Back to resultsA Study of the Efficacy and Safety of Risankizumab in Participants With Crohn's Disease
Primary Purpose
Crohn's Disease
Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Placebo for Risankizumab SC
Risankizumab IV
Placebo for Risankizumab IV
Risankizumab SC
Risankizumab On-Body Injector (OBI)
Sponsored by
About this trial
This is an interventional treatment trial for Crohn's Disease focused on measuring Risankizumab, ABBV-066, BI 655066, SKYRIZI, Crohn's Disease (CD)
Eligibility Criteria
Inclusion Criteria:
- Participants who have entered and completed Study M16-006 or Study M15-991 or other AbbVie risankizumab Crohn's disease study.
- Participants have completed the study M16-006 or M15-991 and have achieved clinical response.
Sub-Study 4:
- Participants receiving maintenance treatment in Sub-study 3 and willing to comply with the requirements of Sub-study 4, including self-administration of sub-cutaneous injections using the on-body injector (OBI).
- Participant has received at least 16 weeks of stable dosing with risankizumab in Sub-study 3 (i.e., no rescue within 16 weeks and participant has surpassed the 72-week mark).
Exclusion Criteria:
- Participants should not be enrolled in Study M16-000 with high grade colonic dysplasia or colon cancer identified during Study M15-991, Study M16-006 or another AbbVie risankizumab Crohn's disease study if the final endoscopy was performed prior to enter Study M16-000 OR is considered by the Investigator, for any reason, to be an unsuitable candidate for the study.
- Participant who has a known hypersensitivity to risankizumab or the excipients of any of the study drugs or the ingredients of Chinese hamster ovary (CHO), OR had an adverse event (AE) during Studies M16-006, M15-991 or another AbbVie risankizumab Crohn's disease study that in the Investigator's judgment makes the participant unsuitable for this study.
- Participant is not in compliance with prior and concomitant medication requirements throughout Studies M16-006, M15-991 or another AbbVie risankizumab Crohn's disease study.
- Confirmed positive urine pregnancy test at the Final Visit of Study M16-006, Study M15-991 or another AbbVie risankizumab Crohn's disease study.
- Have a known history of lymphoproliferative disease, including lymphoma, or signs and symptoms suggestive of possible lymphoproliferative disease, such as lymphadenopathy and/or splenomegaly.
- Any active or chronic recurring infections based on the Investigator's assessment makes the participant an unsuitable candidate for the study.
Sites / Locations
- Digestive Disease Consultants, A Division of Arizona Digestive Health, P.C /ID# 211884
- Phoenix VA Health Care System /ID# 162264
- University of Arizona /ID# 158502
- Atria Clinical Research /ID# 164505
- Southern California Res. Ctr. /ID# 211991
- Duplicate_Newport Huntington Medical Group /ID# 213035
- UC San Diego Health Systems /ID# 155555
- United Medical Doctors /ID# 207888
- TLC Clinical Research Inc /ID# 212719
- Gastrointestinal Biosciences Clinical Trials, LLC /ID# 162657
- United Medical Doctors - Murrieta /ID# 158300
- University of California, San Francisco /ID# 157127
- Cedars-Sinai Medical Center-West Hollywood /ID# 163839
- Peak Gastroenterology Associates, PC /ID# 165843
- Rocky Mountain Pediatric Gastroenterology /ID# 207170
- Western Connecticut Medical Group /ID# 165879
- Brandon Premier Health Care, PA/Gulf Coast Research Group, LLC /ID# 162262
- Clinical Research of West Florida, Inc /ID# 205865
- Clinical Research of West Florida, Inc /ID# 208125
- South Lake Pain Institute, Inc /ID# 162808
- Omega Research Maitland, LLC /ID# 171082
- Universal Axon Clinical Research /ID# 165428
- Nature Coast Clinical Research - Inverness /ID# 159408
- SIH Research Mumtaz, Inc /ID# 163083
- Alliance Medical Research /ID# 163837
- Cfagi Llc /Id# 202479
- Sylvester Comprehensive Cancer Center /ID# 155007
- Coral Research Clinic /ID# 158456
- South Florida Research Ph I-IV, Inc. /ID# 161832
- Gastroenterology Group Naples /ID# 165204
- Advanced Research Institute, Inc /ID# 161966
- Endoscopic Research, Inc. /ID# 205906
- IMIC Inc. Medical Research /ID# 154942
- Atlanta Gastro Assoc /ID# 154724
- Gastroenterology Associates of Central Georgia, LLC /ID# 154850
- Northwestern University /ID# 158261
- The University of Chicago Medical Center /ID# 157124
- NorthShore University HealthSystem /ID# 158265
- Southwest Gastroenterology /ID# 164781
- Cotton-O'Neil Clinical Res Ctr /ID# 154722
- University of Kentucky Chandler Medical Center /ID# 157120
- University of Louisville /ID# 210525
- Gastroenterology Associates LLC - Jefferson Hwy /ID# 161963
- Houma Digestive Health Special /ID# 158264
- Delricht Research /ID# 206644
- Nola Research Works, LLC /ID# 161317
- Louisana Research Center, LLC /ID# 162237
- MGG Group Co, Inc.Chevy Chase Clinical Research /ID# 154832
- Gastro Center of Maryland /ID# 165001
- University of Michigan Comprehensive Cancer Center Michigan Medicine /ID# 157126
- Clin Res Inst of Michigan, LLC /ID# 169179
- Center for Digestive Health /ID# 154683
- Gastroenterology Associates of Western Michigan, PLC d.b.a. West Michigan Clinic /ID# 161313
- Mayo Clinic - Rochester /ID# 163086
- St. Louis University /ID# 161883
- University of Nebraska Medical Center /ID# 210058
- Las Vegas Medical Research /ID# 160170
- Revival Research Institute, Inc /ID# 210985
- NY Scientific /ID# 158294
- Saratoga Schenectady Gastroenterology Associates - Burnt Hills /ID# 213447
- Intercity Advanced Gastroentertology Center /ID# 215205
- Northwell Health Division of Gastroenterology at Great Neck /ID# 168738
- NYU Langone Long Island Clinical Research Associates /ID# 154829
- Digestive Disease Care /ID# 211777
- NYU Langone Medical Center /ID# 160169
- Weill Cornell Medicine /ID# 165878
- Icahn School of Medicine at Mount Sinai - The Mount Sinai Medical Center /ID# 165612
- Columbia Univ Medical Center /ID# 161899
- Lenox Hill Hospital /ID# 168467
- DiGiovanna Institute for Medical Education & Research /ID# 171126
- Univ NC Chapel Hill /ID# 154833
- Atrium Health Carolinas Medical Center /ID# 158428
- Wake Radiology UNC REX Healthcare - Raleigh Office /ID# 154873
- Plains Clinical Research Center, LLC /ID# 169718
- Tri-State Endoscopy Center /ID# 154927
- Cleveland Clinic Main Campus /ID# 209226
- The Ohio State University /ID# 164708
- Optimed Research, Ltd. /ID# 167887
- Hometown Urgent Care and Resea /ID# 170464
- Great Lakes Medical Research, LLC /ID# 201770
- Hightower Clinical /ID# 211993
- Digestive Disease Specialists /ID# 170775
- Adult Gastroenterology Associates - Gen 1 Research /ID# 208864
- Children's Hospital of Pittsburgh of UPMC /ID# 212544
- Digestive Disease Associates, LTD /ID# 208297
- Medical University of South Carolina /ID# 212858
- Gastroenterology Associates, P.A. of Greenville /ID# 154904
- Rapid City Medical Center - GI Research /ID# 163838
- Gastro One /ID# 154726
- East Tennessee Research Institute /ID# 168739
- Clinical Neuroscience Solutions - Memphis /ID# 164180
- Vanderbilt University Medical Center /ID# 157121
- TX Clinical Research Institute /ID# 159404
- Inquest Clinical Research /ID# 165694
- Texas Digestive Disease Consultants /ID# 209946
- Texas Digestive Disease Consultants /ID# 209797
- Baylor Scott & White Center for Inflammatory Bowel Diseases /ID# 159406
- DHAT Research Institute /ID# 158208
- Vilo Research Group Inc /ID# 207655
- Baylor College of Medicine - Baylor Medical Center /ID# 158203
- Centex Studies, Inc. - Houston /ID# 201219
- Clinical Associates in Research Therapeutics of America, LLC /ID# 161323
- Southern Star Research Institute, LLC /ID# 168773
- Baylor Scott & White Center for Diagnostic Medicine /ID# 204131
- Tyler Research Institute, LLC /ID# 166797
- Gastro Health & Nutrition - Victoria /ID# 164290
- Advanced Research Institute /ID# 154907
- Velocity Clinical Research - Salt Lake City /ID# 161778
- Hunter Holmes McGuire VA Medical Center /ID# 159988
- Virginia Mason Medical Center /ID# 155556
- West Virginia University Hospitals /ID# 167941
- Hospital Britanico de Buenos Aires /ID# 168077
- Cemic /Id# 168078
- Hospital Provincial del Centenario /ID# 170886
- Hospital Privado Univesitario /ID# 168076
- Mater Misericordiae Limited /ID# 167220
- Griffith University /ID# 212635
- Lyell McEwin Hospital /ID# 212215
- Emeritus Research /ID# 213512
- Universitaetsklinikum St. Poelten /ID# 166424
- Medizinische Universitaet Graz /ID# 158140
- Krankenhaus der Barmherzigen Brueder Wien /ID# 212060
- Medizinische Universitaet Wien /ID# 158141
- Gomel Regional Clinical Hospital /ID# 205112
- Grodno city clinical hospital #2 /ID# 205113
- Vitebsk Regional Advanced Clin /ID# 206778
- AZ Sint-Maarten /ID# 212876
- Cliniques Universitaires de Bruxelles Hopital Erasme /ID# 157408
- UCL Saint-Luc /ID# 157406
- CHU UCL Namur - site Godinne /ID# 157412
- UZ Gent /ID# 157405
- Universitair Ziekenhuis Leuven /ID# 157407
- AZ-Delta /ID# 157402
- Imelda Ziekenhuis /ID# 157403
- AZ Maria Middelares /ID# 213532
- AZ Groeninge /ID# 211513
- CHU de Liege /ID# 157409
- Groupe Sante CHC - Clinique du MontLegia /ID# 157404
- ZNA - Jan Palfijn /ID# 212877
- University Clinical Centre of the Republic of Srpska /ID# 164513
- Clinical Center University of Sarajevo /ID# 165139
- UMHAT Dr Georgi Stranski EAD /ID# 203976
- University Multiprofile Hospit /ID# 165700
- Second Multiprofile Hospital f /ID# 165702
- Tokuda Hospital Sofia /ID# 165701
- UMHAT Sveti Ivan Rilski /ID# 204815
- UMHAT Tsaritsa Joanna - ISUL /ID# 211242
- MHAT Trakia /ID# 201668
- University of Calgary /ID# 157155
- Allen Whey Khye Lim Professional Corporation /ID# 169763
- University of Alberta - Zeidler Ledcor Centre /ID# 157099
- Covenant Health /ID# 161632
- Fraser Clinical Trials Inc /ID# 159055
- GIRI Gastrointestinal Research Institute /ID# 157096
- Percuro Clinical Research, Ltd /ID# 161631
- QEII - Health Sciences Centre /ID# 157088
- IWK Health Center /ID# 165905
- Hamilton Health Sciences - McMaster University Medical Centre /ID# 157184
- London Health Sciences Center /ID# 157161
- Scott Shulman Medicine Professional Corporation /ID# 165906
- Medicor Research Inc /ID# 157150
- Mount Sinai Hospital /ID# 169764
- Toronto Digestive Disease Asso /ID# 157158
- CISSS de la Monteregie /ID# 161630
- Hotel Dieu de Levis /ID# 214377
- CIUSSS de l'est de l'Ile-de-Montreal - Hopital Maisonneuve-Rosemont /ID# 159056
- Royal Victoria Hospital / McGill University Health Centre /ID# 157085
- Complejo Asistencial Dr. Sotero del Rio /ID# 169384
- Servicio de Salud Occidente Hospital San Juan de Dios /ID# 171122
- Hospital Guillermo Grant Benavente de Concepción /ID# 210760
- Hospital Las Higueras /ID# 167092
- Guangdong Provincial People's Hospital /ID# 212949
- The Sixth Affiliated Hosp Sun /ID# 210784
- The Second Hospital of Hebei Medical University /ID# 212738
- Union Hospital Tongji Medical College Huazhong University of Science and Technol /ID# 211039
- Tongji Hospital Tongji Medical College of HUST /ID# 210858
- Renmin Hospital of Wuhan University /ID# 214874
- The First Affiliated Hospital of Nanchang University /ID# 211036
- Shanghai East Hospital /ID# 212684
- Ruijin Hospital, Shanghai Jiaotong University School of Medicine /ID# 210840
- Renji Hospital, Shanghai Jiaotong University School of Medicine /ID# 210705
- West China Hospital, Sichuan University /ID# 210890
- The second Affiliated hospital of Zhejiang University school of Medicine /ID# 210724
- Sir Run Run Shaw Hospital Zhejiang University School of Medicine /ID# 210625
- Jinhua Municipal Central Hospital /ID# 215628
- The Second Xiangya Hospital of Central South University /ID# 211700
- Tianjin Medical University General Hospital /ID# 210926
- Instituto de Coloproctologia /ID# 158743
- Hospital Pablo Tobon Uribe /ID# 158730
- Hospital Univ San Ignacio /ID# 158734
- Hospital Universitario San Vic /ID# 171486
- Klinicka bolnica Dubrava Zagreb /ID# 157560
- Klinicki bolnicki centar Sestre milosrdnice /ID# 157728
- Klinicki bolnicki centar Zagreb /ID# 157561
- Klinicki bolnicki centar Osijek /ID# 157559
- Klinicki bolnicki centar Split /ID# 157562
- Zadar General Hospital /ID# 157563
- Duplicate_Institut klinicke a experimentalni mediciny (IKEM) /ID# 165465
- Hepato-Gastroenterologie HK, s.r.o. /ID# 163225
- Nemocnice Pardubickeho kraje, a.s. /ID# 163226
- Nemocnice Milosrdnych sester sv. Karla Boromejskeho v Praze /ID# 211306
- Axon Clinical, s.r.o. /ID# 163223
- Fakultni Thomayerova nemocnice /ID# 162941
- ResTrial s.r.o. /ID# 211078
- Nemocnice Horovice - NH Hospital a.s /ID# 211077
- ISCARE a.s. /ID# 225794
- Kobenhavns Universitet - Hvidovre Hospital (HH) /ID# 155530
- Aarhus University Hospital /ID# 155664
- Sjællands Universitetshospital /ID# 155532
- Sygehusenheden Nyborg - OUH /ID# 161525
- Odense Universitets Hospital /ID# 155531
- Zagazig University Hospitals /ID# 164539
- Clinical Research Center, Faculty of Medicine, Alexandria university. /ID# 157187
- Clinical Research Center, Faculty of Medicine, Alexandria university. /ID# 164540
- Clinical Research Center, Faculty of Medicine, Cairo university /ID# 157175
- National Hepatology and Tropical Medicine Research Institute /ID# 157874
- Internal Medicine Department, Faculty of Medicine, AinShams University /ID# 157506
- North Estonia Medical Centre /ID# 164326
- East Tallinn Central Hospital /ID# 157074
- West Tallinn Central Hospital /ID# 157075
- Chu de Nice-Hopital L'Archet Ii /Id# 162557
- HCL - Hopital Lyon Sud /ID# 162560
- CHU Bordeaux - Hopital Haut Leveque /ID# 162558
- CHRU Lille - Hopital Claude Huriez /ID# 162559
- CHU Montpellier - Hôpital Saint Eloi /ID# 215147
- Hopital Beaujon /ID# 166284
- Centre Médico Chirurgical Ambroise Paré Hartmann /ID# 249858
- CHU de SAINT ETIENNE - Hopital Nord /ID# 162562
- CHRU Nancy - Hopitaux de Brabois /ID# 162561
- CHU Amiens-Picardie Site Sud /ID# 165058
- CHU Grenoble - Hopital Michallon /ID# 212834
- CHRU Pontchaillou /ID# 213209
- Universitaetsklinikum Freiburg /ID# 162030
- Praxis fuer Gastroenterologie /ID# 166150
- Universitatsklinikum Mannheim /ID# 162031
- Universitaetsklinikum Ulm /ID# 164990
- Universitaetsklinikum Erlangen /ID# 159343
- Universitaetsklinikum Frankfurt /ID# 212979
- Universitaetsklinikum Muenster /ID# 159344
- Evangelisches Krankenhaus Kalk /ID# 212726
- Praxiszentrum fuer Gastroenterologie /ID# 211966
- Universitaetsklinikum Koeln /ID# 164989
- Zentrum für Gastroenterologie Saar MVZ GmbH /ID# 210528
- Universitaetsklinikum Schleswig-Holstein Campus Kiel /ID# 159349
- Universitaetsklinikum Jena /ID# 159351
- Krankenhaus Waldfriede /ID# 212727
- Charite Universitaetsmedizin Berlin - Campus Mitte /ID# 212220
- Charite Universitaetsmedizin Berlin - Campus Mitte /ID# 212894
- Gastroenterologische Spezialpraxis am Wittenbergplatz /ID# 211974
- MVZ fuer Gastroenterlogie am Bayerischen Platz /ID# 159350
- DRK Kliniken Berlin Westend /ID# 166151
- Stadtisches Klinikum Braunschweig /ID# 163680
- Medizinisches Versorgunszentrum Dachau /ID# 211555
- Agaplesion Markus Krankenhaus /ID# 159345
- Medizinische Hochschule Hannover /ID# 162032
- EUGASTRO GmbH /ID# 212078
- Klinikum Lueneburg /ID# 163678
- Universitaetsklinikum Magdeburg /ID# 211843
- Gastroenterologische Gemeinschaftspraxis Minden /ID# 162029
- Universitaetsklinikum Regensburg /ID# 163813
- General Hospital of Chest Diseases of Athens SOTIRIA /ID# 170914
- Tzaneio general hospital of Piraeus /ID# 206443
- University General Hospital of Heraklion PA.G.N.I /ID# 157422
- General Hospital of Athens Evaggelismos and Ophthalmiatrio of Athens Polyclinic /ID# 157423
- University General Hospital of Ioannina /ID# 157420
- General Hospital of Nikaia-Piraeus "Agios Panteleimon"- general hospital dytikis /ID# 157424
- Theageneio Anticancer Hospital /ID# 163897
- Queen Mary Hospital /ID# 163923
- Tuen Mun Hospital /ID# 163905
- Beaumont Hospital /ID# 157543
- St Vincent's University Hospital /ID# 157540
- University Hospital Galway /ID# 157541
- Soroka University Medical Center /ID# 157794
- The Chaim Sheba Medical Center /ID# 157793
- The Chaim Sheba Medical Center /ID# 171069
- Tel Aviv Sourasky Medical Center /ID# 157792
- Hadassah Medical Center-Hebrew University /ID# 165914
- Duplicate_Rambam Medical Center /ID# 171067
- The Edith Wolfson Medical Center /ID# 217331
- Shaare Zedek Medical Center /ID# 163541
- Shaare Zedek Medical Center /ID# 171068
- Duplicate_AOU Ospendali Riuniti di Ancona /ID# 162436
- University of Catanzaro /ID# 212016
- Duplicate_Azienda Ospedaliero-Universitaria Policlinico di Modena /ID# 212028
- Ospedale Policlinico San Martino /ID# 162439
- Fondazione Policlinico Universitario Campus Bio-Medico di Roma /ID# 162438
- Azienda Ospedaliera San Camillo Forlanini /ID# 155644
- Azienda Ospedaliero-Universitaria Policlinico Umberto I /ID# 166912
- ASST Rhodense/Presidio Ospedaliero di Rho /ID# 212227
- Istituto Clinico Humanitas /ID# 155642
- Azienda Ospedaliera Universitaria Policlinico Tor Vergata /ID# 158022
- Presidio Columbus-Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Un /ID# 155640
- Duplicate_Azienda Ospedaliera Univ. Meyer /ID# 167992
- IRCCS Ospedale Sacro Cuore Don Calabria /ID# 161299
- IRCCS Azienda Ospedaliero-Universitaria di Bologna /ID# 155643
- A.O. Per L'Emergenza Cannizzaro /ID# 161300
- ASST Fatebenefratelli Sacco-Ospedale Sacco /ID# 155639
- Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico /ID# 155641
- A.O. Ospedali Riuniti Villa Sofia - Cervello /ID# 155645
- Duplicate_Fondazione IRCCS Policlinico S. Matteo /ID# 212031
- Aichi Medical University Hospital /ID# 160097
- Nagoya City University Hospital /ID# 160100
- Daido Clinic /ID# 211476
- Nagoya University Hospital /ID# 160116
- Fujita Health University Hospital /ID# 163234
- Tokatsu Tsujinaka Hospital /ID# 163352
- Chiba University Hospital /ID# 217533
- Tsujinaka Hospital Kashiwanoha /ID# 213848
- The Jikei University Kashiwa Hospital /ID# 200030
- Toho University Sakura Medical Center /ID# 160099
- Fukuoka University Hospital /ID# 217793
- Kurume University Hospital /ID# 160106
- NHO Fukuyama Medical Center /ID# 163577
- Hiroshima University Hospital /ID# 160109
- Asahikawa Medical University Hospital /ID# 162848
- Sapporo Tokushukai Hospital /ID# 213492
- Hokkaido P.W.F.A.C. Sapporo-Kosei General Hospital /ID# 160096
- Sapporo Medical University Hospital /ID# 163056
- Nishinomiya Municipal Central Hospital /ID# 210103
- Hyogo Medical University Hospital /ID# 160107
- National Hospital Organization Mito Medical Center /ID# 160092
- Kanazawa University Hospital /ID# 202258
- Gokeikai Ofuna Chuo Hospital /ID# 171066
- Kitasato University Hospital /ID# 171065
- Yokohama City University Medical Center /ID# 163907
- Yokohama Municipal Citizen's Hospital /ID# 207161
- Mie University Hospital /ID# 203640
- Yokkaichi Hazu Medical Center /ID# 163764
- Tohoku University Hospital /ID# 162847
- Tohoku Rosai Hospital /ID# 163229
- Osaka Metropolitan University Hospital /ID# 160117
- Saitama Medical Center /ID# 160093
- Tokitokai Tokito clinic /ID# 160110
- Shiga University of Medical Science Hospital /ID# 164025
- Hamamatsu University Hospital /ID# 205690
- NHO Shizuoka Medical Center /ID# 163057
- Tokyo Medical And Dental University Hospital /ID# 160095
- Tokai University Hachioji Hospital /ID# 160098
- The Jikei University Hospital /ID# 163209
- Kitasato University Kitasato Institute Hospital /ID# 160105
- Kyorin University Hospital /ID# 160114
- Tokyo Women's Medical University Hospital /ID# 205974
- Wakayama Medical University Hospital /ID# 202561
- Yamagata University Hospital /ID# 200159
- Yamanashi Prefectural Central Hospital /ID# 160094
- Hayang University GuriHospital /ID# 158690
- CHA University Bundang Medical Center /ID# 158698
- The Catholic University of Korea, ST. Vincent's Hospital /ID# 158693
- Kangbuk Samsung Hospital /ID# 158694
- Yonsei University Health System Severance Hospital /ID# 158689
- Inje University Haeundae Hospital /ID# 202518
- Dong-A University Hospital /ID# 158699
- Pusan National University Hospital /ID# 158695
- Yeungnam University Medical Center /ID# 158691
- The Catholic University of Korea, Daejeon St.Mary's Hospital /ID# 213554
- Asan Medical Center /ID# 158696
- Samsung Medical Center /ID# 158692
- VCA Polyclinic Aura /ID# 159611
- Pauls Stradins Clinical University Hospital /ID# 159612
- Digestive Disease Center Gastro /ID# 163107
- Hospital of Lithuanian University of Health Sciences Kaunas Clinics /ID# 162583
- Vilnius University Hospital Santaros Klinikos /ID# 162514
- Queen Elizabeth Hospital /ID# 160664
- Universiti Kebangsaan Malaysia (UKM) Medical Centre /ID# 201363
- Universiti Sains Malaysia /ID# 160666
- Investigacion Biomedica para el Desarrollo de Farmacos, S.A. de C.V. /ID# 170734
- JM Research SC /ID# 170729
- Unidad de Atencion Medica e Investigacion en Salud /ID# 170732
- Health Pharma Professional Research S.A de C.V /ID# 170730
- Academisch Medisch Centrum /ID# 157956
- Elisabeth Tweesteden Ziekenhuis /ID# 163632
- Middlemore Clinical Trials /ID# 167226
- Christchurch Hospital /ID# 167224
- Dunedin Hospital /ID# 167227
- Duplicate_Wellington Hospital (Capital and Coast District Health Board) /ID# 167225
- Akershus universitetssykehus /ID# 169379
- Vestre viken - Baerum Sykehus /ID# 212996
- Sykehuset Levanger Helse NT /ID# 201669
- Helse More og Romsdal HF, Alesund sjukehus /ID# 212810
- Planetmed Sp. z o.o. /ID# 202799
- Gastromed /Id# 212476
- Uniwersytecki Szpital Kliniczny nr 1 im. Norberta Barlickiego w Lodzi /ID# 212477
- 1 Wojskowy Szpital Kliniczny Z Poliklinika /Id# 210940
- Samodzielny Publiczny Szpital Kliniczny Nr 4 w Lublinie /ID# 210941
- Centrum Zdrowia MDM /ID# 163570
- Centralny Szpital Kliniczny MSWiA w Warszawie /ID# 163582
- NZOZ Vivamed /ID# 202800
- Instytut Pomnik - Centrum Zdrowia Dziecka /ID# 213580
- Centrum Medyczne Medyk /ID# 212891
- Centrum Medyczne LukaMed Joanna Luka-Wendrowska /ID# 212478
- H-T. Centrum Medyczne - Endoterapia /ID# 212475
- Wojewodzki Szpital Specjalistyczny /ID# 212474
- Solumed Centrum Medyczne /ID# 163569
- Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclaw /ID# 212601
- Hospital da Senhora da Oliveira Guimaraes, EPE /ID# 160737
- Centro Hospitalar Universitário do Algarve, EPE - Hospital de Portimão /ID# 167752
- Centro Hospitalar de Entre Douro e Vouga /ID# 160672
- Hospital Garcia de Orta, EPE /ID# 160745
- Centro Hospitalar Universitário do Algarve, EPE - Hospital Faro /ID# 160713
- Centro Hospitalar Universitario Lisboa Central, EPE - Hospital dos Capuchos /ID# 160673
- Centro Hospitalar de Lisboa Ocidental, EPE - Hospital Egas Moniz /ID# 167751
- Centro Hospitalar Universitario de Lisboa Norte, EPE - Hospital de Santa Maria /ID# 160692
- Hospital de Loures, E.P.E /ID# 207759
- Centro Hospitalar Universitario de Sao Joao, EPE /ID# 160693
- Centro Hosp de Tondela-Viseu /ID# 160699
- Fundeni Clinical Institute /ID# 170899
- Tvm Med Serv Srl /Id# 170902
- Duplicate_Centrul Medical Tuculanu SRL /ID# 170903
- Cabinet Particular Policlinic Algomed /ID# 170900
- Kuzbass Regional Clinical Hospital /ID# 200962
- Duplicate_Perm state medical university n.a. E.A. Vagner /ID# 207439
- Duplicate_St. Petersburg State Pediatric Medical University /ID# 211978
- Professor Pasechnikov Gastroenterology and Pankreatology clinic /ID# 200970
- Tver Regional Clinical Hospital /ID# 206858
- Regional Clinical Hospital #1 /ID# 200973
- Alliance Biomedical Ural Group /ID# 200972
- National Medical Research Center of Coloproctology n.a. A. N. Ryzhikh /ID# 204808
- Novosibirski Gastrocenter /ID# 217552
- City Clinical Hospital No. 31 /ID# 208872
- Ulyanovsk Regional Clinical Hospital /ID# 200964
- Clinical Hosp Center Zvezdara /ID# 157052
- Military Medical Academy /ID# 157053
- University Clinical Center Serbia /ID# 157047
- Clin Hosp Ctr Bezanijska Kosa /ID# 157050
- University Clinical Center Kragujevac /ID# 157049
- Clinical Center Vojvodina /ID# 157046
- University Children's Hospital 'Tirsova' /ID# 211482
- Clinical Hospital Center Dr Dragisa Misovic - Dedinje /ID# 212799
- General Hospital Leskovac /ID# 209575
- National University Hospital /ID# 160667
- Singapore General Hospital /ID# 160668
- KL Ling Gastroenterology and Liver Clinic /ID# 205741
- Fakultna nemocnica s poliklinikou F.D. Roosevelta Banska Bystrica /ID# 156468
- KM Management, spol. s.r.o. /ID# 206764
- GASTRO I., s.r.o. /ID# 156469
- Clinresco Centers /ID# 163865
- Wits Clinical Research Site /ID# 158114
- Spoke Research Inc /ID# 158116
- Private Practice Dr MN Rajabally /ID# 163112
- Hospital Arquitecto Marcide - Complejo Hospitalario Universitario de Ferrol /ID# 157553
- Hospital Universitario de Bellvitge /ID# 208207
- Consorci Corporacio Sanitaria Parc Tauli Sabadell /ID# 159237
- Hospital Universitario Puerta de Hierro, Majadahonda /ID# 157573
- Hospital Universitario Basurto /ID# 205190
- Hospital Clinic de Barcelona /ID# 157552
- Hospital General Universitario Gregorio Maranon /ID# 161145
- Hospital Universitario La Paz /ID# 159235
- Hospital Universitario de Salamanca /ID# 157558
- Hospital Universitario Virgen Macarena /ID# 159967
- Hospital Clinico Universitario de Valencia /ID# 209700
- Hospital Universitario y Politecnico La Fe /ID# 157556
- Hospital Clinico Universitario Lozano Blesa /ID# 212525
- Hospital Universitario Miguel Servet /ID# 157557
- Skane University hospital /ID# 211745
- Karolinska University Hospital Solna /ID# 212025
- GHP Stockholm Gastro Center /ID# 211748
- Danderyd Hospital /ID# 202138
- Sahlgrenska University Hospital /ID# 163792
- Sahlgrenska University Hospital /ID# 163797
- Medicinkliniken, Gastroenheten /ID# 163744
- Universitätsspital Basel /ID# 164554
- Universitatsspital Zurich /ID# 163536
- Inselspital, Universitätsspital Bern /ID# 163535
- China Medical University Hospital /ID# 160141
- Taichung Veterans General Hospital /ID# 160140
- National Cheng Kung University Hospital /ID# 160142
- National Taiwan University Hospital /ID# 162190
- Taipei Veterans General Hosp /ID# 212712
- Kharkiv City Clinical Hospital No.2 n.a. Prof. O.O. Shalimov /ID# 165657
- Municipal Nonprofit Enterprise Kherson city clinical hospital n.a. Y.Y. Karabel /ID# 212399
- Kyiv Municipal Clinical Hospital #18 /ID# 162531
- Medical Center "OK!Clinic+" /ID# 211998
- Communal Noncommercial Institution Consultative and Diagnostic Center of Desnian /ID# 165659
- Medical Center of LLC Medbud-Clinic /ID# 216998
- Kyiv Railway Clinical Hosp No.2 /ID# 217366
- Communal Enterprise Volyn Regional Clinical hospital of the Volyn Regional Coun /ID# 206789
- Lviv Railway Clinical Hospital of branch Healthcare Centers of Public Joint Stoc /ID# 165658
- Transcarpathian Regional Clinical Hospital n.a. Andriy Novak /ID# 167960
- CNE Vinnytsya Regional Clinical Hospital named after N.I.Pirogov /ID# 216474
- Clinic of Scientific Research Institute of Invalid Rehabilitation /ID# 212000
- Royal Devon University Healthcare NHS Foundation Trust /ID# 157544
- Hull University Teaching Hospitals NHS Trust /ID# 158761
- Barts Health NHS Trust /ID# 163713
- Guys and St Thomas NHS Foundation Trust /ID# 157546
- Oxford University Hospitals NHS Foundation Trust /ID# 158036
- NHS Greater Glasgow and Clyde /ID# 202568
- Ashford and St Peter's Hospitals NHS Foundation Trust /ID# 207936
- Barnsley Hospital NHS Foundation Trust /ID# 202773
- University Hospitals Birmingham NHS Foundation Trust /ID# 157545
- Cambridge University Hospitals NHS Foundation Trust /ID# 158034
- NHS Lothian /ID# 207448
- Calderdale and Huddersfield NHS Foundation Trust /ID# 209570
- Leeds Teaching Hospitals NHS Trust /ID# 157550
- King's College Hospital NHS Foundation Trust /ID# 158760
- The Newcastle Upon Tyne Hospitals NHS Foundation Trust /ID# 163708
- Northern Care Alliance NHS Group /ID# 207766
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Arm 8
Arm Type
Placebo Comparator
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Arm Label
Double-blind Placebo for Risankizumab (Sub-Study 1)
Double-blind Risankizumab Dose 1 (Sub-Study 1)
Double-blind Risankizumab Dose 2 (Sub-Study 1)
Maintenance Risankizumab Dose 1 (Sub-Study 2)
Maintenance Risankizumab Dose 2 (Sub-Study 2)
Open-label Risankizumab (Sub-Study 3)
Risankizumab On-Body Injector and Open Label (Sub-Study 4)
CTE: Open Label Continuous Treatment Extension
Arm Description
Participants randomized to receive double-blind placebo for risankizumab for 52 weeks.
Participants randomized to receive double-blind risankizumab dose 1 for 52 weeks.
Participants randomized to receive double-blind risankizumab dose 2 for 52 weeks.
Participants will receive double-blind subcutaneous (SC)risankizumab dose 1 and intravenous placebo at Week 0 followed by open-label SC risankizumab dose 1 from Week 8 through Week 52.
Participants will receive double-blind subcutaneous placebo and intravenous risankizumab dose 3 at Week 0 followed by open-label SC risankizumab dose 1 from Week 8 through Week 52.
Participants who completed Sub-study 1 or Sub-study 2 or other AbbVie risankizumab Crohn's disease study or M16-006 or M15-991 without endoscopy will receive open-label risankizumab dose 1 or dose 2 depending on their preceding study beginning at Week 56.
Participants in Sub-study 3 who meet eligible criteria for Sub-study 4 will receive risankizumab dose 1 or dose 2 via on-body injectors on Weeks 0,8 and 16. Beginning Week 24, participants will receive risankizumab dose 1 or dose 2 via pre-filled syringes Q8W.
Participants who tolerate and derive benefit from receiving risankizumab and complete Sub-study 3 or Sub-study 4 will receive risankizumab dose 1 or dose 2 Q8W.
Outcomes
Primary Outcome Measures
Sub-Study 1: Percentage of Participants With Crohn's Disease Activity Index (CDAI) Clinical Remission
The CDAI is used to evaluate disease activity in patients with Crohn's disease. The CDAI clinical remission is defined as a CDAI score of < 150.
Sub-Study 1: Percentage of Participants With Endoscopic Response
Endoscopic response defined as decrease from Baseline of the induction study in Simple Endoscopic Score for Crohn's Disease (SES-CD).
Sub-Study 3: Number of Participants With Adverse Events
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The investigator assessed the relationship of each event to the use of study drug as either probably related, possibly related, probably not related or not related. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the subject and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent AEs are defined as any event that began or worsened in severity after the first dose of study drug. For more details on adverse events please see the Adverse Event section.
Sub-Study 4: Percentage of Participants With an Observer Rating of Successful Participant Self Administration
Participant who successfully completed the sequence of critical steps in the instructions for use (IFU) without errors to administer study drug via the OBI at Week 0 and 16.
Sub-Study 4: Percentage of Participants who had no Potential Hazards
Measured by an observer on the possible use-related hazards checklist for self-administration with OBI at Week 0 and Week 16.
Sub-Study 4: Percentage of Participants Rating of Acceptability Using Self-Injection Assessment Questionnaire (SIAQ) at Weeks 0, 8, 16
SIAQ evaluations consist of the PRE module, which is self-completed immediately before the first OBI self-injection at baseline, and the POST module, which is self-completed 20 to 40 min following injections at Weeks 0, 8, 16. These modules are completed by participants while alone in a quiet environment.
Participants rate each item of the SIAQ. The ratings are later transformed to scores ranging from 0 (worst experience) to 10 (best experience). The domain score is the mean of the item scores included in the domain. Domain scores are calculated only if at least half of the domain items are completed. Item and domain scores from the PRE module are compared with the corresponding item and domain scores from the POST modules.
Sub-Study 4: Percentage of Participants in CDAI Clinical Remission at Week 0, 16
Clinical remission per average daily stool frequency (SF) and average daily abdominal pain (AP) score.
Secondary Outcome Measures
Sub-Study 1: Percentage of Participants With Clinical Remission
Clinical remission per average daily stool frequency (SF) and average daily AP score.
Sub-Study 1: Percentage of Participants With CDAI Clinical Remission Among Participants With CDAI Clinical Remission in Week 0
The CDAI is used to evaluate disease activity in patients with Crohn's disease
Sub-Study 1: Percentage of Participants With Ulcer-Free Endoscopy
Endoscopic healing was assessed using SES-CD.
Sub-Study 1: Percentage of Participants With Endoscopic Remission
Endoscopic Remission is defined as SES-CD <= 4 and at least a 2 point reduction versus baseline and no subscore greater than 1 in any individual variable, as scored by a central reviewer
Sub-Study 1: Change From Baseline of Induction in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue)
The FACIT-Fatigue is a validated tool that measures an individual's level of fatigue during their usual daily activities over the past week.
Sub-Study 1: Percentage of Participants Who Discontinued Corticosteroid Use for 90 Days and Achieved Clinical Remission in Participants Taking Steroids at Baseline
Participants who discontinued corticosteroid use and achieved clinical remission per average daily SF and average daily AP score.
Sub-Study 1: Percentage of Participants With Crohn's Disease Activity Index (CDAI) Clinical Response
The CDAI is used to evaluate disease activity in patients with Crohn's disease.
Sub-Study 1: Percentage of Participants With Stool Frequency (SF) Remission
SF Remission is defined by an average daily SF <= 2.8 and not worse than baseline.
Sub-Study 1: Percentage of Participants With Abdominal Pain (AP) Remission
AP Remission is defined by an average daily AP <= 1 and not worse than baseline.
Sub-Study 1: Percentage of Participants With CDAI Clinical Remission and Endoscopic Response
The CDAI is used to evaluate disease activity in patients with Crohn's disease. The CDAI clinical remission is defined as a CDAI score of < 150. Endoscopic response defined as decrease from baseline of > 50% of the induction study in Simple Endoscopic Score for Crohn's Disease (SES-CD).
Sub-Study 1: Percentage of Participants With Deep Remission
Deep remission defined as participants with both clinical remission (per average daily SF and average daily AP score) and endoscopic remission (assessed using SES-CD).
Sub-Study 1: Percentage of Participants With Exposure Adjusted Occurrence of CD-related Hospitalizations From Week 0 Through Week 52
Participants with an event that results in admission to the hospital.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03105102
Brief Title
A Study of the Efficacy and Safety of Risankizumab in Participants With Crohn's Disease
Official Title
A Multicenter, Randomized, Double-Blind, Placebo Controlled 52-Week Maintenance and an Open-Label Extension Study of the Efficacy and Safety of Risankizumab in Subjects With Crohn's Disease
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 9, 2018 (Actual)
Primary Completion Date
June 9, 2026 (Anticipated)
Study Completion Date
June 9, 2026 (Anticipated)
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 study consists of 4 sub-studies, as follows:
Sub-study 1 (Randomized, double-blind, placebo controlled study) to evaluate the efficacy and safety of risankizumab versus placebo as maintenance therapy in participants with moderately to severely active Crohn's disease (CD) who responded to intravenous risankizumab induction treatment in Study M16-006 or Study M15-991;
Sub-study 2 (Randomized, exploratory maintenance study) to evaluate the efficacy and safety of two different dosing regimens for risankizumab as maintenance therapy in participants who responded to induction treatment in Study M16-006 or Study M15-991;
Sub-study 3 (Open-label, long-term extension study) to evaluate long-term safety of risankizumab in participants who completed Sub-study 1, Sub-study 2, another AbbVie risankizumab Crohn's disease study, or participants who responded to induction treatment in Study M16-006 or Study M15-991 with no final endoscopy due to the Covid-19 pandemic. Additional objectives are to further investigate long-term efficacy and tolerability of risankizumab;
Sub-study 4 (Open-label On Body Injector (OBI) administration and long-term extension study) to evaluate patient-reported outcomes, efficacy, safety, tolerability, and pharmacokinetics of risankizumab administered via OBI in participants who are receiving maintenance treatment with risankizumab.
OL CTE to ensure uninterrupted care in accordance with local regulations until risankizumab is commercially available for participants who completed Sub-study 3, Sub-study 4.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Crohn's Disease
Keywords
Risankizumab, ABBV-066, BI 655066, SKYRIZI, Crohn's Disease (CD)
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1336 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Double-blind Placebo for Risankizumab (Sub-Study 1)
Arm Type
Placebo Comparator
Arm Description
Participants randomized to receive double-blind placebo for risankizumab for 52 weeks.
Arm Title
Double-blind Risankizumab Dose 1 (Sub-Study 1)
Arm Type
Experimental
Arm Description
Participants randomized to receive double-blind risankizumab dose 1 for 52 weeks.
Arm Title
Double-blind Risankizumab Dose 2 (Sub-Study 1)
Arm Type
Experimental
Arm Description
Participants randomized to receive double-blind risankizumab dose 2 for 52 weeks.
Arm Title
Maintenance Risankizumab Dose 1 (Sub-Study 2)
Arm Type
Experimental
Arm Description
Participants will receive double-blind subcutaneous (SC)risankizumab dose 1 and intravenous placebo at Week 0 followed by open-label SC risankizumab dose 1 from Week 8 through Week 52.
Arm Title
Maintenance Risankizumab Dose 2 (Sub-Study 2)
Arm Type
Experimental
Arm Description
Participants will receive double-blind subcutaneous placebo and intravenous risankizumab dose 3 at Week 0 followed by open-label SC risankizumab dose 1 from Week 8 through Week 52.
Arm Title
Open-label Risankizumab (Sub-Study 3)
Arm Type
Experimental
Arm Description
Participants who completed Sub-study 1 or Sub-study 2 or other AbbVie risankizumab Crohn's disease study or M16-006 or M15-991 without endoscopy will receive open-label risankizumab dose 1 or dose 2 depending on their preceding study beginning at Week 56.
Arm Title
Risankizumab On-Body Injector and Open Label (Sub-Study 4)
Arm Type
Experimental
Arm Description
Participants in Sub-study 3 who meet eligible criteria for Sub-study 4 will receive risankizumab dose 1 or dose 2 via on-body injectors on Weeks 0,8 and 16. Beginning Week 24, participants will receive risankizumab dose 1 or dose 2 via pre-filled syringes Q8W.
Arm Title
CTE: Open Label Continuous Treatment Extension
Arm Type
Experimental
Arm Description
Participants who tolerate and derive benefit from receiving risankizumab and complete Sub-study 3 or Sub-study 4 will receive risankizumab dose 1 or dose 2 Q8W.
Intervention Type
Drug
Intervention Name(s)
Placebo for Risankizumab SC
Intervention Description
Placebo for Risankizumab SC Subcutaneous (SC) Injection
Intervention Type
Drug
Intervention Name(s)
Risankizumab IV
Other Intervention Name(s)
ABBV-066, BI 655066, SKYRIZI
Intervention Description
Risankizumab IV Intravenous (IV) infusion
Intervention Type
Drug
Intervention Name(s)
Placebo for Risankizumab IV
Intervention Description
Placebo for Risankizumab IV Intravenous (IV) infusion
Intervention Type
Drug
Intervention Name(s)
Risankizumab SC
Other Intervention Name(s)
ABBV-066, BI 655066, SKYRIZI
Intervention Description
Risankizumab SC Subcutaneous (SC) injection
Intervention Type
Drug
Intervention Name(s)
Risankizumab On-Body Injector (OBI)
Other Intervention Name(s)
ABBV-066, BI 655066, SKYRIZI
Intervention Description
Subcutaneous (SC) injection; on-body injector (OBI)
Primary Outcome Measure Information:
Title
Sub-Study 1: Percentage of Participants With Crohn's Disease Activity Index (CDAI) Clinical Remission
Description
The CDAI is used to evaluate disease activity in patients with Crohn's disease. The CDAI clinical remission is defined as a CDAI score of < 150.
Time Frame
Week 52
Title
Sub-Study 1: Percentage of Participants With Endoscopic Response
Description
Endoscopic response defined as decrease from Baseline of the induction study in Simple Endoscopic Score for Crohn's Disease (SES-CD).
Time Frame
Week 52
Title
Sub-Study 3: Number of Participants With Adverse Events
Description
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The investigator assessed the relationship of each event to the use of study drug as either probably related, possibly related, probably not related or not related. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the subject and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent AEs are defined as any event that began or worsened in severity after the first dose of study drug. For more details on adverse events please see the Adverse Event section.
Time Frame
Up to Week 220
Title
Sub-Study 4: Percentage of Participants With an Observer Rating of Successful Participant Self Administration
Description
Participant who successfully completed the sequence of critical steps in the instructions for use (IFU) without errors to administer study drug via the OBI at Week 0 and 16.
Time Frame
Up to Week 16
Title
Sub-Study 4: Percentage of Participants who had no Potential Hazards
Description
Measured by an observer on the possible use-related hazards checklist for self-administration with OBI at Week 0 and Week 16.
Time Frame
Up to Week 16
Title
Sub-Study 4: Percentage of Participants Rating of Acceptability Using Self-Injection Assessment Questionnaire (SIAQ) at Weeks 0, 8, 16
Description
SIAQ evaluations consist of the PRE module, which is self-completed immediately before the first OBI self-injection at baseline, and the POST module, which is self-completed 20 to 40 min following injections at Weeks 0, 8, 16. These modules are completed by participants while alone in a quiet environment.
Participants rate each item of the SIAQ. The ratings are later transformed to scores ranging from 0 (worst experience) to 10 (best experience). The domain score is the mean of the item scores included in the domain. Domain scores are calculated only if at least half of the domain items are completed. Item and domain scores from the PRE module are compared with the corresponding item and domain scores from the POST modules.
Time Frame
Up to Week 16
Title
Sub-Study 4: Percentage of Participants in CDAI Clinical Remission at Week 0, 16
Description
Clinical remission per average daily stool frequency (SF) and average daily abdominal pain (AP) score.
Time Frame
Up to Week 16
Secondary Outcome Measure Information:
Title
Sub-Study 1: Percentage of Participants With Clinical Remission
Description
Clinical remission per average daily stool frequency (SF) and average daily AP score.
Time Frame
Week 52
Title
Sub-Study 1: Percentage of Participants With CDAI Clinical Remission Among Participants With CDAI Clinical Remission in Week 0
Description
The CDAI is used to evaluate disease activity in patients with Crohn's disease
Time Frame
Week 52
Title
Sub-Study 1: Percentage of Participants With Ulcer-Free Endoscopy
Description
Endoscopic healing was assessed using SES-CD.
Time Frame
Week 52
Title
Sub-Study 1: Percentage of Participants With Endoscopic Remission
Description
Endoscopic Remission is defined as SES-CD <= 4 and at least a 2 point reduction versus baseline and no subscore greater than 1 in any individual variable, as scored by a central reviewer
Time Frame
Week 52
Title
Sub-Study 1: Change From Baseline of Induction in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue)
Description
The FACIT-Fatigue is a validated tool that measures an individual's level of fatigue during their usual daily activities over the past week.
Time Frame
Week 52
Title
Sub-Study 1: Percentage of Participants Who Discontinued Corticosteroid Use for 90 Days and Achieved Clinical Remission in Participants Taking Steroids at Baseline
Description
Participants who discontinued corticosteroid use and achieved clinical remission per average daily SF and average daily AP score.
Time Frame
Week 52
Title
Sub-Study 1: Percentage of Participants With Crohn's Disease Activity Index (CDAI) Clinical Response
Description
The CDAI is used to evaluate disease activity in patients with Crohn's disease.
Time Frame
Week 52
Title
Sub-Study 1: Percentage of Participants With Stool Frequency (SF) Remission
Description
SF Remission is defined by an average daily SF <= 2.8 and not worse than baseline.
Time Frame
Week 52
Title
Sub-Study 1: Percentage of Participants With Abdominal Pain (AP) Remission
Description
AP Remission is defined by an average daily AP <= 1 and not worse than baseline.
Time Frame
Week 52
Title
Sub-Study 1: Percentage of Participants With CDAI Clinical Remission and Endoscopic Response
Description
The CDAI is used to evaluate disease activity in patients with Crohn's disease. The CDAI clinical remission is defined as a CDAI score of < 150. Endoscopic response defined as decrease from baseline of > 50% of the induction study in Simple Endoscopic Score for Crohn's Disease (SES-CD).
Time Frame
Week 52
Title
Sub-Study 1: Percentage of Participants With Deep Remission
Description
Deep remission defined as participants with both clinical remission (per average daily SF and average daily AP score) and endoscopic remission (assessed using SES-CD).
Time Frame
Week 52
Title
Sub-Study 1: Percentage of Participants With Exposure Adjusted Occurrence of CD-related Hospitalizations From Week 0 Through Week 52
Description
Participants with an event that results in admission to the hospital.
Time Frame
Up to Week 52
Other Pre-specified Outcome Measures:
Title
Sub-Study 2: Percentage of Participants With Crohn's Disease Activity Index (CDAI) Clinical Remission
Description
The CDAI is used to evaluate disease activity in patients with Crohn's disease. The CDAI clinical remission is defined as a CDAI score of < 150.
Time Frame
Week 52
Title
Sub-Study 2: Percentage of Participants With Endoscopic Response
Description
Endoscopic response defined as decrease from Baseline of the induction study in Simple Endoscopic Score for Crohn's Disease (SES-CD).
Time Frame
Week 52
Title
Sub-Study 2: Percentage of Participants With Exposure Adjusted Occurrence of CD-related Hospitalizations From Week 0 Through Week 52
Description
Participants with an event that results in admission to the hospital.
Time Frame
Up to Week 52
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Participants who have entered and completed Study M16-006 or Study M15-991 or other AbbVie risankizumab Crohn's disease study.
Participants have completed the study M16-006 or M15-991 and have achieved clinical response.
Sub-Study 4:
Participants receiving maintenance treatment in Sub-study 3 and willing to comply with the requirements of Sub-study 4, including self-administration of sub-cutaneous injections using the on-body injector (OBI).
Participant has received at least 16 weeks of stable dosing with risankizumab in Sub-study 3 (i.e., no rescue within 16 weeks and participant has surpassed the 72-week mark).
Exclusion Criteria:
Participants should not be enrolled in Study M16-000 with high grade colonic dysplasia or colon cancer identified during Study M15-991, Study M16-006 or another AbbVie risankizumab Crohn's disease study if the final endoscopy was performed prior to enter Study M16-000 OR is considered by the Investigator, for any reason, to be an unsuitable candidate for the study.
Participant who has a known hypersensitivity to risankizumab or the excipients of any of the study drugs or the ingredients of Chinese hamster ovary (CHO), OR had an adverse event (AE) during Studies M16-006, M15-991 or another AbbVie risankizumab Crohn's disease study that in the Investigator's judgment makes the participant unsuitable for this study.
Participant is not in compliance with prior and concomitant medication requirements throughout Studies M16-006, M15-991 or another AbbVie risankizumab Crohn's disease study.
Confirmed positive urine pregnancy test at the Final Visit of Study M16-006, Study M15-991 or another AbbVie risankizumab Crohn's disease study.
Have a known history of lymphoproliferative disease, including lymphoma, or signs and symptoms suggestive of possible lymphoproliferative disease, such as lymphadenopathy and/or splenomegaly.
Any active or chronic recurring infections based on the Investigator's assessment makes the participant an unsuitable candidate for the study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ABBVIE INC.
Organizational Affiliation
AbbVie
Official's Role
Study Director
Facility Information:
Facility Name
Digestive Disease Consultants, A Division of Arizona Digestive Health, P.C /ID# 211884
City
Mesa
State/Province
Arizona
ZIP/Postal Code
85206
Country
United States
Facility Name
Phoenix VA Health Care System /ID# 162264
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85012
Country
United States
Facility Name
University of Arizona /ID# 158502
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724
Country
United States
Facility Name
Atria Clinical Research /ID# 164505
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72209-7040
Country
United States
Facility Name
Southern California Res. Ctr. /ID# 211991
City
Coronado
State/Province
California
ZIP/Postal Code
92118-1408
Country
United States
Facility Name
Duplicate_Newport Huntington Medical Group /ID# 213035
City
Huntington Beach
State/Province
California
ZIP/Postal Code
92648
Country
United States
Facility Name
UC San Diego Health Systems /ID# 155555
City
La Jolla
State/Province
California
ZIP/Postal Code
92093
Country
United States
Facility Name
United Medical Doctors /ID# 207888
City
Los Alamitos
State/Province
California
ZIP/Postal Code
90720-3309
Country
United States
Facility Name
TLC Clinical Research Inc /ID# 212719
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
Gastrointestinal Biosciences Clinical Trials, LLC /ID# 162657
City
Los Angeles
State/Province
California
ZIP/Postal Code
90067-2001
Country
United States
Facility Name
United Medical Doctors - Murrieta /ID# 158300
City
Murrieta
State/Province
California
ZIP/Postal Code
92563
Country
United States
Facility Name
University of California, San Francisco /ID# 157127
City
San Francisco
State/Province
California
ZIP/Postal Code
94158
Country
United States
Facility Name
Cedars-Sinai Medical Center-West Hollywood /ID# 163839
City
West Hollywood
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
Peak Gastroenterology Associates, PC /ID# 165843
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80907
Country
United States
Facility Name
Rocky Mountain Pediatric Gastroenterology /ID# 207170
City
Lone Tree
State/Province
Colorado
ZIP/Postal Code
80124-6798
Country
United States
Facility Name
Western Connecticut Medical Group /ID# 165879
City
Danbury
State/Province
Connecticut
ZIP/Postal Code
06810
Country
United States
Facility Name
Brandon Premier Health Care, PA/Gulf Coast Research Group, LLC /ID# 162262
City
Brandon
State/Province
Florida
ZIP/Postal Code
33510-3107
Country
United States
Facility Name
Clinical Research of West Florida, Inc /ID# 205865
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33765
Country
United States
Facility Name
Clinical Research of West Florida, Inc /ID# 208125
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33765
Country
United States
Facility Name
South Lake Pain Institute, Inc /ID# 162808
City
Clermont
State/Province
Florida
ZIP/Postal Code
34711
Country
United States
Facility Name
Omega Research Maitland, LLC /ID# 171082
City
DeBary
State/Province
Florida
ZIP/Postal Code
32713-2260
Country
United States
Facility Name
Universal Axon Clinical Research /ID# 165428
City
Doral
State/Province
Florida
ZIP/Postal Code
33166
Country
United States
Facility Name
Nature Coast Clinical Research - Inverness /ID# 159408
City
Inverness
State/Province
Florida
ZIP/Postal Code
34452-4717
Country
United States
Facility Name
SIH Research Mumtaz, Inc /ID# 163083
City
Kissimmee
State/Province
Florida
ZIP/Postal Code
34741-4161
Country
United States
Facility Name
Alliance Medical Research /ID# 163837
City
Lighthouse Point
State/Province
Florida
ZIP/Postal Code
33064
Country
United States
Facility Name
Cfagi Llc /Id# 202479
City
Maitland
State/Province
Florida
ZIP/Postal Code
32751-6108
Country
United States
Facility Name
Sylvester Comprehensive Cancer Center /ID# 155007
City
Miami
State/Province
Florida
ZIP/Postal Code
33136-1002
Country
United States
Facility Name
Coral Research Clinic /ID# 158456
City
Miami
State/Province
Florida
ZIP/Postal Code
33186-4643
Country
United States
Facility Name
South Florida Research Ph I-IV, Inc. /ID# 161832
City
Miami
State/Province
Florida
ZIP/Postal Code
33193
Country
United States
Facility Name
Gastroenterology Group Naples /ID# 165204
City
Naples
State/Province
Florida
ZIP/Postal Code
34102
Country
United States
Facility Name
Advanced Research Institute, Inc /ID# 161966
City
New Port Richey
State/Province
Florida
ZIP/Postal Code
34653
Country
United States
Facility Name
Endoscopic Research, Inc. /ID# 205906
City
Orlando
State/Province
Florida
ZIP/Postal Code
32803
Country
United States
Facility Name
IMIC Inc. Medical Research /ID# 154942
City
Palmetto Bay
State/Province
Florida
ZIP/Postal Code
33157
Country
United States
Facility Name
Atlanta Gastro Assoc /ID# 154724
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
Gastroenterology Associates of Central Georgia, LLC /ID# 154850
City
Macon
State/Province
Georgia
ZIP/Postal Code
31201
Country
United States
Facility Name
Northwestern University /ID# 158261
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611-2927
Country
United States
Facility Name
The University of Chicago Medical Center /ID# 157124
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637-1443
Country
United States
Facility Name
NorthShore University HealthSystem /ID# 158265
City
Evanston
State/Province
Illinois
ZIP/Postal Code
60201
Country
United States
Facility Name
Southwest Gastroenterology /ID# 164781
City
Oak Lawn
State/Province
Illinois
ZIP/Postal Code
60453
Country
United States
Facility Name
Cotton-O'Neil Clinical Res Ctr /ID# 154722
City
Topeka
State/Province
Kansas
ZIP/Postal Code
66606
Country
United States
Facility Name
University of Kentucky Chandler Medical Center /ID# 157120
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536
Country
United States
Facility Name
University of Louisville /ID# 210525
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
Gastroenterology Associates LLC - Jefferson Hwy /ID# 161963
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70809
Country
United States
Facility Name
Houma Digestive Health Special /ID# 158264
City
Houma
State/Province
Louisiana
ZIP/Postal Code
70360
Country
United States
Facility Name
Delricht Research /ID# 206644
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70115
Country
United States
Facility Name
Nola Research Works, LLC /ID# 161317
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70115
Country
United States
Facility Name
Louisana Research Center, LLC /ID# 162237
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71105-6800
Country
United States
Facility Name
MGG Group Co, Inc.Chevy Chase Clinical Research /ID# 154832
City
Chevy Chase
State/Province
Maryland
ZIP/Postal Code
20815
Country
United States
Facility Name
Gastro Center of Maryland /ID# 165001
City
Columbia
State/Province
Maryland
ZIP/Postal Code
21045
Country
United States
Facility Name
University of Michigan Comprehensive Cancer Center Michigan Medicine /ID# 157126
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
Clin Res Inst of Michigan, LLC /ID# 169179
City
Chesterfield
State/Province
Michigan
ZIP/Postal Code
48047
Country
United States
Facility Name
Center for Digestive Health /ID# 154683
City
Troy
State/Province
Michigan
ZIP/Postal Code
48098-6363
Country
United States
Facility Name
Gastroenterology Associates of Western Michigan, PLC d.b.a. West Michigan Clinic /ID# 161313
City
Wyoming
State/Province
Michigan
ZIP/Postal Code
49519
Country
United States
Facility Name
Mayo Clinic - Rochester /ID# 163086
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905-0001
Country
United States
Facility Name
St. Louis University /ID# 161883
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63104
Country
United States
Facility Name
University of Nebraska Medical Center /ID# 210058
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68198-2000
Country
United States
Facility Name
Las Vegas Medical Research /ID# 160170
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89113
Country
United States
Facility Name
Revival Research Institute, Inc /ID# 210985
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89128-3157
Country
United States
Facility Name
NY Scientific /ID# 158294
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11235
Country
United States
Facility Name
Saratoga Schenectady Gastroenterology Associates - Burnt Hills /ID# 213447
City
Burnt Hills
State/Province
New York
ZIP/Postal Code
12027
Country
United States
Facility Name
Intercity Advanced Gastroentertology Center /ID# 215205
City
Fresh Meadows
State/Province
New York
ZIP/Postal Code
11366
Country
United States
Facility Name
Northwell Health Division of Gastroenterology at Great Neck /ID# 168738
City
Great Neck
State/Province
New York
ZIP/Postal Code
11021-5206
Country
United States
Facility Name
NYU Langone Long Island Clinical Research Associates /ID# 154829
City
Lake Success
State/Province
New York
ZIP/Postal Code
11042
Country
United States
Facility Name
Digestive Disease Care /ID# 211777
City
New Hyde Park
State/Province
New York
ZIP/Postal Code
11040
Country
United States
Facility Name
NYU Langone Medical Center /ID# 160169
City
New York
State/Province
New York
ZIP/Postal Code
10016-6402
Country
United States
Facility Name
Weill Cornell Medicine /ID# 165878
City
New York
State/Province
New York
ZIP/Postal Code
10022
Country
United States
Facility Name
Icahn School of Medicine at Mount Sinai - The Mount Sinai Medical Center /ID# 165612
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Columbia Univ Medical Center /ID# 161899
City
New York
State/Province
New York
ZIP/Postal Code
10032-3725
Country
United States
Facility Name
Lenox Hill Hospital /ID# 168467
City
New York
State/Province
New York
ZIP/Postal Code
10075
Country
United States
Facility Name
DiGiovanna Institute for Medical Education & Research /ID# 171126
City
North Massapequa
State/Province
New York
ZIP/Postal Code
11758
Country
United States
Facility Name
Univ NC Chapel Hill /ID# 154833
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27514-4220
Country
United States
Facility Name
Atrium Health Carolinas Medical Center /ID# 158428
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28203
Country
United States
Facility Name
Wake Radiology UNC REX Healthcare - Raleigh Office /ID# 154873
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27612
Country
United States
Facility Name
Plains Clinical Research Center, LLC /ID# 169718
City
Fargo
State/Province
North Dakota
ZIP/Postal Code
58104-5925
Country
United States
Facility Name
Tri-State Endoscopy Center /ID# 154927
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
Cleveland Clinic Main Campus /ID# 209226
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
The Ohio State University /ID# 164708
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Optimed Research, Ltd. /ID# 167887
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43235
Country
United States
Facility Name
Hometown Urgent Care and Resea /ID# 170464
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45424
Country
United States
Facility Name
Great Lakes Medical Research, LLC /ID# 201770
City
Mentor
State/Province
Ohio
ZIP/Postal Code
44060-6211
Country
United States
Facility Name
Hightower Clinical /ID# 211993
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73102
Country
United States
Facility Name
Digestive Disease Specialists /ID# 170775
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73112
Country
United States
Facility Name
Adult Gastroenterology Associates - Gen 1 Research /ID# 208864
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74136-7823
Country
United States
Facility Name
Children's Hospital of Pittsburgh of UPMC /ID# 212544
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15224-1334
Country
United States
Facility Name
Digestive Disease Associates, LTD /ID# 208297
City
Wyomissing
State/Province
Pennsylvania
ZIP/Postal Code
19610-2002
Country
United States
Facility Name
Medical University of South Carolina /ID# 212858
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
Gastroenterology Associates, P.A. of Greenville /ID# 154904
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29607
Country
United States
Facility Name
Rapid City Medical Center - GI Research /ID# 163838
City
Rapid City
State/Province
South Dakota
ZIP/Postal Code
57701
Country
United States
Facility Name
Gastro One /ID# 154726
City
Germantown
State/Province
Tennessee
ZIP/Postal Code
38138
Country
United States
Facility Name
East Tennessee Research Institute /ID# 168739
City
Johnson City
State/Province
Tennessee
ZIP/Postal Code
37604
Country
United States
Facility Name
Clinical Neuroscience Solutions - Memphis /ID# 164180
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States
Facility Name
Vanderbilt University Medical Center /ID# 157121
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232-0011
Country
United States
Facility Name
TX Clinical Research Institute /ID# 159404
City
Arlington
State/Province
Texas
ZIP/Postal Code
76012
Country
United States
Facility Name
Inquest Clinical Research /ID# 165694
City
Baytown
State/Province
Texas
ZIP/Postal Code
77521-2415
Country
United States
Facility Name
Texas Digestive Disease Consultants /ID# 209946
City
Cedar Park
State/Province
Texas
ZIP/Postal Code
78613-5028
Country
United States
Facility Name
Texas Digestive Disease Consultants /ID# 209797
City
Cedar Park
State/Province
Texas
ZIP/Postal Code
78613
Country
United States
Facility Name
Baylor Scott & White Center for Inflammatory Bowel Diseases /ID# 159406
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
DHAT Research Institute /ID# 158208
City
Garland
State/Province
Texas
ZIP/Postal Code
75044-2208
Country
United States
Facility Name
Vilo Research Group Inc /ID# 207655
City
Houston
State/Province
Texas
ZIP/Postal Code
77017-2337
Country
United States
Facility Name
Baylor College of Medicine - Baylor Medical Center /ID# 158203
City
Houston
State/Province
Texas
ZIP/Postal Code
77030-3411
Country
United States
Facility Name
Centex Studies, Inc. - Houston /ID# 201219
City
Houston
State/Province
Texas
ZIP/Postal Code
77058
Country
United States
Facility Name
Clinical Associates in Research Therapeutics of America, LLC /ID# 161323
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78212
Country
United States
Facility Name
Southern Star Research Institute, LLC /ID# 168773
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229-5390
Country
United States
Facility Name
Baylor Scott & White Center for Diagnostic Medicine /ID# 204131
City
Temple
State/Province
Texas
ZIP/Postal Code
76508
Country
United States
Facility Name
Tyler Research Institute, LLC /ID# 166797
City
Tyler
State/Province
Texas
ZIP/Postal Code
75701-4464
Country
United States
Facility Name
Gastro Health & Nutrition - Victoria /ID# 164290
City
Victoria
State/Province
Texas
ZIP/Postal Code
77904
Country
United States
Facility Name
Advanced Research Institute /ID# 154907
City
Ogden
State/Province
Utah
ZIP/Postal Code
84403
Country
United States
Facility Name
Velocity Clinical Research - Salt Lake City /ID# 161778
City
West Jordan
State/Province
Utah
ZIP/Postal Code
84088
Country
United States
Facility Name
Hunter Holmes McGuire VA Medical Center /ID# 159988
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23249
Country
United States
Facility Name
Virginia Mason Medical Center /ID# 155556
City
Seattle
State/Province
Washington
ZIP/Postal Code
98101
Country
United States
Facility Name
West Virginia University Hospitals /ID# 167941
City
Morgantown
State/Province
West Virginia
ZIP/Postal Code
26506
Country
United States
Facility Name
Hospital Britanico de Buenos Aires /ID# 168077
City
Ciudad Autonoma de Buenos Aire
State/Province
Ciuadad Autonoma De Buenos Aires
ZIP/Postal Code
1280
Country
Argentina
Facility Name
Cemic /Id# 168078
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# 170886
City
Rosario
State/Province
Santa Fe
ZIP/Postal Code
2000
Country
Argentina
Facility Name
Hospital Privado Univesitario /ID# 168076
City
Cordoba
ZIP/Postal Code
5016
Country
Argentina
Facility Name
Mater Misericordiae Limited /ID# 167220
City
South Brisbane
State/Province
Queensland
ZIP/Postal Code
4101
Country
Australia
Facility Name
Griffith University /ID# 212635
City
Southport
State/Province
Queensland
ZIP/Postal Code
4222
Country
Australia
Facility Name
Lyell McEwin Hospital /ID# 212215
City
Elizabeth Vale
State/Province
South Australia
ZIP/Postal Code
5112
Country
Australia
Facility Name
Emeritus Research /ID# 213512
City
Camberwell
State/Province
Victoria
ZIP/Postal Code
3124
Country
Australia
Facility Name
Universitaetsklinikum St. Poelten /ID# 166424
City
Sankt Poelten
State/Province
Niederoesterreich
ZIP/Postal Code
3100
Country
Austria
Facility Name
Medizinische Universitaet Graz /ID# 158140
City
Graz
State/Province
Steiermark
ZIP/Postal Code
8036
Country
Austria
Facility Name
Krankenhaus der Barmherzigen Brueder Wien /ID# 212060
City
Vienna
State/Province
Wien
ZIP/Postal Code
1020
Country
Austria
Facility Name
Medizinische Universitaet Wien /ID# 158141
City
Vienna
State/Province
Wien
ZIP/Postal Code
1090
Country
Austria
Facility Name
Gomel Regional Clinical Hospital /ID# 205112
City
Gomel
ZIP/Postal Code
246029
Country
Belarus
Facility Name
Grodno city clinical hospital #2 /ID# 205113
City
Grodno
ZIP/Postal Code
230011
Country
Belarus
Facility Name
Vitebsk Regional Advanced Clin /ID# 206778
City
Витебск
ZIP/Postal Code
210001
Country
Belarus
Facility Name
AZ Sint-Maarten /ID# 212876
City
Mechelen
State/Province
Antwerpen
ZIP/Postal Code
2800
Country
Belgium
Facility Name
Cliniques Universitaires de Bruxelles Hopital Erasme /ID# 157408
City
Brussels
State/Province
Bruxelles-Capitale
ZIP/Postal Code
1070
Country
Belgium
Facility Name
UCL Saint-Luc /ID# 157406
City
Woluwe-Saint-Lambert
State/Province
Bruxelles-Capitale
ZIP/Postal Code
1200
Country
Belgium
Facility Name
CHU UCL Namur - site Godinne /ID# 157412
City
Godinne
State/Province
Namur
ZIP/Postal Code
5530
Country
Belgium
Facility Name
UZ Gent /ID# 157405
City
Gent
State/Province
Oost-Vlaanderen
ZIP/Postal Code
9000
Country
Belgium
Facility Name
Universitair Ziekenhuis Leuven /ID# 157407
City
Leuven
State/Province
Vlaams-Brabant
ZIP/Postal Code
3000
Country
Belgium
Facility Name
AZ-Delta /ID# 157402
City
Roeselare
State/Province
West-Vlaanderen
ZIP/Postal Code
8800
Country
Belgium
Facility Name
Imelda Ziekenhuis /ID# 157403
City
Bonheiden
ZIP/Postal Code
2820
Country
Belgium
Facility Name
AZ Maria Middelares /ID# 213532
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
AZ Groeninge /ID# 211513
City
Kortrijk
ZIP/Postal Code
8500
Country
Belgium
Facility Name
CHU de Liege /ID# 157409
City
Liege
ZIP/Postal Code
4000
Country
Belgium
Facility Name
Groupe Sante CHC - Clinique du MontLegia /ID# 157404
City
Liege
ZIP/Postal Code
4000
Country
Belgium
Facility Name
ZNA - Jan Palfijn /ID# 212877
City
Merksem
ZIP/Postal Code
2170
Country
Belgium
Facility Name
University Clinical Centre of the Republic of Srpska /ID# 164513
City
Banja Luka
State/Province
Republika Srpska
ZIP/Postal Code
78000
Country
Bosnia and Herzegovina
Facility Name
Clinical Center University of Sarajevo /ID# 165139
City
Sarajevo
ZIP/Postal Code
71000
Country
Bosnia and Herzegovina
Facility Name
UMHAT Dr Georgi Stranski EAD /ID# 203976
City
Pleven
ZIP/Postal Code
5800
Country
Bulgaria
Facility Name
University Multiprofile Hospit /ID# 165700
City
Plovdiv
ZIP/Postal Code
4001
Country
Bulgaria
Facility Name
Second Multiprofile Hospital f /ID# 165702
City
Sofia
ZIP/Postal Code
1202
Country
Bulgaria
Facility Name
Tokuda Hospital Sofia /ID# 165701
City
Sofia
ZIP/Postal Code
1407
Country
Bulgaria
Facility Name
UMHAT Sveti Ivan Rilski /ID# 204815
City
Sofia
ZIP/Postal Code
1431
Country
Bulgaria
Facility Name
UMHAT Tsaritsa Joanna - ISUL /ID# 211242
City
Sofia
ZIP/Postal Code
1527
Country
Bulgaria
Facility Name
MHAT Trakia /ID# 201668
City
Stara Zagora
ZIP/Postal Code
6004
Country
Bulgaria
Facility Name
University of Calgary /ID# 157155
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4Z6
Country
Canada
Facility Name
Allen Whey Khye Lim Professional Corporation /ID# 169763
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T5R 1W2
Country
Canada
Facility Name
University of Alberta - Zeidler Ledcor Centre /ID# 157099
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2X8
Country
Canada
Facility Name
Covenant Health /ID# 161632
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6K 4B2
Country
Canada
Facility Name
Fraser Clinical Trials Inc /ID# 159055
City
New Westminster
State/Province
British Columbia
ZIP/Postal Code
V3L 3W4
Country
Canada
Facility Name
GIRI Gastrointestinal Research Institute /ID# 157096
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6Z 2K5
Country
Canada
Facility Name
Percuro Clinical Research, Ltd /ID# 161631
City
Victoria
State/Province
British Columbia
ZIP/Postal Code
V8V 3M9
Country
Canada
Facility Name
QEII - Health Sciences Centre /ID# 157088
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 2Y9
Country
Canada
Facility Name
IWK Health Center /ID# 165905
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3K 6R8
Country
Canada
Facility Name
Hamilton Health Sciences - McMaster University Medical Centre /ID# 157184
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8S 4K1
Country
Canada
Facility Name
London Health Sciences Center /ID# 157161
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5W9
Country
Canada
Facility Name
Scott Shulman Medicine Professional Corporation /ID# 165906
City
North Bay
State/Province
Ontario
ZIP/Postal Code
P1B 2H3
Country
Canada
Facility Name
Medicor Research Inc /ID# 157150
City
Sudbury
State/Province
Ontario
ZIP/Postal Code
P3A 1W8
Country
Canada
Facility Name
Mount Sinai Hospital /ID# 169764
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1X5
Country
Canada
Facility Name
Toronto Digestive Disease Asso /ID# 157158
City
Vaughan
State/Province
Ontario
ZIP/Postal Code
L4L 4Y7
Country
Canada
Facility Name
CISSS de la Monteregie /ID# 161630
City
Greenfield Park
State/Province
Quebec
ZIP/Postal Code
J4V 2H1
Country
Canada
Facility Name
Hotel Dieu de Levis /ID# 214377
City
Lévis
State/Province
Quebec
ZIP/Postal Code
G6V 3Z1
Country
Canada
Facility Name
CIUSSS de l'est de l'Ile-de-Montreal - Hopital Maisonneuve-Rosemont /ID# 159056
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H1T 2M4
Country
Canada
Facility Name
Royal Victoria Hospital / McGill University Health Centre /ID# 157085
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H4A 3J1
Country
Canada
Facility Name
Complejo Asistencial Dr. Sotero del Rio /ID# 169384
City
Santiago
State/Province
Region Metropolitana Santiago
ZIP/Postal Code
8207257
Country
Chile
Facility Name
Servicio de Salud Occidente Hospital San Juan de Dios /ID# 171122
City
Santiago
State/Province
Region Metropolitana Santiago
ZIP/Postal Code
8350488
Country
Chile
Facility Name
Hospital Guillermo Grant Benavente de Concepción /ID# 210760
City
Concepción
ZIP/Postal Code
4070038
Country
Chile
Facility Name
Hospital Las Higueras /ID# 167092
City
Talcahuano
ZIP/Postal Code
1740000
Country
Chile
Facility Name
Guangdong Provincial People's Hospital /ID# 212949
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510080
Country
China
Facility Name
The Sixth Affiliated Hosp Sun /ID# 210784
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510655
Country
China
Facility Name
The Second Hospital of Hebei Medical University /ID# 212738
City
Shijiazhuang
State/Province
Hebei
ZIP/Postal Code
050000
Country
China
Facility Name
Union Hospital Tongji Medical College Huazhong University of Science and Technol /ID# 211039
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430022
Country
China
Facility Name
Tongji Hospital Tongji Medical College of HUST /ID# 210858
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430030
Country
China
Facility Name
Renmin Hospital of Wuhan University /ID# 214874
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430060
Country
China
Facility Name
The First Affiliated Hospital of Nanchang University /ID# 211036
City
Nanchang
State/Province
Jiangxi
ZIP/Postal Code
330006
Country
China
Facility Name
Shanghai East Hospital /ID# 212684
City
Pudong New District
State/Province
Shanghai
ZIP/Postal Code
200136
Country
China
Facility Name
Ruijin Hospital, Shanghai Jiaotong University School of Medicine /ID# 210840
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200065
Country
China
Facility Name
Renji Hospital, Shanghai Jiaotong University School of Medicine /ID# 210705
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200127
Country
China
Facility Name
West China Hospital, Sichuan University /ID# 210890
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610041
Country
China
Facility Name
The second Affiliated hospital of Zhejiang University school of Medicine /ID# 210724
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310009
Country
China
Facility Name
Sir Run Run Shaw Hospital Zhejiang University School of Medicine /ID# 210625
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310020
Country
China
Facility Name
Jinhua Municipal Central Hospital /ID# 215628
City
Jinhua
State/Province
Zhejiang
ZIP/Postal Code
321000
Country
China
Facility Name
The Second Xiangya Hospital of Central South University /ID# 211700
City
Changsha
ZIP/Postal Code
410011
Country
China
Facility Name
Tianjin Medical University General Hospital /ID# 210926
City
Tianjin
ZIP/Postal Code
300052
Country
China
Facility Name
Instituto de Coloproctologia /ID# 158743
City
Medellin
State/Province
Antioquia
ZIP/Postal Code
050024
Country
Colombia
Facility Name
Hospital Pablo Tobon Uribe /ID# 158730
City
Medellín
State/Province
Antioquia
ZIP/Postal Code
50034
Country
Colombia
Facility Name
Hospital Univ San Ignacio /ID# 158734
City
Bogota
State/Province
Cundinamarca
ZIP/Postal Code
110231
Country
Colombia
Facility Name
Hospital Universitario San Vic /ID# 171486
City
Medellin
ZIP/Postal Code
50010
Country
Colombia
Facility Name
Klinicka bolnica Dubrava Zagreb /ID# 157560
City
Zagreb
State/Province
Grad Zagreb
ZIP/Postal Code
10000
Country
Croatia
Facility Name
Klinicki bolnicki centar Sestre milosrdnice /ID# 157728
City
Zagreb
State/Province
Grad Zagreb
ZIP/Postal Code
10000
Country
Croatia
Facility Name
Klinicki bolnicki centar Zagreb /ID# 157561
City
Zagreb
State/Province
Grad Zagreb
ZIP/Postal Code
10000
Country
Croatia
Facility Name
Klinicki bolnicki centar Osijek /ID# 157559
City
Osijek
State/Province
Osjecko-baranjska Zupanija
ZIP/Postal Code
31000
Country
Croatia
Facility Name
Klinicki bolnicki centar Split /ID# 157562
City
Split
State/Province
Splitsko-dalmatinska Zupanija
ZIP/Postal Code
21000
Country
Croatia
Facility Name
Zadar General Hospital /ID# 157563
City
Zadar
ZIP/Postal Code
23000
Country
Croatia
Facility Name
Duplicate_Institut klinicke a experimentalni mediciny (IKEM) /ID# 165465
City
Prague 4
State/Province
Praha 4
ZIP/Postal Code
140 00
Country
Czechia
Facility Name
Hepato-Gastroenterologie HK, s.r.o. /ID# 163225
City
Hradec Kralove
ZIP/Postal Code
500 12
Country
Czechia
Facility Name
Nemocnice Pardubickeho kraje, a.s. /ID# 163226
City
Pardubice
ZIP/Postal Code
530 03
Country
Czechia
Facility Name
Nemocnice Milosrdnych sester sv. Karla Boromejskeho v Praze /ID# 211306
City
Praha
ZIP/Postal Code
118 33
Country
Czechia
Facility Name
Axon Clinical, s.r.o. /ID# 163223
City
Praha
ZIP/Postal Code
140 00
Country
Czechia
Facility Name
Fakultni Thomayerova nemocnice /ID# 162941
City
Praha
ZIP/Postal Code
140 59
Country
Czechia
Facility Name
ResTrial s.r.o. /ID# 211078
City
Praha
ZIP/Postal Code
143 00
Country
Czechia
Facility Name
Nemocnice Horovice - NH Hospital a.s /ID# 211077
City
Praha
ZIP/Postal Code
155 00
Country
Czechia
Facility Name
ISCARE a.s. /ID# 225794
City
Praha
ZIP/Postal Code
190 00
Country
Czechia
Facility Name
Kobenhavns Universitet - Hvidovre Hospital (HH) /ID# 155530
City
Hvidovre
State/Province
Hovedstaden
ZIP/Postal Code
2650
Country
Denmark
Facility Name
Aarhus University Hospital /ID# 155664
City
Aarhus N
State/Province
Midtjylland
ZIP/Postal Code
8200
Country
Denmark
Facility Name
Sjællands Universitetshospital /ID# 155532
City
Roskilde
State/Province
Sjælland
ZIP/Postal Code
4000
Country
Denmark
Facility Name
Sygehusenheden Nyborg - OUH /ID# 161525
City
Nyborg
State/Province
Syddanmark
ZIP/Postal Code
5800
Country
Denmark
Facility Name
Odense Universitets Hospital /ID# 155531
City
Odense C
State/Province
Syddanmark
ZIP/Postal Code
5000
Country
Denmark
Facility Name
Zagazig University Hospitals /ID# 164539
City
Al Sharqia
ZIP/Postal Code
44519
Country
Egypt
Facility Name
Clinical Research Center, Faculty of Medicine, Alexandria university. /ID# 157187
City
Alexandria
ZIP/Postal Code
21131
Country
Egypt
Facility Name
Clinical Research Center, Faculty of Medicine, Alexandria university. /ID# 164540
City
Alexandria
ZIP/Postal Code
21131
Country
Egypt
Facility Name
Clinical Research Center, Faculty of Medicine, Cairo university /ID# 157175
City
Cairo
ZIP/Postal Code
11559
Country
Egypt
Facility Name
National Hepatology and Tropical Medicine Research Institute /ID# 157874
City
Cairo
ZIP/Postal Code
11559
Country
Egypt
Facility Name
Internal Medicine Department, Faculty of Medicine, AinShams University /ID# 157506
City
Cairo
ZIP/Postal Code
11566
Country
Egypt
Facility Name
North Estonia Medical Centre /ID# 164326
City
Mustamäe Linnaosa
State/Province
Harjumaa
ZIP/Postal Code
13419
Country
Estonia
Facility Name
East Tallinn Central Hospital /ID# 157074
City
Tallinn
State/Province
Harjumaa
ZIP/Postal Code
11312
Country
Estonia
Facility Name
West Tallinn Central Hospital /ID# 157075
City
Tallinn
ZIP/Postal Code
10617
Country
Estonia
Facility Name
Chu de Nice-Hopital L'Archet Ii /Id# 162557
City
Nice
State/Province
Alpes-Maritimes
ZIP/Postal Code
06200
Country
France
Facility Name
HCL - Hopital Lyon Sud /ID# 162560
City
Pierre Benite CEDEX
State/Province
Auvergne-Rhone-Alpes
ZIP/Postal Code
69495
Country
France
Facility Name
CHU Bordeaux - Hopital Haut Leveque /ID# 162558
City
Pessac
State/Province
Gironde
ZIP/Postal Code
33604
Country
France
Facility Name
CHRU Lille - Hopital Claude Huriez /ID# 162559
City
Lille
State/Province
Hauts-de-France
ZIP/Postal Code
59037
Country
France
Facility Name
CHU Montpellier - Hôpital Saint Eloi /ID# 215147
City
Montpellier Cedex 5
State/Province
Herault
ZIP/Postal Code
34295
Country
France
Facility Name
Hopital Beaujon /ID# 166284
City
Clichy
State/Province
Ile-de-France
ZIP/Postal Code
92110
Country
France
Facility Name
Centre Médico Chirurgical Ambroise Paré Hartmann /ID# 249858
City
Neuilly Sur Seine
State/Province
Ile-de-France
ZIP/Postal Code
92200
Country
France
Facility Name
CHU de SAINT ETIENNE - Hopital Nord /ID# 162562
City
St. Priest En Jarez
State/Province
Loire
ZIP/Postal Code
42270
Country
France
Facility Name
CHRU Nancy - Hopitaux de Brabois /ID# 162561
City
Vandoeuvre-les-Nancy
State/Province
Meurthe-et-Moselle
ZIP/Postal Code
54500
Country
France
Facility Name
CHU Amiens-Picardie Site Sud /ID# 165058
City
Amiens CEDEX 1
State/Province
Somme
ZIP/Postal Code
80054
Country
France
Facility Name
CHU Grenoble - Hopital Michallon /ID# 212834
City
La Tronche
ZIP/Postal Code
38700
Country
France
Facility Name
CHRU Pontchaillou /ID# 213209
City
Rennes
ZIP/Postal Code
35033
Country
France
Facility Name
Universitaetsklinikum Freiburg /ID# 162030
City
Freiburg
State/Province
Baden-Wuerttemberg
ZIP/Postal Code
79106
Country
Germany
Facility Name
Praxis fuer Gastroenterologie /ID# 166150
City
Heidelberg
State/Province
Baden-Wuerttemberg
ZIP/Postal Code
69121
Country
Germany
Facility Name
Universitatsklinikum Mannheim /ID# 162031
City
Mannheim
State/Province
Baden-Wuerttemberg
ZIP/Postal Code
68167
Country
Germany
Facility Name
Universitaetsklinikum Ulm /ID# 164990
City
Ulm
State/Province
Baden-Wuerttemberg
ZIP/Postal Code
89081
Country
Germany
Facility Name
Universitaetsklinikum Erlangen /ID# 159343
City
Erlangen
State/Province
Bayern
ZIP/Postal Code
91054
Country
Germany
Facility Name
Universitaetsklinikum Frankfurt /ID# 212979
City
Frankfurt am Main
State/Province
Hessen
ZIP/Postal Code
60590
Country
Germany
Facility Name
Universitaetsklinikum Muenster /ID# 159344
City
Munster
State/Province
Niedersachsen
ZIP/Postal Code
48149
Country
Germany
Facility Name
Evangelisches Krankenhaus Kalk /ID# 212726
City
Cologne
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
51103
Country
Germany
Facility Name
Praxiszentrum fuer Gastroenterologie /ID# 211966
City
Grevenbroich
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
41515
Country
Germany
Facility Name
Universitaetsklinikum Koeln /ID# 164989
City
Köln
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
50937
Country
Germany
Facility Name
Zentrum für Gastroenterologie Saar MVZ GmbH /ID# 210528
City
Saarbrücken
State/Province
Saarland
ZIP/Postal Code
66111
Country
Germany
Facility Name
Universitaetsklinikum Schleswig-Holstein Campus Kiel /ID# 159349
City
Kiel
State/Province
Schleswig-Holstein
ZIP/Postal Code
24105
Country
Germany
Facility Name
Universitaetsklinikum Jena /ID# 159351
City
Jena
State/Province
Thueringen
ZIP/Postal Code
07747
Country
Germany
Facility Name
Krankenhaus Waldfriede /ID# 212727
City
Berlin-Zehlendorf
ZIP/Postal Code
14163
Country
Germany
Facility Name
Charite Universitaetsmedizin Berlin - Campus Mitte /ID# 212220
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Facility Name
Charite Universitaetsmedizin Berlin - Campus Mitte /ID# 212894
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Facility Name
Gastroenterologische Spezialpraxis am Wittenbergplatz /ID# 211974
City
Berlin
ZIP/Postal Code
10787
Country
Germany
Facility Name
MVZ fuer Gastroenterlogie am Bayerischen Platz /ID# 159350
City
Berlin
ZIP/Postal Code
10825
Country
Germany
Facility Name
DRK Kliniken Berlin Westend /ID# 166151
City
Berlin
ZIP/Postal Code
14050
Country
Germany
Facility Name
Stadtisches Klinikum Braunschweig /ID# 163680
City
Braunschweig
ZIP/Postal Code
38126
Country
Germany
Facility Name
Medizinisches Versorgunszentrum Dachau /ID# 211555
City
Dachau
ZIP/Postal Code
85221
Country
Germany
Facility Name
Agaplesion Markus Krankenhaus /ID# 159345
City
Frankfurt am Main
ZIP/Postal Code
60431
Country
Germany
Facility Name
Medizinische Hochschule Hannover /ID# 162032
City
Hannover
ZIP/Postal Code
30625
Country
Germany
Facility Name
EUGASTRO GmbH /ID# 212078
City
Leipzig
ZIP/Postal Code
04103
Country
Germany
Facility Name
Klinikum Lueneburg /ID# 163678
City
Lueneburg
ZIP/Postal Code
21339
Country
Germany
Facility Name
Universitaetsklinikum Magdeburg /ID# 211843
City
Magdeburg
ZIP/Postal Code
39120
Country
Germany
Facility Name
Gastroenterologische Gemeinschaftspraxis Minden /ID# 162029
City
Minden
ZIP/Postal Code
32423
Country
Germany
Facility Name
Universitaetsklinikum Regensburg /ID# 163813
City
Regensburg
ZIP/Postal Code
93042
Country
Germany
Facility Name
General Hospital of Chest Diseases of Athens SOTIRIA /ID# 170914
City
Athens
State/Province
Attiki
ZIP/Postal Code
11527
Country
Greece
Facility Name
Tzaneio general hospital of Piraeus /ID# 206443
City
Piraeus
State/Province
Attiki
ZIP/Postal Code
18536
Country
Greece
Facility Name
University General Hospital of Heraklion PA.G.N.I /ID# 157422
City
Heraklion
State/Province
Kriti
ZIP/Postal Code
71500
Country
Greece
Facility Name
General Hospital of Athens Evaggelismos and Ophthalmiatrio of Athens Polyclinic /ID# 157423
City
Athens
ZIP/Postal Code
10676
Country
Greece
Facility Name
University General Hospital of Ioannina /ID# 157420
City
Ioannina
ZIP/Postal Code
45500
Country
Greece
Facility Name
General Hospital of Nikaia-Piraeus "Agios Panteleimon"- general hospital dytikis /ID# 157424
City
Pireaus
ZIP/Postal Code
18454
Country
Greece
Facility Name
Theageneio Anticancer Hospital /ID# 163897
City
Thessaloniki
ZIP/Postal Code
54639
Country
Greece
Facility Name
Queen Mary Hospital /ID# 163923
City
Hong Kong
ZIP/Postal Code
999077
Country
Hong Kong
Facility Name
Tuen Mun Hospital /ID# 163905
City
Hong Kong
Country
Hong Kong
Facility Name
Beaumont Hospital /ID# 157543
City
Beaumont
State/Province
Dublin
ZIP/Postal Code
D09 XR63
Country
Ireland
Facility Name
St Vincent's University Hospital /ID# 157540
City
Elm Park
State/Province
Dublin
ZIP/Postal Code
D04 T6F4
Country
Ireland
Facility Name
University Hospital Galway /ID# 157541
City
Galway
ZIP/Postal Code
H91 YR71
Country
Ireland
Facility Name
Soroka University Medical Center /ID# 157794
City
Be'er Sheva
State/Province
HaDarom
ZIP/Postal Code
8443901
Country
Israel
Facility Name
The Chaim Sheba Medical Center /ID# 157793
City
Ramat Gan
State/Province
Tel-Aviv
ZIP/Postal Code
5265601
Country
Israel
Facility Name
The Chaim Sheba Medical Center /ID# 171069
City
Ramat Gan
State/Province
Tel-Aviv
ZIP/Postal Code
5265601
Country
Israel
Facility Name
Tel Aviv Sourasky Medical Center /ID# 157792
City
Tel Aviv-Yafo
State/Province
Tel-Aviv
ZIP/Postal Code
6423906
Country
Israel
Facility Name
Hadassah Medical Center-Hebrew University /ID# 165914
City
Jerusalem
State/Province
Yerushalayim
ZIP/Postal Code
91120
Country
Israel
Facility Name
Duplicate_Rambam Medical Center /ID# 171067
City
Haifa
ZIP/Postal Code
3109601
Country
Israel
Facility Name
The Edith Wolfson Medical Center /ID# 217331
City
Holon
ZIP/Postal Code
5822000
Country
Israel
Facility Name
Shaare Zedek Medical Center /ID# 163541
City
Jerusalem
ZIP/Postal Code
91031
Country
Israel
Facility Name
Shaare Zedek Medical Center /ID# 171068
City
Jerusalem
ZIP/Postal Code
91031
Country
Israel
Facility Name
Duplicate_AOU Ospendali Riuniti di Ancona /ID# 162436
City
Torrette
State/Province
Ancona
ZIP/Postal Code
60123
Country
Italy
Facility Name
University of Catanzaro /ID# 212016
City
Catanzaro
State/Province
Calabria
ZIP/Postal Code
88100
Country
Italy
Facility Name
Duplicate_Azienda Ospedaliero-Universitaria Policlinico di Modena /ID# 212028
City
Modena
State/Province
Emilia-Romagna
ZIP/Postal Code
41124
Country
Italy
Facility Name
Ospedale Policlinico San Martino /ID# 162439
City
Genoa
State/Province
Genova
ZIP/Postal Code
16132
Country
Italy
Facility Name
Fondazione Policlinico Universitario Campus Bio-Medico di Roma /ID# 162438
City
Rome
State/Province
Lazio
ZIP/Postal Code
00128
Country
Italy
Facility Name
Azienda Ospedaliera San Camillo Forlanini /ID# 155644
City
Rome
State/Province
Lazio
ZIP/Postal Code
00152
Country
Italy
Facility Name
Azienda Ospedaliero-Universitaria Policlinico Umberto I /ID# 166912
City
Rome
State/Province
Lazio
ZIP/Postal Code
00161
Country
Italy
Facility Name
ASST Rhodense/Presidio Ospedaliero di Rho /ID# 212227
City
Rho
State/Province
Milano
ZIP/Postal Code
20017
Country
Italy
Facility Name
Istituto Clinico Humanitas /ID# 155642
City
Rozzano
State/Province
Milano
ZIP/Postal Code
20089
Country
Italy
Facility Name
Azienda Ospedaliera Universitaria Policlinico Tor Vergata /ID# 158022
City
Rome
State/Province
Roma
ZIP/Postal Code
00133
Country
Italy
Facility Name
Presidio Columbus-Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Un /ID# 155640
City
Rome
State/Province
Roma
ZIP/Postal Code
00168
Country
Italy
Facility Name
Duplicate_Azienda Ospedaliera Univ. Meyer /ID# 167992
City
Florence
State/Province
Toscana
ZIP/Postal Code
50139
Country
Italy
Facility Name
IRCCS Ospedale Sacro Cuore Don Calabria /ID# 161299
City
Negrar
State/Province
Verona
ZIP/Postal Code
37024
Country
Italy
Facility Name
IRCCS Azienda Ospedaliero-Universitaria di Bologna /ID# 155643
City
Bologna
ZIP/Postal Code
40138
Country
Italy
Facility Name
A.O. Per L'Emergenza Cannizzaro /ID# 161300
City
Catania
ZIP/Postal Code
95126
Country
Italy
Facility Name
ASST Fatebenefratelli Sacco-Ospedale Sacco /ID# 155639
City
Milano
ZIP/Postal Code
20157
Country
Italy
Facility Name
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico /ID# 155641
City
Milan
ZIP/Postal Code
20122
Country
Italy
Facility Name
A.O. Ospedali Riuniti Villa Sofia - Cervello /ID# 155645
City
Palermo
ZIP/Postal Code
90146
Country
Italy
Facility Name
Duplicate_Fondazione IRCCS Policlinico S. Matteo /ID# 212031
City
Pavia
ZIP/Postal Code
27100
Country
Italy
Facility Name
Aichi Medical University Hospital /ID# 160097
City
Nagakute-shi
State/Province
Aichi
ZIP/Postal Code
480-1195
Country
Japan
Facility Name
Nagoya City University Hospital /ID# 160100
City
Nagoya shi
State/Province
Aichi
ZIP/Postal Code
467-8602
Country
Japan
Facility Name
Daido Clinic /ID# 211476
City
Nagoya-shi
State/Province
Aichi
ZIP/Postal Code
457-8511
Country
Japan
Facility Name
Nagoya University Hospital /ID# 160116
City
Nagoya-shi
State/Province
Aichi
ZIP/Postal Code
4668560
Country
Japan
Facility Name
Fujita Health University Hospital /ID# 163234
City
Toyoake-shi
State/Province
Aichi
ZIP/Postal Code
470-1192
Country
Japan
Facility Name
Tokatsu Tsujinaka Hospital /ID# 163352
City
Abiko-shi
State/Province
Chiba
ZIP/Postal Code
270-1168
Country
Japan
Facility Name
Chiba University Hospital /ID# 217533
City
Chiba-shi
State/Province
Chiba
ZIP/Postal Code
260-8677
Country
Japan
Facility Name
Tsujinaka Hospital Kashiwanoha /ID# 213848
City
Kashiwa-shi
State/Province
Chiba
ZIP/Postal Code
277-0871
Country
Japan
Facility Name
The Jikei University Kashiwa Hospital /ID# 200030
City
Kashiwa-shi
State/Province
Chiba
ZIP/Postal Code
277-8567
Country
Japan
Facility Name
Toho University Sakura Medical Center /ID# 160099
City
Sakura-shi
State/Province
Chiba
ZIP/Postal Code
285-8741
Country
Japan
Facility Name
Fukuoka University Hospital /ID# 217793
City
Fukuoka-shi
State/Province
Fukuoka
ZIP/Postal Code
814-0180
Country
Japan
Facility Name
Kurume University Hospital /ID# 160106
City
Kurume-shi
State/Province
Fukuoka
ZIP/Postal Code
830-0011
Country
Japan
Facility Name
NHO Fukuyama Medical Center /ID# 163577
City
Fukuyama-shi
State/Province
Hiroshima
ZIP/Postal Code
720-8520
Country
Japan
Facility Name
Hiroshima University Hospital /ID# 160109
City
Hiroshima-shi
State/Province
Hiroshima
ZIP/Postal Code
734-8551
Country
Japan
Facility Name
Asahikawa Medical University Hospital /ID# 162848
City
Asahikawa-shi
State/Province
Hokkaido
ZIP/Postal Code
078-8510
Country
Japan
Facility Name
Sapporo Tokushukai Hospital /ID# 213492
City
Sapporo-shi
State/Province
Hokkaido
ZIP/Postal Code
004-0041
Country
Japan
Facility Name
Hokkaido P.W.F.A.C. Sapporo-Kosei General Hospital /ID# 160096
City
Sapporo-shi
State/Province
Hokkaido
ZIP/Postal Code
060-0033
Country
Japan
Facility Name
Sapporo Medical University Hospital /ID# 163056
City
Sapporo-shi
State/Province
Hokkaido
ZIP/Postal Code
060-8543
Country
Japan
Facility Name
Nishinomiya Municipal Central Hospital /ID# 210103
City
Nishinomiya-shi
State/Province
Hyogo
ZIP/Postal Code
663-8014
Country
Japan
Facility Name
Hyogo Medical University Hospital /ID# 160107
City
Nishinomiya-shi
State/Province
Hyogo
ZIP/Postal Code
663-8501
Country
Japan
Facility Name
National Hospital Organization Mito Medical Center /ID# 160092
City
Higashi Ibaraki-gun
State/Province
Ibaraki
ZIP/Postal Code
311-3193
Country
Japan
Facility Name
Kanazawa University Hospital /ID# 202258
City
Kanazawa-shi
State/Province
Ishikawa
ZIP/Postal Code
920-8641
Country
Japan
Facility Name
Gokeikai Ofuna Chuo Hospital /ID# 171066
City
Kamakura-shi
State/Province
Kanagawa
ZIP/Postal Code
247-0056
Country
Japan
Facility Name
Kitasato University Hospital /ID# 171065
City
Sagamihara-shi
State/Province
Kanagawa
ZIP/Postal Code
252-0375
Country
Japan
Facility Name
Yokohama City University Medical Center /ID# 163907
City
Yokohama shi
State/Province
Kanagawa
ZIP/Postal Code
232-0024
Country
Japan
Facility Name
Yokohama Municipal Citizen's Hospital /ID# 207161
City
Yokohama-shi
State/Province
Kanagawa
ZIP/Postal Code
221-0855
Country
Japan
Facility Name
Mie University Hospital /ID# 203640
City
Tsu-shi
State/Province
Mie
ZIP/Postal Code
514-8507
Country
Japan
Facility Name
Yokkaichi Hazu Medical Center /ID# 163764
City
Yokkaichi-shi
State/Province
Mie
ZIP/Postal Code
510-0016
Country
Japan
Facility Name
Tohoku University Hospital /ID# 162847
City
Sendai-shi
State/Province
Miyagi
ZIP/Postal Code
9808574
Country
Japan
Facility Name
Tohoku Rosai Hospital /ID# 163229
City
Sendai-shi
State/Province
Miyagi
ZIP/Postal Code
981-8563
Country
Japan
Facility Name
Osaka Metropolitan University Hospital /ID# 160117
City
Osaka-shi
State/Province
Osaka
ZIP/Postal Code
545-8586
Country
Japan
Facility Name
Saitama Medical Center /ID# 160093
City
Kawagoe-shi
State/Province
Saitama
ZIP/Postal Code
350-8550
Country
Japan
Facility Name
Tokitokai Tokito clinic /ID# 160110
City
Saitama-shi
State/Province
Saitama
ZIP/Postal Code
336-0963
Country
Japan
Facility Name
Shiga University of Medical Science Hospital /ID# 164025
City
Otsu-shi
State/Province
Shiga
ZIP/Postal Code
520-2192
Country
Japan
Facility Name
Hamamatsu University Hospital /ID# 205690
City
Hamamatsu-shi
State/Province
Shizuoka
ZIP/Postal Code
431-3192
Country
Japan
Facility Name
NHO Shizuoka Medical Center /ID# 163057
City
Sunto-gun
State/Province
Shizuoka
ZIP/Postal Code
411-8611
Country
Japan
Facility Name
Tokyo Medical And Dental University Hospital /ID# 160095
City
Bunkyo-ku
State/Province
Tokyo
ZIP/Postal Code
113-8519
Country
Japan
Facility Name
Tokai University Hachioji Hospital /ID# 160098
City
Hachioji-shi
State/Province
Tokyo
ZIP/Postal Code
192-0032
Country
Japan
Facility Name
The Jikei University Hospital /ID# 163209
City
Minato-ku
State/Province
Tokyo
ZIP/Postal Code
105-8471
Country
Japan
Facility Name
Kitasato University Kitasato Institute Hospital /ID# 160105
City
Minato-ku
State/Province
Tokyo
ZIP/Postal Code
108-8642
Country
Japan
Facility Name
Kyorin University Hospital /ID# 160114
City
Mitaka-shi
State/Province
Tokyo
ZIP/Postal Code
181-8611
Country
Japan
Facility Name
Tokyo Women's Medical University Hospital /ID# 205974
City
Shinjuku-ku
State/Province
Tokyo
ZIP/Postal Code
162-8666
Country
Japan
Facility Name
Wakayama Medical University Hospital /ID# 202561
City
Wakayama-shi
State/Province
Wakayama
ZIP/Postal Code
641-8510
Country
Japan
Facility Name
Yamagata University Hospital /ID# 200159
City
Yamagata-shi
State/Province
Yamagata
ZIP/Postal Code
990-9585
Country
Japan
Facility Name
Yamanashi Prefectural Central Hospital /ID# 160094
City
Kofu-shi
State/Province
Yamanashi
ZIP/Postal Code
400-8506
Country
Japan
Facility Name
Hayang University GuriHospital /ID# 158690
City
Guri
State/Province
Gyeonggido
ZIP/Postal Code
11923
Country
Korea, Republic of
Facility Name
CHA University Bundang Medical Center /ID# 158698
City
Seongnam si
State/Province
Gyeonggido
ZIP/Postal Code
13496
Country
Korea, Republic of
Facility Name
The Catholic University of Korea, ST. Vincent's Hospital /ID# 158693
City
Suwon
State/Province
Gyeonggido
ZIP/Postal Code
16247
Country
Korea, Republic of
Facility Name
Kangbuk Samsung Hospital /ID# 158694
City
Seoul
State/Province
Seoul Teugbyeolsi
ZIP/Postal Code
03181
Country
Korea, Republic of
Facility Name
Yonsei University Health System Severance Hospital /ID# 158689
City
Seoul
State/Province
Seoul Teugbyeolsi
ZIP/Postal Code
03722
Country
Korea, Republic of
Facility Name
Inje University Haeundae Hospital /ID# 202518
City
Busan
ZIP/Postal Code
48108
Country
Korea, Republic of
Facility Name
Dong-A University Hospital /ID# 158699
City
Busan
ZIP/Postal Code
49201
Country
Korea, Republic of
Facility Name
Pusan National University Hospital /ID# 158695
City
Busan
ZIP/Postal Code
49241
Country
Korea, Republic of
Facility Name
Yeungnam University Medical Center /ID# 158691
City
Daegu
ZIP/Postal Code
42415
Country
Korea, Republic of
Facility Name
The Catholic University of Korea, Daejeon St.Mary's Hospital /ID# 213554
City
Daejeon
ZIP/Postal Code
34943
Country
Korea, Republic of
Facility Name
Asan Medical Center /ID# 158696
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Facility Name
Samsung Medical Center /ID# 158692
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
Facility Name
VCA Polyclinic Aura /ID# 159611
City
Riga
ZIP/Postal Code
1035
Country
Latvia
Facility Name
Pauls Stradins Clinical University Hospital /ID# 159612
City
Riga
ZIP/Postal Code
LV- 1002
Country
Latvia
Facility Name
Digestive Disease Center Gastro /ID# 163107
City
Riga
ZIP/Postal Code
LV-1079
Country
Latvia
Facility Name
Hospital of Lithuanian University of Health Sciences Kaunas Clinics /ID# 162583
City
Kaunas
ZIP/Postal Code
50161
Country
Lithuania
Facility Name
Vilnius University Hospital Santaros Klinikos /ID# 162514
City
Vilnius
ZIP/Postal Code
08661
Country
Lithuania
Facility Name
Queen Elizabeth Hospital /ID# 160664
City
Division Pantai Barat Utara
State/Province
Sabah
ZIP/Postal Code
88200
Country
Malaysia
Facility Name
Universiti Kebangsaan Malaysia (UKM) Medical Centre /ID# 201363
City
Kuala Lumpur
State/Province
Selangor
ZIP/Postal Code
56000
Country
Malaysia
Facility Name
Universiti Sains Malaysia /ID# 160666
City
Kelantan
ZIP/Postal Code
16150
Country
Malaysia
Facility Name
Investigacion Biomedica para el Desarrollo de Farmacos, S.A. de C.V. /ID# 170734
City
Zapopan
State/Province
Jalisco
ZIP/Postal Code
45070
Country
Mexico
Facility Name
JM Research SC /ID# 170729
City
Cuernavaca
State/Province
Morelos
ZIP/Postal Code
62290
Country
Mexico
Facility Name
Unidad de Atencion Medica e Investigacion en Salud /ID# 170732
City
Merida
State/Province
Yucatan
ZIP/Postal Code
97000
Country
Mexico
Facility Name
Health Pharma Professional Research S.A de C.V /ID# 170730
City
Del. Benito Juárez
ZIP/Postal Code
03810
Country
Mexico
Facility Name
Academisch Medisch Centrum /ID# 157956
City
Amsterdam
ZIP/Postal Code
1105 AZ
Country
Netherlands
Facility Name
Elisabeth Tweesteden Ziekenhuis /ID# 163632
City
Tilburg
ZIP/Postal Code
5022 GC
Country
Netherlands
Facility Name
Middlemore Clinical Trials /ID# 167226
City
Papatoetoe
State/Province
Auckland
ZIP/Postal Code
2025
Country
New Zealand
Facility Name
Christchurch Hospital /ID# 167224
City
Christchurch
State/Province
Canterbury
ZIP/Postal Code
8011
Country
New Zealand
Facility Name
Dunedin Hospital /ID# 167227
City
Otago
ZIP/Postal Code
9016
Country
New Zealand
Facility Name
Duplicate_Wellington Hospital (Capital and Coast District Health Board) /ID# 167225
City
Wellington
ZIP/Postal Code
6021
Country
New Zealand
Facility Name
Akershus universitetssykehus /ID# 169379
City
Nordbyhagen
State/Province
Akershus
ZIP/Postal Code
1474
Country
Norway
Facility Name
Vestre viken - Baerum Sykehus /ID# 212996
City
Gjettum
ZIP/Postal Code
1346
Country
Norway
Facility Name
Sykehuset Levanger Helse NT /ID# 201669
City
Levanger
ZIP/Postal Code
7601
Country
Norway
Facility Name
Helse More og Romsdal HF, Alesund sjukehus /ID# 212810
City
Ålesund
ZIP/Postal Code
6017
Country
Norway
Facility Name
Planetmed Sp. z o.o. /ID# 202799
City
Wroclaw
State/Province
Dolnoslaskie
ZIP/Postal Code
52-210
Country
Poland
Facility Name
Gastromed /Id# 212476
City
Torun
State/Province
Kujawsko-pomorskie
ZIP/Postal Code
87-100
Country
Poland
Facility Name
Uniwersytecki Szpital Kliniczny nr 1 im. Norberta Barlickiego w Lodzi /ID# 212477
City
Lodz
State/Province
Lodzkie
ZIP/Postal Code
90-153
Country
Poland
Facility Name
1 Wojskowy Szpital Kliniczny Z Poliklinika /Id# 210940
City
Lublin
State/Province
Lubelskie
ZIP/Postal Code
20-049
Country
Poland
Facility Name
Samodzielny Publiczny Szpital Kliniczny Nr 4 w Lublinie /ID# 210941
City
Lublin
State/Province
Lubelskie
ZIP/Postal Code
20-954
Country
Poland
Facility Name
Centrum Zdrowia MDM /ID# 163570
City
Warszawa
State/Province
Mazowieckie
ZIP/Postal Code
00-635
Country
Poland
Facility Name
Centralny Szpital Kliniczny MSWiA w Warszawie /ID# 163582
City
Warszawa
State/Province
Mazowieckie
ZIP/Postal Code
02-507
Country
Poland
Facility Name
NZOZ Vivamed /ID# 202800
City
Warszawa
State/Province
Mazowieckie
ZIP/Postal Code
03-580
Country
Poland
Facility Name
Instytut Pomnik - Centrum Zdrowia Dziecka /ID# 213580
City
Warszawa
State/Province
Mazowieckie
ZIP/Postal Code
04-730
Country
Poland
Facility Name
Centrum Medyczne Medyk /ID# 212891
City
Rzeszów
State/Province
Podkarpackie
ZIP/Postal Code
35-326
Country
Poland
Facility Name
Centrum Medyczne LukaMed Joanna Luka-Wendrowska /ID# 212478
City
Chojnice
State/Province
Pomorskie
ZIP/Postal Code
89-600
Country
Poland
Facility Name
H-T. Centrum Medyczne - Endoterapia /ID# 212475
City
Tychy
State/Province
Slaskie
ZIP/Postal Code
43-100
Country
Poland
Facility Name
Wojewodzki Szpital Specjalistyczny /ID# 212474
City
Olsztyn
State/Province
Warminsko-mazurskie
ZIP/Postal Code
10-561
Country
Poland
Facility Name
Solumed Centrum Medyczne /ID# 163569
City
Poznan
State/Province
Wielkopolskie
ZIP/Postal Code
60-529
Country
Poland
Facility Name
Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclaw /ID# 212601
City
Wroclaw
ZIP/Postal Code
50-556
Country
Poland
Facility Name
Hospital da Senhora da Oliveira Guimaraes, EPE /ID# 160737
City
Guimaraes
State/Province
Braga
ZIP/Postal Code
4835-044
Country
Portugal
Facility Name
Centro Hospitalar Universitário do Algarve, EPE - Hospital de Portimão /ID# 167752
City
Portimão
State/Province
Faro
ZIP/Postal Code
8500-338
Country
Portugal
Facility Name
Centro Hospitalar de Entre Douro e Vouga /ID# 160672
City
Santa Maria Da Feira
State/Province
Porto
ZIP/Postal Code
4520-211
Country
Portugal
Facility Name
Hospital Garcia de Orta, EPE /ID# 160745
City
Almada
ZIP/Postal Code
2805-267
Country
Portugal
Facility Name
Centro Hospitalar Universitário do Algarve, EPE - Hospital Faro /ID# 160713
City
Faro
ZIP/Postal Code
8000-386
Country
Portugal
Facility Name
Centro Hospitalar Universitario Lisboa Central, EPE - Hospital dos Capuchos /ID# 160673
City
Lisboa
ZIP/Postal Code
1169-050
Country
Portugal
Facility Name
Centro Hospitalar de Lisboa Ocidental, EPE - Hospital Egas Moniz /ID# 167751
City
Lisboa
ZIP/Postal Code
1349-019
Country
Portugal
Facility Name
Centro Hospitalar Universitario de Lisboa Norte, EPE - Hospital de Santa Maria /ID# 160692
City
Lisboa
ZIP/Postal Code
1649-035
Country
Portugal
Facility Name
Hospital de Loures, E.P.E /ID# 207759
City
Loures
ZIP/Postal Code
2674-514
Country
Portugal
Facility Name
Centro Hospitalar Universitario de Sao Joao, EPE /ID# 160693
City
Porto
ZIP/Postal Code
4200-319
Country
Portugal
Facility Name
Centro Hosp de Tondela-Viseu /ID# 160699
City
Viseu
ZIP/Postal Code
3504-509
Country
Portugal
Facility Name
Fundeni Clinical Institute /ID# 170899
City
Bucharest
ZIP/Postal Code
022328
Country
Romania
Facility Name
Tvm Med Serv Srl /Id# 170902
City
Cluj
ZIP/Postal Code
400132
Country
Romania
Facility Name
Duplicate_Centrul Medical Tuculanu SRL /ID# 170903
City
Timisoara
ZIP/Postal Code
300168
Country
Romania
Facility Name
Cabinet Particular Policlinic Algomed /ID# 170900
City
Timișoara
ZIP/Postal Code
300002
Country
Romania
Facility Name
Kuzbass Regional Clinical Hospital /ID# 200962
City
Kemerovo
State/Province
Kemerovskaya Oblast
ZIP/Postal Code
650099
Country
Russian Federation
Facility Name
Duplicate_Perm state medical university n.a. E.A. Vagner /ID# 207439
City
Perm
State/Province
Permskiy Kray
ZIP/Postal Code
614990
Country
Russian Federation
Facility Name
Duplicate_St. Petersburg State Pediatric Medical University /ID# 211978
City
Saint Petersburg
State/Province
Sankt-Peterburg
ZIP/Postal Code
194100
Country
Russian Federation
Facility Name
Professor Pasechnikov Gastroenterology and Pankreatology clinic /ID# 200970
City
Stavropol
State/Province
Stavropol Skiy Kray
ZIP/Postal Code
355012
Country
Russian Federation
Facility Name
Tver Regional Clinical Hospital /ID# 206858
City
Tver
State/Province
Tverskaya Oblast
ZIP/Postal Code
170036
Country
Russian Federation
Facility Name
Regional Clinical Hospital #1 /ID# 200973
City
Tyumen
State/Province
Tyumenskaya Oblast
ZIP/Postal Code
625023
Country
Russian Federation
Facility Name
Alliance Biomedical Ural Group /ID# 200972
City
Izhevsk
State/Province
Udmurtskaya Respublika
ZIP/Postal Code
426061
Country
Russian Federation
Facility Name
National Medical Research Center of Coloproctology n.a. A. N. Ryzhikh /ID# 204808
City
Moscow
ZIP/Postal Code
123423
Country
Russian Federation
Facility Name
Novosibirski Gastrocenter /ID# 217552
City
Novosibirsk
ZIP/Postal Code
630007
Country
Russian Federation
Facility Name
City Clinical Hospital No. 31 /ID# 208872
City
St. Petersburg
ZIP/Postal Code
197110
Country
Russian Federation
Facility Name
Ulyanovsk Regional Clinical Hospital /ID# 200964
City
Ulyanovsk
ZIP/Postal Code
432017
Country
Russian Federation
Facility Name
Clinical Hosp Center Zvezdara /ID# 157052
City
Belgrade
State/Province
Beograd
ZIP/Postal Code
11000
Country
Serbia
Facility Name
Military Medical Academy /ID# 157053
City
Belgrade
State/Province
Beograd
ZIP/Postal Code
11000
Country
Serbia
Facility Name
University Clinical Center Serbia /ID# 157047
City
Belgrade
State/Province
Beograd
ZIP/Postal Code
11000
Country
Serbia
Facility Name
Clin Hosp Ctr Bezanijska Kosa /ID# 157050
City
Belgrade
State/Province
Beograd
ZIP/Postal Code
11080
Country
Serbia
Facility Name
University Clinical Center Kragujevac /ID# 157049
City
Kragujevac
State/Province
Sumadijski Okrug
ZIP/Postal Code
34000
Country
Serbia
Facility Name
Clinical Center Vojvodina /ID# 157046
City
Novi Sad
State/Province
Vojvodina
ZIP/Postal Code
21000
Country
Serbia
Facility Name
University Children's Hospital 'Tirsova' /ID# 211482
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Facility Name
Clinical Hospital Center Dr Dragisa Misovic - Dedinje /ID# 212799
City
Belgrade
ZIP/Postal Code
11040
Country
Serbia
Facility Name
General Hospital Leskovac /ID# 209575
City
Leskovac
ZIP/Postal Code
16000
Country
Serbia
Facility Name
National University Hospital /ID# 160667
City
Singapore
ZIP/Postal Code
119074
Country
Singapore
Facility Name
Singapore General Hospital /ID# 160668
City
Singapore
ZIP/Postal Code
169608
Country
Singapore
Facility Name
KL Ling Gastroenterology and Liver Clinic /ID# 205741
City
Singapore
ZIP/Postal Code
228510
Country
Singapore
Facility Name
Fakultna nemocnica s poliklinikou F.D. Roosevelta Banska Bystrica /ID# 156468
City
Banska Bystrica
ZIP/Postal Code
975 17
Country
Slovakia
Facility Name
KM Management, spol. s.r.o. /ID# 206764
City
Nitra
ZIP/Postal Code
949 01
Country
Slovakia
Facility Name
GASTRO I., s.r.o. /ID# 156469
City
Presov
ZIP/Postal Code
080 01
Country
Slovakia
Facility Name
Clinresco Centers /ID# 163865
City
Johannesburg
State/Province
Gauteng
ZIP/Postal Code
1619
Country
South Africa
Facility Name
Wits Clinical Research Site /ID# 158114
City
Johannesburg
State/Province
Gauteng
ZIP/Postal Code
2193
Country
South Africa
Facility Name
Spoke Research Inc /ID# 158116
City
CAPE TOWN Milnerton
State/Province
Western Cape
ZIP/Postal Code
7441
Country
South Africa
Facility Name
Private Practice Dr MN Rajabally /ID# 163112
City
Cape Town
State/Province
Western Cape
ZIP/Postal Code
7800
Country
South Africa
Facility Name
Hospital Arquitecto Marcide - Complejo Hospitalario Universitario de Ferrol /ID# 157553
City
Ferrol
State/Province
A Coruna
ZIP/Postal Code
15405
Country
Spain
Facility Name
Hospital Universitario de Bellvitge /ID# 208207
City
L'Hospitalet de Llobregat
State/Province
Barcelona
ZIP/Postal Code
08907
Country
Spain
Facility Name
Consorci Corporacio Sanitaria Parc Tauli Sabadell /ID# 159237
City
Sabadell
State/Province
Barcelona
ZIP/Postal Code
08208
Country
Spain
Facility Name
Hospital Universitario Puerta de Hierro, Majadahonda /ID# 157573
City
Majadahonda
State/Province
Madrid
ZIP/Postal Code
28222
Country
Spain
Facility Name
Hospital Universitario Basurto /ID# 205190
City
Bilbao
State/Province
Vizcaya
ZIP/Postal Code
48013
Country
Spain
Facility Name
Hospital Clinic de Barcelona /ID# 157552
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Hospital General Universitario Gregorio Maranon /ID# 161145
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Facility Name
Hospital Universitario La Paz /ID# 159235
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Facility Name
Hospital Universitario de Salamanca /ID# 157558
City
Salamanca
ZIP/Postal Code
37711
Country
Spain
Facility Name
Hospital Universitario Virgen Macarena /ID# 159967
City
Sevilla
ZIP/Postal Code
41009
Country
Spain
Facility Name
Hospital Clinico Universitario de Valencia /ID# 209700
City
Valencia
ZIP/Postal Code
46010
Country
Spain
Facility Name
Hospital Universitario y Politecnico La Fe /ID# 157556
City
Valencia
ZIP/Postal Code
46026
Country
Spain
Facility Name
Hospital Clinico Universitario Lozano Blesa /ID# 212525
City
Zaragoza
ZIP/Postal Code
50009
Country
Spain
Facility Name
Hospital Universitario Miguel Servet /ID# 157557
City
Zaragoza
ZIP/Postal Code
50009
Country
Spain
Facility Name
Skane University hospital /ID# 211745
City
Malmo
State/Province
Skane Lan
ZIP/Postal Code
214 28
Country
Sweden
Facility Name
Karolinska University Hospital Solna /ID# 212025
City
Solna
State/Province
Stockholms Lan
ZIP/Postal Code
171 64
Country
Sweden
Facility Name
GHP Stockholm Gastro Center /ID# 211748
City
Stockholm
State/Province
Stockholms Lan
ZIP/Postal Code
114 28
Country
Sweden
Facility Name
Danderyd Hospital /ID# 202138
City
Stockholm
State/Province
Stockholms Lan
ZIP/Postal Code
182 88
Country
Sweden
Facility Name
Sahlgrenska University Hospital /ID# 163792
City
Gothenburg
State/Province
Vastra Gotalands Lan
ZIP/Postal Code
413 45
Country
Sweden
Facility Name
Sahlgrenska University Hospital /ID# 163797
City
Gothenburg
State/Province
Vastra Gotalands Lan
ZIP/Postal Code
413 46
Country
Sweden
Facility Name
Medicinkliniken, Gastroenheten /ID# 163744
City
Stockholm
ZIP/Postal Code
116 28
Country
Sweden
Facility Name
Universitätsspital Basel /ID# 164554
City
Basel
State/Province
Basel-Stadt
ZIP/Postal Code
4031
Country
Switzerland
Facility Name
Universitatsspital Zurich /ID# 163536
City
Zurich
State/Province
Zuerich
ZIP/Postal Code
8091
Country
Switzerland
Facility Name
Inselspital, Universitätsspital Bern /ID# 163535
City
Bern
ZIP/Postal Code
3010
Country
Switzerland
Facility Name
China Medical University Hospital /ID# 160141
City
Taichung City
ZIP/Postal Code
40447
Country
Taiwan
Facility Name
Taichung Veterans General Hospital /ID# 160140
City
Taichung
ZIP/Postal Code
40705
Country
Taiwan
Facility Name
National Cheng Kung University Hospital /ID# 160142
City
Tainan
ZIP/Postal Code
704
Country
Taiwan
Facility Name
National Taiwan University Hospital /ID# 162190
City
Taipei City
ZIP/Postal Code
100
Country
Taiwan
Facility Name
Taipei Veterans General Hosp /ID# 212712
City
Taipei City
ZIP/Postal Code
11217
Country
Taiwan
Facility Name
Kharkiv City Clinical Hospital No.2 n.a. Prof. O.O. Shalimov /ID# 165657
City
Kharkiv
ZIP/Postal Code
61037
Country
Ukraine
Facility Name
Municipal Nonprofit Enterprise Kherson city clinical hospital n.a. Y.Y. Karabel /ID# 212399
City
Kherson
ZIP/Postal Code
73000
Country
Ukraine
Facility Name
Kyiv Municipal Clinical Hospital #18 /ID# 162531
City
Kyiv
ZIP/Postal Code
01030
Country
Ukraine
Facility Name
Medical Center "OK!Clinic+" /ID# 211998
City
Kyiv
ZIP/Postal Code
02091
Country
Ukraine
Facility Name
Communal Noncommercial Institution Consultative and Diagnostic Center of Desnian /ID# 165659
City
Kyiv
ZIP/Postal Code
02232
Country
Ukraine
Facility Name
Medical Center of LLC Medbud-Clinic /ID# 216998
City
Kyiv
ZIP/Postal Code
03037
Country
Ukraine
Facility Name
Kyiv Railway Clinical Hosp No.2 /ID# 217366
City
Kyiv
ZIP/Postal Code
03049
Country
Ukraine
Facility Name
Communal Enterprise Volyn Regional Clinical hospital of the Volyn Regional Coun /ID# 206789
City
Lutsk
ZIP/Postal Code
43005
Country
Ukraine
Facility Name
Lviv Railway Clinical Hospital of branch Healthcare Centers of Public Joint Stoc /ID# 165658
City
Lviv
ZIP/Postal Code
79000
Country
Ukraine
Facility Name
Transcarpathian Regional Clinical Hospital n.a. Andriy Novak /ID# 167960
City
Uzhgorod
ZIP/Postal Code
88018
Country
Ukraine
Facility Name
CNE Vinnytsya Regional Clinical Hospital named after N.I.Pirogov /ID# 216474
City
Vinnytsia
ZIP/Postal Code
21028
Country
Ukraine
Facility Name
Clinic of Scientific Research Institute of Invalid Rehabilitation /ID# 212000
City
Vinnytsia
ZIP/Postal Code
21029
Country
Ukraine
Facility Name
Royal Devon University Healthcare NHS Foundation Trust /ID# 157544
City
Exeter
State/Province
Devon
ZIP/Postal Code
EX2 5DW
Country
United Kingdom
Facility Name
Hull University Teaching Hospitals NHS Trust /ID# 158761
City
Hull
State/Province
East Riding Of Yorkshire
ZIP/Postal Code
HU3 2JZ
Country
United Kingdom
Facility Name
Barts Health NHS Trust /ID# 163713
City
London
State/Province
London, City Of
ZIP/Postal Code
E1 2ES
Country
United Kingdom
Facility Name
Guys and St Thomas NHS Foundation Trust /ID# 157546
City
London
State/Province
London, City Of
ZIP/Postal Code
SE1 9RT
Country
United Kingdom
Facility Name
Oxford University Hospitals NHS Foundation Trust /ID# 158036
City
Oxford
State/Province
Oxfordshire
ZIP/Postal Code
OX3 9DU
Country
United Kingdom
Facility Name
NHS Greater Glasgow and Clyde /ID# 202568
City
Glasgow
State/Province
Scotland
ZIP/Postal Code
G12 0XH
Country
United Kingdom
Facility Name
Ashford and St Peter's Hospitals NHS Foundation Trust /ID# 207936
City
Chertsey
State/Province
Surrey
ZIP/Postal Code
KT16 0PZ
Country
United Kingdom
Facility Name
Barnsley Hospital NHS Foundation Trust /ID# 202773
City
Barnsley
ZIP/Postal Code
S75 2EP
Country
United Kingdom
Facility Name
University Hospitals Birmingham NHS Foundation Trust /ID# 157545
City
Birmingham
ZIP/Postal Code
B15 2TH
Country
United Kingdom
Facility Name
Cambridge University Hospitals NHS Foundation Trust /ID# 158034
City
Cambridge
ZIP/Postal Code
CB2 0QQ
Country
United Kingdom
Facility Name
NHS Lothian /ID# 207448
City
Edinburgh
ZIP/Postal Code
EH3 9HE
Country
United Kingdom
Facility Name
Calderdale and Huddersfield NHS Foundation Trust /ID# 209570
City
Huddersfield
ZIP/Postal Code
HX3 0PW
Country
United Kingdom
Facility Name
Leeds Teaching Hospitals NHS Trust /ID# 157550
City
Leeds
ZIP/Postal Code
LS9 7TF
Country
United Kingdom
Facility Name
King's College Hospital NHS Foundation Trust /ID# 158760
City
London
ZIP/Postal Code
SE5 9RS
Country
United Kingdom
Facility Name
The Newcastle Upon Tyne Hospitals NHS Foundation Trust /ID# 163708
City
Newcastle upon Tyne
ZIP/Postal Code
NE7 7DN
Country
United Kingdom
Facility Name
Northern Care Alliance NHS Group /ID# 207766
City
Salford
ZIP/Postal Code
M6 8HD
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
IPD Sharing Time Frame
For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
IPD Sharing Access Criteria
Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
IPD Sharing URL
https://vivli.org/ourmember/abbvie/
Citations:
PubMed Identifier
35644155
Citation
Ferrante M, Panaccione R, Baert F, Bossuyt P, Colombel JF, Danese S, Dubinsky M, Feagan BG, Hisamatsu T, Lim A, Lindsay JO, Loftus EV Jr, Panes J, Peyrin-Biroulet L, Ran Z, Rubin DT, Sandborn WJ, Schreiber S, Neimark E, Song A, Kligys K, Pang Y, Pivorunas V, Berg S, Duan WR, Huang B, Kalabic J, Liao X, Robinson A, Wallace K, D'Haens G. Risankizumab as maintenance therapy for moderately to severely active Crohn's disease: results from the multicentre, randomised, double-blind, placebo-controlled, withdrawal phase 3 FORTIFY maintenance trial. Lancet. 2022 May 28;399(10340):2031-2046. doi: 10.1016/S0140-6736(22)00466-4.
Results Reference
derived
Links:
URL
https://www.rxabbvie.com
Description
This clinical study may be evaluating a usage that is not currently FDA approved. Please see US Prescribing Information for approved uses.
Learn more about this trial
A Study of the Efficacy and Safety of Risankizumab in Participants With Crohn's Disease
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