Back to resultsA Study to Assess the Efficacy and Safety of Risankizumab in Participants With Moderately to Severely Active Crohn's Disease Who Failed Prior Biologic Treatment
Primary Purpose
Crohn's Disease
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
placebo for risankizumab IV
risankizumab SC
risankizumab IV
Sponsored by
About this trial
This is an interventional treatment trial for Crohn's Disease focused on measuring ABBV-066, BI 655066
Eligibility Criteria
Inclusion Criteria:
- Male or female aged >=18 to <= 80 years, or minimum age of adult consent according to local regulations, at the Baseline Visit. Where locally permissible, participants 16 to < 18 years of age who meet the definition of Tanner stage 5 for development at the Baseline Visit.
- Confirmed diagnosis of CD for at least 3 months prior to Baseline.
- Crohn's disease activity index (CDAI) score 220 - 450 at Baseline.
- Confirmed diagnosis of moderate to severe CD as assessed by stool frequency (SF), abdominal pain (AP) score, and Simple Endoscopic Score for Crohn's Disease (SES-CD).
- Demonstrated intolerance or inadequate response to biologic therapy for CD.
- If female, participant must meet the contraception recommendations.
Exclusion Criteria:
- Participant with a current diagnosis of ulcerative colitis or indeterminate colitis.
- Participants with unstable doses of concomitant Crohn's disease therapy.
- Receipt of Crohn's disease approved biologic agents (infliximab, adalimumab, certolizumab, vedolizumab, natalizumab within 8 weeks prior to Baseline or ustekinumab within 12 weeks prior to Baseline), or any investigational biologic or other agent or procedure within minimally 35 days or 5 half-lives prior to Baseline, whichever is longer.
- Prior exposure to p19 inhibitors (e.g., risankizumab).
- Complications of Crohn's disease.
- Having an ostomy or ileoanal pouch.
- Known active Coronavirus Disease 2019 (COVID-19) infection.
Sites / Locations
- Phoenix VA Health Care System /ID# 162261
- HonorHealth Research Institute - Shea /ID# 165825
- Digestive Disease Consultants, A Division of Arizona Digestive Health, P.C /ID# 211882
- University of Arizona /ID# 158305
- Duplicate_Atria Clinical Research /ID# 164504
- Southern California Res. Ctr. /ID# 211989
- Newport Huntington Medica /ID# 213034
- UC San Diego Health Systems /ID# 155576
- United Medical Doctors /ID# 207887
- TLC Clinical Research Inc /ID# 212501
- Gastrointestinal Biosciences Clinical Trials, LLC /ID# 162655
- United Medical Doctors - Murrieta /ID# 158278
- Peak Gastroenterology Associates, PC /ID# 165832
- Rocky Mountain Pediatric Gastroenterology /ID# 207171
- Western Connecticut Medical Group /ID# 165874
- Seffner Premier Health Care, PA /ID# 162259
- Clinical Research of West Florida, Inc /ID# 205864
- Clinical Research of West Florida, Inc /ID# 208127
- South Lake Pain Institute, Inc /ID# 162798
- Omega Research Maitland, LLC /ID# 171080
- Universal Axon Clinical Research /ID# 165426
- SIH Research Mumtaz, Inc /ID# 163081
- Alliance Medical Research /ID# 163834
- Cfagi Llc /Id# 202482
- University of Miami /ID# 155011
- Vista Health Research, LLC /ID# 212828
- ITB Research /ID# 161278
- Coral Research Clinic /ID# 158330
- South Florida Research Ph I-IV, Inc. /ID# 161825
- Gastroenterology Group Naples /ID# 165192
- Advanced Research Institute, Inc /ID# 161973
- Endoscopic Research, Inc. /ID# 205903
- IMIC Inc. Medical Research /ID# 154944
- Clinical Research Trials of Florida, Inc. /ID# 201606
- Atlanta Gastro Assoc /ID# 154755
- Gastroenterology Associates of Central Georgia, LLC /ID# 154865
- Northwestern University Division of GI/Hepatology /ID# 158250
- The University of Chicago Medical Center /ID# 157113
- NorthShore University HealthSystem /ID# 158254
- Southwest Gastroenterology /ID# 164764
- Cotton-O'Neil Clinical Res Ctr /ID# 154753
- University of Kentucky Chandler Medical Center /ID# 157109
- University of Louisville /ID# 210523
- Gastroenterology Associates LLC - Jefferson Hwy /ID# 161970
- Houma Digestive Health Special /ID# 158253
- Delricht Research /ID# 206567
- Nola Research Works, LLC /ID# 161271
- Louisana Research Center, LLC /ID# 162239
- MGG Group Co, Inc.Chevy Chase Clinical Research /ID# 154846
- Gastro Center of Maryland /ID# 164766
- Center for Digestive Health /ID# 154697
- Gastroenterology Associates of Western Michigan, PLC d.b.a. West Michigan Clinic /ID# 161267
- Mayo Clinic - Rochester /ID# 163084
- University of Nebraska Medical Center /ID# 210056
- Las Vegas Medical Research /ID# 160167
- Revival Research Institute, Inc /ID# 210986
- NY Scientific /ID# 158272
- Saratoga Schenectady Gastroenterology Associates - Burnt Hills /ID# 213446
- Intercity Advanced Gastroentertology Center /ID# 215204
- Duplicate_Long Island Clinical Research /ID# 154843
- Digestive Disease Care /ID# 211776
- North Shore University Hospital /ID# 168734
- NYU Langone Medical Center /ID# 160166
- Weill Cornell Medicine /ID# 165856
- Icahn School of Medicine at Mount Sinai - The Mount Sinai Medical Center /ID# 165610
- Columbia Univ Medical Center /ID# 167545
- Lenox Hill Hospital /ID# 168466
- DiGiovanna Institute for Medical Education & Research /ID# 171130
- Atrium Health Carolinas Medical Center /ID# 158364
- Vidant Multispecialty Clinic - Kinston /ID# 161109
- Wake Radiology UNC REX Healthcare - Raleigh Office /ID# 154891
- Plains Clinical Research Center, LLC /ID# 169712
- Tri-State Endoscopy /ID# 154939
- Cleveland Clinic Main Campus /ID# 209225
- The Ohio State University /ID# 164706
- Optimed Research, Ltd. /ID# 167877
- Hometown Urgent Care and Resea /ID# 170447
- Great Lakes Medical Research, LLC /ID# 201774
- Hightower Clinical /ID# 211992
- Digestive Disease Specialists /ID# 170772
- Adult Gastroenterology Associates - Gen 1 Research /ID# 208857
- Northwest Gastroenterology Clinic /ID# 158255
- PennState Milton S.Hershey Med /ID# 154894
- Children's Hospital of Pittsburgh of UPMC /ID# 212543
- Digestive Disease Associates, LTD /ID# 208296
- Medical University of South Carolina /ID# 212859
- Gastroenterology Associates, P.A. of Greenville /ID# 154919
- Rapid City Medical Center - GI Research /ID# 163835
- Gastro One /ID# 154757
- East Tennessee Research Institute /ID# 168735
- Duplicate_Clinical Neuroscience Solutions, Inc /ID# 164179
- Vanderbilt University Medical Center /ID# 157110
- TX Clinical Research Institute /ID# 159396
- Inquest Clinical Research /ID# 165696
- Texas Digestive Disease Consultants /ID# 209781
- Texas Digestive Disease Consultants /ID# 209945
- DHAT Research Institute /ID# 158199
- Vilo Research Group Inc /ID# 207654
- CliniCore International, LLC /ID# 158191
- Baylor College of Medicine - Baylor Medical Center /ID# 158194
- Precision Research Institute, LLC /ID# 201072
- Centex Studies, Inc. - Houston /ID# 201218
- Clinical Associates in Research Therapeutics of America, LLC /ID# 161307
- Southern Star Research Institute, LLC /ID# 168772
- Baylor Scott & White Medical Center- Temple /ID# 204129
- Tyler Research Institute, LLC /ID# 166795
- Gastro Health & Nutrition - Victoria /ID# 164284
- HP Clinical Research /ID# 162992
- Advanced Research Institute /ID# 154922
- Velocity Clinical Research - Salt Lake City /ID# 161775
- Hunter Holmes McGuire VA Medical Center /ID# 159977
- Washington Gastroenterology Associates /ID# 162101
- Virginia Mason - Seattle Orthapedics /ID# 155577
- WVU Medicine /ID# 167942
- Hospital Britanico de Buenos Aires /ID# 168081
- Cemic /Id# 168082
- Hospital Provincial del Centenario /ID# 170904
- Hospital Privado Univesitario /ID# 168080
- Mater Misericordiae Limited /ID# 167216
- Griffith University /ID# 212631
- Lyell McEwin Hospital /ID# 211364
- Emeritus Research /ID# 213510
- Footscray Hospital /ID# 211362
- Universitaetsklinikum St. Poelten /ID# 166423
- Duplicate_LKH-Univ. Klinikum Graz /ID# 158134
- Krankenhaus der Barmherzigen Brueder Wien /ID# 211418
- Duplicate_Medical University of Vienna /ID# 158135
- Vitebsk Regional Advanced Clin /ID# 204807
- AZ Sint-Maarten /ID# 212280
- ULB Hospital Erasme /ID# 157386
- UCL Saint-Luc /ID# 157384
- UZ Gent /ID# 157383
- Imelda Ziekenhuis /ID# 157381
- AZ Maria Middelares /ID# 212871
- AZ Groeninge /ID# 212571
- ZNA - Jan Palfijn /ID# 212822
- University Clinical Centre of the Republic of Srpska /ID# 157710
- University Clinical Centre of the Republic of Srpska /ID# 165018
- Clinical Center University of Sarajevo /ID# 165132
- UMHAT Dr Georgi Stranski EAD /ID# 203975
- University Multiprofile Hospit /ID# 165697
- Second Multiprofile Hospital f /ID# 165699
- Acibadem City Clinic UMHAT Tokuda /ID# 165698
- UMHAT Sveti Ivan Rilski /ID# 204713
- UMHAT Tsaritsa Joanna - ISUL /ID# 211241
- MHAT Trakia /ID# 201665
- University Multiprofile Hospit /ID# 167576
- University of Calgary - Heritage Medical Research Clinic /ID# 157156
- Allen Whey Khye Lim Professional Corporation /ID# 169766
- University of Alberta - Zeidler Ledcor Centre /ID# 157100
- Covenant Health /ID# 161636
- Fraser Clinical Trials Inc /ID# 159057
- GIRI Gastrointestinal Research Institute /ID# 157097
- Percuro Clinical Research, Ltd /ID# 161635
- QEII - Health Sciences Centre /ID# 157089
- IWK Health Center /ID# 165909
- London Health Sciences Center /ID# 157162
- Scott Shulman Medicine Professional Corporation /ID# 165910
- Medicor Research Inc /ID# 157151
- Toronto Digestive Disease Asso /ID# 157159
- CISSS de la Monteregie /ID# 161634
- CIUSSS de l'est de l'Ile-de-Montreal - Hopital Maisonneuve-Rosemont /ID# 159058
- CHUM - Centre hospitalier de l'Universite de Montréal /ID# 167070
- Montreal General Hospital - McGill University Health Center /ID# 157086
- Complejo Asistencial Dr. Sotero del Rio /ID# 169383
- Servicio de Salud Occidente Hospital San Juan de Dios /ID# 171121
- Centro de Investigaciones Clínicas Viña del Mar /ID# 203585
- Hospital Guillermo Grant Benavente de Concepción /ID# 210758
- Hospital Las Higueras /ID# 167091
- The Sixth Affiliated Hosp Sun /ID# 210783
- Tongji Hospital Tongji Medical College Huazhong University of Science and Techno /ID# 210857
- Union Hospital affiliated to Tongji Medical College of Huazhong University of Sc /ID# 211040
- The First Affiliated Hospital of Nanchang University /ID# 211035
- Ruijin Hospital, Shanghai Jiaotong University School of Medicine /ID# 210842
- Renji Hospital, Shanghai Jiaotong University School of Medicine /ID# 210706
- Sir Run Run Shaw Hospital Zhejiang University School of Medicine /ID# 210626
- West China Hospital, Sichuan University /ID# 210888
- Shanghai East Hospital /ID# 212671
- Duplicate_Tianjin Med Univ General Hosp /ID# 210925
- Instituto de Coloproctologia /ID# 158740
- Hospital Pablo Tobon Uribe /ID# 158732
- Hospital Univ San Ignacio /ID# 158737
- Duplicate_Klinicka bolnica Dubrava Zagreb /ID# 157719
- Klinicki bolnicki centar Sestre milosrdnice /ID# 157720
- Klinicki bolnicki centar Zagreb /ID# 157703
- UHC Osijek /ID# 157704
- Klinicki bolnicki centar Split /ID# 157705
- Zadar General Hospital /ID# 157706
- Duplicate_Institut klinicke a experimentalni mediciny (IKEM) /ID# 165479
- Hepato-Gastroenterologie HK, s.r.o. /ID# 163218
- CTCenter MaVe s.r.o. /ID# 163215
- Nemocnice Pardubickeho kraje, a.s. /ID# 163219
- Nemocnice Milosrdnych sester sv. Karla Boromejskeho v Praze /ID# 211304
- Axon Clinical, s.r.o. /ID# 163216
- Thomayerova nemocnice /ID# 162942
- ResTrial s.r.o. /ID# 211074
- NH Hospital a.s. /ID# 211073
- Kobenhavns Universitet - Hvidovre Hospital (HH) /ID# 155535
- Aarhus University Hospital /ID# 155534
- Sjællands Universitetshospital, Roskilde /ID# 155537
- Sygehusenheden Nyborg - OUH /ID# 161591
- Aalborg Universitets Hospital /ID# 160685
- Odense Universitets Hospital /ID# 155536
- Zagazig University Hospitals /ID# 164018
- Clinical Research Center, Faculty of Medicine, Alexandria university. /ID# 157876
- Clinical Research Center, Faculty of Medicine, Alexandria university. /ID# 164423
- Clinical Research Center, Faculty of Medicine, Cairo university /ID# 157176
- National Hepatology and Tropical Medicine Research Institute /ID# 157875
- Internal Medicine Department, Faculty of Medicine, AinShams University /ID# 158630
- East Tallinn Central Hospital /ID# 157072
- West Tallinn Central Hospital /ID# 157073
- Chu de Nice-Hopital L'Archet Ii /Id# 162545
- HCL - Hôpital Lyon Sud /ID# 162548
- CHU Bordeaux - Hopital Haut Lévêque /ID# 162546
- CHRU Lille - Hopital Claude Huriez /ID# 162547
- CHU Montpellier - Hôpital Saint Eloi /ID# 215146
- Hapital Beaujon /ID# 166287
- CHU de SAINT ETIENNE - Hopital Nord /ID# 162550
- CHRU Nancy - Hôpitaux de Brabois /ID# 162549
- CHU Amiens-Picardie Site Sud /ID# 165056
- CHU Grenoble - Hopital Michallon /ID# 211980
- Hospital Pontchaillou /ID# 213207
- Praxis fuer Gastroenterologie /ID# 166148
- Universitatsklinikum Mannheim /ID# 162026
- Universitaetsklinikum Tuebingen /ID# 159341
- Universitaetsklinikum Ulm /ID# 164988
- Universitaetsklinikum Erlangen /ID# 159332
- Universitaetsklinikum Frankfurt /ID# 212977
- Evangelisches Krankenhaus Kalk /ID# 212724
- Praxiszentrum fuer Gastroenterologie /ID# 211965
- Universitaetsklinikum Koeln /ID# 164987
- Universitaetsklinikum Muenster /ID# 159333
- Zentrum für Gastroenterologie Saar MVZ GmbH /ID# 210527
- Universitaetsklinikum Schleswig-Holstein Campus Kiel /ID# 159338
- Krankenhaus Waldfriede /ID# 212729
- Charite Universitaetsmedizin Berlin - Campus Mitte /ID# 212218
- Charite Universitaetsmedizin Berlin - Campus Mitte /ID# 212892
- Gastroenterologische Spezialpraxis am Wittenbergplatz /ID# 211976
- MVZ fuer Gastroenterlogie am Bayerischen Platz /ID# 159339
- DRK Kliniken Berlin Westend /ID# 166149
- Stadtisches Klinikum Braunschweig /ID# 163673
- Medizinisches Versorgunszentrum Dachau /ID# 211550
- Agaplesion Markus Krankenhaus /ID# 159334
- Duplicate_Universitaetsklinikum Freiburg /ID# 162025
- Asklepios Westklinikum Hamburg /ID# 159336
- Medizinische Hochschule Hannover /ID# 162027
- EUGASTRO GmbH /ID# 212077
- Klinikum Lueneburg /ID# 163671
- Universitaetsklinikum Magdeburg /ID# 211840
- Gastroenterologische Gemeinschaftspraxis Minden /ID# 162024
- Universitaetsklinikum Regensburg /ID# 163812
- Duplicate_Gastro-Praxis Wiesbaden /ID# 159335
- General Hospital of Chest Diseases of Athens SOTIRIA /ID# 170905
- Tzaneio general hospital of Piraeus /ID# 206441
- University General Hospital of Heraklion PA.G.N.I /ID# 157417
- General Hospital of Athens Evaggelismos and Ophthalmiatrio of Athens Polyclinic /ID# 157418
- University General Hospital of Ioannina /ID# 157415
- General Hospital of Nikaia-Piraeus "Agios Panteleimon"- general hospital dytikis /ID# 157419
- Theageneio Anticancer Hospital /ID# 163922
- Beaumont Hospital /ID# 157572
- St Vincent's University Hospital /ID# 157569
- University Hospital Galway /ID# 157570
- Soroka University Medical Center /ID# 157789
- Sheba Medical Center /ID# 171059
- Tel Aviv Sourasky Medical Center /ID# 157787
- Duplicate_Rambam Medical Center /ID# 171056
- Shaare Zedek Medical Center /ID# 163539
- Shaare Zedek Medical Center /ID# 171055
- Hadassah Medical Center-Hebrew University /ID# 171062
- Duplicate_AOU Ospendali Riuniti di Ancona /ID# 162431
- Duplicate_Universita di Catanzaro Magna Graecia /ID# 212017
- Duplicate_Azienda Ospedaliero-Universitaria Policlinico di Modena /ID# 212018
- Duplicate_Policlinico Universitario Campus Bio-Medico /ID# 162433
- Azienda Ospedaliera San Camillo Forlanini /ID# 155660
- Azienda Ospedaliero-Universitaria Policlinico Umberto I /ID# 166910
- Duplicate_Ospedale Policlinico San Martino/ Università Degli Studi Di Genova /ID# 162434
- ASST Rhodense/Presidio Ospedaliero di Rho /ID# 211453
- Istituto Clinico Humanitas /ID# 155658
- Fondazione PTV Policlinico Tor Vergata /ID# 158023
- Presidio Columbus-Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Un /ID# 155656
- Duplicate_Azienda Ospedaliera Univ. Meyer /ID# 168049
- IRCCS Ospedale Sacro Cuore Don Calabria /ID# 161302
- A.O.U. di Bologna Policlinico S.Orsola-Malpighi /ID# 155659
- A.O. Per L'Emergenza Cannizzaro /ID# 161303
- ASST Fatebenefratelli Sacco-Ospedale Sacco /ID# 155655
- Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico /ID# 155657
- Duplicate_Fondazione IRCCS Policlinico S. Matteo /ID# 212030
- Hanyang University Guri Hospital /ID# 163351
- CHA Bundang Medical center CHA University /ID# 163377
- The Catholic University of Korea, ST. Vincent's Hospital /ID# 163365
- Kangbuk Samsung Hospital /ID# 163354
- Severance Hospital /ID# 163374
- Inje University Haeundae Hospital /ID# 202516
- Duplicate_Dong-A University Hospital /ID# 163370
- Pusan National University Hospital /ID# 163376
- Yeungnam University Medical Center /ID# 163366
- The Catholic University of Korea, Daejeon St.Mary's Hospital /ID# 213553
- Samsung Medical Center /ID# 163426
- Pauls Stradins Clinical University Hospital /ID# 159616
- Riga East Clinical University Hospital /ID# 159615
- Hospital of Lithuanian University of Health Sciences Kaunas Clinics /ID# 162584
- Vinius University Hospital Santaros Klinikos /ID# 162524
- Queen Elizabeth Hospital /ID# 160659
- Universiti Kebangsaan Malaysia (UKM) Medical Centre /ID# 201362
- Universiti Sains Malaysia /ID# 160661
- Investigacion Biomedica para el Desarrollo de Farmacos, S.A. de C.V. /ID# 170766
- JM Research SC /ID# 170762
- Unidad de Atencion Medica e Investigacion en Salud /ID# 170765
- Health Pharma Professional Research S.A de C.V /ID# 170763
- Academisch Medisch Centrum /ID# 157953
- Elisabeth Tweesteden Ziekenhuis /ID# 163620
- Christchurch Hospital /ID# 167212
- Dunedin Hospital /ID# 167215
- Middlemore Clinical Trials /ID# 167214
- Duplicate_Wellington Hospital (Capital and Coast District Health Board) /ID# 167213
- Planetmed Sp. z o.o. /ID# 205159
- Uniwersytecki Szpital Kliniczny nr 1 im. Norberta Barlickiego w Lodzi /ID# 212290
- 1 Wojskowy Szpital Kliniczny Z Poliklinika /Id# 209984
- Samodzielny Publiczny Szpital Kliniczny Nr 4 w Lublinie /ID# 209980
- Centrum Zdrowia MDM /ID# 163602
- Centralny Szpital Kliniczny MSWiA w Warszawie /ID# 163604
- Instytut Pomnik - Centrum Zdrowia Dziecka /ID# 213578
- Centrum Medyczne Medyk /ID# 212888
- Centrum Medyczne LukaMed Joanna Luka-Wendrowska /ID# 212079
- H-T. Centrum Medyczne - Endoterapia /ID# 212458
- Wojewodzki Szpital Specjalistyczny /ID# 212400
- Duplicate_Niepubliczny Zakład Opieki Zdrowotnej VIVAMED Jadwiga Miecz /ID# 202434
- Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclaw /ID# 212534
- Hospital da Senhora da Oliveira Guimaraes, EPE /ID# 160691
- Centro Hospitalar Universitário do Algarve, EPE - Hospital de Portimão /ID# 167754
- Centro Hospitalar de Entre Douro e Vouga /ID# 160676
- Hospital Garcia de Orta, EPE /ID# 160688
- Centro Hospitalar Universitário do Algarve, EPE - Hospital Faro /ID# 160732
- Centro Hospitalar Universitario Lisboa Central, EPE - Hospital dos Capuchos /ID# 160677
- Centro Hospitalar de Lisboa Ocidental, EPE - Hospital Egas Moniz /ID# 167753
- Centro Hospitalar Universitário de Lisboa Norte, EPE - Hospital de Santa Maria /ID# 160741
- Hospital Beatriz Ângelo /ID# 207758
- Centro Hospitalar Universitario de Sao Joao, EPE /ID# 160742
- Centro Hosp de Tondela-Viseu /ID# 160731
- Institutul Clinic Fundeni /ID# 170890
- Duplicate_Institutul Clinic Fundeni /ID# 170888
- Tvm Med Serv Srl /Id# 170891
- Duplicate_Centrul Medical Tuculanu SRL /ID# 170892
- Cabinet Particular Policlinic Algomed /ID# 170889
- Kuzbass Regional Clinical Hospital /ID# 200707
- Duplicate_Perm state medical university n.a. E.A. Vagner /ID# 207438
- Professor Pasechnikov Gastroenterology and Pankreatology clinic /ID# 200701
- Tver Regional Clinical Hospital /ID# 206586
- Regional Clinical Hospital #1 /ID# 200708
- Alliance Biomedical Ural Group /ID# 200703
- National Medical Research Center of Coloproctology n.a. A. N. Ryzhikh /ID# 204806
- City Clinical Hospital No. 31 /ID# 208865
- Ulyanovsk Regional Clinical Hospital /ID# 200700
- Clinical Hosp Center Zvezdara /ID# 156956
- Military Medical Academy /ID# 156963
- University Clinical Center Serbia /ID# 156957
- Duplicate_Clin Hosp Ctr Bezanijska Kosa /ID# 156959
- University Clinical Center Kragujevac /ID# 156961
- Clinical Center Vojvodina /ID# 156958
- University Children's Hospital 'Tirsova' /ID# 211480
- Clinical Hospital Center Dr Dragisa Misovic - Dedinje /ID# 212798
- National University Hospital /ID# 160662
- Singapore General Hospital /ID# 160663
- KL Ling Gastroenterology and Liver Clinic /ID# 205736
- Fakultna nemocnica s poliklinikou F.D. Roosevelta Banska Bystrica /ID# 156453
- Univerzitna nemocnica Martin /ID# 163205
- KM Management, spol. s.r.o. /ID# 206762
- GASTRO I., s.r.o. /ID# 156455
- Wits Clinical Research Site /ID# 171169
- Spoke Research Inc /ID# 171172
- Kingsbury Hospital /ID# 171158
- Private Practice Dr MN Rajabally /ID# 171159
- Hospital Arquitecto Marcide - Complejo Hospitalario Universitario de Ferrol /ID# 157534
- Consorci Corporacio Sanitaria Parc Tauli Sabadell /ID# 159234
- Hospital Universitario Basurto /ID# 205188
- Hospital Clinic de Barcelona /ID# 157533
- Hospital General Universitario Gregorio Maranon /ID# 161144
- Hospital Universitario La Paz /ID# 159232
- Hospital Clinico Universitario de Salamanca /ID# 157539
- Hospital Universitario Virgen Macarena /ID# 159966
- Hospital Clinico Universitario de Valencia /ID# 209699
- Hospital Universitario y Politecnico La Fe /ID# 157537
- Hospital Universitario Miguel Servet /ID# 157538
- Universitätsspital Basel /ID# 166321
- Universitätsspital Zürich /ID# 163528
- China Medical University Hosp /ID# 160130
- Taichung Veterans General Hosp /ID# 160134
- National Cheng Kung University Hospital /ID# 160129
- National Taiwan University Hospital /ID# 162189
- Taipei Veterans General Hosp /ID# 212711
- Duplicate_Transcarpathian Regional Clin. /ID# 167958
- Kyiv Municipal Clinical Hospital #18 /ID# 162527
- NHS Greater Glasgow and Clyde /ID# 202314
- Ashford and St Peter's Hospitals NHS Foundation Trust /ID# 207938
- Barnsley Hospital NHS Foundation Trust /ID# 202772
- University Hospitals Birmingham NHS Foundation Trust /ID# 157577
- Cambridge University Hospitals NHS Foundation Trust /ID# 158037
- NHS Lothian /ID# 207446
- Hull University Teaching Hospitals NHS Trust /ID# 158759
- King's College Hospital NHS Foundation Trusts /ID# 158758
- The Newcastle Upon Tyne Hospitals NHS Foundation Trust /ID# 163889
- Oxford University Hospitals NHS Foundation Trust /ID# 158039
- Duplicate_Northern Care Alliance NHS Group /ID# 207765
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm Type
Experimental
Experimental
Placebo Comparator
Experimental
Experimental
Experimental
Arm Label
Risankizumab Dose 1 (Induction Period 1)
Risankizumab Dose 2 (Induction Period 1)
Placebo (Induction Period 1)
Risankizumab Dose 1 (Induction Period 2)
Risankizumab Dose 2 (Induction Period 2)
Risankizumab Dose 3 (Induction period 2)
Arm Description
Participants randomized to receive risankizumab dose 1 in Induction Period 1.
Participants randomized to receive risankizumab dose 2 in Induction Period 1.
Participants randomized to receive placebo for risankizumab in Induction Period 1.
Participants who received placebo in Period 1 and participants with inadequate response at Week 12 in Period 1 randomized to receive risankizumab dose 1 administered by intravenous (IV) infusion in Period 2.
Participants with inadequate response at Week 12 in Period 1 randomized to receive risankizumab dose 2 administered by subcutaneous (SC) injection in Period 2.
Participants with inadequate response at Week 12 in Period 1 randomized to receive risankizumab dose 3 administered by subcutaneous (SC) injection in Period 2.
Outcomes
Primary Outcome Measures
US Specific: Percentage of Participants With Crohn's Disease Activity Index (CDAI) Clinical Remission
The CDAI consists of 8 components; 7 are based on participant diary entries, participant interviews, physical examinations, measurement of body weight and height and 1 is based on laboratory analysis. CDAI clinical remission of Crohn's disease is defined as CDAI < 150.
US Specific: Percentage of Participants With Endoscopic Response
The SES-CD assesses endoscopic disease severity by evidence of active intestinal mucosal inflammation. Endoscopic response is defined as a decrease in SES-CD > 50% from Baseline (or for participants with isolated ileal disease and a Baseline SES-CD of 4, at least a 2-point reduction from Baseline).
Global Outside of US: Percentage of Participants With Clinical Remission
Clinical remission is defined as using the average daily Stool Frequency (SF) ≤ 2.8 and not worse than Baseline AND average daily Abdominal Pain (AP) score ≤ 1 and not worse than Baseline.
Global Outside of US: Percentage of Participants With Endoscopic Response
The SES-CD assesses endoscopic disease severity by evidence of active intestinal mucosal inflammation. Endoscopic response is defined as a decrease in SES-CD > 50% from Baseline (or for participants with isolated ileal disease and a Baseline SES-CD of 4, at least a 2-point reduction from Baseline).
Secondary Outcome Measures
US Specific: Percentage of Participants With Clinical Remission
Clinical remission is defined as using the average daily Stool Frequency (SF) ≤ 2.8 and not worse than Baseline AND average daily Abdominal Pain (AP) score ≤ 1 and not worse than Baseline.
US Specific: Percentage of Participants With Crohn's Disease Activity Index (CDAI) Clinical Response
Crohn's Disease Activity Index (CDAI) is used to assess the symptoms of participants with Crohn's Disease. Higher CDAI scores indicate more severe disease. CDAI clinical response is defined as reduction of CDAI ≥ 100 points from baseline.
US Specific: Percentage of Participants With Crohn's Disease Activity Index (CDAI) Clinical Response
Crohn's Disease Activity Index (CDAI) is used to assess the symptoms of participants with Crohn's Disease. Higher CDAI scores indicate more severe disease. CDAI clinical response is defined as reduction of CDAI ≥ 100 points from baseline.
US Specific: Change From Baseline of Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue
The FACIT-Fatigue scale is a 13-item tool that measures an individual's level of fatigue during their usual daily activities over the past 7 days. Each of the fatigue and impact of fatigue items are measured on a four point Likert scale. The FACIT Fatigue Scale is the sum of the individual 13 scores and ranges from 0 to 52 where higher scores indicate better the quality of life. A positive change from baseline indicates improvement.
US Specific: Percentage of Participants With Crohn's Disease Activity Index (CDAI) Clinical Remission
Crohn's Disease Activity Index (CDAI) is used to assess the symptoms of participants with Crohn's Disease. Higher CDAI scores indicate more severe disease. CDAI clinical remission of Crohn's disease is defined as CDAI < 150.
US Specific: Percentage of Participants With CDAI Clinical Response and Endoscopic Response
Crohn's Disease Activity Index (CDAI) is used to assess the symptoms of participants with Crohn's Disease. Higher CDAI scores indicate more severe disease. CDAI clinical response is defined as reduction of CDAI ≥ 100 points from baseline.
Endoscopic response was a decrease in Simplified Endoscopic Score for Crohn's Disease (SES-CD) > 50% from Baseline (or for subjects with isolated ileal disease and a Baseline SES-CD of 4, at least a 2 point reduction from Baseline).
US Specific: Percentage of Participants With Stool Frequency (SF) Remission
Stool Frequency (SF) remission is defined as an average daily SF <= 2.8 and not worse than baseline.
US Specific: Percentage of Participants With Abdominal Pain (AP) Remission
The Abdominal Pain rating is an assessment that is graded from 0 to 3: 0= None, 1= Mild, 2= Moderate and 3= Severe. AP remission is defined as average daily AP score <= 1 and not worse than baseline.
US Specific: Percentage of Participants With Endoscopic Remission
Endoscopic remission: SES-CD ≤ 4 and at least a 2 point reduction versus baseline and no subscore greater than 1 in any individual variable
US Specific: Percentage of Participants With Enhanced Clinical Response
Enhanced clinical response: ≥ 60% decrease in average daily SF and/or ≥ 35% decrease in average daily AP score and both not worse than Baseline, and/or clinical remission
US Specific: Percentage of Participants With Ulcer-Free Endoscopy
Ulcer-free endoscopy: SES-CD ulcerated surface subscore of 0 in subjects with SES-CD ulcerated surface subscore ≥ 1 at Baseline
US Specific: Percentage of Participants With Enhanced Clinical Response
Enhanced clinical response: ≥ 60% decrease in average daily SF and/or ≥ 35% decrease in average daily AP score and both not worse than Baseline, and/or clinical remission
US Specific: Percentage of Participants With Resolution of Extra-Intestinal Manifestations (EIMs), in Participants With EIMs at Baseline Baseline
Manifestations of Crohn's disease in areas of the body other than the digestive tract, including eyes, skin, joints, mouth, and liver.
US Specific: Percentage of Participants With CD-Related Hospitalization
Participants with at least one admission to the hospital due to Crohn's Disease.
US Specific: Percentage of Participants Without Draining Fistulas in Participants With Draining Fistulas at Baseline
Participants without draining fistulas at Week 12 in participants who had draining fistulas at baseline.
Global Outside of US: Percentage of Participants With Crohn's Disease Activity Index (CDAI) Clinical Remission
The CDAI consists of 8 components; 6 are based on participant diary entries, participant interviews, and physical examinations, and 2 are based on laboratory analysis, and measurement of body weight and height. CDAI clinical remission of Crohn's disease is defined as CDAI < 150.
Global Outside of US: Percentage of Participants With Crohn's Disease Activity Index (CDAI) Clinical Response
Crohn's Disease Activity Index (CDAI) is used to assess the symptoms of participants with Crohn's Disease. Higher CDAI scores indicate more severe disease. CDAI clinical response is defined as reduction of CDAI ≥ 100 points from baseline.
Global Outside of US: Percentage of Participants With Clinical Remission
Clinical remission is defined as using the average daily Stool Frequency (SF) ≤ 2.8 and not worse than Baseline AND average daily Abdominal Pain (AP) score ≤ 1 and not worse than Baseline.
Global Outside of US: Percentage of Participants With Crohn's Disease Activity Index (CDAI) Clinical Response
Crohn's Disease Activity Index (CDAI) is used to assess the symptoms of participants with Crohn's Disease. Higher CDAI scores indicate more severe disease. CDAI clinical response is defined as reduction of CDAI ≥ 100 points from baseline.
Global Outside of US: Change From Baseline of Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue
The FACIT-Fatigue scale is a 13-item tool that measures an individual's level of fatigue during their usual daily activities over the past 7 days. Each of the fatigue and impact of fatigue items are measured on a four point Likert scale. The FACIT Fatigue Scale is the sum of the individual 13 scores and ranges from 0 to 52 where higher scores indicate better the quality of life. A positive change from baseline indicates improvement.
Global Outside of US: Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score
The IBDQ is a 32-item (ranges 1 - 7) self-report questionnaire for patients with IBD to evaluate the patient reported outcomes across 4 dimensions: bowel symptoms (loose stools, abdominal pain), systemic symptoms (fatigue, altered sleep pattern), social function (work attendance, need to cancel social events), and emotional function (anger, depression, irritability). The IBDQ total Score ranges from 32 to 224 with a higher score indicating better outcome.
Global Outside of US: Percentage of Participants With Enhanced Clinical Response and Endoscopic Response
Enhanced clinical response was defined as ≥ 60% decrease in average daily Stool Frequency and/or ≥ 35% decrease in average daily Abdominal Pain score and both not worse than baseline, and/or clinical remission. Endoscopic Response was defined as a decrease in Simplified Endoscopic Score for Crohn's Disease (SES-CD) > 50% from Baseline (or for subjects with isolated ileal disease and a Baseline SES-CD of 4, at least a 2 point reduction from Baseline).
Global Outside of US:: Percentage of Participants With Endoscopic Remission
Endoscopic remission: SES-CD ≤ 4 and at least a 2 point reduction versus baseline and no subscore greater than 1 in any individual variable
Global Outside of US: Percentage of Participants With Enhanced Clinical Response
Enhanced clinical response: ≥ 60% decrease in average daily SF and/or ≥ 35% decrease in average daily AP score and both not worse than Baseline, and/or clinical remission
Global Outside of US: Percentage of Participants With Ulcer-Free Endoscopy
Ulcer-free endoscopy: SES-CD ulcerated surface subscore of 0 in subjects with SES-CD ulcerated surface subscore ≥ 1 at Baseline
Global Outside of US: Percentage of Participants With Enhanced Clinical Response
Enhanced clinical response: ≥ 60% decrease in average daily SF and/or ≥ 35% decrease in average daily AP score and both not worse than Baseline, and/or clinical remission
Global Outside of US: Percentage of Participants With Resolution of Extra-Intestinal Manifestations (EIMs), in Participants With EIMs at Baseline Baseline
Manifestations of Crohn's disease in areas of the body other than the digestive tract, including eyes, skin, joints, mouth, and liver.
Global Outside of US: Percentage of Participants With CD-Related Hospitalization
Participants with at least one admission to the hospital due to Crohn's Disease.
Global Outside of US: Percentage of Participants Without Draining Fistulas in Participants With Draining Fistulas at Baseline
Participants without draining fistulas at Week 12 in participants who had draining fistulas at baseline.
Global Outside of US: Change From Baseline in Work Productivity and Impairment Questionnaire - Crohn's Disease (WPAI-CD) Overall Work Impairment
WPAI: CD is a questionnaire used to evaluate lost productivity due to CD ; scores are presented as percentages (multiplying the scores by 100), with 0% representing no impact on productivity and 100% representing complete impact on productivity. Total work productivity impairment takes into account both hours missed due to CD symptoms and the patient's assessment of the degree to which CD affected their productivity while working (overall work impairment [OWI]). WPAI outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity.
Global Outside of US: Change From Baseline in Short Form-36 (SF-36) Physical Component Summary (PCS) Score
The Short Form-36 Health Survey determined participants' overall quality of life by assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health. Items 1-4 comprise the physical component of the SF-36. Scores on each item were summed and averaged (range = 0-100); a positive change from Baseline indicates improvement.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03104413
Brief Title
A Study to Assess the Efficacy and Safety of Risankizumab in Participants With Moderately to Severely Active Crohn's Disease Who Failed Prior Biologic Treatment
Official Title
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study to Assess the Efficacy and Safety of Risankizumab in Subjects With Moderately to Severely Active Crohn's Disease Who Failed Prior Biologic Treatment
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
December 18, 2017 (Actual)
Primary Completion Date
November 30, 2020 (Actual)
Study Completion Date
May 19, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AbbVie
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The objective of Study M15-991 is to evaluate the efficacy and safety of risankizumab versus placebo during induction therapy in participants with moderately to severely active CD.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Crohn's Disease
Keywords
ABBV-066, BI 655066
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
618 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Risankizumab Dose 1 (Induction Period 1)
Arm Type
Experimental
Arm Description
Participants randomized to receive risankizumab dose 1 in Induction Period 1.
Arm Title
Risankizumab Dose 2 (Induction Period 1)
Arm Type
Experimental
Arm Description
Participants randomized to receive risankizumab dose 2 in Induction Period 1.
Arm Title
Placebo (Induction Period 1)
Arm Type
Placebo Comparator
Arm Description
Participants randomized to receive placebo for risankizumab in Induction Period 1.
Arm Title
Risankizumab Dose 1 (Induction Period 2)
Arm Type
Experimental
Arm Description
Participants who received placebo in Period 1 and participants with inadequate response at Week 12 in Period 1 randomized to receive risankizumab dose 1 administered by intravenous (IV) infusion in Period 2.
Arm Title
Risankizumab Dose 2 (Induction Period 2)
Arm Type
Experimental
Arm Description
Participants with inadequate response at Week 12 in Period 1 randomized to receive risankizumab dose 2 administered by subcutaneous (SC) injection in Period 2.
Arm Title
Risankizumab Dose 3 (Induction period 2)
Arm Type
Experimental
Arm Description
Participants with inadequate response at Week 12 in Period 1 randomized to receive risankizumab dose 3 administered by subcutaneous (SC) injection in Period 2.
Intervention Type
Drug
Intervention Name(s)
placebo for risankizumab IV
Intervention Description
placebo for risankizumab administered as intravenous (IV) infusion.
Intervention Type
Drug
Intervention Name(s)
risankizumab SC
Other Intervention Name(s)
ABBV-066 BI 655066, SKYRIZI
Intervention Description
risankizumab administered by subcutaneous (SC) injection
Intervention Type
Drug
Intervention Name(s)
risankizumab IV
Other Intervention Name(s)
ABBV-066 BI 655066, SKYRIZI
Intervention Description
risankizumab administered as intravenous (IV) infusion.
Primary Outcome Measure Information:
Title
US Specific: Percentage of Participants With Crohn's Disease Activity Index (CDAI) Clinical Remission
Description
The CDAI consists of 8 components; 7 are based on participant diary entries, participant interviews, physical examinations, measurement of body weight and height and 1 is based on laboratory analysis. CDAI clinical remission of Crohn's disease is defined as CDAI < 150.
Time Frame
Week 12
Title
US Specific: Percentage of Participants With Endoscopic Response
Description
The SES-CD assesses endoscopic disease severity by evidence of active intestinal mucosal inflammation. Endoscopic response is defined as a decrease in SES-CD > 50% from Baseline (or for participants with isolated ileal disease and a Baseline SES-CD of 4, at least a 2-point reduction from Baseline).
Time Frame
Week 12
Title
Global Outside of US: Percentage of Participants With Clinical Remission
Description
Clinical remission is defined as using the average daily Stool Frequency (SF) ≤ 2.8 and not worse than Baseline AND average daily Abdominal Pain (AP) score ≤ 1 and not worse than Baseline.
Time Frame
Week 12
Title
Global Outside of US: Percentage of Participants With Endoscopic Response
Description
The SES-CD assesses endoscopic disease severity by evidence of active intestinal mucosal inflammation. Endoscopic response is defined as a decrease in SES-CD > 50% from Baseline (or for participants with isolated ileal disease and a Baseline SES-CD of 4, at least a 2-point reduction from Baseline).
Time Frame
Week 12
Secondary Outcome Measure Information:
Title
US Specific: Percentage of Participants With Clinical Remission
Description
Clinical remission is defined as using the average daily Stool Frequency (SF) ≤ 2.8 and not worse than Baseline AND average daily Abdominal Pain (AP) score ≤ 1 and not worse than Baseline.
Time Frame
Week 12
Title
US Specific: Percentage of Participants With Crohn's Disease Activity Index (CDAI) Clinical Response
Description
Crohn's Disease Activity Index (CDAI) is used to assess the symptoms of participants with Crohn's Disease. Higher CDAI scores indicate more severe disease. CDAI clinical response is defined as reduction of CDAI ≥ 100 points from baseline.
Time Frame
Week 4
Title
US Specific: Percentage of Participants With Crohn's Disease Activity Index (CDAI) Clinical Response
Description
Crohn's Disease Activity Index (CDAI) is used to assess the symptoms of participants with Crohn's Disease. Higher CDAI scores indicate more severe disease. CDAI clinical response is defined as reduction of CDAI ≥ 100 points from baseline.
Time Frame
Week 12
Title
US Specific: Change From Baseline of Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue
Description
The FACIT-Fatigue scale is a 13-item tool that measures an individual's level of fatigue during their usual daily activities over the past 7 days. Each of the fatigue and impact of fatigue items are measured on a four point Likert scale. The FACIT Fatigue Scale is the sum of the individual 13 scores and ranges from 0 to 52 where higher scores indicate better the quality of life. A positive change from baseline indicates improvement.
Time Frame
Week 12
Title
US Specific: Percentage of Participants With Crohn's Disease Activity Index (CDAI) Clinical Remission
Description
Crohn's Disease Activity Index (CDAI) is used to assess the symptoms of participants with Crohn's Disease. Higher CDAI scores indicate more severe disease. CDAI clinical remission of Crohn's disease is defined as CDAI < 150.
Time Frame
Week 4
Title
US Specific: Percentage of Participants With CDAI Clinical Response and Endoscopic Response
Description
Crohn's Disease Activity Index (CDAI) is used to assess the symptoms of participants with Crohn's Disease. Higher CDAI scores indicate more severe disease. CDAI clinical response is defined as reduction of CDAI ≥ 100 points from baseline.
Endoscopic response was a decrease in Simplified Endoscopic Score for Crohn's Disease (SES-CD) > 50% from Baseline (or for subjects with isolated ileal disease and a Baseline SES-CD of 4, at least a 2 point reduction from Baseline).
Time Frame
Week 12
Title
US Specific: Percentage of Participants With Stool Frequency (SF) Remission
Description
Stool Frequency (SF) remission is defined as an average daily SF <= 2.8 and not worse than baseline.
Time Frame
Week 12
Title
US Specific: Percentage of Participants With Abdominal Pain (AP) Remission
Description
The Abdominal Pain rating is an assessment that is graded from 0 to 3: 0= None, 1= Mild, 2= Moderate and 3= Severe. AP remission is defined as average daily AP score <= 1 and not worse than baseline.
Time Frame
Week 12
Title
US Specific: Percentage of Participants With Endoscopic Remission
Description
Endoscopic remission: SES-CD ≤ 4 and at least a 2 point reduction versus baseline and no subscore greater than 1 in any individual variable
Time Frame
Week 12
Title
US Specific: Percentage of Participants With Enhanced Clinical Response
Description
Enhanced clinical response: ≥ 60% decrease in average daily SF and/or ≥ 35% decrease in average daily AP score and both not worse than Baseline, and/or clinical remission
Time Frame
Week 4
Title
US Specific: Percentage of Participants With Ulcer-Free Endoscopy
Description
Ulcer-free endoscopy: SES-CD ulcerated surface subscore of 0 in subjects with SES-CD ulcerated surface subscore ≥ 1 at Baseline
Time Frame
Week 12
Title
US Specific: Percentage of Participants With Enhanced Clinical Response
Description
Enhanced clinical response: ≥ 60% decrease in average daily SF and/or ≥ 35% decrease in average daily AP score and both not worse than Baseline, and/or clinical remission
Time Frame
Week 12
Title
US Specific: Percentage of Participants With Resolution of Extra-Intestinal Manifestations (EIMs), in Participants With EIMs at Baseline Baseline
Description
Manifestations of Crohn's disease in areas of the body other than the digestive tract, including eyes, skin, joints, mouth, and liver.
Time Frame
Week 12
Title
US Specific: Percentage of Participants With CD-Related Hospitalization
Description
Participants with at least one admission to the hospital due to Crohn's Disease.
Time Frame
Up to Week 12
Title
US Specific: Percentage of Participants Without Draining Fistulas in Participants With Draining Fistulas at Baseline
Description
Participants without draining fistulas at Week 12 in participants who had draining fistulas at baseline.
Time Frame
Week 12
Title
Global Outside of US: Percentage of Participants With Crohn's Disease Activity Index (CDAI) Clinical Remission
Description
The CDAI consists of 8 components; 6 are based on participant diary entries, participant interviews, and physical examinations, and 2 are based on laboratory analysis, and measurement of body weight and height. CDAI clinical remission of Crohn's disease is defined as CDAI < 150.
Time Frame
Week 12
Title
Global Outside of US: Percentage of Participants With Crohn's Disease Activity Index (CDAI) Clinical Response
Description
Crohn's Disease Activity Index (CDAI) is used to assess the symptoms of participants with Crohn's Disease. Higher CDAI scores indicate more severe disease. CDAI clinical response is defined as reduction of CDAI ≥ 100 points from baseline.
Time Frame
Week 4
Title
Global Outside of US: Percentage of Participants With Clinical Remission
Description
Clinical remission is defined as using the average daily Stool Frequency (SF) ≤ 2.8 and not worse than Baseline AND average daily Abdominal Pain (AP) score ≤ 1 and not worse than Baseline.
Time Frame
Week 4
Title
Global Outside of US: Percentage of Participants With Crohn's Disease Activity Index (CDAI) Clinical Response
Description
Crohn's Disease Activity Index (CDAI) is used to assess the symptoms of participants with Crohn's Disease. Higher CDAI scores indicate more severe disease. CDAI clinical response is defined as reduction of CDAI ≥ 100 points from baseline.
Time Frame
Week 12
Title
Global Outside of US: Change From Baseline of Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue
Description
The FACIT-Fatigue scale is a 13-item tool that measures an individual's level of fatigue during their usual daily activities over the past 7 days. Each of the fatigue and impact of fatigue items are measured on a four point Likert scale. The FACIT Fatigue Scale is the sum of the individual 13 scores and ranges from 0 to 52 where higher scores indicate better the quality of life. A positive change from baseline indicates improvement.
Time Frame
Week 12
Title
Global Outside of US: Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score
Description
The IBDQ is a 32-item (ranges 1 - 7) self-report questionnaire for patients with IBD to evaluate the patient reported outcomes across 4 dimensions: bowel symptoms (loose stools, abdominal pain), systemic symptoms (fatigue, altered sleep pattern), social function (work attendance, need to cancel social events), and emotional function (anger, depression, irritability). The IBDQ total Score ranges from 32 to 224 with a higher score indicating better outcome.
Time Frame
Week 12
Title
Global Outside of US: Percentage of Participants With Enhanced Clinical Response and Endoscopic Response
Description
Enhanced clinical response was defined as ≥ 60% decrease in average daily Stool Frequency and/or ≥ 35% decrease in average daily Abdominal Pain score and both not worse than baseline, and/or clinical remission. Endoscopic Response was defined as a decrease in Simplified Endoscopic Score for Crohn's Disease (SES-CD) > 50% from Baseline (or for subjects with isolated ileal disease and a Baseline SES-CD of 4, at least a 2 point reduction from Baseline).
Time Frame
Week 12
Title
Global Outside of US:: Percentage of Participants With Endoscopic Remission
Description
Endoscopic remission: SES-CD ≤ 4 and at least a 2 point reduction versus baseline and no subscore greater than 1 in any individual variable
Time Frame
Week 12
Title
Global Outside of US: Percentage of Participants With Enhanced Clinical Response
Description
Enhanced clinical response: ≥ 60% decrease in average daily SF and/or ≥ 35% decrease in average daily AP score and both not worse than Baseline, and/or clinical remission
Time Frame
Week 4
Title
Global Outside of US: Percentage of Participants With Ulcer-Free Endoscopy
Description
Ulcer-free endoscopy: SES-CD ulcerated surface subscore of 0 in subjects with SES-CD ulcerated surface subscore ≥ 1 at Baseline
Time Frame
Week 12
Title
Global Outside of US: Percentage of Participants With Enhanced Clinical Response
Description
Enhanced clinical response: ≥ 60% decrease in average daily SF and/or ≥ 35% decrease in average daily AP score and both not worse than Baseline, and/or clinical remission
Time Frame
Week 12
Title
Global Outside of US: Percentage of Participants With Resolution of Extra-Intestinal Manifestations (EIMs), in Participants With EIMs at Baseline Baseline
Description
Manifestations of Crohn's disease in areas of the body other than the digestive tract, including eyes, skin, joints, mouth, and liver.
Time Frame
Week 12
Title
Global Outside of US: Percentage of Participants With CD-Related Hospitalization
Description
Participants with at least one admission to the hospital due to Crohn's Disease.
Time Frame
Week 12
Title
Global Outside of US: Percentage of Participants Without Draining Fistulas in Participants With Draining Fistulas at Baseline
Description
Participants without draining fistulas at Week 12 in participants who had draining fistulas at baseline.
Time Frame
Week 12
Title
Global Outside of US: Change From Baseline in Work Productivity and Impairment Questionnaire - Crohn's Disease (WPAI-CD) Overall Work Impairment
Description
WPAI: CD is a questionnaire used to evaluate lost productivity due to CD ; scores are presented as percentages (multiplying the scores by 100), with 0% representing no impact on productivity and 100% representing complete impact on productivity. Total work productivity impairment takes into account both hours missed due to CD symptoms and the patient's assessment of the degree to which CD affected their productivity while working (overall work impairment [OWI]). WPAI outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity.
Time Frame
Week 12
Title
Global Outside of US: Change From Baseline in Short Form-36 (SF-36) Physical Component Summary (PCS) Score
Description
The Short Form-36 Health Survey determined participants' overall quality of life by assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health. Items 1-4 comprise the physical component of the SF-36. Scores on each item were summed and averaged (range = 0-100); a positive change from Baseline indicates improvement.
Time Frame
Week 12
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:
Male or female aged >=18 to <= 80 years, or minimum age of adult consent according to local regulations, at the Baseline Visit. Where locally permissible, participants 16 to < 18 years of age who meet the definition of Tanner stage 5 for development at the Baseline Visit.
Confirmed diagnosis of CD for at least 3 months prior to Baseline.
Crohn's disease activity index (CDAI) score 220 - 450 at Baseline.
Confirmed diagnosis of moderate to severe CD as assessed by stool frequency (SF), abdominal pain (AP) score, and Simple Endoscopic Score for Crohn's Disease (SES-CD).
Demonstrated intolerance or inadequate response to biologic therapy for CD.
If female, participant must meet the contraception recommendations.
Exclusion Criteria:
Participant with a current diagnosis of ulcerative colitis or indeterminate colitis.
Participants with unstable doses of concomitant Crohn's disease therapy.
Receipt of Crohn's disease approved biologic agents (infliximab, adalimumab, certolizumab, vedolizumab, natalizumab within 8 weeks prior to Baseline or ustekinumab within 12 weeks prior to Baseline), or any investigational biologic or other agent or procedure within minimally 35 days or 5 half-lives prior to Baseline, whichever is longer.
Prior exposure to p19 inhibitors (e.g., risankizumab).
Complications of Crohn's disease.
Having an ostomy or ileoanal pouch.
Known active Coronavirus Disease 2019 (COVID-19) infection.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ABBVIE INC.
Organizational Affiliation
AbbVie
Official's Role
Study Director
Facility Information:
Facility Name
Phoenix VA Health Care System /ID# 162261
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85012
Country
United States
Facility Name
HonorHealth Research Institute - Shea /ID# 165825
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85258
Country
United States
Facility Name
Digestive Disease Consultants, A Division of Arizona Digestive Health, P.C /ID# 211882
City
Tempe
State/Province
Arizona
ZIP/Postal Code
85284-2604
Country
United States
Facility Name
University of Arizona /ID# 158305
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724
Country
United States
Facility Name
Duplicate_Atria Clinical Research /ID# 164504
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72209-7040
Country
United States
Facility Name
Southern California Res. Ctr. /ID# 211989
City
Coronado
State/Province
California
ZIP/Postal Code
92118-1408
Country
United States
Facility Name
Newport Huntington Medica /ID# 213034
City
Huntington Beach
State/Province
California
ZIP/Postal Code
92648-5994
Country
United States
Facility Name
UC San Diego Health Systems /ID# 155576
City
La Jolla
State/Province
California
ZIP/Postal Code
92093
Country
United States
Facility Name
United Medical Doctors /ID# 207887
City
Los Alamitos
State/Province
California
ZIP/Postal Code
90720-3309
Country
United States
Facility Name
TLC Clinical Research Inc /ID# 212501
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
Gastrointestinal Biosciences Clinical Trials, LLC /ID# 162655
City
Los Angeles
State/Province
California
ZIP/Postal Code
90067-2001
Country
United States
Facility Name
United Medical Doctors - Murrieta /ID# 158278
City
Murrieta
State/Province
California
ZIP/Postal Code
92563
Country
United States
Facility Name
Peak Gastroenterology Associates, PC /ID# 165832
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80907
Country
United States
Facility Name
Rocky Mountain Pediatric Gastroenterology /ID# 207171
City
Lone Tree
State/Province
Colorado
ZIP/Postal Code
80124-6798
Country
United States
Facility Name
Western Connecticut Medical Group /ID# 165874
City
Danbury
State/Province
Connecticut
ZIP/Postal Code
06810-6000
Country
United States
Facility Name
Seffner Premier Health Care, PA /ID# 162259
City
Brandon
State/Province
Florida
ZIP/Postal Code
33510
Country
United States
Facility Name
Clinical Research of West Florida, Inc /ID# 205864
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33765
Country
United States
Facility Name
Clinical Research of West Florida, Inc /ID# 208127
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33765
Country
United States
Facility Name
South Lake Pain Institute, Inc /ID# 162798
City
Clermont
State/Province
Florida
ZIP/Postal Code
34711
Country
United States
Facility Name
Omega Research Maitland, LLC /ID# 171080
City
DeBary
State/Province
Florida
ZIP/Postal Code
32713-2260
Country
United States
Facility Name
Universal Axon Clinical Research /ID# 165426
City
Doral
State/Province
Florida
ZIP/Postal Code
33166
Country
United States
Facility Name
SIH Research Mumtaz, Inc /ID# 163081
City
Kissimmee
State/Province
Florida
ZIP/Postal Code
34741-4161
Country
United States
Facility Name
Alliance Medical Research /ID# 163834
City
Lighthouse Point
State/Province
Florida
ZIP/Postal Code
33064
Country
United States
Facility Name
Cfagi Llc /Id# 202482
City
Maitland
State/Province
Florida
ZIP/Postal Code
32751-6108
Country
United States
Facility Name
University of Miami /ID# 155011
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Vista Health Research, LLC /ID# 212828
City
Miami
State/Province
Florida
ZIP/Postal Code
33176-1032
Country
United States
Facility Name
ITB Research /ID# 161278
City
Miami
State/Province
Florida
ZIP/Postal Code
33176
Country
United States
Facility Name
Coral Research Clinic /ID# 158330
City
Miami
State/Province
Florida
ZIP/Postal Code
33186-4643
Country
United States
Facility Name
South Florida Research Ph I-IV, Inc. /ID# 161825
City
Miami
State/Province
Florida
ZIP/Postal Code
33193
Country
United States
Facility Name
Gastroenterology Group Naples /ID# 165192
City
Naples
State/Province
Florida
ZIP/Postal Code
34102
Country
United States
Facility Name
Advanced Research Institute, Inc /ID# 161973
City
New Port Richey
State/Province
Florida
ZIP/Postal Code
34653
Country
United States
Facility Name
Endoscopic Research, Inc. /ID# 205903
City
Orlando
State/Province
Florida
ZIP/Postal Code
32803
Country
United States
Facility Name
IMIC Inc. Medical Research /ID# 154944
City
Palmetto Bay
State/Province
Florida
ZIP/Postal Code
33157
Country
United States
Facility Name
Clinical Research Trials of Florida, Inc. /ID# 201606
City
Tampa
State/Province
Florida
ZIP/Postal Code
33607
Country
United States
Facility Name
Atlanta Gastro Assoc /ID# 154755
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
Gastroenterology Associates of Central Georgia, LLC /ID# 154865
City
Macon
State/Province
Georgia
ZIP/Postal Code
31201
Country
United States
Facility Name
Northwestern University Division of GI/Hepatology /ID# 158250
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611-2927
Country
United States
Facility Name
The University of Chicago Medical Center /ID# 157113
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637-1443
Country
United States
Facility Name
NorthShore University HealthSystem /ID# 158254
City
Evanston
State/Province
Illinois
ZIP/Postal Code
60201
Country
United States
Facility Name
Southwest Gastroenterology /ID# 164764
City
Oak Lawn
State/Province
Illinois
ZIP/Postal Code
60453
Country
United States
Facility Name
Cotton-O'Neil Clinical Res Ctr /ID# 154753
City
Topeka
State/Province
Kansas
ZIP/Postal Code
66606
Country
United States
Facility Name
University of Kentucky Chandler Medical Center /ID# 157109
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536
Country
United States
Facility Name
University of Louisville /ID# 210523
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
Gastroenterology Associates LLC - Jefferson Hwy /ID# 161970
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70809
Country
United States
Facility Name
Houma Digestive Health Special /ID# 158253
City
Houma
State/Province
Louisiana
ZIP/Postal Code
70360
Country
United States
Facility Name
Delricht Research /ID# 206567
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70115
Country
United States
Facility Name
Nola Research Works, LLC /ID# 161271
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70115
Country
United States
Facility Name
Louisana Research Center, LLC /ID# 162239
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71105-6800
Country
United States
Facility Name
MGG Group Co, Inc.Chevy Chase Clinical Research /ID# 154846
City
Chevy Chase
State/Province
Maryland
ZIP/Postal Code
20815
Country
United States
Facility Name
Gastro Center of Maryland /ID# 164766
City
Columbia
State/Province
Maryland
ZIP/Postal Code
21045
Country
United States
Facility Name
Center for Digestive Health /ID# 154697
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# 161267
City
Wyoming
State/Province
Michigan
ZIP/Postal Code
49519
Country
United States
Facility Name
Mayo Clinic - Rochester /ID# 163084
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905-0001
Country
United States
Facility Name
University of Nebraska Medical Center /ID# 210056
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68198-2000
Country
United States
Facility Name
Las Vegas Medical Research /ID# 160167
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89113
Country
United States
Facility Name
Revival Research Institute, Inc /ID# 210986
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89128-3157
Country
United States
Facility Name
NY Scientific /ID# 158272
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11235
Country
United States
Facility Name
Saratoga Schenectady Gastroenterology Associates - Burnt Hills /ID# 213446
City
Burnt Hills
State/Province
New York
ZIP/Postal Code
12027
Country
United States
Facility Name
Intercity Advanced Gastroentertology Center /ID# 215204
City
Fresh Meadows
State/Province
New York
ZIP/Postal Code
11366
Country
United States
Facility Name
Duplicate_Long Island Clinical Research /ID# 154843
City
Great Neck
State/Province
New York
ZIP/Postal Code
11021-5343
Country
United States
Facility Name
Digestive Disease Care /ID# 211776
City
New Hyde Park
State/Province
New York
ZIP/Postal Code
11040
Country
United States
Facility Name
North Shore University Hospital /ID# 168734
City
New Hyde Park
State/Province
New York
ZIP/Postal Code
11040
Country
United States
Facility Name
NYU Langone Medical Center /ID# 160166
City
New York
State/Province
New York
ZIP/Postal Code
10016-6402
Country
United States
Facility Name
Weill Cornell Medicine /ID# 165856
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# 165610
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Columbia Univ Medical Center /ID# 167545
City
New York
State/Province
New York
ZIP/Postal Code
10032-3725
Country
United States
Facility Name
Lenox Hill Hospital /ID# 168466
City
New York
State/Province
New York
ZIP/Postal Code
10075
Country
United States
Facility Name
DiGiovanna Institute for Medical Education & Research /ID# 171130
City
North Massapequa
State/Province
New York
ZIP/Postal Code
11758
Country
United States
Facility Name
Atrium Health Carolinas Medical Center /ID# 158364
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28203
Country
United States
Facility Name
Vidant Multispecialty Clinic - Kinston /ID# 161109
City
Kinston
State/Province
North Carolina
ZIP/Postal Code
28501-1589
Country
United States
Facility Name
Wake Radiology UNC REX Healthcare - Raleigh Office /ID# 154891
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27612
Country
United States
Facility Name
Plains Clinical Research Center, LLC /ID# 169712
City
Fargo
State/Province
North Dakota
ZIP/Postal Code
58104-5925
Country
United States
Facility Name
Tri-State Endoscopy /ID# 154939
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
Cleveland Clinic Main Campus /ID# 209225
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
The Ohio State University /ID# 164706
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Optimed Research, Ltd. /ID# 167877
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43235
Country
United States
Facility Name
Hometown Urgent Care and Resea /ID# 170447
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45424
Country
United States
Facility Name
Great Lakes Medical Research, LLC /ID# 201774
City
Mentor
State/Province
Ohio
ZIP/Postal Code
44060-6211
Country
United States
Facility Name
Hightower Clinical /ID# 211992
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73102
Country
United States
Facility Name
Digestive Disease Specialists /ID# 170772
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73112
Country
United States
Facility Name
Adult Gastroenterology Associates - Gen 1 Research /ID# 208857
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74136-7823
Country
United States
Facility Name
Northwest Gastroenterology Clinic /ID# 158255
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States
Facility Name
PennState Milton S.Hershey Med /ID# 154894
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
Facility Name
Children's Hospital of Pittsburgh of UPMC /ID# 212543
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15224-1334
Country
United States
Facility Name
Digestive Disease Associates, LTD /ID# 208296
City
Wyomissing
State/Province
Pennsylvania
ZIP/Postal Code
19610-2002
Country
United States
Facility Name
Medical University of South Carolina /ID# 212859
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
Gastroenterology Associates, P.A. of Greenville /ID# 154919
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29615-3593
Country
United States
Facility Name
Rapid City Medical Center - GI Research /ID# 163835
City
Rapid City
State/Province
South Dakota
ZIP/Postal Code
57701
Country
United States
Facility Name
Gastro One /ID# 154757
City
Germantown
State/Province
Tennessee
ZIP/Postal Code
38138
Country
United States
Facility Name
East Tennessee Research Institute /ID# 168735
City
Johnson City
State/Province
Tennessee
ZIP/Postal Code
37604
Country
United States
Facility Name
Duplicate_Clinical Neuroscience Solutions, Inc /ID# 164179
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States
Facility Name
Vanderbilt University Medical Center /ID# 157110
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232-0011
Country
United States
Facility Name
TX Clinical Research Institute /ID# 159396
City
Arlington
State/Province
Texas
ZIP/Postal Code
76012
Country
United States
Facility Name
Inquest Clinical Research /ID# 165696
City
Baytown
State/Province
Texas
ZIP/Postal Code
77521-2415
Country
United States
Facility Name
Texas Digestive Disease Consultants /ID# 209781
City
Cedar Park
State/Province
Texas
ZIP/Postal Code
78613-5028
Country
United States
Facility Name
Texas Digestive Disease Consultants /ID# 209945
City
Cedar Park
State/Province
Texas
ZIP/Postal Code
78613-5028
Country
United States
Facility Name
DHAT Research Institute /ID# 158199
City
Garland
State/Province
Texas
ZIP/Postal Code
75044-2208
Country
United States
Facility Name
Vilo Research Group Inc /ID# 207654
City
Houston
State/Province
Texas
ZIP/Postal Code
77017-2337
Country
United States
Facility Name
CliniCore International, LLC /ID# 158191
City
Houston
State/Province
Texas
ZIP/Postal Code
77027-6812
Country
United States
Facility Name
Baylor College of Medicine - Baylor Medical Center /ID# 158194
City
Houston
State/Province
Texas
ZIP/Postal Code
77030-3411
Country
United States
Facility Name
Precision Research Institute, LLC /ID# 201072
City
Houston
State/Province
Texas
ZIP/Postal Code
77036
Country
United States
Facility Name
Centex Studies, Inc. - Houston /ID# 201218
City
Houston
State/Province
Texas
ZIP/Postal Code
77058
Country
United States
Facility Name
Clinical Associates in Research Therapeutics of America, LLC /ID# 161307
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78212
Country
United States
Facility Name
Southern Star Research Institute, LLC /ID# 168772
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229-5390
Country
United States
Facility Name
Baylor Scott & White Medical Center- Temple /ID# 204129
City
Temple
State/Province
Texas
ZIP/Postal Code
76508-0001
Country
United States
Facility Name
Tyler Research Institute, LLC /ID# 166795
City
Tyler
State/Province
Texas
ZIP/Postal Code
75701-4464
Country
United States
Facility Name
Gastro Health & Nutrition - Victoria /ID# 164284
City
Victoria
State/Province
Texas
ZIP/Postal Code
77904
Country
United States
Facility Name
HP Clinical Research /ID# 162992
City
Bountiful
State/Province
Utah
ZIP/Postal Code
84010
Country
United States
Facility Name
Advanced Research Institute /ID# 154922
City
Ogden
State/Province
Utah
ZIP/Postal Code
84403
Country
United States
Facility Name
Velocity Clinical Research - Salt Lake City /ID# 161775
City
West Jordan
State/Province
Utah
ZIP/Postal Code
84088
Country
United States
Facility Name
Hunter Holmes McGuire VA Medical Center /ID# 159977
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23249
Country
United States
Facility Name
Washington Gastroenterology Associates /ID# 162101
City
Bellevue
State/Province
Washington
ZIP/Postal Code
98004
Country
United States
Facility Name
Virginia Mason - Seattle Orthapedics /ID# 155577
City
Seattle
State/Province
Washington
ZIP/Postal Code
98101
Country
United States
Facility Name
WVU Medicine /ID# 167942
City
Morgantown
State/Province
West Virginia
ZIP/Postal Code
26506-1200
Country
United States
Facility Name
Hospital Britanico de Buenos Aires /ID# 168081
City
Ciudad Autonoma de Buenos Aire
State/Province
Ciuadad Autonoma De Buenos Aires
ZIP/Postal Code
1280
Country
Argentina
Facility Name
Cemic /Id# 168082
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# 170904
City
Rosario
State/Province
Santa Fe
ZIP/Postal Code
2000
Country
Argentina
Facility Name
Hospital Privado Univesitario /ID# 168080
City
Cordoba
ZIP/Postal Code
5016
Country
Argentina
Facility Name
Mater Misericordiae Limited /ID# 167216
City
South Brisbane
State/Province
Queensland
ZIP/Postal Code
4101
Country
Australia
Facility Name
Griffith University /ID# 212631
City
Southport
State/Province
Queensland
ZIP/Postal Code
4222
Country
Australia
Facility Name
Lyell McEwin Hospital /ID# 211364
City
Elizabeth Vale
State/Province
South Australia
ZIP/Postal Code
5112
Country
Australia
Facility Name
Emeritus Research /ID# 213510
City
Camberwell
State/Province
Victoria
ZIP/Postal Code
3124
Country
Australia
Facility Name
Footscray Hospital /ID# 211362
City
Footscray
State/Province
Victoria
ZIP/Postal Code
3011
Country
Australia
Facility Name
Universitaetsklinikum St. Poelten /ID# 166423
City
Sankt Poelten
State/Province
Niederoesterreich
ZIP/Postal Code
3100
Country
Austria
Facility Name
Duplicate_LKH-Univ. Klinikum Graz /ID# 158134
City
Graz
State/Province
Steiermark
ZIP/Postal Code
8036
Country
Austria
Facility Name
Krankenhaus der Barmherzigen Brueder Wien /ID# 211418
City
Vienna
State/Province
Wien
ZIP/Postal Code
1020
Country
Austria
Facility Name
Duplicate_Medical University of Vienna /ID# 158135
City
Vienna
State/Province
Wien
ZIP/Postal Code
1090
Country
Austria
Facility Name
Vitebsk Regional Advanced Clin /ID# 204807
City
Витебск
ZIP/Postal Code
210001
Country
Belarus
Facility Name
AZ Sint-Maarten /ID# 212280
City
Mechelen
State/Province
Antwerpen
ZIP/Postal Code
2800
Country
Belgium
Facility Name
ULB Hospital Erasme /ID# 157386
City
Brussels
State/Province
Bruxelles-Capitale
ZIP/Postal Code
1070
Country
Belgium
Facility Name
UCL Saint-Luc /ID# 157384
City
Woluwe-Saint-Lambert
State/Province
Bruxelles-Capitale
ZIP/Postal Code
1200
Country
Belgium
Facility Name
UZ Gent /ID# 157383
City
Gent
State/Province
Oost-Vlaanderen
ZIP/Postal Code
9000
Country
Belgium
Facility Name
Imelda Ziekenhuis /ID# 157381
City
Bonheiden
ZIP/Postal Code
2820
Country
Belgium
Facility Name
AZ Maria Middelares /ID# 212871
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
AZ Groeninge /ID# 212571
City
Kortrijk
ZIP/Postal Code
8500
Country
Belgium
Facility Name
ZNA - Jan Palfijn /ID# 212822
City
Merksem
ZIP/Postal Code
2170
Country
Belgium
Facility Name
University Clinical Centre of the Republic of Srpska /ID# 157710
City
Banja Luka
State/Province
Republika Srpska
ZIP/Postal Code
78000
Country
Bosnia and Herzegovina
Facility Name
University Clinical Centre of the Republic of Srpska /ID# 165018
City
Banja Luka
State/Province
Republika Srpska
ZIP/Postal Code
78000
Country
Bosnia and Herzegovina
Facility Name
Clinical Center University of Sarajevo /ID# 165132
City
Sarajevo
ZIP/Postal Code
71000
Country
Bosnia and Herzegovina
Facility Name
UMHAT Dr Georgi Stranski EAD /ID# 203975
City
Pleven
ZIP/Postal Code
5800
Country
Bulgaria
Facility Name
University Multiprofile Hospit /ID# 165697
City
Plovdiv
ZIP/Postal Code
4001
Country
Bulgaria
Facility Name
Second Multiprofile Hospital f /ID# 165699
City
Sofia
ZIP/Postal Code
1202
Country
Bulgaria
Facility Name
Acibadem City Clinic UMHAT Tokuda /ID# 165698
City
Sofia
ZIP/Postal Code
1407
Country
Bulgaria
Facility Name
UMHAT Sveti Ivan Rilski /ID# 204713
City
Sofia
ZIP/Postal Code
1431
Country
Bulgaria
Facility Name
UMHAT Tsaritsa Joanna - ISUL /ID# 211241
City
Sofia
ZIP/Postal Code
1527
Country
Bulgaria
Facility Name
MHAT Trakia /ID# 201665
City
Stara Zagora
ZIP/Postal Code
6004
Country
Bulgaria
Facility Name
University Multiprofile Hospit /ID# 167576
City
Varna
ZIP/Postal Code
9010
Country
Bulgaria
Facility Name
University of Calgary - Heritage Medical Research Clinic /ID# 157156
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4Z6
Country
Canada
Facility Name
Allen Whey Khye Lim Professional Corporation /ID# 169766
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T5R 1W2
Country
Canada
Facility Name
University of Alberta - Zeidler Ledcor Centre /ID# 157100
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2X8
Country
Canada
Facility Name
Covenant Health /ID# 161636
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6K 4B2
Country
Canada
Facility Name
Fraser Clinical Trials Inc /ID# 159057
City
New Westminster
State/Province
British Columbia
ZIP/Postal Code
V3L 3W4
Country
Canada
Facility Name
GIRI Gastrointestinal Research Institute /ID# 157097
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6Z 2K5
Country
Canada
Facility Name
Percuro Clinical Research, Ltd /ID# 161635
City
Victoria
State/Province
British Columbia
ZIP/Postal Code
V8V 3M9
Country
Canada
Facility Name
QEII - Health Sciences Centre /ID# 157089
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 2Y9
Country
Canada
Facility Name
IWK Health Center /ID# 165909
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3K 6R8
Country
Canada
Facility Name
London Health Sciences Center /ID# 157162
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5W9
Country
Canada
Facility Name
Scott Shulman Medicine Professional Corporation /ID# 165910
City
North Bay
State/Province
Ontario
ZIP/Postal Code
P1B 2H3
Country
Canada
Facility Name
Medicor Research Inc /ID# 157151
City
Sudbury
State/Province
Ontario
ZIP/Postal Code
P3A 1W8
Country
Canada
Facility Name
Toronto Digestive Disease Asso /ID# 157159
City
Vaughan
State/Province
Ontario
ZIP/Postal Code
L4L 4Y7
Country
Canada
Facility Name
CISSS de la Monteregie /ID# 161634
City
Greenfield Park
State/Province
Quebec
ZIP/Postal Code
J4V 2H1
Country
Canada
Facility Name
CIUSSS de l'est de l'Ile-de-Montreal - Hopital Maisonneuve-Rosemont /ID# 159058
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H1T 2M4
Country
Canada
Facility Name
CHUM - Centre hospitalier de l'Universite de Montréal /ID# 167070
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2X 3E4
Country
Canada
Facility Name
Montreal General Hospital - McGill University Health Center /ID# 157086
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3G 1A4
Country
Canada
Facility Name
Complejo Asistencial Dr. Sotero del Rio /ID# 169383
City
Santiago
State/Province
Region Metropolitana De Santiago
ZIP/Postal Code
8207257
Country
Chile
Facility Name
Servicio de Salud Occidente Hospital San Juan de Dios /ID# 171121
City
Santiago
State/Province
Region Metropolitana De Santiago
ZIP/Postal Code
8350488
Country
Chile
Facility Name
Centro de Investigaciones Clínicas Viña del Mar /ID# 203585
City
Viña del Mar
State/Province
Valparaíso
ZIP/Postal Code
2540488
Country
Chile
Facility Name
Hospital Guillermo Grant Benavente de Concepción /ID# 210758
City
Concepción
ZIP/Postal Code
4070038
Country
Chile
Facility Name
Hospital Las Higueras /ID# 167091
City
Talcahuano
ZIP/Postal Code
1740000
Country
Chile
Facility Name
The Sixth Affiliated Hosp Sun /ID# 210783
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510655
Country
China
Facility Name
Tongji Hospital Tongji Medical College Huazhong University of Science and Techno /ID# 210857
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430022
Country
China
Facility Name
Union Hospital affiliated to Tongji Medical College of Huazhong University of Sc /ID# 211040
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430022
Country
China
Facility Name
The First Affiliated Hospital of Nanchang University /ID# 211035
City
Nanchang
State/Province
Jiangxi
ZIP/Postal Code
330006
Country
China
Facility Name
Ruijin Hospital, Shanghai Jiaotong University School of Medicine /ID# 210842
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200065
Country
China
Facility Name
Renji Hospital, Shanghai Jiaotong University School of Medicine /ID# 210706
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200127
Country
China
Facility Name
Sir Run Run Shaw Hospital Zhejiang University School of Medicine /ID# 210626
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310020
Country
China
Facility Name
West China Hospital, Sichuan University /ID# 210888
City
Chengdu
ZIP/Postal Code
610041
Country
China
Facility Name
Shanghai East Hospital /ID# 212671
City
Pudong New District
ZIP/Postal Code
200136
Country
China
Facility Name
Duplicate_Tianjin Med Univ General Hosp /ID# 210925
City
Tianjin
ZIP/Postal Code
300052
Country
China
Facility Name
Instituto de Coloproctologia /ID# 158740
City
Medellin
State/Province
Antioquia
ZIP/Postal Code
050024
Country
Colombia
Facility Name
Hospital Pablo Tobon Uribe /ID# 158732
City
Medellín
State/Province
Antioquia
ZIP/Postal Code
50034
Country
Colombia
Facility Name
Hospital Univ San Ignacio /ID# 158737
City
Bogota
State/Province
Cundinamarca
ZIP/Postal Code
110231
Country
Colombia
Facility Name
Duplicate_Klinicka bolnica Dubrava Zagreb /ID# 157719
City
Zagreb
State/Province
Grad Zagreb
ZIP/Postal Code
10000
Country
Croatia
Facility Name
Klinicki bolnicki centar Sestre milosrdnice /ID# 157720
City
Zagreb
State/Province
Grad Zagreb
ZIP/Postal Code
10000
Country
Croatia
Facility Name
Klinicki bolnicki centar Zagreb /ID# 157703
City
Zagreb
State/Province
Grad Zagreb
ZIP/Postal Code
10000
Country
Croatia
Facility Name
UHC Osijek /ID# 157704
City
Osijek
State/Province
Osjecko-baranjska Zupanija
ZIP/Postal Code
31000
Country
Croatia
Facility Name
Klinicki bolnicki centar Split /ID# 157705
City
Split
State/Province
Splitsko-dalmatinska Zupanija
ZIP/Postal Code
21000
Country
Croatia
Facility Name
Zadar General Hospital /ID# 157706
City
Zadar
ZIP/Postal Code
23000
Country
Croatia
Facility Name
Duplicate_Institut klinicke a experimentalni mediciny (IKEM) /ID# 165479
City
Prague 4
State/Province
Praha 4
ZIP/Postal Code
140 00
Country
Czechia
Facility Name
Hepato-Gastroenterologie HK, s.r.o. /ID# 163218
City
Hradec Kralove
ZIP/Postal Code
500 12
Country
Czechia
Facility Name
CTCenter MaVe s.r.o. /ID# 163215
City
Olomouc
ZIP/Postal Code
779 00
Country
Czechia
Facility Name
Nemocnice Pardubickeho kraje, a.s. /ID# 163219
City
Pardubice
ZIP/Postal Code
530 03
Country
Czechia
Facility Name
Nemocnice Milosrdnych sester sv. Karla Boromejskeho v Praze /ID# 211304
City
Praha
ZIP/Postal Code
118 33
Country
Czechia
Facility Name
Axon Clinical, s.r.o. /ID# 163216
City
Praha
ZIP/Postal Code
140 00
Country
Czechia
Facility Name
Thomayerova nemocnice /ID# 162942
City
Praha
ZIP/Postal Code
140 59
Country
Czechia
Facility Name
ResTrial s.r.o. /ID# 211074
City
Praha
ZIP/Postal Code
143 00
Country
Czechia
Facility Name
NH Hospital a.s. /ID# 211073
City
Praha
ZIP/Postal Code
155 00
Country
Czechia
Facility Name
Kobenhavns Universitet - Hvidovre Hospital (HH) /ID# 155535
City
Hvidovre
State/Province
Hovedstaden
ZIP/Postal Code
2650
Country
Denmark
Facility Name
Aarhus University Hospital /ID# 155534
City
Aarhus N
State/Province
Midtjylland
ZIP/Postal Code
8200
Country
Denmark
Facility Name
Sjællands Universitetshospital, Roskilde /ID# 155537
City
Roskilde
State/Province
Sjælland
ZIP/Postal Code
4000
Country
Denmark
Facility Name
Sygehusenheden Nyborg - OUH /ID# 161591
City
Nyborg
State/Province
Syddanmark
ZIP/Postal Code
5800
Country
Denmark
Facility Name
Aalborg Universitets Hospital /ID# 160685
City
Aalborg
ZIP/Postal Code
9000
Country
Denmark
Facility Name
Odense Universitets Hospital /ID# 155536
City
Odense C
ZIP/Postal Code
5000
Country
Denmark
Facility Name
Zagazig University Hospitals /ID# 164018
City
Al Sharqia
ZIP/Postal Code
44519
Country
Egypt
Facility Name
Clinical Research Center, Faculty of Medicine, Alexandria university. /ID# 157876
City
Alexandria
ZIP/Postal Code
21131
Country
Egypt
Facility Name
Clinical Research Center, Faculty of Medicine, Alexandria university. /ID# 164423
City
Alexandria
ZIP/Postal Code
21131
Country
Egypt
Facility Name
Clinical Research Center, Faculty of Medicine, Cairo university /ID# 157176
City
Cairo
ZIP/Postal Code
11559
Country
Egypt
Facility Name
National Hepatology and Tropical Medicine Research Institute /ID# 157875
City
Cairo
ZIP/Postal Code
11559
Country
Egypt
Facility Name
Internal Medicine Department, Faculty of Medicine, AinShams University /ID# 158630
City
Cairo
ZIP/Postal Code
11566
Country
Egypt
Facility Name
East Tallinn Central Hospital /ID# 157072
City
Tallinn
State/Province
Harjumaa
ZIP/Postal Code
10138
Country
Estonia
Facility Name
West Tallinn Central Hospital /ID# 157073
City
Tallinn
ZIP/Postal Code
10617
Country
Estonia
Facility Name
Chu de Nice-Hopital L'Archet Ii /Id# 162545
City
Nice
State/Province
Alpes-Maritimes
ZIP/Postal Code
06200
Country
France
Facility Name
HCL - Hôpital Lyon Sud /ID# 162548
City
Pierre Benite CEDEX
State/Province
Auvergne-Rhone-Alpes
ZIP/Postal Code
69495
Country
France
Facility Name
CHU Bordeaux - Hopital Haut Lévêque /ID# 162546
City
Pessac CEDEX
State/Province
Gironde
ZIP/Postal Code
33604
Country
France
Facility Name
CHRU Lille - Hopital Claude Huriez /ID# 162547
City
Lille
State/Province
Hauts-de-France
ZIP/Postal Code
59037
Country
France
Facility Name
CHU Montpellier - Hôpital Saint Eloi /ID# 215146
City
Montpellier Cedex 5
State/Province
Herault
ZIP/Postal Code
34295
Country
France
Facility Name
Hapital Beaujon /ID# 166287
City
Clichy
State/Province
Ile-de-France
ZIP/Postal Code
92110
Country
France
Facility Name
CHU de SAINT ETIENNE - Hopital Nord /ID# 162550
City
St. Priest En Jarez
State/Province
Loire
ZIP/Postal Code
42270
Country
France
Facility Name
CHRU Nancy - Hôpitaux de Brabois /ID# 162549
City
Vandœuvre-lès-Nancy
State/Province
Meurthe-et-Moselle
ZIP/Postal Code
54500
Country
France
Facility Name
CHU Amiens-Picardie Site Sud /ID# 165056
City
Amiens CEDEX 1
State/Province
Somme
ZIP/Postal Code
80054
Country
France
Facility Name
CHU Grenoble - Hopital Michallon /ID# 211980
City
La Tronche
ZIP/Postal Code
38700
Country
France
Facility Name
Hospital Pontchaillou /ID# 213207
City
Rennes
ZIP/Postal Code
35033
Country
France
Facility Name
Praxis fuer Gastroenterologie /ID# 166148
City
Heidelberg
State/Province
Baden-Wuerttemberg
ZIP/Postal Code
69121
Country
Germany
Facility Name
Universitatsklinikum Mannheim /ID# 162026
City
Mannheim
State/Province
Baden-Wuerttemberg
ZIP/Postal Code
68167
Country
Germany
Facility Name
Universitaetsklinikum Tuebingen /ID# 159341
City
Tübingen
State/Province
Baden-Wuerttemberg
ZIP/Postal Code
72076
Country
Germany
Facility Name
Universitaetsklinikum Ulm /ID# 164988
City
Ulm
State/Province
Baden-Wuerttemberg
ZIP/Postal Code
89081
Country
Germany
Facility Name
Universitaetsklinikum Erlangen /ID# 159332
City
Erlangen
State/Province
Bayern
ZIP/Postal Code
91054
Country
Germany
Facility Name
Universitaetsklinikum Frankfurt /ID# 212977
City
Frankfurt am Main
State/Province
Hessen
ZIP/Postal Code
60590
Country
Germany
Facility Name
Evangelisches Krankenhaus Kalk /ID# 212724
City
Cologne
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
51103
Country
Germany
Facility Name
Praxiszentrum fuer Gastroenterologie /ID# 211965
City
Grevenbroich
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
41515
Country
Germany
Facility Name
Universitaetsklinikum Koeln /ID# 164987
City
Köln
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
50937
Country
Germany
Facility Name
Universitaetsklinikum Muenster /ID# 159333
City
Muenster
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
48149
Country
Germany
Facility Name
Zentrum für Gastroenterologie Saar MVZ GmbH /ID# 210527
City
Saarbrücken
State/Province
Saarland
ZIP/Postal Code
66111
Country
Germany
Facility Name
Universitaetsklinikum Schleswig-Holstein Campus Kiel /ID# 159338
City
Kiel
State/Province
Schleswig-Holstein
ZIP/Postal Code
24105
Country
Germany
Facility Name
Krankenhaus Waldfriede /ID# 212729
City
Berlin-Zehlendorf
ZIP/Postal Code
14163
Country
Germany
Facility Name
Charite Universitaetsmedizin Berlin - Campus Mitte /ID# 212218
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Facility Name
Charite Universitaetsmedizin Berlin - Campus Mitte /ID# 212892
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Facility Name
Gastroenterologische Spezialpraxis am Wittenbergplatz /ID# 211976
City
Berlin
ZIP/Postal Code
10787
Country
Germany
Facility Name
MVZ fuer Gastroenterlogie am Bayerischen Platz /ID# 159339
City
Berlin
ZIP/Postal Code
10825
Country
Germany
Facility Name
DRK Kliniken Berlin Westend /ID# 166149
City
Berlin
ZIP/Postal Code
14050
Country
Germany
Facility Name
Stadtisches Klinikum Braunschweig /ID# 163673
City
Braunschweig
ZIP/Postal Code
38126
Country
Germany
Facility Name
Medizinisches Versorgunszentrum Dachau /ID# 211550
City
Dachau
ZIP/Postal Code
85221
Country
Germany
Facility Name
Agaplesion Markus Krankenhaus /ID# 159334
City
Frankfurt am Main
ZIP/Postal Code
60431
Country
Germany
Facility Name
Duplicate_Universitaetsklinikum Freiburg /ID# 162025
City
Freiburg
ZIP/Postal Code
79106
Country
Germany
Facility Name
Asklepios Westklinikum Hamburg /ID# 159336
City
Hamburg
ZIP/Postal Code
22559
Country
Germany
Facility Name
Medizinische Hochschule Hannover /ID# 162027
City
Hannover
ZIP/Postal Code
30625
Country
Germany
Facility Name
EUGASTRO GmbH /ID# 212077
City
Leipzig
ZIP/Postal Code
04103
Country
Germany
Facility Name
Klinikum Lueneburg /ID# 163671
City
Lueneburg
ZIP/Postal Code
21339
Country
Germany
Facility Name
Universitaetsklinikum Magdeburg /ID# 211840
City
Magdeburg
ZIP/Postal Code
39120
Country
Germany
Facility Name
Gastroenterologische Gemeinschaftspraxis Minden /ID# 162024
City
Minden
ZIP/Postal Code
32423
Country
Germany
Facility Name
Universitaetsklinikum Regensburg /ID# 163812
City
Regensburg
ZIP/Postal Code
93042
Country
Germany
Facility Name
Duplicate_Gastro-Praxis Wiesbaden /ID# 159335
City
Wiesbaden
ZIP/Postal Code
65189
Country
Germany
Facility Name
General Hospital of Chest Diseases of Athens SOTIRIA /ID# 170905
City
Athens
State/Province
Attiki
ZIP/Postal Code
11527
Country
Greece
Facility Name
Tzaneio general hospital of Piraeus /ID# 206441
City
Piraeus
State/Province
Attiki
ZIP/Postal Code
18536
Country
Greece
Facility Name
University General Hospital of Heraklion PA.G.N.I /ID# 157417
City
Heraklion
State/Province
Kriti
ZIP/Postal Code
71307
Country
Greece
Facility Name
General Hospital of Athens Evaggelismos and Ophthalmiatrio of Athens Polyclinic /ID# 157418
City
Athens
ZIP/Postal Code
10676
Country
Greece
Facility Name
University General Hospital of Ioannina /ID# 157415
City
Ioannina
ZIP/Postal Code
45500
Country
Greece
Facility Name
General Hospital of Nikaia-Piraeus "Agios Panteleimon"- general hospital dytikis /ID# 157419
City
Pireaus
ZIP/Postal Code
18454
Country
Greece
Facility Name
Theageneio Anticancer Hospital /ID# 163922
City
Thessaloniki
ZIP/Postal Code
54639
Country
Greece
Facility Name
Beaumont Hospital /ID# 157572
City
Beaumont
State/Province
Dublin
ZIP/Postal Code
D09 XR63
Country
Ireland
Facility Name
St Vincent's University Hospital /ID# 157569
City
Elm Park
State/Province
Dublin
ZIP/Postal Code
D04 T6F4
Country
Ireland
Facility Name
University Hospital Galway /ID# 157570
City
Galway
ZIP/Postal Code
H91 YR71
Country
Ireland
Facility Name
Soroka University Medical Center /ID# 157789
City
Be'er Sheva
State/Province
HaDarom
ZIP/Postal Code
8443901
Country
Israel
Facility Name
Sheba Medical Center /ID# 171059
City
Ramat Gan
State/Province
Tel-Aviv
ZIP/Postal Code
5239424
Country
Israel
Facility Name
Tel Aviv Sourasky Medical Center /ID# 157787
City
Tel Aviv-Yafo
State/Province
Tel-Aviv
ZIP/Postal Code
6423906
Country
Israel
Facility Name
Duplicate_Rambam Medical Center /ID# 171056
City
Haifa
ZIP/Postal Code
3109601
Country
Israel
Facility Name
Shaare Zedek Medical Center /ID# 163539
City
Jerusalem
ZIP/Postal Code
91031
Country
Israel
Facility Name
Shaare Zedek Medical Center /ID# 171055
City
Jerusalem
ZIP/Postal Code
91031
Country
Israel
Facility Name
Hadassah Medical Center-Hebrew University /ID# 171062
City
Jerusalem
ZIP/Postal Code
91120
Country
Israel
Facility Name
Duplicate_AOU Ospendali Riuniti di Ancona /ID# 162431
City
Torrette
State/Province
Ancona
ZIP/Postal Code
60123
Country
Italy
Facility Name
Duplicate_Universita di Catanzaro Magna Graecia /ID# 212017
City
Catanzaro
State/Province
Calabria
ZIP/Postal Code
88100
Country
Italy
Facility Name
Duplicate_Azienda Ospedaliero-Universitaria Policlinico di Modena /ID# 212018
City
Modena
State/Province
Emilia-Romagna
ZIP/Postal Code
41124
Country
Italy
Facility Name
Duplicate_Policlinico Universitario Campus Bio-Medico /ID# 162433
City
Rome
State/Province
Lazio
ZIP/Postal Code
00128
Country
Italy
Facility Name
Azienda Ospedaliera San Camillo Forlanini /ID# 155660
City
Rome
State/Province
Lazio
ZIP/Postal Code
00152
Country
Italy
Facility Name
Azienda Ospedaliero-Universitaria Policlinico Umberto I /ID# 166910
City
Rome
State/Province
Lazio
ZIP/Postal Code
00161
Country
Italy
Facility Name
Duplicate_Ospedale Policlinico San Martino/ Università Degli Studi Di Genova /ID# 162434
City
Genoa
State/Province
Liguria
ZIP/Postal Code
16132
Country
Italy
Facility Name
ASST Rhodense/Presidio Ospedaliero di Rho /ID# 211453
City
Rho
State/Province
Milano
ZIP/Postal Code
20017
Country
Italy
Facility Name
Istituto Clinico Humanitas /ID# 155658
City
Rozzano
State/Province
Milano
ZIP/Postal Code
20089
Country
Italy
Facility Name
Fondazione PTV Policlinico Tor Vergata /ID# 158023
City
Rome
State/Province
Roma
ZIP/Postal Code
00133
Country
Italy
Facility Name
Presidio Columbus-Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Un /ID# 155656
City
Rome
State/Province
Roma
ZIP/Postal Code
00168
Country
Italy
Facility Name
Duplicate_Azienda Ospedaliera Univ. Meyer /ID# 168049
City
Florence
State/Province
Toscana
ZIP/Postal Code
50139
Country
Italy
Facility Name
IRCCS Ospedale Sacro Cuore Don Calabria /ID# 161302
City
Negrar
State/Province
Verona
ZIP/Postal Code
37024
Country
Italy
Facility Name
A.O.U. di Bologna Policlinico S.Orsola-Malpighi /ID# 155659
City
Bologna
ZIP/Postal Code
40138
Country
Italy
Facility Name
A.O. Per L'Emergenza Cannizzaro /ID# 161303
City
Catania
ZIP/Postal Code
95126
Country
Italy
Facility Name
ASST Fatebenefratelli Sacco-Ospedale Sacco /ID# 155655
City
Milano
ZIP/Postal Code
20157
Country
Italy
Facility Name
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico /ID# 155657
City
Milan
ZIP/Postal Code
20122
Country
Italy
Facility Name
Duplicate_Fondazione IRCCS Policlinico S. Matteo /ID# 212030
City
Pavia
ZIP/Postal Code
27100
Country
Italy
Facility Name
Hanyang University Guri Hospital /ID# 163351
City
Guri
State/Province
Gyeonggido
ZIP/Postal Code
11923
Country
Korea, Republic of
Facility Name
CHA Bundang Medical center CHA University /ID# 163377
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# 163365
City
Suwon
State/Province
Gyeonggido
ZIP/Postal Code
16247
Country
Korea, Republic of
Facility Name
Kangbuk Samsung Hospital /ID# 163354
City
Seoul
State/Province
Seoul Teugbyeolsi
ZIP/Postal Code
03181
Country
Korea, Republic of
Facility Name
Severance Hospital /ID# 163374
City
Seoul
State/Province
Seoul Teugbyeolsi
ZIP/Postal Code
03722
Country
Korea, Republic of
Facility Name
Inje University Haeundae Hospital /ID# 202516
City
Busan
ZIP/Postal Code
48108
Country
Korea, Republic of
Facility Name
Duplicate_Dong-A University Hospital /ID# 163370
City
Busan
ZIP/Postal Code
49201
Country
Korea, Republic of
Facility Name
Pusan National University Hospital /ID# 163376
City
Busan
ZIP/Postal Code
49241
Country
Korea, Republic of
Facility Name
Yeungnam University Medical Center /ID# 163366
City
Daegu
ZIP/Postal Code
42415
Country
Korea, Republic of
Facility Name
The Catholic University of Korea, Daejeon St.Mary's Hospital /ID# 213553
City
Daejeon
ZIP/Postal Code
34943
Country
Korea, Republic of
Facility Name
Samsung Medical Center /ID# 163426
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
Facility Name
Pauls Stradins Clinical University Hospital /ID# 159616
City
Riga
ZIP/Postal Code
1002
Country
Latvia
Facility Name
Riga East Clinical University Hospital /ID# 159615
City
Riga
ZIP/Postal Code
LV-1079
Country
Latvia
Facility Name
Hospital of Lithuanian University of Health Sciences Kaunas Clinics /ID# 162584
City
Kaunas
ZIP/Postal Code
50161
Country
Lithuania
Facility Name
Vinius University Hospital Santaros Klinikos /ID# 162524
City
Vilnius
ZIP/Postal Code
08661
Country
Lithuania
Facility Name
Queen Elizabeth Hospital /ID# 160659
City
Division Pantai Barat Utara
State/Province
Sabah
ZIP/Postal Code
88200
Country
Malaysia
Facility Name
Universiti Kebangsaan Malaysia (UKM) Medical Centre /ID# 201362
City
Kuala Lumpur
State/Province
Selangor
ZIP/Postal Code
56000
Country
Malaysia
Facility Name
Universiti Sains Malaysia /ID# 160661
City
Kelantan
ZIP/Postal Code
16150
Country
Malaysia
Facility Name
Investigacion Biomedica para el Desarrollo de Farmacos, S.A. de C.V. /ID# 170766
City
Zapopan
State/Province
Jalisco
ZIP/Postal Code
45070
Country
Mexico
Facility Name
JM Research SC /ID# 170762
City
Cuernavaca
State/Province
Morelos
ZIP/Postal Code
62290
Country
Mexico
Facility Name
Unidad de Atencion Medica e Investigacion en Salud /ID# 170765
City
Merida
State/Province
Yucatan
ZIP/Postal Code
97000
Country
Mexico
Facility Name
Health Pharma Professional Research S.A de C.V /ID# 170763
City
Del. Benito Juárez
ZIP/Postal Code
03810
Country
Mexico
Facility Name
Academisch Medisch Centrum /ID# 157953
City
Amsterdam
ZIP/Postal Code
1105 AZ
Country
Netherlands
Facility Name
Elisabeth Tweesteden Ziekenhuis /ID# 163620
City
Tilburg
ZIP/Postal Code
5022 GC
Country
Netherlands
Facility Name
Christchurch Hospital /ID# 167212
City
Christchurch
State/Province
Canterbury
ZIP/Postal Code
8011
Country
New Zealand
Facility Name
Dunedin Hospital /ID# 167215
City
Dunedin
State/Province
Otago
ZIP/Postal Code
9016
Country
New Zealand
Facility Name
Middlemore Clinical Trials /ID# 167214
City
Auckland
ZIP/Postal Code
2025
Country
New Zealand
Facility Name
Duplicate_Wellington Hospital (Capital and Coast District Health Board) /ID# 167213
City
Wellington
ZIP/Postal Code
6021
Country
New Zealand
Facility Name
Planetmed Sp. z o.o. /ID# 205159
City
Wroclaw
State/Province
Dolnoslaskie
ZIP/Postal Code
52-210
Country
Poland
Facility Name
Uniwersytecki Szpital Kliniczny nr 1 im. Norberta Barlickiego w Lodzi /ID# 212290
City
Lodz
State/Province
Lodzkie
ZIP/Postal Code
90-153
Country
Poland
Facility Name
1 Wojskowy Szpital Kliniczny Z Poliklinika /Id# 209984
City
Lublin
State/Province
Lubelskie
ZIP/Postal Code
20-049
Country
Poland
Facility Name
Samodzielny Publiczny Szpital Kliniczny Nr 4 w Lublinie /ID# 209980
City
Lublin
State/Province
Lubelskie
ZIP/Postal Code
20-954
Country
Poland
Facility Name
Centrum Zdrowia MDM /ID# 163602
City
Warszawa
State/Province
Mazowieckie
ZIP/Postal Code
00-635
Country
Poland
Facility Name
Centralny Szpital Kliniczny MSWiA w Warszawie /ID# 163604
City
Warszawa
State/Province
Mazowieckie
ZIP/Postal Code
02-507
Country
Poland
Facility Name
Instytut Pomnik - Centrum Zdrowia Dziecka /ID# 213578
City
Warszawa
State/Province
Mazowieckie
ZIP/Postal Code
04-730
Country
Poland
Facility Name
Centrum Medyczne Medyk /ID# 212888
City
Rzeszów
State/Province
Podkarpackie
ZIP/Postal Code
35-326
Country
Poland
Facility Name
Centrum Medyczne LukaMed Joanna Luka-Wendrowska /ID# 212079
City
Chojnice
State/Province
Pomorskie
ZIP/Postal Code
89-600
Country
Poland
Facility Name
H-T. Centrum Medyczne - Endoterapia /ID# 212458
City
Tychy
State/Province
Slaskie
ZIP/Postal Code
43-100
Country
Poland
Facility Name
Wojewodzki Szpital Specjalistyczny /ID# 212400
City
Olsztyn
State/Province
Warminsko-mazurskie
ZIP/Postal Code
10-561
Country
Poland
Facility Name
Duplicate_Niepubliczny Zakład Opieki Zdrowotnej VIVAMED Jadwiga Miecz /ID# 202434
City
Warsaw
ZIP/Postal Code
03-580
Country
Poland
Facility Name
Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclaw /ID# 212534
City
Wroclaw
ZIP/Postal Code
50-556
Country
Poland
Facility Name
Hospital da Senhora da Oliveira Guimaraes, EPE /ID# 160691
City
Guimaraes
State/Province
Braga
ZIP/Postal Code
4835-044
Country
Portugal
Facility Name
Centro Hospitalar Universitário do Algarve, EPE - Hospital de Portimão /ID# 167754
City
Portimão
State/Province
Faro
ZIP/Postal Code
8500-338
Country
Portugal
Facility Name
Centro Hospitalar de Entre Douro e Vouga /ID# 160676
City
Santa Maria Da Feira
State/Province
Porto
ZIP/Postal Code
4520-211
Country
Portugal
Facility Name
Hospital Garcia de Orta, EPE /ID# 160688
City
Almada
ZIP/Postal Code
2805-267
Country
Portugal
Facility Name
Centro Hospitalar Universitário do Algarve, EPE - Hospital Faro /ID# 160732
City
Faro
ZIP/Postal Code
8000-386
Country
Portugal
Facility Name
Centro Hospitalar Universitario Lisboa Central, EPE - Hospital dos Capuchos /ID# 160677
City
Lisboa
ZIP/Postal Code
1169-050
Country
Portugal
Facility Name
Centro Hospitalar de Lisboa Ocidental, EPE - Hospital Egas Moniz /ID# 167753
City
Lisboa
ZIP/Postal Code
1349-019
Country
Portugal
Facility Name
Centro Hospitalar Universitário de Lisboa Norte, EPE - Hospital de Santa Maria /ID# 160741
City
Lisboa
ZIP/Postal Code
1649-035
Country
Portugal
Facility Name
Hospital Beatriz Ângelo /ID# 207758
City
Loures
ZIP/Postal Code
2674-514
Country
Portugal
Facility Name
Centro Hospitalar Universitario de Sao Joao, EPE /ID# 160742
City
Porto
ZIP/Postal Code
4200-319
Country
Portugal
Facility Name
Centro Hosp de Tondela-Viseu /ID# 160731
City
Viseu
ZIP/Postal Code
3504-509
Country
Portugal
Facility Name
Institutul Clinic Fundeni /ID# 170890
City
Sector 2
State/Province
Bucuresti
ZIP/Postal Code
022328
Country
Romania
Facility Name
Duplicate_Institutul Clinic Fundeni /ID# 170888
City
Bucharest
ZIP/Postal Code
022328
Country
Romania
Facility Name
Tvm Med Serv Srl /Id# 170891
City
Cluj
ZIP/Postal Code
400132
Country
Romania
Facility Name
Duplicate_Centrul Medical Tuculanu SRL /ID# 170892
City
Timisoara
ZIP/Postal Code
300168
Country
Romania
Facility Name
Cabinet Particular Policlinic Algomed /ID# 170889
City
Timișoara
ZIP/Postal Code
300002
Country
Romania
Facility Name
Kuzbass Regional Clinical Hospital /ID# 200707
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# 207438
City
Perm
State/Province
Permskiy Kray
ZIP/Postal Code
614990
Country
Russian Federation
Facility Name
Professor Pasechnikov Gastroenterology and Pankreatology clinic /ID# 200701
City
Stavropol
State/Province
Stavropol Skiy Kray
ZIP/Postal Code
355012
Country
Russian Federation
Facility Name
Tver Regional Clinical Hospital /ID# 206586
City
Tver
State/Province
Tverskaya Oblast
ZIP/Postal Code
170036
Country
Russian Federation
Facility Name
Regional Clinical Hospital #1 /ID# 200708
City
Tyumen
State/Province
Tyumenskaya Oblast
ZIP/Postal Code
625023
Country
Russian Federation
Facility Name
Alliance Biomedical Ural Group /ID# 200703
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# 204806
City
Moscow
ZIP/Postal Code
123423
Country
Russian Federation
Facility Name
City Clinical Hospital No. 31 /ID# 208865
City
St. Petersburg
ZIP/Postal Code
197110
Country
Russian Federation
Facility Name
Ulyanovsk Regional Clinical Hospital /ID# 200700
City
Ulyanovsk
ZIP/Postal Code
432017
Country
Russian Federation
Facility Name
Clinical Hosp Center Zvezdara /ID# 156956
City
Belgrade
State/Province
Beograd
ZIP/Postal Code
11000
Country
Serbia
Facility Name
Military Medical Academy /ID# 156963
City
Belgrade
State/Province
Beograd
ZIP/Postal Code
11000
Country
Serbia
Facility Name
University Clinical Center Serbia /ID# 156957
City
Belgrade
State/Province
Beograd
ZIP/Postal Code
11000
Country
Serbia
Facility Name
Duplicate_Clin Hosp Ctr Bezanijska Kosa /ID# 156959
City
Belgrade
State/Province
Beograd
ZIP/Postal Code
11080
Country
Serbia
Facility Name
University Clinical Center Kragujevac /ID# 156961
City
Kragujevac
State/Province
Sumadijski Okrug
ZIP/Postal Code
34000
Country
Serbia
Facility Name
Clinical Center Vojvodina /ID# 156958
City
Novi Sad
State/Province
Vojvodina
ZIP/Postal Code
21000
Country
Serbia
Facility Name
University Children's Hospital 'Tirsova' /ID# 211480
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Facility Name
Clinical Hospital Center Dr Dragisa Misovic - Dedinje /ID# 212798
City
Belgrade
ZIP/Postal Code
11040
Country
Serbia
Facility Name
National University Hospital /ID# 160662
City
Singapore
ZIP/Postal Code
119074
Country
Singapore
Facility Name
Singapore General Hospital /ID# 160663
City
Singapore
ZIP/Postal Code
169608
Country
Singapore
Facility Name
KL Ling Gastroenterology and Liver Clinic /ID# 205736
City
Singapore
ZIP/Postal Code
228510
Country
Singapore
Facility Name
Fakultna nemocnica s poliklinikou F.D. Roosevelta Banska Bystrica /ID# 156453
City
Banska Bystrica
ZIP/Postal Code
975 17
Country
Slovakia
Facility Name
Univerzitna nemocnica Martin /ID# 163205
City
Martin
ZIP/Postal Code
036 01
Country
Slovakia
Facility Name
KM Management, spol. s.r.o. /ID# 206762
City
Nitra
ZIP/Postal Code
949 01
Country
Slovakia
Facility Name
GASTRO I., s.r.o. /ID# 156455
City
Presov
ZIP/Postal Code
080 01
Country
Slovakia
Facility Name
Wits Clinical Research Site /ID# 171169
City
Johannesburg
State/Province
Gauteng
ZIP/Postal Code
2193
Country
South Africa
Facility Name
Spoke Research Inc /ID# 171172
City
CAPE TOWN Milnerton
State/Province
Western Cape
ZIP/Postal Code
7441
Country
South Africa
Facility Name
Kingsbury Hospital /ID# 171158
City
Cape Town
State/Province
Western Cape
ZIP/Postal Code
7708
Country
South Africa
Facility Name
Private Practice Dr MN Rajabally /ID# 171159
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# 157534
City
Ferrol
State/Province
A Coruna
ZIP/Postal Code
15405
Country
Spain
Facility Name
Consorci Corporacio Sanitaria Parc Tauli Sabadell /ID# 159234
City
Sabadell
State/Province
Barcelona
ZIP/Postal Code
08208
Country
Spain
Facility Name
Hospital Universitario Basurto /ID# 205188
City
Bilbao
State/Province
Vizcaya
ZIP/Postal Code
48013
Country
Spain
Facility Name
Hospital Clinic de Barcelona /ID# 157533
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Hospital General Universitario Gregorio Maranon /ID# 161144
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Facility Name
Hospital Universitario La Paz /ID# 159232
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Facility Name
Hospital Clinico Universitario de Salamanca /ID# 157539
City
Salamanca
ZIP/Postal Code
37007
Country
Spain
Facility Name
Hospital Universitario Virgen Macarena /ID# 159966
City
Sevilla
ZIP/Postal Code
41009
Country
Spain
Facility Name
Hospital Clinico Universitario de Valencia /ID# 209699
City
Valencia
ZIP/Postal Code
46010
Country
Spain
Facility Name
Hospital Universitario y Politecnico La Fe /ID# 157537
City
Valencia
ZIP/Postal Code
46026
Country
Spain
Facility Name
Hospital Universitario Miguel Servet /ID# 157538
City
Zaragoza
ZIP/Postal Code
50009
Country
Spain
Facility Name
Universitätsspital Basel /ID# 166321
City
Basel
State/Province
Basel-Stadt
ZIP/Postal Code
4031
Country
Switzerland
Facility Name
Universitätsspital Zürich /ID# 163528
City
Zürich
State/Province
Zuerich
ZIP/Postal Code
8091
Country
Switzerland
Facility Name
China Medical University Hosp /ID# 160130
City
Taichung City
ZIP/Postal Code
40447
Country
Taiwan
Facility Name
Taichung Veterans General Hosp /ID# 160134
City
Taichung
ZIP/Postal Code
407
Country
Taiwan
Facility Name
National Cheng Kung University Hospital /ID# 160129
City
Tainan City
ZIP/Postal Code
70403
Country
Taiwan
Facility Name
National Taiwan University Hospital /ID# 162189
City
Taipei City
ZIP/Postal Code
100
Country
Taiwan
Facility Name
Taipei Veterans General Hosp /ID# 212711
City
Taipei City
ZIP/Postal Code
11217
Country
Taiwan
Facility Name
Duplicate_Transcarpathian Regional Clin. /ID# 167958
City
Uzhhorod
ZIP/Postal Code
88000
Country
Ukraine
Facility Name
Kyiv Municipal Clinical Hospital #18 /ID# 162527
City
Київ
ZIP/Postal Code
01030
Country
Ukraine
Facility Name
NHS Greater Glasgow and Clyde /ID# 202314
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# 207938
City
Chertsey
State/Province
Surrey
ZIP/Postal Code
KT16 0PZ
Country
United Kingdom
Facility Name
Barnsley Hospital NHS Foundation Trust /ID# 202772
City
Barnsley
ZIP/Postal Code
S75 2EP
Country
United Kingdom
Facility Name
University Hospitals Birmingham NHS Foundation Trust /ID# 157577
City
Birmingham
ZIP/Postal Code
B15 2TH
Country
United Kingdom
Facility Name
Cambridge University Hospitals NHS Foundation Trust /ID# 158037
City
Cambridge
ZIP/Postal Code
CB2 0QQ
Country
United Kingdom
Facility Name
NHS Lothian /ID# 207446
City
Edinburgh
ZIP/Postal Code
EH3 9HE
Country
United Kingdom
Facility Name
Hull University Teaching Hospitals NHS Trust /ID# 158759
City
Hull
ZIP/Postal Code
HU3 2JZ
Country
United Kingdom
Facility Name
King's College Hospital NHS Foundation Trusts /ID# 158758
City
London
ZIP/Postal Code
SE5 9RS
Country
United Kingdom
Facility Name
The Newcastle Upon Tyne Hospitals NHS Foundation Trust /ID# 163889
City
Newcastle Upon Tyne
ZIP/Postal Code
NE7 7DN
Country
United Kingdom
Facility Name
Oxford University Hospitals NHS Foundation Trust /ID# 158039
City
Oxford
ZIP/Postal Code
OX3 9DU
Country
United Kingdom
Facility Name
Duplicate_Northern Care Alliance NHS Group /ID# 207765
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 and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
IPD Sharing Time Frame
For details on when studies are available for sharing, please refer to the link below.
IPD Sharing Access Criteria
Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Use Agreement (DUA). For more information on the process, or to submit a request, visit the following link.
IPD Sharing URL
https://vivli.org/ourmember/abbvie/
Citations:
PubMed Identifier
35644154
Citation
D'Haens G, 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, Ferrante M. Risankizumab as induction therapy for Crohn's disease: results from the phase 3 ADVANCE and MOTIVATE induction trials. Lancet. 2022 May 28;399(10340):2015-2030. doi: 10.1016/S0140-6736(22)00467-6.
Results Reference
derived
Links:
URL
https://www.rxabbvie.com
Description
Related info
Learn more about this trial
A Study to Assess the Efficacy and Safety of Risankizumab in Participants With Moderately to Severely Active Crohn's Disease Who Failed Prior Biologic Treatment
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