En studie av Guselkumab subkutan terapi hos deltakere med moderat til alvorlig aktiv Crohns sykdom (GRAVITI)
24. september 2026 oppdatert av: Janssen Research & Development, LLC
En randomisert, dobbeltblind, placebokontrollert, parallellgruppe, multisenterstudie for å evaluere effektiviteten og sikkerheten til Guselkumab subkutan induksjonsterapi hos deltakere med moderat til alvorlig aktiv Crohns sykdom
The purpose of this study is to evaluate the efficacy and safety of guselkumab in participants with Crohn's disease.
Studieoversikt
Status
Aktiv, ikke rekrutterende
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Faktiske)
350
Fase
- Fase 3
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Clayton, Australia, 3168
- Monash Health, Monash Medical Centre
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North Mackay, Australia, 4740
- Coral Sea Clinical Research Institute
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Aalst, Belgia, 9300
- OLV Ziekenhuis Aalst
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Brussels, Belgia, 1070
- Hopital Erasme
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Brussels, Belgia, 1000
- CHU Saint-Pierre
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Ghent, Belgia, 9000
- Universitair Ziekenhuis Gent
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Roeselare, Belgia, 8800
- Algemeen Ziekenhuis Delta
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Banja Luka, Bosnia og Herzegovina, 78000
- University hospital Clinical centre Banja Luka
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Sarajevo, Bosnia og Herzegovina, 71000
- Clinical Center University of Sarajevo
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Sarajevo, Bosnia og Herzegovina, 71000
- Polyclinic Dr. Al-Tawil
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Tešanj, Bosnia og Herzegovina, 74260
- General Hospital Tesanj
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Tuzla, Bosnia og Herzegovina, 75000
- Plava poliklinika Tuzla
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Zenica, Bosnia og Herzegovina, 72000
- Cantonal Hospital Zenica
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Botucatu, Brasil, 18608-025
- Universidade Estadual Paulista 'Julio De Mesquita Filho'
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Brasília, Brasil, 70200-730
- CCB Centro Cardiologico de Brasilia Ltda - CCB Cardiologia
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Brasília, Brasil, 72145 450
- Chronos Clinica Medica Ltda
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Campinas, Brasil, 13060-904
- Sociedade Campineira de Educacao e Instrucao Hospital e Maternidade Celso Pierro
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Curitiba, Brasil, 80430-180
- CDC - Centro Digestivo de Curitiba
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Fortaleza, Brasil, 60430-370
- Universidade Federal Do Ceara
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Jaú, Brasil, 17201-130
- Centro de Estudos Clínicos do Interior Paulista - CECIP
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Macaé, Brasil, 27910-020
- Cliged
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Natal, Brasil, 59062 000
- Liga Norte Riograndense Contra O Cancer
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Passo Fundo, Brasil, 99010-120
- Instituto Mederi de Pesquisa e Saude
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Porto Alegre, Brasil, 90035-003
- Hospital das Clinicas de Porto Alegre
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Porto Alegre, Brasil, 90035-001
- Associacao Hospitalar Moinhos de Vento
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Porto Alegre, Brasil, 90160-092
- Associacao dos Funcionarios Publicos do Estado do Rio Grande do Sul - Hospital Ernesto Dornelles
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Porto Alegre, Brasil, 90430-001
- NPCRS Nucleo de Pesquisa Clinica do Rio Grande do Sul
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Recife, Brasil, 51011040
- Hospital das Clinicas - Universidade Federal de Pernambuco
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Salvador, Brasil, 40110-060
- Universidade Federal da Bahia - Hospital Professor Edgard Santos
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Salvador, Brasil, 40150150
- SER - Servicos Especializados em Reumatologia da Bahia
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Santo André, Brasil, 09080-110
- Pesquisare Saude
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Santos, Brasil, 11075-101
- Irmandade da Santa Casa da Misericórdia de Santos
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São Bernardo do Campo, Brasil, 09715-090
- CEMEC - Centro Multidisciplinar de Estudos Clínicos
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São José do Rio Preto, Brasil, 15015-110
- Kaiser Hospta
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São José do Rio Preto, Brasil, 15090-000
- Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto Hospital de Base
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São Paulo, Brasil, 04543-000
- Instituto D Or de Pesquisa e Ensino IDOR
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São Paulo, Brasil, 03325-050
- BR TRIALS Ensaios Clinicos e Consultoria Ltda
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São Paulo, Brasil, 04039-004
- Instituto de Assistencia Medica ao Servidor Publico Estadual IAMSPE
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São Paulo, Brasil, 04543-011
- Hepatogastro
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Teresina, Brasil, 64049-550
- Fundacao Universidade Federal do Piaui - Universidade Federal do Piaui
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Votuporanga, Brasil, 15501 405
- Integral Centro de Pesquisas Clinicas
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Ontario
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London, Ontario, Canada, N6A 5A5
- London Health Sciences Centre
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North Bay, Ontario, Canada, P1B 2H3
- North Bay Dermatology Centre
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Esbjerg, Danmark, 6700
- Sydvestjysk Sygehus
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Hilleroed, Danmark, 3400
- Nordsjaellands Hospital - Hillerod
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Alabama
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Dothan, Alabama, Forente stater, 36305
- Digestive Health Specialists of the Southeast
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Arizona
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Chandler, Arizona, Forente stater, 85224-1636
- Advanced Gastro P.C
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Scottsdale, Arizona, Forente stater, 85260
- Reliance Research
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Arkansas
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Little Rock, Arkansas, Forente stater, 72205-6414
- Moore Clinical Trials, LLC
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Little Rock, Arkansas, Forente stater, 72223
- Central Arkansas Veterans Healthcare System
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California
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Anaheim, California, Forente stater, 92805
- Clinnova Research
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Lancaster, California, Forente stater, 93534
- Om Research LLC
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Lancaster, California, Forente stater, 93534
- Om Research LLC 1
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Los Alamitos, California, Forente stater, 90720
- United Gastroenterologists
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Los Angeles, California, Forente stater, 90048
- Paul Wallace MD
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Pasadena, California, Forente stater, 77505-3950
- Digestive System Healthcare
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San Diego, California, Forente stater, 92103
- Clinical Applications Laboratories, Inc
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San Diego, California, Forente stater, 92103-2120
- Northshore Gastroenterology Research, LLC
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Santa Maria, California, Forente stater, 93454
- Santa Maria Gastroenterology
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Walnut Creek, California, Forente stater, 94598
- Clinical Research of California
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Colorado
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Grand Junction, Colorado, Forente stater, 81505-1027
- Amel Med LLC Research
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Connecticut
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Danbury, Connecticut, Forente stater, 06810
- Western Connecticut Health Network/Danbury Hospital
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Florida
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Clearwater, Florida, Forente stater, 33762-5323
- Gastroenterology Associates of SW Florida
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Coconut Creek, Florida, Forente stater, 33066
- Pioneer Research Solutions Inc.
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DeBary, Florida, Forente stater, 32713
- Omega Research Consultants
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Hialeah, Florida, Forente stater, 33016
- Harmony Medical Research Institute, Inc.
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Kissimmee, Florida, Forente stater, 34741
- Central Florida Gastro Research
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Miami, Florida, Forente stater, 33155
- Community Research Foundation, Inc.
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Naples, Florida, Forente stater, 34102
- Gastroenterology Group Of Naples
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Orlando, Florida, Forente stater, 32803-1853
- Center for Digestive Health
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Orlando, Florida, Forente stater, 32819
- Central Florida Internists
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St. Petersburg, Florida, Forente stater, 33705
- Synergy Clinical Research
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Georgia
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Atlanta, Georgia, Forente stater, 30328
- Agile Clinical Research Trials, LLC
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Atlanta, Georgia, Forente stater, 30224
- Atlanta Gastroenterology Specialists, PC
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Decatur, Georgia, Forente stater, 30033
- Atlanta Center For Gastroenterology
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Macon, Georgia, Forente stater, 31201
- Gastroenterolgy Associates of Central GA
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Roswell, Georgia, Forente stater, 30076-4943
- Gastroenterology Consultants
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Idaho
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Boise, Idaho, Forente stater, 83706
- USF Asthma, Allergy, Immunology Clinical Research Unit
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Idaho Falls, Idaho, Forente stater, 83404
- Grand Teton Research Group, PLLC
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Illinois
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Oakbrook Terrace, Illinois, Forente stater, 60618
- Lemah Creek Clinical Research
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Kansas
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Kansas City, Kansas, Forente stater, 66103-2937
- University of Kansas Medical Center
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Leawood, Kansas, Forente stater, 66211
- BVL Clinical Research
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Topeka, Kansas, Forente stater, 66606
- Cotton O'Neil Digestive Health Center
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Kentucky
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Crestview Hills, Kentucky, Forente stater, 41017
- Tri-State Gastroenterology Assoc
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Louisiana
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Marrero, Louisiana, Forente stater, 70072
- Tandem Clinical Research
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Maryland
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Baltimore, Maryland, Forente stater, 21202-2102
- Institute for Digestive Health and Liver Disease
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Glen Burnie, Maryland, Forente stater, 21061
- Woodholme Gastroenterology Associates
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Massachusetts
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Chelmsford, Massachusetts, Forente stater, 01824
- Digestive Health Specialists PC
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South Dartmouth, Massachusetts, Forente stater, 02747
- FC Research, LLC
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Michigan
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Chesterfield, Michigan, Forente stater, 48047
- Clinical Research Institute of Michigan, LLC
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Livonia, Michigan, Forente stater, 48152
- Detroit Clinical Research Center
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Mississippi
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Jackson, Mississippi, Forente stater, 39216
- University of Mississippi Medical Center
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New York
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Brooklyn, New York, Forente stater, 11203
- SUNY Downstate Medical Center
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Jackson Heights, New York, Forente stater, 11372
- Smart Medical Research
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Middletown, New York, Forente stater, 10941
- Crystal Run Healthcare LLP
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New York, New York, Forente stater, 10075
- New York Gastroenterology Associates
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North Massapequa, New York, Forente stater, 11758
- DiGiovanna Institute for Medical Education & Research
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Queens, New York, Forente stater, 11375
- A1 Clinical Network
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North Carolina
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Charlotte, North Carolina, Forente stater, 28207
- Carolinas Medical Center
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Charlotte, North Carolina, Forente stater, 28277
- Onsite Clinical Solutions
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Greenville, North Carolina, Forente stater, 27834
- Carolina Research
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Winston-Salem, North Carolina, Forente stater, 27103
- Gastroenterology Associates of the Piedmont, P.A.
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Ohio
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Columbus, Ohio, Forente stater, 43214
- Central Ohio Endoscopy Center LLC
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Dayton, Ohio, Forente stater, 45440
- Dayton Gastroenterology, Inc
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Mentor, Ohio, Forente stater, 44060
- Great Lakes Gastroenterology
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Oklahoma
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Oklahoma City, Oklahoma, Forente stater, 73104
- Oklahoma University Health Science Center
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Oklahoma City, Oklahoma, Forente stater, 73112
- Integris Baptist Office
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Oklahoma City, Oklahoma, Forente stater, 73120
- Central Sooner Research
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Tulsa, Oklahoma, Forente stater, 74137-7061
- Essential Medical Research
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Oregon
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Portland, Oregon, Forente stater, 97220-9428
- The Oregon Clinic
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Pennsylvania
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Smithfield, Pennsylvania, Forente stater, 15478
- Frontier Clinical Research
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South Carolina
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Greenville, South Carolina, Forente stater, 29615
- Gastroenterology Associates P.A.
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Myrtle Beach, South Carolina, Forente stater, 29572
- Carolina Health Specialists
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Texas
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Lubbock, Texas, Forente stater, 79424
- West Texas Clinical Research
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Richmond, Texas, Forente stater, 77407
- Victoria Gastroenterology
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San Antonio, Texas, Forente stater, 78229
- Gastroenterology Clinic Of San Antonio P A
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San Antonio, Texas, Forente stater, 78232
- Wellness Clinical Research
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Southlake, Texas, Forente stater, 76092
- Texas Digestive Disease Consultants
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Tyler, Texas, Forente stater, 75701
- Digestive Health Specialists of Tyler
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Utah
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Salt Lake City, Utah, Forente stater, 84124
- Care Access Research- Salt Lake City
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Virginia
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Burke, Virginia, Forente stater, 22015
- Burke Internal Medicine and Research
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Chesapeake, Virginia, Forente stater, 23320
- Gastroenterology Associates of Tidewater
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Bayonne, Frankrike, 64100
- Centre Hospitalier de la Cote Basque
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Besançon, Frankrike, 25000
- CHRU Besancon Hopital Jean Minjoz
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Colombes, Frankrike, 92701
- Hopital Louis Mourier
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Nantes, Frankrike, 44093
- CHU de Nantes hotel Dieu
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Nice, Frankrike, 06202
- CHU de Nice Hopital de l Archet
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Paris, Frankrike, 75877
- Hôpital Bichat
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Pierre-Bénite, Frankrike, 69495
- Hospices Civils de Lyon HCL
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Reims, Frankrike, 51092
- Hôpital Robert Debré
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Saint-Priest-en-Jarez, Frankrike, 42270
- CHU Saint Etienne Hopital Nord
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Strasbourg, Frankrike, 67098
- CHRU Strasbourg
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Toulouse, Frankrike, 31059
- CHU Rangueil
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Afula, Israel, 1834111
- Haemek Medical Center
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Beersheba, Israel, 84101
- Soroka University Medical Center
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Ramat Gan, Israel, 5265601
- The Chaim Sheba Medical Center
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Rehovot, Israel, 76100
- Kaplan Medical Center
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Tzrifin, Israel, 70300
- Assaf Harofeh Medical Center
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Bologna, Italia, 40138
- Policlinico Sant'Orsola Malpighi
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Milan, Italia, 20132
- Istituto Clinico Humanitas Rozzano, IRCCS
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Roma, Italia, 168
- Policlinico Universitario Agostino Gemelli
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Roma, Italia, 00128
- Università Campus Biomedico di Roma
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Bunkyō City, Japan, 113-8431
- Juntendo University Hospital
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Chūōku, Japan, 1040061
- Ginza central clinic
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Fukui-ken, Japan, 910-8526
- Fukui Prefectural Hospital
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Fukuoka, Japan, 814-0180
- Fukuoka University Hospital
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Fukuoka, Japan, 815-8555
- Japanese Red Cross Fukuoka Hospital
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Fukuyama, Japan, 720-8520
- National Hospital Organization Fukuyama Medical Center
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Gamagōri, Japan, 443-8501
- Gamagori City Hospital
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Gunma, Japan, 371-0034
- Gunma University Hospital
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Hachinohe, Japan, 031-8555
- Hachinohe City Hospital
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Hamamatsu, Japan, 431 3192
- Hamamatsu University Hospital
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Hamamatsu, Japan, 432-8061
- Matsuda Hospital
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Higashi-Ibaraki, Japan, 311-3193
- National Hospital Organization Mito Medical Center
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Hiroshima, Japan, 737-8505
- Kure Kyosai Hospital
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Iizuka-shi, Japan, 820-8505
- National Hospital Organization Shikoku Cancer Center
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Kagoshima, Japan, 890-8520
- Kagoshima University Hospital
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Kagoshima, Japan, 892-0843
- Kagoshima IBD Gastroenterology Clinic
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Kashiwa, Japan, 277-0871
- Tsujinaka Hospital Kashiwanoha
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Kitakyushu, Japan, 800-0229
- Kyushu Rosai Hospital
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Kobe, Japan, 650 0017
- Kobe University Hospital
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Kofu, Japan, 400-8506
- Yamanashi Prefectural Central Hospital
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Koshigaya, Japan, 343-8555
- Dokkyo Medical University Saitama Medical Center
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Kurume, Japan, 839-0809
- Hidaka Coloproctologic Clinic
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Kyoto, Japan, 602-8566
- University Hospital Kyoto Prefectural University of Medicine
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Kyoto, Japan, 602-8026
- Japanese Red Cross Kyoto Daini Hospital
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Morioka, Japan, 020-8505
- Iwate Medical University Hospital
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Nagasaki, Japan, 852-8501
- Nagasaki University Hospital
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Nagoya, Japan, 460-0022
- Yokoyama IBD Clinic
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Nakagami-gun, Japan, 901-2132
- University of the Ryukyus Hospital
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Niigata, Japan, 951 8520
- Niigata University Medical And Dental Hospital
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Nishinomiya, Japan, 663-8014
- Nishinomiya Municipal Central Hospital
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Osaka, Japan, 540-0006
- National Hospital Organization Osaka National Hospital
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Osaka, Japan, 558-8558
- Osaka General Medical Center
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Osaka, Japan, 543-8555
- Japanese Red Cross Osaka Hospital
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Osaka, Japan, 530-0011
- Kinshukai Infusion Clinic
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Sapporo, Japan, 065-0033
- Sapporo Higashi Tokushukai Hospital
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Sendai, Japan, 981-3213
- Takagi Clinic
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Sunto-gun, Japan, 411-8611
- National Hospital Organization Shizuoka Medical Center
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Tokyo, Japan, 160-0023
- Tokyo Medical University Hospital
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Toyota, Japan, 470-0396
- Toyota Kosei Hospital
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Yokohama, Japan, 232 0024
- Yokohama City University Medical Center
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Ōita, Japan, 870-0033
- Oita Red Cross Hospital
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Ōtsu, Japan, 520-2192
- Shiga University of Medical Science Hospital
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Amman, Jordan, 11183
- Khalidi Hospital and Medical Center
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Amman, Jordan, 11194
- The Speciality Hospital (TSH) / Advanced Clinical Center
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Amman, Jordan, 11196
- Istiklal Hospital
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Amman, Jordan, 1184
- Abdali Hospital
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Irbid, Jordan, 21110
- Irbid Specialty Hospital
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Irbid, Jordan, 22110
- Pharmaceutical Research Center Jordan University of Science and Technology Rheumatology
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Bengbu, Kina, 233004
- The Affiliated Hospital of Bengbu Medical College
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Changsha, Kina, 410008
- Xiangya Hospital Central South University
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Changsha, Kina, 410011
- The second Xiangya Hospital of Central South University
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Changzhou, Kina, 213004
- Changzhou No 2 Peoples Hospital
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Chengdu, Kina, 610041
- West China Hospital Sichuan University
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Chongqing, Kina, 400013
- Chongqing Medical University
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Foshan, Kina, 528010
- The First People's Hospital of Foshan
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Fuzhou, Kina, 350005
- The First Affiliated Hospital of Fujian Medical University
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Ganzhou, Kina, 341000
- First Affiliated Hospital of Gannan Medical University
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Guangzhou, Kina, 510180
- Guangzhou First Municipal People's Hospital
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Guangzhou, Kina, 510080
- Guangdong Provincial People's Hospital
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Guangzhou, Kina, 510260
- Guangzhou Medical University
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Hangzhou, Kina, 310006
- Affiliated Hangzhou First People's Hospital, Zhejiang University School of Medicine
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Hangzhou, Kina, 310016
- Sir Run Run Shaw Hospital Zhejiang University School of Medicine
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Hefei, Kina, 230022
- The First Affiliated Hospital of Anhui Medical University
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Nanchang, Kina, 330006
- The First Affiliated Hospital of NanChang University
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Nanjing, Kina, 210008
- Nanjing Drum Tower Hospital
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Nanjing, Kina, 210006
- Nanjing 1st Hospital
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Quanzhou, Kina, 362002
- The First Hospital of Quanzhou
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Shanghai, Kina, 200040
- Huashan Hospital Fudan University
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Shanghai, Kina, 200120
- Shanghai East Hospital
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Shenyang, Kina, 110022
- Shengjing Hospital Of China Medical University
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Suzhou, Kina
- The first affiliated hospital of suzhou University
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Wuxi, Kina, 214023
- Wuxi People s Hospital
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Yangzhou, Kina, 225001
- Yangzhou First People's Hospital
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Zhuzhou, Kina, 412007
- ZhuZhou Central Hospital
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Bjelovar, Kroatia, 43000
- Opca bolnica Bjelovar
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Split, Kroatia, 21000
- University Hospital Center Split
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Zadar, Kroatia, 23000
- Opca bolnica Zadar
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Zagreb, Kroatia, 10000
- Poliklinika Solmed
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-
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Kaunas, Litauen, 44307
- Lietuvos sveikatos mokslų universiteto ligoninė Kauno klinik
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Vilnius, Litauen, LT-08661
- Vilnius University Hospital Santaros Klinikos, Public Institution
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Johor Bharu, Malaysia, 80100
- Hospital Sultanah Aminah
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Kota Bharu, Malaysia, 16150
- Hospital University Sains Malaysia
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Kota Kinabalu, Malaysia, 88586
- Hospital Raja Permaisuri Bainun
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Kuala Lumpur, Malaysia, 59100
- University Malaya Medical Centre
-
Kuantan, Malaysia, 25100
- Hospital Tengku Ampuan Afzan
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-
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Amsterdam, Nederland, 1091 AC
- Onze Lieve Vrouwe Gasthuis
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Rotterdam, Nederland, 3045 PM
- Sint Franciscus Gasthuis
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Tilburg, Nederland, 5022 GC
- Elisabeth-TweeSteden Ziekenhuis
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-
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Christchurch, New Zealand, 8011
- Christchurch Hospital
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Dunedin, New Zealand, 9016
- Dunedin Hospital
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Bialystok, Polen, 15-322
- Gastromed Kralisz Romatowski Stachurska Sp. j.
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Bydgoszcz, Polen, 85 231
- NZOZ Centrum Medyczne KERmed
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Chojnice, Polen, 89-600
- Centrum Medyczne Lukamed
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Chojnice, Polen, 89 600
- Centrum Medyczne Lukamed Sp z o o
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Chrzanów, Polen, 32-500
- Sahlgrenska University Hospital
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Knurów, Polen, 44 190
- MZ Badania Slowik Zymla Spolka jawna
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Krakow, Polen, 30 149
- Malopolskie Centrum Kliniczne
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Krakow, Polen, 30 363
- Centrum Medyczne Plejady
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Krakow, Polen, 31 637
- Centrum Medyczne ProMiMed
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Lodz, Polen, 90-752
- IP Clinic Sp. z o.o.
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Lodz, Polen, 91 034
- Centrum Medyczne Med Gastr
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Lodz, Polen, 90-644
- AmiCare Centrum Medyczne
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Lublin, Polen, 20-412
- ETG Lublin
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Lublin, Polen, 20 582
- REUMED Zespol Poradni Specjalistycznych Filia nr 2
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Nowy Targ, Polen, 34 400
- Allmedica
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Olsztyn, Polen, 10 561
- Wojewodzki Szpital Specjalistyczny w Olsztynie
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Opole, Polen, 45-819
- Twoja Przychodnia 1
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Piotrkow Trybunalski, Polen, 97 300
- Centrum Medyczne
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Poznan, Polen, 60 309
- EMC Instytut Medyczny SA PL CERTUS
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Poznan, Polen, 61 441
- Synexus Polska Sp z o o
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Poznan, Polen, 61 324
- Twoja Przychodnia
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Rzeszów, Polen, 35-326
- Centrum Medyczne Medyk
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Skorzewo, Polen, 60-185
- Centrum Medyczne Promed
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Sopot, Polen, 81-756
- Endoskopia Sp z o.o.
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Sosnowiec, Polen, 41-200
- Kiepury Clinic
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Straszów, Polen, 28 200
- KO Med Centrum Medyczne
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Szczecin, Polen, 71-434
- Twoja Przychodnia - Szczecinskie Centrum Medyczne
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Szczecin, Polen, 71-685
- Sonomed Sp. z o.o.
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Torun, Polen, 87 100
- GASTROMED Kopon Zmudzinski i wspolnicy SP j Specjalistyczne Centrum Gastrologii i Endoskopii
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Tychy, Polen, 43-100
- H-T Centrum Medyczne Endoterapia
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Warsaw, Polen, 02-507
- Centralny Szpital Kliniczny MSWiA w Warszawie
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Warsaw, Polen, 02 653
- Endoterapia
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Warsaw, Polen, 00 632
- Centrum Zdrowia Matki Dziecka i Mlodziezy
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Warsaw, Polen, 02 798
- Medical Concierge Centrum Medyczne
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Warsaw, Polen, 03 580
- NZOZ Vivamed
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Warsaw, Polen, 03-712
- Gabinety Lekarskie Bodyclinic
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Warsaw, Polen, 04-501
- IBD Point Profesor Kierkus
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Wierzchosławice, Polen, 33-122
- Centrum Zdrowia Tuchow
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Wroclaw, Polen, 50-556
- Uniwersytecki Szpital Kliniczny im. J. Mikulicza-Radeckiego
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Wroclaw, Polen, 53 149
- Przychodnia Vistamed
-
Wroclaw, Polen, 53 611
- Centrum Medyczne Melita Medical
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Wroclaw, Polen, 50-449
- Centrum Medyczne Melita Medical 2
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Włocławek, Polen, 87-800
- Centrum Diagnostyczno - Lecznicze Barska sp. z o.o. Szpital Specjalistyczny Barska
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Zamość, Polen, 22-400
- Pro Life Medica Sp z o o ETG Zamosc
-
-
-
-
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Banská Bystrica, Slovakia, 974 01
- FNsP F.D.R. Banska Bystrica
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Košice, Slovakia, 040 13
- ENDOMED s.r.o
-
Prešov, Slovakia, 080 01
- GASTRO I. s.r.o.
-
-
-
-
-
Gijón, Spania, 33394
- Hosp. de Cabuenes
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Huelva, Spania, 21005
- Hosp. Gral. Juan Ramon Jimenez
-
Huelva, Spania, 21002
- Hosp. Gral. Juan Ramon Jimenez 1
-
Madrid, Spania, 28031
- Hosp. Univ. Infanta Leonor
-
Seville, Spania, 41009
- Hosp. Virgen Macarena
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Vigo, Spania, 36213
- Hosp. Alvaro Cunqueiro
-
Villajoyosa, Spania, 03570
- Hosp. de La Marina Baixa
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-
-
-
-
Busan, Sør -Korea, 41404
- Kyungpook National University Chilgok Hospital
-
Busan, Sør -Korea, 48108
- Inje University Haeundae Paik Hospital
-
Busan, Sør -Korea, 49267
- Kosin University Gospel Hospital
-
Busan, Sør -Korea, 602739
- DongA Medical Center
-
Daegu, Sør -Korea, 42415
- Yeungnam University Medical Center
-
Daejeon, Sør -Korea, 34943
- The Catholic University of Korea Seoul St.Mary's Hospital
-
Dongdaemun-gu, Sør -Korea, 02447
- Kyung Hee University Hospital
-
Goyang-si, Sør -Korea, 10326
- Dongguk University Ilsan Hospital
-
Gwangju, Sør -Korea, 61469
- Chonnam National University Hospital
-
Gyeonggi-do, Sør -Korea, 13496
- CHA Bundang Medical Center, CHA University
-
Gyeonggi-do, Sør -Korea, 16247
- The Catholic university of Korea, St. Vincent's Hospital
-
Seoul, Sør -Korea, 06351
- Samsung Medical Center
-
Seoul, Sør -Korea, 03181
- Kangbuk Samsung Hospital
-
Seoul, Sør -Korea, 03722
- Yonsei University College of Medicine
-
Seoul, Sør -Korea, 06591
- The Catholic University of Korea Seoul St Mary s Hospital
-
Suwon, Sør -Korea, 16499
- Ajou University Hospital
-
Wŏnju, Sør -Korea, 26426
- Wonju Christian Hospital
-
Yangch’ŏn-gu, Sør -Korea, 07985
- Ewha Womans University Mokdong Hospital
-
-
-
-
-
Kaoshiung, Taiwan, 80756
- Kaohsiung Medical University Chung Ho Memorial Hospital
-
Taichung, Taiwan, 40447
- China Medical University Hospital
-
Taipei, Taiwan, 100
- National Taiwan University Hospital, Division of Infectious Diseases
-
Taipei, Taiwan, 110301
- Taipei Medical University
-
Taoyuan, Taiwan, 33305
- Linkou Chang Gung Memorial Hospital
-
-
-
-
-
Brno, Tsjekkia, 636 00
- Fakultni nemocnice Brno
-
Hradec Králové, Tsjekkia, 500 05
- Fakultni nemocnice Hradec Kralove
-
Kladno, Tsjekkia, 27259
- Oblastni nemocnice Kladno a.s.
-
Prague, Tsjekkia, 100 34
- Fakultni nemocnice Kralovske Vinohrady
-
Slaný, Tsjekkia, 274 01
- Nemocnice Slany
-
-
-
-
-
Ankara, Tyrkia (Türkiye), 06100
- Ankara Numune Egitim ve Arastirma Hastanesi
-
Ankara, Tyrkia (Türkiye), 06230
- Hacettepe University Hospital
-
Ankara, Tyrkia (Türkiye), 06560
- Gazi University Medical Faculty
-
Istanbul, Tyrkia (Türkiye), 34349
- Acibadem Fulya Hospital
-
Izmir, Tyrkia (Türkiye), 35040
- Ege Universitesi Tip Fakultesi
-
Mersin, Tyrkia (Türkiye), 33343
- Mersin University Medical Faculty
-
Samsun, Tyrkia (Türkiye), 55420
- Ondokuz Mayis University
-
Zonguldak, Tyrkia (Türkiye), 67000
- Bülent Ecevit Üniversitesi Sağlık Uygulama ve Araştırma Hastanesi
-
-
-
-
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Berlin, Tyskland, 14050
- DRK Kliniken Westend
-
Berlin, Tyskland, 14163
- Krankenhaus Waldfriede Mitte
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Berlin, Tyskland, 10117
- Charite Universitatsmedizin Berlin, Campus Mitte (CCM) Allergie Center
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Berlin, Tyskland, 10318
- CED Studienzentrum Karlshorst
-
Braunschweig, Tyskland, 38126
- Staedtisches Klinikum Braunschweig
-
Cologne, Tyskland, 51103
- Evangelisches Krankenhaus Kalk
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Dachau, Tyskland, 85221
- Medizinisches Versorgungszentrum (MVZ) Dachau
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Duisburg, Tyskland, 47055
- MVZ Sanaklinikum Duisburg
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Halle, Tyskland, 6108
- Studiengesellschaft Mitteldeutschland GmbH
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Hanover, Tyskland, 30625
- Medizinische Hochschule Hannover
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Jerichow, Tyskland, 39319
- Praxisgemeinschaft Jerichow
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Mannheim, Tyskland, 68167
- Universitaetsklinikum Mannheim
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Nordhausen, Tyskland, 99734
- Tumorzentrum Nordthüringen Medizinisches Versorgungszentrum
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-
-
-
-
Budapest, Ungarn, 1036
- Obudai Egeszsegugyi Centrum Kft
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Budapest, Ungarn, H-1088
- Semmelweis Egyetem
-
Budapest, Ungarn, H-1136
- Pannónia Magánorvosi Centrum Kft
-
Budapest, Ungarn, 1097
- Egyesített Szent István és Szent László Kórház
-
Budapest, Ungarn, 1126
- Mh Egészségügyi Központ
-
Budapest, Ungarn, 1125
- Eszak Kozep budai Centrum Uj Szent Janos Korhaz es Szakrendelo Budai Csaladkozpontu
-
Kistarcsa, Ungarn, 2143
- Pest Megyei Flor Ferenc Korhaz
-
Mohács, Ungarn, 7700
- Mohacsi Korhaz
-
Pécs, Ungarn, 7624
- Pecsi Tudomanyegyetem Orvostudomanyi Es Egeszsegtudomanyi Centrum, I. Belgyogyaszati Klinika
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Szombathely, Ungarn, H-9700
- Markusovszky Egyetemi Oktatokorhaz
-
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
- Diagnosis of Crohn's disease (CD) of at least 3 months in duration
- Have moderate to severe CD as assessed by CDAI, stool frequency, and abdominal pain score, and Simple Endoscopic Score for Crohn's disease (SES-CD).
- Demonstrated intolerance or inadequate response to conventional or to biologic therapy for CD
Exclusion Criteria:
- Current diagnosis of ulcerative colitis or indeterminate colitis
- Complications of Crohn's disease that require surgical intervention or confound efficacy assessments
- Unstable doses of concomitant Crohn's disease therapy
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Group 1: Guselkumab
Participants will receive guselkumab (Dose 1) injection subcutaneously followed by guselkumab (Dose 2) injection subcutaneously. |
Guselkumab (Dose 1) will be administered by subcutaneous (SC) injection. Guselkumab (Dose 2) will be administered by SC injection. |
|
Eksperimentell: Group 2: Guselkumab
Participants will receive guselkumab (Dose 1) injection subcutaneously followed by guselkumab (Dose 3) injection subcutaneously. |
Guselkumab (Dose 1) will be administered by subcutaneous (SC) injection. Guselkumab (Dose 3) will be administered by SC injection. |
|
Placebo komparator: Group 3: Placebo
Participants will receive placebo injection subcutaneously. |
Placebo will be administered by SC injection. |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Percentage of Participants Who Achieved Clinical Remission at Week 12
Tidsramme: At Week 12
|
Clinical remission was defined as a Crohn's Disease Activity Index (CDAI) score <150. The multi-item CDAI score assessed severity of illness by collecting information on 8 different Crohn's disease-related variables (extraintestinal manifestations, abdominal mass, weight, hematocrit, use of antidiarrheal drug(s) and/or opiates, total number of liquid or very soft stools, abdominal pain/cramps, and general well-being). The last 3 variables were scored over 7 days by the participant on a diary card. The total CDAI score ranged from 0 (improvement in disease activity) to 600 (more disease activity) and a decrease in total CDAI score over time indicates improvement in disease activity. |
At Week 12
|
|
Percentage of Participants Who Achieved Endoscopic Response at Week 12
Tidsramme: At Week 12
|
Percentage of participants who achieved endoscopic response at Week 12 were reported. Endoscopic response was defined as greater than or equal to (>=) 50 percent (%) improvement from baseline in the Simple Endoscopic Score for Crohn's Disease (SES-CD) score. SES-CD evaluated 4 endoscopic components (presence and size of ulcer, extent of ulcerated surface, extent of affected surface, and presence and type of narrowing) across 5 ileocolonic segments (ileum, right colon, transverse colon, left colon, and rectum), each scored from 0 (best) to 3 (worst) for each segment except narrowing component for which the maximum total score (that is, stricturing) was 11 points. The total SES-CD score was the sum of all the component scores across all the segments and it ranged from 0 (best) to 56 (worst), where higher scores indicated more severe disease. |
At Week 12
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Percentage of Participants Who Achieved Clinical Remission at Week 24
Tidsramme: At Week 24
|
Percentage of participants who achieved clinical remission at Week 24 were reported. Clinical remission was defined as a Crohn's Disease Activity Index (CDAI) score <150. The multi-item CDAI score assessed severity of illness by collecting information on 8 different Crohn's disease-related variables (extraintestinal manifestations, abdominal mass, weight, hematocrit, use of antidiarrheal drug(s) and/or opiates, total number of liquid or very soft stools, abdominal pain/cramps, and general well-being). The last 3 variables were scored over 7 days by the participant on a diary card. The total CDAI score ranged from 0 (improvement in disease activity) to 600 (more disease activity) and a decrease in total CDAI score over time indicates improvement in disease activity. |
At Week 24
|
|
Percentage of Participants Who Achieved Patient-reported Outcome (PRO)-2 Remission at Week 12
Tidsramme: At Week 12
|
Percentage of participants who achieved PRO-2 remission at Week 12 were reported. PRO-2 remission was defined as an abdominal pain (AP) mean daily score <=1, and stool frequency (SF) mean daily score <=3, and no worsening of AP or SF from baseline. Mean daily AP score based on the CDAI was defined as the sum of abdominal pain/cramps ratings in the previous 7 days in a diary card divided by the total number of days assessments were performed. Average daily SF score based on the CDAI was defined as the sum of number of liquid or very soft stools in the previous 7 days in a diary card divided by the total number of days assessments were performed. Mean daily SF and AP scores at a scheduled visit were not calculated if total number of days of assessment was less than 5. Higher PRO-2 scores indicated more severe disease. |
At Week 12
|
|
Percentage of Participants Who Achieved Clinical Response at Week 12
Tidsramme: At Week 12
|
Clinical response was defined as a decrease from baseline in CDAI score >= 100 points or CDAI score < 150. The multi-item CDAI score assessed severity of illness by collecting information on 8 different Crohn's disease-related variables (extraintestinal manifestations, abdominal mass, weight, hematocrit, use of antidiarrheal drug(s) and/or opiates, total number of liquid or very soft stools, abdominal pain/cramps, and general well-being). The last 3 variables were scored over 7 days by the participant on a diary card. The total CDAI score ranged from 0 (improvement in disease activity) to 600 (more disease activity) and a decrease in total CDAI score over time indicates improvement in disease activity. |
At Week 12
|
|
Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) Through Week 48
Tidsramme: Placebo, Guselkumab 400 mg + 100 mg, and Guselkumab 400 mg + 200 mg: From Week 0 up to Week 48; Placebo arm subset - Rescue Treatment: From Week 16 up to Week 48
|
Percentage of participants with TEAEs through Week 48 were reported. An adverse event (AE) was any untoward medical occurrence in a clinical study participant participating in a clinical study and does not necessarily have a causal relationship with the study drug. An AE that occurred at or after the initial administration of study drug (Week 0) through data cutoff of Week 48 was considered treatment-emergent. |
Placebo, Guselkumab 400 mg + 100 mg, and Guselkumab 400 mg + 200 mg: From Week 0 up to Week 48; Placebo arm subset - Rescue Treatment: From Week 16 up to Week 48
|
|
Percentage of Participants With Treatment-Emergent Serious Adverse Events (TESAEs) Through Week 48
Tidsramme: Placebo, Guselkumab 400 mg + 100 mg, and Guselkumab 400 mg + 200 mg: From Week 0 up to Week 48; Placebo arm subset - Rescue Treatment: From Week 16 up to Week 48
|
Percentage of participants with TESAEs through Week 48 were reported. An SAE was any untoward medical occurrence in a clinical study participant resulting in any of the following outcomes or was deemed significant for any other reason: death, life-threatening (immediate risk of dying), initial or prolonged inpatient hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect. An AE does not necessarily have a causal relationship with the study drug. Any SAE that occurred at or after the initial administration of study drug (Week 0) through the data cutoff of Week 48 was considered treatment-emergent. |
Placebo, Guselkumab 400 mg + 100 mg, and Guselkumab 400 mg + 200 mg: From Week 0 up to Week 48; Placebo arm subset - Rescue Treatment: From Week 16 up to Week 48
|
|
Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) Leading to Discontinuation of Study Drug Through Week 48
Tidsramme: Placebo, Guselkumab 400 mg + 100 mg, and Guselkumab 400 mg + 200 mg: From Week 0 up to Week 48; Placebo arm subset - Rescue Treatment: From Week 16 up to Week 48
|
Percentage of participants with TEAEs leading to discontinuation of study drug through Week 48 were reported. An adverse event (AE) was any untoward medical occurrence in a clinical study participant participating in a clinical study and does not necessarily have a causal relationship with the study drug. An AE that occurred at or after the initial administration of study drug (Week 0) through data cutoff of Week 48 was considered treatment-emergent. |
Placebo, Guselkumab 400 mg + 100 mg, and Guselkumab 400 mg + 200 mg: From Week 0 up to Week 48; Placebo arm subset - Rescue Treatment: From Week 16 up to Week 48
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Etterforskere
- Studieleder: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
19. januar 2022
Primær fullføring (Faktiske)
4. juli 2023
Studiet fullført (Antatt)
30. oktober 2028
Datoer for studieregistrering
Først innsendt
17. januar 2022
Først innsendt som oppfylte QC-kriteriene
17. januar 2022
Først lagt ut (Faktiske)
19. januar 2022
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
25. september 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
24. september 2026
Sist bekreftet
1. september 2026
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- CR109125
- 2020-006165-11 (EudraCT-nummer)
- CNTO1959CRD3004 (Annen identifikator: Janssen Research & Development, LLC)
- 2023-504737-41-00 (Registeridentifikator: EUCT number)
- 2023 (U.S. NIH-stipend/kontrakt)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
JA
IPD-planbeskrivelse
The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Ja
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .