A Study of Guselkumab Subcutaneous Therapy in Participants With Moderately to Severely Active Crohn's Disease Clinical Trial Results and Information

A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy and Safety of Guselkumab Subcutaneous Induction Therapy in Participants With Moderately to Severely Active Crohn's Disease

ClinicalTrials.gov processed this data on October 25, 2024. Link to the current ClinicalTrials.gov record.

Recruitment Status

ACTIVE, NOT RECRUITING (See Contacts and Locations)
Verified October 2024 by Janssen Research & Development, LLC

Sponsor

Janssen Research & Development, LLC

Information Provided by (Responsible Party)

Janssen Research & Development, LLC

Clinicaltrials.gov Identifier

NCT05197049
Other Study ID Numbers: CR109125
First Submitted: January 17, 2022
First Posted: January 19, 2022
Last Update Posted: October 29, 2024
Last Verified: October 2024
History of Changes

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Study Description

Not Provided

Condition or Disease	Intervention/Treatment
Crohn Disease	Drug: Guselkumab Dose 1 Drug: Guselkumab Dose 2 Drug: Guselkumab Dose 3 Drug: Placebo

Study Design

Study Type	Interventional
Actual Enrollment	350 participants
Design Allocation	Randomized
Interventional Model	Parallel Assignment
Masking	Double
Primary Purpose	Treatment
Official Title	A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy and Safety of Guselkumab Subcutaneous Induction Therapy in Participants With Moderately to Severely Active Crohn's Disease
Study Start Date	January 19, 2022
Actual Primary Completion Date	July 4, 2023
Anticipated Study Completion Date	March 31, 2025

Groups and Cohorts

Group/ Cohort	Intervention/ Treatment
Group 1: Guselkumab Participants will receive guselkumab (Dose 1) injection subcutaneously followed by guselkumab (Dose 2) injection subcutaneously.	Drug: Guselkumab Dose 1 Guselkumab (Dose 1) will be administered by subcutaneous (SC) injection. Drug: Guselkumab Dose 2
Group 2: Guselkumab Participants will receive guselkumab (Dose 1) injection subcutaneously followed by guselkumab (Dose 3) injection subcutaneously.	Drug: Guselkumab Dose 1 Guselkumab (Dose 1) will be administered by subcutaneous (SC) injection. Drug: Guselkumab Dose 3
Group 3: Placebo Participants will receive placebo injection subcutaneously.	Drug: Placebo

Outcome Measures

Primary Outcome Measures

Clinical Remission at Week 12 [Week 12]
Clinical Remission is based on Crohn's Disease Activity Index (CDAI).
Endoscopic Response at Week 12 [Week 12]
Endoscopic response is based on change from baseline in the Simple Endoscopic Score for Crohn's Disease (SES-CD).

Secondary Outcome Measures

Clinical Remission at Week 24 [Week 24]
Clinical Remission is based in CDAI.
Patient-reported Outcome (PRO)-2 Remission at Week 12 [Week 12]
PRO-2 remission is based on abdominal pain (AP) and stool frequency (SF) score.
Clinical Response at Week 12 [Week 12]
Clinical response is based on change from baseline in CDAI.
Percentage of Participants with Adverse Events (AEs), Serious Adverse Events (SAEs) and AEs Leading to Discontinuation of Study Intervention [Up to 260 Weeks]
Percentage of participants with AEs, SAEs and AEs leading to discontinuation of study intervention will be reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/ biological agent under study. A SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.

Eligibility Criteria

Ages Eligible for Study	18 Years and Older (Adult, Older Adult)
Sexes Eligible for Study	All
Accepts Healthy Volunteers	No
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

Contacts and Locations

Sponsors and Collaborators	Janssen Research & Development, LLC
Locations	Digestive Health Specialists of the Southeast \| Dothan, Alabama, United States, 36305 Advanced Gastro P.C \| Chandler, Arizona, United States, 85224-1636 Reliance Research \| Scottsdale, Arizona, United States, 85260 Moore Clinical Trials, LLC \| Little Rock, Arkansas, United States, 72205-6414 Central Arkansas Veterans Healthcare System \| Little Rock, Arkansas, United States, 72223 Om Research LLC \| Lancaster, California, United States, 93534 United Gastroenterologists \| Los Alamitos, California, United States, 90720 Paul Wallace MD \| Los Angeles, California, United States, 90048 Clinnova Research \| Orange, California, United States, 92868 Digestive System Healthcare \| Pasadena, California, United States, 77505-3950 Northshore Gastroenterology Research, LLC \| San Diego, California, United States, 92103-2120 Clinical Applications Laboratories, Inc \| San Diego, California, United States, 92103 Santa Maria Gastroenterology \| Santa Maria, California, United States, 93454 Clinical Research of California \| Walnut Creek, California, United States, 94598 Amel Med LLC Research \| Grand Junction, Colorado, United States, 81505-1027 Western Connecticut Health Network/Danbury Hospital \| Danbury, Connecticut, United States, 06810 Gastroenterology Associates of SW Florida \| Clearwater, Florida, United States, 33762-5323 Pioneer Research Solutions Inc. \| Coconut Creek, Florida, United States, 33066 Omega Research Consultants \| DeBary, Florida, United States, 32713 Harmony Medical Research Institute, Inc. \| Hialeah, Florida, United States, 33016 Central Florida Gastro Research \| Kissimmee, Florida, United States, 34741 Community Research Foundation, Inc. \| Miami, Florida, United States, 33155 Gastroenterology Group Of Naples \| Naples, Florida, United States, 34102 Center for Digestive Health \| Orlando, Florida, United States, 32803-1853 Central Florida Internists \| Orlando, Florida, United States, 32819 Synergy Clinical Research \| Saint Petersburg, Florida, United States, 33705 Atlanta Gastroenterology Specialists, PC \| Atlanta, Georgia, United States, 30224 Agile Clinical Research Trials, LLC \| Atlanta, Georgia, United States, 30328 Atlanta Center For Gastroenterology \| Decatur, Georgia, United States, 30033 Gastroenterolgy Associates of Central GA \| Macon, Georgia, United States, 31201 Gastroenterology Consultants \| Roswell, Georgia, United States, 30076-4943 USF Asthma, Allergy, Immunology Clinical Research Unit \| Boise, Idaho, United States, 83706 Grand Teton Research Group, PLLC \| Idaho Falls, Idaho, United States, 83404 Lemah Creek Clinical Research \| Oakbrook Terrace, Illinois, United States, 60618 University of Kansas Medical Center \| Kansas City, Kansas, United States, 66103-2937 BVL Clinical Research \| Leawood, Kansas, United States, 66211 Cotton O'Neil Digestive Health Center \| Topeka, Kansas, United States, 66606 Tri-State Gastroenterology Assoc \| Crestview Hills, Kentucky, United States, 41017 Tandem Clinical Research \| Marrero, Louisiana, United States, 70072 Institute for Digestive Health and Liver Disease \| Baltimore, Maryland, United States, 21202-2102 Woodholme Gastroenterology Associates \| Glen Burnie, Maryland, United States, 21061 Digestive Health Specialists PC \| Chelmsford, Massachusetts, United States, 01824 FC Research, LLC \| South Dartmouth, Massachusetts, United States, 02747 Clinical Research Institute of Michigan, LLC \| Chesterfield, Michigan, United States, 48047 Detroit Clinical Research Center \| Livonia, Michigan, United States, 48152 University of Mississippi Medical Center \| Jackson, Mississippi, United States, 39216 SUNY Downstate Medical Center \| Brooklyn, New York, United States, 11203 Smart Medical Research \| Jackson Heights, New York, United States, 11372 Crystal Run Healthcare LLP \| Middletown, New York, United States, 10941 New York Gastroenterology Associates \| New York, New York, United States, 10075 DiGiovanna Institute for Medical Education & Research \| North Massapequa, New York, United States, 11758 A1 Clinical Network \| Queens, New York, United States, 11375 Carolinas Medical Center \| Charlotte, North Carolina, United States, 28207 Onsite Clinical Solutions \| Charlotte, North Carolina, United States, 28277 Carolina Research \| Greenville, North Carolina, United States, 27834 Gastroenterology Associates of the Piedmont, P.A. \| Winston-Salem, North Carolina, United States, 27103 Central Ohio Endoscopy Center LLC \| Columbus, Ohio, United States, 43214 Dayton Gastroenterology, Inc \| Dayton, Ohio, United States, 45440 Great Lakes Gastroenterology \| Mentor, Ohio, United States, 44060 Oklahoma University Health Science Center \| Oklahoma City, Oklahoma, United States, 73104 Integris Baptist Office \| Oklahoma City, Oklahoma, United States, 73112 Central Sooner Research \| Oklahoma City, Oklahoma, United States, 73120 Essential Medical Research \| Tulsa, Oklahoma, United States, 74137-7061 The Oregon Clinic \| Portland, Oregon, United States, 97220-9428 Frontier Clinical Research \| Smithfield, Pennsylvania, United States, 15478 Gastroenterology Associates P.A. \| Greenville, South Carolina, United States, 29615 Carolina Health Specialists \| Myrtle Beach, South Carolina, United States, 29572 West Texas Clinical Research \| Lubbock, Texas, United States, 79424 Victoria Gastroenterology \| Richmond, Texas, United States, 77407 Gastroenterology Clinic Of San Antonio P A \| San Antonio, Texas, United States, 78229 Wellness Clinical Research \| San Antonio, Texas, United States, 78232 Texas Digestive Disease Consultants \| Southlake, Texas, United States, 76092 Digestive Health Specialists of Tyler \| Tyler, Texas, United States, 75701 Care Access Research- Salt Lake City \| Salt Lake City, Utah, United States, 84124 Burke Internal Medicine and Research \| Burke, Virginia, United States, 22015 Gastroenterology Associates of Tidewater \| Chesapeake, Virginia, United States, 23320 Monash Health, Monash Medical Centre \| Clayton, Australia, 3168 Coral Sea Clinical Research Institute \| North Mackay, Australia, 4740 OLV Ziekenhuis Aalst \| Aalst, Belgium, 9300 CHU Saint-Pierre \| Bruxelles, Belgium, 1000 Hopital Erasme \| Bruxelles, Belgium, 1070 Universitair Ziekenhuis Gent \| Gent, Belgium, 9000 Algemeen Ziekenhuis Delta \| Roeselare, Belgium, 8800 University hospital Clinical centre Banja Luka \| Banja Luka, Bosnia and Herzegovina, 78000 Clinical Center University of Sarajevo \| Sarajevo, Bosnia and Herzegovina, 71000 Polyclinic Dr. Al-Tawil \| Sarajevo, Bosnia and Herzegovina, 71000 General Hospital Tesanj \| Tesanj, Bosnia and Herzegovina, 74260 Plava poliklinika Tuzla \| Tuzla, Bosnia and Herzegovina, 75000 Cantonal Hospital Zenica \| Zenica, Bosnia and Herzegovina, 72000 Universidade Estadual Paulista 'Julio De Mesquita Filho' \| Botucatu, Brazil, 18608-025 CCB Centro Cardiologico de Brasilia Ltda - CCB Cardiologia \| Brasilia, Brazil, 70200-730 Chronos Clinica Medica Ltda \| Brasilia, Brazil, 72145 450 Sociedade Campineira de Educacao e Instrucao Hospital e Maternidade Celso Pierro \| Campinas, Brazil, 13060-904 CDC - Centro Digestivo de Curitiba \| Curitiba, Brazil, 80430-180 Universidade Federal Do Ceara \| Fortaleza, Brazil, 60430-370 Centro de Estudos Clínicos do Interior Paulista - CECIP \| Jau, Brazil, 17201-130 Cliged \| Macae, Brazil, 27910-020 Liga Norte Riograndense Contra O Cancer \| Natal, Brazil, 59062 000 Instituto Mederi de Pesquisa e Saude \| Passo Fundo, Brazil, 99010-120 Associacao Hospitalar Moinhos de Vento \| Porto Alegre, Brazil, 90035-001 Hospital das Clinicas de Porto Alegre \| Porto Alegre, Brazil, 90035-003 Associacao dos Funcionarios Publicos do Estado do Rio Grande do Sul - Hospital Ernesto Dornelles \| Porto Alegre, Brazil, 90160-092 NPCRS Nucleo de Pesquisa Clinica do Rio Grande do Sul \| Porto Alegre, Brazil, 90430-001 Hospital das Clinicas - Universidade Federal de Pernambuco \| Recife, Brazil, 51011040 Universidade Federal da Bahia - Hospital Professor Edgard Santos \| Salvador, Brazil, 40110-060 SER - Servicos Especializados em Reumatologia da Bahia \| Salvador, Brazil, 40150150 Pesquisare Saude \| Santo Andre, Brazil, 09080-110 Irmandade da Santa Casa da Misericórdia de Santos \| Santos, Brazil, 11075-101 Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto Hospital de Base \| Sao Jose do Rio Preto, Brazil, 15090-000 BR TRIALS Ensaios Clinicos e Consultoria Ltda \| Sao Paulo, Brazil, 03325-050 Instituto de Assistencia Medica ao Servidor Publico Estadual IAMSPE \| Sao Paulo, Brazil, 04039-004 Hepatogastro \| Sao Paulo, Brazil, 04543-011 CEMEC - Centro Multidisciplinar de Estudos Clínicos \| São Bernardo do Campo, Brazil, 09715-090 Kaiser Hospta \| São José Do Rio Preto, Brazil, 15015-110 Instituto D Or de Pesquisa e Ensino IDOR \| São Paulo, Brazil, 04543-000 Fundacao Universidade Federal do Piaui - Universidade Federal do Piaui \| Teresina, Brazil, 64049-550 Instituto D Or de Pesquisa e Ensino IDOR \| Votuporanga, Brazil, 15501-405 London Health Sciences Centre \| London, Ontario, Canada, N6A 5A5 North Bay Dermatology Centre \| North Bay, Ontario, Canada, P1B 2H3 The Affiliated Hospital of Bengbu Medical College \| Bengbu, China, 233004 Xiangya Hospital Central South University \| Changsha, China, 410008 The second Xiangya Hospital of Central South University \| Changsha, China, 410011 Changzhou No 2 Peoples Hospital \| Changzhou City, China, 213004 West China Hospital Sichuan University \| Chengdu, China, 610041 The First People's Hospital of Foshan \| China, China, Chongqing Medical University \| Chongqing, China, 400013 The First Affiliated Hospital of Fujian Medical University \| Fuzhou, China, 350005 First Affiliated Hospital of Gannan Medical University \| Ganzhou, China, 341000 Guangdong Provincial People's Hospital \| Guangzhou, China, 510080 Guangzhou First Municipal People's Hospital \| GuangZhou, China, 510180 Guangzhou Medical University \| Guangzhou, China, 510260 Affiliated Hangzhou First People's Hospital, Zhejiang University School of Medicine \| Hangzhou, China, 310006 Sir Run Run Shaw Hospital, Zhejiang University School of Medicine \| Hangzhou, China, 310016 The First Affiliated Hospital of Anhui Medical University \| Hefei, China, 230022 The First Affiliated Hospital of NanChang University \| Nanchang, China, 330006 Nanjing 1st Hospital \| Nanjing, China, 210006 Nanjing Drum Tower Hospital \| Nanjing, China, 210008 The First Hospital of Quanzhou \| Quanzhou, China, 362002 Huashan Hospital Fudan University \| Shanghai, China, 200040 Shanghai East Hospital \| Shanghai, China, 200120 Shengjing Hospital Of China Medical University \| Shenyang, China, 110022 The first affiliated hospital of suzhou University \| Suzhou, China, Wuxi People s Hospital \| Wuxi, China, 214023 Yangzhou First People's Hospital \| Yangzhou, China, 225001 ZhuZhou Central Hospital \| ZhuZhou, China, 412007 Opca bolnica Bjelovar \| Bjelovar, Croatia, 43000 University Hospital Center Split \| Split, Croatia, 21000 Opca bolnica Zadar \| Zadar, Croatia, 23000 Poliklinika Solmed \| Zagreb, Croatia, 10000 Fakultni nemocnice Brno \| Brno, Czechia, 636 00 Fakultni nemocnice Hradec Kralove \| Hradec Kralove, Czechia, 500 05 Oblastni nemocnice Kladno a.s. \| Kladno, Czechia, 27259 Fakultni nemocnice Kralovske Vinohrady \| Praha 10, Czechia, 100 34 Nemocnice Slany \| Slany, Czechia, 274 01 Sydvestjysk Sygehus \| Esbjerg, Denmark, 6700 Nordsjaellands Hospital - Hillerod \| Hilleroed, Denmark, 3400 Centre Hospitalier de la Cote Basque \| Bayonne, France, 64100 CHRU Besancon Hopital Jean Minjoz \| Besancon Cedex, France, 25000 Hopital Louis Mourier \| Colombes Cedex, France, 92701 CHU de Nantes hotel Dieu \| Nantes, France, 44093 CHU de Nice Hopital de l Archet \| Nice, France, 06202 Hôpital Bichat \| Paris, France, 75877 Hospices Civils de Lyon HCL \| Pierre Bénite, France, 69495 Hôpital Robert Debré \| Reims, France, 51092 CHU Saint Etienne Hopital Nord \| Saint-Priest en Jarez, France, 42270 CHRU Strasbourg \| Strasbourg, France, 67098 CHU Rangueil \| Toulouse, France, 31059 Gastroenterologische Spezialpraxis - Berlin-Karlshorst \| Berlin-Karlshorst, Germany, 10318 Charite Universitatsmedizin Berlin, Campus Mitte (CCM) Allergie Center \| Berlin, Germany, 10117 DRK Kliniken Westend \| Berlin, Germany, 14050 Krankenhaus Waldfriede Mitte \| Berlin, Germany, 14163 Staedtisches Klinikum Braunschweig \| Braunschweig, Germany, 38126 Medizinisches Versorgungszentrum (MVZ) Dachau \| Dachau, Germany, 85221 MVZ Sanaklinikum Duisburg \| Duisburg, Germany, 47055 BSF Studiengesellschaft \| Halle, Germany, 6108 Medizinische Hochschule Hannover \| Hannover, Germany, 30625 Praxisgemeinschaft Jerichow \| Jerichow, Germany, 39319 Evangelisches Krankenhaus Kalk \| Köln, Germany, 51103 Universitaetsklinikum Mannheim \| Mannheim, Germany, 68167 Tumorzentrum Nordthüringen Medizinisches Versorgungszentrum \| Nordhausen, Germany, 99734 Obudai Egeszsegugyi Centrum Kft \| Budapest, Hungary, 1036 Egyesített Szent István és Szent László Kórház \| Budapest, Hungary, 1097 Eszak Kozep budai Centrum Uj Szent Janos Korhaz es Szakrendelo Budai Csaladkozpontu \| Budapest, Hungary, 1125 Mh Egészségügyi Központ \| Budapest, Hungary, 1126 Semmelweis Egyetem \| Budapest, Hungary, H-1088 Pannónia Magánorvosi Centrum Kft \| Budapest, Hungary, H-1136 Pest Megyei Flor Ferenc Korhaz \| Kistarcsa, Hungary, 2143 Mohacsi Korhaz \| Mohacs, Hungary, 7700 Pecsi Tudomanyegyetem Orvostudomanyi Es Egeszsegtudomanyi Centrum, I. Belgyogyaszati Klinika \| Pecs, Hungary, 7624 Haemek Medical Center \| Afula, Israel, 1834111 Soroka University Medical Center \| Beer-Sheva, Israel, 84101 The Chaim Sheba Medical Center \| Ramat Gan, Israel, 5265601 Kaplan Medical Center \| Rehovot, Israel, 76100 Assaf Harofeh Medical Center \| Tzrifin, Israel, 70300 Policlinico Sant'Orsola Malpighi \| Bologna, Italy, 40138 Istituto Clinico Humanitas Rozzano, IRCCS \| Milano, Italy, 20132 Università Campus Biomedico di Roma \| Roma, Italy, 00128 Policlinico Universitario Agostino Gemelli \| Roma, Italy, 168 Juntendo University Hospital \| Bunkyo-ku, Japan, 113-8431 Ginza central clinic \| Chuo-ku, Japan, 1040061 Fukui Prefectural Hospital \| Fukui-ken, Japan, 910-8526 Fukuoka University Hospital \| Fukuoka, Japan, 814-0180 Japanese Red Cross Fukuoka Hospital \| Fukuoka, Japan, 815-8555 National Hospital Organization Fukuyama Medical Center \| Fukuyama, Japan, 720-8520 Gamagori City Hospital \| Gamagori, Japan, 443-8501 Gunma University Hospital \| Gunma, Japan, 371-0034 Hachinohe City Hospital \| Hachinohe, Japan, 031-8555 Matsuda Hospital \| Hamamatsu-shi, Japan, 432-8061 Hamamatsu University Hospital \| Hamamatsu, Japan, 431 3192 National Hospital Organization Mito Medical Center \| Higashi-Ibaraki, Japan, 311-3193 Kure Kyosai Hospital \| Hiroshima, Japan, 737-8505 National Hospital Organization Shikoku Cancer Center \| Iizuka-shi, Japan, 820-8505 Kagoshima University Hospital \| Kagoshima, Japan, 890-8520 Kagoshima IBD Gastroenterology Clinic \| Kagoshima, Japan, 892-0843 Tsujinaka Hospital Kashiwanoha \| Kashiwa, Japan, 277-0871 Kyushu Rosai Hospital \| Kita-kyushu, Japan, 800-0229 Kobe University Hospital \| Kobe, Japan, 650 0017 Yamanashi Prefectural Central Hospital \| Kofu, Japan, 400-8506 Dokkyo Medical University Saitama Medical Center \| Koshigaya, Japan, 343-8555 Hidaka Coloproctologic Clinic \| Kurume, Japan, 839-0809 Japanese Red Cross Kyoto Daini Hospital \| Kyoto, Japan, 602-8026 University Hospital Kyoto Prefectural University of Medicine \| Kyoto, Japan, 602-8566 Iwate Medical University Hospital \| Morioka, Japan, 020-8505 Nagasaki University Hospital \| Nagasaki, Japan, 852-8501 Yokoyama IBD Clinic \| Nagoya, Japan, 460-0022 University of the Ryukyus Hospital \| Nakagami-gun, Japan, 901-2132 Niigata University Medical And Dental Hospital \| Niigata, Japan, 951 8520 Nishinomiya Municipal Central Hospital \| Nishinomiya, Japan, 663-8014 Oita Red Cross Hospital \| Oita, Japan, 870-0033 National Hospital Organization Osaka National Hospital \| Osaka-shi, Japan, 540-0006 Kinshukai Infusion Clinic \| Osaka, Japan, 530-0011 Japanese Red Cross Osaka Hospital \| Osaka, Japan, 543-8555 Osaka General Medical Center \| Osaka, Japan, 558-8558 Shiga University of Medical Science Hospital \| Otsu, Japan, 520-2192 Sapporo Higashi Tokushukai Hospital \| Sapporo, Japan, 065-0033 Takagi Clinic \| Sendai, Japan, 981-3213 National Hospital Organization Shizuoka Medical Center \| Sunto-gun, Japan, 411-8611 Tokyo Medical University Hospital \| Tokyo, Japan, 160-0023 Toyota Kosei Hospital \| Toyota, Japan, 470-0396 Yokohama City University Medical Center \| Yokohama, Japan, 232 0024 Khalidi Hospital and Medical Center \| Amman, Jordan, 11183 The Speciality Hospital (TSH) / Advanced Clinical Center \| Amman, Jordan, 11194 Istiklal Hospital \| Amman, Jordan, 11196 Abdali Hospital \| Amman, Jordan, 1184 Irbid Specialty Hospital \| Irbid, Jordan, 21110 King Abdullah University Hospital \| Irbid, Jordan, 22110 Kyungpook National University Chilgok Hospital \| Busan, Korea, Republic of, 41404 Inje University Haeundae Paik Hospital \| Busan, Korea, Republic of, 48108 Kosin University Gospel Hospital \| Busan, Korea, Republic of, 49267 DongA Medical Center \| Busan, Korea, Republic of, 602739 Yeungnam University Medical Center \| Daegu, Korea, Republic of, 42415 The Catholic University of Korea Seoul St.Mary's Hospital \| Daejeon, Korea, Republic of, 34943 Kyung Hee University Hospital \| Dongdaemun-gu, Korea, Republic of, 2447 Dongguk University Ilsan Hospital \| Goyang-si, Korea, Republic of, 10326 Chonnam National University Hospital \| Gwangju, Korea, Republic of, 61469 The Catholic university of Korea, St. Vincent's Hospital \| Gyeonggi-do, Korea, Republic of, 16247 CHA Bundang Medical Center, CHA University \| Gyeonggi, Korea, Republic of, 13496 Kangbuk Samsung Hospital \| Seoul, Korea, Republic of, 03181 Yonsei University College of Medicine \| Seoul, Korea, Republic of, 03722 Samsung Medical Center \| Seoul, Korea, Republic of, 06351 The Catholic University of Korea Seoul St Mary s Hospital \| Seoul, Korea, Republic of, 06591 Ajou University Hospital \| Suwon, Korea, Republic of, 16499 Wonju Christian Hospital \| Wonju, Korea, Republic of, 26426 Ewha Womans University Mokdong Hospital \| YangCheon-Gu, Korea, Republic of, 07985 Lietuvos sveikatos mokslų universiteto ligoninė Kauno klinik \| Kaunas, Lithuania, 44307 Vilnius University Hospital Santaros Klinikos, Public Institution \| Vilnius, Lithuania, LT-08661 Hospital Sultanah Aminah \| Johor Bharu, Malaysia, 80100 Hospital University Sains Malaysia \| Kota Bharu, Malaysia, 16150 Hospital Raja Permaisuri Bainun \| Kota Kinabalu, Malaysia, 88586 University Malaya Medical Centre \| Kuala Lumpur, Malaysia, 59100 Hospital Tengku Ampuan Afzan \| Kuantan, Malaysia, 25100 Onze Lieve Vrouwe Gasthuis \| Amsterdam, Netherlands, 1091 AC Sint Franciscus Gasthuis \| Rotterdam, Netherlands, 3045 PM Elisabeth-TweeSteden Ziekenhuis \| Tilburg, Netherlands, 5022 GC Christchurch Hospital \| Christchurch, New Zealand, 8011 Dunedin Hospital \| Dunedin, New Zealand, 9016 Gastromed Kralisz Romatowski Stachurska Sp. j. \| Bialystok, Poland, 15-322 10 Wojskowy Szpital Kliniczny z Poliklinika, SP ZOZ \| Bydgoszcz, Poland, 85-681 Centrum Medyczne Lukamed \| Chojnice, Poland, 89-600 Sahlgrenska University Hospital \| Chrzanow, Poland, 32-500 Private Practice - Dr. Krzysztof Cymerman \| Gdynia, Poland, 81-157 Centrum Medyczne Clw-Med Aneta Cichomska i Joanna Luka-Wendrowska sp.j. \| Grudziadz, Poland, 86-300 Malopolskie Centrum Kliniczne \| Krakow, Poland, 30 149 Centrum Medyczne Plejady \| Krakow, Poland, 30-363 Centrum Medyczne ProMiMed \| Krakow, Poland, 31-637 AmiCare Centrum Medyczne \| Lodz, Poland, 90-644 IP Clinic Sp. z o.o. \| Lodz, Poland, 90-752 Centrum Medyczne Med-Gastr \| Lodz, Poland, 91-034 ETG Lublin \| Lublin, Poland, 20-412 Niepubliczny Zaklad Opieki Zdrowotnej \| Lublin, Poland, 20-582 Allmedica \| Nowy Targ, Poland, 34-400 Wojewodzki Szpital Specjalistyczny w Olsztynie \| Olsztyn, Poland, 10-561 Twoja Przychodnia \| Opole, Poland, 45-819 Centrum Medyczne \| Piotrkow Trybunalski, Poland, 97-300 EMC Instytut Medyczny SA PL CERTUS \| Poznan, Poland, 60 309 Twoja Przychodnia \| Poznan, Poland, 61-293 Synexus Polska Sp. z o.o. \| Poznan, Poland, 61-441 Centrum Medyczne Medyk \| Rzeszow, Poland, 35-326 Centrum Medyczne Promed \| Skorzewo, Poland, 60-185 Endoskopia Sp z o.o. \| Sopot, Poland, 81-756 Kiepury Clinic \| Sosnowiec, Poland, 41-200 KO-Med Centrum Medyczne \| Straszów, Poland, 28-200 Twoja Przychodnia - Szczecinskie Centrum Medyczne \| Szczecin, Poland, 71-434 Sonomed Sp. z o.o. \| Szczecin, Poland, 71-685 GASTROMED Kopon, Zmudzinski i wspolnicy SP.j., Specjalistyczne Centrum Gastrologii i Endoskopii \| Torun, Poland, 87-100 H-T Centrum Medyczne Endoterapia \| Tychy, Poland, 43-100 Endoterapia \| Warsaw, Poland, 02-653 Centrum Zdrowia Matki, Dziecka i Młodzieży \| Warszawa, Poland, 00-632 Centralny Szpital Kliniczny MSWiA w Warszawie \| Warszawa, Poland, 02-507 Medical Concierge Centrum Medyczne \| Warszawa, Poland, 02-798 NZOZ Vivamed \| Warszawa, Poland, 03-580 Gabinety Lekarskie Bodyclinic \| Warszawa, Poland, 03-712 IBD Point Profesor Kierkus \| Warszawa, Poland, 04-501 Centrum Zdrowia Tuchow \| Wierzchoslawice, Poland, 33-122 Centrum Diagnostyczno - Lecznicze Barska sp. z o.o. Szpital Specjalistyczny Barska \| Wloclawek, Poland, 87-800 Centrum Medyczne Melita Medical \| Wroclaw, Poland, 50-449 Melita Medical Sp. z o.o. \| Wroclaw, Poland, 50-449 Uniwersytecki Szpital Kliniczny im. J. Mikulicza-Radeckiego \| Wroclaw, Poland, 50-556 Przychodnia Vistamed \| Wrocław, Poland, 53-149 ETG Zamosc \| Zamosc, Poland, 22-400 FNsP F.D.R. Banska Bystrica \| Banska Bystrica, Slovakia, 974 01 ENDOMED s.r.o \| Kosice, Slovakia, 040 13 GASTRO I. s.r.o. \| Presov, Slovakia, 080 01 Hosp. de Cabuenes \| Gijón, Spain, 33394 Hosp. Gral. Juan Ramon Jimenez \| Huelva, Spain, 21005 Hosp. Univ. Infanta Leonor \| Madrid, Spain, 28031 Hosp. Virgen Macarena \| Sevilla, Spain, 41009 Hosp. Alvaro Cunqueiro \| Vigo, Spain, 36213 Hosp. de La Marina Baixa \| Villajoyosa, Spain, 03570 Kaohsiung Medical University Chung Ho Memorial Hospital \| Kaoshiung, Taiwan, 80756 China Medical University Hospital \| Taichung, Taiwan, 40447 National Taiwan University Hospital, Division of Infectious Diseases \| Taipei, Taiwan, 100 Taipei Medical University \| Taipei, Taiwan, 110301 Linkou Chang Gung Memorial Hospital \| Taoyuan, Taiwan, 33305 Ankara Numune Egitim ve Arastirma Hastanesi \| Ankara, Turkey, 06100 Hacettepe University Hospital \| Ankara, Turkey, 06230 Gazi University Medical Faculty \| Ankara, Turkey, 06560 Acibadem Fulya Hospital \| Istanbul, Turkey, 34349 Ege Universitesi Tip Fakultesi \| Izmir, Turkey, 35040 Mersin University Medical Faculty \| Mersin, Turkey, 33343 Ondokuz Mayis University \| Samsun, Turkey, 55420 Bülent Ecevit Üniversitesi Sağlık Uygulama ve Araştırma Hastanesi \| Zonguldak, Turkey, 67000
Investigators

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Additional Relevant MeSH Terms

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