A Phase 2b/3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Protocol to Evaluate the Efficacy and Safety of Guselkumab in Participants With Moderately to Severely Active Ulcerative Colitis

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

Recruitment Status

ACTIVE, NOT RECRUITING - HAS RESULTS
 (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

NCT04033445
Other Study ID Numbers: CR108657
First Submitted: July 24, 2019
First Posted: July 26, 2019
Results First Posted: November 18, 2024
Last Update Posted: November 18, 2024
Last Verified: October 2024
History of Changes

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Study Description

Not Provided
Condition or Disease Intervention/Treatment
  • Ulcerative Colitis
  • Drug: Placebo
  • Drug: Guselkumab

Study Design

Study TypeInterventional
Actual Enrollment1064 participants
Design AllocationRandomized
Interventional ModelParallel Assignment
MaskingDouble
Primary PurposeTreatment
Official TitleA Phase 2b/3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Protocol to Evaluate the Efficacy and Safety of Guselkumab in Participants With Moderately to Severely Active Ulcerative Colitis
Study Start DateSeptember 26, 2019
Actual Primary Completion DateSeptember 19, 2023
Anticipated Study Completion DateOctober 27, 2027

Groups and Cohorts

Group/ CohortIntervention/ Treatment
  • Induction Study 1: Guselkumab Dose 1
    • Participants will receive guselkumab dose 1 intravenously (IV) in Induction Study 1. Subsequent study treatment will be determined by the participant's clinical response status at Week 12.
  • Drug: Guselkumab
    • Induction Study 1: Guselkumab Dose 2
      • Participants will receive guselkumab dose 2 IV in Induction Study 1. Subsequent study treatment will be determined by the participant's clinical response status at Week 12.
    • Drug: Guselkumab
      • Induction Study 1: Placebo IV
        • Participants will receive matching placebo IV in Induction Study 1. Subsequent study treatment will be determined by the participant's clinical response status at Week 12. Clinical nonresponders will be administered guselkumab IV.
      • Drug: Placebo
        • Participants will receive matching placebo IV or SC.
      • Induction Study 2: Guselkumab IV
        • Participants will receive guselkumab IV in Induction Study 2. Subsequent study treatment will be determined by the participant's clinical response status at Week 12.
      • Drug: Guselkumab
        • Induction Study 2: Placebo IV
          • Participants will receive matching placebo IV in Induction Study 2. Subsequent study treatment will be determined by the participant's clinical response status at Week 12. Clinical nonresponders will be administered guselkumab IV.
        • Drug: Placebo
          • Participants will receive matching placebo IV or SC.
        • Maintenance Study: Maintenance Dose Regimen 1
          • Participants will receive guselkumab maintenance dose regimen 1 subcutaneously (SC) every 4 weeks (q4w).
        • Drug: Guselkumab
          • Maintenance Study: Maintenance Dose Regimen 2
            • Participants will receive guselkumab maintenance dose regimen 2 SC every 8 weeks (q8w).
          • Drug: Guselkumab
            • Maintenance Study: Placebo SC
              • Participants will receive matching placebo SC q4w.
            • Drug: Placebo
              • Participants will receive matching placebo IV or SC.

            Outcome Measures

            Primary Outcome Measures

            1. Induction Study 1: Percentage of Participants With Clinical Response at Week I-12 [At Week I-12]
              Clinical response was defined as a decrease from induction baseline in the modified Mayo score by greater than or equal to (>=) 30 percent (%) and >=2 points, with either a >=1 point decrease from baseline (Week 0 of IS-1) in the rectal bleeding subscore or a rectal bleeding subscore of 0 or 1. The modified Mayo scores consisted of 3 subscores: stool frequency, rectal bleeding and endoscopic subscore, each subscore graded from 0 (normal) to 3 (severe) with higher scores indicating more severe disease. These individual subscores were summed up to give a total modified Mayo score range of 0 (normal) to 9 (severe disease), where higher scores indicated more severe disease activity. This outcome measure was planned to be analyzed for specified arms only.
            2. Induction Study 2: Percentage of Participants With Clinical Remission at Week I-12 [At Week I-12]
              Clinical remission was based on the modified Mayo score. Clinical remission was defined as Mayo stool frequency subscore of 0 or 1 and not increased from baseline (Week 0 of IS-2), a Mayo rectal bleeding subscore of 0, and Mayo endoscopic subscore of 0 or 1 with no friability. The modified Mayo scores consisted of 3 subscores: stool frequency, rectal bleeding and endoscopic subscore, each subscore graded from 0 (normal) to 3 (severe) with higher scores indicating more severe disease. These individual subscores were summed up to give a total modified Mayo score range of 0 (normal) to 9 (severe disease), where higher scores indicated more severe disease activity. This outcome measure was planned to be analyzed for specified arms only.
            3. Maintenance Study: Percentage of Participants With Clinical Remission at Week M-44 [At Week M-44]
              Clinical remission was based on the modified Mayo score. Clinical remission was defined as Mayo stool frequency subscore of 0 or 1 and not increased from baseline (Week 0 of IS-1 and IS-2), a Mayo rectal bleeding subscore of 0, and Mayo endoscopic subscore of 0 or 1 with no friability. The modified Mayo scores consisted of 3 subscores: stool frequency, rectal bleeding and endoscopic subscore, each subscore graded from 0 (normal) to 3 (severe) with higher scores indicating more severe disease. These individual subscores were summed up to give a total modified Mayo score range of 0 (normal) to 9 (severe disease), where higher scores indicated more severe disease activity. This outcome measure was planned to be analyzed for randomized arms only.

            Eligibility Criteria

            Ages Eligible for Study 18 Years and Older (Adult, Older Adult)
            Sexes Eligible for Study All
            Accepts Healthy Volunteers No
            Inclusion Criteria
            • Documented diagnosis of ulcerative colitis (UC)
            • Moderately to severely active UC, defined by modified Mayo score
            • Demonstrated inadequate response or intolerance to medical therapies specified in the protocol
            • Screening laboratory test results within the parameters specified in the protocol
            Exclusion Criteria
            • Diagnosis of indeterminate colitis, microscopic colitis, ischemic colitis, or Crohn's disease or clinical findings suggestive of Crohn's disease
            • UC limited to the rectum only or to less than (<) 20 centimeter (cm) of the colon
            • Presence of a stoma
            • Presence or history of a fistula
            • Receiving prohibited medications and/or treatment

            Contacts and Locations

            Sponsors and Collaborators Janssen Research & Development, LLC
            Locations
            • Om Research LLC | Lancaster, California, United States, 93534
            • UCLA | Los Angeles, California, United States, 90095
            • Peak Gastroenterology Associates | Colorado Springs, Colorado, United States, 80907
            • Florida Research Network, LLC | Gainesville, Florida, United States, 32605
            • University of Florida Health Jacksonville | Gainesville, Florida, United States, 32608
            • Harmony Medical Research Institute, Inc. | Hialeah, Florida, United States, 33016
            • UF Health Jacksonville Gastroenterology Emerson | Jacksonville, Florida, United States, 32209
            • I.H.S. Health. LLC | Kissimmee, Florida, United States, 34741
            • Columbus Clinical Services LLC | Miami, Florida, United States, 33125
            • Vista Health Research, LLC | Miami, Florida, United States, 33176
            • Orlando Health | Orlando, Florida, United States, 32806
            • Care Access Research, Orlando | Orlando, Florida, United States, 32825
            • Synexus Clinical Research US Inc | Pinellas Park, Florida, United States, 33781
            • Univ. of South Florida Med. Group | Tampa, Florida, United States, 33606
            • Atlanta Gastroenterology Associates | Atlanta, Georgia, United States, 30224
            • Morehouse School of Medicine | Atlanta, Georgia, United States, 30310
            • The Emory Clinic | Atlanta, Georgia, United States, 30322
            • Atlanta Gastroenterology Associates | Atlanta, Georgia, United States, 30342
            • Atlanta Center For Gastroenterology | Decatur, Georgia, United States, 30033
            • Gastroenterolgy Associates of Central GA | Macon, Georgia, United States, 31201
            • University of Chicago | Chicago, Illinois, United States, 60637
            • Health Science Research Center | Pratt, Kansas, United States, 67124
            • Tri-State Gastroenterology Assoc | Crestview Hills, Kentucky, United States, 41017
            • Baystate Medical Center | Springfield, Massachusetts, United States, 01199
            • Clinical Research Institute of Michigan, LLC | Clinton Township, Michigan, United States, 48038
            • Revive Research Institute | Farmington Hills, Michigan, United States, 48334
            • Infusion Associates | Grand Rapids, Michigan, United States, 49525
            • Mid-America Gastro-Intestinal Consultants | Kansas City, Missouri, United States, 64111
            • Barnes-jewish Hospital | Saint Louis, Missouri, United States, 63108
            • Las Vegas Medical Research | Las Vegas, Nevada, United States, 89113
            • University of North Carolina at Chapel Hill | Chapel Hill, North Carolina, United States, 27514
            • Duke University Hospital Medical Center | Raleigh, North Carolina, United States, 27609
            • Synexus Clinical Research US Inc | Columbus, Ohio, United States, 43212
            • Digestive Specialists, Inc | Springboro, Ohio, United States, 45066
            • Gastro Intestinal Research Institute of Northern Ohio LLC | Westlake, Ohio, United States, 44145
            • Care Access Research, Poland | Youngstown, Ohio, United States, 44514
            • Digestive Disease Specialists Inc | Oklahoma City, Oklahoma, United States, 73112
            • US Digestive Health | Wyomissing, Pennsylvania, United States, 19610
            • Synexus Clinical Research US Inc | Anderson, South Carolina, United States, 29621-2062
            • Gastroenterology Associates of Orangeburg, SC | Orangeburg, South Carolina, United States, 29118
            • Erlanger Health System | Chattanooga, Tennessee, United States, 37403
            • Vanderbilt University Medical Center | Nashville, Tennessee, United States, 37212
            • Baylor College of Medicine | Houston, Texas, United States, 77030
            • Caprock Gastro Research | Lubbock, Texas, United States, 79424
            • Tyler Research Institute, LLC | Tyler, Texas, United States, 75701
            • Care Access Research, Ogden | Ogden, Utah, United States, 84403
            • Care Access Research- Salt Lake City | Salt Lake City, Utah, United States, 84124
            • Gastroenterology Associates of Tidewater | Chesapeake, Virginia, United States, 23320
            • UW-Harborview Medical Center | Seattle, Washington, United States, 98104
            • Providence Medical Group | Spokane, Washington, United States, 99208
            • Velocity Clinical Research Spokane | Spokane, Washington, United States, 99218
            • Care Access Research, Casper | Casper, Wyoming, United States, 10456
            • CEMIC (Centro de Educación Médica e Investigaciones Clínicas) | Buenos Aires, Argentina, 1431
            • Cer Instituto Medico | Buenos Aires, Argentina, 1878
            • CINME Centro de Investigaciones Metabolicas | Buenos Aires, Argentina, C1027AAP
            • Hospital General de Agudos José Maria Ramos Mejía | Buenos Aires, Argentina, C1221ADC
            • Centro Médico Dra. De Salvo | Caba, Argentina, C1426ABP
            • Clinica Adventista Belgrano | Ciudad De Buenos Aires, Argentina, C1430EGF
            • Sanatorio Duarte Quiroz | Cordoba, Argentina, X5002AOQ
            • Hospital de Alta Complejidad en Red 'El Cruce' | Florencio Varela, Argentina, 1888
            • Centro de Investigaciones Medicas Mar Del Plata | Mar Del Plata, Argentina, B7600FYK
            • Fundacion de Estudios Clinicos | Rosario, Argentina, 2000
            • Hospital Provincial del Centenario | Rosario, Argentina, S2000KDS
            • Emeritus Research | Camberwell, Australia, 3124
            • Monash Health | Clayton, Australia, 3156
            • Western Health | Footscray, Australia, 3011
            • Fiona Stanley Hospital | Murdoch, Australia, 6150
            • Royal Perth Hospital | Perth, Australia, 6000
            • Mater Hospital | South Brisbane, Australia, 4101
            • St John of God Subiaco Hospital | Subiaco, Australia, 6008
            • Princess Alexandra Hospital | Woolloongabba, Australia, 4102
            • Universitaetsklinikum Salzburg Landeskrankenhaus | Salzburg, Austria, 5020
            • AZ Sint-Lucas | Brugge, Belgium, 8310
            • Hopital Erasme | Brussels, Belgium, 1070
            • CHU Saint-Pierre | Bruxelles, Belgium, 1000
            • AZ Maria Middelares | Gent, Belgium, 9000
            • Universitair Ziekenhuis Gent | Gent, Belgium, 9000
            • Algemeen Ziekenhuis Jan Palfijn Merksem | Merksem, Belgium, 2170
            • Algemeen Ziekenhuis Delta | Roeselare, Belgium, 8800
            • L2IP Instituto de Pesquisas Clinicas | Brasilia, Brazil, 70200 730
            • Sociedade Campineira de Educacao e Instrucao Hospital e Maternidade Celso Pierro | Campinas, Brazil, 13060-904
            • CDC - Centro Digestivo de Curitiba | Curitiba, Brazil, 80430-180
            • Eurolatino Pesquisas Medicas Ltda | Juiz de Fora, Brazil, 36033-318
            • Instituto Mederi de Pesquisa e Saude | Passo Fundo, Brazil, 99010-120
            • Hospital das Clinicas de Porto Alegre | Porto Alegre, Brazil, 90035-903
            • NPCRS Nucleo de Pesquisa Clinica do Rio Grande do Sul | Porto Alegre, Brazil, 90430-001
            • Universidade Federal do Rio de Janeiro - Faculdade de Medicina | Rio de Janeiro, Brazil, 21941-913
            • CLIAGEN - Clinica de Atencao em Gastroenterologia Especializada e Nutricao | Salvador, Brazil, 41500-300
            • BR Trials | Sao Paulo, Brazil, 01236030
            • Onco Star SP Oncologia Ltda | Sao Paulo, Brazil, 04532-030
            • CPQuali Pesquisa Clinica LTDA ME | São Paulo, Brazil, 01228-900
            • Fundacao Universidade Federal do Piaui - Universidade Federal do Piaui | Teresina, Brazil, 64049-550
            • Eurolatino Pesquisas Medicas Ltda | Uberlandia, Brazil, 38400-368
            • Medical Centre Asklepii OOD | Dupnitsa, Bulgaria, 2600
            • Medical Center-1-Sevlievo EOOD | Sevlievo, Bulgaria, 5400
            • 2-nd MHAT | Sofia, Bulgaria, 1202
            • 4th MHAT - Sofia | Sofia, Bulgaria, 1606
            • DCC Convex EOOD | Sofia, Bulgaria, 1680
            • Acibadem City Clinic - Oncology Center | Sofia, Bulgaria, 1784
            • MHAT 'St. Marina' EAD | Varna, Bulgaria, 9010
            • MHAT Dr Stefan Cherkezov | Veliko Tarnovo, Bulgaria, 5000
            • G I R I GI Research Institute Foundation | Vancouver, British Columbia, Canada, V6Z 2K5
            • Health Sciences Centre | Winnipeg, Manitoba, Canada, R3A 1R9
            • Barrie GI Associates | Barrie, Ontario, Canada, L4M 7G1
            • Toronto Immune & Digestive Health Institute Inc. | Toronto, Ontario, Canada, M6A 3B4
            • Hopital Maisonneuve Rosemont | Montreal, Quebec, Canada, H1T 2M4
            • Royal University Hospital | Saskatoon, Saskatchewan, Canada, S7N 0W8
            • Capital Medical University, Beijing Friendship Hospital | Beijing, China, 100050
            • Peking University Third Hospital | Beijing, China, 100191
            • China-Japan Union Hospital of Jilin University | Changchun, China, 130033
            • The second Xiangya Hospital of Central South University | Changsha, China, 200120
            • The Third Xiangya Hospital of Central Sourth University | Changsha, China, 40013
            • West China Hospital of Sichuan University | Chengdu, China, 610041
            • Daping Hospital | Chongqing, China, 400042
            • The Second Hospital To Dalian Medical University | Dalian, China, 116027
            • First Affiliated Hospital of Gannan Medical University | Ganzhou, China, 341000
            • The First Affiliated Hospital Sun Yat sen University | Guangzhou, China, 510080
            • The Sixth Affiliated Hospital Sun Yat sen University | Guangzhou, China, 510610
            • The First Affiliated Hospital Zhejiang University College of Medicine | Hangzhou, China, 310003
            • The Second Affiliated Hospital of Zhejiang University | Hangzhou, China, 310009
            • Sir Run Run Shaw Hospital, Zhejiang University School of Medicine | Hangzhou, China, 310016
            • The First Affiliated Hospital of Anhui Medical University | Hefei, China, 230022
            • First Affiliated Hospital of Kunming Medical Unversity | Kunming City, China, 650032
            • The First Affiliated Hospital of NanChang University | Nanchang, China, 330006
            • Nanjing Drum Tower Hospital | Nanjing, China, 210008
            • Zhongda Hospital Southeast University | Nanjing, China, 210009
            • Jiangsu Province Hospital | Nanjing, China, 210029
            • Ruijing Hospital Affiliated To Shanghai Jiaotong University School Of Medicine | Shanghai, China, 200025
            • Shengjing Hospital Of China Medical University | Shenyang, China, 110004
            • The Second Hospital Affiliated To Suzhou University | Suzhou, China, 215168
            • The first affiliated hospital of suzhou University | Suzhou, China,
            • Tianjin Medical University General Hospital | Tianjin, China, 300011
            • Wuhan Union Hospital | Wuhan, China, 430022
            • Tongji Hospital, Tongji Medical College of HUST | Wuhan, China, 430030
            • Wuxi People s Hospital | Wuxi, China, 214023
            • Nemocnice Ceske Budejovice a s | Ceske Budejovice, Czechia, 37001
            • Endohope Havirov s.r.o. | Havirov, Czechia, 736 01
            • Gastroenterologie, s.r.o., Hradec Kralove | Hradec Kralova, Czechia, 500 02
            • MUDr. Gregar s.r.o. | Olomouc, Czechia, 779 00
            • Vitkovicka nemocnice a.s. | Ostrava, Czechia, 703 84
            • Artroscan s r o | Ostrava, Czechia, 722 00
            • AXON Clinical s.r.o. | Prague, Czechia, 15000
            • Synexus Czech s.r.o. | Praha 2, Czechia, 120 00
            • ResTrial GastroEndo, s.r.o | Praha 4, Czechia, 143 00
            • Nemocnice na Homolce | Praha 5, Czechia, 150 30
            • ISCARE a.s. | Praha 9, Czechia, 190 00
            • Nemocnice Strakonice, a.s. | Strakonice, Czechia, 386 29
            • CHU caen | Caen, France, 14033
            • Hopital Beaujon | Clichy, France, 92110
            • CHRU de Lille Hopital Claude Huriez | Lille, France, 59000
            • Hopital Saint Eloi | Montpellier, France, 34295
            • CHU de Nice Hopital de l Archet | Nice Cedex 3, France, 62002
            • Hopital Saint Antoine | Paris, France, 75571
            • Hopital Haut-Leveque, CMC Magellan | Pessac, France, 33604
            • Centre Hospitalier Lyon Sud | Pierre-Benite, France, 69495
            • CHU Saint Etienne Hopital Nord | Saint-Priest en Jarez, France, 42270
            • Nouvel Hopital Civil | Strasbourg, France, 67091
            • CHU Rangueil | Toulouse, France, 31059
            • CHRU Nancy Brabois | Vandoeuvre les Nancy, France, 54511
            • Universitaetsklinikum Charite, Campus Virchow Klinikum | Berlin, Germany, 13353
            • BSF Studiengesellschaft | Halle, Germany, 06108
            • Medizinische Hochschule Hannover | Hannover, Germany, 30625
            • Praxisgemeinschaft Jerichow | Jerichow, Germany, 39319
            • Staedtisches Klinikum Lueneburg | Lueneburg, Germany, 21339
            • Zentrum für Gastroenterologie Saar MVZ GmbH | Saarbrücken, Germany, 66111
            • Universitaetsklinikum Ulm | Ulm, Germany, 89081
            • Synexus Magyarorszag Kft | Budapest, Hungary, 1036
            • Magyar Honvedseg Egeszsegugyi Kozpont | Budapest, Hungary, 1062
            • Semmelweis University | Budapest, Hungary, 1082
            • Semmelweis University | Budapest, Hungary, 1088
            • Vasutegeszsegugyi Nonprofit Kozhasznu Kft | Debrecen, Hungary, 4025
            • Debreceni Egyetem Klinikai Kozpont | Debrecen, Hungary, H-4032
            • Gyongyosi Bugat Pal Korhaz | Gyongyos, Hungary, 3200
            • Synexus Magyarorszag Kft | Gyula, Hungary, 5700
            • Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Orvostudomanyi Kar, Belgyogyaszati Klinika | Szeged, Hungary, 6725
            • St Vincent's University Hospital | Dublin 4, Ireland, D04T6F4
            • Beaumont Hospital | Dublin, Ireland, 9
            • University Hospital Galway - Ireland | Galway, Ireland, H91YR71
            • Rambam Medical Center | Haifa, Israel, 31096
            • Bnai Zion Medical Center | Haifa, Israel, 3449419
            • Wolfson Medical Center | Holon, Israel, 58100
            • Shaare Zedek Medical Center | Jerusalem, Israel, 91031
            • Lev Talpiot Clinic | Jerusalem, Israel, 93624
            • Galilee Medical Center | Naharia, Israel, 2210001
            • Tel Aviv Sourasky Medical Center | Tel Aviv, Israel, 6423914
            • Policlinico Sant'Orsola Malpighi | Bologna, Italy, 40138
            • Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico | Milano, Italy, 20122
            • Ospedale Classificato Equiparato Sacro Cuore Don Calabria di Negrar | Negrar, Italy, 37024
            • Azienda Ospedaliera di Padova | Padova, Italy, 35128
            • Ospedale Villa Sofia-Cervello | Palermo, Italy, 90146
            • Azienda Ospedaliera G.Salvini Ospedale di Rho | RHO, Italy,
            • Università Campus Biomedico di Roma | Roma, Italy, 00128
            • Fondazione Policlinico Gemelli Università Cattolica | Roma, Italy, 00168
            • Istituto Clinico Humanitas Rozzano, IRCCS | Rozzano, Italy, 20089
            • Casa Sollievo Della Sofferenza IRCCS | San Giovanni Rotondo, Italy, 71013
            • AO Ordine Mauriziano | Torino, Italy, 10128
            • Institute of Science Tokyo Hospital | Bunkyo ku, Japan, 113 8519
            • Juntendo University Hospital Urayasu | Chiba, Japan, 279 0021
            • Fukuoka University Chikushi Hospital | Chikushino, Japan, 818-8502
            • Ehime Prefectural Central Hospital | Ehime, Japan, 790-0024
            • Sai Gastroenterology Proctology | Fujiidera-shi, Japan, 583-0027
            • Kitakyushu Municipal Medical Center | Fukuoka-ken, Japan, 802-0077
            • Fukuoka University Hospital | Fukuoka, Japan, 814-0180
            • Fukushima Medical University Hospital | Fukushima, Japan, 960-1295
            • Gifu University Hospital | Gifu, Japan, 501-1194
            • Hachinohe City Hospital | Hachinohe, Japan, 031-8555
            • Tokai University Hachioji Hospital | Hachioji, Japan, 192-0032
            • Hakodate Goryoukaku Hospital | Hakodate, Japan, 040-8611
            • Matsunami General Hospital | Hashima-gun, Japan, 501-6062
            • National Hospital Organization Hirosaki General Medical Center | Hirosaki, Japan, 036-8545
            • Hirosaki University Hospital | Hirosaki, Japan, 036-8563
            • Kure Kyosai Hospital | Hiroshima, Japan, 737-8505
            • Asahikawa Medical University Hospital | Hokkaido, Japan, 078 8510
            • Mito Saiseikai General Hospital | Ibaraki, Japan, 311-4198
            • Shimane University Hospital | Izumo, Japan, 693-8501
            • Kagoshima University Hospital | Kagoshima City, Japan, 890-8544
            • Imamura General Hospital | Kagoshima, Japan, 890-0064
            • Izuro Imamura Hospital | Kagoshima, Japan, 892-0824
            • Kagoshima IBD Gastroenterology Clinic | Kagoshima, Japan, 892-0843
            • Sameshima Hospital | Kagoshima, Japan, 892-0846
            • St Marianna University Hospital | Kanagawa, Japan, 216 8511
            • Matsushima Hospital | Kanagawa, Japan, 220-0041
            • Kanazawa University Hospital | Kanazawa, Japan, 920 8641
            • National Hospital Organization Kanazawa Medical Center | Kanazawa, Japan, 920-8650
            • Nara Medical University Hospital | Kashihara, Japan, 634-8522
            • The Jikei University Kashiwa Hospital | Kashiwa, Japan, 277 -8567
            • Tsujinaka Hospital Kashiwanoha | Kashiwa, Japan, 277-0871
            • Kyushu Rosai Hospital | Kitakyushu, Japan, 800-0296
            • Aoyama Naika Clinic | Kobe, Japan, 650-0015
            • Kobe University Hospital | Kobe, Japan, 650-0017
            • National Hospital Organization Kochi National Hospital | Kochi, Japan, 780-8077
            • Yamanashi Prefectural Central Hospital | Kofu, Japan, 400-8506
            • Kumagaya General Hospital | Kumagaya-shi, Japan, 360-8567
            • National Hospital Organization Kure Medical Center and Chugoku Cancer Center | Kure, Japan, 736-0023
            • University Hospital Kyoto Prefectural University of Medicine | Kyoto, Japan, 602-8566
            • National Hospital Organization Matsumoto Medical Center | Matsumoto, Japan, 399-8701
            • National Hospital Organization Tokyo Medical Center | Meguro-ku, Japan, 152-8902
            • Kitasato University Kitasato Institute Hospital | Minato-ku, Japan, 108-8642
            • Kyorin University Hospital | Mitaka, Japan, 181-8611
            • Takagi Clinic | Miyagi, Japan, 981-3213
            • Iwate Medical University Uchimaru Medical Center | Morioka, Japan, 020-8505
            • Nagoya University Hospital | Nagoya, Japan, 466 8560
            • Nagoya City University Hospital | Nagoya, Japan, 467 8602
            • Nagaoka Chuo General Hospital | Niigata, Japan, 940-8653
            • Hyogo Medical University Hospital | Nishinomiya-shi, Japan, 663-8501
            • Oita Red Cross Hospital | Oita, Japan, 870-0033
            • Shinbeppu Hospital | Oita, Japan, 874-8538
            • Nakagami Hospital | Okinawa, Japan, 904-2195
            • Kindai University Hospital | Osaka Sayama shi, Japan, 589 8511
            • Japanese Red Cross Osaka Hospital | Osaka, Japan, 543-0027
            • Osaka Metropolitan University Hospital | Osaka, Japan, 545 8586
            • Izumiotsu Municipal Hospital | Osaka, Japan, 595-0027
            • Osaki Citizen Hospital | Osaki, Japan, 989-6183
            • Japan Community Health Care Organization Saitama Medical Center | Saitama, Japan, 330-0074
            • Toho University Sakura Medical Center | Sakura, Japan, 285-8741
            • Sapporo Tokushukai Hospital | Sapporo, Japan, 004-0041
            • Hokkaido P.W.F.A.C. Sapporo-Kosei General Hospital | Sapporo, Japan, 060-0033
            • Sapporo Medical University Hospital | Sapporo, Japan, 060-8543
            • Sapporo IBD Clinic | Sapporo, Japan, 064-0919
            • Sapporo Higashi Tokushukai Hospital | Sapporo, Japan, 065-0033
            • Tokyo Yamate Medical Center | Shinjuku-ku, Japan, 169-0073
            • Matsuda Hospital | Shizuoka, Japan, 432-8061
            • Tokyo Metropolitan Bokutoh Hospital | Sumida ku, Japan, 130 8575
            • Kagawa Prefectural Central Hospital | Takamatsu, Japan, 760-8557
            • Tokushima University Hospital | Tokushima, Japan, 770-8503
            • The Jikei University Hospital | Tokyo, Japan, 105 8471
            • Mie University Hospital | Tsu, Japan, 514-8507
            • Yokkaichi Hazu Medical Center | Yokkaichi, Japan, 510-0016
            • Yokohama Municipal Citizen's Hospital | Yokohama, Japan, 221 0855
            • University of Fukui Hospital | Yoshida, Japan, 910-1193
            • Jordan University Hospital | Amman, Jordan, 11942
            • Istishari Hospital | Amman, Jordan,
            • Khalidi Hospital and Medical Center | Amman, Jordan,
            • Irbid Specialty Hospital | Irbid, Jordan, 21166
            • King Abdullah University Hospital | Irbid, Jordan, 22110
            • Inje University Haeundae Paik Hospital | Busan, Korea, Republic of, 612-896
            • Yeungnam University Hospital | Daegu, Korea, Republic of, 42415
            • Korea University Ansan Hospital | Gyeonggi-do, Korea, Republic of, 15355
            • The Catholic university of Korea, St. Vincent's Hospital | Gyeonggi-do, Korea, Republic of, 16247
            • Gachon University Gil Medical Center | Incheon, Korea, Republic of, 21565
            • Seoul National University Bundang Hospital | Seongnam-si, Korea, Republic of, 13620
            • KyungHee University Hospital | Seoul, Korea, Republic of, 02447
            • Severance Hospital Yonsei University Health System | Seoul, Korea, Republic of, 03722
            • Asan Medical Center | Seoul, Korea, Republic of, 05505
            • Samsung Medical Center | Seoul, Korea, Republic of, 06351
            • The Catholic University of Korea Seoul St Mary s Hospital | Seoul, Korea, Republic of, 06591
            • Chung-Ang University Hospital | Seoul, Korea, Republic of, 06973
            • Ajou University Hospital | Suwon, Korea, Republic of, 16499
            • Pauls Stradins Clinical University Hospital | Riga, Latvia, LV-1002
            • Pauls Stradins Clinical University Hospital | Riga, Latvia, LV1002
            • Health Centre 4 Centre of Diagnostics | Riga, Latvia, LV1003
            • Digestive Diseases Centre GASTRO | Riga, Latvia, LV1079
            • Hospital Serdang | Kajang, Malaysia, 43000
            • Hospital University Sains Malaysia | Kelantan, Malaysia, 16150
            • Pusat Perubatan Universiti Kebangsaan Malaysia | Kuala Lumpur, Malaysia, 56000
            • University Malaya Medical Centre | Kuala Lumpur, Malaysia, 59100
            • Onze Lieve Vrouwe Gasthuis | Amsterdam, Netherlands, 1091 AC
            • Albert Schweitzer Ziekenhuis | Dordrecht, Netherlands, 3318 AT
            • Radboudumc | Nijmegen, Netherlands, 6525 GA
            • Dunedin Hospital | Dunedin, New Zealand, 9016
            • Auckland City Hospital | Grafton, New Zealand, 1023
            • Waikato Hospital | Hamilton, New Zealand, 3204
            • Gastromed Kralisz Romatowski Stachurska Sp. j. | Bialystok, Poland, 15-322
            • Centrum Medyczne Medis ManerMed Sp Z O O | Bydgoszcz, Poland, 85 229
            • Centrum Medyczne Plejady | Krakow, Poland, 30-363
            • Centrum Medyczne Promed | Krakow, Poland, 31-513
            • Gastromed ZOZ | Lublin, Poland, 20-583
            • Medicome Sp z o.o. | Oswiecim, Poland, 32-600
            • Centrum Medyczne Medyk | Rzeszow, Poland, 35-326
            • Endoskopia Sp z o.o. | Sopot, Poland, 81-756
            • Twoja Przychodnia - Szczecinskie Centrum Medyczne | Szczecin, Poland, 71-434
            • GASTROMED Sp. z o.o. | Torun, Poland, 87-100
            • Panstwowy Instytut Medyczny Ministerstwa Spraw Wewnetrznych i Administracji | Warszawa, Poland, 02-507
            • Wojskowy Instytut Medyczny | Warszawa, Poland, 04-141
            • Medical Network WIP Warsaw IBD Point Profesor Kierkus | Warszawa, Poland, 04-501
            • Melita Medical Sp. z o.o. | Wroclaw, Poland, 50-449
            • Wromedica | Wroclaw, Poland, 51-685
            • ETG Zamosc | Zamosc, Poland, 22-400
            • Centro Hospitalar e Universitário de Coimbra, EPE | Coimbra, Portugal, 3000-075
            • Centro Hospitalar do Porto, EPE | Porto, Portugal, 4099-001
            • Uls Sao Joao - Hosp. Sao Joao | Porto, Portugal, 4200 319
            • Centro Hospitalar de Entre o Douro e Vouga, E.P.E | Santa Maria da Feira, Portugal, 4520-211
            • Centro Hospitalar de Tondela Viseu, EPE | Viseu, Portugal, 3504-509
            • Medical Center Meditsinskie Tekhnologii | Ekaterinburg, Russian Federation, 620075
            • OOO MO New Hospital | Ekaterinburg, Russian Federation, 620109
            • Immanuel Kant Baltic Federal University | Kaliningrad, Russian Federation, 236016
            • Road Clinical Hospital at the Nizhny Novgorod Station of the Russian Railways | Nizhniy Novgorod, Russian Federation, 603140
            • Medical Center SibNovoMed LLC | Novosibirsk, Russian Federation, 630005
            • LLC 'Novosibirsk Gastrocentr' | Novosibirsk, Russian Federation, 630007
            • City Clinical Hospital #2 | Perm, Russian Federation, 614068
            • Rostov State Medical University | Rostov-On-Don, Russian Federation, 344022
            • All-Russian Center of Emergency and Radiation Medicine MCRS | Saint-Petersburg, Russian Federation, 194044
            • Eco-safety Ltd | Saint-Petersburg, Russian Federation, 196143
            • Medical University Reaviz | Samara, Russian Federation, 443001
            • NUZ 'Railway Clinical Hospital on Samara station of LLC 'Russian Railways' | Samara, Russian Federation, 443041
            • Saratov Regional Clinical Hospital | Saratov, Russian Federation, 410053
            • International Medical Centre SOGAZ | St-Petersburg, Russian Federation, 191186
            • GBUZ Respublican Clinical Hospital n.a. GG Kuvatova | Ufa, Russian Federation, 450005
            • City Clinical Hospital # 21 | Ufa, Russian Federation, 450071
            • Regional Clinical Hospital | Yaroslavl, Russian Federation, 150062
            • Zvezdara University Medical Center | Belgrade, Serbia, 11000
            • General Hospital 'Dr Radivoj Simonovic' | Sombor, Serbia, 25101
            • General Hospital 'Djordje Joanovic' | Zrenjanin, Serbia, 23000
            • FNsP F.D.R. Banska Bystrica | Banska Bystrica, Slovakia, 975 17
            • Gastroenterology Department GASTROMART s.r.o. | Bardejov, Slovakia, 085 01
            • Gastroenterology Center ASSIDUO | Bratislava, Slovakia, 811 08
            • Cliniq s.r.o. | Bratislava, Slovakia, 811 09
            • ENDOMED s.r.o | Kosice, Slovakia, 040 13
            • GASTRO I. s.r.o. | Presov, Slovakia, 080 01
            • Accout Center, s.r.o., Gastroenterologická ambulancia | Sahy, Slovakia, 93601
            • Hosp. Univ. Germans Trias I Pujol | Badalona, Spain, 08916
            • Hosp Clinic de Barcelona | Barcelona, Spain, 08036
            • Hosp. Univ. Dr. Josep Trueta | Girona, Spain, 17007
            • Hosp. Univ. La Paz | Madrid, Spain, 28046
            • Hosp. Univ. Marques de Valdecilla | Santander, Spain, 39008
            • Hosp. Virgen Del Rocio | Sevilla, Spain, 41013
            • Hosp. Ntra. Sra. de Valme | Sevilla, Spain, 41014
            • Karolinska Universitetssjukhuset | Stockholm, Sweden, SE-171 76
            • Uppsala University | Uppsala, Sweden, SE 75185
            • Chang-Hua Christian Hospital | Changhua, Taiwan, 50006
            • Taichung Veterans General Hospital | Taichung, Taiwan, 40705
            • National Taiwan University Hospital | Taipei, Taiwan, 10002
            • Chang-Gung Memorial Hospital, LinKou Branch | Taoyuan, Taiwan, 33305
            • Hacettepe University Hospital | Ankara, Turkey, 06230
            • Gazi University Hospital | Ankara, Turkey, 06560
            • Trakya University Medical Faculty | Edirne, Turkey, 22030
            • Istanbul University Istanbul Medical Faculty | Istanbul, Turkey, 34093
            • Istanbul University Cerrahpasa Medical Faculty | Istanbul, Turkey, 34098
            • Medicana International Istanbul | Istanbul, Turkey, 34520
            • BAU Medical Park Goztepe Hospital | Istanbul, Turkey, 34732
            • Acibadem Kozyatagi Hospital | Istanbul, Turkey, 34734
            • Ege University Medical Faculty | Izmir, Turkey, 35100
            • Dokuz Eylul University Medical Faculty | Izmir, Turkey, 35330
            • Kocaeli University Medical Faculty | Kocaeli, Turkey, 41380
            • Mersin University Medical Faculty Hospital | Mersin, Turkey, 33110
            • Ivano-Frankivsk Regional Clinical Hospital | Ivano-Frankivsk, Ukraine, 76008
            • Communal Nonprofit Enterprise 'City Clinical Hospital # 2 N.A. Prof. O.O. Shalimov' | Kharkiv, Ukraine, 61037
            • SI 'L.T. Maloyi National Institute of Therapy of National Academy of Medical Sciences of Ukraine | Kharkiv, Ukraine, 61039
            • Municipal Institution 'Kherson City Clinical Hospital n.a. Y.Y.Karabelesh' | Kherson, Ukraine, 73003
            • Medical Center 'Ok Clinic' of LLC 'International Institute of Clinical Studies' | Kyiv, Ukraine, 02091
            • MC PE Sygma | Kyiv, Ukraine, 04116
            • Lviv Clinical Hospital on Railway Transport of Affiliate Healthcare center of JSC Ukrainian Railway | Lviv, Ukraine, 79007
            • Communal Nonprofit Enterprise of Lviv Regional Council 'Lviv Regional Clinical Hospital' | Lviv, Ukraine, 79010
            • Municipal Non-profit Enterprise 'Odesa Regional Clinical Hospital' Odesa Regional Council | Odesa, Ukraine, 65025
            • Sumy State University, Sumy Regional Clinical Hospital | Sumy, Ukraine, 40022
            • Municipal institution of Tepnopil Regional Council 'Ternopil University Hospital' | Ternopil, Ukraine, 46002
            • Medical Center Ltd 'Health Clinic', Department Of General Therapy | Vinnytsya, Ukraine, 21009
            • Vinnitsia Regional Clinical Hospital n.a. M. I. Pyrogov | Vinnytsya, Ukraine, 21018
            • Glasgow Royal Infirmary | Glasgow, United Kingdom, G4 0SF
            • Guy's and St Thomas' Hospital | London, United Kingdom, SE1 7EH
            • St George's Hospital | London, United Kingdom, SW17 0QT
            Investigators

              Study Documents (Full Text)

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              Additional Relevant MeSH Terms

              • Colitis
              • Colitis, Ulcerative
              • Ulcer
              • Gastroenteritis
              • Gastrointestinal Diseases
              • Digestive System Diseases
              • Colonic Diseases
              • Intestinal Diseases
              • Pathologic Processes
              • Inflammatory Bowel Diseases