Crohn's Disease Clinical Trial
— DUET-CDOfficial title:
A Phase 2b Randomized, Double-blind, Active-and Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy and Safety of Induction and Maintenance Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Crohn's Disease
The purpose of this study is to evaluate the efficacy of JNJ-78934804 at Week 48 compared to guselkumab and golimumab.
| Status | Recruiting |
| Enrollment | 715 |
| Est. completion date | March 27, 2029 |
| Est. primary completion date | May 27, 2025 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 65 Years |
| Eligibility | Inclusion Criteria: - Diagnosis of Crohn's disease (CD) for at least 3 months prior to baseline - Confirmed diagnosis of moderate to severe CD as assessed by Crohn's disease activity index (CDAI), stool frequency (SF), abdominal pain (AP) score and simple endoscopic score for Crohn's disease (SES-CD) - Demonstrated inadequate response, loss of response, or intolerance to at least one biologic approved for the treatment of Crohn's disease - If female and of childbearing potential, must meet the contraception and reproduction requirements Exclusion Criteria: - Complications of CD that may be anticipated to require surgery - Currently has or is suspected to have an abscess. Recent cutaneous and perianal abscesses are not exclusionary if drained and adequately treated at least 3 weeks before baseline, or 8 weeks before baseline for intra-abdominal abscesses, provided that there is no anticipated need for any further surgery - Has had any kind of bowel resection within 24 weeks, or any other intra-abdominal or other major surgery within 12 weeks - Has a draining (example, functioning) stoma or ostomy - Currently has a malignancy or has a history of malignancy within 5 years before screening (with the exception of a nonmelanoma skin cancer or cervical carcinoma in situ that has been adequately treated with no evidence of recurrence for greater than or equal do (>=) 12 months before the first dose of study intervention) - Has a history of, or ongoing, chronic or recurrent infectious disease, including but not limited to, sinopulmonary infections, bronchiectasis, recurrent renal/urinary tract infections (example, pyelonephritis, cystitis), an open, draining, or infected skin wound, or an ulcer |
| Country | Name | City | State |
|---|---|---|---|
| Australia | The Queen Elizabeth Hospital | Adelaide | |
| Australia | Box Hill Hospital | Box Hill | |
| Australia | Monash Health, Monash Medical Centre | Clayton | |
| Australia | Western Health | Footscray | |
| Australia | St Vincent's hospital | Melbourne | |
| Australia | Royal Prince Alfred Hospital | Newtown | |
| Australia | Royal Adelaide Hospital | North Terrace | |
| Australia | Royal Melbourne Hospital | Parkville | |
| Austria | Landeskrankenhaus Salzburg, Universitätsklinik f. Innere Medizin III | Salzburg | |
| Austria | Akh Wien | Vienna | |
| Austria | Klinikum Wels Grieskirchen | Wels | |
| Austria | Akh Wien | Wien | |
| Belgium | GZA Ziekenhuizen | Antwerpen | |
| Belgium | Algemeen Ziekenhuis Sint-Jan | Brugge | |
| Belgium | Cliniques Universitaires Saint Luc | Bruxelles | |
| Belgium | AZ Maria Middelares | Gent | |
| Belgium | UZ Leuven | Leuven | |
| Belgium | CHU de Liege | Liege | |
| Belgium | CHC MontLegia | Liège | |
| Belgium | Az Sint-Maarten | Mechelen | |
| Belgium | Algemeen Ziekenhuis Delta | Roeselare | |
| Belgium | Vitaz | Sint-Niklaas | |
| Brazil | Hospital Das Clinicas Da Ufmg | Belo Horizonte - MG | |
| Brazil | Fundacao para o Desenvolvimento Medico Hospitalar (UNESP Botucatu) | Botucatu | |
| Brazil | Chronos Clinica Medica Ltda | Brasilia | |
| Brazil | Impar Servicos Hospitalares S/A - Hospital Brasilia | Brasilia | |
| Brazil | Centro Digestivo de Curitiba - Instituto de Pesquisa Clínica | Curitiba | |
| Brazil | Centro de Estudos Clínicos do Interior Paulista - CECIP | Jau | |
| Brazil | Liga Norte Riograndense Contra O Cancer | Natal | |
| Brazil | Associacao Hospitalar Moinhos de Vento | Porto Alegre | |
| Brazil | Hospital das Clinicas de Porto Alegre | Porto Alegre | |
| Brazil | NPCRS Nucleo de Pesquisa Clinica do Rio Grande do Sul | Porto Alegre | |
| Brazil | Santa Casa de Misericordia de Porto Alegre | Porto Alegre | |
| Brazil | Hospital Das Clinicas Da Faculdade De Medicina De RPUSP HCRP | Ribeirao Preto | |
| Brazil | Universidade Federal do Rio de Janeiro - Faculdade de Medicina | Rio de Janeiro | |
| Brazil | Pesquisare Saude | Santo Andre | |
| Brazil | Irmandade da Santa Casa da Misericórdia de Santos | Santos | |
| Brazil | Kaiser Hospta | São José Do Rio Preto | |
| Brazil | BR Trials | Sao Paulo | |
| Brazil | CPQuali Pesquisa Clinica LTDA ME | Sao Paulo | |
| Brazil | Hepatogastro | Sao Paulo | |
| Brazil | Instituto de Assistencia Medica ao Servidor Publico Estadual IAMSPE | Sao Paulo | |
| Brazil | Instituto D Or de Pesquisa e Ensino (IDOR) | São Paulo | |
| Bulgaria | MHAT Tzaritza Joanna | Sofia | |
| Bulgaria | UMHAT 'Aleksandrovska' EAD | Sofia | |
| Canada | Barrie GI Associates | Barrie | Ontario |
| Canada | Viable Clinical Research | Bridgewater | |
| Canada | Foothills Hospital | Calgary | Alberta |
| Canada | Viable Clinical Research | Dartmouth | Nova Scotia |
| Canada | Covenant Health/Grey Nuns hospital | Edmonton | Alberta |
| Canada | Gastroenterology and Internal Medicine Research Institute (GIRI) | Edmonton | Alberta |
| Canada | University of Alberta Hospital | Edmonton | Alberta |
| Canada | Nova Scotia Health Authority | Halifax | Nova Scotia |
| Canada | London Health Sciences Centre | London | Ontario |
| Canada | CIUSSS de l'Est-de-l'Île-de-Montréal Installation Hôpital Maisonneuve-Rosemont | Montreal | Quebec |
| Canada | McGill University - Health Centre - Montreal General Hospital | Montreal | Quebec |
| Canada | Fraser Clinical Trials Inc. | New Westminster | British Columbia |
| Canada | Hopital Chicoutimi | Saguenay | |
| Canada | St. Jerome Medical Research | Saint-Jerome | Quebec |
| Canada | Royal University Hospital | Saskatoon | Saskatchewan |
| Canada | Toronto Immune & Digestive Health Institute Inc. | Toronto | Ontario |
| Canada | GIRI Gastrointestinal Research Institute | Vancouver | British Columbia |
| Canada | The Gordon & Leslie Diamond Health Care Center | Vancouver | British Columbia |
| Canada | The Medical Arts Health Research Group | Vancouver | British Columbia |
| Canada | PerCuro Clinical Research Ltd. | Victoria | British Columbia |
| Canada | CMIIM, Centre médical L'Enjeu | Ville Mont-Royal | Quebec |
| Canada | Winnipeg Health Sciences Centre | Winnipeg | Manitoba |
| China | China Japan Friendship Hospital | Beijing | |
| China | The second Xiangya Hospital of Central South University | Changsha | |
| China | Changzhou No 2 Peoples Hospital | Changzhou City | |
| China | West China Hospital Sichuan University | Chengdu | |
| China | Chongqing Medical University | Chongqing | |
| China | The First People's Hospital of Foshan | Foshan | |
| China | Guangzhou First Municipal People's Hospital | Guangzhou | |
| China | Sun Yat-sen University - The Sixth Affiliated Hospital Guangdong Gastrointestinal Hospital | Guangzhou | |
| China | Hainan General Hospital | Haikou | |
| China | Sir Run Run Shaw Hospital, Zhejiang University School of Medicine | Hangzhou | |
| China | Jinhua municipal central hospital | Jinhua | |
| China | The First Affiliated Hospital of NanChang University | Nanchang | |
| China | Nanjing Drum Tower Hospital | Nanjing | |
| China | Zhongda Hospital Southeast University | Nanjing | |
| China | Ruijin Hospital Shanghai Jiao Tong University | Shanghai | |
| China | Shanghai East Hospital | Shanghai | |
| China | Renmin Hospital of Wuhan University | Wuhan | |
| China | The Central Hospital of Wuhan | Wuhan | |
| China | Wuhan Union Hospital | Wuhan | |
| China | Wuxi People s Hospital | Wuxi | |
| China | Zhongshan Hospital, Xiamen University | Xiamen | |
| China | Yangzhou First People's Hospital | Yangzhou | |
| China | ZhuZhou Central Hospital | ZhuZhou | |
| Croatia | Opca bolnica Bjelovar | Bjelovar | |
| Croatia | University Hospital Center Split | Split | |
| Croatia | University Hospital Dubrava | Zagreb | |
| Czechia | Vojenska nemocnice Brno | Brno | |
| Czechia | ISCARE a.s. | Praha 9 | |
| Czechia | Detska klinika Masarykovy nemocnice v Usti nad Labem | Usti nad Labem | |
| Denmark | Aarhus University Hospital | Aarhus | |
| Denmark | Bispebjerg Og Frederiksberg Hospital | Copenhagen | |
| Denmark | Herlev Hospital, University of Copenhagen | Herlev | |
| Denmark | Odense Universitetshospital | Odense | |
| Estonia | Tallinn Children's Hospital | Tallinn | |
| Estonia | West Tallinn Central Hospital | Tallinn | |
| Estonia | Tartu University Hospital | Tartu | |
| France | CHU Amiens - Hopital Sud | AMIENS cedex 1 | |
| France | CHRU De Besancon | Besancon | |
| France | Centre Hospitalier Universitaire(CHU) - Hopital Henri Mondor | Créteil | |
| France | CHU Grenoble | Grenoble | |
| France | Hopital Nord Marseille | Marseille | |
| France | CHU de Nantes hotel Dieu | Nantes | |
| France | Clinique Ambroise Pare | Neuilly-sur-Seine | |
| France | CHU de Nice Hopital de l Archet | Nice | |
| France | Hopital Saint Louis - Service de Gastro-Entérologie, 1 Avenue Claude Vellefaux | Paris | |
| France | Centre Hospitalier Lyon Sud | Pierre-Bénite | |
| France | CHRU Hopital de Pontchaillou | Rennes | |
| France | Hôpital Yves Le Foll | Saint-Brieuc | |
| France | Centre hospitalier universitaire de St Etienne | Saint-Etienne | |
| France | CHU Rangueil | Toulouse | |
| France | CHRU Nancy Brabois | Vandoeuvre les Nancy | |
| Germany | Charite Campus Benjamin Franklin | Berlin | |
| Germany | Charite Universitaetsmedizin Berlin - Campus Charite Mitte | Berlin | |
| Germany | Krankenhaus Waldfriede Mitte | Berlin | |
| Germany | Praxis Für Gastroenteroligie | Berlin | |
| Germany | Gastroenterologische Spezialpraxis - Berlin-Karlshorst | Berlin-Karlshorst | |
| Germany | Medizinisches Versorgungszentrum (MVZ) Dachau | Dachau | |
| Germany | University Hospital Dresden | Dresden | |
| Germany | MVZ Sanaklinikum Duisburg | Duisburg | |
| Germany | Universitaetsklinik Erlangen | Erlangen | |
| Germany | Universitaetsklinikum Essen | Essen | |
| Germany | JWG-University Hospital | Frankfurt | |
| Germany | Agaplesion Frankfurter Diakonie Kliniken GmbH, Markus Krankenhaus | Frankfurt/Main | |
| Germany | Universitatsklinikum Freiburg | Freiburg | |
| Germany | Klinikum Fulda - Tumorklinik - Germany | Fulda | |
| Germany | Curiositas ad Sanum Studien und Beratungs GmBH | Haag | |
| Germany | BSF Studiengesellschaft | Halle | |
| Germany | Martin-Luther-Universitaet Halle-Wittenberg - Universitaetsk | Halle Saale | |
| Germany | CTC North GmbH & Co. KG, Am Universitätsklinikum Hamburg-Eppendorf | Hamburg | |
| Germany | Medizinische Hochschule Hannover | Hannover | |
| Germany | Gastroenterology Outpatient Clinic Prof. Ehehalt/Dr. Hemstäd | Heidelberg | |
| Germany | University Hospital Heidelberg | Heidelberg | |
| Germany | Universitatsklinikum Jena | Jena | |
| Germany | Praxisgemeinschaft Jerichow | Jerichow | |
| Germany | Gastroenterologie Opernstrasse | Kassel | |
| Germany | Universitatsklinikum Schleswig Holstein Kiel | Kiel | |
| Germany | Evangelisches Krankenhaus Kalk | Köln | |
| Germany | Eugastro GmbH | Leipzig | |
| Germany | Staedtisches Klinikum Lueneburg | Lueneburg | |
| Germany | Medizinische Fakultät Mannheim der Universität Heidelberg | Mannheim | |
| Germany | Gastroenterologische Gemeinschaftspraxis Minden | Minden | |
| Germany | Klinikum der Universitaet Muenchen | Munich | |
| Germany | Universitatsklinikum Munster | Munster | |
| Germany | MVZ Portal 10 | Münster | |
| Germany | Medius Klinik Nürtingen | Nürtingen | |
| Germany | Universitaetsklinikum Regensburg | Regensburg | |
| Germany | Universitaetsmedizin Rostock | Rostock | |
| Germany | Zentrum für Gastroenterologie Saar MVZ GmbH | Saarbrücken | |
| Germany | Universitatsklinikum Tubingen | Tübingen | |
| Germany | Universitatsklinikum Ulm | Ulm | |
| Germany | Universitatsklinikum Wurzburg | Würzburg | |
| Greece | General Hospital of Athens 'Ippokrateion' | Athens | |
| Greece | Sotiria General State Hospital of Chest Diseases | Athens | |
| Greece | Hippokration Hospital | Thessaloniki | |
| Hungary | Obudai Egeszsegugyi Centrum Kft | Budapest | |
| Hungary | Semmelweis Egyetem | Budapest | |
| Hungary | Semmelweis Egyetem I.Belgyogyaszati Klinika | Budapest | |
| Hungary | Bugat Pal Korhaz | Gyongyos | |
| Hungary | Szegedi Tudomanyegyetem | Szeged | |
| Hungary | Markusovszky Egyetemi Oktatokorhaz | Szombathely | |
| India | ICON Hospital Orchid Medi services and Research Private Limited | Ahmedabad | |
| India | M S Ramaiah Medical College and Hospital | Bengaluru | |
| India | Siksha O Anusandhan University - Institute of Medical Scienc | Bhubaneswar | |
| India | Srm Institutes For Medical Science (Sims) | Chennai | |
| India | Fortis Memorial Research Institute | Gurugram | |
| India | Asian Institute Of Gastroenterology | Hyderabad | |
| India | Yashoda Super Speciality Hospitals | Hyderabad | |
| India | P.D. Hinduja National Hospital and - Medical Research Center | Mumbai | |
| India | All India Institute of Medical Sciences | New Delhi | |
| India | Yashoda Super Speciality Hospitals | Secunderabad | |
| India | Gujarat Gastro and Vascular Hospital | Surat | |
| India | Surat Institute of Digestive Sciences Hospitals | Surat | |
| Israel | Haemek Medical Center - Afula | Afula | |
| Israel | Bnai Zion Medical Center | Haifa | |
| Israel | Rambam Medical Center | Haifa | |
| Israel | Hadassah Hebrew University Medical Center | Jerusalem | |
| Israel | Shaare Zedek Medical Center | Jerusalem | |
| Israel | Rabin Med Ctr Beilinson Hosp | Petah Tikva | |
| Israel | Kaplan Medical Center | Rehovot | |
| Israel | Tel Aviv Sourasky Medical Center | Tel Aviv | |
| Israel | The Chaim Sheba Medical Center | Tel Hashomer | |
| Israel | Assaf Harofeh Medical Center | Tzrifin | |
| Italy | Università degli Studi di Bari | Bari | |
| Italy | A.O. Per L' Emergenza Cannizzaro - U.O. Chirurgia Generale | Catania | |
| Italy | AOU Policlinico G.Martino | Messina | |
| Italy | Ospedale San Raffaele | Milano | |
| Italy | Ospedale Specializzato in Gastroenterologia Saverio de Bellis | Monopoli | |
| Italy | Azienda Ospedaliero Universitaria di Cagliari - Policlinico Duilio Casula di Monserrato | Monserrato | |
| Italy | Azienda Ospedaliera San Gerardo | Monza | |
| Italy | Ospedale Classificato Equiparato Sacro Cuore Don Calabria di Negrar | Negrar ( Ve) | |
| Italy | Ospedale Villa Sofia-Cervello | Palermo | |
| Italy | Catholic University of Sacred Hearth | Roma | |
| Italy | IRCCS Humanitas Rozzano-IBD Center Malattie Infiammatorie Croniche Intestinali | Rozzano | |
| Italy | Ospedale Molinette, AO Città della Salute e della Scienza di | Torino | |
| Japan | Asahikawa Medical University Hospital | Asahikawa | |
| Japan | Tokyo Medical and Dental University Hospital | Bunkyo Ku | |
| Japan | Fukuoka University Chikushi Hospital | Chikushino | |
| Japan | Fukuoka University Hospital | Fukuoka-shi | |
| Japan | Tokai University Hachioji Hospital | Hachioji | |
| Japan | Hamamatsu University Hospital | Hamamatsu | |
| Japan | Hirosaki University Hospital | Hirosaki | |
| Japan | National Hospital Organization Hirosaki General Medical Center | Hirosaki | |
| Japan | Hitachi General Hospital | Hitachi | |
| Japan | Hospital of the University of Occupational and Environmental Health | Hukuoka | |
| Japan | The Hospital of Hyogo College of Medicine | Hyogo | |
| Japan | Kagoshima IBD Gastroenterology Clinic | Kagoshima | |
| Japan | Kagoshima University Hospital | Kagoshima | |
| Japan | Ofuna Chuo Hospital | Kamakura | |
| Japan | Kanazawa University Hospital | Kanazawa | |
| Japan | Tsujinaka Hospital Kashiwanoha | Kashiwa | |
| Japan | Saitama Medical University Saitama Medical Center | Kawagoe | |
| Japan | Kyushu Rosai Hospital | Kitakyushu | |
| Japan | Kobe University Hospital | Kobe | |
| Japan | Japanese Red Cross Kumamoto Hospital | Kumamoto | |
| Japan | Kurume University Hospital | Kurume | |
| Japan | University Hospital Kyoto Perfectural University of Medicine | Kyoto | |
| Japan | Kyorin University Hospital | Mitaka | |
| Japan | Iwate Medical University Hospital | Morioka | |
| Japan | Nagaoka Red Cross Hospital | Nagaoka | |
| Japan | Nagasaki University Hospital | Nagasaki | |
| Japan | Nagoya University Hospital | Nagoya | |
| Japan | Niigata University Medical And Dental Hospital | Niigata | |
| Japan | Okayama University Hospital | Okayama-shi | |
| Japan | Japan Community Health Care Organization Osaka Hospital | Osaka | |
| Japan | Kinshukai Infusion Clinic | Osaka | |
| Japan | Osaka City University Hospital | Osaka | |
| Japan | Shiga University of Medical Science Hospital | Otsu | |
| Japan | Saga University Hospital | Saga-shi | |
| Japan | Tokitokai Tokito Clinic Coloproctology Center | Saitama | |
| Japan | Toho University Sakura Medical Center | Sakura | |
| Japan | Hokkaido P.W.F.A.C. Sapporo-Kosei General Hospital | Sapporo | |
| Japan | Sapporo Higashi Tokushukai Hospital | Sapporo | |
| Japan | Sapporo Medical University Hospital | Sapporo | |
| Japan | Sapporo Tokushukai Hospital | Sapporo | |
| Japan | Tohoku University Hospital | Sendai | |
| Japan | Dokkyo Medical University Hospital | Shimotsuga-gun | |
| Japan | Jichi Medical University Hospital | Shimotsuke | |
| Japan | Tokyo Women's Medical University Hospital | Shinjuku-Ku | |
| Japan | Tokyo Metropolitan Bokutoh Hospital | Sumida ku | |
| Japan | Takamatsu Red Cross Hospital | Takamatsu | |
| Japan | Kitasato University Kitasato Institute Hospital | Tokyo | |
| Japan | National Center for Global Health and Medicine | Tokyo | |
| Japan | The Jikei University Hospital | Tokyo | |
| Japan | Toyama Prefectural Central Hospital | Toyama | |
| Japan | Ieda Hospital | Toyota | |
| Japan | Mie University Hospital | Tsu | |
| Japan | Yokohama City University Medical Center | Yokohama | |
| Jordan | Abdali Hospital | Amman | |
| Jordan | Jordan University Hospital | Amman | |
| Jordan | Irbid Specialty Hospital | Irbid | |
| Jordan | King Abdullah University Hospital | Irbid | |
| Korea, Republic of | Inje University Haeundae Paik Hospital | Busan | |
| Korea, Republic of | Kosin University Gospel Hospital | Busan | |
| Korea, Republic of | Kyungpook National University Hospital | Daegu | |
| Korea, Republic of | Yeungnam University Hospital | Daegu | |
| Korea, Republic of | Dongguk University Ilsan Hospital | Goyang-si | |
| Korea, Republic of | Chosun university hospital | Gwangju | |
| Korea, Republic of | Hallym University Dongtan Sacred Heart Hospital | Hwaseong-si | |
| Korea, Republic of | Seoul National University Bundang Hospital | Seongnam-si | |
| Korea, Republic of | Asan Medical Center | Seoul | |
| Korea, Republic of | Gangnam Severance Hospital, Yonsei University Health System | Seoul | |
| Korea, Republic of | Kangbuk Samsung Hospital | Seoul | |
| Korea, Republic of | Kyung Hee University Hospital | Seoul | |
| Korea, Republic of | Severance Hospital Yonsei University Health System | Seoul | |
| Korea, Republic of | The Catholic University of Korea Seoul St.Mary's Hospital | Seoul | |
| Korea, Republic of | The Catholic University of Korea Seoul St.Mary's Hospital | Seoul | |
| Korea, Republic of | Ajou University Hospital | Suwon | |
| Malaysia | Hospital Sultanah Bahiyah | Alor Setar | |
| Malaysia | Hospital Ampang | Ampang | |
| Malaysia | Hospital Pulau Pinang | George Town | |
| Malaysia | University Malaya Medical Centre | Kuala Lumpur | |
| Netherlands | Academisch Medisch Centrum Universiteit van Amsterdam | Amsterdam | |
| Netherlands | Albert Schweitzer Ziekenhuis | Dordrecht | |
| Netherlands | Leiden University Medical Center | Leiden | |
| Netherlands | Maastricht Universitair Medisch Centrum | Maastricht | |
| Netherlands | Erasmus MC | Rotterdam | |
| Netherlands | UMC Utrecht | Utrecht | |
| New Zealand | Dunedin Hospital | Dunedin | |
| New Zealand | Hutt Hospital | Lower Hutt | |
| New Zealand | Wellington Hospital | Wellington | |
| Norway | Alesund sjukehus | Alesund | |
| Norway | Akershus Universitetssykehus | Lørenskog | |
| Norway | Oslo University Hospital HF Ulleval sykehus | Oslo | |
| Norway | Universitetssykehuset Nord-Norge HF | Tromso | |
| Poland | Szpital Uniwersytecki nr 2 im dr Jana Biziela w Bydgoszczy | Bydgoszcz | |
| Poland | Centrum Medyczne Plejady | Krakow | |
| Poland | Centrum Medyczne Promed | Krakow | |
| Poland | AmiCare Centrum Medyczne | Lodz | |
| Poland | Gastromed ZOZ | Lublin | |
| Poland | Wojewodzki Szpital Specjalistyczny w Olsztynie | Olsztyn | |
| Poland | Synexus Polska Sp. z o.o. | Poznan | |
| Poland | Twoja Przychodnia | Poznan | |
| Poland | Centrum Medyczne Medyk | Rzeszow | |
| Poland | Endoskopia Sp z o.o. | Sopot | |
| Poland | Sonomed Sp. z o.o. | Szczecin | |
| Poland | GASTROMED Sp. z o.o. | Torun | |
| Poland | Centralny Szpital Kliniczny Mswia | Warszawa | |
| Poland | Centrum Zdrowia Matki, Dziecka i Mlodziezy | Warszawa | |
| Poland | NZOZ Vivamed | Warszawa | |
| Poland | Reumatika-Centrum Reumatologii, NZOZ | Warszawa | |
| Poland | Wojskowy Instytut Medyczny | Warszawa | |
| Poland | Centrum Diagnostyczno - Lecznicze Barska sp. z o.o. Szpital Specjalistyczny Barska | Wloclawek | |
| Poland | Centrum Medyczne Oporow | Wroclaw | |
| Poland | Melita Medical Sp. z o.o. | Wroclaw | |
| Poland | ETG Zamosc | Zamosc | |
| Portugal | Centro Hospitalar Lisboa Norte EPE Hosp. Santa Maria | Lisboa | |
| Portugal | Hospital de Portimao-Centro Hospitalar do Barlavento Algarvio | Portimao | |
| Portugal | Centro Hospitalar Vila Nova de Gaia | Porto | |
| Portugal | Centro Hospitalar de Entre o Douro e Vouga, E.P.E | Santa Maria da Feira | |
| Singapore | Gi Associates Gastroenterology | Singapore | |
| Singapore | KL Ling Gastroenterology and Liver Clinic | Singapore | |
| Singapore | Singapore General Hospital | Singapore | |
| Singapore | Tan Tock Seng Hospital | Singapore | |
| Slovenia | Splosna bolnisnica Celje | Celje | |
| Slovenia | Univerzitetni klinicni center Ljubljana | Ljubljana | |
| South Africa | Worthwhile Clinical Trials Lakeview Hospital | Benoni | |
| South Africa | Clinical Research Centre University of Cape Town | Cape Town | |
| South Africa | Groote Schur Hospital | Cape Town | |
| South Africa | Inspired GI Care | Cape Town | |
| South Africa | Mediclinic Panorama | Cape Town | |
| South Africa | Hillcrest private | Durban | |
| Spain | Hosp. Univ. La Paz | Madrid | |
| Spain | Hosp. de Navarra | Pamplona | |
| Spain | Hosp. Montecelo | Pontevedra | |
| Spain | Corporacio Sanitari Parc Tauli | Sabadell | |
| Spain | Hosp. Univ. Marques de Valdecilla | Santander | |
| Spain | Hosp. Univ. de Torrejon | Torrejón de Ardoz | |
| Sweden | Universitetssjukhuset Orebro | Orebro | |
| Sweden | Karolinska University Hospital | Solna | |
| Sweden | Ersta sjukhus | Stockholm | |
| Switzerland | Universitatsspital Basel | Basel | |
| Switzerland | Gastroenterologische Praxis Balsiger und Seibold | Bern | |
| Switzerland | INSELSPITAL Universitatsspital Bern | Bern | |
| Switzerland | Kantonsspital St Gallen | St. Gallen | |
| Switzerland | UniversitaetsSpital Zuerich | Zuerich | |
| Taiwan | Chang-Hua Christian Hospital | Changhua | |
| Taiwan | China Medical University Hospital | Taichung | |
| Taiwan | National Cheng Kung University Hospital | Tainan | |
| Taiwan | National Taiwan University Hospital | Taipei | |
| United Kingdom | Royal Victoria Hospital | Belfast | |
| United Kingdom | University Hospitals Birmingham NHS Foundation Trust | Birmingham | |
| United Kingdom | Addenbrooke's Hospital | Cambridge | |
| United Kingdom | Glasgow Royal Infirmary | Glasgow | |
| United Kingdom | Queen Elizabeth University Hospital | Glasgow | |
| United Kingdom | Velocity Clinical Research | High Wycombe | |
| United Kingdom | St George's Healthcare NHS Trust | London | |
| United Kingdom | Whipps Cross University Hospital | London | |
| United Kingdom | John Radcliffe Hospital | Oxford | |
| United Kingdom | New Cross Hospital | Wolverhampton. | |
| United States | Om Research LLC | Apple Valley | California |
| United States | Valley Gastroenterology Medical Group | Arcadia | California |
| United States | Atlanta Gastroenterology Associates | Atlanta | Georgia |
| United States | University of Mississippi Medical Center | Atlanta | Georgia |
| United States | University of Colorado | Aurora | Colorado |
| United States | Amel Med LLC Research | Austin | Texas |
| United States | Washington Gastroenterology, PLLC | Bellevue | Washington |
| United States | University of Alabama Liver Center | Birmingham | Alabama |
| United States | University of North Carolina | Chapel Hill | North Carolina |
| United States | Medical University of South Carolina | Charleston | South Carolina |
| United States | Tryon Medical Group | Charlotte | North Carolina |
| United States | University of Virginia | Charlottesville | Virginia |
| United States | Brigham & Women's Hospital | Chestnut Hill | Massachusetts |
| United States | Chevy Chase Clinical Research | Chevy Chase | Maryland |
| United States | Northwestern University | Chicago | Illinois |
| United States | Cleveland Clinic | Cleveland | Ohio |
| United States | University Hospitals Case Medical Center | Cleveland | Ohio |
| United States | Pioneer Research Solutions Inc. | Coconut Creek | Florida |
| United States | Southern California Research Center | Coronado | California |
| United States | Tri-State Gastroenterology Assoc | Crestview Hills | Kentucky |
| United States | Baylor University Medical Center | Dallas | Texas |
| United States | UT Southwestern Medical Center | Dallas | Texas |
| United States | Gastrointestinal Associates LLP | Flowood | Mississippi |
| United States | Saint Francis Hospital | Germantown | Tennessee |
| United States | Northwell Health | Great Neck | New York |
| United States | Medical Research Center of Connecticut | Hamden | Connecticut |
| United States | Susquehanna Gastroenterology Associates | Harrisburg | Pennsylvania |
| United States | Galen Medical Group | Hixson | Tennessee |
| United States | Homestead Associates in Research Inc | Homestead | Florida |
| United States | Accurate Clinical Research | Houston | Texas |
| United States | Marshall Health Clinical Research Center | Huntington | West Virginia |
| United States | IU Health University Hospital | Indianapolis | Indiana |
| United States | A1 Clinical Research | Jackson Heights | New York |
| United States | Etsu Quillen College Of Medicine | Johnson City | Tennessee |
| United States | Osceola Mental Health D/B/A Park Place Behavioral Health Care | Kissimmee | Florida |
| United States | Gastroenterology Clinic of Acadiana | Lafayette | Louisiana |
| United States | Florida Research Center Inc. | Lakewood Ranch | Florida |
| United States | Desert Gastroenterology Associates | Lancaster | California |
| United States | Care Access Las Vegas | Las Vegas | Nevada |
| United States | Las Vegas Medical Research | Las Vegas | Nevada |
| United States | Dartmouth Hitchcock | Lebanon | New Hampshire |
| United States | University of Kentucky | Lexington | Kentucky |
| United States | Moore Clinical Trials, LLC | Little Rock | Arkansas |
| United States | Detroit Clinical Research Center | Livonia | Michigan |
| United States | Cedars Sinai Medical Center | Los Angeles | California |
| United States | UCLA | Los Angeles | California |
| United States | Jewish Hospital | Louisville | Kentucky |
| United States | Gastroenterolgy Associates of Central GA | Macon | Georgia |
| United States | Gastrointestinal Specialists of Georgia | Marietta | Georgia |
| United States | Tandem Clinical Research | Marrero | Louisiana |
| United States | University of Miami Hospital | Miami | Florida |
| United States | Gastroenterology Group Of Naples | Naples | Florida |
| United States | Vanderbilt University Medical Center | Nashville | Tennessee |
| United States | Gastroenterology of Southern Indiana | New Albany | Indiana |
| United States | Yale University School Of Medicine | New Haven | Connecticut |
| United States | Ochsner Medical Center | New Orleans | Louisiana |
| United States | Lenox Hill Hospital | New York | New York |
| United States | Weill Cornell Medical College | New York | New York |
| United States | Hoag Memorial Hospital | Newport Beach | California |
| United States | Omega Research Consultants | Orlando | Florida |
| United States | University of Pennsylvania - Perelman School of Medicine | Philadelphia | Pennsylvania |
| United States | The Oregon Clinic | Portland | Oregon |
| United States | Hunter Holmes McGuire Veterans Affairs Medical Center | Richmond | Virginia |
| United States | Digestive Disease Associates | Rock Hill | South Carolina |
| United States | Synergy Clinical Research | Saint Petersburg | Florida |
| United States | Care Access Research- Salt Lake City | Salt Lake City | Utah |
| United States | Gastroenterology Clinic Of San Antonio P A | San Antonio | Texas |
| United States | Medical Associates Research Group, Inc. | San Diego | California |
| United States | University of California San Francisco | San Francisco | California |
| United States | Swedish Medical Center | Seattle | Washington |
| United States | University of Washington Digestive Disease Center | Seattle | Washington |
| United States | Frontier Clinical Research | Smithfield | Pennsylvania |
| United States | FC Research, LLC | South Dartmouth | Massachusetts |
| United States | Texas Digestive Disease Consultants | Southlake | Texas |
| United States | Digestive Health Specialists | Tacoma | Washington |
| United States | GCP Clinical Research | Tampa | Florida |
| United States | Cotton O'Neil Digestive Health Center | Topeka | Kansas |
| United States | Del Sol Research Management, LLC | Tucson | Arizona |
| United States | Digestive Health Specialists | Tyler | Texas |
| United States | Mohawk Valley Endoscopy Center | Utica | New York |
| United States | MedStar Georgetown University Hospital | Washington | District of Columbia |
| United States | Northshore Gastroenterology Research, LLC | Westlake | Ohio |
| United States | Ascension via Christi Research | Wichita | Kansas |
| United States | Univ. of KS School of Med | Wichita | Kansas |
| United States | PMG Research of Winston-Salem | Winston-Salem | North Carolina |
| United States | Huron Gastroenterology Associates Center for Digestive Care | Ypsilanti | Michigan |
| Lead Sponsor | Collaborator |
|---|---|
| Janssen Research & Development, LLC |
United States, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, China, Croatia, Czechia, Denmark, Estonia, France, Germany, Greece, Hungary, India, Israel, Italy, Japan, Jordan, Korea, Republic of, Malaysia, Netherlands, New Zealand, Norway, Poland, Portugal, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Percentage of Participants with Clinical Remission at Week 48 | Percentage of participants with clinical remission at Week 48 will be reported. Clinical remission is based on the Crohn's Disease Activity Index (CDAI). | Week 48 | |
| Primary | Percentage of Participants with Endoscopic Response at Week 48 | Percentage of participants with endoscopic response at Week 48 will be reported. Endoscopic response is based on change from baseline in the Simple Endoscopic Score for Crohn's Disease (SES-CD). | Week 48 | |
| Secondary | Percentage of Participants with Patient-reported Outcomes (PRO)-2 Remission at Week 48 | Percentage of participants with PRO-2 remission at Week 48 will be reported. PRO-2 remission is based on the average daily abdominal pain (AP) and stool frequency (SF) scores. | Week 48 | |
| Secondary | Percentage of Participants with Endoscopic Remission at Week 48 | Percentage of participants with endoscopic remission at Week 48 will be reported. Endoscopic remission is based on the SES-CD. | Week 48 | |
| Secondary | Percentage of Participants with Clinical Remission at Week 24 | Percentage of participants with clinical remission at Week 24 will be reported. Clinical remission is based on the Crohn's Disease Activity Index (CDAI). | Week 24 | |
| Secondary | Percentage of Participants with Endoscopic Response at Week 24 | Percentage of participants with endoscopic response at Week 24 will be reported. Endoscopic response is based on change from baseline in the Simple Endoscopic Score for Crohn's Disease (SES-CD). | Week 24 | |
| Secondary | Percentage of Participants with Adverse Events (AEs) | An AE is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. | Up to Week 48 | |
| Secondary | Percentage of Participants with Serious Adverse Events (SAEs) | A SAE is any untoward medical occurrence that at any dose: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is a suspected transmission of any infectious agent via a medicinal product; is medically important. | Up to Week 48 | |
| Secondary | Serum Concentrations of Guselkumab Over Time | Serum concentrations of guselkumab over time will be reported. Serum samples will be analyzed to determine concentrations of guselkumab using a validated, specific, and sensitive method. | Up to Week 48 | |
| Secondary | Serum Concentrations of Golimumab Over Time | Serum concentrations of golimumab over time will be reported. Serum samples will be analyzed to determine concentrations of golimumab using a validated, specific, and sensitive method. | Up to Week 48 | |
| Secondary | Percentage of Participants with Antibodies to Guselkumab | Percentage of participants with antibodies to guselkumab will be reported. | Up to Week 48 | |
| Secondary | Titers of Antibodies to Guselkumab | Titers of antibodies to guselkumab will be reported. | Up to Week 48 | |
| Secondary | Percentage of Participants with Antibodies to Golimumab | Percentage of participants with antibodies to golimumab will be reported. | Up to Week 48 | |
| Secondary | Titers of Antibodies to Golimumab | Titers of antibodies to golimumab will be reported. | Up to Week 48 | |
| Secondary | Percentage of Participants with Neutralizing Antibodies to Guselkumab. | Percentage of participants with neutralizing antibodies to guselkumab will be reported. | Up to Week 48 | |
| Secondary | Percentage of Participants with Neutralizing Antibodies to Golimumab | Percentage of participants with neutralizing antibodies to golimumab will be reported. | Up to Week 48 |
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