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Study for Participants With Ulcerative Colitis Previously Enrolled in Etrolizumab Phase II/III Studies (COTTONWOOD)

Primary Purpose

Ulcerative Colitis

Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Etrolizumab
Sponsored by
Hoffmann-La Roche
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ulcerative Colitis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Part 1 (Open-label Extension)

- Participants previously enrolled in the Phase II OLE study or Phase III controlled studies who meet the eligibility criteria for open-label etrolizumab for those studies as described in the protocol

Part 2 (Safety Monitoring)

  • Participants whose safety follow-up or PML follow-up is not completed within Study GA27927 and participants who had their last dose of etrolizumab in July 2016 in Study GA27927 and are not eligible or willing to enroll in Part 1 (OLE)
  • Participants who participated in one of the etrolizumab Phase III studies and are not eligible or willing to enter Part 1 (OLE)
  • Participants who transfer from Part 1 (OLE)
  • Completion of the 12-week safety follow-up prior to entering.

Exclusion Criteria:

Part 1 (Open-label Extension)

  • Withdrawal of consent from and participant not compliant in the Phase II OLE study or any of the Phase III studies
  • Participant who discontinued etrolizumab/etrolizumab placebo prior to Week 10 or did not perform the Week 10 visit of the Phase III Studies GA28948, GA28949, GA29102, and GA29103
  • Participant who discontinued etrolizumab/etrolizumab placebo prior to Week 14 or did not perform the Week 14 visit of the Phase III Study GA28950
  • Any new, significant, uncontrolled condition

Sites / Locations

  • University of Alabama Medical Center
  • University of California San Diego Medical Center
  • University of California, Irvine Medical Center
  • SDG Clinical Research
  • University of California at San Francisco
  • Ventura Clinical Trials
  • Peak Gastroenterology Associates
  • Clinical Research of the Rockies
  • Rocky Mountain Gastroenterology Associates
  • Innovative Medical Research of South Florida, Inc.
  • West Central Gastroenterology d/b/a Gastro Florida
  • IMIC, Inc
  • Regenerate Clinical Trials
  • FQL Research, LLC
  • Gastroenterology Group of Naples
  • Advanced Research Institute, Inc.
  • Internal Medicine Specialists
  • Shafran Gastroenterology Center
  • Atlanta Gastroenterology Associates
  • Gastroenterology Associates of Central Georgia
  • Gastrointestinal Specialists of Georgia, PC
  • Atlanta Gastroenterology Specialists, PC
  • Northwestern University Feinberg School Of Medicine
  • University of Chicago Medical Center; Medicine, Section of Pulmonary
  • Southwest Gastroenterology
  • Aquiant Research
  • Cotton-O'Neil Clinical Research Center, Digestive Health
  • Gastroenterology Associates, LLC
  • Louisiana Research Center, LLC
  • Massachusetts General Hospital; Crohn's & Colitis Center
  • University of Michigan
  • Henry Ford Health System
  • Center for Digestive Health
  • Huron Gastroenterology Associates
  • Regents of the University of Minnesota
  • University of Mississippi Medical Center
  • Ehrhardt Clinical Research, LLC
  • Kansas City Research Institute, LLC
  • Clinica Peruano Americana S.A.
  • NYU Langone Medical Center
  • Concorde Medical Group
  • Weill Cornell Medical College (WCMC) - Judith Jaffe Multiple Sclerosis Center (JJMSC)
  • Asheville Gastroenterology Associates, P.A.
  • University of North Carolina at Chapel Hill
  • Kinston Medical Specialists
  • Consultants for Clin. Rsrch
  • UC Health Clinical Trials Office; Division of Digestive Diseases
  • Great Lakes Gastroenterology Research, LLC
  • Gastroenterology Center of the Midsouth, P.C.
  • Vanderbilt University Medical Center
  • Texas Digestive Disease Consultants - Dallas
  • Wellness Clinical Research Center
  • Texas Digestive Disease Consultants - Southlake
  • Tyler Research Institute, LLC
  • Ericksen Research and Development
  • University of Utah School of Medicine
  • McGuire Research Institute; Gastroenterology
  • Washington Gastroenterology
  • Instituto Medico DAMIC
  • Hospital Provincial del Centenario
  • Bankstown-Lidcombe Hospital
  • Concord Repatriation General Hospital
  • Royal Brisbane and Women's Hospital
  • Mater Adult Hospital
  • Princess Alexandra Hospital
  • Royal Adelaide Hospital
  • Flinders Medical Centre
  • Launceston General Hospital; Gastroenterology Research
  • Monash Medical Centre
  • St Vincent's Hospital Melbourne
  • Footscray Hospital
  • St Frances Xavier Cabrini Hospital
  • Royal Melbourne Hospital; Department of Colorectal Medicine and Genetics
  • Fiona Stanley Hospital
  • LKH - Universitätsklinikum der PMU Salzburg
  • Medizinische Universität Wien
  • GZA Ziekenhuizen - Campus Sint-Vincentius
  • Imeldaziekenhuis
  • CHU St Pierre (St Pierre)
  • UZ Brussel
  • Cliniques Universitaires Saint-Luc; Pharmacy
  • UZ Gent
  • AZ Sint Elisabeth Herentals
  • UZ Leuven; Neurology
  • AZ Delta (Campus Rumbeke)
  • Hospital Universitario Prof Edgar Santos-Ufba; Ambulatorio Magalhaes Neto 3Andar- Dermatologia
  • Hospital Universitario Walter Cantidio - UFC
  • CCBR - Brasilia
  • Instituto Goiano de Gastroenterologia e Endoscopia Digestiva Ltda
  • Hospital Felicio Rocho
  • Centro Digestivo de Curitiba
  • Hospital Universitario Clementino Fraga Filho - UFRJ
  • Hospital Moinhos de Vento
  • Hospital das Clinicas - UFRGS
  • Hospital Ernesto Dornelles
  • UNESP - Faculdade de Medicina da Universidade Estadual Paulista - Campus Botucatu
  • CAEP - Centro Avancado de Estudos e Pesquisas Ltda.
  • CECIP - Centro de Estudos Clínicos do Interior Paulista
  • Pesquisare Saúde Sociedade Simples
  • Hospital Estadual Mario Covas
  • Hospital Sírio-Libanês
  • Hospital do Servidor Público Estadual/HSPE-SP
  • Medical Centre "Asklepii", OOD
  • DCC Sv. Pantaleymon OOD; II-nd Clinic of Neurology
  • Medical center Medconsult Pleven OOD
  • MHAT - Ruse, AD
  • MHAT "Hadzhi Dimitar", OOD
  • "City Clinic UMHAC" EOOD
  • UMHAT "Sv. Ivan Rilski", EAD
  • UMHAT Tsaritsa Yoanna - ISUL, EAD
  • Diagnostic Consultation Center CONVEX EOOD
  • Medical Center "Nov Rehabilitatsionen Tsentar", EOOD
  • MHAT 'Sv. Marina', EAD; First Children's Clinic
  • MC Medica Plus
  • University of Calgary
  • Zeidler Ledcor Centre - University of Alberta; Division of Gasroenterology
  • Pacific Gastroenterology Associates
  • Queen Elizabeth II Health Sciences Centre; Gastroenterology Research
  • Guelph GI & Surgery Clinic
  • University Hospital - London Health Sciences Centre
  • Taunton Health Centre
  • Mount Sinai Hospital
  • Toronto Liver Centre
  • Toronto Digestive Disease Associates
  • Centre de santé et de services sociaux Champlain-Charles-Le Moyne
  • Hotel Dieu de Levis
  • Hôpital Maisonneuve - Rosemont
  • Royal University Hospital
  • RTS - Fundación Valle de Lili
  • Instituto de Coloproctologia ICO S.A.S.
  • Clinical Hospital Centre Osijek
  • Clinical Hospital Sveti Duh; Department of Neurology
  • Vojenska nemocnice Brno
  • Fakultni nemocnice u sv. Anny v Brne; I.Interni kardioangiologicka klinika
  • Fakultni nemocnice Hradec Kralove
  • Hepato-Gastroenterologie HK, s.r.o.
  • Oblastni nemocnice Kladno, a.s., nemocnice Stredoces. kraje; Endoskopicke centrum
  • PreventaMed, s.r.o.
  • Mestska Nemocnice Ostrava
  • Pardubicka krajska nemocnice a.s.
  • Nemocnice Na Bulovce
  • ISCARE a.s.
  • Krajska zdravotni, a.s. ? Masarykova nemocnice v Usti nad Labem, o.z., Ocni oddeleni
  • Krajska nemocnice T. Bati, a.s.
  • Herlev og Gentofte Hospital
  • Rigshospitalet; Medicinsk gastroenterologisk klinik
  • Ålborg Universitets Hospital; Gastromedicinsk
  • OÜ Innomedica
  • East Tallinn Central Hospital
  • West Tallinn Central Hospital
  • North Estonia Medical Centre Foundation
  • Tartu University Hospital
  • CHU Amiens - Hopital Sud
  • CHU de Caen Hopital Cote de Nacre
  • CHU Tours - Hôpital Trousseau
  • Hôpital Beaujon
  • Hopital Claude Huriez - CHU Lille
  • CHU Hopital Saint Eloi
  • CHU Nice - Hopital de l'Archet 2
  • Hôpital Saint-Louis
  • CHU Bordeaux - Hôpital Haut-Lévêque
  • Centre Hospitalier Lyon Sud; Service de Gastro-Enterologie
  • CHU Saint Etienne - Hôpital Nord
  • Höpital Hautepierre; Pediatrie1
  • CHU de Toulouse - Hôpital Rangueil
  • Hôpital de Brabois Adultes
  • Charite Universitaetsmedizin Berlin - Campus Charite Mitte
  • Charite Universitaetsmedizin Berlin - Campus Benjamin Franklin
  • DRK Kliniken Berlin Westend
  • Krankenhaus Waldfriede e. V.
  • Berufsgenossenschaftliches Universitaetsklinikum Bergmannsheil GmbH
  • Universitaetsklinikum Erlangen
  • Klinikum der Johann Wolfgang Goethe-Universitaet
  • Universitaetsklinikum Freiburg; Urology
  • Universitaetsklinikum Halle (Saale)
  • Hamburgisches Forschungsinstitut fuer CED
  • Universitätsklinikum Hamburg-Eppendorf
  • Gastroenterologie Eppendorfer Baum
  • Medizinische Hochschule Hannover; Klinik für Gastroenterologie, Hepatologie und Endokrinologie
  • Universitaetsklinikum Jena; Apotheke des Uniersitätsklinikums Jena
  • Universitaetsklinikum Schleswig-Holstein, Campus Kiel
  • Medizinisches Zentrum Klinikum Lueneburg
  • Klinikum Mannheim GmbH Universitätsklinikum
  • Universitaetsklinikum Muenster
  • Gemeinschaftspraxis Dres. Joachim Mueller und Steffi Appelt
  • Universitaetsklinikum Ulm
  • University General Hospital of Heraklion
  • University of Hong Kong
  • DRC Gyogyszervizsgalo Kozpont Kft
  • Bekes Megyei Kozponti Korhaz Dr. Rethy Pal Tagkorhaza
  • Semmelweis Egyetem
  • Eszak-Kozep-budai Centrum, Uj Szent Janos Korhaz es Szakrendelo
  • Pannónia Klinika Magánorvosi
  • Magyar Honvedseg Egeszsegugyi Kozpont; Fázis I-es Klinikai Farmakológiai Vizsgálóhely
  • Endomedix Diagnosztikai Kozpont
  • Vasutegeszsegugyi Kft. - Debreceni Egeszsegugyi Kozpont
  • Debreceni Egyetem Klinikai Kozpont
  • Markhot Ferenc Oktato Korhaz es Rendelointezet
  • Petz Aladar Megyei Oktato Korhaz
  • Pest Megyei Flor Ferenc Korhaz
  • Borsod-Abauj-Zemplen Megyei Korhaz es Egyetemi Oktato Korhaz
  • Pecsi Tudomanyegyetem
  • Csongrad Megyei Dr. Bugyi Istvan Korhaz
  • Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz
  • Deccan College of Medical Sciences and Allied Hospitals; Department of Gastroenterology
  • Nirmal Hospital
  • K.L.E. Society's Dr. Prabhakar Kore Hospital and Medical Research Centre
  • M. S. Ramaiah Medical College and Hospital
  • Kasturba Medical College & Hospital
  • Midas institute of Gastroenterology
  • Ruby Hall Clinic
  • Dayanand Medical College and Hospital
  • S. R. Kalla Memorial Gastro & General Hospital
  • King Edward Memorial Hospital Research Centre
  • Bnai Zion Medical Center; Internal Medicine
  • Shaare Zedek Medical Center
  • Hadassah University Hospital - Ein Kerem
  • Holy Family Hospital
  • Rabin Medical Center Beilinson Campus; Gaucher Clinic Genetics Institute
  • Kaplan Medical Center
  • Assaf Harofeh
  • Chaim Sheba Medical Center; Pediatrics B North and Pediatric Endocrinology Unit
  • Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpigh
  • A.O.U. Policlinico di Modena
  • Azienda Ospedaliero Universitaria di Parma
  • Azienda Ospedaliera Universitaria Policlinico Tor Vergata
  • Ospedale Sandro Pertini
  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS
  • Azienda Ospedaliera San Camillo Forlanini
  • Azienda Ospedaliero Universitaria San Martino
  • Fondazione Poliambulanza Istituto Ospedaliero
  • Azienda Ospedaliera Fatebenefratelli e Oftalmico
  • Azienda Socio Sanitaria Territoriale Niguarda (Grande Ospedale Metropolitano Niguarda)
  • Azienda Socio Sanitaria Territoriale Fatebenefratelli (Presidio Ospedale Sacco)
  • Ospedale di Circolo; Neuropsichiatria Infantile
  • Istituto Clinico Humanitas
  • I.R.C.C.S Policlinico San Donato
  • IRCCS Ospedale Casa Sollievo della Soffenza; Stru Comp di Gastroenterologia ed Endoscopia digest
  • Ospedale Mauriziano Umberto I
  • Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone
  • Azienda Ospedaliera Universitaria Careggi
  • Azienda Ospedaliera di Padova
  • Dong-A University Hospital
  • Pusan National University Hospital
  • Kyungpook National University Medical Center
  • Keimyung University Dongsan Medical Center
  • Kyungpook National University Hospital
  • Yeungnam Univ. Hospital
  • Korea University Ansan Hospital
  • Seoul National University Bundang Hospital
  • CHA Bundang Medical Centre; CHA university
  • Seoul National University Hospital
  • Kangbuk Samsung Hospital
  • Severance Hospital, Yonsei University Health System
  • Samsung Medical Center
  • Asan Medical Center.
  • Ajou University Hospital
  • The Catholic University of Korea St. Vincent's Hospital
  • Yonsei University Wonju Severance Christian Hospital
  • Central Outpatient Clinic
  • Pauls Stradins Clinical University Hospital
  • Digestive Diseases Center "Gastro"
  • Hospital of Lithuanian University of Health. Sciences Kaunas Clinics
  • Klaipeda Seamen's Hospital, Public Institution
  • Vilnius University Hospital Santariskiu Clinic, Public Institution; Cardiology
  • Pusat Perubatan Universiti Kebangsaan Malaysia
  • University Malaya Medical Center
  • Hospital Tengku Ampuan Afzan
  • Hospital Raja Perempuan Zainab II; Department of Medicine
  • Centro Integral en Reumatología S.A. de C.V. (CIRSA)
  • Accelerium S. de R.L. de C.V.
  • Hospital Universitario Dr Jose Eleuterio Gonzalez; Universidad Autónoma de Nuevo León
  • Centro Regiomontano de Estudios Clínicos Roma S.C.
  • Phylasis Clinicas Research S de RL de CV
  • Amsterdam UMC Location VUMC
  • Amsterdam UMC Location AMC
  • Radboudumc
  • North Shore Hospital
  • Middlemore Hospital
  • Dunedin Hospital
  • Waikato Hospital
  • Shakespeare Specialist Group
  • Tauranga Hospital
  • Akershus universitetssykehus HF
  • AppleTreeClinics Sp. z o.o.
  • Nasz Lekarz Osrodek Badan Klinicznych
  • Centrum Medyczne Lukamed Joanna Luka
  • Centrum Medyczne Sw. Lukasza
  • 7 Szpital Marynarki Wojennej z Przychodnia SPZOZ im. W. Lasinskiego
  • Pro Familia Altera Sp z o.o.
  • Nzoz All-Medicus
  • Uniwersyteckie Centrum Kliniczne im. prof. K. Gibinskiego SUM
  • NZOZ Centrum Medyczne ProMiMed
  • Centrum Opieki Zdrowotnej Orkan-Med
  • Indywidualna Specjalistyczna Praktyka Lekarska
  • GASTROMED Sp. z o.o.
  • Allmedica Badania Kliniczne Sp z o.o. Sp K.
  • Wojewodzki Specjalistyczny Szpital w Olsztynie
  • SOLUMED Centrum Medyczne
  • Centrum Medyczne Medyk
  • Gabinet Lekarski, Bartosz Korczowski
  • Specjalistyczna Praktyka Lekarska Dr med. Marek Horynski; endoskopia
  • Niepubliczny Zaklad Opieki Zdrowotnej SONOMED
  • Twoja Przychodnia-Szczecinskie Centrum Medyczne
  • Centrum Zdrowia MDM
  • Zespó Przychodni Specjalistycznych PRIMA
  • Endoterapia PFG Sp. z o.o.
  • Narodowy Instytut Onkologii im. Marii Sk?odowskiej-Curie - Pa?stwowy Instytut Badawczy
  • Nzoz Vivamed
  • Przychodnia EuroMediCare
  • PlanetMed
  • LexMedica Osrodek Badan Klinicznych
  • Hospital de Braga
  • Hospital da Senhora da Oliveira Guimarães
  • Spitalul Clinic Colentina
  • S.C MedLife S.A
  • Centrul Medical Unirea SRL
  • Centrul de Gastroenterologie Dr. Goldis
  • Yusupov Hospital
  • SBEI HPE Altai StateMedicalUniversityofMoH andSD
  • Baltic Medicine
  • CJSC Nasledniki
  • FSBIH Central Clinical Hospital of RAS
  • FSBI ?State Scientific Centre of Coloproctology" of the MoH of RF; Gastroenterology
  • SBHI of NN region ?RCH of NN n.a. N.A.Semashko?
  • SEIHPE "Rostov SMU of MoH of RF"
  • FFSBI "The Nikiforov Russian Center of Emergency and Radiation Medicine"; Pulmonology
  • SPb SBIH "City Multy-field Hospital # 2"; Intensive Pulmonology and Thoracal Surgery
  • SBIH City Clinical Hospital #31
  • City Hospital #26
  • LLC International Medical Centre ?SOGAZ?
  • FSBMEI HPE "Military Medical Academy n.a. S.M. Kirov" of the MoD of the RF; Therapy
  • Pavlov First Saint Petersburg State Medical University
  • SPb SHI "City Hospital #9"
  • Medical and Sanitary Division of Severstal
  • SBEI HPE "Voronezh State Medical University n.a. N.N. Burdenko" of the MoH of the RF
  • Irkutsk State Medical Academy of Continuing Education
  • FSBI "Scientific Research Institute of Physyology and Basic Medicine" under the SB of RAMS
  • BHI of Omsk region Clinical Oncology Dispensary
  • SBEI of HPE "Omsk SMA" Ministry of healthcare of RF"
  • Stavropol Regional Clinical Diagnostic Consultative Center
  • FSBEI HE "Stavropol State Medical University" of Ministry of Healthcare of Russian Federation
  • Clinical Center Zvezdara
  • Military Medical Academy
  • Clinical Center Zemun
  • Clinical Center Kragujevac
  • General Hospital Djordje Joanovic
  • Singapore General Hospital
  • Fakultna nemocnica s poliklinikou F.D. Roosevelta
  • Nemocnica A.Lena Humenne, n.o.
  • KM Management spol. s r.o.
  • Gastro I, s.r.o.
  • Svet zdravia a.s.
  • Endomed, s.r.o.
  • Accout Center s.r.o.
  • Netcare Universitas Private Hospital
  • Dr MJ Prins Practice
  • Dr JP Wright Practice
  • Emmed Research
  • Corporacio Sanitaria Parc Tauli
  • Fundacion Hospital de Alcorcon; Servicio de Digestivo
  • Centro Médico Teknon
  • Hospital Universitari de Girona Dr Josep Trueta
  • Hospital Universitario de la Princesa
  • Hospital Universitario La Paz
  • Hospital Universitario de Fuenlabrada
  • Hospital Universitari i Politecnic La Fe
  • Hospital Universitario Miguel Servet
  • Inselspital-Universitaetsspital Bern
  • Crohn-Colitis Zentrum Bern - Gemeinschaftspraxis Balsiger, Seibold und Partner
  • Gazi University Medical Faculty; Gastroenterology
  • Haydarpasa Numune Training and Research Hospital; Medical Oncology
  • Kocaeli Universitesi Tip Fakultesi; Infectious Diseases
  • CNE Prof. O.O. Shalimov Kharkiv City Clinical Hospital #2 of KCC
  • Communal Non-commercial Enterprise of Kharkiv Regional Council Regional Clinical Hospital
  • Communal Institution of Kyiv Regional Council Kyiv Regional Clinical Hospital
  • CI of SRC Sumy RCH Dept of Gasroenterology Sumy SU MI
  • LLC Gastroenterology Center IBD Team
  • CNE Kyiv CCH #18
  • CI of Kyiv RC Kyiv Regional Clinical Hospital
  • Medical Center of Limited Liability Company Medical Clinic Blagomed
  • Med Center of International Institute of Clinical Trials LLC; Medical Center "OK!Clinic+"
  • CI of Kyiv RC Regional Clinical Hospital #2
  • Lviv Regional Clinical Hospital
  • CI UDH Dept of Ther SHEI Fac of PGE&Pre-Univ Training
  • A.Novak Transcarpathian Regional Clinical Hospital
  • RCNECRCH Dept of Surgery, SHEI Ukr BSMU
  • CI City Hospital #1
  • RCI Chernivtsi RCH Gastroenterology Bukovinsky SMU
  • SI Dnipropetrovsk MA of MOHU SI Institute of gastroenterology of AMSU
  • GI L.T.Malaya Therapy National Institute of the NAMS of Ukraine
  • CI of Healthcare Kharkiv CCH #13
  • CI Kherson Afanasii and Olha Tropiny City Clinical Hospital
  • CNI Consultative and Diagnostic Center of Desnianskyi District of Kyiv
  • Odessa regional clinical Hospital
  • M.V. Sklifosovskyi Poltava RCH Dept of Gastroenterology HSEIU UMSA
  • M.V. Sklifosovskyi Poltava RCH Outpatient UMSA HSEIU Ukrainian Medical Stomatological Academy
  • Private Small Enterprise Medical Center Pulse
  • M.I. Pyrogov VRCH Dept of Gastroenterology M.I. Pyrogov VNMU
  • MCIC Health Clinic BO LTD TPC Slaomed
  • Co Ltd. Diaservice
  • CI City Hospital #7
  • Addenbrooke's Hospital
  • University Hospital Coventry
  • Royal Devon and Exeter Hospital (Wonford)
  • St James University Hospital
  • The Royal London Hospital
  • University College London Hospital
  • St Thomas Hospital
  • King's College London
  • Fairfield General Hospital
  • Royal Victoria Infirmary
  • Nottingham University Hospitals; QMC Campus
  • Southampton General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Part 1: Open-label Extension

Part 2: Safety Monitoring

Arm Description

Participants with moderate to severe UC who were enrolled in the Phase II OLE study or the Phase III studies, and who meet the eligibility criteria for enrollment will receive open-label etrolizumab in Part 1 (OLE).

All participants from Part 1 (OLE), participants whose PML follow-up is not completed within the Phase II OLE study, and participants transferring from the Phase III double-blind studies after the 12-week safety follow-up will be monitored for PML (92 weeks).

Outcomes

Primary Outcome Measures

Percentage of Participants With Clinical Remission as Determined by the Partial Mayo Clinic Score (pMCS) - Part 1
Percentage of Participants With Remission as Determined by the Mayo Clinic Score (MCS) - Part 1
Percentage of Participants With Endoscopic Remission
Percentage of Participants With Anti-therapeutic Antibodies to Etrolizumab - Part 1
Percentage of Participants With Adverse Events - Part 1
Percentage of Participants With Progressive Multifocal Leukoencephalopathy (PML) - Part 2
Change From Baseline in pMCS at Year 9

Secondary Outcome Measures

Full Information

First Posted
April 16, 2014
Last Updated
September 11, 2023
Sponsor
Hoffmann-La Roche
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1. Study Identification

Unique Protocol Identification Number
NCT02118584
Brief Title
Study for Participants With Ulcerative Colitis Previously Enrolled in Etrolizumab Phase II/III Studies
Acronym
COTTONWOOD
Official Title
An Open-Label Extension and Safety Monitoring Study of Moderate to Severe Ulcerative Colitis Patients Previously Enrolled in Etrolizumab Phase II/III Studies
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 15, 2014 (Actual)
Primary Completion Date
June 11, 2024 (Anticipated)
Study Completion Date
June 11, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This two-part, part 1: open-label extension (OLE) and part 2: safety monitoring (SM) study will examine the efficacy and safety of continued etrolizumab treatment in moderate to severe ulcerative colitis (UC) participants previously enrolled in etrolizumab Phase II/III studies. Participants with moderate to severe UC who were enrolled in the Phase II OLE study (GA27927 [NCT01461317]) or the Phase III studies (GA28948 [NCT02163759], GA28949 [NCT02171429], GA28950 [NCT02100696], GA29102 [NCT02165215], and GA29103 [NCT02136069]) were included. Participants from the Phase II OLE study or the Phase III studies who are not eligible or willing to receive etrolizumab in the OLE-SM study, and who have completed the 12-week safety follow-up period will be enrolled in Part 2. Part 1 of OLE-SM will continue for up to 9 years after the first participant is enrolled into the study. Following Part 1, participants will enter Part 2 for a period of 92 weeks.

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 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1822 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Part 1: Open-label Extension
Arm Type
Experimental
Arm Description
Participants with moderate to severe UC who were enrolled in the Phase II OLE study or the Phase III studies, and who meet the eligibility criteria for enrollment will receive open-label etrolizumab in Part 1 (OLE).
Arm Title
Part 2: Safety Monitoring
Arm Type
No Intervention
Arm Description
All participants from Part 1 (OLE), participants whose PML follow-up is not completed within the Phase II OLE study, and participants transferring from the Phase III double-blind studies after the 12-week safety follow-up will be monitored for PML (92 weeks).
Intervention Type
Drug
Intervention Name(s)
Etrolizumab
Other Intervention Name(s)
RG7413, RO5490261, PRO145223, rhuMAb Beta7
Intervention Description
Participants will receive etrolizumab 105 milligrams (mg), administered subcutaneously (SC) every 4 weeks for up to 9 years or until either commercial availability or the Sponsor's decision to terminate the study.
Primary Outcome Measure Information:
Title
Percentage of Participants With Clinical Remission as Determined by the Partial Mayo Clinic Score (pMCS) - Part 1
Time Frame
Baseline up to 9 years (assessed at Baseline, Week 4, 8, 12 thereafter every 12 weeks up to 9 years after the first participant is enrolled or until commercial availability, whichever is earlier, or until sponsor's decision to terminate the study)
Title
Percentage of Participants With Remission as Determined by the Mayo Clinic Score (MCS) - Part 1
Time Frame
Week 108
Title
Percentage of Participants With Endoscopic Remission
Time Frame
Week 108
Title
Percentage of Participants With Anti-therapeutic Antibodies to Etrolizumab - Part 1
Time Frame
Baseline, Week 12, every 48 weeks, week 108, at early withdrawal from treatment up to 9 years after first participant enrolled or until commercial availability, whichever is earlier, or until sponsor's decision to terminate the study)
Title
Percentage of Participants With Adverse Events - Part 1
Time Frame
Baseline up to 9 years after the first participant is enrolled or until commercial availability, whichever is earlier, or until the Sponsor's decision to terminate the study
Title
Percentage of Participants With Progressive Multifocal Leukoencephalopathy (PML) - Part 2
Time Frame
104 weeks
Title
Change From Baseline in pMCS at Year 9
Time Frame
Baseline, Year 9

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Part 1 (Open-label Extension) - Participants previously enrolled in the Phase II OLE study or Phase III controlled studies who meet the eligibility criteria for open-label etrolizumab for those studies as described in the protocol Part 2 (Safety Monitoring) Participants whose safety follow-up or PML follow-up is not completed within Study GA27927 and participants who had their last dose of etrolizumab in July 2016 in Study GA27927 and are not eligible or willing to enroll in Part 1 (OLE) Participants who participated in one of the etrolizumab Phase III studies and are not eligible or willing to enter Part 1 (OLE) Participants who transfer from Part 1 (OLE) Completion of the 12-week safety follow-up prior to entering. Exclusion Criteria: Part 1 (Open-label Extension) Withdrawal of consent from and participant not compliant in the Phase II OLE study or any of the Phase III studies Participant who discontinued etrolizumab/etrolizumab placebo prior to Week 10 or did not perform the Week 10 visit of the Phase III Studies GA28948, GA28949, GA29102, and GA29103 Participant who discontinued etrolizumab/etrolizumab placebo prior to Week 14 or did not perform the Week 14 visit of the Phase III Study GA28950 Any new, significant, uncontrolled condition
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
Facility Information:
Facility Name
University of Alabama Medical Center
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
University of California San Diego Medical Center
City
La Jolla
State/Province
California
ZIP/Postal Code
92093-5354
Country
United States
Facility Name
University of California, Irvine Medical Center
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
SDG Clinical Research
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
University of California at San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
Ventura Clinical Trials
City
Ventura
State/Province
California
ZIP/Postal Code
93003
Country
United States
Facility Name
Peak Gastroenterology Associates
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80907
Country
United States
Facility Name
Clinical Research of the Rockies
City
Lafayette
State/Province
Colorado
ZIP/Postal Code
80026
Country
United States
Facility Name
Rocky Mountain Gastroenterology Associates
City
Wheat Ridge
State/Province
Colorado
ZIP/Postal Code
80033
Country
United States
Facility Name
Innovative Medical Research of South Florida, Inc.
City
Aventura
State/Province
Florida
ZIP/Postal Code
33180
Country
United States
Facility Name
West Central Gastroenterology d/b/a Gastro Florida
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33756
Country
United States
Facility Name
IMIC, Inc
City
Miami Beach
State/Province
Florida
ZIP/Postal Code
33140
Country
United States
Facility Name
Regenerate Clinical Trials
City
Miami
State/Province
Florida
ZIP/Postal Code
33155
Country
United States
Facility Name
FQL Research, LLC
City
Miramar
State/Province
Florida
ZIP/Postal Code
33025
Country
United States
Facility Name
Gastroenterology Group of Naples
City
Naples
State/Province
Florida
ZIP/Postal Code
34102
Country
United States
Facility Name
Advanced Research Institute, Inc.
City
New Port Richey
State/Province
Florida
ZIP/Postal Code
34653
Country
United States
Facility Name
Internal Medicine Specialists
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Shafran Gastroenterology Center
City
Winter Park
State/Province
Florida
ZIP/Postal Code
32789
Country
United States
Facility Name
Atlanta Gastroenterology Associates
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
Gastroenterology Associates of Central Georgia
City
Macon
State/Province
Georgia
ZIP/Postal Code
31201
Country
United States
Facility Name
Gastrointestinal Specialists of Georgia, PC
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Facility Name
Atlanta Gastroenterology Specialists, PC
City
Suwanee
State/Province
Georgia
ZIP/Postal Code
30024
Country
United States
Facility Name
Northwestern University Feinberg School Of Medicine
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
University of Chicago Medical Center; Medicine, Section of Pulmonary
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Southwest Gastroenterology
City
Oak Lawn
State/Province
Illinois
ZIP/Postal Code
60453
Country
United States
Facility Name
Aquiant Research
City
New Albany
State/Province
Indiana
ZIP/Postal Code
47150
Country
United States
Facility Name
Cotton-O'Neil Clinical Research Center, Digestive Health
City
Topeka
State/Province
Kansas
ZIP/Postal Code
66606
Country
United States
Facility Name
Gastroenterology Associates, LLC
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70809
Country
United States
Facility Name
Louisiana Research Center, LLC
City
Shreveport
State/Province
Louisiana
Country
United States
Facility Name
Massachusetts General Hospital; Crohn's & Colitis Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
Henry Ford Health System
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Center for Digestive Health
City
Troy
State/Province
Michigan
ZIP/Postal Code
48098
Country
United States
Facility Name
Huron Gastroenterology Associates
City
Ypsilanti
State/Province
Michigan
ZIP/Postal Code
48197
Country
United States
Facility Name
Regents of the University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Facility Name
University of Mississippi Medical Center
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39216
Country
United States
Facility Name
Ehrhardt Clinical Research, LLC
City
Belton
State/Province
Missouri
ZIP/Postal Code
64012
Country
United States
Facility Name
Kansas City Research Institute, LLC
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64131
Country
United States
Facility Name
Clinica Peruano Americana S.A.
City
Great Neck
State/Province
New York
ZIP/Postal Code
11021
Country
United States
Facility Name
NYU Langone Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10016-9451
Country
United States
Facility Name
Concorde Medical Group
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Weill Cornell Medical College (WCMC) - Judith Jaffe Multiple Sclerosis Center (JJMSC)
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Asheville Gastroenterology Associates, P.A.
City
Asheville
State/Province
North Carolina
ZIP/Postal Code
28801
Country
United States
Facility Name
University of North Carolina at Chapel Hill
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Facility Name
Kinston Medical Specialists
City
Kinston
State/Province
North Carolina
ZIP/Postal Code
28501
Country
United States
Facility Name
Consultants for Clin. Rsrch
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
UC Health Clinical Trials Office; Division of Digestive Diseases
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267
Country
United States
Facility Name
Great Lakes Gastroenterology Research, LLC
City
Mentor
State/Province
Ohio
ZIP/Postal Code
44060
Country
United States
Facility Name
Gastroenterology Center of the Midsouth, P.C.
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38120
Country
United States
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37212
Country
United States
Facility Name
Texas Digestive Disease Consultants - Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Wellness Clinical Research Center
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78232
Country
United States
Facility Name
Texas Digestive Disease Consultants - Southlake
City
Southlake
State/Province
Texas
ZIP/Postal Code
76092
Country
United States
Facility Name
Tyler Research Institute, LLC
City
Tyler
State/Province
Texas
ZIP/Postal Code
75701
Country
United States
Facility Name
Ericksen Research and Development
City
Clinton
State/Province
Utah
ZIP/Postal Code
84015
Country
United States
Facility Name
University of Utah School of Medicine
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132
Country
United States
Facility Name
McGuire Research Institute; Gastroenterology
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23249
Country
United States
Facility Name
Washington Gastroenterology
City
Bellevue
State/Province
Washington
ZIP/Postal Code
98004
Country
United States
Facility Name
Instituto Medico DAMIC
City
Cordoba
ZIP/Postal Code
X5003DCE
Country
Argentina
Facility Name
Hospital Provincial del Centenario
City
Rosario
ZIP/Postal Code
S2002KDS
Country
Argentina
Facility Name
Bankstown-Lidcombe Hospital
City
Bankstown
State/Province
New South Wales
ZIP/Postal Code
2200
Country
Australia
Facility Name
Concord Repatriation General Hospital
City
Concord
State/Province
New South Wales
ZIP/Postal Code
2139
Country
Australia
Facility Name
Royal Brisbane and Women's Hospital
City
Herston
State/Province
Queensland
ZIP/Postal Code
4029
Country
Australia
Facility Name
Mater Adult Hospital
City
Mackay
State/Province
Queensland
ZIP/Postal Code
4740
Country
Australia
Facility Name
Princess Alexandra Hospital
City
Woolloongabba
State/Province
Queensland
ZIP/Postal Code
4102
Country
Australia
Facility Name
Royal Adelaide Hospital
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5000
Country
Australia
Facility Name
Flinders Medical Centre
City
Bedford Park
State/Province
South Australia
ZIP/Postal Code
5042
Country
Australia
Facility Name
Launceston General Hospital; Gastroenterology Research
City
Launceston
State/Province
Tasmania
ZIP/Postal Code
7250
Country
Australia
Facility Name
Monash Medical Centre
City
Clayton
State/Province
Victoria
ZIP/Postal Code
3168
Country
Australia
Facility Name
St Vincent's Hospital Melbourne
City
Fitzroy
State/Province
Victoria
ZIP/Postal Code
3065
Country
Australia
Facility Name
Footscray Hospital
City
Footscray
State/Province
Victoria
ZIP/Postal Code
3011
Country
Australia
Facility Name
St Frances Xavier Cabrini Hospital
City
Malvern
State/Province
Victoria
ZIP/Postal Code
3144
Country
Australia
Facility Name
Royal Melbourne Hospital; Department of Colorectal Medicine and Genetics
City
Parkville
State/Province
Victoria
ZIP/Postal Code
3050
Country
Australia
Facility Name
Fiona Stanley Hospital
City
Murdoch
State/Province
Western Australia
ZIP/Postal Code
6150
Country
Australia
Facility Name
LKH - Universitätsklinikum der PMU Salzburg
City
Salzburg
ZIP/Postal Code
5020
Country
Austria
Facility Name
Medizinische Universität Wien
City
Wien
ZIP/Postal Code
1090
Country
Austria
Facility Name
GZA Ziekenhuizen - Campus Sint-Vincentius
City
Antwerpen
ZIP/Postal Code
2018
Country
Belgium
Facility Name
Imeldaziekenhuis
City
Bonheiden
ZIP/Postal Code
2820
Country
Belgium
Facility Name
CHU St Pierre (St Pierre)
City
Brussels
ZIP/Postal Code
1000
Country
Belgium
Facility Name
UZ Brussel
City
Brussel
ZIP/Postal Code
1090
Country
Belgium
Facility Name
Cliniques Universitaires Saint-Luc; Pharmacy
City
Bruxelles
ZIP/Postal Code
1200
Country
Belgium
Facility Name
UZ Gent
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
AZ Sint Elisabeth Herentals
City
Herentals
ZIP/Postal Code
2200
Country
Belgium
Facility Name
UZ Leuven; Neurology
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
AZ Delta (Campus Rumbeke)
City
Roeselare
ZIP/Postal Code
8800
Country
Belgium
Facility Name
Hospital Universitario Prof Edgar Santos-Ufba; Ambulatorio Magalhaes Neto 3Andar- Dermatologia
City
Salvador
State/Province
BA
ZIP/Postal Code
41110-170
Country
Brazil
Facility Name
Hospital Universitario Walter Cantidio - UFC
City
Fortaleza
State/Province
CE
ZIP/Postal Code
60430-370
Country
Brazil
Facility Name
CCBR - Brasilia
City
Brasilia
State/Province
DF
ZIP/Postal Code
70200-730
Country
Brazil
Facility Name
Instituto Goiano de Gastroenterologia e Endoscopia Digestiva Ltda
City
Goiânia
State/Province
GO
ZIP/Postal Code
74535-170
Country
Brazil
Facility Name
Hospital Felicio Rocho
City
Belo Horizonte
State/Province
MG
ZIP/Postal Code
30110-068
Country
Brazil
Facility Name
Centro Digestivo de Curitiba
City
Curitiba
State/Province
PR
ZIP/Postal Code
80430-160
Country
Brazil
Facility Name
Hospital Universitario Clementino Fraga Filho - UFRJ
City
Rio de Janeiro
State/Province
RJ
ZIP/Postal Code
21941-913
Country
Brazil
Facility Name
Hospital Moinhos de Vento
City
Porto Alegre
State/Province
RS
ZIP/Postal Code
90035-000
Country
Brazil
Facility Name
Hospital das Clinicas - UFRGS
City
Porto Alegre
State/Province
RS
ZIP/Postal Code
90035-903
Country
Brazil
Facility Name
Hospital Ernesto Dornelles
City
Porto Alegre
State/Province
RS
ZIP/Postal Code
90160-092
Country
Brazil
Facility Name
UNESP - Faculdade de Medicina da Universidade Estadual Paulista - Campus Botucatu
City
Botucatu
State/Province
SP
ZIP/Postal Code
18618-970
Country
Brazil
Facility Name
CAEP - Centro Avancado de Estudos e Pesquisas Ltda.
City
Campinas
State/Province
SP
ZIP/Postal Code
13087-567
Country
Brazil
Facility Name
CECIP - Centro de Estudos Clínicos do Interior Paulista
City
Jaú
State/Province
SP
ZIP/Postal Code
17210-190
Country
Brazil
Facility Name
Pesquisare Saúde Sociedade Simples
City
Santo Andre
State/Province
SP
ZIP/Postal Code
09080-000
Country
Brazil
Facility Name
Hospital Estadual Mario Covas
City
Sao Bernardo Do Campo
State/Province
SP
ZIP/Postal Code
09715-090
Country
Brazil
Facility Name
Hospital Sírio-Libanês
City
Sao Paulo
State/Province
SP
ZIP/Postal Code
01308-050
Country
Brazil
Facility Name
Hospital do Servidor Público Estadual/HSPE-SP
City
São Paulo
State/Province
SP
ZIP/Postal Code
04039-901
Country
Brazil
Facility Name
Medical Centre "Asklepii", OOD
City
Dupnitsa
ZIP/Postal Code
2600
Country
Bulgaria
Facility Name
DCC Sv. Pantaleymon OOD; II-nd Clinic of Neurology
City
Pleven
ZIP/Postal Code
5800
Country
Bulgaria
Facility Name
Medical center Medconsult Pleven OOD
City
Pleven
ZIP/Postal Code
5800
Country
Bulgaria
Facility Name
MHAT - Ruse, AD
City
Ruse
ZIP/Postal Code
7002
Country
Bulgaria
Facility Name
MHAT "Hadzhi Dimitar", OOD
City
Sliven
ZIP/Postal Code
8800
Country
Bulgaria
Facility Name
"City Clinic UMHAC" EOOD
City
Sofia
ZIP/Postal Code
1407
Country
Bulgaria
Facility Name
UMHAT "Sv. Ivan Rilski", EAD
City
Sofia
ZIP/Postal Code
1431
Country
Bulgaria
Facility Name
UMHAT Tsaritsa Yoanna - ISUL, EAD
City
Sofia
ZIP/Postal Code
1527
Country
Bulgaria
Facility Name
Diagnostic Consultation Center CONVEX EOOD
City
Sofia
ZIP/Postal Code
1680
Country
Bulgaria
Facility Name
Medical Center "Nov Rehabilitatsionen Tsentar", EOOD
City
Stara Zagora
ZIP/Postal Code
6000
Country
Bulgaria
Facility Name
MHAT 'Sv. Marina', EAD; First Children's Clinic
City
Varna
ZIP/Postal Code
9010
Country
Bulgaria
Facility Name
MC Medica Plus
City
Veliko Tarnovo
ZIP/Postal Code
5000
Country
Bulgaria
Facility Name
University of Calgary
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 2T9
Country
Canada
Facility Name
Zeidler Ledcor Centre - University of Alberta; Division of Gasroenterology
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2X8
Country
Canada
Facility Name
Pacific Gastroenterology Associates
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6Z 2K5
Country
Canada
Facility Name
Queen Elizabeth II Health Sciences Centre; Gastroenterology Research
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 1V7
Country
Canada
Facility Name
Guelph GI & Surgery Clinic
City
Guelph
State/Province
Ontario
ZIP/Postal Code
N1H 3R3
Country
Canada
Facility Name
University Hospital - London Health Sciences Centre
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5A5
Country
Canada
Facility Name
Taunton Health Centre
City
Oshawa
State/Province
Ontario
ZIP/Postal Code
L1H 7K4
Country
Canada
Facility Name
Mount Sinai Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1X5
Country
Canada
Facility Name
Toronto Liver Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M6H 3M1
Country
Canada
Facility Name
Toronto Digestive Disease Associates
City
Vaughan
State/Province
Ontario
ZIP/Postal Code
L4L 4Y7
Country
Canada
Facility Name
Centre de santé et de services sociaux Champlain-Charles-Le Moyne
City
Greenfield Park
State/Province
Quebec
ZIP/Postal Code
J4V 2H1
Country
Canada
Facility Name
Hotel Dieu de Levis
City
Levis
State/Province
Quebec
ZIP/Postal Code
G6V 3Z1
Country
Canada
Facility Name
Hôpital Maisonneuve - Rosemont
City
Montreal
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
RTS - Fundación Valle de Lili
City
Cali
ZIP/Postal Code
0
Country
Colombia
Facility Name
Instituto de Coloproctologia ICO S.A.S.
City
Medellin
ZIP/Postal Code
050025
Country
Colombia
Facility Name
Clinical Hospital Centre Osijek
City
Osijek
ZIP/Postal Code
31000
Country
Croatia
Facility Name
Clinical Hospital Sveti Duh; Department of Neurology
City
Zagreb
ZIP/Postal Code
10000
Country
Croatia
Facility Name
Vojenska nemocnice Brno
City
Brno
ZIP/Postal Code
636 00
Country
Czechia
Facility Name
Fakultni nemocnice u sv. Anny v Brne; I.Interni kardioangiologicka klinika
City
Brno
ZIP/Postal Code
65691
Country
Czechia
Facility Name
Fakultni nemocnice Hradec Kralove
City
Hradec Kralove
ZIP/Postal Code
500 05
Country
Czechia
Facility Name
Hepato-Gastroenterologie HK, s.r.o.
City
Hradec Kralove
ZIP/Postal Code
500 12
Country
Czechia
Facility Name
Oblastni nemocnice Kladno, a.s., nemocnice Stredoces. kraje; Endoskopicke centrum
City
Kladno
ZIP/Postal Code
272 59
Country
Czechia
Facility Name
PreventaMed, s.r.o.
City
Olomouc
ZIP/Postal Code
779 00
Country
Czechia
Facility Name
Mestska Nemocnice Ostrava
City
Ostrava
ZIP/Postal Code
728 80
Country
Czechia
Facility Name
Pardubicka krajska nemocnice a.s.
City
Pardubice
ZIP/Postal Code
532 03
Country
Czechia
Facility Name
Nemocnice Na Bulovce
City
Prague
ZIP/Postal Code
180 01
Country
Czechia
Facility Name
ISCARE a.s.
City
Praha 7
ZIP/Postal Code
170 04
Country
Czechia
Facility Name
Krajska zdravotni, a.s. ? Masarykova nemocnice v Usti nad Labem, o.z., Ocni oddeleni
City
Usti Nad Labem
ZIP/Postal Code
401 13
Country
Czechia
Facility Name
Krajska nemocnice T. Bati, a.s.
City
Zlin
ZIP/Postal Code
76001
Country
Czechia
Facility Name
Herlev og Gentofte Hospital
City
Herlev
ZIP/Postal Code
2730
Country
Denmark
Facility Name
Rigshospitalet; Medicinsk gastroenterologisk klinik
City
København Ø
ZIP/Postal Code
2100
Country
Denmark
Facility Name
Ålborg Universitets Hospital; Gastromedicinsk
City
Ålborg
ZIP/Postal Code
9000
Country
Denmark
Facility Name
OÜ Innomedica
City
Tallinn
ZIP/Postal Code
10117
Country
Estonia
Facility Name
East Tallinn Central Hospital
City
Tallinn
ZIP/Postal Code
10138
Country
Estonia
Facility Name
West Tallinn Central Hospital
City
Tallinn
ZIP/Postal Code
10617
Country
Estonia
Facility Name
North Estonia Medical Centre Foundation
City
Tallinn
ZIP/Postal Code
13419
Country
Estonia
Facility Name
Tartu University Hospital
City
Tartu
ZIP/Postal Code
51014
Country
Estonia
Facility Name
CHU Amiens - Hopital Sud
City
Amiens
ZIP/Postal Code
80054
Country
France
Facility Name
CHU de Caen Hopital Cote de Nacre
City
Caen
ZIP/Postal Code
14033
Country
France
Facility Name
CHU Tours - Hôpital Trousseau
City
Chambray les Tours
ZIP/Postal Code
37170
Country
France
Facility Name
Hôpital Beaujon
City
Clichy cedex
ZIP/Postal Code
92110
Country
France
Facility Name
Hopital Claude Huriez - CHU Lille
City
Lille
ZIP/Postal Code
59037
Country
France
Facility Name
CHU Hopital Saint Eloi
City
Montpellier
ZIP/Postal Code
34295
Country
France
Facility Name
CHU Nice - Hopital de l'Archet 2
City
Nice
ZIP/Postal Code
06202
Country
France
Facility Name
Hôpital Saint-Louis
City
Paris
ZIP/Postal Code
75475
Country
France
Facility Name
CHU Bordeaux - Hôpital Haut-Lévêque
City
Pessac
ZIP/Postal Code
33600
Country
France
Facility Name
Centre Hospitalier Lyon Sud; Service de Gastro-Enterologie
City
Pierre-Benite
ZIP/Postal Code
69495
Country
France
Facility Name
CHU Saint Etienne - Hôpital Nord
City
Saint Etienne
ZIP/Postal Code
42055
Country
France
Facility Name
Höpital Hautepierre; Pediatrie1
City
Strasbourg
ZIP/Postal Code
67098
Country
France
Facility Name
CHU de Toulouse - Hôpital Rangueil
City
Toulouse Cedex 09
ZIP/Postal Code
31059
Country
France
Facility Name
Hôpital de Brabois Adultes
City
Vandoeuvre-les-nancy
ZIP/Postal Code
54511
Country
France
Facility Name
Charite Universitaetsmedizin Berlin - Campus Charite Mitte
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Facility Name
Charite Universitaetsmedizin Berlin - Campus Benjamin Franklin
City
Berlin
ZIP/Postal Code
12200
Country
Germany
Facility Name
DRK Kliniken Berlin Westend
City
Berlin
ZIP/Postal Code
14050
Country
Germany
Facility Name
Krankenhaus Waldfriede e. V.
City
Berlin
ZIP/Postal Code
14163
Country
Germany
Facility Name
Berufsgenossenschaftliches Universitaetsklinikum Bergmannsheil GmbH
City
Bochum
ZIP/Postal Code
44789
Country
Germany
Facility Name
Universitaetsklinikum Erlangen
City
Erlangen
ZIP/Postal Code
91054
Country
Germany
Facility Name
Klinikum der Johann Wolfgang Goethe-Universitaet
City
Frankfurt
ZIP/Postal Code
60590
Country
Germany
Facility Name
Universitaetsklinikum Freiburg; Urology
City
Freiburg
ZIP/Postal Code
79106
Country
Germany
Facility Name
Universitaetsklinikum Halle (Saale)
City
Halle
ZIP/Postal Code
06120
Country
Germany
Facility Name
Hamburgisches Forschungsinstitut fuer CED
City
Hamburg
ZIP/Postal Code
20148
Country
Germany
Facility Name
Universitätsklinikum Hamburg-Eppendorf
City
Hamburg
ZIP/Postal Code
20246
Country
Germany
Facility Name
Gastroenterologie Eppendorfer Baum
City
Hamburg
ZIP/Postal Code
20249
Country
Germany
Facility Name
Medizinische Hochschule Hannover; Klinik für Gastroenterologie, Hepatologie und Endokrinologie
City
Hannover
ZIP/Postal Code
30625
Country
Germany
Facility Name
Universitaetsklinikum Jena; Apotheke des Uniersitätsklinikums Jena
City
Jena
ZIP/Postal Code
07740
Country
Germany
Facility Name
Universitaetsklinikum Schleswig-Holstein, Campus Kiel
City
Kiel
ZIP/Postal Code
24116
Country
Germany
Facility Name
Medizinisches Zentrum Klinikum Lueneburg
City
Lueneburg
ZIP/Postal Code
21339
Country
Germany
Facility Name
Klinikum Mannheim GmbH Universitätsklinikum
City
Mannheim
ZIP/Postal Code
68167
Country
Germany
Facility Name
Universitaetsklinikum Muenster
City
Muenster
ZIP/Postal Code
48149
Country
Germany
Facility Name
Gemeinschaftspraxis Dres. Joachim Mueller und Steffi Appelt
City
Schweinfurt
ZIP/Postal Code
97421
Country
Germany
Facility Name
Universitaetsklinikum Ulm
City
Ulm
ZIP/Postal Code
89081
Country
Germany
Facility Name
University General Hospital of Heraklion
City
Herakleion
ZIP/Postal Code
711 10
Country
Greece
Facility Name
University of Hong Kong
City
Hong Kong
Country
Hong Kong
Facility Name
DRC Gyogyszervizsgalo Kozpont Kft
City
Balatonfured
ZIP/Postal Code
8230
Country
Hungary
Facility Name
Bekes Megyei Kozponti Korhaz Dr. Rethy Pal Tagkorhaza
City
Bekescsaba
ZIP/Postal Code
5600
Country
Hungary
Facility Name
Semmelweis Egyetem
City
Budapest
ZIP/Postal Code
1088
Country
Hungary
Facility Name
Eszak-Kozep-budai Centrum, Uj Szent Janos Korhaz es Szakrendelo
City
Budapest
ZIP/Postal Code
1125
Country
Hungary
Facility Name
Pannónia Klinika Magánorvosi
City
Budapest
ZIP/Postal Code
1136
Country
Hungary
Facility Name
Magyar Honvedseg Egeszsegugyi Kozpont; Fázis I-es Klinikai Farmakológiai Vizsgálóhely
City
Budapest
ZIP/Postal Code
H-1077
Country
Hungary
Facility Name
Endomedix Diagnosztikai Kozpont
City
Budapest
Country
Hungary
Facility Name
Vasutegeszsegugyi Kft. - Debreceni Egeszsegugyi Kozpont
City
Debrecen
ZIP/Postal Code
4025
Country
Hungary
Facility Name
Debreceni Egyetem Klinikai Kozpont
City
Debrecen
ZIP/Postal Code
4032
Country
Hungary
Facility Name
Markhot Ferenc Oktato Korhaz es Rendelointezet
City
Eger
ZIP/Postal Code
3300
Country
Hungary
Facility Name
Petz Aladar Megyei Oktato Korhaz
City
Gyor
ZIP/Postal Code
9024
Country
Hungary
Facility Name
Pest Megyei Flor Ferenc Korhaz
City
Kistarcsa
ZIP/Postal Code
2143
Country
Hungary
Facility Name
Borsod-Abauj-Zemplen Megyei Korhaz es Egyetemi Oktato Korhaz
City
Miskolc
ZIP/Postal Code
3526
Country
Hungary
Facility Name
Pecsi Tudomanyegyetem
City
Pecs
ZIP/Postal Code
7624
Country
Hungary
Facility Name
Csongrad Megyei Dr. Bugyi Istvan Korhaz
City
Szentes
ZIP/Postal Code
6600
Country
Hungary
Facility Name
Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz
City
Székesfehérvár
ZIP/Postal Code
8000
Country
Hungary
Facility Name
Deccan College of Medical Sciences and Allied Hospitals; Department of Gastroenterology
City
Hyderabad
State/Province
Andhra Pradesh
ZIP/Postal Code
500058
Country
India
Facility Name
Nirmal Hospital
City
Surat
State/Province
Gujarat
ZIP/Postal Code
395002
Country
India
Facility Name
K.L.E. Society's Dr. Prabhakar Kore Hospital and Medical Research Centre
City
Belgaum
State/Province
Karnataka
ZIP/Postal Code
590010
Country
India
Facility Name
M. S. Ramaiah Medical College and Hospital
City
Bengaluru
State/Province
Karnataka
ZIP/Postal Code
560054
Country
India
Facility Name
Kasturba Medical College & Hospital
City
Manglore
State/Province
Karnataka
ZIP/Postal Code
575001
Country
India
Facility Name
Midas institute of Gastroenterology
City
Nagpur
State/Province
Maharashtra
ZIP/Postal Code
440012
Country
India
Facility Name
Ruby Hall Clinic
City
Pune
State/Province
Maharashtra
ZIP/Postal Code
411001
Country
India
Facility Name
Dayanand Medical College and Hospital
City
Ludhiana
State/Province
Punjab
ZIP/Postal Code
141001
Country
India
Facility Name
S. R. Kalla Memorial Gastro & General Hospital
City
Jaipur
State/Province
Rajasthan
ZIP/Postal Code
302001
Country
India
Facility Name
King Edward Memorial Hospital Research Centre
City
Pune
ZIP/Postal Code
411011
Country
India
Facility Name
Bnai Zion Medical Center; Internal Medicine
City
Haifa
ZIP/Postal Code
3339419
Country
Israel
Facility Name
Shaare Zedek Medical Center
City
Jerusalem
ZIP/Postal Code
9103102
Country
Israel
Facility Name
Hadassah University Hospital - Ein Kerem
City
Jerusalem
ZIP/Postal Code
9112001
Country
Israel
Facility Name
Holy Family Hospital
City
Nazareth
ZIP/Postal Code
1641101
Country
Israel
Facility Name
Rabin Medical Center Beilinson Campus; Gaucher Clinic Genetics Institute
City
Petach Tiqwa
ZIP/Postal Code
49100
Country
Israel
Facility Name
Kaplan Medical Center
City
Rehovot
ZIP/Postal Code
7610001
Country
Israel
Facility Name
Assaf Harofeh
City
Rishon Lezion
ZIP/Postal Code
7505001
Country
Israel
Facility Name
Chaim Sheba Medical Center; Pediatrics B North and Pediatric Endocrinology Unit
City
Tel Hashomer
ZIP/Postal Code
52621
Country
Israel
Facility Name
Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpigh
City
Bologna
State/Province
Emilia-Romagna
ZIP/Postal Code
40138
Country
Italy
Facility Name
A.O.U. Policlinico di Modena
City
Modena
State/Province
Emilia-Romagna
ZIP/Postal Code
40124
Country
Italy
Facility Name
Azienda Ospedaliero Universitaria di Parma
City
Parma
State/Province
Emilia-Romagna
ZIP/Postal Code
43126
Country
Italy
Facility Name
Azienda Ospedaliera Universitaria Policlinico Tor Vergata
City
Roma
State/Province
Lazio
ZIP/Postal Code
00133
Country
Italy
Facility Name
Ospedale Sandro Pertini
City
Roma
State/Province
Lazio
ZIP/Postal Code
00157
Country
Italy
Facility Name
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
City
Roma
State/Province
Lazio
ZIP/Postal Code
00168
Country
Italy
Facility Name
Azienda Ospedaliera San Camillo Forlanini
City
Roma
State/Province
Lazio
ZIP/Postal Code
151
Country
Italy
Facility Name
Azienda Ospedaliero Universitaria San Martino
City
Genova
State/Province
Liguria
ZIP/Postal Code
16132
Country
Italy
Facility Name
Fondazione Poliambulanza Istituto Ospedaliero
City
Brescia
State/Province
Lombardia
ZIP/Postal Code
25124
Country
Italy
Facility Name
Azienda Ospedaliera Fatebenefratelli e Oftalmico
City
Milano
State/Province
Lombardia
ZIP/Postal Code
20121
Country
Italy
Facility Name
Azienda Socio Sanitaria Territoriale Niguarda (Grande Ospedale Metropolitano Niguarda)
City
Milano
State/Province
Lombardia
ZIP/Postal Code
20162
Country
Italy
Facility Name
Azienda Socio Sanitaria Territoriale Fatebenefratelli (Presidio Ospedale Sacco)
City
Milano
State/Province
Lombardia
Country
Italy
Facility Name
Ospedale di Circolo; Neuropsichiatria Infantile
City
Rho
State/Province
Lombardia
ZIP/Postal Code
20017
Country
Italy
Facility Name
Istituto Clinico Humanitas
City
Rozzano (MI)
State/Province
Lombardia
ZIP/Postal Code
20089
Country
Italy
Facility Name
I.R.C.C.S Policlinico San Donato
City
San Donato Milanese (MI)
State/Province
Lombardia
ZIP/Postal Code
20097
Country
Italy
Facility Name
IRCCS Ospedale Casa Sollievo della Soffenza; Stru Comp di Gastroenterologia ed Endoscopia digest
City
San Giovanni Rotondo
State/Province
Lombardia
ZIP/Postal Code
71013
Country
Italy
Facility Name
Ospedale Mauriziano Umberto I
City
Torino
State/Province
Piemonte
ZIP/Postal Code
10128
Country
Italy
Facility Name
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone
City
Palermo
State/Province
Sicilia
ZIP/Postal Code
90127
Country
Italy
Facility Name
Azienda Ospedaliera Universitaria Careggi
City
Florence
State/Province
Toscana
ZIP/Postal Code
50134
Country
Italy
Facility Name
Azienda Ospedaliera di Padova
City
Padova
State/Province
Veneto
ZIP/Postal Code
35128
Country
Italy
Facility Name
Dong-A University Hospital
City
Busan
ZIP/Postal Code
49201
Country
Korea, Republic of
Facility Name
Pusan National University Hospital
City
Busan
ZIP/Postal Code
602-739
Country
Korea, Republic of
Facility Name
Kyungpook National University Medical Center
City
Daegu
ZIP/Postal Code
41404
Country
Korea, Republic of
Facility Name
Keimyung University Dongsan Medical Center
City
Daegu
ZIP/Postal Code
41931
Country
Korea, Republic of
Facility Name
Kyungpook National University Hospital
City
Daegu
ZIP/Postal Code
41944
Country
Korea, Republic of
Facility Name
Yeungnam Univ. Hospital
City
Daegu
ZIP/Postal Code
705-717
Country
Korea, Republic of
Facility Name
Korea University Ansan Hospital
City
Gyeonggi-do
ZIP/Postal Code
15355
Country
Korea, Republic of
Facility Name
Seoul National University Bundang Hospital
City
Seongnam-si
ZIP/Postal Code
463-707
Country
Korea, Republic of
Facility Name
CHA Bundang Medical Centre; CHA university
City
Seongnam
ZIP/Postal Code
13520
Country
Korea, Republic of
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Facility Name
Kangbuk Samsung Hospital
City
Seoul
ZIP/Postal Code
03181
Country
Korea, Republic of
Facility Name
Severance Hospital, Yonsei University Health System
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
Facility Name
Asan Medical Center.
City
Seoul
ZIP/Postal Code
5505
Country
Korea, Republic of
Facility Name
Ajou University Hospital
City
Suwon City
ZIP/Postal Code
443-721
Country
Korea, Republic of
Facility Name
The Catholic University of Korea St. Vincent's Hospital
City
Suwon-si
ZIP/Postal Code
16247
Country
Korea, Republic of
Facility Name
Yonsei University Wonju Severance Christian Hospital
City
Wonju-Si
ZIP/Postal Code
220-701
Country
Korea, Republic of
Facility Name
Central Outpatient Clinic
City
Daugavpils
ZIP/Postal Code
LV-5401
Country
Latvia
Facility Name
Pauls Stradins Clinical University Hospital
City
R?ga
ZIP/Postal Code
LV-1002
Country
Latvia
Facility Name
Digestive Diseases Center "Gastro"
City
R?ga
ZIP/Postal Code
LV-1079
Country
Latvia
Facility Name
Hospital of Lithuanian University of Health. Sciences Kaunas Clinics
City
Kaunas
ZIP/Postal Code
50009
Country
Lithuania
Facility Name
Klaipeda Seamen's Hospital, Public Institution
City
Klaipeda
ZIP/Postal Code
92288
Country
Lithuania
Facility Name
Vilnius University Hospital Santariskiu Clinic, Public Institution; Cardiology
City
Vilnius
ZIP/Postal Code
LT-08661
Country
Lithuania
Facility Name
Pusat Perubatan Universiti Kebangsaan Malaysia
City
Kuala Lumpur
State/Province
FED. Territory OF Kuala Lumpur
ZIP/Postal Code
56000
Country
Malaysia
Facility Name
University Malaya Medical Center
City
Kuala Lumpur
State/Province
FED. Territory OF Kuala Lumpur
ZIP/Postal Code
59100
Country
Malaysia
Facility Name
Hospital Tengku Ampuan Afzan
City
Kuantan
State/Province
Pahang
ZIP/Postal Code
25100
Country
Malaysia
Facility Name
Hospital Raja Perempuan Zainab II; Department of Medicine
City
Kota Bahru
ZIP/Postal Code
15586
Country
Malaysia
Facility Name
Centro Integral en Reumatología S.A. de C.V. (CIRSA)
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
44160
Country
Mexico
Facility Name
Accelerium S. de R.L. de C.V.
City
Monterrey
State/Province
Nuevo LEON
ZIP/Postal Code
64000
Country
Mexico
Facility Name
Hospital Universitario Dr Jose Eleuterio Gonzalez; Universidad Autónoma de Nuevo León
City
Monterrey
State/Province
Nuevo LEON
ZIP/Postal Code
64460
Country
Mexico
Facility Name
Centro Regiomontano de Estudios Clínicos Roma S.C.
City
Monterrey
State/Province
Nuevo LEON
ZIP/Postal Code
64610
Country
Mexico
Facility Name
Phylasis Clinicas Research S de RL de CV
City
Cuautitlán Izcalli
ZIP/Postal Code
54769
Country
Mexico
Facility Name
Amsterdam UMC Location VUMC
City
Amsterdam
ZIP/Postal Code
1081 HV
Country
Netherlands
Facility Name
Amsterdam UMC Location AMC
City
Amsterdam
ZIP/Postal Code
1105 AZ
Country
Netherlands
Facility Name
Radboudumc
City
NL -nijmegen
ZIP/Postal Code
6525 GA
Country
Netherlands
Facility Name
North Shore Hospital
City
Auckland
ZIP/Postal Code
0620
Country
New Zealand
Facility Name
Middlemore Hospital
City
Auckland
Country
New Zealand
Facility Name
Dunedin Hospital
City
Dunedin
Country
New Zealand
Facility Name
Waikato Hospital
City
Hamilton
ZIP/Postal Code
3248
Country
New Zealand
Facility Name
Shakespeare Specialist Group
City
Takapuna
ZIP/Postal Code
0620
Country
New Zealand
Facility Name
Tauranga Hospital
City
Tauranga
ZIP/Postal Code
3143
Country
New Zealand
Facility Name
Akershus universitetssykehus HF
City
Lørenskog
ZIP/Postal Code
1478
Country
Norway
Facility Name
AppleTreeClinics Sp. z o.o.
City
?ód?
ZIP/Postal Code
90-349
Country
Poland
Facility Name
Nasz Lekarz Osrodek Badan Klinicznych
City
Bydgoszcz
ZIP/Postal Code
85-312
Country
Poland
Facility Name
Centrum Medyczne Lukamed Joanna Luka
City
Chojnice
ZIP/Postal Code
89-600
Country
Poland
Facility Name
Centrum Medyczne Sw. Lukasza
City
Cz?stochowa
ZIP/Postal Code
42-202
Country
Poland
Facility Name
7 Szpital Marynarki Wojennej z Przychodnia SPZOZ im. W. Lasinskiego
City
Gdansk
ZIP/Postal Code
80-305
Country
Poland
Facility Name
Pro Familia Altera Sp z o.o.
City
Katowice
ZIP/Postal Code
40-645
Country
Poland
Facility Name
Nzoz All-Medicus
City
Katowice
ZIP/Postal Code
40-660
Country
Poland
Facility Name
Uniwersyteckie Centrum Kliniczne im. prof. K. Gibinskiego SUM
City
Katowice
ZIP/Postal Code
40-752
Country
Poland
Facility Name
NZOZ Centrum Medyczne ProMiMed
City
Krakow
ZIP/Postal Code
31-637
Country
Poland
Facility Name
Centrum Opieki Zdrowotnej Orkan-Med
City
Ksawerow
ZIP/Postal Code
95-054
Country
Poland
Facility Name
Indywidualna Specjalistyczna Praktyka Lekarska
City
Lublin
ZIP/Postal Code
20-015
Country
Poland
Facility Name
GASTROMED Sp. z o.o.
City
Lublin
ZIP/Postal Code
20-582
Country
Poland
Facility Name
Allmedica Badania Kliniczne Sp z o.o. Sp K.
City
Nowy Targ
ZIP/Postal Code
34-400
Country
Poland
Facility Name
Wojewodzki Specjalistyczny Szpital w Olsztynie
City
Olsztyn
ZIP/Postal Code
10-561
Country
Poland
Facility Name
SOLUMED Centrum Medyczne
City
Pozna?
ZIP/Postal Code
60-529
Country
Poland
Facility Name
Centrum Medyczne Medyk
City
Rzeszow
ZIP/Postal Code
35-055
Country
Poland
Facility Name
Gabinet Lekarski, Bartosz Korczowski
City
Rzeszów
ZIP/Postal Code
35-302
Country
Poland
Facility Name
Specjalistyczna Praktyka Lekarska Dr med. Marek Horynski; endoskopia
City
Sopot
ZIP/Postal Code
81-756
Country
Poland
Facility Name
Niepubliczny Zaklad Opieki Zdrowotnej SONOMED
City
Szczecin
ZIP/Postal Code
70-351
Country
Poland
Facility Name
Twoja Przychodnia-Szczecinskie Centrum Medyczne
City
Szczecin
ZIP/Postal Code
71-434
Country
Poland
Facility Name
Centrum Zdrowia MDM
City
Warszawa
ZIP/Postal Code
00-635
Country
Poland
Facility Name
Zespó Przychodni Specjalistycznych PRIMA
City
Warszawa
ZIP/Postal Code
02-018
Country
Poland
Facility Name
Endoterapia PFG Sp. z o.o.
City
Warszawa
ZIP/Postal Code
02-653
Country
Poland
Facility Name
Narodowy Instytut Onkologii im. Marii Sk?odowskiej-Curie - Pa?stwowy Instytut Badawczy
City
Warszawa
ZIP/Postal Code
02-781
Country
Poland
Facility Name
Nzoz Vivamed
City
Warszawa
ZIP/Postal Code
03-580
Country
Poland
Facility Name
Przychodnia EuroMediCare
City
Wroc?aw
ZIP/Postal Code
50-220
Country
Poland
Facility Name
PlanetMed
City
Wroc?aw
ZIP/Postal Code
52-210
Country
Poland
Facility Name
LexMedica Osrodek Badan Klinicznych
City
Wroclaw
ZIP/Postal Code
53-114
Country
Poland
Facility Name
Hospital de Braga
City
Braga
ZIP/Postal Code
4710-243
Country
Portugal
Facility Name
Hospital da Senhora da Oliveira Guimarães
City
Guimarães
ZIP/Postal Code
4835-044
Country
Portugal
Facility Name
Spitalul Clinic Colentina
City
Bucharest
ZIP/Postal Code
772202
Country
Romania
Facility Name
S.C MedLife S.A
City
Bucuresti
ZIP/Postal Code
010719
Country
Romania
Facility Name
Centrul Medical Unirea SRL
City
Bucuresti
ZIP/Postal Code
040055
Country
Romania
Facility Name
Centrul de Gastroenterologie Dr. Goldis
City
Timisoara
ZIP/Postal Code
300002
Country
Romania
Facility Name
Yusupov Hospital
City
Moskva
State/Province
Adygeja
ZIP/Postal Code
127015
Country
Russian Federation
Facility Name
SBEI HPE Altai StateMedicalUniversityofMoH andSD
City
Barnaul
State/Province
Altaj
ZIP/Postal Code
656050
Country
Russian Federation
Facility Name
Baltic Medicine
City
St.Petersburg
State/Province
Leningrad
ZIP/Postal Code
194356
Country
Russian Federation
Facility Name
CJSC Nasledniki
City
Moscow
State/Province
Moskovskaja Oblast
ZIP/Postal Code
119192
Country
Russian Federation
Facility Name
FSBIH Central Clinical Hospital of RAS
City
Moscow
State/Province
Moskovskaja Oblast
ZIP/Postal Code
119333
Country
Russian Federation
Facility Name
FSBI ?State Scientific Centre of Coloproctology" of the MoH of RF; Gastroenterology
City
Moscow
State/Province
Moskovskaja Oblast
ZIP/Postal Code
123154
Country
Russian Federation
Facility Name
SBHI of NN region ?RCH of NN n.a. N.A.Semashko?
City
Nizhny Novgorod
State/Province
Niznij Novgorod
ZIP/Postal Code
603126
Country
Russian Federation
Facility Name
SEIHPE "Rostov SMU of MoH of RF"
City
Rostov-on-Don
State/Province
Rostov
ZIP/Postal Code
344022
Country
Russian Federation
Facility Name
FFSBI "The Nikiforov Russian Center of Emergency and Radiation Medicine"; Pulmonology
City
Sankt-peterburg
State/Province
Sankt Petersburg
ZIP/Postal Code
194044
Country
Russian Federation
Facility Name
SPb SBIH "City Multy-field Hospital # 2"; Intensive Pulmonology and Thoracal Surgery
City
Sankt-peterburg
State/Province
Sankt Petersburg
ZIP/Postal Code
194354
Country
Russian Federation
Facility Name
SBIH City Clinical Hospital #31
City
Sankt-peterburg
State/Province
Sankt Petersburg
ZIP/Postal Code
197110
Country
Russian Federation
Facility Name
City Hospital #26
City
St Petersburg
State/Province
Sankt Petersburg
ZIP/Postal Code
196247
Country
Russian Federation
Facility Name
LLC International Medical Centre ?SOGAZ?
City
St-petersburg
State/Province
Sankt Petersburg
ZIP/Postal Code
198035
Country
Russian Federation
Facility Name
FSBMEI HPE "Military Medical Academy n.a. S.M. Kirov" of the MoD of the RF; Therapy
City
St. Petersburg
State/Province
Sankt Petersburg
ZIP/Postal Code
193163
Country
Russian Federation
Facility Name
Pavlov First Saint Petersburg State Medical University
City
St. Petersburg
State/Province
Sankt Petersburg
ZIP/Postal Code
197022
Country
Russian Federation
Facility Name
SPb SHI "City Hospital #9"
City
St. Petersburg
State/Province
Sankt Petersburg
ZIP/Postal Code
197110
Country
Russian Federation
Facility Name
Medical and Sanitary Division of Severstal
City
Cherepovets
State/Province
Vologda
ZIP/Postal Code
162600
Country
Russian Federation
Facility Name
SBEI HPE "Voronezh State Medical University n.a. N.N. Burdenko" of the MoH of the RF
City
Voronezh
State/Province
Voronez
ZIP/Postal Code
394036
Country
Russian Federation
Facility Name
Irkutsk State Medical Academy of Continuing Education
City
Irkutsk
ZIP/Postal Code
664079
Country
Russian Federation
Facility Name
FSBI "Scientific Research Institute of Physyology and Basic Medicine" under the SB of RAMS
City
Novosibirsk
ZIP/Postal Code
630117
Country
Russian Federation
Facility Name
BHI of Omsk region Clinical Oncology Dispensary
City
Omsk
ZIP/Postal Code
644013
Country
Russian Federation
Facility Name
SBEI of HPE "Omsk SMA" Ministry of healthcare of RF"
City
Omsk
ZIP/Postal Code
644043
Country
Russian Federation
Facility Name
Stavropol Regional Clinical Diagnostic Consultative Center
City
Stavropol
ZIP/Postal Code
355017
Country
Russian Federation
Facility Name
FSBEI HE "Stavropol State Medical University" of Ministry of Healthcare of Russian Federation
City
Stavropol
ZIP/Postal Code
355018
Country
Russian Federation
Facility Name
Clinical Center Zvezdara
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Facility Name
Military Medical Academy
City
Belgrade
ZIP/Postal Code
11040
Country
Serbia
Facility Name
Clinical Center Zemun
City
Belgrade
ZIP/Postal Code
11080
Country
Serbia
Facility Name
Clinical Center Kragujevac
City
Kragujevac
ZIP/Postal Code
34000
Country
Serbia
Facility Name
General Hospital Djordje Joanovic
City
Zrenjanin
ZIP/Postal Code
23000
Country
Serbia
Facility Name
Singapore General Hospital
City
Singapore
ZIP/Postal Code
169608
Country
Singapore
Facility Name
Fakultna nemocnica s poliklinikou F.D. Roosevelta
City
Banska Bystrica
ZIP/Postal Code
974 01
Country
Slovakia
Facility Name
Nemocnica A.Lena Humenne, n.o.
City
Humenné
ZIP/Postal Code
066 01
Country
Slovakia
Facility Name
KM Management spol. s r.o.
City
Nitra
ZIP/Postal Code
94901
Country
Slovakia
Facility Name
Gastro I, s.r.o.
City
Prešov
ZIP/Postal Code
080 01
Country
Slovakia
Facility Name
Svet zdravia a.s.
City
Rimavská Sobota
ZIP/Postal Code
979 01
Country
Slovakia
Facility Name
Endomed, s.r.o.
City
Vranov Nad Top?ou
ZIP/Postal Code
093 01
Country
Slovakia
Facility Name
Accout Center s.r.o.
City
Šahy
ZIP/Postal Code
936 01
Country
Slovakia
Facility Name
Netcare Universitas Private Hospital
City
Bloemfontein
ZIP/Postal Code
9301
Country
South Africa
Facility Name
Dr MJ Prins Practice
City
Cape Town
ZIP/Postal Code
7500
Country
South Africa
Facility Name
Dr JP Wright Practice
City
Cape Town
ZIP/Postal Code
7708
Country
South Africa
Facility Name
Emmed Research
City
Pretoria
ZIP/Postal Code
0002
Country
South Africa
Facility Name
Corporacio Sanitaria Parc Tauli
City
Sabadell
State/Province
Barcelona
ZIP/Postal Code
08208
Country
Spain
Facility Name
Fundacion Hospital de Alcorcon; Servicio de Digestivo
City
Alcorcon
State/Province
Madrid
ZIP/Postal Code
28922
Country
Spain
Facility Name
Centro Médico Teknon
City
Barcelona
Country
Spain
Facility Name
Hospital Universitari de Girona Dr Josep Trueta
City
Girona
ZIP/Postal Code
17007
Country
Spain
Facility Name
Hospital Universitario de la Princesa
City
Madrid
ZIP/Postal Code
28006
Country
Spain
Facility Name
Hospital Universitario La Paz
City
Madrid
ZIP/Postal Code
280146
Country
Spain
Facility Name
Hospital Universitario de Fuenlabrada
City
Madrid
ZIP/Postal Code
28942
Country
Spain
Facility Name
Hospital Universitari i Politecnic La Fe
City
Valencia
ZIP/Postal Code
46026
Country
Spain
Facility Name
Hospital Universitario Miguel Servet
City
Zaragoza
ZIP/Postal Code
50009
Country
Spain
Facility Name
Inselspital-Universitaetsspital Bern
City
Bern
ZIP/Postal Code
3010
Country
Switzerland
Facility Name
Crohn-Colitis Zentrum Bern - Gemeinschaftspraxis Balsiger, Seibold und Partner
City
Bern
ZIP/Postal Code
3012
Country
Switzerland
Facility Name
Gazi University Medical Faculty; Gastroenterology
City
Ankara
ZIP/Postal Code
06500
Country
Turkey
Facility Name
Haydarpasa Numune Training and Research Hospital; Medical Oncology
City
Istanbul
ZIP/Postal Code
34668
Country
Turkey
Facility Name
Kocaeli Universitesi Tip Fakultesi; Infectious Diseases
City
Kocaeli
ZIP/Postal Code
41380
Country
Turkey
Facility Name
CNE Prof. O.O. Shalimov Kharkiv City Clinical Hospital #2 of KCC
City
Kharkiv
State/Province
Kharkiv Governorate
ZIP/Postal Code
61037
Country
Ukraine
Facility Name
Communal Non-commercial Enterprise of Kharkiv Regional Council Regional Clinical Hospital
City
Kharkiv
State/Province
Kharkiv Governorate
ZIP/Postal Code
61058
Country
Ukraine
Facility Name
Communal Institution of Kyiv Regional Council Kyiv Regional Clinical Hospital
City
Kyiv
State/Province
Kharkiv Governorate
ZIP/Postal Code
04107
Country
Ukraine
Facility Name
CI of SRC Sumy RCH Dept of Gasroenterology Sumy SU MI
City
Sumy
State/Province
Kharkiv Governorate
ZIP/Postal Code
40022
Country
Ukraine
Facility Name
LLC Gastroenterology Center IBD Team
City
Zaporizhzhia
State/Province
Kharkiv Governorate
ZIP/Postal Code
69000
Country
Ukraine
Facility Name
CNE Kyiv CCH #18
City
Kyiv
State/Province
KIEV Governorate
ZIP/Postal Code
01030
Country
Ukraine
Facility Name
CI of Kyiv RC Kyiv Regional Clinical Hospital
City
Kyiv
State/Province
KIEV Governorate
ZIP/Postal Code
04107
Country
Ukraine
Facility Name
Medical Center of Limited Liability Company Medical Clinic Blagomed
City
Kyiv
State/Province
KIEV Governorate
ZIP/Postal Code
1023
Country
Ukraine
Facility Name
Med Center of International Institute of Clinical Trials LLC; Medical Center "OK!Clinic+"
City
Kyiv
State/Province
KIEV Governorate
ZIP/Postal Code
2091
Country
Ukraine
Facility Name
CI of Kyiv RC Regional Clinical Hospital #2
City
Kyiv
State/Province
KIEV Governorate
ZIP/Postal Code
4073
Country
Ukraine
Facility Name
Lviv Regional Clinical Hospital
City
Lviv
State/Province
KIEV Governorate
ZIP/Postal Code
79010
Country
Ukraine
Facility Name
CI UDH Dept of Ther SHEI Fac of PGE&Pre-Univ Training
City
Uzhgorod
State/Province
KIEV Governorate
ZIP/Postal Code
88009
Country
Ukraine
Facility Name
A.Novak Transcarpathian Regional Clinical Hospital
City
Uzhgorod
State/Province
KIEV Governorate
ZIP/Postal Code
88018
Country
Ukraine
Facility Name
RCNECRCH Dept of Surgery, SHEI Ukr BSMU
City
Chernivtsi
State/Province
Podolia Governorate
ZIP/Postal Code
58002
Country
Ukraine
Facility Name
CI City Hospital #1
City
Zaporizhzhia
State/Province
Tavria Okruha
ZIP/Postal Code
69104
Country
Ukraine
Facility Name
RCI Chernivtsi RCH Gastroenterology Bukovinsky SMU
City
Chernivtsi
ZIP/Postal Code
58002
Country
Ukraine
Facility Name
SI Dnipropetrovsk MA of MOHU SI Institute of gastroenterology of AMSU
City
Dnipropetrovsk
ZIP/Postal Code
49074
Country
Ukraine
Facility Name
GI L.T.Malaya Therapy National Institute of the NAMS of Ukraine
City
Kharkiv
ZIP/Postal Code
61039
Country
Ukraine
Facility Name
CI of Healthcare Kharkiv CCH #13
City
Kharkiv
ZIP/Postal Code
61124
Country
Ukraine
Facility Name
CI Kherson Afanasii and Olha Tropiny City Clinical Hospital
City
Kherson
ZIP/Postal Code
73000
Country
Ukraine
Facility Name
CNI Consultative and Diagnostic Center of Desnianskyi District of Kyiv
City
Kyiv
ZIP/Postal Code
02232
Country
Ukraine
Facility Name
Odessa regional clinical Hospital
City
Odessa
ZIP/Postal Code
65117
Country
Ukraine
Facility Name
M.V. Sklifosovskyi Poltava RCH Dept of Gastroenterology HSEIU UMSA
City
Poltava
ZIP/Postal Code
36011
Country
Ukraine
Facility Name
M.V. Sklifosovskyi Poltava RCH Outpatient UMSA HSEIU Ukrainian Medical Stomatological Academy
City
Poltava
ZIP/Postal Code
36011
Country
Ukraine
Facility Name
Private Small Enterprise Medical Center Pulse
City
Vinnytsia
ZIP/Postal Code
21001
Country
Ukraine
Facility Name
M.I. Pyrogov VRCH Dept of Gastroenterology M.I. Pyrogov VNMU
City
Vinnytsia
ZIP/Postal Code
21018
Country
Ukraine
Facility Name
MCIC Health Clinic BO LTD TPC Slaomed
City
Vinnytsia
ZIP/Postal Code
21029
Country
Ukraine
Facility Name
Co Ltd. Diaservice
City
Zaporizhzhia
ZIP/Postal Code
69035
Country
Ukraine
Facility Name
CI City Hospital #7
City
Zaporizhzhia
ZIP/Postal Code
69118
Country
Ukraine
Facility Name
Addenbrooke's Hospital
City
Cambridge
ZIP/Postal Code
CB2 0QQ
Country
United Kingdom
Facility Name
University Hospital Coventry
City
Coventry
ZIP/Postal Code
CV2 2DX
Country
United Kingdom
Facility Name
Royal Devon and Exeter Hospital (Wonford)
City
Exeter
ZIP/Postal Code
EX2 5DW
Country
United Kingdom
Facility Name
St James University Hospital
City
Leeds
ZIP/Postal Code
LS9 7TF
Country
United Kingdom
Facility Name
The Royal London Hospital
City
London
ZIP/Postal Code
E1 1FR
Country
United Kingdom
Facility Name
University College London Hospital
City
London
ZIP/Postal Code
N7 9NH
Country
United Kingdom
Facility Name
St Thomas Hospital
City
London
ZIP/Postal Code
SE1 7EH
Country
United Kingdom
Facility Name
King's College London
City
London
ZIP/Postal Code
SE5 9NU
Country
United Kingdom
Facility Name
Fairfield General Hospital
City
Manchester
ZIP/Postal Code
M8 5RB
Country
United Kingdom
Facility Name
Royal Victoria Infirmary
City
Newcastle upon Tyne
ZIP/Postal Code
NE1 4LP
Country
United Kingdom
Facility Name
Nottingham University Hospitals; QMC Campus
City
Nottingham
ZIP/Postal Code
NG7 2UH
Country
United Kingdom
Facility Name
Southampton General Hospital
City
Southampton
ZIP/Postal Code
SO16 6YD
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
32445184
Citation
Sandborn WJ, Vermeire S, Tyrrell H, Hassanali A, Lacey S, Tole S, Tatro AR; Etrolizumab Global Steering Committee. Etrolizumab for the Treatment of Ulcerative Colitis and Crohn's Disease: An Overview of the Phase 3 Clinical Program. Adv Ther. 2020 Jul;37(7):3417-3431. doi: 10.1007/s12325-020-01366-2. Epub 2020 May 22.
Results Reference
derived

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Study for Participants With Ulcerative Colitis Previously Enrolled in Etrolizumab Phase II/III Studies

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