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Een onderzoek naar subcutane therapie met Guselkumab bij deelnemers met matig tot ernstig actieve ziekte van Crohn (GRAVITI)

24 september 2026 bijgewerkt door: Janssen Research & Development, LLC

Een gerandomiseerde, dubbelblinde, placebogecontroleerde, parallelle groep, multicenter studie om de werkzaamheid en veiligheid van subcutane inductietherapie met Guselkumab te evalueren bij deelnemers met matig tot ernstig actieve ziekte van Crohn

The purpose of this study is to evaluate the efficacy and safety of guselkumab in participants with Crohn's disease.

Studie Overzicht

Toestand

Actief, niet wervend

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Werkelijk)

350

Fase

  • Fase 3

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Australië
      • Clayton, Australië, 3168
        • Monash Health, Monash Medical Centre
      • North Mackay, Australië, 4740
        • Coral Sea Clinical Research Institute
  • België
      • Aalst, België, 9300
        • OLV Ziekenhuis Aalst
      • Brussels, België, 1070
        • Hopital Erasme
      • Brussels, België, 1000
        • CHU Saint-Pierre
      • Ghent, België, 9000
        • Universitair Ziekenhuis Gent
      • Roeselare, België, 8800
        • Algemeen Ziekenhuis Delta
  • Bosnië-Herzegovina
      • Banja Luka, Bosnië-Herzegovina, 78000
        • University hospital Clinical centre Banja Luka
      • Sarajevo, Bosnië-Herzegovina, 71000
        • Clinical Center University of Sarajevo
      • Sarajevo, Bosnië-Herzegovina, 71000
        • Polyclinic Dr. Al-Tawil
      • Tešanj, Bosnië-Herzegovina, 74260
        • General Hospital Tesanj
      • Tuzla, Bosnië-Herzegovina, 75000
        • Plava poliklinika Tuzla
      • Zenica, Bosnië-Herzegovina, 72000
        • Cantonal Hospital Zenica
  • Brazilië
      • Botucatu, Brazilië, 18608-025
        • Universidade Estadual Paulista 'Julio De Mesquita Filho'
      • Brasília, Brazilië, 70200-730
        • CCB Centro Cardiologico de Brasilia Ltda - CCB Cardiologia
      • Brasília, Brazilië, 72145 450
        • Chronos Clinica Medica Ltda
      • Campinas, Brazilië, 13060-904
        • Sociedade Campineira de Educacao e Instrucao Hospital e Maternidade Celso Pierro
      • Curitiba, Brazilië, 80430-180
        • CDC - Centro Digestivo de Curitiba
      • Fortaleza, Brazilië, 60430-370
        • Universidade Federal Do Ceara
      • Jaú, Brazilië, 17201-130
        • Centro de Estudos Clínicos do Interior Paulista - CECIP
      • Macaé, Brazilië, 27910-020
        • Cliged
      • Natal, Brazilië, 59062 000
        • Liga Norte Riograndense Contra O Cancer
      • Passo Fundo, Brazilië, 99010-120
        • Instituto Mederi de Pesquisa e Saude
      • Porto Alegre, Brazilië, 90035-003
        • Hospital das Clinicas de Porto Alegre
      • Porto Alegre, Brazilië, 90035-001
        • Associacao Hospitalar Moinhos de Vento
      • Porto Alegre, Brazilië, 90160-092
        • Associacao dos Funcionarios Publicos do Estado do Rio Grande do Sul - Hospital Ernesto Dornelles
      • Porto Alegre, Brazilië, 90430-001
        • NPCRS Nucleo de Pesquisa Clinica do Rio Grande do Sul
      • Recife, Brazilië, 51011040
        • Hospital das Clinicas - Universidade Federal de Pernambuco
      • Salvador, Brazilië, 40110-060
        • Universidade Federal da Bahia - Hospital Professor Edgard Santos
      • Salvador, Brazilië, 40150150
        • SER - Servicos Especializados em Reumatologia da Bahia
      • Santo André, Brazilië, 09080-110
        • Pesquisare Saude
      • Santos, Brazilië, 11075-101
        • Irmandade da Santa Casa da Misericórdia de Santos
      • São Bernardo do Campo, Brazilië, 09715-090
        • CEMEC - Centro Multidisciplinar de Estudos Clínicos
      • São José do Rio Preto, Brazilië, 15015-110
        • Kaiser Hospta
      • São José do Rio Preto, Brazilië, 15090-000
        • Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto Hospital de Base
      • São Paulo, Brazilië, 04543-000
        • Instituto D Or de Pesquisa e Ensino IDOR
      • São Paulo, Brazilië, 03325-050
        • BR TRIALS Ensaios Clinicos e Consultoria Ltda
      • São Paulo, Brazilië, 04039-004
        • Instituto de Assistencia Medica ao Servidor Publico Estadual IAMSPE
      • São Paulo, Brazilië, 04543-011
        • Hepatogastro
      • Teresina, Brazilië, 64049-550
        • Fundacao Universidade Federal do Piaui - Universidade Federal do Piaui
      • Votuporanga, Brazilië, 15501 405
        • Integral Centro de Pesquisas Clinicas
  • Canada
    • Ontario
      • London, Ontario, Canada, N6A 5A5
        • London Health Sciences Centre
      • North Bay, Ontario, Canada, P1B 2H3
        • North Bay Dermatology Centre
  • China
      • Bengbu, China, 233004
        • The Affiliated Hospital of Bengbu Medical College
      • Changsha, China, 410008
        • Xiangya Hospital Central South University
      • Changsha, China, 410011
        • The second Xiangya Hospital of Central South University
      • Changzhou, China, 213004
        • Changzhou No 2 Peoples Hospital
      • Chengdu, China, 610041
        • West China Hospital Sichuan University
      • Chongqing, China, 400013
        • Chongqing Medical University
      • Foshan, China, 528010
        • The First People's Hospital of Foshan
      • Fuzhou, China, 350005
        • The First Affiliated Hospital of Fujian Medical University
      • Ganzhou, China, 341000
        • First Affiliated Hospital of Gannan Medical University
      • Guangzhou, China, 510180
        • Guangzhou First Municipal People's Hospital
      • Guangzhou, China, 510080
        • Guangdong Provincial People's Hospital
      • Guangzhou, China, 510260
        • Guangzhou Medical University
      • Hangzhou, China, 310006
        • Affiliated Hangzhou First People's Hospital, Zhejiang University School of Medicine
      • Hangzhou, China, 310016
        • Sir Run Run Shaw Hospital Zhejiang University School of Medicine
      • Hefei, China, 230022
        • The First Affiliated Hospital of Anhui Medical University
      • Nanchang, China, 330006
        • The First Affiliated Hospital of NanChang University
      • Nanjing, China, 210008
        • Nanjing Drum Tower Hospital
      • Nanjing, China, 210006
        • Nanjing 1st Hospital
      • Quanzhou, China, 362002
        • The First Hospital of Quanzhou
      • Shanghai, China, 200040
        • Huashan Hospital Fudan University
      • Shanghai, China, 200120
        • Shanghai East Hospital
      • Shenyang, China, 110022
        • Shengjing Hospital Of China Medical University
      • Suzhou, China
        • The first affiliated hospital of suzhou University
      • Wuxi, China, 214023
        • Wuxi People s Hospital
      • Yangzhou, China, 225001
        • Yangzhou First People's Hospital
      • Zhuzhou, China, 412007
        • ZhuZhou Central Hospital
  • Denemarken
      • Esbjerg, Denemarken, 6700
        • Sydvestjysk Sygehus
      • Hilleroed, Denemarken, 3400
        • Nordsjaellands Hospital - Hillerod
  • Duitsland
      • Berlin, Duitsland, 14050
        • DRK Kliniken Westend
      • Berlin, Duitsland, 14163
        • Krankenhaus Waldfriede Mitte
      • Berlin, Duitsland, 10117
        • Charite Universitatsmedizin Berlin, Campus Mitte (CCM) Allergie Center
      • Berlin, Duitsland, 10318
        • CED Studienzentrum Karlshorst
      • Braunschweig, Duitsland, 38126
        • Staedtisches Klinikum Braunschweig
      • Cologne, Duitsland, 51103
        • Evangelisches Krankenhaus Kalk
      • Dachau, Duitsland, 85221
        • Medizinisches Versorgungszentrum (MVZ) Dachau
      • Duisburg, Duitsland, 47055
        • MVZ Sanaklinikum Duisburg
      • Halle, Duitsland, 6108
        • Studiengesellschaft Mitteldeutschland GmbH
      • Hanover, Duitsland, 30625
        • Medizinische Hochschule Hannover
      • Jerichow, Duitsland, 39319
        • Praxisgemeinschaft Jerichow
      • Mannheim, Duitsland, 68167
        • Universitaetsklinikum Mannheim
      • Nordhausen, Duitsland, 99734
        • Tumorzentrum Nordthüringen Medizinisches Versorgungszentrum
  • Frankrijk
      • Bayonne, Frankrijk, 64100
        • Centre Hospitalier de la Cote Basque
      • Besançon, Frankrijk, 25000
        • CHRU Besancon Hopital Jean Minjoz
      • Colombes, Frankrijk, 92701
        • Hopital Louis Mourier
      • Nantes, Frankrijk, 44093
        • CHU de Nantes hotel Dieu
      • Nice, Frankrijk, 06202
        • CHU de Nice Hopital de l Archet
      • Paris, Frankrijk, 75877
        • Hôpital Bichat
      • Pierre-Bénite, Frankrijk, 69495
        • Hospices Civils de Lyon HCL
      • Reims, Frankrijk, 51092
        • Hôpital Robert Debré
      • Saint-Priest-en-Jarez, Frankrijk, 42270
        • CHU Saint Etienne Hopital Nord
      • Strasbourg, Frankrijk, 67098
        • CHRU Strasbourg
      • Toulouse, Frankrijk, 31059
        • CHU Rangueil
  • Hongarije
      • Budapest, Hongarije, 1036
        • Obudai Egeszsegugyi Centrum Kft
      • Budapest, Hongarije, H-1088
        • Semmelweis Egyetem
      • Budapest, Hongarije, H-1136
        • Pannónia Magánorvosi Centrum Kft
      • Budapest, Hongarije, 1097
        • Egyesített Szent István és Szent László Kórház
      • Budapest, Hongarije, 1126
        • Mh Egészségügyi Központ
      • Budapest, Hongarije, 1125
        • Eszak Kozep budai Centrum Uj Szent Janos Korhaz es Szakrendelo Budai Csaladkozpontu
      • Kistarcsa, Hongarije, 2143
        • Pest Megyei Flor Ferenc Korhaz
      • Mohács, Hongarije, 7700
        • Mohacsi Korhaz
      • Pécs, Hongarije, 7624
        • Pecsi Tudomanyegyetem Orvostudomanyi Es Egeszsegtudomanyi Centrum, I. Belgyogyaszati Klinika
      • Szombathely, Hongarije, H-9700
        • Markusovszky Egyetemi Oktatokorhaz
  • Israël
      • Afula, Israël, 1834111
        • Haemek Medical Center
      • Beersheba, Israël, 84101
        • Soroka University Medical Center
      • Ramat Gan, Israël, 5265601
        • The Chaim Sheba Medical Center
      • Rehovot, Israël, 76100
        • Kaplan Medical Center
      • Tzrifin, Israël, 70300
        • Assaf Harofeh Medical Center
  • Italië
      • Bologna, Italië, 40138
        • Policlinico Sant'Orsola Malpighi
      • Milan, Italië, 20132
        • Istituto Clinico Humanitas Rozzano, IRCCS
      • Roma, Italië, 168
        • Policlinico Universitario Agostino Gemelli
      • Roma, Italië, 00128
        • Università Campus Biomedico di Roma
  • Japan
      • Bunkyō City, Japan, 113-8431
        • Juntendo University Hospital
      • Chūōku, Japan, 1040061
        • Ginza central clinic
      • Fukui-ken, Japan, 910-8526
        • Fukui Prefectural Hospital
      • Fukuoka, Japan, 814-0180
        • Fukuoka University Hospital
      • Fukuoka, Japan, 815-8555
        • Japanese Red Cross Fukuoka Hospital
      • Fukuyama, Japan, 720-8520
        • National Hospital Organization Fukuyama Medical Center
      • Gamagōri, Japan, 443-8501
        • Gamagori City Hospital
      • Gunma, Japan, 371-0034
        • Gunma University Hospital
      • Hachinohe, Japan, 031-8555
        • Hachinohe City Hospital
      • Hamamatsu, Japan, 431 3192
        • Hamamatsu University Hospital
      • Hamamatsu, Japan, 432-8061
        • Matsuda Hospital
      • Higashi-Ibaraki, Japan, 311-3193
        • National Hospital Organization Mito Medical Center
      • Hiroshima, Japan, 737-8505
        • Kure Kyosai Hospital
      • Iizuka-shi, Japan, 820-8505
        • National Hospital Organization Shikoku Cancer Center
      • Kagoshima, Japan, 890-8520
        • Kagoshima University Hospital
      • Kagoshima, Japan, 892-0843
        • Kagoshima IBD Gastroenterology Clinic
      • Kashiwa, Japan, 277-0871
        • Tsujinaka Hospital Kashiwanoha
      • Kitakyushu, Japan, 800-0229
        • Kyushu Rosai Hospital
      • Kobe, Japan, 650 0017
        • Kobe University Hospital
      • Kofu, Japan, 400-8506
        • Yamanashi Prefectural Central Hospital
      • Koshigaya, Japan, 343-8555
        • Dokkyo Medical University Saitama Medical Center
      • Kurume, Japan, 839-0809
        • Hidaka Coloproctologic Clinic
      • Kyoto, Japan, 602-8566
        • University Hospital Kyoto Prefectural University of Medicine
      • Kyoto, Japan, 602-8026
        • Japanese Red Cross Kyoto Daini Hospital
      • Morioka, Japan, 020-8505
        • Iwate Medical University Hospital
      • Nagasaki, Japan, 852-8501
        • Nagasaki University Hospital
      • Nagoya, Japan, 460-0022
        • Yokoyama IBD Clinic
      • Nakagami-gun, Japan, 901-2132
        • University of the Ryukyus Hospital
      • Niigata, Japan, 951 8520
        • Niigata University Medical And Dental Hospital
      • Nishinomiya, Japan, 663-8014
        • Nishinomiya Municipal Central Hospital
      • Osaka, Japan, 540-0006
        • National Hospital Organization Osaka National Hospital
      • Osaka, Japan, 558-8558
        • Osaka General Medical Center
      • Osaka, Japan, 543-8555
        • Japanese Red Cross Osaka Hospital
      • Osaka, Japan, 530-0011
        • Kinshukai Infusion Clinic
      • Sapporo, Japan, 065-0033
        • Sapporo Higashi Tokushukai Hospital
      • Sendai, Japan, 981-3213
        • Takagi Clinic
      • Sunto-gun, Japan, 411-8611
        • National Hospital Organization Shizuoka Medical Center
      • Tokyo, Japan, 160-0023
        • Tokyo Medical University Hospital
      • Toyota, Japan, 470-0396
        • Toyota Kosei Hospital
      • Yokohama, Japan, 232 0024
        • Yokohama City University Medical Center
      • Ōita, Japan, 870-0033
        • Oita Red Cross Hospital
      • Ōtsu, Japan, 520-2192
        • Shiga University of Medical Science Hospital
  • Jordanië
      • Amman, Jordanië, 11183
        • Khalidi Hospital and Medical Center
      • Amman, Jordanië, 11194
        • The Speciality Hospital (TSH) / Advanced Clinical Center
      • Amman, Jordanië, 11196
        • Istiklal Hospital
      • Amman, Jordanië, 1184
        • Abdali Hospital
      • Irbid, Jordanië, 21110
        • Irbid Specialty Hospital
      • Irbid, Jordanië, 22110
        • Pharmaceutical Research Center Jordan University of Science and Technology Rheumatology
  • Kroatië
      • Bjelovar, Kroatië, 43000
        • Opca bolnica Bjelovar
      • Split, Kroatië, 21000
        • University Hospital Center Split
      • Zadar, Kroatië, 23000
        • Opca bolnica Zadar
      • Zagreb, Kroatië, 10000
        • Poliklinika Solmed
  • Litouwen
      • Kaunas, Litouwen, 44307
        • Lietuvos sveikatos mokslų universiteto ligoninė Kauno klinik
      • Vilnius, Litouwen, LT-08661
        • Vilnius University Hospital Santaros Klinikos, Public Institution
  • Maleisië
      • Johor Bharu, Maleisië, 80100
        • Hospital Sultanah Aminah
      • Kota Bharu, Maleisië, 16150
        • Hospital University Sains Malaysia
      • Kota Kinabalu, Maleisië, 88586
        • Hospital Raja Permaisuri Bainun
      • Kuala Lumpur, Maleisië, 59100
        • University Malaya Medical Centre
      • Kuantan, Maleisië, 25100
        • Hospital Tengku Ampuan Afzan
  • Nederland
      • Amsterdam, Nederland, 1091 AC
        • Onze Lieve Vrouwe Gasthuis
      • Rotterdam, Nederland, 3045 PM
        • Sint Franciscus Gasthuis
      • Tilburg, Nederland, 5022 GC
        • Elisabeth-TweeSteden Ziekenhuis
  • Nieuw-Zeeland
      • Christchurch, Nieuw-Zeeland, 8011
        • Christchurch Hospital
      • Dunedin, Nieuw-Zeeland, 9016
        • Dunedin Hospital
  • Polen
      • Bialystok, Polen, 15-322
        • Gastromed Kralisz Romatowski Stachurska Sp. j.
      • Bydgoszcz, Polen, 85 231
        • NZOZ Centrum Medyczne KERmed
      • Chojnice, Polen, 89-600
        • Centrum Medyczne Lukamed
      • Chojnice, Polen, 89 600
        • Centrum Medyczne Lukamed Sp z o o
      • Chrzanów, Polen, 32-500
        • Sahlgrenska University Hospital
      • Knurów, Polen, 44 190
        • MZ Badania Slowik Zymla Spolka jawna
      • Krakow, Polen, 30 149
        • Malopolskie Centrum Kliniczne
      • Krakow, Polen, 30 363
        • Centrum Medyczne Plejady
      • Krakow, Polen, 31 637
        • Centrum Medyczne ProMiMed
      • Lodz, Polen, 90-752
        • IP Clinic Sp. z o.o.
      • Lodz, Polen, 91 034
        • Centrum Medyczne Med Gastr
      • Lodz, Polen, 90-644
        • AmiCare Centrum Medyczne
      • Lublin, Polen, 20-412
        • ETG Lublin
      • Lublin, Polen, 20 582
        • REUMED Zespol Poradni Specjalistycznych Filia nr 2
      • Nowy Targ, Polen, 34 400
        • Allmedica
      • Olsztyn, Polen, 10 561
        • Wojewodzki Szpital Specjalistyczny w Olsztynie
      • Opole, Polen, 45-819
        • Twoja Przychodnia 1
      • Piotrkow Trybunalski, Polen, 97 300
        • Centrum Medyczne
      • Poznan, Polen, 60 309
        • EMC Instytut Medyczny SA PL CERTUS
      • Poznan, Polen, 61 441
        • Synexus Polska Sp z o o
      • Poznan, Polen, 61 324
        • Twoja Przychodnia
      • Rzeszów, Polen, 35-326
        • Centrum Medyczne Medyk
      • Skorzewo, Polen, 60-185
        • Centrum Medyczne Promed
      • Sopot, Polen, 81-756
        • Endoskopia Sp z o.o.
      • Sosnowiec, Polen, 41-200
        • Kiepury Clinic
      • Straszów, Polen, 28 200
        • KO Med Centrum Medyczne
      • Szczecin, Polen, 71-434
        • Twoja Przychodnia - Szczecinskie Centrum Medyczne
      • Szczecin, Polen, 71-685
        • Sonomed Sp. z o.o.
      • Torun, Polen, 87 100
        • GASTROMED Kopon Zmudzinski i wspolnicy SP j Specjalistyczne Centrum Gastrologii i Endoskopii
      • Tychy, Polen, 43-100
        • H-T Centrum Medyczne Endoterapia
      • Warsaw, Polen, 02-507
        • Centralny Szpital Kliniczny MSWiA w Warszawie
      • Warsaw, Polen, 02 653
        • Endoterapia
      • Warsaw, Polen, 00 632
        • Centrum Zdrowia Matki Dziecka i Mlodziezy
      • Warsaw, Polen, 02 798
        • Medical Concierge Centrum Medyczne
      • Warsaw, Polen, 03 580
        • NZOZ Vivamed
      • Warsaw, Polen, 03-712
        • Gabinety Lekarskie Bodyclinic
      • Warsaw, Polen, 04-501
        • IBD Point Profesor Kierkus
      • Wierzchosławice, Polen, 33-122
        • Centrum Zdrowia Tuchow
      • Wroclaw, Polen, 50-556
        • Uniwersytecki Szpital Kliniczny im. J. Mikulicza-Radeckiego
      • Wroclaw, Polen, 53 149
        • Przychodnia Vistamed
      • Wroclaw, Polen, 53 611
        • Centrum Medyczne Melita Medical
      • Wroclaw, Polen, 50-449
        • Centrum Medyczne Melita Medical 2
      • Włocławek, Polen, 87-800
        • Centrum Diagnostyczno - Lecznicze Barska sp. z o.o. Szpital Specjalistyczny Barska
      • Zamość, Polen, 22-400
        • Pro Life Medica Sp z o o ETG Zamosc
  • Slowakije
      • Banská Bystrica, Slowakije, 974 01
        • FNsP F.D.R. Banska Bystrica
      • Košice, Slowakije, 040 13
        • ENDOMED s.r.o
      • Prešov, Slowakije, 080 01
        • GASTRO I. s.r.o.
  • Spanje
      • Gijón, Spanje, 33394
        • Hosp. de Cabuenes
      • Huelva, Spanje, 21005
        • Hosp. Gral. Juan Ramon Jimenez
      • Huelva, Spanje, 21002
        • Hosp. Gral. Juan Ramon Jimenez 1
      • Madrid, Spanje, 28031
        • Hosp. Univ. Infanta Leonor
      • Seville, Spanje, 41009
        • Hosp. Virgen Macarena
      • Vigo, Spanje, 36213
        • Hosp. Alvaro Cunqueiro
      • Villajoyosa, Spanje, 03570
        • Hosp. de La Marina Baixa
  • Taiwan
      • 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
  • Tsjechië
      • Brno, Tsjechië, 636 00
        • Fakultni nemocnice Brno
      • Hradec Králové, Tsjechië, 500 05
        • Fakultni nemocnice Hradec Kralove
      • Kladno, Tsjechië, 27259
        • Oblastni nemocnice Kladno a.s.
      • Prague, Tsjechië, 100 34
        • Fakultni nemocnice Kralovske Vinohrady
      • Slaný, Tsjechië, 274 01
        • Nemocnice Slany
  • Turkije (Türkiye)
      • Ankara, Turkije (Türkiye), 06100
        • Ankara Numune Egitim ve Arastirma Hastanesi
      • Ankara, Turkije (Türkiye), 06230
        • Hacettepe University Hospital
      • Ankara, Turkije (Türkiye), 06560
        • Gazi University Medical Faculty
      • Istanbul, Turkije (Türkiye), 34349
        • Acibadem Fulya Hospital
      • Izmir, Turkije (Türkiye), 35040
        • Ege Universitesi Tip Fakultesi
      • Mersin, Turkije (Türkiye), 33343
        • Mersin University Medical Faculty
      • Samsun, Turkije (Türkiye), 55420
        • Ondokuz Mayis University
      • Zonguldak, Turkije (Türkiye), 67000
        • Bülent Ecevit Üniversitesi Sağlık Uygulama ve Araştırma Hastanesi
  • Verenigde Staten
    • Alabama
      • Dothan, Alabama, Verenigde Staten, 36305
        • Digestive Health Specialists of the Southeast
    • Arizona
      • Chandler, Arizona, Verenigde Staten, 85224-1636
        • Advanced Gastro P.C
      • Scottsdale, Arizona, Verenigde Staten, 85260
        • Reliance Research
    • Arkansas
      • Little Rock, Arkansas, Verenigde Staten, 72205-6414
        • Moore Clinical Trials, LLC
      • Little Rock, Arkansas, Verenigde Staten, 72223
        • Central Arkansas Veterans Healthcare System
    • California
      • Anaheim, California, Verenigde Staten, 92805
        • Clinnova Research
      • Lancaster, California, Verenigde Staten, 93534
        • Om Research LLC
      • Lancaster, California, Verenigde Staten, 93534
        • Om Research LLC 1
      • Los Alamitos, California, Verenigde Staten, 90720
        • United Gastroenterologists
      • Los Angeles, California, Verenigde Staten, 90048
        • Paul Wallace MD
      • Pasadena, California, Verenigde Staten, 77505-3950
        • Digestive System Healthcare
      • San Diego, California, Verenigde Staten, 92103
        • Clinical Applications Laboratories, Inc
      • San Diego, California, Verenigde Staten, 92103-2120
        • Northshore Gastroenterology Research, LLC
      • Santa Maria, California, Verenigde Staten, 93454
        • Santa Maria Gastroenterology
      • Walnut Creek, California, Verenigde Staten, 94598
        • Clinical Research of California
    • Colorado
      • Grand Junction, Colorado, Verenigde Staten, 81505-1027
        • Amel Med LLC Research
    • Connecticut
      • Danbury, Connecticut, Verenigde Staten, 06810
        • Western Connecticut Health Network/Danbury Hospital
    • Florida
      • Clearwater, Florida, Verenigde Staten, 33762-5323
        • Gastroenterology Associates of SW Florida
      • Coconut Creek, Florida, Verenigde Staten, 33066
        • Pioneer Research Solutions Inc.
      • DeBary, Florida, Verenigde Staten, 32713
        • Omega Research Consultants
      • Hialeah, Florida, Verenigde Staten, 33016
        • Harmony Medical Research Institute, Inc.
      • Kissimmee, Florida, Verenigde Staten, 34741
        • Central Florida Gastro Research
      • Miami, Florida, Verenigde Staten, 33155
        • Community Research Foundation, Inc.
      • Naples, Florida, Verenigde Staten, 34102
        • Gastroenterology Group Of Naples
      • Orlando, Florida, Verenigde Staten, 32803-1853
        • Center for Digestive Health
      • Orlando, Florida, Verenigde Staten, 32819
        • Central Florida Internists
      • St. Petersburg, Florida, Verenigde Staten, 33705
        • Synergy Clinical Research
    • Georgia
      • Atlanta, Georgia, Verenigde Staten, 30328
        • Agile Clinical Research Trials, LLC
      • Atlanta, Georgia, Verenigde Staten, 30224
        • Atlanta Gastroenterology Specialists, PC
      • Decatur, Georgia, Verenigde Staten, 30033
        • Atlanta Center For Gastroenterology
      • Macon, Georgia, Verenigde Staten, 31201
        • Gastroenterolgy Associates of Central GA
      • Roswell, Georgia, Verenigde Staten, 30076-4943
        • Gastroenterology Consultants
    • Idaho
      • Boise, Idaho, Verenigde Staten, 83706
        • USF Asthma, Allergy, Immunology Clinical Research Unit
      • Idaho Falls, Idaho, Verenigde Staten, 83404
        • Grand Teton Research Group, PLLC
    • Illinois
      • Oakbrook Terrace, Illinois, Verenigde Staten, 60618
        • Lemah Creek Clinical Research
    • Kansas
      • Kansas City, Kansas, Verenigde Staten, 66103-2937
        • University of Kansas Medical Center
      • Leawood, Kansas, Verenigde Staten, 66211
        • BVL Clinical Research
      • Topeka, Kansas, Verenigde Staten, 66606
        • Cotton O'Neil Digestive Health Center
    • Kentucky
      • Crestview Hills, Kentucky, Verenigde Staten, 41017
        • Tri-State Gastroenterology Assoc
    • Louisiana
      • Marrero, Louisiana, Verenigde Staten, 70072
        • Tandem Clinical Research
    • Maryland
      • Baltimore, Maryland, Verenigde Staten, 21202-2102
        • Institute for Digestive Health and Liver Disease
      • Glen Burnie, Maryland, Verenigde Staten, 21061
        • Woodholme Gastroenterology Associates
    • Massachusetts
      • Chelmsford, Massachusetts, Verenigde Staten, 01824
        • Digestive Health Specialists PC
      • South Dartmouth, Massachusetts, Verenigde Staten, 02747
        • FC Research, LLC
    • Michigan
      • Chesterfield, Michigan, Verenigde Staten, 48047
        • Clinical Research Institute of Michigan, LLC
      • Livonia, Michigan, Verenigde Staten, 48152
        • Detroit Clinical Research Center
    • Mississippi
      • Jackson, Mississippi, Verenigde Staten, 39216
        • University of Mississippi Medical Center
    • New York
      • Brooklyn, New York, Verenigde Staten, 11203
        • SUNY Downstate Medical Center
      • Jackson Heights, New York, Verenigde Staten, 11372
        • Smart Medical Research
      • Middletown, New York, Verenigde Staten, 10941
        • Crystal Run Healthcare LLP
      • New York, New York, Verenigde Staten, 10075
        • New York Gastroenterology Associates
      • North Massapequa, New York, Verenigde Staten, 11758
        • DiGiovanna Institute for Medical Education & Research
      • Queens, New York, Verenigde Staten, 11375
        • A1 Clinical Network
    • North Carolina
      • Charlotte, North Carolina, Verenigde Staten, 28207
        • Carolinas Medical Center
      • Charlotte, North Carolina, Verenigde Staten, 28277
        • Onsite Clinical Solutions
      • Greenville, North Carolina, Verenigde Staten, 27834
        • Carolina Research
      • Winston-Salem, North Carolina, Verenigde Staten, 27103
        • Gastroenterology Associates of the Piedmont, P.A.
    • Ohio
      • Columbus, Ohio, Verenigde Staten, 43214
        • Central Ohio Endoscopy Center LLC
      • Dayton, Ohio, Verenigde Staten, 45440
        • Dayton Gastroenterology, Inc
      • Mentor, Ohio, Verenigde Staten, 44060
        • Great Lakes Gastroenterology
    • Oklahoma
      • Oklahoma City, Oklahoma, Verenigde Staten, 73104
        • Oklahoma University Health Science Center
      • Oklahoma City, Oklahoma, Verenigde Staten, 73112
        • Integris Baptist Office
      • Oklahoma City, Oklahoma, Verenigde Staten, 73120
        • Central Sooner Research
      • Tulsa, Oklahoma, Verenigde Staten, 74137-7061
        • Essential Medical Research
    • Oregon
      • Portland, Oregon, Verenigde Staten, 97220-9428
        • The Oregon Clinic
    • Pennsylvania
      • Smithfield, Pennsylvania, Verenigde Staten, 15478
        • Frontier Clinical Research
    • South Carolina
      • Greenville, South Carolina, Verenigde Staten, 29615
        • Gastroenterology Associates P.A.
      • Myrtle Beach, South Carolina, Verenigde Staten, 29572
        • Carolina Health Specialists
    • Texas
      • Lubbock, Texas, Verenigde Staten, 79424
        • West Texas Clinical Research
      • Richmond, Texas, Verenigde Staten, 77407
        • Victoria Gastroenterology
      • San Antonio, Texas, Verenigde Staten, 78229
        • Gastroenterology Clinic Of San Antonio P A
      • San Antonio, Texas, Verenigde Staten, 78232
        • Wellness Clinical Research
      • Southlake, Texas, Verenigde Staten, 76092
        • Texas Digestive Disease Consultants
      • Tyler, Texas, Verenigde Staten, 75701
        • Digestive Health Specialists of Tyler
    • Utah
      • Salt Lake City, Utah, Verenigde Staten, 84124
        • Care Access Research- Salt Lake City
    • Virginia
      • Burke, Virginia, Verenigde Staten, 22015
        • Burke Internal Medicine and Research
      • Chesapeake, Virginia, Verenigde Staten, 23320
        • Gastroenterology Associates of Tidewater
  • Zuid -Korea
      • Busan, Zuid -Korea, 41404
        • Kyungpook National University Chilgok Hospital
      • Busan, Zuid -Korea, 48108
        • Inje University Haeundae Paik Hospital
      • Busan, Zuid -Korea, 49267
        • Kosin University Gospel Hospital
      • Busan, Zuid -Korea, 602739
        • DongA Medical Center
      • Daegu, Zuid -Korea, 42415
        • Yeungnam University Medical Center
      • Daejeon, Zuid -Korea, 34943
        • The Catholic University of Korea Seoul St.Mary's Hospital
      • Dongdaemun-gu, Zuid -Korea, 02447
        • Kyung Hee University Hospital
      • Goyang-si, Zuid -Korea, 10326
        • Dongguk University Ilsan Hospital
      • Gwangju, Zuid -Korea, 61469
        • Chonnam National University Hospital
      • Gyeonggi-do, Zuid -Korea, 13496
        • CHA Bundang Medical Center, CHA University
      • Gyeonggi-do, Zuid -Korea, 16247
        • The Catholic university of Korea, St. Vincent's Hospital
      • Seoul, Zuid -Korea, 06351
        • Samsung Medical Center
      • Seoul, Zuid -Korea, 03181
        • Kangbuk Samsung Hospital
      • Seoul, Zuid -Korea, 03722
        • Yonsei University College of Medicine
      • Seoul, Zuid -Korea, 06591
        • The Catholic University of Korea Seoul St Mary s Hospital
      • Suwon, Zuid -Korea, 16499
        • Ajou University Hospital
      • Wŏnju, Zuid -Korea, 26426
        • Wonju Christian Hospital
      • Yangch’ŏn-gu, Zuid -Korea, 07985
        • Ewha Womans University Mokdong Hospital

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Dubbele

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Group 1: Guselkumab

Participants will receive guselkumab (Dose 1) injection subcutaneously followed by guselkumab (Dose 2) injection subcutaneously.
Geneesmiddel: Guselkumab Dose 1

Guselkumab (Dose 1) will be administered by subcutaneous (SC) injection.

Geneesmiddel: Guselkumab Dose 2

Guselkumab (Dose 2) will be administered by SC injection.
Experimenteel: Group 2: Guselkumab

Participants will receive guselkumab (Dose 1) injection subcutaneously followed by guselkumab (Dose 3) injection subcutaneously.
Geneesmiddel: Guselkumab Dose 1

Guselkumab (Dose 1) will be administered by subcutaneous (SC) injection.

Geneesmiddel: Guselkumab Dose 3

Guselkumab (Dose 3) will be administered by SC injection.
Placebo-vergelijker: Group 3: Placebo

Participants will receive placebo injection subcutaneously.
Geneesmiddel: Placebo

Placebo will be administered by SC injection.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Percentage of Participants Who Achieved Clinical Remission at Week 12
Tijdsspanne: 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
Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Percentage of Participants Who Achieved Clinical Remission at Week 24
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Janssen Research & Development, LLC

Onderzoekers

  • Studie directeur: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

19 januari 2022

Primaire voltooiing (Werkelijk)

4 juli 2023

Studie voltooiing (Geschat)

30 oktober 2028

Studieregistratiedata

Eerst ingediend

17 januari 2022

Eerst ingediend dat voldeed aan de QC-criteria

17 januari 2022

Eerst geplaatst (Werkelijk)

19 januari 2022

Updates van studierecords

Laatste update geplaatst (Werkelijk)

25 september 2026

Laatste update ingediend die voldeed aan QC-criteria

24 september 2026

Laatst geverifieerd

1 september 2026

Meer informatie

Termen gerelateerd aan deze studie

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • CR109125
  • 2020-006165-11 (EudraCT-nummer)
  • CNTO1959CRD3004 (Andere identificatie: Janssen Research & Development, LLC)
  • 2023-504737-41-00 (Register-ID: EUCT number)
  • 2023 (Subsidie/contract van de Amerikaanse NIH)

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

JA

Beschrijving IPD-plan

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

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Ja

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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