State/Province
Aichi
ZIP/Postal Code
441-8570
Country
Japan
Facility Name
Hirosaki National Hospital /ID# 165944
City
Hirosaki-shi
State/Province
Aomori
ZIP/Postal Code
036-8545
Country
Japan
Facility Name
Toho University Sakura Medical Center /ID# 165949
City
Sakura-shi
State/Province
Chiba
ZIP/Postal Code
285-8741
Country
Japan
Facility Name
Kurume University Hospital /ID# 166004
City
Kurume-shi
State/Province
Fukuoka
ZIP/Postal Code
830-0011
Country
Japan
Facility Name
National Hospital Organization Takasaki General Medical Center /ID# 167136
City
Takasaki-shi
State/Province
Gunma
ZIP/Postal Code
370-0829
Country
Japan
Facility Name
NHO Fukuyama Medical Center /ID# 167139
City
Fukuyama-shi
State/Province
Hiroshima
ZIP/Postal Code
720-8520
Country
Japan
Facility Name
Hiroshima University Hospital /ID# 166006
City
Hiroshima-shi
State/Province
Hiroshima
ZIP/Postal Code
734-8551
Country
Japan
Facility Name
Asahikawa Medical University Hospital /ID# 167133
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# 165943
City
Sapporo-shi
State/Province
Hokkaido
ZIP/Postal Code
060-0033
Country
Japan
Facility Name
Sapporo Medical University Hospital /ID# 167137
City
Sapporo-shi
State/Province
Hokkaido
ZIP/Postal Code
060-8543
Country
Japan
Facility Name
Aoyama Clinic /ID# 166001
City
Kobe-shi
State/Province
Hyogo
ZIP/Postal Code
650-0015
Country
Japan
Facility Name
Hyogo College of Medicine College Hospital /Id# 200173
City
Nishinomiya-shi
State/Province
Hyogo
ZIP/Postal Code
663-8501
Country
Japan
Facility Name
Kanazawa University Hospital /ID# 169215
City
Kanazawa-shi
State/Province
Ishikawa
ZIP/Postal Code
920-8641
Country
Japan
Facility Name
Iwate Medical University Uchimaru Medical Center /ID# 202407
City
Morioka-shi
State/Province
Iwate
ZIP/Postal Code
020-8505
Country
Japan
Facility Name
Imamura General Hospital /ID# 227136
City
Kagoshima-shi
State/Province
Kagoshima
ZIP/Postal Code
890-0064
Country
Japan
Facility Name
Idzuro Imamura Hospital /ID# 206651
City
Kagoshima-shi
State/Province
Kagoshima
ZIP/Postal Code
892-0824
Country
Japan
Facility Name
Sameshima Hospital /ID# 206674
City
Kagoshima-shi
State/Province
Kagoshima
ZIP/Postal Code
892-0846
Country
Japan
Facility Name
Japanese Red Cross Kyoto Daiichi Hosital /ID# 165958
City
Kyoto-shi
State/Province
Kyoto
ZIP/Postal Code
605-0981
Country
Japan
Facility Name
Kyoto University Hospital /ID# 169888
City
Kyoto-shi
State/Province
Kyoto
ZIP/Postal Code
606-8507
Country
Japan
Facility Name
Yokkaichi Hazu Medical Center /ID# 167191
City
Yokkaichi-shi
State/Province
Mie
ZIP/Postal Code
510-0016
Country
Japan
Facility Name
Tohoku University Hospital /ID# 167135
City
Sendai-shi
State/Province
Miyagi
ZIP/Postal Code
9808574
Country
Japan
Facility Name
Nara Medical University Hospital /ID# 169216
City
Kashihara-shi
State/Province
Nara
ZIP/Postal Code
634-8522
Country
Japan
Facility Name
Kenseikai Dongo Hospital /ID# 208103
City
Yamatotakada-shi
State/Province
Nara
ZIP/Postal Code
635-0022
Country
Japan
Facility Name
Niigata University Medical & Dental Hospital /ID# 170044
City
Niigata-shi
State/Province
Niigata
ZIP/Postal Code
951-8520
Country
Japan
Facility Name
Ishida Clinic of IBD and Gastroenterology /ID# 167134
City
Oita-shi
State/Province
Oita
ZIP/Postal Code
870-0823
Country
Japan
Facility Name
Chikuba Hospital for Proctological and Gastrointestinal Diseases /ID# 166002
City
Kurashiki-shi
State/Province
Okayama
ZIP/Postal Code
710-0142
Country
Japan
Facility Name
Okayama University Hospital /ID# 167355
City
Okayama-shi
State/Province
Okayama
ZIP/Postal Code
700-8558
Country
Japan
Facility Name
Kinshukai Infusion Clinic /ID# 218871
City
Osaka-shi
State/Province
Osaka
ZIP/Postal Code
530-0011
Country
Japan
Facility Name
Osaka City University Hospital /ID# 166007
City
Osaka-shi
State/Province
Osaka
ZIP/Postal Code
545-8586
Country
Japan
Facility Name
Osaka University Hospital /ID# 169662
City
Suita-shi
State/Province
Osaka
ZIP/Postal Code
565-0871
Country
Japan
Facility Name
Osaka Medical and Pharmaceutical University Hospital /ID# 206324
City
Takatsuki-shi
State/Province
Osaka
ZIP/Postal Code
569-8686
Country
Japan
Facility Name
Tokitokai Tokito clinic /ID# 165945
City
Saitama-shi
State/Province
Saitama
ZIP/Postal Code
336-0963
Country
Japan
Facility Name
Shiga University of Medical Science Hospital /ID# 167141
City
Otsu-shi
State/Province
Shiga
ZIP/Postal Code
520-2192
Country
Japan
Facility Name
NHO Shizuoka Medical Center /ID# 167138
City
Sunto-gun
State/Province
Shizuoka
ZIP/Postal Code
411-8611
Country
Japan
Facility Name
Tokyo Medical And Dental University, Medical Hospital /ID# 165948
City
Bunkyo-ku
State/Province
Tokyo
ZIP/Postal Code
113-8519
Country
Japan
Facility Name
Duplicate_Tokai University Hachioji Hospital /ID# 165951
City
Hachioji-shi
State/Province
Tokyo
ZIP/Postal Code
192-0032
Country
Japan
Facility Name
The Jikei University Hospital /ID# 167142
City
Minato-ku
State/Province
Tokyo
ZIP/Postal Code
105-8471
Country
Japan
Facility Name
Kyorin University Hospital /ID# 165950
City
Mitaka-shi
State/Province
Tokyo
ZIP/Postal Code
181-8611
Country
Japan
Facility Name
Tokyo Women's Medical University Hospital /ID# 205981
City
Shinjuku-ku
State/Province
Tokyo
ZIP/Postal Code
162-8666
Country
Japan
Facility Name
Toyama Prefectural Central Hospital /ID# 217833
City
Toyama-shi
State/Province
Toyama
ZIP/Postal Code
930-8550
Country
Japan
Facility Name
Japanese Red Cross Wakayama Medical Center /ID# 200638
City
Wakayama-shi
State/Province
Wakayama
ZIP/Postal Code
640-8558
Country
Japan
Facility Name
Wakayama Medical University Hospital /ID# 169481
City
Wakayama-shi
State/Province
Wakayama
ZIP/Postal Code
641-8510
Country
Japan
Facility Name
Yamagata University Hospital /ID# 200156
City
Yamagata-shi
State/Province
Yamagata
ZIP/Postal Code
990-9585
Country
Japan
Facility Name
Hayang University GuriHospital /ID# 167578
City
Guri
State/Province
Gyeonggido
ZIP/Postal Code
11923
Country
Korea, Republic of
Facility Name
CHA University Bundang Medical Center /ID# 167583
City
Seongnam si
State/Province
Gyeonggido
ZIP/Postal Code
13496
Country
Korea, Republic of
Facility Name
Kangbuk Samsung Hospital /ID# 167577
City
Seoul
State/Province
Seoul Teugbyeolsi
ZIP/Postal Code
03181
Country
Korea, Republic of
Facility Name
Yonsei University Health System Severance Hospital /ID# 167581
City
Seoul
State/Province
Seoul Teugbyeolsi
ZIP/Postal Code
03722
Country
Korea, Republic of
Facility Name
Inje University Haeundae Hospital /ID# 202629
City
Busan
ZIP/Postal Code
48108
Country
Korea, Republic of
Facility Name
Dong-A University Hospital /ID# 167582
City
Busan
ZIP/Postal Code
49201
Country
Korea, Republic of
Facility Name
Pusan National University Hospital /ID# 167580
City
Busan
ZIP/Postal Code
49241
Country
Korea, Republic of
Facility Name
Kyungpook National Univ Hosp /ID# 207015
City
Daegu
ZIP/Postal Code
41944
Country
Korea, Republic of
Facility Name
Samsung Medical Center /ID# 167579
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
Facility Name
Chung-Ang University Hostipal /ID# 207017
City
Seoul
ZIP/Postal Code
06973
Country
Korea, Republic of
Facility Name
Pauls Stradins Clinical University Hospital /ID# 169493
City
Riga
ZIP/Postal Code
1002
Country
Latvia
Facility Name
Digestive Disease Center Gastro /ID# 169517
City
Riga
ZIP/Postal Code
LV-1079
Country
Latvia
Facility Name
Riga East Clinical University Hospital /ID# 169496
City
Riga
ZIP/Postal Code
LV-1079
Country
Latvia
Facility Name
Hospital of Lithuanian University of Health Sciences Kaunas Clinics /ID# 207263
City
Kaunas
ZIP/Postal Code
50161
Country
Lithuania
Facility Name
Vilnius University Hospital Santaros Klinikos /ID# 203285
City
Vilnius
ZIP/Postal Code
08661
Country
Lithuania
Facility Name
Hospital Sultanah Bahiyah /ID# 202627
City
Alor Setar
State/Province
Kedah
ZIP/Postal Code
05460
Country
Malaysia
Facility Name
Universiti Kebangsaan Malaysia (UKM) Medical Centre /ID# 170778
City
Kuala Lumpur
State/Province
Selangor
ZIP/Postal Code
56000
Country
Malaysia
Facility Name
Instituto de Investigaciones Aplicadas a la Neurociencias A.C. /ID# 207143
City
Victoria de Durango
State/Province
Durango
ZIP/Postal Code
34000
Country
Mexico
Facility Name
Morales Vargas Centro de Investigacion S.C. /ID# 203495
City
Leon
State/Province
Guanajuato
ZIP/Postal Code
37000
Country
Mexico
Facility Name
Clinica de Investigacion en Reumatologia y Obesidad S.C. /ID# 206779
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
44650
Country
Mexico
Facility Name
Radboud Universitair Medisch Centrum /ID# 166925
City
Nijmegen
State/Province
Gelderland
ZIP/Postal Code
6525 GA
Country
Netherlands
Facility Name
Zuyderland Medisch Centrum /ID# 169698
City
Heerlen
State/Province
Limburg
ZIP/Postal Code
6419 PC
Country
Netherlands
Facility Name
Academisch Medisch Centrum /ID# 166924
City
Amsterdam
ZIP/Postal Code
1105 AZ
Country
Netherlands
Facility Name
Medisch Spectrum Twente /ID# 170297
City
Enschede
ZIP/Postal Code
7512 KZ
Country
Netherlands
Facility Name
Vistamed /ID# 208570
City
Wroclaw
State/Province
Dolnoslaskie
ZIP/Postal Code
53-149
Country
Poland
Facility Name
Malopolskie Centrum Kliniczne /ID# 202166
City
Krakow
State/Province
Malopolskie
ZIP/Postal Code
30-149
Country
Poland
Facility Name
WIP Warsaw IBD Point Profesor Kierkus /ID# 224300
City
Warsaw
State/Province
Mazowieckie
ZIP/Postal Code
00-728
Country
Poland
Facility Name
Centrum Medyczne Reuma Park w Warszawie /ID# 200488
City
Warsaw
State/Province
Mazowieckie
ZIP/Postal Code
02-691
Country
Poland
Facility Name
Centrum Zdrowia MDM /ID# 200486
City
Warszawa
State/Province
Mazowieckie
ZIP/Postal Code
00-635
Country
Poland
Facility Name
Hospital da Senhora da Oliveira Guimaraes, EPE /ID# 170225
City
Guimaraes
State/Province
Braga
ZIP/Postal Code
4835-044
Country
Portugal
Facility Name
Hospital Egas Moniz /ID# 170249
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# 200606
City
Ponte de Lima
State/Province
Viana Do Castelo
ZIP/Postal Code
4990-041
Country
Portugal
Facility Name
Hospital Garcia de Orta, EPE /ID# 170234
City
Almada
ZIP/Postal Code
2805-267
Country
Portugal
Facility Name
Centro Hospitalar Universitario de Sao Joao, EPE /ID# 170231
City
Porto
ZIP/Postal Code
4200-319
Country
Portugal
Facility Name
Mindful Medical Research /ID# 203357
City
San Juan
ZIP/Postal Code
00918-3756
Country
Puerto Rico
Facility Name
School of Medicine University of Puerto Rico-Medical Science Campus /ID# 166770
City
San Juan
ZIP/Postal Code
00935
Country
Puerto Rico
Facility Name
Institutul Clinic Fundeni /ID# 167826
City
Sector 2
State/Province
Bucuresti
ZIP/Postal Code
022328
Country
Romania
Facility Name
Clinica GASTRO MED SRL /ID# 206367
City
Cluj-Napoca
State/Province
Cluj
ZIP/Postal Code
400380
Country
Romania
Facility Name
Cabinet Particular Policlinic Algomed /ID# 167827
City
Timișoara
ZIP/Postal Code
300002
Country
Romania
Facility Name
Immanuel Kant Baltic Federal University /ID# 202128
City
Kaliningrad
State/Province
Kaliningradskaya Oblast
ZIP/Postal Code
236016
Country
Russian Federation
Facility Name
LLC Medical Center /ID# 209233
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# 202988
City
Perm
State/Province
Permskiy Kray
ZIP/Postal Code
614109
Country
Russian Federation
Facility Name
LLC Novaya Klinika /ID# 206615
City
Pyatigorsk
State/Province
Stavropol Skiy Kray
ZIP/Postal Code
357500
Country
Russian Federation
Facility Name
Professor Pasechnikov Gastroenterology and Pankreatology clinic /ID# 202995
City
Stavropol
State/Province
Stavropol Skiy Kray
ZIP/Postal Code
355012
Country
Russian Federation
Facility Name
Kazan State Medical University /ID# 169574
City
Kazan
State/Province
Tatarstan, Respublika
ZIP/Postal Code
420012
Country
Russian Federation
Facility Name
Olla-Med Clinic /ID# 208721
City
Moscow
ZIP/Postal Code
105554
Country
Russian Federation
Facility Name
P.A. Bayandin Murmansk Regiona /ID# 169575
City
Murmansk
ZIP/Postal Code
183047
Country
Russian Federation
Facility Name
Republican hospital named after V.A. Baranov /ID# 206487
City
Petrozavodsk
ZIP/Postal Code
185019
Country
Russian Federation
Facility Name
Euromedservice /ID# 206609
City
Pushkin
ZIP/Postal Code
196603
Country
Russian Federation
Facility Name
X7 Clinical Research Center /ID# 216349
City
Saint Petersburg
ZIP/Postal Code
194156
Country
Russian Federation
Facility Name
City Clinical Hospital No. 31 /ID# 208870
City
St. Petersburg
ZIP/Postal Code
197110
Country
Russian Federation
Facility Name
Clinical Hosp Center Zvezdara /ID# 168221
City
Belgrade
State/Province
Beograd
ZIP/Postal Code
11000
Country
Serbia
Facility Name
Military Medical Academy /ID# 168784
City
Belgrade
State/Province
Beograd
ZIP/Postal Code
11000
Country
Serbia
Facility Name
University Clinical Center Serbia /ID# 168220
City
Belgrade
State/Province
Beograd
ZIP/Postal Code
11000
Country
Serbia
Facility Name
Clin Hosp Ctr Bezanijska Kosa /ID# 168799
City
Belgrade
State/Province
Beograd
ZIP/Postal Code
11080
Country
Serbia
Facility Name
University Clinical Center Kragujevac /ID# 205858
City
Kragujevac
State/Province
Sumadijski Okrug
ZIP/Postal Code
34000
Country
Serbia
Facility Name
Clinical Center Vojvodina /ID# 168222
City
Novi Sad
State/Province
Vojvodina
ZIP/Postal Code
21000
Country
Serbia
Facility Name
KL Ling Gastroenterology and Liver Clinic /ID# 217963
City
Singapore
ZIP/Postal Code
228510
Country
Singapore
Facility Name
Gleneagles Medical Centre /ID# 206530
City
Singapore
ZIP/Postal Code
258499
Country
Singapore
Facility Name
Tan Tock Seng Hospital /ID# 203159
City
Singapore
ZIP/Postal Code
308433
Country
Singapore
Facility Name
Fakultna nemocnica s poliklinikou F.D. Roosevelta Banska Bystrica /ID# 169952
City
Banska Bystrica
ZIP/Postal Code
975 17
Country
Slovakia
Facility Name
KM Management, spol. s.r.o. /ID# 170199
City
Nitra
ZIP/Postal Code
949 01
Country
Slovakia
Facility Name
Univ Medical Ctr Ljubljana /ID# 211042
City
Ljubljana
ZIP/Postal Code
1000
Country
Slovenia
Facility Name
Farmovs (Pty) Ltd /Id# 207536
City
Bloemfontein
State/Province
Free State
ZIP/Postal Code
9301
Country
South Africa
Facility Name
Lenasia Clinical Trial Centre /ID# 205144
City
Johannesburg
State/Province
Gauteng
ZIP/Postal Code
1820
Country
South Africa
Facility Name
Wits Clinical Research Site /ID# 170851
City
Johannesburg
State/Province
Gauteng
ZIP/Postal Code
2193
Country
South Africa
Facility Name
Dr JP Wright /ID# 170885
City
Cape Town
State/Province
Western Cape
ZIP/Postal Code
7708
Country
South Africa
Facility Name
Private Practice Dr MN Rajabally /ID# 169852
City
Cape Town
State/Province
Western Cape
ZIP/Postal Code
7800
Country
South Africa
Facility Name
Hospital Unversitario Marques de Valdecilla /ID# 202039
City
Santander
State/Province
Cantabria
ZIP/Postal Code
39008
Country
Spain
Facility Name
Hospital Universitari Son Espases /ID# 201997
City
Palma de Mallorca
State/Province
Illes Balears
ZIP/Postal Code
07120
Country
Spain
Facility Name
Hospital Universitario Dr. Negrin /ID# 171238
City
Las Palmas de Gran Canaria
State/Province
Las Palmas
ZIP/Postal Code
35010
Country
Spain
Facility Name
Complejo Hospitalario de Navarra /ID# 202038
City
Pamplona
State/Province
Navarra
ZIP/Postal Code
31008
Country
Spain
Facility Name
Hospital Universitario A Coruna - CHUAC /ID# 203908
City
A Coruna
ZIP/Postal Code
15006
Country
Spain
Facility Name
Hospital Universitario Vall d'Hebron /ID# 171237
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Hospital Clinic de Barcelona /ID# 171242
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Hospital Universitario de Girona Doctor Josep Trueta /ID# 202040
City
Girona
ZIP/Postal Code
17007
Country
Spain
Facility Name
Hospital Juan Ramon Jimenez /ID# 171243
City
Huelva
ZIP/Postal Code
21005
Country
Spain
Facility Name
Hospital Universitario La Paz /ID# 171241
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Facility Name
Hospital Universitario Virgen Macarena /ID# 171240
City
Sevilla
ZIP/Postal Code
41009
Country
Spain
Facility Name
Hospital Universitario y Politecnico La Fe /ID# 201988
City
Valencia
ZIP/Postal Code
46026
Country
Spain
Facility Name
Hallands Hospital Halmstad /ID# 170840
City
Halmstad
State/Province
Hallands Lan
ZIP/Postal Code
302 33
Country
Sweden
Facility Name
Alingsas lasarett /ID# 170838
City
Alingsas
State/Province
Vastra Gotalands Lan
ZIP/Postal Code
441 33
Country
Sweden
Facility Name
Sodra Alvsborgs sjukhus /ID# 202889
City
Boras
State/Province
Vastra Gotalands Lan
ZIP/Postal Code
501 82
Country
Sweden
Facility Name
Sahlgrenska University Hospital /ID# 169031
City
Gothenburg
State/Province
Vastra Gotalands Lan
ZIP/Postal Code
413 46
Country
Sweden
Facility Name
Universitätsspital Zürich /ID# 170999
City
Zürich
State/Province
Zuerich
ZIP/Postal Code
8091
Country
Switzerland
Facility Name
Inselspital, Universitätsspital Bern /ID# 171006
City
Bern
ZIP/Postal Code
3010
Country
Switzerland
Facility Name
National Taiwan University Hospital /ID# 169789
City
Taipei City
ZIP/Postal Code
100
Country
Taiwan
Facility Name
Linkou Chang Gung Memorial Ho /ID# 169788
City
Taoyuan City
ZIP/Postal Code
333
Country
Taiwan
Facility Name
Acibadem Kozyatagi Hospital /ID# 209405
City
Kadikoy
State/Province
Istanbul
ZIP/Postal Code
34742
Country
Turkey
Facility Name
Erciyes University Medical Fac /ID# 171321
City
Melikgazi
State/Province
Kayseri
ZIP/Postal Code
38030
Country
Turkey
Facility Name
Ankara Univ Medical Faculty /ID# 206412
City
Ankara
ZIP/Postal Code
06590
Country
Turkey
Facility Name
Inonu Universitesi Turgut Ozal /ID# 201267
City
Battalgazi/malatya
ZIP/Postal Code
44280
Country
Turkey
Facility Name
Mustafa Kemal University Medic /ID# 171318
City
Hatay
ZIP/Postal Code
31001
Country
Turkey
Facility Name
Istanbul University-Cerrahpasa, Cerrahpasa Medical Faculty /ID# 200280
City
Istanbul
ZIP/Postal Code
34098
Country
Turkey
Facility Name
Marmara Universitesi Pendik Egitim ve Arastirma Hastanesi /ID# 171316
City
Istanbul
ZIP/Postal Code
34899
Country
Turkey
Facility Name
Mersin University Medical /ID# 171320
City
Mersin
ZIP/Postal Code
33343
Country
Turkey
Facility Name
Sisli Etfal Train & Res Hosp /ID# 171317
City
Sisli
ZIP/Postal Code
34371
Country
Turkey
Facility Name
Gazi Universitesi Tip Fakultes /ID# 217443
City
Yenimahalle
ZIP/Postal Code
06560
Country
Turkey
Facility Name
South Eastern Health and Social Care Trust /ID# 205322
City
Belfast
State/Province
Antrim
ZIP/Postal Code
BT16 1RH
Country
United Kingdom
Facility Name
Warrington and Halton Hospitals NHS Foundation Trust /ID# 171388
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# 209085
City
Warrington
State/Province
Cheshire West And Chester
ZIP/Postal Code
WA5 1QG
Country
United Kingdom
Facility Name
Barts Health NHS Trust /ID# 218829
City
London
State/Province
London, City Of
ZIP/Postal Code
E1 2ES
Country
United Kingdom
Facility Name
Royal United Hospitals Bath /ID# 169084
City
Bath
ZIP/Postal Code
BA1 3NG
Country
United Kingdom
Facility Name
University Hospitals Birmingham NHS Foundation Trust /ID# 169080
City
Birmingham
ZIP/Postal Code
B15 2TH
Country
United Kingdom
Facility Name
The Dudley Group NHS Foundation Trust /ID# 169079
City
Dudley
ZIP/Postal Code
DY1 2HQ
Country
United Kingdom
Facility Name
London North West University Healthcare NHS Trust /ID# 169078
City
Harrow
ZIP/Postal Code
HA1 3UJ
Country
United Kingdom
Facility Name
King's College Hospital NHS Foundation Trusts /ID# 169082
City
London
ZIP/Postal Code
SE5 9RS
Country
United Kingdom
Facility Name
The Newcastle Upon Tyne Hospitals NHS Foundation Trust /ID# 169085
City
Newcastle Upon Tyne
ZIP/Postal Code
NE7 7DN
Country
United Kingdom
Facility Name
Stockport NHS foundation trust /ID# 208718
City
Stockport
ZIP/Postal Code
SK2 7JE
Country
United Kingdom
Facility Name
Taunton and Somerset NHS Foundation Trust /ID# 209664
City
Taunton
ZIP/Postal Code
TA1 5DA
Country
United Kingdom
Facility Name
St George's University Hospitals NHS Foundation Trust /ID# 205551
City
Tooting
ZIP/Postal Code
SW17 0QT
Country
United Kingdom
Facility Name
The Royal Wolverhampton NHS Trust /ID# 171387
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 and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
IPD Sharing Time Frame
For details on when studies are available for sharing, please refer to the link below.
IPD Sharing Access Criteria
Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Use Agreement (DUA). For more information on the process, or to submit a request, visit the following link.
IPD Sharing URL
https://vivli.org/ourmember/abbvie/
Links:
URL
http://rxabbvie.com
Description
RINVOQ® (upadacitinib) extended-release tablets prescribing information

Learn more about this trial

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

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