Clinical trial NCT02118584: Study for Participants With Ulcerative Colitis Previously Enrolled in Etrolizumab Phase II/III Studies
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
Overall status: TERMINATED
Phase: PHASE3
Conditions: Ulcerative Colitis
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2014-04-21
Enrollment: 1822
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Part 1: Percentage of Participants With Clinical Remission as Determined by the Partial Mayo Clinic Score (pMCS)
timeFrame: Baseline, Weeks 4, 8, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312 and 324 weeks
measure: Part 1: Percentage of Participants With Remission as Determined by the Mayo Clinic Score (MCS)
timeFrame: At OLE Week 108
measure: Part 1: Percentage of Participants With Endoscopic Remission
timeFrame: At OLE Week 108
measure: Part 1: Number of Participants With Adverse Events (AEs) and Severity of AEs Assessed Using National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 [NCI CTCAE v4.0]
timeFrame: From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years)
measure: Part 1: Number of Participants With Serious Adverse Events (SAEs)
timeFrame: From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years)
measure: Part 1: Number of Participants With Infection Related AEs and Severity of Infection-Related AEs Assessed Using NCI CTCAE v4.0
timeFrame: From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years)
measure: Part 1: Number of Participants With Serious Infection Related AES
timeFrame: From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years)
measure: Part 1: Number of Participants With Injection Site Reactions and Severity of Injection Site Reactions Assessed Using NCI CTCAE v4.0
timeFrame: From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years)
measure: Part 1: Number of Participants With AEs Leading to Etrolizumab Discontinuation
timeFrame: From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years)
measure: Part 1: Number of Participants With Malignancies
timeFrame: From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years)
measure: Part 1: Number of Participants With Hypersensitivity Reactions and Severity of Hypersensitivity Assessed Using NCI-CTCAE v4.0
timeFrame: From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years)
measure: Part 2: Number of Participants With Confirmed Progressive Multifocal Leukoencephalopathy (PML) During the Post-Treatment PML Monitoring Period
timeFrame: From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama Medical Center
state: Alabama
city: La Jolla
country: United States
facility: University of California San Diego Medical Center
state: California
city: Orange
country: United States
facility: University of California, Irvine Medical Center
state: California
city: San Diego
country: United States
facility: SDG Clinical Research
state: California
city: San Francisco
country: United States
facility: University of California at San Francisco
state: California
city: Ventura
country: United States
facility: Ventura Clinical Trials
state: California
city: Colorado Springs
country: United States
facility: Peak Gastroenterology Associates
state: Colorado
city: Lafayette
country: United States
facility: Clinical Research of the Rockies
state: Colorado
city: Wheat Ridge
country: United States
facility: Rocky Mountain Gastroenterology Associates
state: Colorado
city: Aventura
country: United States
facility: Innovative Medical Research of South Florida, Inc.
state: Florida
city: Clearwater
country: United States
facility: West Central Gastroenterology d/b/a Gastro Florida
state: Florida
city: Miami Beach
country: United States
facility: IMIC, Inc
state: Florida
city: Miami
country: United States
facility: Regenerate Clinical Trials
state: Florida
city: Miramar
country: United States
facility: FQL Research, LLC
state: Florida
city: Naples
country: United States
facility: Gastroenterology Group of Naples
state: Florida
city: New Port Richey
country: United States
facility: Advanced Research Institute, Inc.
state: Florida
city: Orlando
country: United States
facility: Internal Medicine Specialists
state: Florida
city: Winter Park
country: United States
facility: Shafran Gastroenterology Center
state: Florida
city: Atlanta
country: United States
facility: Atlanta Gastroenterology Associates
state: Georgia
city: Macon
country: United States
facility: Gastroenterology Associates of Central Georgia
state: Georgia
city: Marietta
country: United States
facility: Gastrointestinal Specialists of Georgia, PC
state: Georgia
city: Suwanee
country: United States
facility: Atlanta Gastroenterology Specialists, PC
state: Georgia
city: Chicago
country: United States
facility: Northwestern University Feinberg School Of Medicine
state: Illinois
city: Chicago
country: United States
facility: University of Chicago Medical Center; Medicine, Section of Pulmonary
state: Illinois
city: Oak Lawn
country: United States
facility: Southwest Gastroenterology
state: Illinois
city: New Albany
country: United States
facility: Aquiant Research
state: Indiana
city: Topeka
country: United States
facility: Cotton-O'Neil Clinical Research Center, Digestive Health
state: Kansas
city: Baton Rouge
country: United States
facility: Gastroenterology Associates, LLC
state: Louisiana
city: Shreveport
country: United States
facility: Louisiana Research Center, LLC
state: Louisiana
city: Boston
country: United States
facility: Massachusetts General Hospital; Crohn's & Colitis Center
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Detroit
country: United States
facility: Henry Ford Health System
state: Michigan
city: Troy
country: United States
facility: Center for Digestive Health
state: Michigan
city: Ypsilanti
country: United States
facility: Huron Gastroenterology Associates
state: Michigan
city: Minneapolis
country: United States
facility: Regents of the University of Minnesota
state: Minnesota
city: Jackson
country: United States
facility: University of Mississippi Medical Center
state: Mississippi
city: Belton
country: United States
facility: Ehrhardt Clinical Research, LLC
state: Missouri
city: Kansas City
country: United States
facility: Kansas City Research Institute, LLC
state: Missouri
city: Great Neck
country: United States
facility: Clinica Peruano Americana S.A.
state: New York
city: New York
country: United States
facility: NYU Langone Medical Center
state: New York
city: New York
country: United States
facility: Weill Cornell Medical College (WCMC) - Judith Jaffe Multiple Sclerosis Center (JJMSC)
state: New York
city: Asheville
country: United States
facility: Asheville Gastroenterology Associates, P.A.
state: North Carolina
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill
state: North Carolina
city: Kinston
country: United States
facility: Kinston Medical Specialists
state: North Carolina
city: Cincinnati
country: United States
facility: Consultants for Clin. Rsrch
state: Ohio
city: Cincinnati
country: United States
facility: UC Health Clinical Trials Office; Division of Digestive Diseases
state: Ohio
city: Mentor
country: United States
facility: Great Lakes Gastroenterology Research, LLC
state: Ohio
city: Memphis
country: United States
facility: Gastroenterology Center of the Midsouth, P.C.
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Dallas
country: United States
facility: Texas Digestive Disease Consultants - Dallas
state: Texas
city: San Antonio
country: United States
facility: Wellness Clinical Research Center
state: Texas
city: Southlake
country: United States
facility: Texas Digestive Disease Consultants - Southlake
state: Texas
city: Tyler
country: United States
facility: Tyler Research Institute, LLC
state: Texas
city: Clinton
country: United States
facility: Ericksen Research and Development
state: Utah
city: Salt Lake City
country: United States
facility: University of Utah School of Medicine
state: Utah
city: Richmond
country: United States
facility: McGuire Research Institute; Gastroenterology
state: Virginia
city: Bellevue
country: United States
facility: Washington Gastroenterology
state: Washington
city: Cordoba
country: Argentina
facility: Instituto Medico DAMIC
city: Rosario
country: Argentina
facility: Hospital Provincial del Centenario
city: Bankstown
country: Australia
facility: Bankstown-Lidcombe Hospital
state: New South Wales
city: Concord
country: Australia
facility: Concord Repatriation General Hospital
state: New South Wales
city: Herston
country: Australia
facility: Royal Brisbane and Women's Hospital
state: Queensland
city: Mackay
country: Australia
facility: Mater Adult Hospital
state: Queensland
city: Woolloongabba
country: Australia
facility: Princess Alexandra Hospital
state: Queensland
city: Adelaide
country: Australia
facility: Royal Adelaide Hospital
state: South Australia
city: Bedford Park
country: Australia
facility: Flinders Medical Centre
state: South Australia
city: Launceston
country: Australia
facility: Launceston General Hospital; Gastroenterology Research
state: Tasmania
city: Clayton
country: Australia
facility: Monash Medical Centre
state: Victoria
city: Fitzroy
country: Australia
facility: St Vincent's Hospital Melbourne
state: Victoria
city: Footscray
country: Australia
facility: Footscray Hospital
state: Victoria
city: Malvern
country: Australia
facility: St Frances Xavier Cabrini Hospital
state: Victoria
city: Parkville
country: Australia
facility: Royal Melbourne Hospital; Department of Colorectal Medicine and Genetics
state: Victoria
city: Murdoch
country: Australia
facility: Fiona Stanley Hospital
state: Western Australia
city: Salzburg
country: Austria
facility: LKH - Universitätsklinikum der PMU Salzburg
city: Wien
country: Austria
facility: Medizinische Universität Wien
city: Antwerpen
country: Belgium
facility: GZA Ziekenhuizen - Campus Sint-Vincentius
city: Bonheiden
country: Belgium
facility: Imeldaziekenhuis
city: Brussels
country: Belgium
facility: CHU St Pierre (St Pierre)
city: Brussel
country: Belgium
facility: UZ Brussel
city: Bruxelles
country: Belgium
facility: Cliniques Universitaires Saint-Luc; Pharmacy
city: Gent
country: Belgium
facility: UZ Gent
city: Herentals
country: Belgium
facility: AZ Sint Elisabeth Herentals
city: Leuven
country: Belgium
facility: UZ Leuven; Neurology
city: Roeselare
country: Belgium
facility: AZ Delta (Campus Rumbeke)
city: Salvador
country: Brazil
facility: Hospital Universitario Prof Edgar Santos-Ufba; Ambulatorio Magalhaes Neto 3Andar- Dermatologia
state: BA
city: Fortaleza
country: Brazil
facility: Hospital Universitario Walter Cantidio - UFC
state: CE
city: Brasilia
country: Brazil
facility: CCBR - Brasilia
state: DF
city: Goiânia
country: Brazil
facility: Instituto Goiano de Gastroenterologia e Endoscopia Digestiva Ltda
state: GO
city: Belo Horizonte
country: Brazil
facility: Hospital Felicio Rocho
state: MG
city: Curitiba
country: Brazil
facility: Centro Digestivo de Curitiba
state: PR
city: Rio de Janeiro
country: Brazil
facility: Hospital Universitario Clementino Fraga Filho - UFRJ
state: RJ
city: Porto Alegre
country: Brazil
facility: Hospital Moinhos de Vento
state: RS
city: Porto Alegre
country: Brazil
facility: Hospital das Clinicas - UFRGS
state: RS
city: Porto Alegre
country: Brazil
facility: Hospital Ernesto Dornelles
state: RS
city: Botucatu
country: Brazil
facility: UNESP - Faculdade de Medicina da Universidade Estadual Paulista - Campus Botucatu
state: SP
city: Campinas
country: Brazil
facility: CAEP - Centro Avancado de Estudos e Pesquisas Ltda.
state: SP
city: Jaú
country: Brazil
facility: CECIP - Centro de Estudos Clínicos do Interior Paulista
state: SP
city: Santo Andre
country: Brazil
facility: Pesquisare Saúde Sociedade Simples
state: SP
city: Sao Bernardo Do Campo
country: Brazil
facility: Hospital Estadual Mario Covas
state: SP
city: Sao Paulo
country: Brazil
facility: Hospital Sírio-Libanês
state: SP
city: São Paulo
country: Brazil
facility: Hospital do Servidor Público Estadual/HSPE-SP
state: SP
city: Dupnitsa
country: Bulgaria
facility: Medical Centre "Asklepii", OOD
city: Pleven
country: Bulgaria
facility: DCC Sv. Pantaleymon OOD; II-nd Clinic of Neurology
city: Pleven
country: Bulgaria
facility: Medical center Medconsult Pleven OOD
city: Ruse
country: Bulgaria
facility: MHAT - Ruse, AD
city: Sliven
country: Bulgaria
facility: MHAT "Hadzhi Dimitar", OOD
city: Sofia
country: Bulgaria
facility: "City Clinic UMHAC" EOOD
city: Sofia
country: Bulgaria
facility: UMHAT "Sv. Ivan Rilski", EAD
city: Sofia
country: Bulgaria
facility: UMHAT Tsaritsa Yoanna - ISUL, EAD
city: Sofia
country: Bulgaria
facility: Diagnostic Consultation Center CONVEX EOOD
city: Stara Zagora
country: Bulgaria
facility: Medical Center "Nov Rehabilitatsionen Tsentar", EOOD
city: Varna
country: Bulgaria
facility: MHAT 'Sv. Marina', EAD; First Children's Clinic
city: Veliko Tarnovo
country: Bulgaria
facility: MC Medica Plus
city: Calgary
country: Canada
facility: University of Calgary
state: Alberta
city: Edmonton
country: Canada
facility: Zeidler Ledcor Centre - University of Alberta; Division of Gasroenterology
state: Alberta
city: Vancouver
country: Canada
facility: Pacific Gastroenterology Associates
state: British Columbia
city: Halifax
country: Canada
facility: Queen Elizabeth II Health Sciences Centre; Gastroenterology Research
state: Nova Scotia
city: Guelph
country: Canada
facility: Guelph GI & Surgery Clinic
state: Ontario
city: London
country: Canada
facility: University Hospital - London Health Sciences Centre
state: Ontario
city: Oshawa
country: Canada
facility: Taunton Health Centre
state: Ontario
city: Toronto
country: Canada
facility: Mount Sinai Hospital
state: Ontario
city: Toronto
country: Canada
facility: Toronto Liver Centre
state: Ontario
city: Vaughan
country: Canada
facility: Toronto Digestive Disease Associates
state: Ontario
city: Greenfield Park
country: Canada
facility: Centre de santé et de services sociaux Champlain-Charles-Le Moyne
state: Quebec
city: Levis
country: Canada
facility: Hotel Dieu de Levis
state: Quebec
city: Montreal
country: Canada
facility: Hôpital Maisonneuve - Rosemont
state: Quebec
city: Saskatoon
country: Canada
facility: Royal University Hospital
state: Saskatchewan
city: Cali
country: Colombia
facility: RTS - Fundación Valle de Lili
city: Medellin
country: Colombia
facility: Instituto de Coloproctologia ICO S.A.S.
city: Osijek
country: Croatia
facility: Clinical Hospital Centre Osijek
city: Zagreb
country: Croatia
facility: Clinical Hospital Sveti Duh; Department of Neurology
city: Brno
country: Czechia
facility: Vojenska nemocnice Brno
city: Brno
country: Czechia
facility: Fakultni nemocnice u sv. Anny v Brne; I.Interni kardioangiologicka klinika
city: Hradec Kralove
country: Czechia
facility: Fakultni nemocnice Hradec Kralove
city: Hradec Kralove
country: Czechia
facility: Hepato-Gastroenterologie HK, s.r.o.
city: Kladno
country: Czechia
facility: Oblastni nemocnice Kladno, a.s., nemocnice Stredoces. kraje; Endoskopicke centrum
city: Olomouc
country: Czechia
facility: PreventaMed, s.r.o.
city: Ostrava
country: Czechia
facility: Mestska Nemocnice Ostrava
city: Pardubice
country: Czechia
facility: Pardubicka krajska nemocnice a.s.
city: Prague
country: Czechia
facility: Nemocnice Na Bulovce
city: Praha 7
country: Czechia
facility: ISCARE a.s.
city: Usti Nad Labem
country: Czechia
facility: Krajska zdravotni, a.s. ? Masarykova nemocnice v Usti nad Labem, o.z., Ocni oddeleni
city: Zlin
country: Czechia
facility: Krajska nemocnice T. Bati, a.s.
city: Hellerup
country: Denmark
facility: Herlev og Gentofte Hospital
city: København Ø
country: Denmark
facility: Rigshospitalet; Afdeling for Tarmsvigt og Leversygdomme
city: Ålborg
country: Denmark
facility: Ålborg Universitets Hospital; Gastromedicinsk
city: Tallinn
country: Estonia
facility: OÜ Innomedica
city: Tallinn
country: Estonia
facility: East Tallinn Central Hospital
city: Tallinn
country: Estonia
facility: West Tallinn Central Hospital
city: Tallinn
country: Estonia
facility: North Estonia Medical Centre Foundation
city: Tartu
country: Estonia
facility: Tartu University Hospital
city: Amiens
country: France
facility: CHU Amiens - Hopital Sud
city: Caen
country: France
facility: CHU de Caen Hopital Cote de Nacre
city: Chambray les Tours
country: France
facility: CHU Tours - Hôpital Trousseau
city: Clichy cedex
country: France
facility: Hôpital Beaujon
city: Lille
country: France
facility: Hopital Claude Huriez - CHU Lille
city: Montpellier
country: France
facility: CHU Hopital Saint Eloi
city: Nice
country: France
facility: CHU Nice - Hopital de l'Archet 2
city: Paris
country: France
facility: Hôpital Saint-Louis
city: Pessac
country: France
facility: CHU Bordeaux - Hôpital Haut-Lévêque
city: Pierre-Benite
country: France
facility: Centre Hospitalier Lyon Sud; Service de Gastro-Enterologie
city: Saint Etienne
country: France
facility: CHU Saint Etienne - Hôpital Nord
city: Strasbourg
country: France
facility: Höpital Hautepierre; Pediatrie1
city: Toulouse Cedex 09
country: France
facility: CHU de Toulouse - Hôpital Rangueil
city: Vandoeuvre-les-nancy
country: France
facility: Hôpital de Brabois Adultes
city: Berlin
country: Germany
facility: Charite Universitaetsmedizin Berlin - Campus Charite Mitte
city: Berlin
country: Germany
facility: Charite Universitaetsmedizin Berlin - Campus Benjamin Franklin
city: Berlin
country: Germany
facility: DRK Kliniken Berlin Westend
city: Berlin
country: Germany
facility: Krankenhaus Waldfriede e. V.
city: Bochum
country: Germany
facility: Berufsgenossenschaftliches Universitaetsklinikum Bergmannsheil GmbH
city: Erlangen
country: Germany
facility: Universitaetsklinikum Erlangen
city: Frankfurt
country: Germany
facility: Klinikum der Johann Wolfgang Goethe-Universitaet
city: Freiburg
country: Germany
facility: Universitaetsklinikum Freiburg; Urology
city: Halle
country: Germany
facility: Universitaetsklinikum Halle (Saale)
city: Hamburg
country: Germany
facility: Hamburgisches Forschungsinstitut fuer CED
city: Hamburg
country: Germany
facility: Universitätsklinikum Hamburg-Eppendorf
city: Hamburg
country: Germany
facility: Gastroenterologie Eppendorfer Baum
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover; Klinik für Gastroenterologie, Hepatologie und Endokrinologie
city: Jena
country: Germany
facility: Universitaetsklinikum Jena; Apotheke des Uniersitätsklinikums Jena
city: Kiel
country: Germany
facility: Universitaetsklinikum Schleswig-Holstein, Campus Kiel
city: Lueneburg
country: Germany
facility: Medizinisches Zentrum Klinikum Lueneburg
city: Mannheim
country: Germany
facility: Klinikum Mannheim GmbH Universitätsklinikum
city: Muenster
country: Germany
facility: Universitaetsklinikum Muenster
city: Schweinfurt
country: Germany
facility: Gemeinschaftspraxis Dres. Joachim Mueller und Steffi Appelt
city: Ulm
country: Germany
facility: Universitaetsklinikum Ulm
city: Heraklio
country: Greece
facility: University General Hospital of Heraklion
city: Hong Kong
country: Hong Kong
facility: University of Hong Kong
city: Balatonfured
country: Hungary
facility: DRC Gyogyszervizsgalo Kozpont Kft
city: Bekescsaba
country: Hungary
facility: Bekes Megyei Kozponti Korhaz Dr. Rethy Pal Tagkorhaza
city: Budapest
country: Hungary
facility: Semmelweis Egyetem; Belgyogyaszati es Hematologiai Klinika
city: Budapest
country: Hungary
facility: Eszak-Kozep-budai Centrum, Uj Szent Janos Korhaz es Szakrendelo
city: Budapest
country: Hungary
facility: Pannónia Klinika Magánorvosi
city: Budapest
country: Hungary
facility: Magyar Honvedseg Egeszsegugyi Kozpont; Fázis I-es Klinikai Farmakológiai Vizsgálóhely
city: Budapest
country: Hungary
facility: Endomedix Diagnosztikai Kozpont
city: Debrecen
country: Hungary
facility: Vasutegeszsegugyi Kft. - Debreceni Egeszsegugyi Kozpont
city: Debrecen
country: Hungary
facility: Debreceni Egyetem Klinikai Kozpont
city: Eger
country: Hungary
facility: Markhot Ferenc Oktato Korhaz es Rendelointezet
city: Gyor
country: Hungary
facility: Petz Aladar Megyei Oktato Korhaz
city: Kistarcsa
country: Hungary
facility: Pest Megyei Flor Ferenc Korhaz
city: Miskolc
country: Hungary
facility: Borsod-Abauj-Zemplen Megyei Korhaz es Egyetemi Oktato Korhaz
city: Pecs
country: Hungary
facility: Pecsi Tudomanyegyetem
city: Szentes
country: Hungary
facility: Csongrad Megyei Dr. Bugyi Istvan Korhaz
city: Székesfehérvár
country: Hungary
facility: Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz
city: Hyderabad
country: India
facility: Deccan College of Medical Sciences and Allied Hospitals; Department of Gastroenterology
state: Andhra Pradesh
city: Surat
country: India
facility: Nirmal Hospital
state: Gujarat
city: Belgaum
country: India
facility: K.L.E. Society's Dr. Prabhakar Kore Hospital and Medical Research Centre
state: Karnataka
city: Bengaluru
country: India
facility: M. S. Ramaiah Medical College and Hospital
state: Karnataka
city: Manglore
country: India
facility: Kasturba Medical College & Hospital
state: Karnataka
city: Nagpur
country: India
facility: Midas institute of Gastroenterology
state: Maharashtra
city: Pune
country: India
facility: Ruby Hall Clinic
state: Maharashtra
city: Ludhiana
country: India
facility: Dayanand Medical College and Hospital
state: Punjab
city: Jaipur
country: India
facility: S. R. Kalla Memorial Gastro & General Hospital
state: Rajasthan
city: Pune
country: India
facility: King Edward Memorial Hospital Research Centre
city: Haifa
country: Israel
facility: Bnai Zion Medical Center; Internal Medicine
city: Jerusalem
country: Israel
facility: Shaare Zedek Medical Center
city: Jerusalem
country: Israel
facility: Hadassah University Hospital - Ein Kerem
city: Nazareth
country: Israel
facility: Holy Family Hospital
city: Petach Tiqwa
country: Israel
facility: Rabin Medical Center Beilinson Campus; Gaucher Clinic Genetics Institute
city: Rehovot
country: Israel
facility: Kaplan Medical Center
city: Rishon Lezion
country: Israel
facility: Assaf Harofeh
city: Tel Hashomer
country: Israel
facility: Chaim Sheba Medical Center; Pediatrics B North and Pediatric Endocrinology Unit
city: Bologna
country: Italy
facility: Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpigh
state: Emilia-Romagna
city: Modena
country: Italy
facility: A.O.U. Policlinico di Modena
state: Emilia-Romagna
city: Parma
country: Italy
facility: Azienda Ospedaliero Universitaria di Parma
state: Emilia-Romagna
city: Roma
country: Italy
facility: Azienda Ospedaliera Universitaria Policlinico Tor Vergata
state: Lazio
city: Roma
country: Italy
facility: Ospedale Sandro Pertini
state: Lazio
city: Roma
country: Italy
facility: Azienda Ospedaliera San Camillo Forlanini
state: Lazio
city: Rome
country: Italy
facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
state: Lazio
city: Brescia
country: Italy
facility: Fondazione Poliambulanza Istituto Ospedaliero
state: Lombardia
city: Milano
country: Italy
facility: Azienda Ospedaliera Fatebenefratelli e Oftalmico
state: Lombardia
city: Milano
country: Italy
facility: Azienda Socio Sanitaria Territoriale Niguarda (Grande Ospedale Metropolitano Niguarda)
state: Lombardia
city: Milano
country: Italy
facility: Azienda Socio Sanitaria Territoriale Fatebenefratelli (Presidio Ospedale Sacco)
state: Lombardia
city: Rho
country: Italy
facility: Ospedale di Circolo; Neuropsichiatria Infantile
state: Lombardia
city: Rozzano (MI)
country: Italy
facility: Istituto Clinico Humanitas
state: Lombardia
city: San Donato Milanese (MI)
country: Italy
facility: I.R.C.C.S Policlinico San Donato
state: Lombardia
city: San Giovanni Rotondo
country: Italy
facility: IRCCS Ospedale Casa Sollievo della Soffenza; Stru Comp di Gastroenterologia ed Endoscopia digest
state: Lombardia
city: Torino
country: Italy
facility: Ospedale Mauriziano Umberto I
state: Piemonte
city: Palermo
country: Italy
facility: Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone
state: Sicilia
city: Florence
country: Italy
facility: Azienda Ospedaliera Universitaria Careggi
state: Toscana
city: Padova
country: Italy
facility: Azienda Ospedaliera di Padova
state: Veneto
city: Busan
country: Korea, Republic of
facility: Dong-A University Hospital
city: Busan
country: Korea, Republic of
facility: Pusan National University Hospital
city: Daegu
country: Korea, Republic of
facility: Kyungpook National University Medical Center
city: Daegu
country: Korea, Republic of
facility: Keimyung University Dongsan Medical Center
city: Daegu
country: Korea, Republic of
facility: Kyungpook National University Hospital
city: Daegu
country: Korea, Republic of
facility: Yeungnam Univ. Hospital
city: Gyeonggi-do
country: Korea, Republic of
facility: Korea University Ansan Hospital
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
city: Seongnam
country: Korea, Republic of
facility: CHA Bundang Medical Centre; CHA university
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Kangbuk Samsung Hospital
city: Seoul
country: Korea, Republic of
facility: Severance Hospital, Yonsei University Health System
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center.
city: Suwon City
country: Korea, Republic of
facility: Ajou University Hospital
city: Suwon
country: Korea, Republic of
facility: The Catholic University of Korea St. Vincent's Hospital
city: Wonju-si
country: Korea, Republic of
facility: Yonsei University Wonju Severance Christian Hospital
city: Daugavpils
country: Latvia
facility: Central Outpatient Clinic
city: R?ga
country: Latvia
facility: Pauls Stradins Clinical University Hospital
city: R?ga
country: Latvia
facility: Digestive Diseases Center "Gastro"
city: Kaunas
country: Lithuania
facility: Hospital of Lithuanian University of Health. Sciences Kaunas Clinics
city: Klaipeda
country: Lithuania
facility: Klaipeda Seamen's Hospital, Public Institution
city: Vilnius
country: Lithuania
facility: Vilnius University Hospital Santariskiu Clinic, Public Institution; Cardiology
city: Kuala Lumpur
country: Malaysia
facility: Pusat Perubatan Universiti Kebangsaan Malaysia
state: FED. Territory OF Kuala Lumpur
city: Kuala Lumpur
country: Malaysia
facility: University Malaya Medical Center
state: FED. Territory OF Kuala Lumpur
city: Kuantan
country: Malaysia
facility: Hospital Tengku Ampuan Afzan
state: Pahang
city: Kota Bahru
country: Malaysia
facility: Hospital Raja Perempuan Zainab II; Department of Medicine
city: Guadalajara
country: Mexico
facility: Centro Integral en Reumatología S.A. de C.V. (CIRSA)
state: Jalisco
city: Monterrey
country: Mexico
facility: Accelerium S. de R.L. de C.V.
state: Nuevo LEON
city: Monterrey
country: Mexico
facility: Hospital Universitario Dr Jose Eleuterio Gonzalez; Universidad Autónoma de Nuevo León
state: Nuevo LEON
city: Monterrey
country: Mexico
facility: Centro Regiomontano de Estudios Clínicos Roma S.C.
state: Nuevo LEON
city: Cuautitlán Izcalli
country: Mexico
facility: Phylasis Clinicas Research S de RL de CV
city: Amsterdam
country: Netherlands
facility: Amsterdam UMC Location VUMC
city: Amsterdam
country: Netherlands
facility: Amsterdam UMC Location AMC
city: NL -nijmegen
country: Netherlands
facility: Radboudumc
city: Auckland
country: New Zealand
facility: North Shore Hospital
city: Auckland
country: New Zealand
facility: Middlemore Hospital
city: Dunedin
country: New Zealand
facility: Dunedin Hospital
city: Hamilton
country: New Zealand
facility: Waikato Hospital
city: Takapuna
country: New Zealand
facility: Shakespeare Specialist Group
city: Tauranga
country: New Zealand
facility: Tauranga Hospital
city: Lørenskog
country: Norway
facility: Akershus universitetssykehus HF
city: ?ód?
country: Poland
facility: AppleTreeClinics Sp. z o.o.
city: Bydgoszcz
country: Poland
facility: Nasz Lekarz Osrodek Badan Klinicznych
city: Chojnice
country: Poland
facility: Centrum Medyczne Lukamed Joanna Luka
city: Cz?stochowa
country: Poland
facility: Centrum Medyczne Sw. Lukasza
city: Gdansk
country: Poland
facility: 7 Szpital Marynarki Wojennej z Przychodnia SPZOZ im. W. Lasinskiego
city: Katowice
country: Poland
facility: Pro Familia Altera Sp z o.o.
city: Katowice
country: Poland
facility: Nzoz All-Medicus
city: Katowice
country: Poland
facility: Uniwersyteckie Centrum Kliniczne im. prof. K. Gibinskiego SUM
city: Krakow
country: Poland
facility: NZOZ Centrum Medyczne ProMiMed
city: Ksawerow
country: Poland
facility: Centrum Opieki Zdrowotnej Orkan-Med
city: Lublin
country: Poland
facility: Indywidualna Specjalistyczna Praktyka Lekarska
city: Lublin
country: Poland
facility: GASTROMED Sp. z o.o.
city: Nowy Targ
country: Poland
facility: Allmedica Badania Kliniczne Sp z o.o. Sp K.
city: Olsztyn
country: Poland
facility: Wojewodzki Specjalistyczny Szpital w Olsztynie
city: Pozna?
country: Poland
facility: SOLUMED Centrum Medyczne
city: Rzeszow
country: Poland
facility: Centrum Medyczne Medyk
city: Rzeszów
country: Poland
facility: Gabinet Lekarski, Bartosz Korczowski
city: Sopot
country: Poland
facility: Specjalistyczna Praktyka Lekarska Dr med. Marek Horynski; endoskopia
city: Szczecin
country: Poland
facility: Niepubliczny Zaklad Opieki Zdrowotnej SONOMED
city: Szczecin
country: Poland
facility: Twoja Przychodnia-Szczecinskie Centrum Medyczne
city: Warszawa
country: Poland
facility: Centrum Zdrowia MDM
city: Warszawa
country: Poland
facility: Zespó Przychodni Specjalistycznych PRIMA
city: Warszawa
country: Poland
facility: Endoterapia PFG Sp. z o.o.
city: Warszawa
country: Poland
facility: Narodowy Instytut Onkologii im. Marii Sk?odowskiej-Curie - Pa?stwowy Instytut Badawczy
city: Warszawa
country: Poland
facility: Nzoz Vivamed
city: Wroc?aw
country: Poland
facility: Przychodnia EuroMediCare
city: Wroc?aw
country: Poland
facility: PlanetMed
city: Wroclaw
country: Poland
facility: LexMedica Osrodek Badan Klinicznych
city: Braga
country: Portugal
facility: Hospital de Braga
city: Guimarães
country: Portugal
facility: Hospital da Senhora da Oliveira Guimarães
city: Bucharest
country: Romania
facility: Spitalul Clinic Colentina
city: Bucuresti
country: Romania
facility: S.C MedLife S.A
city: Bucuresti
country: Romania
facility: Centrul Medical Unirea SRL
city: Timisoara
country: Romania
facility: Centrul de Gastroenterologie Dr. Goldis
city: Moskva
country: Russian Federation
facility: Yusupov Hospital
state: Adygeja
city: Barnaul
country: Russian Federation
facility: SBEI HPE Altai StateMedicalUniversityofMoH andSD
state: Altaj
city: St.Petersburg
country: Russian Federation
facility: Baltic Medicine
state: Leningrad
city: Moscow
country: Russian Federation
facility: FSBIH Central Clinical Hospital of RAS
state: Moskovskaja Oblast
city: Moscow
country: Russian Federation
facility: FSBI ?State Scientific Centre of Coloproctology" of the MoH of RF; Gastroenterology
state: Moskovskaja Oblast
city: Nizhny Novgorod
country: Russian Federation
facility: SBHI of NN region ?RCH of NN n.a. N.A.Semashko?
state: Niznij Novgorod
city: Rostov-on-Don
country: Russian Federation
facility: SEIHPE "Rostov SMU of MoH of RF"
state: Rostov
city: Sankt-peterburg
country: Russian Federation
facility: FFSBI "The Nikiforov Russian Center of Emergency and Radiation Medicine"; Pulmonology
state: Sankt Petersburg
city: Sankt-peterburg
country: Russian Federation
facility: SPb SBIH "City Multy-field Hospital # 2"; Intensive Pulmonology and Thoracal Surgery
state: Sankt Petersburg
city: Sankt-peterburg
country: Russian Federation
facility: SBIH City Clinical Hospital #31
state: Sankt Petersburg
city: St Petersburg
country: Russian Federation
facility: City Hospital #26
state: Sankt Petersburg
city: St-petersburg
country: Russian Federation
facility: LLC International Medical Centre ?SOGAZ?
state: Sankt Petersburg
city: St. Petersburg
country: Russian Federation
facility: FSBMEI HPE "Military Medical Academy n.a. S.M. Kirov" of the MoD of the RF; Therapy
state: Sankt Petersburg
city: St. Petersburg
country: Russian Federation
facility: Pavlov First Saint Petersburg State Medical University
state: Sankt Petersburg
city: St. Petersburg
country: Russian Federation
facility: SPb SHI "City Hospital #9"
state: Sankt Petersburg
city: Cherepovets
country: Russian Federation
facility: Medical and Sanitary Division of Severstal
state: Vologda
city: Voronezh
country: Russian Federation
facility: SBEI HPE "Voronezh State Medical University n.a. N.N. Burdenko" of the MoH of the RF
state: Voronez
city: Irkutsk
country: Russian Federation
facility: Irkutsk State Medical Academy of Continuing Education
city: Novosibirsk
country: Russian Federation
facility: FSBI "Scientific Research Institute of Physyology and Basic Medicine" under the SB of RAMS
city: Omsk
country: Russian Federation
facility: BHI of Omsk region Clinical Oncology Dispensary
city: Omsk
country: Russian Federation
facility: SBEI of HPE "Omsk SMA" Ministry of healthcare of RF"
city: Stavropol
country: Russian Federation
facility: Stavropol Regional Clinical Diagnostic Consultative Center
city: Stavropol
country: Russian Federation
facility: FSBEI HE "Stavropol State Medical University" of Ministry of Healthcare of Russian Federation
city: Belgrade
country: Serbia
facility: Clinical Center Zvezdara
city: Belgrade
country: Serbia
facility: Military Medical Academy
city: Belgrade
country: Serbia
facility: Clinical Center Zemun
city: Kragujevac
country: Serbia
facility: Clinical Center Kragujevac
city: Zrenjanin
country: Serbia
facility: General Hospital Djordje Joanovic
city: Singapore
country: Singapore
facility: Singapore General Hospital
city: Banska Bystrica
country: Slovakia
facility: Fakultna nemocnica s poliklinikou F.D. Roosevelta
city: Humenné
country: Slovakia
facility: Nemocnica A.Lena Humenne, n.o.
city: Košice
country: Slovakia
facility: Endomed, s.r.o.
city: Nitra
country: Slovakia
facility: KM Management spol. s r.o.
city: Prešov
country: Slovakia
facility: Gastro I, s.r.o.
city: Rimavská Sobota
country: Slovakia
facility: Svet zdravia a.s.
city: Šahy
country: Slovakia
facility: Accout Center s.r.o.
city: Bloemfontein
country: South Africa
facility: Netcare Universitas Private Hospital
city: Cape Town
country: South Africa
facility: Dr MJ Prins Practice
city: Cape Town
country: South Africa
facility: Dr JP Wright Practice
city: Pretoria
country: South Africa
facility: Emmed Research
city: Sabadell
country: Spain
facility: Corporacio Sanitaria Parc Tauli
state: Barcelona
city: Alcorcon
country: Spain
facility: Fundacion Hospital de Alcorcon; Servicio de Digestivo
state: Madrid
city: Barcelona
country: Spain
facility: Centro Médico Teknon
city: Girona
country: Spain
facility: Hospital Universitari de Girona Dr Josep Trueta
city: Madrid
country: Spain
facility: Hospital Universitario de la Princesa
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
city: Madrid
country: Spain
facility: Hospital Universitario de Fuenlabrada
city: Valencia
country: Spain
facility: Hospital Universitari i Politecnic La Fe
city: Zaragoza
country: Spain
facility: Hospital Universitario Miguel Servet
city: Bern
country: Switzerland
facility: Inselspital-Universitaetsspital Bern
city: Bern
country: Switzerland
facility: Crohn-Colitis Zentrum Bern - Gemeinschaftspraxis Balsiger, Seibold und Partner
city: Ankara
country: Turkey
facility: Gazi University Medical Faculty; Gastroenterology
city: Istanbul
country: Turkey
facility: Haydarpasa Numune Training and Research Hospital; Medical Oncology
city: Kocaeli
country: Turkey
facility: Kocaeli Universitesi Tip Fakultesi; Infectious Diseases
city: Kharkiv
country: Ukraine
facility: CNE Prof. O.O. Shalimov Kharkiv City Clinical Hospital #2 of KCC
state: Kharkiv Governorate
city: Kharkiv
country: Ukraine
facility: Communal Non-commercial Enterprise of Kharkiv Regional Council Regional Clinical Hospital
state: Kharkiv Governorate
city: Kyiv
country: Ukraine
facility: Communal Institution of Kyiv Regional Council Kyiv Regional Clinical Hospital
state: Kharkiv Governorate
city: Sumy
country: Ukraine
facility: CI of SRC Sumy RCH Dept of Gasroenterology Sumy SU MI
state: Kharkiv Governorate
city: Zaporizhzhia
country: Ukraine
facility: LLC Gastroenterology Center IBD Team
state: Kharkiv Governorate
city: Kyiv
country: Ukraine
facility: CNE Kyiv CCH #18
state: KIEV Governorate
city: Kyiv
country: Ukraine
facility: CI of Kyiv RC Kyiv Regional Clinical Hospital
state: KIEV Governorate
city: Kyiv
country: Ukraine
facility: Medical Center of Limited Liability Company Medical Clinic Blagomed
state: KIEV Governorate
city: Kyiv
country: Ukraine
facility: Med Center of International Institute of Clinical Trials LLC; Medical Center "OK!Clinic+"
state: KIEV Governorate
city: Kyiv
country: Ukraine
facility: CI of Kyiv RC Regional Clinical Hospital #2
state: KIEV Governorate
city: Lviv
country: Ukraine
facility: Lviv Regional Clinical Hospital
state: KIEV Governorate
city: Uzhgorod
country: Ukraine
facility: CI UDH Dept of Ther SHEI Fac of PGE&Pre-Univ Training
state: KIEV Governorate
city: Uzhgorod
country: Ukraine
facility: A.Novak Transcarpathian Regional Clinical Hospital
state: KIEV Governorate
city: Chernivtsi
country: Ukraine
facility: RCNECRCH Dept of Surgery, SHEI Ukr BSMU
state: Podolia Governorate
city: Zaporizhzhia
country: Ukraine
facility: CI City Hospital #1
state: Tavria Okruha
city: Chernivtsi
country: Ukraine
facility: RCI Chernivtsi RCH Gastroenterology Bukovinsky SMU
city: Dnipropetrovsk
country: Ukraine
facility: SI Dnipropetrovsk MA of MOHU SI Institute of gastroenterology of AMSU
city: Kharkiv
country: Ukraine
facility: GI L.T.Malaya Therapy National Institute of the NAMS of Ukraine
city: Kharkiv
country: Ukraine
facility: CI of Healthcare Kharkiv CCH #13
city: Kherson
country: Ukraine
facility: CI Kherson Afanasii and Olha Tropiny City Clinical Hospital
city: Kyiv
country: Ukraine
facility: CNI Consultative and Diagnostic Center of Desnianskyi District of Kyiv
city: Odessa
country: Ukraine
facility: Odessa regional clinical Hospital
city: Poltava
country: Ukraine
facility: M.V. Sklifosovskyi Poltava RCH Dept of Gastroenterology HSEIU UMSA
city: Poltava
country: Ukraine
facility: M.V. Sklifosovskyi Poltava RCH Outpatient UMSA HSEIU Ukrainian Medical Stomatological Academy
city: Vinnytsia
country: Ukraine
facility: Private Small Enterprise Medical Center Pulse
city: Vinnytsia
country: Ukraine
facility: M.I. Pyrogov VRCH Dept of Gastroenterology M.I. Pyrogov VNMU
city: Vinnytsia
country: Ukraine
facility: MCIC Health Clinic BO LTD TPC Slaomed
city: Zaporizhzhia
country: Ukraine
facility: Co Ltd. Diaservice
city: Zaporizhzhia
country: Ukraine
facility: CI City Hospital #7
city: Cambridge
country: United Kingdom
facility: Addenbrooke's Hospital
city: Coventry
country: United Kingdom
facility: University Hospital Coventry
city: Exeter
country: United Kingdom
facility: Royal Devon and Exeter Hospital (Wonford)
city: Leeds
country: United Kingdom
facility: St James University Hospital
city: London
country: United Kingdom
facility: The Royal London Hospital
city: London
country: United Kingdom
facility: University College London Hospital
city: London
country: United Kingdom
facility: St Thomas Hospital
city: London
country: United Kingdom
facility: King's College London
city: Manchester
country: United Kingdom
facility: Fairfield General Hospital
city: Newcastle upon Tyne
country: United Kingdom
facility: Royal Victoria Infirmary
city: Nottingham
country: United Kingdom
facility: Nottingham University Hospitals; QMC Campus
city: Southampton
country: United Kingdom
facility: Southampton General Hospital
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
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.