A Phase 3, Multicenter, Randomized, Efficacy Assessor-Blinded Study of Risankizumab Compared to Ustekinumab for the Treatment of Adult Subjects With Moderate to Severe Crohn's Disease Who Have Failed Anti-TNF Therapy

ClinicalTrials.gov processed this data on June 17, 2024. Link to the current ClinicalTrials.gov record.

Recruitment Status

ACTIVE, NOT RECRUITING (See Contacts and Locations)
Verified June 2024 by AbbVie

Sponsor

AbbVie

Information Provided by (Responsible Party)

AbbVie

Clinicaltrials.gov Identifier

NCT04524611
Other Study ID Numbers: M20-259
First Submitted: August 20, 2020
First Posted: August 24, 2020
Last Update Posted: June 18, 2024
Last Verified: June 2024
History of Changes

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Study Description

Not Provided
Condition or Disease Intervention/Treatment
  • Crohn's Disease (CD)
  • Drug: Risankizumab
  • Drug: Risankizumab
  • Drug: Ustekinumab
  • Drug: Ustekinumab

Study Design

Study TypeInterventional
Actual Enrollment527 participants
Design AllocationRandomized
Interventional ModelParallel Assignment
MaskingSingle
Primary PurposeTreatment
Official TitleA Phase 3, Multicenter, Randomized, Efficacy Assessor-Blinded Study of Risankizumab Compared to Ustekinumab for the Treatment of Adult Subjects With Moderate to Severe Crohn's Disease Who Have Failed Anti-TNF Therapy
Study Start DateSeptember 30, 2020
Anticipated Primary Completion DateFebruary 15, 2028
Anticipated Study Completion DateFebruary 15, 2028

Groups and Cohorts

Group/ CohortIntervention/ Treatment
  • Risankizumab Dose A Followed by Dose B
    • Participants will receive intravenous risankizumab dose A at Week 0, 4 ,8 followed by subcutaneous (SC) risankizumab dose B every 8 weeks through Week 48. Participants who complete the Week 48 visit will continue SC risankizumab for up to an additional 220 weeks.
  • Drug: Risankizumab
    • Intravenous (IV) Infusion
  • Ustekinumab
    • Participants will receive weight-based intravenous ustekinumab at Week 0 followed by subcutaneous ustekinumab every 8 weeks through Week 48.
  • Drug: Ustekinumab

    Outcome Measures

    Primary Outcome Measures

    1. Percentage of Participants Achieving Clinical Remission at Week 24 [Week 24]
      Clinical remission is defined as Crohn's disease activity index (CDAI)<150.
    2. Percentage of Participants Achieving Endoscopic Remission [Week 48]
      Endoscopic remission is defined as Simple Endoscopic Score for Crohn's Disease (SES-CD) <= 4 and at least a 2-point reduction versus Baseline and no sub score greater than 1 in any individual variable, as scored by a central reviewer.
    3. Number of Participants Reporting Adverse Events [Up to 220 Weeks]
      An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent adverse events/treatment-emergent serious adverse events (TEAEs/TESAEs) are defined as any event that began or worsened in severity on or after the first dose of study drug.

    Secondary Outcome Measures

    1. Percentage of Participants Achieving Clinical Remission at Week 48 [Week 48]
      Clinical remission is defined as Crohn's disease activity index (CDAI)<150.
    2. Percentage of Participants Achieving Endoscopic Response at Week 48 [Week 48]
      Endoscopic response is defined as decrease in Simple Endoscopic Score for Crohn's Disease (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).
    3. Percentage of Participants Achieving Endoscopic Response at Week 24 [Week 24]
      Endoscopic response is defined as decrease in Simple Endoscopic Score for Crohn's Disease (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).
    4. Percentage of Participants Achieving Steroid-Free Endoscopic Remission [Week 48]
      Steroid-free endoscopic remission is defined as participants with endoscopic remission and not receiving steroids at Week 48.
    5. Percentage of Participants Achieving Steroid-Free Clinical Remission [Week 48]
      Steroid-free clinical remission is defined as participants with clinical remission and not receiving steroids at Week 48.

    Eligibility Criteria

    Ages Eligible for Study 18 Years to 80 Years (Adult, Older Adult)
    Sexes Eligible for Study All
    Accepts Healthy Volunteers No
    Inclusion Criteria
    • Confirmed diagnosis of Crohn's disease (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 Crohn's Disease as assessed by stool frequency (SF), abdominal pain (AP) score, and Simple Endoscopic score for CD (SES-CD).
    • Demonstrated intolerance or inadequate response to one or more anti-tumor necrosis factor (TNF) therapies.
    Exclusion Criteria
    • Current diagnosis of ulcerative colitis or indeterminate colitis.
    • Receipt of CD approved biologic agents prior to Baseline (as detailed in protocol), or any investigational biologic or other agent or procedure prior to Baseline (as detailed in protocol).
    • Prior exposure to p19 and/or p40 inhibitors (e.g., risankizumab and ustekinumab).
    • Currently know complications of CD (strictures, short bowel, etc).

    Contacts and Locations

    Sponsors and Collaborators AbbVie
    Locations
    • Advanced Gastroenterology, P.C /ID# 224396 | Chandler, Arizona, United States, 85224-1636
    • Southern California Res. Ctr. /ID# 223484 | Coronado, California, United States, 92118-1408
    • Hoag Memorial Hosp Presbyterian /ID# 224373 | Irvine, California, United States, 92618
    • United Medical Doctors /ID# 223486 | Los Alamitos, California, United States, 90720-3309
    • TLC Clinical Research Inc /ID# 223467 | Los Angeles, California, United States, 90048
    • Duplicate_UC Davis Medical Center /ID# 225700 | Sacramento, California, United States, 95817
    • Duplicate_University of California, San Francisco /ID# 223621 | San Francisco, California, United States, 94158
    • Duplicate_Western Connecticut Medical Group /ID# 223478 | Danbury, Connecticut, United States, 06810
    • Duplicate_Medical Research Center of CT /ID# 223540 | Hamden, Connecticut, United States, 06518
    • Yale Univ Digestive Diseases /ID# 224463 | New Haven, Connecticut, United States, 06510
    • Omega Research Maitland, LLC /ID# 223463 | DeBary, Florida, United States, 32713-2260
    • Nature Coast Clinical Research - Inverness /ID# 223600 | Inverness, Florida, United States, 34452-4717
    • University of Miami /ID# 223496 | Miami, Florida, United States, 33136
    • Gastroenterology Group Naples /ID# 223516 | Naples, Florida, United States, 34102
    • Advanced Research Institute, Inc /ID# 223470 | New Port Richey, Florida, United States, 34653
    • Endoscopic Research, Inc. /ID# 223505 | Orlando, Florida, United States, 32803
    • Duplicate_University of South Florida /ID# 224733 | Tampa, Florida, United States, 33612
    • Atlanta Gastro Assoc /ID# 223537 | Atlanta, Georgia, United States, 30342
    • Gastroenterology Associates of Central Georgia, LLC /ID# 223525 | Macon, Georgia, United States, 31201
    • The University of Chicago DCAM /ID# 223520 | Chicago, Illinois, United States, 60637
    • NorthShore University HealthSystem /ID# 223538 | Evanston, Illinois, United States, 60201
    • Southwest Gastroenterology /ID# 223509 | Oak Lawn, Illinois, United States, 60453
    • University of Louisville Hospital /ID# 223471 | Louisville, Kentucky, United States, 40202
    • GI Alliance /ID# 223508 | Baton Rouge, Louisiana, United States, 70809
    • Nola Research Works, LLC /ID# 223489 | New Orleans, Louisiana, United States, 70115
    • Louisiana Research Center, LLC /ID# 223503 | Shreveport, Louisiana, United States, 71105-6800
    • Duplicate_MGG Group Co, Inc.Chevy Chase Clinical Research /ID# 223499 | Chevy Chase, Maryland, United States, 20815
    • Gastro Center of Maryland /ID# 223518 | Columbia, Maryland, United States, 21045
    • Massachusetts General Hospital /Id# 224335 | Boston, Massachusetts, United States, 02114
    • Beth Israel Deaconess Medical Center /ID# 228094 | Boston, Massachusetts, United States, 02215-5400
    • University of Michigan Comprehensive Cancer Center Michigan Medicine /ID# 223597 | Ann Arbor, Michigan, United States, 48109
    • AA Medical Research Center - Flint /ID# 224384 | Flint, Michigan, United States, 48504
    • Gastroenterology Associates of Western Michigan, PLC d.b.a. West Michigan Clinic /ID# 223465 | Wyoming, Michigan, United States, 49519
    • Mayo Clinic - Rochester /ID# 223506 | Rochester, Minnesota, United States, 55905-0001
    • Las Vegas Medical Research /ID# 223533 | Las Vegas, Nevada, United States, 89113
    • Univ New Mexico /ID# 223515 | Albuquerque, New Mexico, United States, 87131
    • NY Scientific /ID# 223479 | Brooklyn, New York, United States, 11235
    • Saratoga Schenectady Gastroenterology Associates - Burnt Hills /ID# 224048 | Burnt Hills, New York, United States, 12027
    • Intercity Advanced Gastroentertology Center /ID# 224313 | Fresh Meadows, New York, United States, 11366
    • North Shore University Hospital /ID# 224356 | New Hyde Park, New York, United States, 11040
    • The Mount Sinai Hospital /ID# 223687 | New York, New York, United States, 10029
    • Columbia Univ Medical Center /ID# 224215 | New York, New York, United States, 10032-3725
    • Lenox Hill Hospital /ID# 223534 | New York, New York, United States, 10075
    • Univ NC Chapel Hill /ID# 224405 | Chapel Hill, North Carolina, United States, 27514-4220
    • Atrium Health Wake Forest Baptist Medical Center /ID# 224406 | Winston-Salem, North Carolina, United States, 27157-0001
    • Plains Clinical Research Center, LLC /ID# 223522 | Fargo, North Dakota, United States, 58104-5925
    • University of Cincinnati Medical Center /ID# 224614 | Cincinnati, Ohio, United States, 45219-2364
    • Cleveland Clinic Main Campus /ID# 223691 | Cleveland, Ohio, United States, 44195
    • DSI Research, LLC /ID# 234116 | Springboro, Ohio, United States, 45066-1615
    • Hightower Clinical /ID# 223566 | Oklahoma City, Oklahoma, United States, 73102
    • Digestive Disease Specialists /ID# 223528 | Oklahoma City, Oklahoma, United States, 73112
    • Penn State Milton S. Hershey Medical Center /ID# 224216 | Hershey, Pennsylvania, United States, 17033-2360
    • Guthrie Medical Group, PC /ID# 223910 | Sayre, Pennsylvania, United States, 18840
    • Digestive Disease Associates, LTD /ID# 223462 | Wyomissing, Pennsylvania, United States, 19610-2002
    • Medical University of South Carolina /ID# 223485 | Charleston, South Carolina, United States, 29425
    • Consultants in Gastroenterology - Columbia NE /ID# 224263 | Columbia, South Carolina, United States, 29203-8902
    • Gastroenterology Associates, P.A. of Greenville /ID# 223497 | Greenville, South Carolina, United States, 29607
    • Gastro One /ID# 223539 | Cordova, Tennessee, United States, 38018
    • Vanderbilt University Medical Center /ID# 224610 | Nashville, Tennessee, United States, 37232-0011
    • Baylor Scott & White Center for Inflammatory Bowel Diseases /ID# 223512 | Dallas, Texas, United States, 75246
    • Duplicate_DHAT Research Institute /ID# 223521 | Garland, Texas, United States, 75044-2208
    • Vilo Research Group Inc /ID# 223513 | Houston, Texas, United States, 77017-2337
    • Duplicate_Baylor College of Medicine - Baylor Medical Center /ID# 223488 | Houston, Texas, United States, 77030-3411
    • Clinical Associates in Research Therapeutics of America, LLC /ID# 223510 | San Antonio, Texas, United States, 78212
    • Southern Star Research Institute, LLC /ID# 223598 | San Antonio, Texas, United States, 78229-5390
    • Texas Digestive Disease Consultants - Southlake /ID# 224264 | Southlake, Texas, United States, 76092
    • Tyler Research Institute, LLC /ID# 223469 | Tyler, Texas, United States, 75701
    • University of Vermont Medical Center /ID# 224047 | Burlington, Vermont, United States, 05401-1473
    • Richmond VA Medical Center /ID# 223586 | Richmond, Virginia, United States, 23249
    • Virginia Mason Hospital & Medical Center /ID# 224253 | Seattle, Washington, United States, 98101
    • Harborview Medical Center /ID# 224464 | Seattle, Washington, United States, 98104-2420
    • West Virginia University Hospitals /ID# 223501 | Morgantown, West Virginia, United States, 26506
    • Hospital Italiano de Buenos Aires /ID# 224550 | Ciudad Autonoma Buenos Aires, Ciudad Autonoma De Buenos Aires, Argentina, 1199
    • CINME Centro de Investigaciones Metabolicas /ID# 223447 | Ciudad Autonoma de Buenos Aire, Ciudad Autonoma De Buenos Aires, Argentina, 1027
    • Gedyt /ID# 224698 | Ciudad Autonoma de Buenos Aire, Ciudad Autonoma De Buenos Aires, Argentina, 1115
    • Hospital Britanico de Buenos Aires /ID# 223432 | Ciudad Autonoma de Buenos Aire, Ciudad Autonoma De Buenos Aires, Argentina, 1280
    • Cemic /Id# 223670 | Ciudad Autonoma de Buenos Aire, Ciudad Autonoma De Buenos Aires, Argentina, 1431
    • Duplicate_Sanatorio 9 de Julio /ID# 226086 | San Miguel de Tucuman, Tucuman, Argentina, 4000
    • Hospital Privado Universitario - Hospital Privado Centro Medico de Cordoba S.A. /ID# 223433 | Cordoba, Argentina, 5016
    • Wollongong Hospital /ID# 224688 | Wollongong, New South Wales, Australia, 2500
    • Mater Misericordiae Limited /ID# 223642 | South Brisbane, Queensland, Australia, 4101
    • Griffith University /ID# 223641 | Southport, Queensland, Australia, 4222
    • Lyell McEwin Hospital /ID# 223643 | Elizabeth Vale, South Australia, Australia, 5112
    • Monash Medical Centre /ID# 224599 | Clayton, Victoria, Australia, 3168
    • Universitaetsklinikum St. Poelten /ID# 223437 | Sankt Poelten, Niederoesterreich, Austria, 3100
    • Ordensklinikum Linz GmbH Barmherzige Schwestern /ID# 223440 | Linz, Oberoesterreich, Austria, 4010
    • Medizinische Universitaet Wien /ID# 223438 | Vienna, Wien, Austria, 1090
    • Universite Libre de Bruxelles - Hopital Erasme /ID# 223902 | Anderlecht, Bruxelles-Capitale, Belgium, 1070
    • Cliniques Universitaires UCL Saint-Luc /ID# 223900 | Woluwe-Saint-Lambert, Bruxelles-Capitale, Belgium, 1200
    • Duplicate_CHU UCL Namur - site Godinne /ID# 223905 | Godinne, Namur, Belgium, 5530
    • UZ Gent /ID# 223899 | Gent, Oost-Vlaanderen, Belgium, 9000
    • Vitaz /Id# 224511 | Sint-Niklaas, Oost-Vlaanderen, Belgium, 9100
    • Universitair Ziekenhuis Leuven /ID# 223901 | Leuven, Vlaams-Brabant, Belgium, 3000
    • AZ-Delta /ID# 223896 | Roeselare, West-Vlaanderen, Belgium, 8800
    • AZ Maria Middelares /ID# 223908 | Gent, Belgium, 9000
    • CHU de Liege /ID# 223904 | Liege, Belgium, 4000
    • Groupe Sante CHC - Clinique du MontLegia /ID# 223898 | Liege, Belgium, 4000
    • ZNA - Jan Palfijn /ID# 223907 | Merksem, Belgium, 2170
    • Faculdade de Medicina do ABC /ID# 223231 | Santo André, La Spezia, Brazil, 09060-870
    • Upeclin Fmb - Unesp /Id# 223234 | Botucatu, Sao Paulo, Brazil, 18618-686
    • Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto /ID# 223233 | Ribeirão Preto, Sao Paulo, Brazil, 14049-900
    • Kaiser Clinica e Hospital Dia /ID# 223232 | Sao Jose Do Rio Preto, Sao Paulo, Brazil, 15015-110
    • Hospital Tsaritsa Yoanna /ID# 223822 | Sofiya, Sofia, Bulgaria, 1527
    • UMHAT Kaspela EOOD /ID# 223415 | Plovdiv, Bulgaria, 4001
    • 2nd Mhat /ID# 223425 | Sofia, Bulgaria, 1202
    • Acibadem City Clinic Tokuda University Hospital EAD /ID# 223757 | Sofia, Bulgaria, 1407
    • University of Calgary /ID# 223750 | Calgary, Alberta, Canada, T2N 4Z6
    • Allen Whey Khye Lim Professional Corporation /ID# 223755 | Edmonton, Alberta, Canada, T5R 1W2
    • Covenant Health /ID# 223753 | Edmonton, Alberta, Canada, T6K 4B2
    • Fraser Clinical Trials Inc /ID# 223742 | New Westminster, British Columbia, Canada, V3L 3W4
    • Percuro Clinical Research, Ltd /ID# 223747 | Victoria, British Columbia, Canada, V8V 3M9
    • QEII - Health Sciences Centre /ID# 223748 | Halifax, Nova Scotia, Canada, B3H 2Y9
    • London Health Sciences Center- University Hospital /ID# 223741 | London, Ontario, Canada, N6A 5W9
    • Scott Shulman Medicine Professional Corporation /ID# 223754 | North Bay, Ontario, Canada, P1B 2H3
    • Mount Sinai Hospital /ID# 223752 | Toronto, Ontario, Canada, M5G 1X5
    • Axler, Toronto, ON. Canada /ID# 223740 | Toronto, Ontario, Canada, M9V 0A9
    • CISSS de la Monteregie /ID# 224399 | Greenfield Park, Quebec, Canada, J4V 2H1
    • CSSS Alphonse-Desjardins, CHAU de Levis /ID# 223744 | Levis, Quebec, Canada, G6V 3Z1
    • CHUS - Hopital Fleurimont /ID# 224819 | Sherbrooke, Quebec, Canada, J1H 5N4
    • Montreal General Hospital- McGill University Health Center /ID# 223743 | Montreal, Canada, H3G 1A4
    • Sociedad de Servicios Medicos Walsen Galmez /ID# 224032 | Santiago, Region Metropolitana De Santiago, Chile, 7500010
    • Hospital Guillermo Grant Benavente de Concepción /ID# 223668 | Concepción, Chile, 4070038
    • Hospital Las Higueras /ID# 223669 | Talcahuano, Chile, 1740000
    • Anhui Provincial Hospital /ID# 224832 | Hefei, Anhui, China, 230001
    • Peking University Third Hospital /ID# 224479 | Beijing, Beijing, China, 100191
    • Chongqing General Hospital /ID# 232305 | Chongqing, Chongqing, China, 400013
    • Zhongshan Hospital Xiamen University /ID# 224663 | Xiamen, Fujian, China, 361004
    • Zhujiang Hospital of Southern Medical University /ID# 224524 | Guangzhou, Guangdong, China, 510280
    • The Sixth Affiliated Hosp Sun /ID# 224416 | Guangzhou, Guangdong, China, 510655
    • The Second Affiliated Hospital of Zhengzhou University /ID# 224528 | Zhengzhou, Henan, China, 450014
    • Union Hospital Tongji Medical College Huazhong University of Science and Technol /ID# 224545 | Wuhan, Hubei, China, 430022
    • Tongji Hospital Tongji Medical College of HUST /ID# 224428 | Wuhan, Hubei, China, 430030
    • Renmin Hospital of Wuhan University /ID# 224525 | Wuhan, Hubei, China, 430060
    • Duplicate_The Third Xiangya Hospital of Central South University /ID# 224754 | Changsha, Hunan, China, 410013
    • Changzhou No.2 People's Hospital /ID# 238965 | Changzhou, Jiangsu, China, 213000
    • Nanjing Drum Tower Hospital /ID# 224746 | Nanjing, Jiangsu, China, 210008
    • Wuxi People's Hospital /ID# 224426 | Wuxi, Jiangsu, China, 214023
    • The First Affiliated Hospital of Nanchang University /ID# 224507 | Nanchang, Jiangxi, China, 330006
    • Shengjing Hospital of China Medical University /ID# 224478 | Shenyang, Liaoning, China, 110022
    • Renji Hospital, Shanghai Jiaotong University School of Medicine /ID# 224420 | Shanghai, Shanghai, China, 200127
    • West China Hospital, Sichuan University /ID# 224786 | Chengdu, Sichuan, China, 610041
    • The second affiliated hospital of Zhejiang University school of medicine /ID# 224662 | Hangzhou, Zhejiang, China, 310009
    • Sir Run Run Shaw Hospital of Zhejiang University School of Medicine /ID# 224421 | Hangzhou, Zhejiang, China, 310018
    • The Second Xiangya Hospital of Central South University /ID# 224684 | Changsha, China, 410011
    • Iscare Klinické Centrum /ID# 223279 | Prague, Praha 9, Czechia, 190 00
    • Nemocnice Ceske Budejovice a.s. /ID# 224219 | Ceske Budejovice, Czechia, 370 01
    • Hepato-Gastroenterologie HK, s.r.o. /ID# 223277 | Hradec Kralove, Czechia, 500 12
    • Nemocnice Pardubickeho kraje, a.s. /ID# 223256 | Pardubice, Czechia, 530 03
    • Axon Clinical, s.r.o. /ID# 223260 | Praha, Czechia, 140 00
    • Nemocnice Horovice - NH Hospital a.s /ID# 223276 | Praha, Czechia, 155 00
    • Chu de Nice-Hopital Larchet Ii /Id# 223763 | Nice, Alpes-Maritimes, France, 06200
    • CHU Clermont-Ferrand /ID# 224529 | Clermont, Auvergne-Rhone-Alpes, France, 63100
    • APHM - Hopital Nord /ID# 223869 | Marseille, Bouches-du-Rhone, France, 13015
    • Duplicate_CHU Bordeaux - Hopital Haut Leveque /ID# 223764 | Pessac, Gironde, France, 33604
    • CHU Montpellier - Hopital Saint Eloi /ID# 223860 | Montpellier Cedex 5, Herault, France, 34295
    • Hopital Beaujon /ID# 223863 | Clichy, Ile-de-France, France, 92110
    • Centre Medico Chirurgical Ambroise Pare Hartmann /ID# 249859 | Neuilly Sur Seine, Ile-de-France, France, 92200
    • Duplicate_CHU Grenoble - Hopital Michallon /ID# 224091 | La Tronche, Isere, France, 38700
    • CHU Reims - Hôpital Robert Debre /ID# 224530 | Reims CEDEX, Marne, France, 51092
    • CHRU Nancy - Hopitaux de Brabois /ID# 223767 | Vandoeuvre-les-Nancy, Meurthe-et-Moselle, France, 54500
    • CHRU Lille - Hopital Claude Huriez /ID# 223765 | Lille, Nord, France, 59037
    • CHU de Nantes, Hotel Dieu -HME /ID# 241098 | Nantes, Pays-de-la-Loire, France, 44000
    • Clinique Jules Verne /ID# 223870 | Nantes, France, 44300
    • Polyclinique Grand Sud /ID# 224092 | Nimes Cedex, France, 30932
    • Centre Hospitalier Universitaire de Saint Étienne - Hôpital Nord /ID# 223768 | St-Priest-en-Jarez, France, 42270
    • Hopital Universitaire Purpan Hopital Rangueil /ID# 224732 | Toulouse, France, 31059
    • Universitaetsklinikum Freiburg /ID# 223406 | Freiburg, Baden-Wuerttemberg, Germany, 79106
    • Universitatsklinikum Mannheim /ID# 223410 | Mannheim, Baden-Wuerttemberg, Germany, 68167
    • Universitaetsklinikum Ulm /ID# 223400 | Ulm, Baden-Wuerttemberg, Germany, 89081
    • Universitaetsklinikum Erlangen /ID# 223404 | Erlangen, Bayern, Germany, 91054
    • Universitatsklinik Regensburg /ID# 223407 | Ratisbon, Bayern, Germany, 93053
    • Duplicate_Agaplesion Markus Krankenhaus /ID# 223673 | Frankfurt am Main, Hessen, Germany, 60431
    • Universitaetsklinikum Frankfurt /ID# 223396 | Frankfurt am Main, Hessen, Germany, 60590
    • Praxiszentrum fuer Gastroenterologie /ID# 223409 | Grevenbroich, Nordrhein-Westfalen, Germany, 41515
    • Zentrum für Gastroenterologie Saar MVZ GmbH /ID# 223482 | Saarbrücken, Saarland, Germany, 66111
    • Eugastro /ID# 223401 | Leipzig, Sachsen, Germany, 04103
    • Universitaetsklinikum Schleswig-Holstein Campus Kiel /ID# 223395 | Kiel, Schleswig-Holstein, Germany, 24105
    • Krankenhaus Waldfriede /ID# 223397 | Berlin-Zehlendorf, Germany, 14163
    • Duplicate_Charite Universitaetsmedizin Berlin - Campus Mitte /ID# 223405 | Berlin, Germany, 10117
    • Praxis Dr. Michael Mross /ID# 229110 | Berlin, Germany, 10318
    • MVZ fuer Gastroenterlogie am Bayerischen Platz /ID# 223411 | Berlin, Germany, 10825
    • DRK Kliniken Berlin Westend /ID# 223412 | Berlin, Germany, 14050
    • Universitaetsklinikum Carl Gustav Carus an der TU Dresden /ID# 223403 | Dresden, Germany, 01307
    • Medizinische Hochschule Hannover /ID# 223402 | Hannover, Germany, 30625
    • Klinikum Lueneburg /ID# 223408 | Lueneburg, Germany, 21339
    • Otto-von-Guericke-Universitaet /ID# 223413 | Magdeburg, Germany, 39120
    • Medizinisches Versorgungszentrum Portal 10 /ID# 224552 | Muenster, Germany, 48155
    • General Hospital of Athens Ippokratio /ID# 223344 | Athens, Attiki, Greece, 11527
    • General Hospital of Chest Diseases of Athens SOTIRIA /ID# 223342 | Athens, Attiki, Greece, 11527
    • University General Hospital of Heraklion PA.G.N.I /ID# 223336 | Heraklion, Kriti, Greece, 71500
    • General Hospital of Athens Evaggelismos and Ophthalmiatrio of Athens Polyclinic /ID# 223338 | Athens, Greece, 10676
    • University General Hospital of Ioannina /ID# 223339 | Ioannina, Greece, 45500
    • General Hospital of Nikaia-Piraeus "Agios Panteleimon" /ID# 223340 | Nikaia, Greece, 18454
    • General Hospital of Thessaloniki Hippokrateio /ID# 223887 | Thessaloniki, Greece, 54642
    • Duplicate_Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont /ID# 223774 | Szeged, Csongrad, Hungary, 6725
    • Duplicate_Debreceni Egyetem Klinikai Kozpont /ID# 223773 | Debrecen, Hajdu-Bihar, Hungary, 4032
    • Duplicate_Clinfan Szolgaltato Kft. /ID# 224751 | Szekszard, Tolna, Hungary, 7100
    • Clinexpert Kft /ID# 223775 | Budapest, Hungary, 1033
    • Semmelweis Egyetem /ID# 223772 | Budapest, Hungary, 1085
    • The Edith Wolfson Medical Center /ID# 227652 | Ashkelon, HaDarom, Israel, 5822000
    • Soroka University Medical Center /ID# 223556 | Be'er Sheva, HaDarom, Israel, 8410101
    • Yitzhak Shamir Medical Center /ID# 224686 | Zerifin, HaMerkaz, Israel, 70300
    • The Chaim Sheba Medical Center /ID# 223557 | Ramat Gan, Tel-Aviv, Israel, 5265601
    • Tel Aviv Sourasky Medical Center /ID# 223551 | Tel Aviv, Tel-Aviv, Israel, 6423906
    • Shaare Zedek Medical Center /ID# 223549 | Jerusalem, Yerushalayim, Israel, 91031
    • Rabin Medical Center /ID# 223558 | Haifa, Israel, 4941492
    • Ospedale Policlinico San Martino /ID# 223329 | Genoa, Genova, Italy, 16132
    • Ospedale San Raffaele IRCCS /ID# 241167 | Milan, Milano, Italy, 20132
    • ASST Rhodense/Presidio Ospedaliero di Rho /ID# 223335 | Rho, Milano, Italy, 20017
    • Azienda Ospedaliera Universitaria Policlinico Tor Vergata /ID# 223332 | Rome, Roma, Italy, 00133
    • Azienda Ospedaliera San Camillo Forlanini /ID# 223325 | Rome, Roma, Italy, 00152
    • Policlinico Agostino Gemelli /ID# 223323 | Rome, Roma, Italy, 00168
    • IRCCS Ospedale Sacro Cuore Don Calabria /ID# 223327 | Negrar, Verona, Italy, 37024
    • IRCCS Azienda Ospedaliero-Universitaria di Bologna /ID# 223330 | Bologna, Italy, 40138
    • Azienda Ospedaliera G. Brotzu /ID# 241165 | Cagliari, Italy, 09121
    • Azienda Ospedaliero Universitaria di Cagliari- Presidio Ospedaliero /ID# 223474 | Cagliari, Italy, 09124
    • ASST Fatebenefratelli Sacco-Ospedale Sacco /ID# 223322 | Milano, Italy, 20157
    • Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico /ID# 223324 | Milan, Italy, 20122
    • A.O. Ospedali Riuniti Villa Sofia - Cervello /ID# 223333 | Palermo, Italy, 90146
    • Duplicate_The Catholic University of Korea, Daejeon St.Mary's Hospital /ID# 223456 | 중구, Daejeon Gwang Yeogsi, Korea, Republic of, 34943
    • Duplicate_Dong-A University Hospital /ID# 223455 | 서구, Gyeongsangnamdo, Korea, Republic of, 49201
    • Duplicate_Kangbuk Samsung Hospital /ID# 223452 | Seoul, Seoul Teugbyeolsi, Korea, Republic of, 03181
    • Samsung Medical Center /ID# 223453 | Seoul, Korea, Republic of, 06351
    • Centro de Investigacion en Artritis y Osteoporosis S.C. /ID# 227179 | Mexicali, Baja California, Mexico, 21200
    • BRCR Global Mexico /ID# 223970 | Guadalajara, Jalisco, Mexico, 44600
    • Centro Medico Zambrano Hellion /ID# 224025 | San Pedro Garza Garcia, Nuevo Leon, Mexico, 66278
    • Medical Care & Research SA de CV /ID# 223974 | Mérida, Yucatan, Mexico, 97070
    • Faicic S de Rl de Cv /Id# 226990 | Veracruz, Mexico, 91900
    • Radboud Universitair Medisch Centrum /ID# 233750 | Nijmegen, Gelderland, Netherlands, 6525 GA
    • Amsterdam UMC, locatie AMC /ID# 223228 | Amsterdam, Noord-Holland, Netherlands, 1105 AZ
    • Elisabeth Tweesteden Ziekenhuis /ID# 223229 | Tilburg, Netherlands, 5022 GC
    • Universitair Medisch Centrum Utrecht /ID# 223696 | Utrecht, Netherlands, 3584 CX
    • Gastromed Sp. z o.o /ID# 223705 | Torun, Kujawsko-pomorskie, Poland, 87-100
    • Malopolskie Centrum Kliniczne /ID# 223708 | Krakow, Malopolskie, Poland, 30-149
    • NZOZ Vivamed Jadwiga Miecz /ID# 223706 | Warszawa, Mazowieckie, Poland, 03-580
    • Duplicate_Institutul Clinic Fundeni /ID# 223914 | Bucharest, Bucuresti, Romania, 022328
    • Sana Monitoring /Id# 223682 | Bucharest, Romania, 011025
    • Spitalul Clinic Colentina /ID# 223680 | Bucuresti, Romania, 020121
    • Univ Emergency Hosp Bucharest /ID# 223579 | Bucuresti, Romania, 050098
    • Spitalul Clinic Judetean de Urgenta Targu Mures /ID# 224017 | Targu Mures, Romania, 540136
    • Targu Mures Emergency Clinical County Hospital /ID# 223613 | Targu Mures, Romania, 540136
    • Cabinet Particular Policlinic Algomed /ID# 223578 | Timișoara, Romania, 300002
    • Immanuel Kant Baltic Federal University /ID# 224224 | Kaliningrad, Kaliningradskaya Oblast, Russian Federation, 236016
    • National Medical Research Center of Coloproctology n.a. A. N. Ryzhikh /ID# 224222 | Moscow, Russian Federation, 123423
    • City Clinical Hospital No. 31 /ID# 224223 | St. Petersburg, Russian Federation, 197110
    • KM Management, spol. s.r.o. /ID# 223304 | Nitra, Nitriansky Kraj, Slovakia, 949 01
    • Duplicate_GASTRO I., s.r.o. /ID# 223303 | Presov, Presovsky Kraj, Slovakia, 080 01
    • Fakultna nemocnica s poliklinikou F.D. Roosevelta Banska Bystrica /ID# 223302 | Banska Bystrica, Slovakia, 975 17
    • Fakultna nemocnica s poliklinikou Nove Zamky /ID# 224580 | Nove Zamky, Slovakia, 940 34
    • Lenasia Clinical Trial Centre /ID# 224306 | Johannesburg, Gauteng, South Africa, 1820
    • Spoke Research Inc /ID# 223803 | CAPE TOWN Milnerton, Western Cape, South Africa, 7441
    • Dr MJ Prins /ID# 224304 | Cape Town, Western Cape, South Africa, 7500
    • Private Practice Dr MN Rajabally /ID# 223805 | Cape Town, Western Cape, South Africa, 7800
    • Hospital Arquitecto Marcide - Complejo Hospitalario Universitario de Ferrol /ID# 223356 | Ferrol, A Coruna, Spain, 15405
    • Hospital Clínico Universitario de Santiago-CHUS /ID# 226554 | Santiago de Compostela, A Coruna, Spain, 15706
    • Hospital Universitario Central de Asturias /ID# 223368 | Oviedo, Asturias, Spain, 33011
    • Hospital Universitario Germans Trias i Pujol /ID# 223436 | Badalona, Barcelona, Spain, 08916
    • Duplicate_Hospital Universitario de Bellvitge /ID# 225719 | L'Hospitalet de Llobregat, Barcelona, Spain, 08907
    • Hospital Universitario de Fuenlabrada /ID# 223371 | Fuenlabrada, Madrid, Spain, 28942
    • Hospital Universitario Puerta de Hierro - Majadahonda /ID# 223319 | Majadahonda, Madrid, Spain, 28222
    • Hospital General Universitario de Alicante Doctor Balmis /ID# 223552 | Alicante, Spain, 03010
    • Hospital Clinic de Barcelona /ID# 223355 | Barcelona, Spain, 08036
    • Hospital General Universitario Gregorio Maranon /ID# 223317 | Madrid, Spain, 28007
    • Hospital Clinico Universitario San Carlos /ID# 223367 | Madrid, Spain, 28040
    • Hospital Universitario La Paz /ID# 223318 | Madrid, Spain, 28046
    • Hospital Universitario Virgen Macarena /ID# 223315 | Sevilla, Spain, 41009
    • Hospital Universitario Virgen del Rocio /ID# 223476 | Sevilla, Spain, 41013
    • Hospital Clinico Universitario de Valencia /ID# 223321 | Valencia, Spain, 46010
    • Hospital Universitario y Politecnico La Fe /ID# 223314 | Valencia, Spain, 46026
    • Karolinska University Hospital Solna /ID# 223423 | Solna, Stockholms Lan, Sweden, 171 64
    • GHP Stockholm Gastro Center /ID# 223420 | Stockholm, Stockholms Lan, Sweden, 114 28
    • Duplicate_Falu Lasarett /ID# 227222 | Falun, Sweden, 791 31
    • Danderyds sjukhus AB /ID# 223363 | Stockholm, Sweden, 182 88
    • Universitätsspital Basel /ID# 223711 | Basel Town, Basel-Stadt, Switzerland, 4031
    • Duplicate_Universitatsspital Zurich /ID# 223712 | Zurich, Zuerich, Switzerland, 8091
    • Inselspital, Universitaetsspital Bern /ID# 223590 | Bern, Switzerland, 3010
    • Gazi Universitesi Tip Fakultes /ID# 223386 | Yenimahalle, Ankara, Turkey, 06560
    • Ankara Univ Medical Faculty /ID# 223388 | Ankara, Turkey, 06590
    • Istanbul University-Cerrahpasa, Cerrahpasa Medical Faculty /ID# 223387 | Istanbul, Turkey, 34098
    • Mersin University Medical /ID# 223385 | Mersin, Turkey, 33343
    • Kyiv City Clinical Hospital No.18 /ID# 223700 | Kyiv, Ukraine, 01030
    • Lviv Regional Clinical Hospital /ID# 223661 | Lviv, Ukraine, 79010
    • Medical Center of LLC DIASERVIS /ID# 224249 | Zaporizhzhia, Ukraine, 69076
    • Addenbrooke's Hospital /ID# 223648 | Cambridge, Cambridgeshire, United Kingdom, CB2 2QQ
    • Royal Devon & Exeter Hospital /ID# 223644 | Exeter, Devon, United Kingdom, EX2 5DW
    • University Hospital Southampton NHS Foundation Trust /ID# 224351 | Southampton, Hampshire, United Kingdom, SO16 6YD
    • East and North Hertfordshire NHS Trust /ID# 224607 | Stevenage, Hertfordshire, United Kingdom, SG1 4AB
    • Barts Health NHS Trust /ID# 223651 | London, London, City Of, United Kingdom, E1 2ES
    • Guys and St Thomas NHS Foundation Trust /ID# 223647 | London, London, City Of, United Kingdom, SE1 9RT
    • Duplicate_Nottingham University Hospitals NHS Trust /ID# 224179 | Nottingham, Nottinghamshire, United Kingdom, NG5 1PB
    • Oxford University Hospitals NHS Foundation Trust /ID# 223645 | Oxford, Oxfordshire, United Kingdom, OX3 9DU
    • NHS Greater Glasgow and Clyde /ID# 223653 | Glasgow, Scotland, United Kingdom, G12 0XH
    • Belfast Health and Social Care Trust /ID# 224023 | Belfast, United Kingdom, BT9 7AB
    • NHS Lothian /ID# 223646 | Edinburgh, United Kingdom, EH3 9HE
    • Calderdale and Huddersfield NHS Foundation Trust /ID# 223654 | Huddersfield, United Kingdom, HX3 0PW
    • King's College Hospital NHS Foundation Trust /ID# 223649 | London, United Kingdom, SE5 9RS
    • The Newcastle Upon Tyne Hospitals NHS Foundation Trust /ID# 223655 | Newcastle upon Tyne, United Kingdom, NE3 3HD
    • Northern Care Alliance NHS Group /ID# 223650 | Salford, United Kingdom, M6 8HD
    • NHS Forth Valley /ID# 224657 | Stirling, United Kingdom, FK9 4SW
    • St George's University Hospitals NHS Foundation Trust /ID# 223656 | Tooting, United Kingdom, SW17 0QT
    Investigators

      More Information

      Additional Information

      Additional Relevant MeSH Terms

      • Crohn Disease
      • Inflammatory Bowel Diseases
      • Gastroenteritis
      • Gastrointestinal Diseases
      • Digestive System Diseases
      • Intestinal Diseases