Clinical trial NCT02403323: Open-Label Extension and Safety Study for Participants With Crohn's Disease Previously Enrolled in the Etrolizumab Phase III Study GA29144
Official title: An Open-Label Extension and Safety Monitoring Study of Patients With Moderately to Severely Active Crohn's Disease Previously Enrolled in the Etrolizumab Phase III Protocol GA29144
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Crohn Disease
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2015-03-31
Enrollment: 790
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This open-label extension and safety monitoring study is composed of two parts: Part 1 will evaluate the long-term safety and efficacy of continued etrolizumab treatment in participants with moderately to severely active Crohn's disease who were previously enrolled in the etrolizumab Phase III Study GA29144 (NCT02394028) and who meet eligibility criteria for enrollment into Part 1. In Part 2, participants who have stopped etrolizumab treatment (either by exiting Part 1 of this study or by entering directly from Study GA29144 \[NCT02394028\]) will be monitored for 92 weeks for progressive multifocal leukoencephalopathy (PML) and other safety events.


Eligibility criteria: Inclusion Criteria:

Part 1 Open-Label Extension:

* Patients previously enrolled in etrolizumab Phase III study GA29144 (NCT02394028) who meet the eligibility criteria for open-label etrolizumab as described in the protocol

Part 2 Safety Monitoring:

* Patients who participated in etrolizumab Phase III study GA29144 (NCT02394028) and are not eligible or choose not to enter Part 1
* Patients who transfer from Part 1
* Completion of the 12-week safety follow-up period prior to entering

Exclusion Criteria:

Part 1 Open-Label Extension:

* Any new, significant, uncontrolled condition

Part 2 Safety Monitoring:

* No exclusion criteria

Primary outcomes:
measure: Part 1: Number of Participants With Crohn's Disease Activity Index (CDAI) Remission at 12-week Intervals
timeFrame: Day 1 and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240 and 252 of OLE
measure: Part 1: Number of Participants With Clinical Remission at 12-week Intervals
timeFrame: Day 1 and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240 and 252 of OLE
measure: Part 1: Number of Participants With Improvement in Simple Endoscopic Score for Crohn's Disease (SES-CD) Score at Week 108
timeFrame: At OLE Week 108
measure: Part 1: Number of Participants With Adverse Event (AE) and Severity of AEs as 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 6.3 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 6.3 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 6.3 years)
measure: Part 1: Incidence Rate of Infection-related Adverse Event
timeFrame: From Day 1 up to end of 12-week safety follow up in OLE (approximately 6.3 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 6.3 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 safety 12-week follow-up in OLE (approximately 6.3 years)
measure: Part 1: Number of Participants With Adverse Events Leading to Etrolizumab Discontinuation
timeFrame: From Day 1 up to end of 12-week safety follow up in OLE (approximately 6.3 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 6.3 years)
measure: Part 1: Incidence Rate of Malignancies
timeFrame: From Day 1 up to end of 12-week safety follow up in OLE (approximately 6.3 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 6.3 years)
measure: Part 2: Number of Participants With Confirmed or Suspected Progressive Multifocal Leukoencephalopathy (PML)
timeFrame: From end of safety follow-up in Part 1 or study GA29144 up to maximum of 92 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Arcadia
country: United States
facility: Valley Gastroenterology Consultants
state: California
city: La Jolla
country: United States
facility: University of California San Diego Medical Center
state: California
city: Long Beach
country: United States
facility: VA Long Beach Healthcare System
state: California
city: San Carlos
country: United States
facility: Digestive Care Associates, A Medical Corporation
state: California
city: San Diego
country: United States
facility: SDG Clinical Research
state: California
city: San Francisco
country: United States
facility: Uni. of California at San Francisco; Dept Pediatric, Div. of Gastroenterology, Hepatology & Nutri
state: California
city: Colorado Springs
country: United States
facility: Peak Gastroenterology Associates
state: Colorado
city: Aventura
country: United States
facility: Innovative Medical Research of South Florida
state: Florida
city: Clearwater
country: United States
facility: West Central Gastroenterology d/b/a Gastro Florida
state: Florida
city: Gainesville
country: United States
facility: University of Florida College of Medicine
state: Florida
city: Jacksonville
country: United States
facility: Borland-Groover Clinic
state: Florida
city: Miami Beach
country: United States
facility: IMIC, Inc
state: Florida
city: Miramar
country: United States
facility: FQL Research, LLC
state: Florida
city: Winter Park
country: United States
facility: Shafran Gastroenterology Center
state: Florida
city: Atlanta
country: United States
facility: Emory University Hospital
state: Georgia
city: Atlanta
country: United States
facility: Atlanta Gastroenterology Associates
state: Georgia
city: Columbus
country: United States
facility: Columbus Regional Research Institute
state: Georgia
city: Decatur
country: United States
facility: Atlanta Center for Gastroenterology, PC
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: Spokane
country: United States
facility: Advanced Clinical Research
state: Idaho
city: Chicago
country: United States
facility: Northwestern Uni-Feinberg School of Medicine
state: Illinois
city: Chicago
country: United States
facility: University of Chicago Medical Center
state: Illinois
city: Oak Lawn
country: United States
facility: Southwest Gastroenterology
state: Illinois
city: Urbana
country: United States
facility: Carle Foundation Hospital
state: Illinois
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: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Grand Rapids
country: United States
facility: Gastroenterology Associates of Western Michigan, P.L.C.
state: Michigan
city: Novi
country: United States
facility: Henry Ford Health System
state: Michigan
city: Troy
country: United States
facility: Center for Digestive Health
state: Michigan
city: Rochester
country: United States
facility: Mayo Clinic - Rochester
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: New York
country: United States
facility: Concorde Medical Group
state: New York
city: New York
country: United States
facility: Weill Cornell Medical College-New York Presbyterian Hospital
state: New York
city: New York
country: United States
facility: Lenox Hill Hospital
state: New York
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill
state: North Carolina
city: Charlotte
country: United States
facility: Charlotte Gastroenterology and Hepatology, P.L.L.C
state: North Carolina
city: Kinston
country: United States
facility: Vidant Medical Group, LLC DBA Vidant Multispeciality Clinic-Kinston
state: North Carolina
city: Cincinnati
country: United States
facility: Consultants for Clinical Research Inc.
state: Ohio
city: Mentor
country: United States
facility: Great Lakes Gastroenterology Research, LLC
state: Ohio
city: Oklahoma City
country: United States
facility: Digestive Disease Specialists, Inc.
state: Oklahoma
city: Harrisburg
country: United States
facility: Great Lakes Medical Research, LLC
state: Pennsylvania
city: Greenville
country: United States
facility: Innovative Clinical Research
state: South Carolina
city: Germantown
country: United States
facility: Gastro One
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center; Internal Medicne
state: Texas
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
city: Houston
country: United States
facility: Methodist Hospital Research Institute
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: Digestive Health Specialists of Tyler
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: Seattle
country: United States
facility: Digestive Disease Institute; Virginia Mason Medical Center
state: Washington
city: Madison
country: United States
facility: University of Wisconsin
state: Wisconsin
city: Caba
country: Argentina
facility: Hospital Italiano
city: Garran
country: Australia
facility: The Canberra Hospital
state: Australian Capital Territory
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: Sippy Downs
country: Australia
facility: University of the Sunshine Coast
state: Queensland
city: South Brisbane
country: Australia
facility: Mater Adult Hospital
state: Queensland
city: Woolloongabba
country: Australia
facility: Princess Alexandra Hospital
state: Queensland
city: Bedford Park
country: Australia
facility: Flinders Medical Centre
state: South Australia
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: Prahan
country: Australia
facility: The Alfred Hospital
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: Brussel
country: Belgium
facility: UZ Brussel
city: Bruxelles
country: Belgium
facility: CHU St Pierre (César de Paepe) X
city: Bruxelles
country: Belgium
facility: ULB Hopital Erasme; Service de Néphrologie
city: Edegem
country: Belgium
facility: UZ Antwerpen
city: Gent
country: Belgium
facility: AZ Maria Middelares
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: Instituto Brasil de Pesquisa Clínica-IBPCLIN S/A
state: RJ
city: Passo Fundo
country: Brazil
facility: Hospital Sao Vicente de Paulo
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: Santo Andre
country: Brazil
facility: Pesquisare Saúde Sociedade Simples
state: SP
city: Santo Andre
country: Brazil
facility: Praxis Pesquisa Médica
state: SP
city: Sao Bernardo Do Campo
country: Brazil
facility: Hospital Estadual Mario Covas
state: SP
city: Sao Jose do Rio Preto
country: Brazil
facility: Hospital de Base de Sao Jose do Rio Preto
state: SP
city: Sao Paulo
country: Brazil
facility: Hospital Sírio-Libanês
state: SP
city: Sao Paulo
country: Brazil
facility: Universidade Federal de Sao Paulo - UNIFES
state: SP
city: São Paulo
country: Brazil
facility: Hospital do Servidor Público Estadual/HSPE-SP
state: SP
city: Sofia
country: Bulgaria
facility: "City Clinic UMHAC" EOOD
city: Sofia
country: Bulgaria
facility: UMHAT "Sv. Ivan Rilski", EAD
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: (G.I.R.I.) GI Research Institute
state: British Columbia
city: Winnipeg
country: Canada
facility: Winnipeg Regional Health Authority; Neurosurgery Department
state: Manitoba
city: Halifax
country: Canada
facility: Queen Elizabeth II Health Sciences Centre; Gastroenterology Research
state: Nova Scotia
city: London
country: Canada
facility: University Hospital - London Health Sciences Centre
state: Ontario
city: Oshawa
country: Canada
facility: Taunton Health Centre
state: Ontario
city: Ottawa
country: Canada
facility: The Ottawa Hospital - Riverside Campus; Gastrointestinal Clinical Research Unit
state: Ontario
city: Toronto
country: Canada
facility: Mount Sinai Hospital
state: Ontario
city: Vaughan
country: Canada
facility: Toronto Digestive Disease Associates
state: Ontario
city: Montreal
country: Canada
facility: Hôpital Maisonneuve - Rosemont
state: Quebec
city: Montreal
country: Canada
facility: McGill University Health Centre - Glen Site
state: Quebec
city: Saskatoon
country: Canada
facility: Royal University Hospital
state: Saskatchewan
city: Osijek
country: Croatia
facility: Clinical Hospital Centre Osijek
city: Pula
country: Croatia
facility: General Hospital Pula
city: Zagreb
country: Croatia
facility: Clinical Hospital Center Sestre Milosrdnice
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: Ceske Budejovice
country: Czechia
facility: Nemocnice Ceske Budejovice a.s.
city: Hradec Kralove
country: Czechia
facility: Gastroenterologie s.r.o.
city: Hradec Kralove
country: Czechia
facility: Fakultni nemocnice Hradec Kralove
city: Hradec Kralove
country: Czechia
facility: Hepato-Gastroenterologie HK, s.r.o.
city: Olomouc
country: Czechia
facility: PreventaMed, s.r.o.
city: Ostrava - Poruba
country: Czechia
facility: Fakultni nemocnice Ostrava
city: Praha 7
country: Czechia
facility: ISCARE a.s.
city: Praha
country: Czechia
facility: Fakultni nemocnice Kralovske Vinohrady
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: Clichy cedex
country: France
facility: Hôpital Beaujon
city: Lille
country: France
facility: Hopital Claude Huriez - CHU Lille
city: Nantes
country: France
facility: CHU NANTES - Hôtel Dieu; Pharmacy
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: Groupe Hospitalier Sud - Hôpital Haut-Lévêque - USN
city: Pierre-Benite
country: France
facility: Centre Hospitalier Lyon Sud; Service de Gastro-Enterologie
city: Reims
country: France
facility: CHU du Reims - Hopital Robert Debré
city: Saint Etienne
country: France
facility: CHU Saint Etienne - Hôpital Nord
city: Strasbourg
country: France
facility: Höpital Hautepierre; Pediatrie1
city: Vandoeuvre-les-nancy
country: France
facility: Hôpital de Brabois Adultes
city: Berlin
country: Germany
facility: Charite-Campus Virchow Klinikum; Hepatologie und Gastroenterologie
city: Berlin
country: Germany
facility: Krankenhaus Waldfriede e. V.
city: Bochum
country: Germany
facility: Berufsgenossenschaftliches Universitaetsklinikum Bergmannsheil GmbH
city: Frankfurt
country: Germany
facility: Klinikum der Johann Wolfgang Goethe-Universitaet
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover
city: Mannheim
country: Germany
facility: Klinikum Mannheim GmbH Universitätsklinikum
city: Schweinfurt
country: Germany
facility: Gemeinschaftspraxis
city: Ulm
country: Germany
facility: Universitaetsklinikum Ulm
city: Bekescsaba
country: Hungary
facility: Bekes Megyei Kozponti Korhaz Dr. Rethy Pal Tagkorhaza
city: Budapest
country: Hungary
facility: Obudai Egeszsegugyi Centrum Kft.
city: Budapest
country: Hungary
facility: Semmelweis Egyetem; Belgyogyaszati es Hematologiai Klinika
city: Budapest
country: Hungary
facility: Szt Janos Korhaz es EbudaiEgyesitettKorhazak
city: Budapest
country: Hungary
facility: Pannonia Maganorvosi Centrum
city: Debrecen
country: Hungary
facility: Debreceni Egyetem Klinikai Központ; B?rgyógyászati Klinika
city: Gyor
country: Hungary
facility: Petz Aladar Megyei Oktato Korhaz
city: Kistarcsa
country: Hungary
facility: Pest Megyei Flor Ferenc Korhaz
city: Afula
country: Israel
facility: Haemek Medical Center
city: Beer Sheva
country: Israel
facility: Soroka University Medical Centre
city: Holon
country: Israel
facility: Wolfson Medical Center
city: Jerusalem
country: Israel
facility: Shaare Zedek Medical Center
city: Nazareth
country: Israel
facility: Holy Family Hospital
city: Petach Tikva
country: Israel
facility: Rabin Medical Center-Beilinson Campus
city: Tel Aviv
country: Israel
facility: Tel Aviv Sourasky Medical Center; Pharmacy
city: Modena
country: Italy
facility: A.O.U. Policlinico di Modena
state: Emilia-Romagna
city: Roma
country: Italy
facility: Policlinico Universitario Agostino Gemelli; Farmacia
state: Lazio
city: Roma
country: Italy
facility: Azienda Ospedaliera San Camillo Forlanini
state: Lazio
city: Milano
country: Italy
facility: Asst Fatebenefratelli Sacco (Fatebenefratelli)
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: Florence
country: Italy
facility: Azienda Ospedaliera Universitaria Careggi
state: Toscana
city: Busan
country: Korea, Republic of
facility: Dong-A University Hospital
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: Kangbuk Samsung Hospital
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Wonju-si
country: Korea, Republic of
facility: Yonsei University Wonju Severance Christian Hospital
city: R?ga
country: Latvia
facility: Pauls Stradins Clinical University Hospital
city: Riga
country: Latvia
facility: Riga East Clinical University Hospital, clinic "Gailezers"; Department of Endoscopy
city: Kaunas
country: Lithuania
facility: Hospital of Lithuanian University of Health. Sciences Kaunas Clinics
city: Vilnius
country: Lithuania
facility: Vilnius University Hospital Santariskiu Clinics, Public Inst; Department of Clinical Pharmacology
city: Tlalnepantla de Baz
country: Mexico
facility: Clinical Research Institute
state: Mexico CITY (federal District)
city: Mérida
country: Mexico
facility: Medical Care & Research SA de CV
state: Yucatan
city: Amsterdam
country: Netherlands
facility: Amsterdam UMC, Locatie VUMC; Gastroenterology
city: Amsterdam
country: Netherlands
facility: Amsterdam UMC Location AMC
city: Leiden
country: Netherlands
facility: Leids Universitair Medisch Centrum; Cardiology
city: Maastricht
country: Netherlands
facility: Maastricht University Medical Center
city: Rotterdam
country: Netherlands
facility: Erasmus Medisch Centrum
city: Sittard-Geleen
country: Netherlands
facility: Zuyderland Medisch Centrum - Sittard Geleen
city: Tilburg
country: Netherlands
facility: ETZ TweeSteden
city: Auckland
country: New Zealand
facility: North Shore Hospital
city: Christchurch
country: New Zealand
facility: Christchurch Hospital NZ
city: Dunedin
country: New Zealand
facility: Dunedin Public Hospital
city: Hamilton
country: New Zealand
facility: Waikato Hospital
city: Lower Hutt
country: New Zealand
facility: Hutt Hospital
city: Takapuna
country: New Zealand
facility: Shakespeare Specialist Group
city: Tauranga
country: New Zealand
facility: Tauranga Hospital
city: Bia?ystok
country: Poland
facility: SP ZOZ Wojewodzki Szpital Zespolony im. J. Sniadeckiego
city: Bydgoszcz
country: Poland
facility: Nasz Lekarz Osrodek Badan Klinicznych
city: Elblag
country: Poland
facility: Elblaski Szpital Specjalistyczny z Przychodnia SP ZOZ
city: Kielce
country: Poland
facility: ETG Kielce
city: Ksawerow
country: Poland
facility: Centrum Opieki Zdrowotnej Orkan-Med
city: Lublin
country: Poland
facility: Indywidualna Specjalistyczna Praktyka Lekarska
city: Nowy Targ
country: Poland
facility: Allmedica Badania Kliniczne Sp z o.o. Sp K.
city: Rzeszow
country: Poland
facility: Centrum Medyczne "MEDYK"
city: Rzeszów
country: Poland
facility: Gabinet Lekarski, Bartosz Korczowski
city: Szczecin
country: Poland
facility: Niepubliczny Zaklad Opieki Zdrowotnej SONOMED
city: Szczecin
country: Poland
facility: Twoja Przychodnia-Szczecinskie Centrum Medyczne
city: Toru?
country: Poland
facility: Gastromed Kopon Zmudzinski i Wspolnicy Sp.j.Specjalistyczne Centrum Gastrologii i Endoskopii Specj
city: Warszawa
country: Poland
facility: Centrum Zdrowia MDM
city: Warszawa
country: Poland
facility: Zespó Przychodni Specjalistycznych PRIMA
city: Wroc?aw
country: Poland
facility: Przychodnia EuroMediCare
city: Wroc?aw
country: Poland
facility: PlanetMed sp. z o.o.
city: Wroclaw
country: Poland
facility: LexMedica Osrodek Badan Klinicznych
city: Bucuresti
country: Romania
facility: S.C MedLife S.A
city: Sector 2
country: Romania
facility: Spitalul Clinic Colentina
city: Timisoara
country: Romania
facility: Centrul de Gastroenterologie Dr. Goldis
city: Barnaul
country: Russian Federation
facility: SBEI HPE Altai StateMedicalUniversityofMoH andSD
state: Altaj
city: Novosibirsk
country: Russian Federation
facility: LLC "Novosibirsk GastroCenter"
state: Altaj
city: St.Petersburg
country: Russian Federation
facility: Baltic Medicine
state: Leningrad
city: Moscow
country: Russian Federation
facility: LEC at SBIH of Moscow "City Clinical Hospital # 24"; Gastroenterology
state: Moskovskaja Oblast
city: Rostov-on-Don
country: Russian Federation
facility: SEIHPE "Rostov SMU of MoH of RF"
state: Rostov
city: Pushkin
country: Russian Federation
facility: Evromedservis LCC
state: Sankt Petersburg
city: Saint-Petersburg
country: Russian Federation
facility: Federal State Military Educational Inst. of High Prof. Edu Military Medical Acad; Therapy department
state: Sankt Petersburg
city: Sankt-peterburg
country: Russian Federation
facility: North-Western Medical University n.a. I.I. Mechnikov; Rheumatology
state: Sankt Petersburg
city: Sankt-peterburg
country: Russian Federation
facility: SBIH City Clinical Hospital #31
state: Sankt Petersburg
city: Irkutsk
country: Russian Federation
facility: Irkutsk State Medical Academy of Continuing Education
city: Novosibirsk
country: Russian Federation
facility: SBEIHPE Novosibirsk State Medical University
city: Omsk
country: Russian Federation
facility: BHI of Omsk region Clinical Oncology Dispensary
city: Belgrade
country: Serbia
facility: Clinical Center Zvezdara
city: Belgrade
country: Serbia
facility: Military Medical Academy
city: Zrenjanin
country: Serbia
facility: General Hospital Djordje Joanovic
city: Košice
country: Slovakia
facility: Endomed, s.r.o.
city: Nitra
country: Slovakia
facility: KM Management spol. s r.o.
city: Šahy
country: Slovakia
facility: Accout Center s.r.o.
city: Cape Town
country: South Africa
facility: Dr D Epstein Practice
city: Pretoria
country: South Africa
facility: Emmed Research
city: Hospitalet de Llobregat
country: Spain
facility: Hospital Universitario de Bellvitge
state: Barcelona
city: Barcelona
country: Spain
facility: Hospital Clínic i Provincial; Servicio de Farmacia
city: Cordoba
country: Spain
facility: Hospital Reina Sofia; Medical Oncology
city: Huelva
country: Spain
facility: Hospital Juan Ramón Jiménez
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: Sevilla
country: Spain
facility: Hospital Universitario Virgen Macarena
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen del Rocio
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: Zürich
country: Switzerland
facility: Universitätsspital Zürich
city: Ankara
country: Turkey
facility: Hacettepe University Medical Faculty; Gastroenterology
city: Ankara
country: Turkey
facility: Gazi University Medical Faculty
city: Istanbul
country: Turkey
facility: Acibadem Fulya Hospital; Neurology
city: Istanbul
country: Turkey
facility: Haydarpasa Numune Training and Research Hospital; Gastroenterology
city: Kadiköy
country: Turkey
facility: Medeniyet University Goztepe Training and Research Hospital.
city: Kocaeli
country: Turkey
facility: Kocaeli Universitesi Tip Fakultesi; Infectious Diseases
city: Kozyata?i
country: Turkey
facility: Acibadem Kozyatagi Hospital; Gastroenterology
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: CI of Healthcare Kharkiv Reg Clin Hosp-Center of Med Emergency & Accident Medicine
state: Kharkiv Governorate
city: Zaporizhzhia
country: Ukraine
facility: LLC Gastroenterology Center IBD Team
state: Kharkiv 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: Ivano-Frankivsk
country: Ukraine
facility: Ivano-Frankivsk Regional Clinical Hospital
state: Kuban People's Republica
city: Chernivtsi
country: Ukraine
facility: RCI Chernivtsi RCH Dep of Surgery Bukovinian SMU
city: Kharkiv
country: Ukraine
facility: CHI Kharkiv City Clinical Hospital #13
city: Odesa
country: Ukraine
facility: Railway Transport Odesa CH of Healthcare Ctr Branch of PJSC Ukrainian Railway Dept of Therapy #2
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 MC LLC Health Clinic
city: Belfast
country: United Kingdom
facility: Royal Victoria Hospital
city: Coventry
country: United Kingdom
facility: University Hospital Coventry
city: Exeter
country: United Kingdom
facility: Royal Devon and Exeter Hospital (Wonford)
city: Kings Lynn
country: United Kingdom
facility: Queen Elizabeth Hospital
city: Leeds
country: United Kingdom
facility: St James University Hospital
city: Liverpool
country: United Kingdom
facility: Royal Liverpool University Hospital
city: London
country: United Kingdom
facility: Whipps Cross Hospital
city: London
country: United Kingdom
facility: University College London Hospital
city: Manchester
country: United Kingdom
facility: Fairfield General Hospital
city: Newcastle Upon Tyne
country: United Kingdom
facility: Royal Victoria Infirmary; Stroke unit
city: Nottingham
country: United Kingdom
facility: Nottingham University Hospitals Queen's Medical Centre
city: Reading
country: United Kingdom
facility: Royal Berkshire Hospital
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.