Study for Participants With Ulcerative Colitis Previously Enrolled in Etrolizumab Phase II/III Studies
NCT ID: NCT02118584
Last Updated: 2024-10-23
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE3
1822 participants
INTERVENTIONAL
2014-09-15
2023-10-05
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Part 1: Open-label Extension
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).
Etrolizumab
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.
Part 2: Safety Monitoring
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).
No interventions assigned to this group
Interventions
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Etrolizumab
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
\- 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
* 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
18 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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University of Alabama Medical Center
Birmingham, Alabama, United States
University of California San Diego Medical Center
La Jolla, California, United States
University of California, Irvine Medical Center
Orange, California, United States
SDG Clinical Research
San Diego, California, United States
University of California at San Francisco
San Francisco, California, United States
Ventura Clinical Trials
Ventura, California, United States
Peak Gastroenterology Associates
Colorado Springs, Colorado, United States
Clinical Research of the Rockies
Lafayette, Colorado, United States
Rocky Mountain Gastroenterology Associates
Wheat Ridge, Colorado, United States
Innovative Medical Research of South Florida, Inc.
Aventura, Florida, United States
West Central Gastroenterology d/b/a Gastro Florida
Clearwater, Florida, United States
Regenerate Clinical Trials
Miami, Florida, United States
IMIC, Inc
Miami Beach, Florida, United States
FQL Research, LLC
Miramar, Florida, United States
Gastroenterology Group of Naples
Naples, Florida, United States
Advanced Research Institute, Inc.
New Port Richey, Florida, United States
Internal Medicine Specialists
Orlando, Florida, United States
Shafran Gastroenterology Center
Winter Park, Florida, United States
Atlanta Gastroenterology Associates
Atlanta, Georgia, United States
Gastroenterology Associates of Central Georgia
Macon, Georgia, United States
Gastrointestinal Specialists of Georgia, PC
Marietta, Georgia, United States
Atlanta Gastroenterology Specialists, PC
Suwanee, Georgia, United States
Northwestern University Feinberg School Of Medicine
Chicago, Illinois, United States
University of Chicago Medical Center; Medicine, Section of Pulmonary
Chicago, Illinois, United States
Southwest Gastroenterology
Oak Lawn, Illinois, United States
Aquiant Research
New Albany, Indiana, United States
Cotton-O'Neil Clinical Research Center, Digestive Health
Topeka, Kansas, United States
Gastroenterology Associates, LLC
Baton Rouge, Louisiana, United States
Louisiana Research Center, LLC
Shreveport, Louisiana, United States
Massachusetts General Hospital; Crohn's & Colitis Center
Boston, Massachusetts, United States
University of Michigan
Ann Arbor, Michigan, United States
Henry Ford Health System
Detroit, Michigan, United States
Center for Digestive Health
Troy, Michigan, United States
Huron Gastroenterology Associates
Ypsilanti, Michigan, United States
Regents of the University of Minnesota
Minneapolis, Minnesota, United States
University of Mississippi Medical Center
Jackson, Mississippi, United States
Ehrhardt Clinical Research, LLC
Belton, Missouri, United States
Kansas City Research Institute, LLC
Kansas City, Missouri, United States
Clinica Peruano Americana S.A.
Great Neck, New York, United States
NYU Langone Medical Center
New York, New York, United States
Weill Cornell Medical College (WCMC) - Judith Jaffe Multiple Sclerosis Center (JJMSC)
New York, New York, United States
Asheville Gastroenterology Associates, P.A.
Asheville, North Carolina, United States
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States
Kinston Medical Specialists
Kinston, North Carolina, United States
Consultants for Clin. Rsrch
Cincinnati, Ohio, United States
UC Health Clinical Trials Office; Division of Digestive Diseases
Cincinnati, Ohio, United States
Great Lakes Gastroenterology Research, LLC
Mentor, Ohio, United States
Gastroenterology Center of the Midsouth, P.C.
Memphis, Tennessee, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Texas Digestive Disease Consultants - Dallas
Dallas, Texas, United States
Wellness Clinical Research Center
San Antonio, Texas, United States
Texas Digestive Disease Consultants - Southlake
Southlake, Texas, United States
Tyler Research Institute, LLC
Tyler, Texas, United States
Ericksen Research and Development
Clinton, Utah, United States
University of Utah School of Medicine
Salt Lake City, Utah, United States
McGuire Research Institute; Gastroenterology
Richmond, Virginia, United States
Washington Gastroenterology
Bellevue, Washington, United States
Instituto Medico DAMIC
Córdoba, , Argentina
Hospital Provincial del Centenario
Rosario, , Argentina
Bankstown-Lidcombe Hospital
Bankstown, New South Wales, Australia
Concord Repatriation General Hospital
Concord, New South Wales, Australia
Royal Brisbane and Women's Hospital
Herston, Queensland, Australia
Mater Adult Hospital
Mackay, Queensland, Australia
Princess Alexandra Hospital
Woolloongabba, Queensland, Australia
Royal Adelaide Hospital
Adelaide, South Australia, Australia
Flinders Medical Centre
Bedford Park, South Australia, Australia
Launceston General Hospital; Gastroenterology Research
Launceston, Tasmania, Australia
Monash Medical Centre
Clayton, Victoria, Australia
St Vincent's Hospital Melbourne
Fitzroy, Victoria, Australia
Footscray Hospital
Footscray, Victoria, Australia
St Frances Xavier Cabrini Hospital
Malvern, Victoria, Australia
Royal Melbourne Hospital; Department of Colorectal Medicine and Genetics
Parkville, Victoria, Australia
Fiona Stanley Hospital
Murdoch, Western Australia, Australia
LKH - Universitätsklinikum der PMU Salzburg
Salzburg, , Austria
Medizinische Universität Wien
Vienna, , Austria
GZA Ziekenhuizen - Campus Sint-Vincentius
Antwerp, , Belgium
Imeldaziekenhuis
Bonheiden, , Belgium
CHU St Pierre (St Pierre)
Brussels, , Belgium
UZ Brussel
Brussels, , Belgium
Cliniques Universitaires Saint-Luc; Pharmacy
Brussels, , Belgium
UZ Gent
Ghent, , Belgium
AZ Sint Elisabeth Herentals
Herentals, , Belgium
UZ Leuven; Neurology
Leuven, , Belgium
AZ Delta (Campus Rumbeke)
Roeselare, , Belgium
Hospital Universitario Walter Cantidio - UFC
Fortaleza, Ceará, Brazil
Hospital Universitario Prof Edgar Santos-Ufba; Ambulatorio Magalhaes Neto 3Andar- Dermatologia
Salvador, Estado de Bahia, Brazil
CCBR - Brasilia
Brasília, Federal District, Brazil
Instituto Goiano de Gastroenterologia e Endoscopia Digestiva Ltda
Goiânia, Goiás, Brazil
Hospital Felicio Rocho
Belo Horizonte, Minas Gerais, Brazil
Centro Digestivo de Curitiba
Curitiba, Paraná, Brazil
Hospital Universitario Clementino Fraga Filho - UFRJ
Rio de Janeiro, Rio de Janeiro, Brazil
Hospital Moinhos de Vento
Porto Alegre, Rio Grande do Sul, Brazil
Hospital das Clinicas - UFRGS
Porto Alegre, Rio Grande do Sul, Brazil
Hospital Ernesto Dornelles
Porto Alegre, Rio Grande do Sul, Brazil
UNESP - Faculdade de Medicina da Universidade Estadual Paulista - Campus Botucatu
Botucatu, São Paulo, Brazil
CAEP - Centro Avancado de Estudos e Pesquisas Ltda.
Campinas, São Paulo, Brazil
CECIP - Centro de Estudos Clínicos do Interior Paulista
Jaú, São Paulo, Brazil
Pesquisare Saúde Sociedade Simples
Santo André, São Paulo, Brazil
Hospital Estadual Mario Covas
São Bernardo do Campo, São Paulo, Brazil
Hospital Sírio-Libanês
São Paulo, São Paulo, Brazil
Hospital do Servidor Público Estadual/HSPE-SP
São Paulo, São Paulo, Brazil
Medical Centre "Asklepii", OOD
Dupnitsa, , Bulgaria
DCC Sv. Pantaleymon OOD; II-nd Clinic of Neurology
Pleven, , Bulgaria
Medical center Medconsult Pleven OOD
Pleven, , Bulgaria
MHAT - Ruse, AD
Rousse, , Bulgaria
MHAT "Hadzhi Dimitar", OOD
Sliven, , Bulgaria
"City Clinic UMHAC" EOOD
Sofia, , Bulgaria
UMHAT "Sv. Ivan Rilski", EAD
Sofia, , Bulgaria
UMHAT Tsaritsa Yoanna - ISUL, EAD
Sofia, , Bulgaria
Diagnostic Consultation Center CONVEX EOOD
Sofia, , Bulgaria
Medical Center "Nov Rehabilitatsionen Tsentar", EOOD
Stara Zagora, , Bulgaria
MHAT 'Sv. Marina', EAD; First Children's Clinic
Varna, , Bulgaria
MC Medica Plus
Veliko Tarnovo, , Bulgaria
University of Calgary
Calgary, Alberta, Canada
Zeidler Ledcor Centre - University of Alberta; Division of Gasroenterology
Edmonton, Alberta, Canada
Pacific Gastroenterology Associates
Vancouver, British Columbia, Canada
Queen Elizabeth II Health Sciences Centre; Gastroenterology Research
Halifax, Nova Scotia, Canada
Guelph GI & Surgery Clinic
Guelph, Ontario, Canada
University Hospital - London Health Sciences Centre
London, Ontario, Canada
Taunton Health Centre
Oshawa, Ontario, Canada
Mount Sinai Hospital
Toronto, Ontario, Canada
Toronto Liver Centre
Toronto, Ontario, Canada
Toronto Digestive Disease Associates
Vaughan, Ontario, Canada
Centre de santé et de services sociaux Champlain-Charles-Le Moyne
Greenfield Park, Quebec, Canada
Hotel Dieu de Levis
Lévis, Quebec, Canada
Hôpital Maisonneuve - Rosemont
Montreal, Quebec, Canada
Royal University Hospital
Saskatoon, Saskatchewan, Canada
RTS - Fundación Valle de Lili
Cali, , Colombia
Instituto de Coloproctologia ICO S.A.S.
Medellín, , Colombia
Clinical Hospital Centre Osijek
Osijek, , Croatia
Clinical Hospital Sveti Duh; Department of Neurology
Zagreb, , Croatia
Vojenska nemocnice Brno
Brno, , Czechia
Fakultni nemocnice u sv. Anny v Brne; I.Interni kardioangiologicka klinika
Brno, , Czechia
Fakultni nemocnice Hradec Kralove
Hradec Králové, , Czechia
Hepato-Gastroenterologie HK, s.r.o.
Hradec Králové, , Czechia
Oblastni nemocnice Kladno, a.s., nemocnice Stredoces. kraje; Endoskopicke centrum
Kladno, , Czechia
PreventaMed, s.r.o.
Olomouc, , Czechia
Mestska Nemocnice Ostrava
Ostrava, , Czechia
Pardubicka krajska nemocnice a.s.
Pardubice, , Czechia
ISCARE a.s.
Prague, , Czechia
Nemocnice Na Bulovce
Prague, , Czechia
Krajska zdravotni, a.s. ? Masarykova nemocnice v Usti nad Labem, o.z., Ocni oddeleni
Ústí nad Labem, , Czechia
Krajska nemocnice T. Bati, a.s.
Zlín, , Czechia
Ålborg Universitets Hospital; Gastromedicinsk
Aalborg, , Denmark
Herlev og Gentofte Hospital
Hellerup, , Denmark
Rigshospitalet; Afdeling for Tarmsvigt og Leversygdomme
København Ø, , Denmark
OÜ Innomedica
Tallinn, , Estonia
East Tallinn Central Hospital
Tallinn, , Estonia
West Tallinn Central Hospital
Tallinn, , Estonia
North Estonia Medical Centre Foundation
Tallinn, , Estonia
Tartu University Hospital
Tartu, , Estonia
CHU Amiens - Hopital Sud
Amiens, , France
CHU de Caen Hopital Cote de Nacre
Caen, , France
CHU Tours - Hôpital Trousseau
Chambray-lès-Tours, , France
Hôpital Beaujon
Clichy, , France
Hopital Claude Huriez - CHU Lille
Lille, , France
CHU Hopital Saint Eloi
Montpellier, , France
CHU Nice - Hopital de l'Archet 2
Nice, , France
Hôpital Saint-Louis
Paris, , France
CHU Bordeaux - Hôpital Haut-Lévêque
Pessac, , France
Centre Hospitalier Lyon Sud; Service de Gastro-Enterologie
Pierre-Bénite, , France
CHU Saint Etienne - Hôpital Nord
Saint-Etienne, , France
Höpital Hautepierre; Pediatrie1
Strasbourg, , France
CHU de Toulouse - Hôpital Rangueil
Toulouse, , France
Hôpital de Brabois Adultes
Vandœuvre-lès-Nancy, , France
Charite Universitaetsmedizin Berlin - Campus Charite Mitte
Berlin, , Germany
Charite Universitaetsmedizin Berlin - Campus Benjamin Franklin
Berlin, , Germany
DRK Kliniken Berlin Westend
Berlin, , Germany
Krankenhaus Waldfriede e. V.
Berlin, , Germany
Berufsgenossenschaftliches Universitaetsklinikum Bergmannsheil GmbH
Bochum, , Germany
Universitaetsklinikum Erlangen
Erlangen, , Germany
Klinikum der Johann Wolfgang Goethe-Universitaet
Frankfurt, , Germany
Universitaetsklinikum Freiburg; Urology
Freiburg im Breisgau, , Germany
Universitaetsklinikum Halle (Saale)
Halle, , Germany
Hamburgisches Forschungsinstitut fuer CED
Hamburg, , Germany
Universitätsklinikum Hamburg-Eppendorf
Hamburg, , Germany
Gastroenterologie Eppendorfer Baum
Hamburg, , Germany
Medizinische Hochschule Hannover; Klinik für Gastroenterologie, Hepatologie und Endokrinologie
Hanover, , Germany
Universitaetsklinikum Jena; Apotheke des Uniersitätsklinikums Jena
Jena, , Germany
Universitaetsklinikum Schleswig-Holstein, Campus Kiel
Kiel, , Germany
Medizinisches Zentrum Klinikum Lueneburg
Lüneburg, , Germany
Klinikum Mannheim GmbH Universitätsklinikum
Mannheim, , Germany
Universitaetsklinikum Muenster
Münster, , Germany
Gemeinschaftspraxis Dres. Joachim Mueller und Steffi Appelt
Schweinfurt, , Germany
Universitaetsklinikum Ulm
Ulm, , Germany
University General Hospital of Heraklion
Heraklio, , Greece
University of Hong Kong
Hong Kong, , Hong Kong
DRC Gyogyszervizsgalo Kozpont Kft
Balatonfüred, , Hungary
Bekes Megyei Kozponti Korhaz Dr. Rethy Pal Tagkorhaza
Békéscsaba, , Hungary
Semmelweis Egyetem; Belgyogyaszati es Hematologiai Klinika
Budapest, , Hungary
Eszak-Kozep-budai Centrum, Uj Szent Janos Korhaz es Szakrendelo
Budapest, , Hungary
Pannónia Klinika Magánorvosi
Budapest, , Hungary
Magyar Honvedseg Egeszsegugyi Kozpont; Fázis I-es Klinikai Farmakológiai Vizsgálóhely
Budapest, , Hungary
Endomedix Diagnosztikai Kozpont
Budapest, , Hungary
Vasutegeszsegugyi Kft. - Debreceni Egeszsegugyi Kozpont
Debrecen, , Hungary
Debreceni Egyetem Klinikai Kozpont
Debrecen, , Hungary
Markhot Ferenc Oktato Korhaz es Rendelointezet
Eger, , Hungary
Petz Aladar Megyei Oktato Korhaz
Győr, , Hungary
Pest Megyei Flor Ferenc Korhaz
Kistarcsa, , Hungary
Borsod-Abauj-Zemplen Megyei Korhaz es Egyetemi Oktato Korhaz
Miskolc, , Hungary
Pecsi Tudomanyegyetem
Pécs, , Hungary
Csongrad Megyei Dr. Bugyi Istvan Korhaz
Szentes, , Hungary
Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz
Székesfehérvár, , Hungary
Deccan College of Medical Sciences and Allied Hospitals; Department of Gastroenterology
Hyderabad, Andhra Pradesh, India
Nirmal Hospital
Surat, Gujarat, India
K.L.E. Society's Dr. Prabhakar Kore Hospital and Medical Research Centre
Belagavi, Karnataka, India
M. S. Ramaiah Medical College and Hospital
Bengaluru, Karnataka, India
Kasturba Medical College & Hospital
Manglore, Karnataka, India
Midas institute of Gastroenterology
Nagpur, Maharashtra, India
Ruby Hall Clinic
Pune, Maharashtra, India
Dayanand Medical College and Hospital
Ludhiana, Punjab, India
S. R. Kalla Memorial Gastro & General Hospital
Jaipur, Rajasthan, India
King Edward Memorial Hospital Research Centre
Pune, , India
Bnai Zion Medical Center; Internal Medicine
Haifa, , Israel
Shaare Zedek Medical Center
Jerusalem, , Israel
Hadassah University Hospital - Ein Kerem
Jerusalem, , Israel
Holy Family Hospital
Nazareth, , Israel
Rabin Medical Center Beilinson Campus; Gaucher Clinic Genetics Institute
Petach Tiqwa, , Israel
Kaplan Medical Center
Rehovot, , Israel
Assaf Harofeh
Rishon LeZiyyon, , Israel
Chaim Sheba Medical Center; Pediatrics B North and Pediatric Endocrinology Unit
Tel Litwinsky, , Israel
Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpigh
Bologna, Emilia-Romagna, Italy
A.O.U. Policlinico di Modena
Modena, Emilia-Romagna, Italy
Azienda Ospedaliero Universitaria di Parma
Parma, Emilia-Romagna, Italy
Azienda Ospedaliera Universitaria Policlinico Tor Vergata
Rome, Lazio, Italy
Ospedale Sandro Pertini
Rome, Lazio, Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Rome, Lazio, Italy
Azienda Ospedaliera San Camillo Forlanini
Rome, Lazio, Italy
Fondazione Poliambulanza Istituto Ospedaliero
Brescia, Lombardy, Italy
Azienda Ospedaliera Fatebenefratelli e Oftalmico
Milan, Lombardy, Italy
Azienda Socio Sanitaria Territoriale Niguarda (Grande Ospedale Metropolitano Niguarda)
Milan, Lombardy, Italy
Azienda Socio Sanitaria Territoriale Fatebenefratelli (Presidio Ospedale Sacco)
Milan, Lombardy, Italy
Ospedale di Circolo; Neuropsichiatria Infantile
Rho, Lombardy, Italy
Istituto Clinico Humanitas
Rozzano (MI), Lombardy, Italy
I.R.C.C.S Policlinico San Donato
San Donato Milanese (MI), Lombardy, Italy
IRCCS Ospedale Casa Sollievo della Soffenza; Stru Comp di Gastroenterologia ed Endoscopia digest
San Giovanni Rotondo, Lombardy, Italy
Ospedale Mauriziano Umberto I
Turin, Piedmont, Italy
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone
Palermo, Sicily, Italy
Azienda Ospedaliera Universitaria Careggi
Florence, Tuscany, Italy
Azienda Ospedaliera di Padova
Padua, Veneto, Italy
Central Outpatient Clinic
Daugavpils, , Latvia
Pauls Stradins Clinical University Hospital
R?ga, , Latvia
Digestive Diseases Center "Gastro"
R?ga, , Latvia
Hospital of Lithuanian University of Health. Sciences Kaunas Clinics
Kaunas, , Lithuania
Klaipeda Seamen's Hospital, Public Institution
Klaipėda, , Lithuania
Vilnius University Hospital Santariskiu Clinic, Public Institution; Cardiology
Vilnius, , Lithuania
Pusat Perubatan Universiti Kebangsaan Malaysia
Kuala Lumpur, FED. Territory of Kuala Lumpur, Malaysia
University Malaya Medical Center
Kuala Lumpur, FED. Territory of Kuala Lumpur, Malaysia
Hospital Tengku Ampuan Afzan
Kuantan, Pahang, Malaysia
Hospital Raja Perempuan Zainab II; Department of Medicine
Kota Bharu, , Malaysia
Centro Integral en Reumatología S.A. de C.V. (CIRSA)
Guadalajara, Jalisco, Mexico
Accelerium S. de R.L. de C.V.
Monterrey, Nuevo León, Mexico
Hospital Universitario Dr Jose Eleuterio Gonzalez; Universidad Autónoma de Nuevo León
Monterrey, Nuevo León, Mexico
Centro Regiomontano de Estudios Clínicos Roma S.C.
Monterrey, Nuevo León, Mexico
Phylasis Clinicas Research S de RL de CV
Cuautitlán Izcalli, , Mexico
Amsterdam UMC Location VUMC
Amsterdam, , Netherlands
Amsterdam UMC Location AMC
Amsterdam, , Netherlands
Radboudumc
NL -nijmegen, , Netherlands
North Shore Hospital
Auckland, , New Zealand
Middlemore Hospital
Auckland, , New Zealand
Dunedin Hospital
Dunedin, , New Zealand
Waikato Hospital
Hamilton, , New Zealand
Shakespeare Specialist Group
Takapuna, , New Zealand
Tauranga Hospital
Tauranga, , New Zealand
Akershus universitetssykehus HF
Lørenskog, , Norway
AppleTreeClinics Sp. z o.o.
?ód?, , Poland
Nasz Lekarz Osrodek Badan Klinicznych
Bydgoszcz, , Poland
Centrum Medyczne Lukamed Joanna Luka
Chojnice, , Poland
Centrum Medyczne Sw. Lukasza
Cz?stochowa, , Poland
7 Szpital Marynarki Wojennej z Przychodnia SPZOZ im. W. Lasinskiego
Gdansk, , Poland
Pro Familia Altera Sp z o.o.
Katowice, , Poland
Nzoz All-Medicus
Katowice, , Poland
Uniwersyteckie Centrum Kliniczne im. prof. K. Gibinskiego SUM
Katowice, , Poland
NZOZ Centrum Medyczne ProMiMed
Krakow, , Poland
Centrum Opieki Zdrowotnej Orkan-Med
Ksawerów, , Poland
Indywidualna Specjalistyczna Praktyka Lekarska
Lublin, , Poland
GASTROMED Sp. z o.o.
Lublin, , Poland
Allmedica Badania Kliniczne Sp z o.o. Sp K.
Nowy Targ, , Poland
Wojewodzki Specjalistyczny Szpital w Olsztynie
Olsztyn, , Poland
SOLUMED Centrum Medyczne
Późna, , Poland
Centrum Medyczne Medyk
Rzeszów, , Poland
Gabinet Lekarski, Bartosz Korczowski
Rzeszów, , Poland
Specjalistyczna Praktyka Lekarska Dr med. Marek Horynski; endoskopia
Sopot, , Poland
Niepubliczny Zaklad Opieki Zdrowotnej SONOMED
Szczecin, , Poland
Twoja Przychodnia-Szczecinskie Centrum Medyczne
Szczecin, , Poland
Centrum Zdrowia MDM
Warsaw, , Poland
Zespó Przychodni Specjalistycznych PRIMA
Warsaw, , Poland
Endoterapia PFG Sp. z o.o.
Warsaw, , Poland
Narodowy Instytut Onkologii im. Marii Sk?odowskiej-Curie - Pa?stwowy Instytut Badawczy
Warsaw, , Poland
Nzoz Vivamed
Warsaw, , Poland
Przychodnia EuroMediCare
Wroc?aw, , Poland
PlanetMed
Wroc?aw, , Poland
LexMedica Osrodek Badan Klinicznych
Wroclaw, , Poland
Hospital de Braga
Braga, , Portugal
Hospital da Senhora da Oliveira Guimarães
Guimarães, , Portugal
S.C MedLife S.A
Bucharest, , Romania
Centrul Medical Unirea SRL
Bucharest, , Romania
Spitalul Clinic Colentina
Bucharest, , Romania
Centrul de Gastroenterologie Dr. Goldis
Timișoara, , Romania
Yusupov Hospital
Moskva, Adygeya Republic, Russia
SBEI HPE Altai StateMedicalUniversityofMoH andSD
Barnaul, Altayskiy Kray, Russia
FSBIH Central Clinical Hospital of RAS
Moscow, Moscow Oblast, Russia
FSBI ?State Scientific Centre of Coloproctology" of the MoH of RF; Gastroenterology
Moscow, Moscow Oblast, Russia
SBHI of NN region ?RCH of NN n.a. N.A.Semashko?
Nizhny Novgorod, Niznij Novgorod, Russia
SEIHPE "Rostov SMU of MoH of RF"
Rostov-on-Don, Rostov Oblast, Russia
FSBMEI HPE "Military Medical Academy n.a. S.M. Kirov" of the MoD of the RF; Therapy
Saint Petersburg, Sankt-Peterburg, Russia
FFSBI "The Nikiforov Russian Center of Emergency and Radiation Medicine"; Pulmonology
Saint Petersburg, Sankt-Peterburg, Russia
SPb SBIH "City Multy-field Hospital # 2"; Intensive Pulmonology and Thoracal Surgery
Saint Petersburg, Sankt-Peterburg, Russia
Baltic Medicine
Saint Petersburg, Sankt-Peterburg, Russia
City Hospital #26
Saint Petersburg, Sankt-Peterburg, Russia
Pavlov First Saint Petersburg State Medical University
Saint Petersburg, Sankt-Peterburg, Russia
SBIH City Clinical Hospital #31
Saint Petersburg, Sankt-Peterburg, Russia
SPb SHI "City Hospital #9"
Saint Petersburg, Sankt-Peterburg, Russia
LLC International Medical Centre ?SOGAZ?
Saint Petersburg, Sankt-Peterburg, Russia
Medical and Sanitary Division of Severstal
Cherepovets, Vologda Oblast, Russia
SBEI HPE "Voronezh State Medical University n.a. N.N. Burdenko" of the MoH of the RF
Voronezh, Voronez, Russia
Irkutsk State Medical Academy of Continuing Education
Irkutsk, , Russia
FSBI "Scientific Research Institute of Physyology and Basic Medicine" under the SB of RAMS
Novosibirsk, , Russia
BHI of Omsk region Clinical Oncology Dispensary
Omsk, , Russia
SBEI of HPE "Omsk SMA" Ministry of healthcare of RF"
Omsk, , Russia
Stavropol Regional Clinical Diagnostic Consultative Center
Stavropol, , Russia
FSBEI HE "Stavropol State Medical University" of Ministry of Healthcare of Russian Federation
Stavropol, , Russia
Clinical Center Zvezdara
Belgrade, , Serbia
Military Medical Academy
Belgrade, , Serbia
Clinical Center Zemun
Belgrade, , Serbia
Clinical Center Kragujevac
Kragujevac, , Serbia
General Hospital Djordje Joanovic
Zrenjanin, , Serbia
Singapore General Hospital
Singapore, , Singapore
Fakultna nemocnica s poliklinikou F.D. Roosevelta
Banská Bystrica, , Slovakia
Nemocnica A.Lena Humenne, n.o.
Humenné, , Slovakia
Endomed, s.r.o.
Košice, , Slovakia
KM Management spol. s r.o.
Nitra, , Slovakia
Gastro I, s.r.o.
Prešov, , Slovakia
Svet zdravia a.s.
Rimavská Sobota, , Slovakia
Accout Center s.r.o.
Šahy, , Slovakia
Netcare Universitas Private Hospital
Bloemfontein, , South Africa
Dr MJ Prins Practice
Cape Town, , South Africa
Dr JP Wright Practice
Cape Town, , South Africa
Emmed Research
Pretoria, , South Africa
Dong-A University Hospital
Busan, , South Korea
Pusan National University Hospital
Busan, , South Korea
Kyungpook National University Medical Center
Daegu, , South Korea
Keimyung University Dongsan Medical Center
Daegu, , South Korea
Kyungpook National University Hospital
Daegu, , South Korea
Yeungnam Univ. Hospital
Daegu, , South Korea
Korea University Ansan Hospital
Gyeonggi-do, , South Korea
CHA Bundang Medical Centre; CHA university
Seongnam, , South Korea
Seoul National University Bundang Hospital
Seongnam-si, , South Korea
Seoul National University Hospital
Seoul, , South Korea
Kangbuk Samsung Hospital
Seoul, , South Korea
Severance Hospital, Yonsei University Health System
Seoul, , South Korea
Samsung Medical Center
Seoul, , South Korea
Asan Medical Center.
Seoul, , South Korea
The Catholic University of Korea St. Vincent's Hospital
Suwon, , South Korea
Ajou University Hospital
Suwon, , South Korea
Yonsei University Wonju Severance Christian Hospital
Wŏnju, , South Korea
Corporacio Sanitaria Parc Tauli
Sabadell, Barcelona, Spain
Fundacion Hospital de Alcorcon; Servicio de Digestivo
Alcorcón, Madrid, Spain
Centro Médico Teknon
Barcelona, , Spain
Hospital Universitari de Girona Dr Josep Trueta
Girona, , Spain
Hospital Universitario de la Princesa
Madrid, , Spain
Hospital Universitario La Paz
Madrid, , Spain
Hospital Universitario de Fuenlabrada
Madrid, , Spain
Hospital Universitari i Politecnic La Fe
Valencia, , Spain
Hospital Universitario Miguel Servet
Zaragoza, , Spain
Inselspital-Universitaetsspital Bern
Bern, , Switzerland
Crohn-Colitis Zentrum Bern - Gemeinschaftspraxis Balsiger, Seibold und Partner
Bern, , Switzerland
Gazi University Medical Faculty; Gastroenterology
Ankara, , Turkey (Türkiye)
Haydarpasa Numune Training and Research Hospital; Medical Oncology
Istanbul, , Turkey (Türkiye)
Kocaeli Universitesi Tip Fakultesi; Infectious Diseases
Kocaeli, , Turkey (Türkiye)
CNE Prof. O.O. Shalimov Kharkiv City Clinical Hospital #2 of KCC
Kharkiv, Kharkiv Governorate, Ukraine
Communal Non-commercial Enterprise of Kharkiv Regional Council Regional Clinical Hospital
Kharkiv, Kharkiv Governorate, Ukraine
Communal Institution of Kyiv Regional Council Kyiv Regional Clinical Hospital
Kyiv, Kharkiv Governorate, Ukraine
CI of SRC Sumy RCH Dept of Gasroenterology Sumy SU MI
Sumy, Kharkiv Governorate, Ukraine
LLC Gastroenterology Center IBD Team
Zaporizhzhia, Kharkiv Governorate, Ukraine
CNE Kyiv CCH #18
Kyiv, KIEV Governorate, Ukraine
CI of Kyiv RC Kyiv Regional Clinical Hospital
Kyiv, KIEV Governorate, Ukraine
Medical Center of Limited Liability Company Medical Clinic Blagomed
Kyiv, KIEV Governorate, Ukraine
Med Center of International Institute of Clinical Trials LLC; Medical Center "OK!Clinic+"
Kyiv, KIEV Governorate, Ukraine
CI of Kyiv RC Regional Clinical Hospital #2
Kyiv, KIEV Governorate, Ukraine
Lviv Regional Clinical Hospital
Lviv, KIEV Governorate, Ukraine
CI UDH Dept of Ther SHEI Fac of PGE&Pre-Univ Training
Uzhhorod, KIEV Governorate, Ukraine
A.Novak Transcarpathian Regional Clinical Hospital
Uzhhorod, KIEV Governorate, Ukraine
RCNECRCH Dept of Surgery, SHEI Ukr BSMU
Chernivtsi, Podolia Governorate, Ukraine
CI City Hospital #1
Zaporizhzhia, Tavria Okruha, Ukraine
RCI Chernivtsi RCH Gastroenterology Bukovinsky SMU
Chernivtsi, , Ukraine
SI Dnipropetrovsk MA of MOHU SI Institute of gastroenterology of AMSU
Dnipropetrovsk, , Ukraine
GI L.T.Malaya Therapy National Institute of the NAMS of Ukraine
Kharkiv, , Ukraine
CI of Healthcare Kharkiv CCH #13
Kharkiv, , Ukraine
CI Kherson Afanasii and Olha Tropiny City Clinical Hospital
Kherson, , Ukraine
CNI Consultative and Diagnostic Center of Desnianskyi District of Kyiv
Kyiv, , Ukraine
Odessa regional clinical Hospital
Odesa, , Ukraine
M.V. Sklifosovskyi Poltava RCH Dept of Gastroenterology HSEIU UMSA
Poltava, , Ukraine
M.V. Sklifosovskyi Poltava RCH Outpatient UMSA HSEIU Ukrainian Medical Stomatological Academy
Poltava, , Ukraine
Private Small Enterprise Medical Center Pulse
Vinnytsia, , Ukraine
M.I. Pyrogov VRCH Dept of Gastroenterology M.I. Pyrogov VNMU
Vinnytsia, , Ukraine
MCIC Health Clinic BO LTD TPC Slaomed
Vinnytsia, , Ukraine
Co Ltd. Diaservice
Zaporizhzhia, , Ukraine
CI City Hospital #7
Zaporizhzhia, , Ukraine
Addenbrooke's Hospital
Cambridge, , United Kingdom
University Hospital Coventry
Coventry, , United Kingdom
Royal Devon and Exeter Hospital (Wonford)
Exeter, , United Kingdom
St James University Hospital
Leeds, , United Kingdom
The Royal London Hospital
London, , United Kingdom
University College London Hospital
London, , United Kingdom
St Thomas Hospital
London, , United Kingdom
King's College London
London, , United Kingdom
Fairfield General Hospital
Manchester, , United Kingdom
Royal Victoria Infirmary
Newcastle upon Tyne, , United Kingdom
Nottingham University Hospitals; QMC Campus
Nottingham, , United Kingdom
Southampton General Hospital
Southampton, , United Kingdom
Countries
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References
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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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2013-004435-72
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
GA28951
Identifier Type: -
Identifier Source: org_study_id
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