Back to resultsA Study of Guselkumab in Participants With Moderately to Severely Active Ulcerative Colitis (QUASAR)
Primary Purpose
Ulcerative Colitis
Status
Active
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Placebo
Guselkumab
Sponsored by
About this trial
This is an interventional treatment trial for Ulcerative Colitis
Eligibility Criteria
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
Sites / Locations
- Om Research LLC
- UCLA
- Peak Gastroenterology Associates
- Florida Research Network, LLC
- University of Florida Health Jacksonville
- Harmony Medical Research Institute, Inc.
- UF Health Jacksonville Gastroenterology- Emerson
- I.H.S. Health. LLC
- Columbus Clinical Services LLC
- Vista Health Research, LLC
- Orlando Health
- Care Access Research, Orlando
- Synexus Clinical Research US, Inc
- Univ. of South Florida Med. Group
- Atlanta Gastroenterology Associates
- Morehouse School of Medicine
- Emory Clinic
- Atlanta Gastroenterology Associates
- Atlanta Center For Gastroenterology
- Gastroenterolgy Associates of Central GA
- University of Chicago
- Health Science Research Center
- Tri-State Gastroenterology Assoc
- Baystate Medical Center
- Clinical Research Institute of Michigan, LLC
- Revive Research Institute
- Infusion Associates
- Mid-America Gastro-Intestinal Consultants
- Barnes-jewish Hospital
- Las Vegas Medical Research
- University of North Carolina at Chapel Hill
- Duke University Hospital Medical Center
- Synexus Clinical Research US, Inc
- Digestive Specialists, Inc
- Northshore Gastroenterology Research, LLC
- Care Access Research, Poland
- Digestive Disease Specialists Inc
- US Digestive Health
- Synexus Clinical Research US, Inc
- Gastroenterology Associates of Orangeburg, SC
- Erlanger Health System
- Vanderbilt University Medical Center
- Baylor College of Medicine
- Caprock Gastro Research
- Tyler Research Institute, LLC
- Care Access Research, Ogden
- Care Access Research- Salt Lake City
- Gastroenterology Associates of Tidewater
- UW-Harborview Medical Center
- Velocity Clinical Research Spokane
- Providence Medical Group
- Care Access Research, Casper
- CEMIC (Centro de Educación Médica e Investigaciones Clínicas)
- Cer Instituto Medico
- CINME - Centro de Investigaciones Metabolicas
- Hospital General de Agudos José Maria Ramos Mejía
- Centro Médico Dra. De Salvo
- Clínica Adventista Belgrano
- Sanatorio Duarte Quiroz
- Hospital de Alta Complejidad en Red 'El Cruce'
- Centro de Investigaciones Medicas Mar Del Plata
- Fundacion de Estudios Clinicos
- Hospital Provincial del Centenario
- Emeritus Research
- Monash Health
- Western Health
- Fiona Stanley Hospital
- Royal Perth Hospital
- Mater Hospital
- St John of God Subiaco Hospital
- Princess Alexandra Hospital
- Universitätsklinikum Salzburg - Landeskrankenhaus
- AZ Sint-Lucas
- Hopital Erasme
- CHU Saint-Pierre
- AZ Maria Middelares
- Universitair Ziekenhuis Gent
- Algemeen Ziekenhuis Jan Palfijn Merksem
- Algemeen Ziekenhuis Delta
- L2IP - Instituto de Pesquisas Clinicas
- Sociedade Campineira de Educacao e Instrucao - Hospital e Maternidade Celso Pierro
- CDC - Centro Digestivo de Curitiba
- Eurolatino Pesquisas Medicas Ltda
- Instituto Mederi de Pesquisa e Saude
- Hospital das Clinicas de Porto Alegre
- NPCRS - Nucleo de Pesquisa Clinica do Rio Grande do Sul
- Universidade Federal do Rio de Janeiro - Faculdade de Medicina
- CLIAGEN - Clinica de Atencao em Gastroenterologia Especializada e Nutricao
- Onco Star SP Oncologia Ltda
- CPQuali Pesquisa Clinica LTDA ME
- BR Trials
- Fundacao Universidade Federal do Piaui - Universidade Federal do Piaui
- Eurolatino Pesquisas Medicas Ltda
- Medical Centre Asklepii OOD
- Medical Center-1-Sevlievo EOOD
- 2-nd MHAT
- 4th MHAT - Sofia
- DCC Convex EOOD
- Acibadem City Clinic - Oncology Center
- MHAT 'St. Marina' EAD
- MHAT Dr Stefan Cherkezov
- GIRI Gastrointestinal Research Institute
- Health Sciences Centre
- Barrie GI Associates
- Toronto Immune & Digestive Health Institute Inc.
- Hopital Maisonneuve-Rosemont
- Royal University Hospital
- Capital Medical University, Beijing Friendship Hospital
- Peking University Third Hospital
- China-Japan Union Hospital of Jilin University
- The second Xiangya Hospital of Central South University
- The Third Xiangya Hospital of Central Sourth University
- West China Hospital of Sichuan University
- Daping Hospital
- The Second Hospital To Dalian Medical University
- First Affiliated Hospital of Gannan Medical University
- The First Affiliated Hospital, Sun Yat-sen University
- Sun Yat-sen University - The Sixth Affiliated Hospital Guangdong Gastrointestinal Hospital
- The First Affiliated Hospital, Zhejiang University College of Medicine
- The Second Affiliated Hospital of Zhejiang University
- Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
- The 1st affiliated hospital of Anhui Medical University
- First Affiliated Hospital of Kunming Medical Unversity
- The First Affiliated Hospital of NanChang University
- Nanjing Drum Tower Hospital
- Zhongda Hospital,Southeast University
- Jiangsu Province Hospital
- Ruijing Hospital Affiliated To Shanghai Jiaotong University School Of Medicine
- Shengjing Hospital of China Medical University
- The Second Hospital Affiliated To Suzhou University
- The first affiliated hospital of suzhou University
- Tianjin Medical University General Hospital
- Wuhan Union Hospital
- Tongji Hospital, Tongji Medical College of HUST
- Wuxi People's Hospital
- Nemocnice Ceske Budejovice, a.s.
- Endohope Havirov s.r.o.
- Gastroenterologie, s.r.o., Hradec Kralove
- MUDr. Gregar s.r.o.
- Vitkovicka nemocnice a.s.
- Artroscan s.r.o.
- AXON Clinical s.r.o.
- Synexus Czech s.r.o.
- ResTrial GastroEndo, s.r.o
- Nemocnice na Homolce
- ISCARE a.s.
- Nemocnice Strakonice, a.s.
- CHU caen
- Hopital Beaujon
- CHRU de Lille - Hopital Claude Huriez
- Hopital Saint Eloi
- CHU de Nice Hopital de l Archet
- Hopital Saint Antoine
- Hopital Haut-Leveque, CMC Magellan
- Centre Hospitalier Lyon Sud
- CHU Saint-Etienne - Hôpital Nord
- Nouvel Hôpital Civil
- CHU Rangueil
- CHRU Nancy-Brabois
- Universitaetsklinikum Charite, Campus Virchow Klinikum
- BSF Studiengesellschaft
- Medizinische Hochschule Hannover
- Praxisgemeinschaft Jerichow
- Staedtisches Klinikum Lueneburg
- Zentrum für Gastroenterologie Saar MVZ GmbH
- Universitaetsklinikum Ulm
- Synexus Magyarorszag Kft.
- Magyar Honvedseg Egeszsegugyi Kozpont
- Semmelweis Egyetem
- Semmelweis Egyetem, Ii. Belgyogyaszati Klinika
- Vasutegeszsegugyi Nonprofit Kozhasznu Kft Debreceni Kozpont
- Debreceni Egyetem Klinikai Kozpont
- Bugat Pal Korhaz
- Synexus Magyarorszag Kft
- Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Orvostudomanyi Kar, Belgyogyaszati Klinika
- St Vincent's University Hospital
- Beaumont Hospital
- University Hospital Galway - Ireland
- Rambam Medical Center
- Bnai Zion Medical Center
- Wolfson Medical Center
- Shaare Zedek Medical Center
- Lev Talpiot Clinic
- Galilee Medical Center
- Tel Aviv Sourasky Medical Center
- Policlinico Sant'Orsola Malpighi
- Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
- Ospedale Classificato Equiparato Sacro Cuore Don Calabria di Negrar
- Azienda Ospedaliera di Padova
- Ospedale Villa Sofia-Cervello
- Azienda Ospedaliera G.Salvini Ospedale di Rho
- Università Campus Biomedico di Roma
- Fondazione Policlinico Gemelli Università Cattolica
- Istituto Clinico Humanitas Rozzano, IRCCS
- Casa Sollievo della Sofferenza, IRCCS
- AO Ordine Mauriziano
- Tokyo Medical and Dental University Hospital
- The Jikei University Kashiwa Hospital
- Juntendo University Hospital Urayasu
- Fukuoka University Chikushi Hospital
- Ehime Prefectural Central Hospital
- Sai Clinic, Gastrointestinal and Protology Divisions
- Kitakyushu Municipal Medical Center
- Fukuoka University Hospital
- Fukushima Medical University Hospital
- Gifu University Hospital
- Hachinohe City Hospital
- Tokai University Hachioji Hospital
- Hakodate Goryokaku Hospital
- Matsunami General Hospital
- National Hospital Organization Hirosaki General Medical Center
- Hirosaki University Hospital
- Kure Kyosai Hospital
- Asahikawa Medical University Hospital
- Mito Saiseikai General Hospital
- Shimane University Hospital
- Kagoshima University Hospital
- Imamura General Hospital
- Izuro Imamura Hospital
- Kagoshima IBD Gastroenterology Clinic
- Sameshima Hospital
- St.Marianna University Hospital
- Matsushima Clinic
- Kanazawa University Hospital
- National Hospital Organization Kanazawa Medical Center
- Nara Medical University Hospital
- Tsujinaka Hospital Kashiwanoha
- Kyushu Rosai Hospital
- Aoyama Naika Clinic
- Kobe University Hospital
- National Hospital Organization Kochi National Hospital
- Yamanashi Prefectural Central Hospital
- Kumagaya General Hospital
- National Hospital Organization Kure Medical Center and Chugoku Cancer Center
- University Hospital Kyoto Perfectural University of Medicine
- National Hospital Organization Matsumoto Medical Center
- Kitasato University Kitasato Institute Hospital
- Kyorin University Hospital
- Takagi Clinic
- Osaki Citizen Hospital
- Iwate Medical University Hospital
- Nagoya University Hospital
- Nagoya City University Hospital
- Nagaoka Chuo General Hospital
- The Hospital of Hyogo College of Medicine
- Oita Red Cross Hospital
- Shinbeppu Hospital
- Nakagami Hospital
- Kindai University Hospital
- Japanese Red Cross Osaka Hospital
- Osaka City University Hospital
- Izumiotsu Municipal Hospital
- Japan Community Health Care Organization Saitama Medical Center
- Toho University Sakura Medical Center
- Sapporo Tokushukai Hospital
- Hokkaido P.W.F.A.C. Sapporo-Kosei General Hospital
- Sapporo Medical University Hospital
- Sapporo IBD Clinic
- Sapporo Higashi Tokushukai Hospital
- Tokyo Yamate Medical Center
- Matsuda Hospital
- Tokyo Metropolitan Bokutoh Hospital
- Kagawa Prefectural Central Hospital
- Tokushima University Hospital
- The Jikei University Hospital
- National Hospital Organization Tokyo Medical Center
- Mie University Hospital
- Yokkaichi Hazu Medical Center
- Yokohama Municipal Citizen's Hospital
- University of Fukui Hospital
- Jordan University Hospital
- Istishari Hospital
- Khalidi Hospital and Medical Center
- Irbid Specialty Hospital
- King Abdullah University Hospital
- Inje University Haeundae Paik Hospital
- Yeungnam University Hospital
- Seoul National University Bundang Hospital
- Korea University Ansan Hospital
- The Catholic university of Korea, St. Vincent's Hospital
- Gachon University Gil Medical Center
- KyungHee University Hospital
- Severance Hospital, Yonsei University Health System
- Asan Medical Center
- Samsung Medical Center
- The Catholic University of Korea, Seoul St. Mary's Hospital
- Chung-Ang University Hospital
- Ajou University Hospital
- Pauls Stradins Clinical University Hospital
- Pauls Stradins Clinical University Hospital
- Health Centre 4 Centre of Diagnostics
- Digestive Diseases Centre GASTRO
- Hospital Serdang
- Hospital University Sains Malaysia
- Pusat Perubatan Universiti Kebangsaan Malaysia
- University Malaya Medical Centre
- Onze Lieve Vrouwe Gasthuis
- Albert Schweitzer Ziekenhuis
- Radboudumc
- Dunedin Hospital
- Auckland City Hospital
- Waikato Hospital
- Gastromed Kralisz Romatowski Stachurska Sp. j.
- Szpital Uniwersytecki nr 2 im. dr. Jana Biziela w Bydgoszczy
- Centrum Medyczne Plejady
- Centrum Medyczne Promed
- Gastromed ZOZ
- Medicome Sp z o.o.
- Centrum Medyczne Medyk
- Endoskopia Sp z o.o.
- Twoja Przychodnia - Szczecinskie Centrum Medyczne
- GASTROMED Sp. z o.o.
- WIP Warsaw IBD Point Profesor Kierkus
- Centralny Szpital Kliniczny Mswia
- Wojskowy Instytut Medyczny
- Melita Medical Sp. z o.o.
- Wromedica
- ETG Zamosc
- Centro Hospitalar e Universitário de Coimbra, EPE
- Centro Hospitalar do Porto, EPE
- Centro Hospitalar de São João, EPE
- Centro Hospitalar de Entre o Douro e Vouga, E.P.E
- Centro Hospitalar de Tondela Viseu, EPE
- Medical Center Meditsinskie Tekhnologii
- OOO MO New Hospital
- Immanuel Kant Baltic Federal University
- Road Clinical Hospital at the Nizhny Novgorod Station of the Russian Railways
- Medical Center SibNovoMed LLC
- LLC 'Novosibirsk Gastrocentr'
- City Clinical Hospital #2
- Rostov State Medical University
- All-Russian Center of Emergency and Radiation Medicine MCRS
- Eco-safety Ltd
- Medical University Reaviz
- NUZ 'Railway Clinical Hospital on Samara station of LLC 'Russian Railways'
- Saratov Regional Clinical Hospital
- International Medical Centre SOGAZ
- GBUZ Respublican Clinical Hospital n.a. GG Kuvatova
- City Clinical Hospital # 21
- Regional Clinical Hospital
- Zvezdara University Medical Center
- General Hospital 'Dr Radivoj Simonovic'
- General Hospital 'Djordje Joanovic'
- FNsP F.D.R. Banska Bystrica
- Gastroenterology Department GASTROMART s.r.o.
- Gastroenterology Center ASSIDUO
- Cliniq s.r.o.
- ENDOMED s.r.o
- GASTRO I. s.r.o.
- Accout Center, s.r.o., Gastroenterologická ambulancia
- Hosp. Univ. Germans Trias I Pujol
- Hosp. Clinic I Provincial de Barcelona
- Hosp. Univ. Dr. Josep Trueta
- Hosp. Univ. La Paz
- Hosp. Univ. Marques de Valdecilla
- Hosp. Virgen Del Rocio
- Hosp. Ntra. Sra. de Valme
- Karolinska Universitetssjukhuset
- Uppsala University
- Chang-Hua Christian Hospital
- Taichung Veterans General Hospital
- National Taiwan University Hospital
- Chang-Gung Memorial Hospital, LinKou Branch
- Hacettepe University Hospital
- Gazi University Hospital
- Trakya University Medical Faculty
- Istanbul University Istanbul Medical Faculty
- Istanbul University Cerrahpasa Medical Faculty
- Medicana International Istanbul
- BAU Medical Park Goztepe Hospital
- Acibadem Kozyatagi Hospital
- Ege University Medical Faculty
- Dokuz Eylul University Medical Faculty
- Kocaeli University Medical Faculty
- Mersin University Medical Faculty Hospital
- Ivano-Frankivsk Regional Clinical Hospital
- Communal Nonprofit Enterprise 'City Clinical Hospital # 2 N.A. Prof. O.O. Shalimov'
- SI 'L.T. Maloyi National Institute of Therapy of National Academy of Medical Sciences of Ukraine'
- Municipal Institution 'Kherson City Clinical Hospital n.a. Y.Y.Karabelesh'
- Kyiv City Clinical Hospital #18
- Medical Center 'Ok Clinic' of LLC 'International Institute of Clinical Studies'
- Lviv Clinical Hospital on Railway Transport of Affiliate Healthcare center of JSC Ukrainian Railway
- Communal Nonprofit Enterprise of Lviv Regional Council 'Lviv Regional Clinical Hospital'
- Municipal Non-profit Enterprise 'Odesa Regional Clinical Hospital' Odesa Regional Council
- Sumy State University, Sumy Regional Clinical Hospital
- Municipal institution of Tepnopil Regional Council 'Ternopil University Hospital'
- Medical Center Ltd 'Health Clinic', Department Of General Therapy
- Vinnitsia Regional Clinical Hospital n.a. M. I. Pyrogov
- Glasgow Royal Infirmary
- Guy's and St Thomas' Hospital
- St George's Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Arm 8
Arm Type
Experimental
Experimental
Placebo Comparator
Experimental
Placebo Comparator
Experimental
Experimental
Placebo Comparator
Arm Label
Induction Study 1: Guselkumab Dose 1
Induction Study 1: Guselkumab Dose 2
Induction Study 1: Placebo IV
Induction Study 2: Guselkumab IV
Induction Study 2: Placebo IV
Maintenance Study: Maintenance Dose Regimen 1
Maintenance Study: Maintenance Dose Regimen 2
Maintenance Study: Placebo SC
Arm Description
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.
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.
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.
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.
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.
Participants will receive guselkumab maintenance dose regimen 1 subcutaneously (SC) every 4 weeks (q4w).
Participants will receive guselkumab maintenance dose regimen 2 SC every 8 weeks (q8w).
Participants will receive matching placebo SC q4w.
Outcomes
Primary Outcome Measures
Induction Study 1: Clinical Response at Week 12
Clinical response per modified Mayo score.
Induction Study 2: Clinical Remission at Week 12
Clinical remission per modified Mayo score.
Maintenance Study: Clinical Remission at Week 44
Clinical remission per modified Mayo score.
Secondary Outcome Measures
Induction Study 1: Clinical Remission at Week 12
Clinical remission per modified Mayo score.
Induction Study 1: Symptomatic Remission at Week 12
Symptomatic remission per stool frequency and rectal bleeding subscores.
Induction Study 1: Endoscopic Healing at Week 12
Endoscopic healing per endoscopy subscore.
Induction Study 1: Histo-Endoscopic Mucosal Healing at Week 12
Histo-endoscopic mucosal healing per endoscopy subscore and histologic grading.
Induction Study 1: Endoscopic Normalization at Week 12
Endoscopic normalization per endoscopy subscore.
Induction Study 2: Symptomatic Remission at Week 12
Symptomatic remission per stool frequency and rectal bleeding subscores.
Induction Study 2: Endoscopic Healing at Week 12
Endoscopic healing per endoscopy subscore.
Induction Study 2: Clinical Response at Week 12
Clinical response per modified Mayo score.
Induction Study 2: Symptomatic Remission at Week 4
Symptomatic remission per stool frequency and rectal bleeding subscores.
Induction Study 2: Inflammatory Bowel Disease Questionnaire (IBDQ) Remission at Week 12
IBDQ remission is defined as total IBDQ score greater than or equal to (>=) 170. IBDQ is a validated, 32-item, self-reported questionnaire for participants with inflammatory bowel disease (IBD) that will be used to evaluate the disease-specific health-related quality of life across 4 dimensional scores: bowel symptoms (loose stools, abdominal pain), systemic functions (fatigue, altered sleep pattern), social function (work attendance, need to cancel social events), and emotional function (anger, depression, irritability). Scores range from 32 to 224, with higher scores indicating better outcomes.
Induction Study 2: Histo-Endoscopic Mucosal Healing at Week 12
Histo-endoscopic mucosal healing per endoscopy subscore and histologic grading.
Induction Study 2: Fatigue Response at Week 12
Fatigue response is defined as an improvement from induction baseline in patient-reported outcomes measurement information system (PROMIS)-fatigue short form 7a. The PROMIS Fatigue Short Form 7a contains 7 items evaluating fatigue-related symptoms (that is, tiredness, exhaustion, mental tiredness, and lack of energy) and associated impacts on daily activities (that is, activity limitations related to work, self-care, and exercise). PROMIS Fatigue Short Form 7a has a recall period of past 7 days.
Induction Study 2: Symptomatic Remission at Week 2
Symptomatic remission per stool frequency and rectal bleeding subscores.
Induction Study 2: Endoscopic Normalization at Week 12
Endoscopic normalization per endoscopy subscore.
Maintenance Study: Symptomatic Remission at Week 44
Symptomatic remission per stool frequency and rectal bleeding subscores.
Maintenance Study: Endoscopic Healing at Week 44
Endoscopic healing per endoscopy subscore.
Maintenance Study: Corticosteroid-free Clinical Remission at Week 44
Corticosteroid-free clinical remission per modified Mayo score.
Maintenance Study: Clinical Response at Week 44
Clinical response per modified Mayo score.
Maintenance Study: Histo-Endoscopic Mucosal Healing at Week 44
Histo-endoscopic mucosal healing per endoscopy subscore and histologic grading.
Maintenance Study: IBDQ Remission at Week 44
IBDQ remission is defined as total IBDQ score >= 170. IBDQ is a validated, 32-item, self-reported questionnaire for participants with IBD that will be used to evaluate the disease-specific health-related quality of life across 4 dimensional scores: bowel symptoms (loose stools, abdominal pain), systemic functions (fatigue, altered sleep pattern), social function (work attendance, need to cancel social events), and emotional function (anger, depression, irritability). Scores range from 32 to 224, with higher scores indicating better outcomes.
Maintenance Study: Fatigue Response at Week 44
Fatigue response is defined as an improvement from induction baseline in PROMIS-fatigue short form 7a. The PROMIS Fatigue Short Form 7a contains 7 items evaluating fatigue-related symptoms (that is, tiredness, exhaustion, mental tiredness, and lack of energy) and associated impacts on daily activities (that is, activity limitations related to work, self-care, and exercise). PROMIS Fatigue Short Form 7a has a recall period of past 7 days.
Maintenance Study: Clinical Remission at Week 44 Among the Participants Who had Achieved Clinical Remission at Maintenance Baseline
Clinical remission per modified Mayo score.
Maintenance Study: Endoscopic Normalization at Week 44
Endoscopic normalization per endoscopy subscore.
Full Information
NCT ID
NCT04033445
First Posted
July 24, 2019
Last Updated
October 10, 2023
Sponsor
Janssen Research & Development, LLC
1. Study Identification
Unique Protocol Identification Number
NCT04033445
Brief Title
A Study of Guselkumab in Participants With Moderately to Severely Active Ulcerative Colitis
Acronym
QUASAR
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 26, 2019 (Actual)
Primary Completion Date
September 19, 2023 (Actual)
Study Completion Date
October 31, 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Janssen Research & Development, LLC
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of guselkumab in participants with moderately to severely active ulcerative colitis (UC).
Detailed Description
UC is a chronic disease of the large intestine, in which the lining of the colon becomes inflamed and develops ulcers. Guselkumab is a fully human immunoglobulin G1 lambda monoclonal antibody (mAb) that binds to human interleukin (IL)-23 with high affinity. The study is designed to answer scientific questions pertaining to the efficacy and safety of guselkumab in the treatment of moderately to severely active UC. Overall, the study will evaluate long-term guselkumab treatment. Efficacy, safety, pharmacokinetics (PK), immunogenicity, and biomarkers will be assessed at specified time points.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ulcerative Colitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
1064 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Induction Study 1: Guselkumab Dose 1
Arm Type
Experimental
Arm Description
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.
Arm Title
Induction Study 1: Guselkumab Dose 2
Arm Type
Experimental
Arm Description
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.
Arm Title
Induction Study 1: Placebo IV
Arm Type
Placebo Comparator
Arm Description
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.
Arm Title
Induction Study 2: Guselkumab IV
Arm Type
Experimental
Arm Description
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.
Arm Title
Induction Study 2: Placebo IV
Arm Type
Placebo Comparator
Arm Description
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.
Arm Title
Maintenance Study: Maintenance Dose Regimen 1
Arm Type
Experimental
Arm Description
Participants will receive guselkumab maintenance dose regimen 1 subcutaneously (SC) every 4 weeks (q4w).
Arm Title
Maintenance Study: Maintenance Dose Regimen 2
Arm Type
Experimental
Arm Description
Participants will receive guselkumab maintenance dose regimen 2 SC every 8 weeks (q8w).
Arm Title
Maintenance Study: Placebo SC
Arm Type
Placebo Comparator
Arm Description
Participants will receive matching placebo SC q4w.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Participants will receive matching placebo IV or SC.
Intervention Type
Drug
Intervention Name(s)
Guselkumab
Intervention Description
Participants will receive guselkumab IV or SC.
Primary Outcome Measure Information:
Title
Induction Study 1: Clinical Response at Week 12
Description
Clinical response per modified Mayo score.
Time Frame
Week 12
Title
Induction Study 2: Clinical Remission at Week 12
Description
Clinical remission per modified Mayo score.
Time Frame
Week 12
Title
Maintenance Study: Clinical Remission at Week 44
Description
Clinical remission per modified Mayo score.
Time Frame
Week 44
Secondary Outcome Measure Information:
Title
Induction Study 1: Clinical Remission at Week 12
Description
Clinical remission per modified Mayo score.
Time Frame
Week 12
Title
Induction Study 1: Symptomatic Remission at Week 12
Description
Symptomatic remission per stool frequency and rectal bleeding subscores.
Time Frame
Week 12
Title
Induction Study 1: Endoscopic Healing at Week 12
Description
Endoscopic healing per endoscopy subscore.
Time Frame
Week 12
Title
Induction Study 1: Histo-Endoscopic Mucosal Healing at Week 12
Description
Histo-endoscopic mucosal healing per endoscopy subscore and histologic grading.
Time Frame
Week 12
Title
Induction Study 1: Endoscopic Normalization at Week 12
Description
Endoscopic normalization per endoscopy subscore.
Time Frame
Week 12
Title
Induction Study 2: Symptomatic Remission at Week 12
Description
Symptomatic remission per stool frequency and rectal bleeding subscores.
Time Frame
Week 12
Title
Induction Study 2: Endoscopic Healing at Week 12
Description
Endoscopic healing per endoscopy subscore.
Time Frame
Week 12
Title
Induction Study 2: Clinical Response at Week 12
Description
Clinical response per modified Mayo score.
Time Frame
Week 12
Title
Induction Study 2: Symptomatic Remission at Week 4
Description
Symptomatic remission per stool frequency and rectal bleeding subscores.
Time Frame
Week 4
Title
Induction Study 2: Inflammatory Bowel Disease Questionnaire (IBDQ) Remission at Week 12
Description
IBDQ remission is defined as total IBDQ score greater than or equal to (>=) 170. IBDQ is a validated, 32-item, self-reported questionnaire for participants with inflammatory bowel disease (IBD) that will be used to evaluate the disease-specific health-related quality of life across 4 dimensional scores: bowel symptoms (loose stools, abdominal pain), systemic functions (fatigue, altered sleep pattern), social function (work attendance, need to cancel social events), and emotional function (anger, depression, irritability). Scores range from 32 to 224, with higher scores indicating better outcomes.
Time Frame
Week 12
Title
Induction Study 2: Histo-Endoscopic Mucosal Healing at Week 12
Description
Histo-endoscopic mucosal healing per endoscopy subscore and histologic grading.
Time Frame
Week 12
Title
Induction Study 2: Fatigue Response at Week 12
Description
Fatigue response is defined as an improvement from induction baseline in patient-reported outcomes measurement information system (PROMIS)-fatigue short form 7a. The PROMIS Fatigue Short Form 7a contains 7 items evaluating fatigue-related symptoms (that is, tiredness, exhaustion, mental tiredness, and lack of energy) and associated impacts on daily activities (that is, activity limitations related to work, self-care, and exercise). PROMIS Fatigue Short Form 7a has a recall period of past 7 days.
Time Frame
Week 12
Title
Induction Study 2: Symptomatic Remission at Week 2
Description
Symptomatic remission per stool frequency and rectal bleeding subscores.
Time Frame
Week 2
Title
Induction Study 2: Endoscopic Normalization at Week 12
Description
Endoscopic normalization per endoscopy subscore.
Time Frame
Week 12
Title
Maintenance Study: Symptomatic Remission at Week 44
Description
Symptomatic remission per stool frequency and rectal bleeding subscores.
Time Frame
Week 44
Title
Maintenance Study: Endoscopic Healing at Week 44
Description
Endoscopic healing per endoscopy subscore.
Time Frame
Week 44
Title
Maintenance Study: Corticosteroid-free Clinical Remission at Week 44
Description
Corticosteroid-free clinical remission per modified Mayo score.
Time Frame
Week 44
Title
Maintenance Study: Clinical Response at Week 44
Description
Clinical response per modified Mayo score.
Time Frame
Week 44
Title
Maintenance Study: Histo-Endoscopic Mucosal Healing at Week 44
Description
Histo-endoscopic mucosal healing per endoscopy subscore and histologic grading.
Time Frame
Week 44
Title
Maintenance Study: IBDQ Remission at Week 44
Description
IBDQ remission is defined as total IBDQ score >= 170. IBDQ is a validated, 32-item, self-reported questionnaire for participants with IBD that will be used to evaluate the disease-specific health-related quality of life across 4 dimensional scores: bowel symptoms (loose stools, abdominal pain), systemic functions (fatigue, altered sleep pattern), social function (work attendance, need to cancel social events), and emotional function (anger, depression, irritability). Scores range from 32 to 224, with higher scores indicating better outcomes.
Time Frame
Week 44
Title
Maintenance Study: Fatigue Response at Week 44
Description
Fatigue response is defined as an improvement from induction baseline in PROMIS-fatigue short form 7a. The PROMIS Fatigue Short Form 7a contains 7 items evaluating fatigue-related symptoms (that is, tiredness, exhaustion, mental tiredness, and lack of energy) and associated impacts on daily activities (that is, activity limitations related to work, self-care, and exercise). PROMIS Fatigue Short Form 7a has a recall period of past 7 days.
Time Frame
Week 44
Title
Maintenance Study: Clinical Remission at Week 44 Among the Participants Who had Achieved Clinical Remission at Maintenance Baseline
Description
Clinical remission per modified Mayo score.
Time Frame
Week 44
Title
Maintenance Study: Endoscopic Normalization at Week 44
Description
Endoscopic normalization per endoscopy subscore.
Time Frame
Week 44
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Janssen Research & Development, LLC Clinical Trial
Organizational Affiliation
Janssen Research & Development, LLC
Official's Role
Study Director
Facility Information:
Facility Name
Om Research LLC
City
Lancaster
State/Province
California
ZIP/Postal Code
93534
Country
United States
Facility Name
UCLA
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
Peak Gastroenterology Associates
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80907
Country
United States
Facility Name
Florida Research Network, LLC
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32605
Country
United States
Facility Name
University of Florida Health Jacksonville
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32608
Country
United States
Facility Name
Harmony Medical Research Institute, Inc.
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33016
Country
United States
Facility Name
UF Health Jacksonville Gastroenterology- Emerson
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32209
Country
United States
Facility Name
I.H.S. Health. LLC
City
Kissimmee
State/Province
Florida
ZIP/Postal Code
34741
Country
United States
Facility Name
Columbus Clinical Services LLC
City
Miami
State/Province
Florida
ZIP/Postal Code
33125
Country
United States
Facility Name
Vista Health Research, LLC
City
Miami
State/Province
Florida
ZIP/Postal Code
33176
Country
United States
Facility Name
Orlando Health
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Care Access Research, Orlando
City
Orlando
State/Province
Florida
ZIP/Postal Code
32825
Country
United States
Facility Name
Synexus Clinical Research US, Inc
City
Pinellas Park
State/Province
Florida
ZIP/Postal Code
33781
Country
United States
Facility Name
Univ. of South Florida Med. Group
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606
Country
United States
Facility Name
Atlanta Gastroenterology Associates
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30224
Country
United States
Facility Name
Morehouse School of Medicine
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30310
Country
United States
Facility Name
Emory Clinic
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Atlanta Gastroenterology Associates
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
Atlanta Center For Gastroenterology
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30033
Country
United States
Facility Name
Gastroenterolgy Associates of Central GA
City
Macon
State/Province
Georgia
ZIP/Postal Code
31201
Country
United States
Facility Name
University of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Health Science Research Center
City
Pratt
State/Province
Kansas
ZIP/Postal Code
67124
Country
United States
Facility Name
Tri-State Gastroenterology Assoc
City
Crestview Hills
State/Province
Kentucky
ZIP/Postal Code
41017
Country
United States
Facility Name
Baystate Medical Center
City
Springfield
State/Province
Massachusetts
ZIP/Postal Code
01199
Country
United States
Facility Name
Clinical Research Institute of Michigan, LLC
City
Chesterfield
State/Province
Michigan
ZIP/Postal Code
48047
Country
United States
Facility Name
Revive Research Institute
City
Farmington Hills
State/Province
Michigan
ZIP/Postal Code
48334
Country
United States
Facility Name
Infusion Associates
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49525
Country
United States
Facility Name
Mid-America Gastro-Intestinal Consultants
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64111
Country
United States
Facility Name
Barnes-jewish Hospital
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63108
Country
United States
Facility Name
Las Vegas Medical Research
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89113
Country
United States
Facility Name
University of North Carolina at Chapel Hill
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27514
Country
United States
Facility Name
Duke University Hospital Medical Center
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27609
Country
United States
Facility Name
Synexus Clinical Research US, Inc
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43212
Country
United States
Facility Name
Digestive Specialists, Inc
City
Springboro
State/Province
Ohio
ZIP/Postal Code
45066
Country
United States
Facility Name
Northshore Gastroenterology Research, LLC
City
Westlake
State/Province
Ohio
ZIP/Postal Code
44145
Country
United States
Facility Name
Care Access Research, Poland
City
Youngstown
State/Province
Ohio
ZIP/Postal Code
44514
Country
United States
Facility Name
Digestive Disease Specialists Inc
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73112
Country
United States
Facility Name
US Digestive Health
City
Wyomissing
State/Province
Pennsylvania
ZIP/Postal Code
19610
Country
United States
Facility Name
Synexus Clinical Research US, Inc
City
Anderson
State/Province
South Carolina
ZIP/Postal Code
29621-2062
Country
United States
Facility Name
Gastroenterology Associates of Orangeburg, SC
City
Orangeburg
State/Province
South Carolina
ZIP/Postal Code
29118
Country
United States
Facility Name
Erlanger Health System
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37403
Country
United States
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37212
Country
United States
Facility Name
Baylor College of Medicine
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Caprock Gastro Research
City
Lubbock
State/Province
Texas
ZIP/Postal Code
79424
Country
United States
Facility Name
Tyler Research Institute, LLC
City
Tyler
State/Province
Texas
ZIP/Postal Code
75701
Country
United States
Facility Name
Care Access Research, Ogden
City
Ogden
State/Province
Utah
ZIP/Postal Code
84403
Country
United States
Facility Name
Care Access Research- Salt Lake City
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84124
Country
United States
Facility Name
Gastroenterology Associates of Tidewater
City
Chesapeake
State/Province
Virginia
ZIP/Postal Code
23320
Country
United States
Facility Name
UW-Harborview Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Facility Name
Velocity Clinical Research Spokane
City
Spokane
State/Province
Washington
ZIP/Postal Code
99204
Country
United States
Facility Name
Providence Medical Group
City
Spokane
State/Province
Washington
ZIP/Postal Code
99208
Country
United States
Facility Name
Care Access Research, Casper
City
Casper
State/Province
Wyoming
ZIP/Postal Code
10456
Country
United States
Facility Name
CEMIC (Centro de Educación Médica e Investigaciones Clínicas)
City
Buenos Aires
ZIP/Postal Code
1431
Country
Argentina
Facility Name
Cer Instituto Medico
City
Buenos Aires
ZIP/Postal Code
1878
Country
Argentina
Facility Name
CINME - Centro de Investigaciones Metabolicas
City
Buenos Aires
ZIP/Postal Code
C1027AAP
Country
Argentina
Facility Name
Hospital General de Agudos José Maria Ramos Mejía
City
Buenos Aires
ZIP/Postal Code
C1221ADC
Country
Argentina
Facility Name
Centro Médico Dra. De Salvo
City
Caba
ZIP/Postal Code
C1426ABP
Country
Argentina
Facility Name
Clínica Adventista Belgrano
City
Ciudad De Buenos Aires
ZIP/Postal Code
C1430EGF
Country
Argentina
Facility Name
Sanatorio Duarte Quiroz
City
Cordoba
ZIP/Postal Code
X5002AOQ
Country
Argentina
Facility Name
Hospital de Alta Complejidad en Red 'El Cruce'
City
Florencio Varela
ZIP/Postal Code
1888
Country
Argentina
Facility Name
Centro de Investigaciones Medicas Mar Del Plata
City
Mar Del Plata
ZIP/Postal Code
B7600FYK
Country
Argentina
Facility Name
Fundacion de Estudios Clinicos
City
Rosario
ZIP/Postal Code
2000
Country
Argentina
Facility Name
Hospital Provincial del Centenario
City
Rosario
ZIP/Postal Code
S2000KDS
Country
Argentina
Facility Name
Emeritus Research
City
Camberwell
ZIP/Postal Code
3124
Country
Australia
Facility Name
Monash Health
City
Clayton
ZIP/Postal Code
3156
Country
Australia
Facility Name
Western Health
City
Footscray
ZIP/Postal Code
3011
Country
Australia
Facility Name
Fiona Stanley Hospital
City
Murdoch
ZIP/Postal Code
6150
Country
Australia
Facility Name
Royal Perth Hospital
City
Perth
ZIP/Postal Code
6000
Country
Australia
Facility Name
Mater Hospital
City
South Brisbane
ZIP/Postal Code
4101
Country
Australia
Facility Name
St John of God Subiaco Hospital
City
Subiaco
ZIP/Postal Code
6008
Country
Australia
Facility Name
Princess Alexandra Hospital
City
Woolloongabba
ZIP/Postal Code
4102
Country
Australia
Facility Name
Universitätsklinikum Salzburg - Landeskrankenhaus
City
Salzburg
ZIP/Postal Code
5020
Country
Austria
Facility Name
AZ Sint-Lucas
City
Brugge
ZIP/Postal Code
8310
Country
Belgium
Facility Name
Hopital Erasme
City
Brussels
ZIP/Postal Code
1070
Country
Belgium
Facility Name
CHU Saint-Pierre
City
Bruxelles
ZIP/Postal Code
1000
Country
Belgium
Facility Name
AZ Maria Middelares
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
Universitair Ziekenhuis Gent
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
Algemeen Ziekenhuis Jan Palfijn Merksem
City
Merksem
ZIP/Postal Code
2170
Country
Belgium
Facility Name
Algemeen Ziekenhuis Delta
City
Roeselare
ZIP/Postal Code
8800
Country
Belgium
Facility Name
L2IP - Instituto de Pesquisas Clinicas
City
Brasilia
ZIP/Postal Code
70200-730
Country
Brazil
Facility Name
Sociedade Campineira de Educacao e Instrucao - Hospital e Maternidade Celso Pierro
City
Campinas
ZIP/Postal Code
13060-904
Country
Brazil
Facility Name
CDC - Centro Digestivo de Curitiba
City
Curitiba
ZIP/Postal Code
80430-180
Country
Brazil
Facility Name
Eurolatino Pesquisas Medicas Ltda
City
Juiz de Fora
ZIP/Postal Code
36033-318
Country
Brazil
Facility Name
Instituto Mederi de Pesquisa e Saude
City
Passo Fundo
ZIP/Postal Code
99010-120
Country
Brazil
Facility Name
Hospital das Clinicas de Porto Alegre
City
Porto Alegre
ZIP/Postal Code
90035-903
Country
Brazil
Facility Name
NPCRS - Nucleo de Pesquisa Clinica do Rio Grande do Sul
City
Porto Alegre
ZIP/Postal Code
90430-001
Country
Brazil
Facility Name
Universidade Federal do Rio de Janeiro - Faculdade de Medicina
City
Rio de Janeiro
ZIP/Postal Code
21941-913
Country
Brazil
Facility Name
CLIAGEN - Clinica de Atencao em Gastroenterologia Especializada e Nutricao
City
Salvador
ZIP/Postal Code
41500-300
Country
Brazil
Facility Name
Onco Star SP Oncologia Ltda
City
Sao Paulo
ZIP/Postal Code
04532-030
Country
Brazil
Facility Name
CPQuali Pesquisa Clinica LTDA ME
City
São Paulo
ZIP/Postal Code
01228-900
Country
Brazil
Facility Name
BR Trials
City
São Paulo
ZIP/Postal Code
05003-090
Country
Brazil
Facility Name
Fundacao Universidade Federal do Piaui - Universidade Federal do Piaui
City
Teresina
ZIP/Postal Code
64049-550
Country
Brazil
Facility Name
Eurolatino Pesquisas Medicas Ltda
City
Uberlandia
ZIP/Postal Code
38400-368
Country
Brazil
Facility Name
Medical Centre Asklepii OOD
City
Dupnitsa
ZIP/Postal Code
2600
Country
Bulgaria
Facility Name
Medical Center-1-Sevlievo EOOD
City
Sevlievo
ZIP/Postal Code
5400
Country
Bulgaria
Facility Name
2-nd MHAT
City
Sofia
ZIP/Postal Code
1202
Country
Bulgaria
Facility Name
4th MHAT - Sofia
City
Sofia
ZIP/Postal Code
1606
Country
Bulgaria
Facility Name
DCC Convex EOOD
City
Sofia
ZIP/Postal Code
1680
Country
Bulgaria
Facility Name
Acibadem City Clinic - Oncology Center
City
Sofia
ZIP/Postal Code
1784
Country
Bulgaria
Facility Name
MHAT 'St. Marina' EAD
City
Varna
ZIP/Postal Code
9010
Country
Bulgaria
Facility Name
MHAT Dr Stefan Cherkezov
City
Veliko Tarnovo
ZIP/Postal Code
5000
Country
Bulgaria
Facility Name
GIRI Gastrointestinal Research Institute
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6Z 2K5
Country
Canada
Facility Name
Health Sciences Centre
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3A 1R9
Country
Canada
Facility Name
Barrie GI Associates
City
Barrie
State/Province
Ontario
ZIP/Postal Code
L4M 7G1
Country
Canada
Facility Name
Toronto Immune & Digestive Health Institute Inc.
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M6A 3B4
Country
Canada
Facility Name
Hopital Maisonneuve-Rosemont
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H1T 2M4
Country
Canada
Facility Name
Royal University Hospital
City
Saskatoon
State/Province
Saskatchewan
ZIP/Postal Code
S7N 0W8
Country
Canada
Facility Name
Capital Medical University, Beijing Friendship Hospital
City
Beijing
ZIP/Postal Code
100050
Country
China
Facility Name
Peking University Third Hospital
City
Beijing
ZIP/Postal Code
100191
Country
China
Facility Name
China-Japan Union Hospital of Jilin University
City
Changchun
ZIP/Postal Code
130033
Country
China
Facility Name
The second Xiangya Hospital of Central South University
City
Changsha
ZIP/Postal Code
200120
Country
China
Facility Name
The Third Xiangya Hospital of Central Sourth University
City
Changsha
ZIP/Postal Code
40013
Country
China
Facility Name
West China Hospital of Sichuan University
City
Chengdu
ZIP/Postal Code
610041
Country
China
Facility Name
Daping Hospital
City
Chongqing
ZIP/Postal Code
400042
Country
China
Facility Name
The Second Hospital To Dalian Medical University
City
Dalian
ZIP/Postal Code
116027
Country
China
Facility Name
First Affiliated Hospital of Gannan Medical University
City
Ganzhou
ZIP/Postal Code
341000
Country
China
Facility Name
The First Affiliated Hospital, Sun Yat-sen University
City
Guangzhou
ZIP/Postal Code
510080
Country
China
Facility Name
Sun Yat-sen University - The Sixth Affiliated Hospital Guangdong Gastrointestinal Hospital
City
Guangzhou
ZIP/Postal Code
510610
Country
China
Facility Name
The First Affiliated Hospital, Zhejiang University College of Medicine
City
Hangzhou
ZIP/Postal Code
310003
Country
China
Facility Name
The Second Affiliated Hospital of Zhejiang University
City
Hangzhou
ZIP/Postal Code
310003
Country
China
Facility Name
Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
City
Hangzhou
ZIP/Postal Code
310016
Country
China
Facility Name
The 1st affiliated hospital of Anhui Medical University
City
Hefei
ZIP/Postal Code
230022
Country
China
Facility Name
First Affiliated Hospital of Kunming Medical Unversity
City
Kunming
ZIP/Postal Code
650032
Country
China
Facility Name
The First Affiliated Hospital of NanChang University
City
Nanchang
ZIP/Postal Code
330006
Country
China
Facility Name
Nanjing Drum Tower Hospital
City
Nanjing
ZIP/Postal Code
210008
Country
China
Facility Name
Zhongda Hospital,Southeast University
City
Nanjing
ZIP/Postal Code
210009
Country
China
Facility Name
Jiangsu Province Hospital
City
Nanjing
ZIP/Postal Code
210029
Country
China
Facility Name
Ruijing Hospital Affiliated To Shanghai Jiaotong University School Of Medicine
City
Shanghai
ZIP/Postal Code
200025
Country
China
Facility Name
Shengjing Hospital of China Medical University
City
Shenyang
ZIP/Postal Code
110004
Country
China
Facility Name
The Second Hospital Affiliated To Suzhou University
City
Suzhou
ZIP/Postal Code
215168
Country
China
Facility Name
The first affiliated hospital of suzhou University
City
Suzhou
Country
China
Facility Name
Tianjin Medical University General Hospital
City
Tianjin
ZIP/Postal Code
300011
Country
China
Facility Name
Wuhan Union Hospital
City
Wuhan
ZIP/Postal Code
430022
Country
China
Facility Name
Tongji Hospital, Tongji Medical College of HUST
City
Wuhan
ZIP/Postal Code
430030
Country
China
Facility Name
Wuxi People's Hospital
City
Wuxi
ZIP/Postal Code
214023
Country
China
Facility Name
Nemocnice Ceske Budejovice, a.s.
City
Ceske Budejovice
ZIP/Postal Code
37001
Country
Czechia
Facility Name
Endohope Havirov s.r.o.
City
Havirov
ZIP/Postal Code
736 01
Country
Czechia
Facility Name
Gastroenterologie, s.r.o., Hradec Kralove
City
Hradec Kralova
ZIP/Postal Code
500 02
Country
Czechia
Facility Name
MUDr. Gregar s.r.o.
City
Olomouc
ZIP/Postal Code
779 00
Country
Czechia
Facility Name
Vitkovicka nemocnice a.s.
City
Ostrava
ZIP/Postal Code
703 84
Country
Czechia
Facility Name
Artroscan s.r.o.
City
Ostrava
ZIP/Postal Code
722 00
Country
Czechia
Facility Name
AXON Clinical s.r.o.
City
Prague
ZIP/Postal Code
15000
Country
Czechia
Facility Name
Synexus Czech s.r.o.
City
Praha 2
ZIP/Postal Code
120 00
Country
Czechia
Facility Name
ResTrial GastroEndo, s.r.o
City
Praha 4
ZIP/Postal Code
143 00
Country
Czechia
Facility Name
Nemocnice na Homolce
City
Praha 5
ZIP/Postal Code
150 30
Country
Czechia
Facility Name
ISCARE a.s.
City
Praha 9
ZIP/Postal Code
190 00
Country
Czechia
Facility Name
Nemocnice Strakonice, a.s.
City
Strakonice
ZIP/Postal Code
386 29
Country
Czechia
Facility Name
CHU caen
City
Caen
ZIP/Postal Code
14033
Country
France
Facility Name
Hopital Beaujon
City
Clichy
ZIP/Postal Code
92110
Country
France
Facility Name
CHRU de Lille - Hopital Claude Huriez
City
Lille
ZIP/Postal Code
59000
Country
France
Facility Name
Hopital Saint Eloi
City
Montpellier
ZIP/Postal Code
34295
Country
France
Facility Name
CHU de Nice Hopital de l Archet
City
Nice Cedex 3
ZIP/Postal Code
62002
Country
France
Facility Name
Hopital Saint Antoine
City
Paris
ZIP/Postal Code
75571
Country
France
Facility Name
Hopital Haut-Leveque, CMC Magellan
City
Pessac
ZIP/Postal Code
33604
Country
France
Facility Name
Centre Hospitalier Lyon Sud
City
Pierre-Bénite
ZIP/Postal Code
69495
Country
France
Facility Name
CHU Saint-Etienne - Hôpital Nord
City
Saint-Priest en Jarez
ZIP/Postal Code
42270
Country
France
Facility Name
Nouvel Hôpital Civil
City
Strasbourg
ZIP/Postal Code
67091
Country
France
Facility Name
CHU Rangueil
City
Toulouse
ZIP/Postal Code
31059
Country
France
Facility Name
CHRU Nancy-Brabois
City
Vandoeuvre-les-Nancy
ZIP/Postal Code
54511
Country
France
Facility Name
Universitaetsklinikum Charite, Campus Virchow Klinikum
City
Berlin
ZIP/Postal Code
13353
Country
Germany
Facility Name
BSF Studiengesellschaft
City
Halle
ZIP/Postal Code
6108
Country
Germany
Facility Name
Medizinische Hochschule Hannover
City
Hannover
ZIP/Postal Code
30625
Country
Germany
Facility Name
Praxisgemeinschaft Jerichow
City
Jerichow
ZIP/Postal Code
39319
Country
Germany
Facility Name
Staedtisches Klinikum Lueneburg
City
Lueneburg
ZIP/Postal Code
21339
Country
Germany
Facility Name
Zentrum für Gastroenterologie Saar MVZ GmbH
City
Saarbrücken
ZIP/Postal Code
66111
Country
Germany
Facility Name
Universitaetsklinikum Ulm
City
Ulm
ZIP/Postal Code
89081
Country
Germany
Facility Name
Synexus Magyarorszag Kft.
City
Budapest
ZIP/Postal Code
1036
Country
Hungary
Facility Name
Magyar Honvedseg Egeszsegugyi Kozpont
City
Budapest
ZIP/Postal Code
1062
Country
Hungary
Facility Name
Semmelweis Egyetem
City
Budapest
ZIP/Postal Code
1082
Country
Hungary
Facility Name
Semmelweis Egyetem, Ii. Belgyogyaszati Klinika
City
Budapest
ZIP/Postal Code
1088
Country
Hungary
Facility Name
Vasutegeszsegugyi Nonprofit Kozhasznu Kft Debreceni Kozpont
City
Debrecen
ZIP/Postal Code
4025
Country
Hungary
Facility Name
Debreceni Egyetem Klinikai Kozpont
City
Debrecen
ZIP/Postal Code
H-4032
Country
Hungary
Facility Name
Bugat Pal Korhaz
City
Gyongyos
ZIP/Postal Code
3200
Country
Hungary
Facility Name
Synexus Magyarorszag Kft
City
Gyula
ZIP/Postal Code
5700
Country
Hungary
Facility Name
Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Orvostudomanyi Kar, Belgyogyaszati Klinika
City
Szeged
ZIP/Postal Code
6725
Country
Hungary
Facility Name
St Vincent's University Hospital
City
Dublin 4
ZIP/Postal Code
D04T6F4
Country
Ireland
Facility Name
Beaumont Hospital
City
Dublin
ZIP/Postal Code
9
Country
Ireland
Facility Name
University Hospital Galway - Ireland
City
Galway
ZIP/Postal Code
H91YR71
Country
Ireland
Facility Name
Rambam Medical Center
City
Haifa
ZIP/Postal Code
31096
Country
Israel
Facility Name
Bnai Zion Medical Center
City
Haifa
ZIP/Postal Code
3449419
Country
Israel
Facility Name
Wolfson Medical Center
City
Holon
ZIP/Postal Code
58100
Country
Israel
Facility Name
Shaare Zedek Medical Center
City
Jerusalem
ZIP/Postal Code
91031
Country
Israel
Facility Name
Lev Talpiot Clinic
City
Jerusalem
ZIP/Postal Code
93624
Country
Israel
Facility Name
Galilee Medical Center
City
Naharia
ZIP/Postal Code
2210001
Country
Israel
Facility Name
Tel Aviv Sourasky Medical Center
City
Tel Aviv
ZIP/Postal Code
6423914
Country
Israel
Facility Name
Policlinico Sant'Orsola Malpighi
City
Bologna
ZIP/Postal Code
40138
Country
Italy
Facility Name
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
City
Milano
ZIP/Postal Code
20122
Country
Italy
Facility Name
Ospedale Classificato Equiparato Sacro Cuore Don Calabria di Negrar
City
Negrar ( Ve)
ZIP/Postal Code
37024
Country
Italy
Facility Name
Azienda Ospedaliera di Padova
City
Padova
ZIP/Postal Code
35128
Country
Italy
Facility Name
Ospedale Villa Sofia-Cervello
City
Palermo
ZIP/Postal Code
90146
Country
Italy
Facility Name
Azienda Ospedaliera G.Salvini Ospedale di Rho
City
RHO
Country
Italy
Facility Name
Università Campus Biomedico di Roma
City
Roma
ZIP/Postal Code
00128
Country
Italy
Facility Name
Fondazione Policlinico Gemelli Università Cattolica
City
Roma
ZIP/Postal Code
00168
Country
Italy
Facility Name
Istituto Clinico Humanitas Rozzano, IRCCS
City
Rozzano
ZIP/Postal Code
20089
Country
Italy
Facility Name
Casa Sollievo della Sofferenza, IRCCS
City
San Giovanni Rotondo
ZIP/Postal Code
71013
Country
Italy
Facility Name
AO Ordine Mauriziano
City
Torino
ZIP/Postal Code
10128
Country
Italy
Facility Name
Tokyo Medical and Dental University Hospital
City
Bunkyo-Ku
ZIP/Postal Code
113-8519
Country
Japan
Facility Name
The Jikei University Kashiwa Hospital
City
Chiba
ZIP/Postal Code
277 -8567
Country
Japan
Facility Name
Juntendo University Hospital Urayasu
City
Chiba
ZIP/Postal Code
279-0021
Country
Japan
Facility Name
Fukuoka University Chikushi Hospital
City
Chikushino
ZIP/Postal Code
818-8502
Country
Japan
Facility Name
Ehime Prefectural Central Hospital
City
Ehime
ZIP/Postal Code
790-0024
Country
Japan
Facility Name
Sai Clinic, Gastrointestinal and Protology Divisions
City
Fujiidera-shi
ZIP/Postal Code
583-0027
Country
Japan
Facility Name
Kitakyushu Municipal Medical Center
City
Fukuoka-ken
ZIP/Postal Code
802-0077
Country
Japan
Facility Name
Fukuoka University Hospital
City
Fukuoka
ZIP/Postal Code
814-0180
Country
Japan
Facility Name
Fukushima Medical University Hospital
City
Fukushima
ZIP/Postal Code
960-1295
Country
Japan
Facility Name
Gifu University Hospital
City
Gifu
ZIP/Postal Code
501-1194
Country
Japan
Facility Name
Hachinohe City Hospital
City
Hachinohe
ZIP/Postal Code
031-8555
Country
Japan
Facility Name
Tokai University Hachioji Hospital
City
Hachioji
ZIP/Postal Code
192-0032
Country
Japan
Facility Name
Hakodate Goryokaku Hospital
City
Hakodate
ZIP/Postal Code
040-8611
Country
Japan
Facility Name
Matsunami General Hospital
City
Hashima-gun
ZIP/Postal Code
501-6062
Country
Japan
Facility Name
National Hospital Organization Hirosaki General Medical Center
City
Hirosaki
ZIP/Postal Code
036-8545
Country
Japan
Facility Name
Hirosaki University Hospital
City
Hirosaki
ZIP/Postal Code
036-8563
Country
Japan
Facility Name
Kure Kyosai Hospital
City
Hiroshima
ZIP/Postal Code
737-8505
Country
Japan
Facility Name
Asahikawa Medical University Hospital
City
Hokkaido
ZIP/Postal Code
078-8510
Country
Japan
Facility Name
Mito Saiseikai General Hospital
City
Ibaraki
ZIP/Postal Code
311-4198
Country
Japan
Facility Name
Shimane University Hospital
City
Izumo
ZIP/Postal Code
693-8501
Country
Japan
Facility Name
Kagoshima University Hospital
City
Kagoshima City
ZIP/Postal Code
890-8544
Country
Japan
Facility Name
Imamura General Hospital
City
Kagoshima
ZIP/Postal Code
890-0064
Country
Japan
Facility Name
Izuro Imamura Hospital
City
Kagoshima
ZIP/Postal Code
892-0824
Country
Japan
Facility Name
Kagoshima IBD Gastroenterology Clinic
City
Kagoshima
ZIP/Postal Code
892-0843
Country
Japan
Facility Name
Sameshima Hospital
City
Kagoshima
ZIP/Postal Code
892-0846
Country
Japan
Facility Name
St.Marianna University Hospital
City
Kanagawa
ZIP/Postal Code
216-8511
Country
Japan
Facility Name
Matsushima Clinic
City
Kanagawa
ZIP/Postal Code
220-0041
Country
Japan
Facility Name
Kanazawa University Hospital
City
Kanazawa
ZIP/Postal Code
920-8641
Country
Japan
Facility Name
National Hospital Organization Kanazawa Medical Center
City
Kanazawa
ZIP/Postal Code
920-8650
Country
Japan
Facility Name
Nara Medical University Hospital
City
Kashihara
ZIP/Postal Code
634-8522
Country
Japan
Facility Name
Tsujinaka Hospital Kashiwanoha
City
Kashiwa
ZIP/Postal Code
277-0871
Country
Japan
Facility Name
Kyushu Rosai Hospital
City
Kitakyushu
ZIP/Postal Code
800-0296
Country
Japan
Facility Name
Aoyama Naika Clinic
City
Kobe
ZIP/Postal Code
650-0015
Country
Japan
Facility Name
Kobe University Hospital
City
Kobe
ZIP/Postal Code
650-0017
Country
Japan
Facility Name
National Hospital Organization Kochi National Hospital
City
Kochi
ZIP/Postal Code
780-8077
Country
Japan
Facility Name
Yamanashi Prefectural Central Hospital
City
Kofu
ZIP/Postal Code
400-8506
Country
Japan
Facility Name
Kumagaya General Hospital
City
Kumagaya-shi
ZIP/Postal Code
360-8567
Country
Japan
Facility Name
National Hospital Organization Kure Medical Center and Chugoku Cancer Center
City
Kure
ZIP/Postal Code
736-0023
Country
Japan
Facility Name
University Hospital Kyoto Perfectural University of Medicine
City
Kyoto
ZIP/Postal Code
602-8566
Country
Japan
Facility Name
National Hospital Organization Matsumoto Medical Center
City
Matsumoto
ZIP/Postal Code
399-8701
Country
Japan
Facility Name
Kitasato University Kitasato Institute Hospital
City
Minato-ku
ZIP/Postal Code
108-8642
Country
Japan
Facility Name
Kyorin University Hospital
City
Mitaka
ZIP/Postal Code
181-8611
Country
Japan
Facility Name
Takagi Clinic
City
Miyagi
ZIP/Postal Code
981-3213
Country
Japan
Facility Name
Osaki Citizen Hospital
City
Miyagi
ZIP/Postal Code
989-6183
Country
Japan
Facility Name
Iwate Medical University Hospital
City
Morioka-shi
ZIP/Postal Code
020-8505
Country
Japan
Facility Name
Nagoya University Hospital
City
Nagoya
ZIP/Postal Code
466-8560
Country
Japan
Facility Name
Nagoya City University Hospital
City
Nagoya
ZIP/Postal Code
467-8602
Country
Japan
Facility Name
Nagaoka Chuo General Hospital
City
Niigata
ZIP/Postal Code
940-8653
Country
Japan
Facility Name
The Hospital of Hyogo College of Medicine
City
Nishinomiya
ZIP/Postal Code
663-8501
Country
Japan
Facility Name
Oita Red Cross Hospital
City
Oita
ZIP/Postal Code
870-0033
Country
Japan
Facility Name
Shinbeppu Hospital
City
Oita
ZIP/Postal Code
874-8538
Country
Japan
Facility Name
Nakagami Hospital
City
Okinawa
ZIP/Postal Code
904-2195
Country
Japan
Facility Name
Kindai University Hospital
City
Osaka-Sayama
ZIP/Postal Code
589-8511
Country
Japan
Facility Name
Japanese Red Cross Osaka Hospital
City
Osaka
ZIP/Postal Code
543-8555
Country
Japan
Facility Name
Osaka City University Hospital
City
Osaka
ZIP/Postal Code
545-8586
Country
Japan
Facility Name
Izumiotsu Municipal Hospital
City
Osaka
ZIP/Postal Code
595-0027
Country
Japan
Facility Name
Japan Community Health Care Organization Saitama Medical Center
City
Saitama
ZIP/Postal Code
330-0074
Country
Japan
Facility Name
Toho University Sakura Medical Center
City
Sakura
ZIP/Postal Code
285-8741
Country
Japan
Facility Name
Sapporo Tokushukai Hospital
City
Sapporo
ZIP/Postal Code
004-0041
Country
Japan
Facility Name
Hokkaido P.W.F.A.C. Sapporo-Kosei General Hospital
City
Sapporo
ZIP/Postal Code
060-0033
Country
Japan
Facility Name
Sapporo Medical University Hospital
City
Sapporo
ZIP/Postal Code
060-8543
Country
Japan
Facility Name
Sapporo IBD Clinic
City
Sapporo
ZIP/Postal Code
064-0919
Country
Japan
Facility Name
Sapporo Higashi Tokushukai Hospital
City
Sapporo
ZIP/Postal Code
065-0033
Country
Japan
Facility Name
Tokyo Yamate Medical Center
City
Shinjuku-ku
ZIP/Postal Code
169-0073
Country
Japan
Facility Name
Matsuda Hospital
City
Shizuoka
ZIP/Postal Code
432-8061
Country
Japan
Facility Name
Tokyo Metropolitan Bokutoh Hospital
City
Sumida-ku
ZIP/Postal Code
130-8575
Country
Japan
Facility Name
Kagawa Prefectural Central Hospital
City
Takamatsu
ZIP/Postal Code
760-8557
Country
Japan
Facility Name
Tokushima University Hospital
City
Tokushima
ZIP/Postal Code
770-8503
Country
Japan
Facility Name
The Jikei University Hospital
City
Tokyo
ZIP/Postal Code
105-8471
Country
Japan
Facility Name
National Hospital Organization Tokyo Medical Center
City
Tokyo
ZIP/Postal Code
152-8902
Country
Japan
Facility Name
Mie University Hospital
City
Tsu
ZIP/Postal Code
514-8507
Country
Japan
Facility Name
Yokkaichi Hazu Medical Center
City
Yokkaichi
ZIP/Postal Code
510-0016
Country
Japan
Facility Name
Yokohama Municipal Citizen's Hospital
City
Yokohama
ZIP/Postal Code
221-0855
Country
Japan
Facility Name
University of Fukui Hospital
City
Yoshida
ZIP/Postal Code
910-1193
Country
Japan
Facility Name
Jordan University Hospital
City
Amman
ZIP/Postal Code
11942
Country
Jordan
Facility Name
Istishari Hospital
City
Amman
Country
Jordan
Facility Name
Khalidi Hospital and Medical Center
City
Amman
Country
Jordan
Facility Name
Irbid Specialty Hospital
City
Irbid
ZIP/Postal Code
21166
Country
Jordan
Facility Name
King Abdullah University Hospital
City
Irbid
ZIP/Postal Code
22110
Country
Jordan
Facility Name
Inje University Haeundae Paik Hospital
City
Busan
ZIP/Postal Code
612-896
Country
Korea, Republic of
Facility Name
Yeungnam University Hospital
City
Daegu
ZIP/Postal Code
42415
Country
Korea, Republic of
Facility Name
Seoul National University Bundang Hospital
City
Gyeonggi-do
ZIP/Postal Code
13620
Country
Korea, Republic of
Facility Name
Korea University Ansan Hospital
City
Gyeonggi-do
ZIP/Postal Code
15355
Country
Korea, Republic of
Facility Name
The Catholic university of Korea, St. Vincent's Hospital
City
Gyeonggi-do
ZIP/Postal Code
16247
Country
Korea, Republic of
Facility Name
Gachon University Gil Medical Center
City
Incheon
ZIP/Postal Code
21565
Country
Korea, Republic of
Facility Name
KyungHee University Hospital
City
Seoul
ZIP/Postal Code
02447
Country
Korea, Republic of
Facility Name
Severance Hospital, Yonsei University Health System
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of
Facility Name
Asan Medical Center
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
Facility Name
The Catholic University of Korea, Seoul St. Mary's Hospital
City
Seoul
ZIP/Postal Code
06591
Country
Korea, Republic of
Facility Name
Chung-Ang University Hospital
City
Seoul
ZIP/Postal Code
06973
Country
Korea, Republic of
Facility Name
Ajou University Hospital
City
Suwon
ZIP/Postal Code
16499
Country
Korea, Republic of
Facility Name
Pauls Stradins Clinical University Hospital
City
Riga
ZIP/Postal Code
LV-1002
Country
Latvia
Facility Name
Pauls Stradins Clinical University Hospital
City
Riga
ZIP/Postal Code
LV1002
Country
Latvia
Facility Name
Health Centre 4 Centre of Diagnostics
City
Riga
ZIP/Postal Code
LV1003
Country
Latvia
Facility Name
Digestive Diseases Centre GASTRO
City
Riga
ZIP/Postal Code
LV1079
Country
Latvia
Facility Name
Hospital Serdang
City
Kajang
ZIP/Postal Code
43000
Country
Malaysia
Facility Name
Hospital University Sains Malaysia
City
Kelantan
ZIP/Postal Code
16150
Country
Malaysia
Facility Name
Pusat Perubatan Universiti Kebangsaan Malaysia
City
Kuala Lumpur
ZIP/Postal Code
56000
Country
Malaysia
Facility Name
University Malaya Medical Centre
City
Kuala Lumpur
ZIP/Postal Code
59100
Country
Malaysia
Facility Name
Onze Lieve Vrouwe Gasthuis
City
Amsterdam
ZIP/Postal Code
1091 AC
Country
Netherlands
Facility Name
Albert Schweitzer Ziekenhuis
City
Dordrecht
ZIP/Postal Code
3318 AT
Country
Netherlands
Facility Name
Radboudumc
City
Nijmegen
ZIP/Postal Code
6525 GA
Country
Netherlands
Facility Name
Dunedin Hospital
City
Dunedin
ZIP/Postal Code
9016
Country
New Zealand
Facility Name
Auckland City Hospital
City
Grafton
ZIP/Postal Code
1023
Country
New Zealand
Facility Name
Waikato Hospital
City
Hamilton
ZIP/Postal Code
3204
Country
New Zealand
Facility Name
Gastromed Kralisz Romatowski Stachurska Sp. j.
City
Bialystok
ZIP/Postal Code
15-322
Country
Poland
Facility Name
Szpital Uniwersytecki nr 2 im. dr. Jana Biziela w Bydgoszczy
City
Bydgoszcz
ZIP/Postal Code
85-168
Country
Poland
Facility Name
Centrum Medyczne Plejady
City
Krakow
ZIP/Postal Code
30-363
Country
Poland
Facility Name
Centrum Medyczne Promed
City
Krakow
ZIP/Postal Code
31-513
Country
Poland
Facility Name
Gastromed ZOZ
City
Lublin
ZIP/Postal Code
20-583
Country
Poland
Facility Name
Medicome Sp z o.o.
City
Oswiecim
ZIP/Postal Code
32-600
Country
Poland
Facility Name
Centrum Medyczne Medyk
City
Rzeszow
ZIP/Postal Code
35-326
Country
Poland
Facility Name
Endoskopia Sp z o.o.
City
Sopot
ZIP/Postal Code
81-756
Country
Poland
Facility Name
Twoja Przychodnia - Szczecinskie Centrum Medyczne
City
Szczecin
ZIP/Postal Code
71-434
Country
Poland
Facility Name
GASTROMED Sp. z o.o.
City
Torun
ZIP/Postal Code
87-100
Country
Poland
Facility Name
WIP Warsaw IBD Point Profesor Kierkus
City
Warszawa
ZIP/Postal Code
00-728
Country
Poland
Facility Name
Centralny Szpital Kliniczny Mswia
City
Warszawa
ZIP/Postal Code
02-507
Country
Poland
Facility Name
Wojskowy Instytut Medyczny
City
Warszawa
ZIP/Postal Code
04-141
Country
Poland
Facility Name
Melita Medical Sp. z o.o.
City
Wroclaw
ZIP/Postal Code
50-449
Country
Poland
Facility Name
Wromedica
City
Wroclaw
ZIP/Postal Code
51-685
Country
Poland
Facility Name
ETG Zamosc
City
Zamosc
ZIP/Postal Code
22-400
Country
Poland
Facility Name
Centro Hospitalar e Universitário de Coimbra, EPE
City
Coimbra
ZIP/Postal Code
3000-075
Country
Portugal
Facility Name
Centro Hospitalar do Porto, EPE
City
Porto
ZIP/Postal Code
4099-001
Country
Portugal
Facility Name
Centro Hospitalar de São João, EPE
City
Porto
ZIP/Postal Code
4200-319
Country
Portugal
Facility Name
Centro Hospitalar de Entre o Douro e Vouga, E.P.E
City
Santa Maria da Feira
ZIP/Postal Code
4520-211
Country
Portugal
Facility Name
Centro Hospitalar de Tondela Viseu, EPE
City
Viseu
ZIP/Postal Code
3504-509
Country
Portugal
Facility Name
Medical Center Meditsinskie Tekhnologii
City
Ekaterinburg
ZIP/Postal Code
620075
Country
Russian Federation
Facility Name
OOO MO New Hospital
City
Ekaterinburg
ZIP/Postal Code
620109
Country
Russian Federation
Facility Name
Immanuel Kant Baltic Federal University
City
Kaliningrad
ZIP/Postal Code
236016
Country
Russian Federation
Facility Name
Road Clinical Hospital at the Nizhny Novgorod Station of the Russian Railways
City
Nizhniy Novgorod
ZIP/Postal Code
603140
Country
Russian Federation
Facility Name
Medical Center SibNovoMed LLC
City
Novosibirsk
ZIP/Postal Code
630005
Country
Russian Federation
Facility Name
LLC 'Novosibirsk Gastrocentr'
City
Novosibirsk
ZIP/Postal Code
630007
Country
Russian Federation
Facility Name
City Clinical Hospital #2
City
Perm
ZIP/Postal Code
614068
Country
Russian Federation
Facility Name
Rostov State Medical University
City
Rostov-On-Don
ZIP/Postal Code
344022
Country
Russian Federation
Facility Name
All-Russian Center of Emergency and Radiation Medicine MCRS
City
Saint-Petersburg
ZIP/Postal Code
194044
Country
Russian Federation
Facility Name
Eco-safety Ltd
City
Saint-Petersburg
ZIP/Postal Code
196143
Country
Russian Federation
Facility Name
Medical University Reaviz
City
Samara
ZIP/Postal Code
443001
Country
Russian Federation
Facility Name
NUZ 'Railway Clinical Hospital on Samara station of LLC 'Russian Railways'
City
Samara
ZIP/Postal Code
443041
Country
Russian Federation
Facility Name
Saratov Regional Clinical Hospital
City
Saratov
ZIP/Postal Code
410053
Country
Russian Federation
Facility Name
International Medical Centre SOGAZ
City
St-Petersburg
ZIP/Postal Code
191186
Country
Russian Federation
Facility Name
GBUZ Respublican Clinical Hospital n.a. GG Kuvatova
City
Ufa
ZIP/Postal Code
450005
Country
Russian Federation
Facility Name
City Clinical Hospital # 21
City
Ufa
ZIP/Postal Code
450071
Country
Russian Federation
Facility Name
Regional Clinical Hospital
City
Yaroslavl
ZIP/Postal Code
150062
Country
Russian Federation
Facility Name
Zvezdara University Medical Center
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Facility Name
General Hospital 'Dr Radivoj Simonovic'
City
Sombor
ZIP/Postal Code
25101
Country
Serbia
Facility Name
General Hospital 'Djordje Joanovic'
City
Zrenjanin
ZIP/Postal Code
23000
Country
Serbia
Facility Name
FNsP F.D.R. Banska Bystrica
City
Banska Bystrica
ZIP/Postal Code
975 17
Country
Slovakia
Facility Name
Gastroenterology Department GASTROMART s.r.o.
City
Bardejov
ZIP/Postal Code
085 01
Country
Slovakia
Facility Name
Gastroenterology Center ASSIDUO
City
Bratislava
ZIP/Postal Code
811 08
Country
Slovakia
Facility Name
Cliniq s.r.o.
City
Bratislava
ZIP/Postal Code
811 09
Country
Slovakia
Facility Name
ENDOMED s.r.o
City
Kosice
ZIP/Postal Code
040 13
Country
Slovakia
Facility Name
GASTRO I. s.r.o.
City
Presov
ZIP/Postal Code
080 01
Country
Slovakia
Facility Name
Accout Center, s.r.o., Gastroenterologická ambulancia
City
Sahy
ZIP/Postal Code
93601
Country
Slovakia
Facility Name
Hosp. Univ. Germans Trias I Pujol
City
Badalona
ZIP/Postal Code
08916
Country
Spain
Facility Name
Hosp. Clinic I Provincial de Barcelona
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Hosp. Univ. Dr. Josep Trueta
City
Girona
ZIP/Postal Code
17007
Country
Spain
Facility Name
Hosp. Univ. La Paz
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Facility Name
Hosp. Univ. Marques de Valdecilla
City
Santander
ZIP/Postal Code
39008
Country
Spain
Facility Name
Hosp. Virgen Del Rocio
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Facility Name
Hosp. Ntra. Sra. de Valme
City
Sevilla
ZIP/Postal Code
41014
Country
Spain
Facility Name
Karolinska Universitetssjukhuset
City
Stockholm
ZIP/Postal Code
SE-171 76
Country
Sweden
Facility Name
Uppsala University
City
Uppsala
ZIP/Postal Code
SE-75185
Country
Sweden
Facility Name
Chang-Hua Christian Hospital
City
Changhua
ZIP/Postal Code
50006
Country
Taiwan
Facility Name
Taichung Veterans General Hospital
City
Taichung
ZIP/Postal Code
40705
Country
Taiwan
Facility Name
National Taiwan University Hospital
City
Taipei
ZIP/Postal Code
10002
Country
Taiwan
Facility Name
Chang-Gung Memorial Hospital, LinKou Branch
City
Taoyuan
ZIP/Postal Code
33305
Country
Taiwan
Facility Name
Hacettepe University Hospital
City
Ankara
ZIP/Postal Code
06230
Country
Turkey
Facility Name
Gazi University Hospital
City
Ankara
ZIP/Postal Code
06560
Country
Turkey
Facility Name
Trakya University Medical Faculty
City
Edirne
ZIP/Postal Code
22030
Country
Turkey
Facility Name
Istanbul University Istanbul Medical Faculty
City
Istanbul
ZIP/Postal Code
34093
Country
Turkey
Facility Name
Istanbul University Cerrahpasa Medical Faculty
City
Istanbul
ZIP/Postal Code
34098
Country
Turkey
Facility Name
Medicana International Istanbul
City
Istanbul
ZIP/Postal Code
34520
Country
Turkey
Facility Name
BAU Medical Park Goztepe Hospital
City
Istanbul
ZIP/Postal Code
34732
Country
Turkey
Facility Name
Acibadem Kozyatagi Hospital
City
Istanbul
ZIP/Postal Code
34734
Country
Turkey
Facility Name
Ege University Medical Faculty
City
Izmir
ZIP/Postal Code
35100
Country
Turkey
Facility Name
Dokuz Eylul University Medical Faculty
City
Izmir
ZIP/Postal Code
35330
Country
Turkey
Facility Name
Kocaeli University Medical Faculty
City
Kocaeli
ZIP/Postal Code
41380
Country
Turkey
Facility Name
Mersin University Medical Faculty Hospital
City
Mersin
ZIP/Postal Code
33110
Country
Turkey
Facility Name
Ivano-Frankivsk Regional Clinical Hospital
City
Ivano-Frankivsk
ZIP/Postal Code
76008
Country
Ukraine
Facility Name
Communal Nonprofit Enterprise 'City Clinical Hospital # 2 N.A. Prof. O.O. Shalimov'
City
Kharkiv
ZIP/Postal Code
61037
Country
Ukraine
Facility Name
SI 'L.T. Maloyi National Institute of Therapy of National Academy of Medical Sciences of Ukraine'
City
Kharkiv
ZIP/Postal Code
61039
Country
Ukraine
Facility Name
Municipal Institution 'Kherson City Clinical Hospital n.a. Y.Y.Karabelesh'
City
Kherson
ZIP/Postal Code
73003
Country
Ukraine
Facility Name
Kyiv City Clinical Hospital #18
City
Kyiv
ZIP/Postal Code
01030
Country
Ukraine
Facility Name
Medical Center 'Ok Clinic' of LLC 'International Institute of Clinical Studies'
City
Kyiv
ZIP/Postal Code
02091
Country
Ukraine
Facility Name
Lviv Clinical Hospital on Railway Transport of Affiliate Healthcare center of JSC Ukrainian Railway
City
Lviv
ZIP/Postal Code
79007
Country
Ukraine
Facility Name
Communal Nonprofit Enterprise of Lviv Regional Council 'Lviv Regional Clinical Hospital'
City
Lviv
ZIP/Postal Code
79010
Country
Ukraine
Facility Name
Municipal Non-profit Enterprise 'Odesa Regional Clinical Hospital' Odesa Regional Council
City
Odesa
ZIP/Postal Code
65025
Country
Ukraine
Facility Name
Sumy State University, Sumy Regional Clinical Hospital
City
Sumy
ZIP/Postal Code
40022
Country
Ukraine
Facility Name
Municipal institution of Tepnopil Regional Council 'Ternopil University Hospital'
City
Ternopil
ZIP/Postal Code
46002
Country
Ukraine
Facility Name
Medical Center Ltd 'Health Clinic', Department Of General Therapy
City
Vinnytsya
ZIP/Postal Code
21009
Country
Ukraine
Facility Name
Vinnitsia Regional Clinical Hospital n.a. M. I. Pyrogov
City
Vinnytsya
ZIP/Postal Code
21018
Country
Ukraine
Facility Name
Glasgow Royal Infirmary
City
Glasgow
ZIP/Postal Code
G4 0SF
Country
United Kingdom
Facility Name
Guy's and St Thomas' Hospital
City
London
ZIP/Postal Code
SE1 7EH
Country
United Kingdom
Facility Name
St George's Hospital
City
London
ZIP/Postal Code
SW17 0QT
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
IPD Sharing URL
https://www.janssen.com/clinical-trials/transparency
Learn more about this trial
A Study of Guselkumab in Participants With Moderately to Severely Active Ulcerative Colitis
We'll reach out to this number within 24 hrs