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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT02118584
Other study ID # GA28951
Secondary ID 2013-004435-72
Status Terminated
Phase Phase 3
First received
Last updated
Start date September 15, 2014
Est. completion date October 5, 2023

Study information

Verified date October 2023
Source Hoffmann-La Roche
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Terminated
Enrollment 1822
Est. completion date October 5, 2023
Est. primary completion date October 5, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
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.

Locations

Country Name City State
Argentina Instituto Medico DAMIC Cordoba
Argentina Hospital Provincial del Centenario Rosario
Australia Royal Adelaide Hospital Adelaide South Australia
Australia Bankstown-Lidcombe Hospital Bankstown New South Wales
Australia Flinders Medical Centre Bedford Park South Australia
Australia Monash Medical Centre Clayton Victoria
Australia Concord Repatriation General Hospital Concord New South Wales
Australia St Vincent's Hospital Melbourne Fitzroy Victoria
Australia Footscray Hospital Footscray Victoria
Australia Royal Brisbane and Women's Hospital Herston Queensland
Australia Launceston General Hospital; Gastroenterology Research Launceston Tasmania
Australia Mater Adult Hospital Mackay Queensland
Australia St Frances Xavier Cabrini Hospital Malvern Victoria
Australia Fiona Stanley Hospital Murdoch Western Australia
Australia Royal Melbourne Hospital; Department of Colorectal Medicine and Genetics Parkville Victoria
Australia Princess Alexandra Hospital Woolloongabba Queensland
Austria LKH - Universitätsklinikum der PMU Salzburg Salzburg
Austria Medizinische Universität Wien Wien
Belgium GZA Ziekenhuizen - Campus Sint-Vincentius Antwerpen
Belgium Imeldaziekenhuis Bonheiden
Belgium UZ Brussel Brussel
Belgium CHU St Pierre (St Pierre) Brussels
Belgium Cliniques Universitaires Saint-Luc; Pharmacy Bruxelles
Belgium UZ Gent Gent
Belgium AZ Sint Elisabeth Herentals Herentals
Belgium UZ Leuven; Neurology Leuven
Belgium AZ Delta (Campus Rumbeke) Roeselare
Brazil Hospital Felicio Rocho Belo Horizonte MG
Brazil UNESP - Faculdade de Medicina da Universidade Estadual Paulista - Campus Botucatu Botucatu SP
Brazil CCBR - Brasilia Brasilia DF
Brazil CAEP - Centro Avancado de Estudos e Pesquisas Ltda. Campinas SP
Brazil Centro Digestivo de Curitiba Curitiba PR
Brazil Hospital Universitario Walter Cantidio - UFC Fortaleza CE
Brazil Instituto Goiano de Gastroenterologia e Endoscopia Digestiva Ltda Goiânia GO
Brazil CECIP - Centro de Estudos Clínicos do Interior Paulista Jaú SP
Brazil Hospital das Clinicas - UFRGS Porto Alegre RS
Brazil Hospital Ernesto Dornelles Porto Alegre RS
Brazil Hospital Moinhos de Vento Porto Alegre RS
Brazil Hospital Universitario Clementino Fraga Filho - UFRJ Rio de Janeiro RJ
Brazil Hospital Universitario Prof Edgar Santos-Ufba; Ambulatorio Magalhaes Neto 3Andar- Dermatologia Salvador BA
Brazil Pesquisare Saúde Sociedade Simples Santo Andre SP
Brazil Hospital Estadual Mario Covas Sao Bernardo Do Campo SP
Brazil Hospital Sírio-Libanês Sao Paulo SP
Brazil Hospital do Servidor Público Estadual/HSPE-SP São Paulo SP
Bulgaria 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 Ruse
Bulgaria MHAT "Hadzhi Dimitar", OOD Sliven
Bulgaria "City Clinic UMHAC" EOOD Sofia
Bulgaria Diagnostic Consultation Center CONVEX EOOD Sofia
Bulgaria UMHAT "Sv. Ivan Rilski", EAD Sofia
Bulgaria UMHAT Tsaritsa Yoanna - ISUL, EAD 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
Canada University of Calgary Calgary Alberta
Canada Zeidler Ledcor Centre - University of Alberta; Division of Gasroenterology Edmonton Alberta
Canada Centre de santé et de services sociaux Champlain-Charles-Le Moyne Greenfield Park Quebec
Canada Guelph GI & Surgery Clinic Guelph Ontario
Canada Queen Elizabeth II Health Sciences Centre; Gastroenterology Research Halifax Nova Scotia
Canada Hotel Dieu de Levis Levis Quebec
Canada University Hospital - London Health Sciences Centre London Ontario
Canada Hôpital Maisonneuve - Rosemont Montreal Quebec
Canada Taunton Health Centre Oshawa Ontario
Canada Royal University Hospital Saskatoon Saskatchewan
Canada Mount Sinai Hospital Toronto Ontario
Canada Toronto Liver Centre Toronto Ontario
Canada Pacific Gastroenterology Associates Vancouver British Columbia
Canada Toronto Digestive Disease Associates Vaughan Ontario
Colombia RTS - Fundación Valle de Lili Cali
Colombia Instituto de Coloproctologia ICO S.A.S. Medellin
Croatia Clinical Hospital Centre Osijek Osijek
Croatia Clinical Hospital Sveti Duh; Department of Neurology Zagreb
Czechia Fakultni nemocnice u sv. Anny v Brne; I.Interni kardioangiologicka klinika Brno
Czechia Vojenska nemocnice Brno Brno
Czechia Fakultni nemocnice Hradec Kralove Hradec Kralove
Czechia Hepato-Gastroenterologie HK, s.r.o. Hradec Kralove
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 Nemocnice Na Bulovce Prague
Czechia ISCARE a.s. Praha 7
Czechia Krajska zdravotni, a.s. ? Masarykova nemocnice v Usti nad Labem, o.z., Ocni oddeleni Usti Nad Labem
Czechia Krajska nemocnice T. Bati, a.s. Zlin
Denmark Ålborg Universitets Hospital; Gastromedicinsk Ålborg
Denmark Herlev og Gentofte Hospital Herlev
Denmark Rigshospitalet; Medicinsk gastroenterologisk klinik København Ø
Estonia East Tallinn Central Hospital Tallinn
Estonia North Estonia Medical Centre Foundation Tallinn
Estonia OÜ Innomedica Tallinn
Estonia West Tallinn Central Hospital Tallinn
Estonia Tartu University Hospital Tartu
France CHU Amiens - Hopital Sud Amiens
France CHU de Caen Hopital Cote de Nacre Caen
France CHU Tours - Hôpital Trousseau Chambray les Tours
France Hôpital Beaujon Clichy cedex
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-Benite
France CHU Saint Etienne - Hôpital Nord Saint Etienne
France Höpital Hautepierre; Pediatrie1 Strasbourg
France CHU de Toulouse - Hôpital Rangueil Toulouse Cedex 09
France Hôpital de Brabois Adultes Vandoeuvre-les-nancy
Germany Charite Universitaetsmedizin Berlin - Campus Benjamin Franklin Berlin
Germany Charite Universitaetsmedizin Berlin - Campus Charite Mitte 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
Germany Universitaetsklinikum Halle (Saale) Halle
Germany Gastroenterologie Eppendorfer Baum Hamburg
Germany Hamburgisches Forschungsinstitut fuer CED Hamburg
Germany Universitätsklinikum Hamburg-Eppendorf Hamburg
Germany Medizinische Hochschule Hannover; Klinik für Gastroenterologie, Hepatologie und Endokrinologie Hannover
Germany Universitaetsklinikum Jena; Apotheke des Uniersitätsklinikums Jena Jena
Germany Universitaetsklinikum Schleswig-Holstein, Campus Kiel Kiel
Germany Medizinisches Zentrum Klinikum Lueneburg Lueneburg
Germany Klinikum Mannheim GmbH Universitätsklinikum Mannheim
Germany Universitaetsklinikum Muenster Muenster
Germany Gemeinschaftspraxis Dres. Joachim Mueller und Steffi Appelt Schweinfurt
Germany Universitaetsklinikum Ulm Ulm
Greece University General Hospital of Heraklion Heraklio
Hong Kong University of Hong Kong Hong Kong
Hungary DRC Gyogyszervizsgalo Kozpont Kft Balatonfured
Hungary Bekes Megyei Kozponti Korhaz Dr. Rethy Pal Tagkorhaza Bekescsaba
Hungary Endomedix Diagnosztikai Kozpont Budapest
Hungary Eszak-Kozep-budai Centrum, Uj Szent Janos Korhaz es Szakrendelo Budapest
Hungary Magyar Honvedseg Egeszsegugyi Kozpont; Fázis I-es Klinikai Farmakológiai Vizsgálóhely Budapest
Hungary Pannónia Klinika Magánorvosi Budapest
Hungary Semmelweis Egyetem Budapest
Hungary Debreceni Egyetem Klinikai Kozpont Debrecen
Hungary Vasutegeszsegugyi Kft. - Debreceni Egeszsegugyi Kozpont Debrecen
Hungary Markhot Ferenc Oktato Korhaz es Rendelointezet Eger
Hungary Petz Aladar Megyei Oktato Korhaz Gyor
Hungary Pest Megyei Flor Ferenc Korhaz Kistarcsa
Hungary Borsod-Abauj-Zemplen Megyei Korhaz es Egyetemi Oktato Korhaz Miskolc
Hungary Pecsi Tudomanyegyetem Pecs
Hungary Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz Székesfehérvár
Hungary Csongrad Megyei Dr. Bugyi Istvan Korhaz Szentes
India K.L.E. Society's Dr. Prabhakar Kore Hospital and Medical Research Centre Belgaum Karnataka
India M. S. Ramaiah Medical College and Hospital Bengaluru Karnataka
India Deccan College of Medical Sciences and Allied Hospitals; Department of Gastroenterology Hyderabad Andhra Pradesh
India S. R. Kalla Memorial Gastro & General Hospital Jaipur Rajasthan
India Dayanand Medical College and Hospital Ludhiana Punjab
India Kasturba Medical College & Hospital Manglore Karnataka
India Midas institute of Gastroenterology Nagpur Maharashtra
India King Edward Memorial Hospital Research Centre Pune
India Ruby Hall Clinic Pune Maharashtra
India Nirmal Hospital Surat Gujarat
Israel Bnai Zion Medical Center; Internal Medicine Haifa
Israel Hadassah University Hospital - Ein Kerem Jerusalem
Israel Shaare Zedek Medical Center 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 Lezion
Israel Chaim Sheba Medical Center; Pediatrics B North and Pediatric Endocrinology Unit Tel Hashomer
Italy Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpigh Bologna Emilia-Romagna
Italy Fondazione Poliambulanza Istituto Ospedaliero Brescia Lombardia
Italy Azienda Ospedaliera Universitaria Careggi Florence Toscana
Italy Azienda Ospedaliero Universitaria San Martino Genova Liguria
Italy Azienda Ospedaliera Fatebenefratelli e Oftalmico Milano Lombardia
Italy Azienda Socio Sanitaria Territoriale Fatebenefratelli (Presidio Ospedale Sacco) Milano Lombardia
Italy Azienda Socio Sanitaria Territoriale Niguarda (Grande Ospedale Metropolitano Niguarda) Milano Lombardia
Italy A.O.U. Policlinico di Modena Modena Emilia-Romagna
Italy Azienda Ospedaliera di Padova Padova Veneto
Italy Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Palermo Sicilia
Italy Azienda Ospedaliero Universitaria di Parma Parma Emilia-Romagna
Italy Ospedale di Circolo; Neuropsichiatria Infantile Rho Lombardia
Italy Azienda Ospedaliera San Camillo Forlanini Roma Lazio
Italy Azienda Ospedaliera Universitaria Policlinico Tor Vergata Roma Lazio
Italy Fondazione Policlinico Universitario Agostino Gemelli IRCCS Roma Lazio
Italy Ospedale Sandro Pertini Roma Lazio
Italy Istituto Clinico Humanitas Rozzano (MI) Lombardia
Italy I.R.C.C.S Policlinico San Donato San Donato Milanese (MI) Lombardia
Italy IRCCS Ospedale Casa Sollievo della Soffenza; Stru Comp di Gastroenterologia ed Endoscopia digest San Giovanni Rotondo Lombardia
Italy Ospedale Mauriziano Umberto I Torino Piemonte
Korea, Republic of Dong-A University Hospital Busan
Korea, Republic of Pusan National University Hospital Busan
Korea, Republic of Keimyung University Dongsan Medical Center Daegu
Korea, Republic of Kyungpook National University Hospital Daegu
Korea, Republic of Kyungpook National University Medical Center Daegu
Korea, Republic of Yeungnam Univ. Hospital Daegu
Korea, Republic of Korea University Ansan Hospital Gyeonggi-do
Korea, Republic of CHA Bundang Medical Centre; CHA university Seongnam
Korea, Republic of Seoul National University Bundang Hospital Seongnam-si
Korea, Republic of Asan Medical Center. Seoul
Korea, Republic of Kangbuk Samsung Hospital Seoul
Korea, Republic of Samsung Medical Center Seoul
Korea, Republic of Seoul National University Hospital Seoul
Korea, Republic of Severance Hospital, Yonsei University Health System Seoul
Korea, Republic of Ajou University Hospital Suwon City
Korea, Republic of The Catholic University of Korea St. Vincent's Hospital Suwon-si
Korea, Republic of Yonsei University Wonju Severance Christian Hospital Wonju-Si
Latvia Central Outpatient Clinic Daugavpils
Latvia Digestive Diseases Center "Gastro" R?ga
Latvia Pauls Stradins Clinical University Hospital R?ga
Lithuania Hospital of Lithuanian University of Health. Sciences Kaunas Clinics Kaunas
Lithuania Klaipeda Seamen's Hospital, Public Institution Klaipeda
Lithuania Vilnius University Hospital Santariskiu Clinic, Public Institution; Cardiology Vilnius
Malaysia Hospital Raja Perempuan Zainab II; Department of Medicine Kota Bahru
Malaysia 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
Mexico Phylasis Clinicas Research S de RL de CV Cuautitlán Izcalli
Mexico Centro Integral en Reumatología S.A. de C.V. (CIRSA) Guadalajara Jalisco
Mexico Accelerium S. de R.L. de C.V. Monterrey Nuevo LEON
Mexico Centro Regiomontano de Estudios Clínicos Roma S.C. Monterrey Nuevo LEON
Mexico Hospital Universitario Dr Jose Eleuterio Gonzalez; Universidad Autónoma de Nuevo León Monterrey Nuevo LEON
Netherlands Amsterdam UMC Location AMC Amsterdam
Netherlands Amsterdam UMC Location VUMC Amsterdam
Netherlands Radboudumc NL -nijmegen
New Zealand Middlemore Hospital Auckland
New Zealand North Shore Hospital Auckland
New Zealand Dunedin Hospital Dunedin
New Zealand Waikato Hospital Hamilton
New Zealand Shakespeare Specialist Group Takapuna
New Zealand Tauranga Hospital Tauranga
Norway Akershus universitetssykehus HF Lørenskog
Poland 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 Nzoz All-Medicus Katowice
Poland Pro Familia Altera Sp z o.o. Katowice
Poland Uniwersyteckie Centrum Kliniczne im. prof. K. Gibinskiego SUM Katowice
Poland NZOZ Centrum Medyczne ProMiMed Krakow
Poland Centrum Opieki Zdrowotnej Orkan-Med Ksawerow
Poland GASTROMED Sp. z o.o. Lublin
Poland Indywidualna Specjalistyczna Praktyka Lekarska Lublin
Poland Allmedica Badania Kliniczne Sp z o.o. Sp K. Nowy Targ
Poland Wojewodzki Specjalistyczny Szpital w Olsztynie Olsztyn
Poland SOLUMED Centrum Medyczne Pozna?
Poland Centrum Medyczne Medyk Rzeszow
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 Warszawa
Poland Endoterapia PFG Sp. z o.o. Warszawa
Poland Narodowy Instytut Onkologii im. Marii Sk?odowskiej-Curie - Pa?stwowy Instytut Badawczy Warszawa
Poland Nzoz Vivamed Warszawa
Poland Zespó Przychodni Specjalistycznych PRIMA Warszawa
Poland PlanetMed Wroc?aw
Poland Przychodnia EuroMediCare Wroc?aw
Poland LexMedica Osrodek Badan Klinicznych Wroclaw
Portugal Hospital de Braga Braga
Portugal Hospital da Senhora da Oliveira Guimarães Guimarães
Romania Spitalul Clinic Colentina Bucharest
Romania Centrul Medical Unirea SRL Bucuresti
Romania S.C MedLife S.A Bucuresti
Romania Centrul de Gastroenterologie Dr. Goldis Timisoara
Russian Federation SBEI HPE Altai StateMedicalUniversityofMoH andSD Barnaul Altaj
Russian Federation Medical and Sanitary Division of Severstal Cherepovets Vologda
Russian Federation Irkutsk State Medical Academy of Continuing Education Irkutsk
Russian Federation CJSC Nasledniki Moscow Moskovskaja Oblast
Russian Federation FSBI ?State Scientific Centre of Coloproctology" of the MoH of RF; Gastroenterology Moscow Moskovskaja Oblast
Russian Federation FSBIH Central Clinical Hospital of RAS Moscow Moskovskaja Oblast
Russian Federation Yusupov Hospital Moskva Adygeja
Russian Federation SBHI of NN region ?RCH of NN n.a. N.A.Semashko? Nizhny Novgorod Niznij Novgorod
Russian Federation FSBI "Scientific Research Institute of Physyology and Basic Medicine" under the SB of RAMS Novosibirsk
Russian Federation BHI of Omsk region Clinical Oncology Dispensary Omsk
Russian Federation SBEI of HPE "Omsk SMA" Ministry of healthcare of RF" Omsk
Russian Federation SEIHPE "Rostov SMU of MoH of RF" Rostov-on-Don Rostov
Russian Federation FFSBI "The Nikiforov Russian Center of Emergency and Radiation Medicine"; Pulmonology Sankt-peterburg Sankt Petersburg
Russian Federation SBIH City Clinical Hospital #31 Sankt-peterburg Sankt Petersburg
Russian Federation SPb SBIH "City Multy-field Hospital # 2"; Intensive Pulmonology and Thoracal Surgery Sankt-peterburg Sankt Petersburg
Russian Federation City Hospital #26 St Petersburg Sankt Petersburg
Russian Federation LLC International Medical Centre ?SOGAZ? St-petersburg Sankt Petersburg
Russian Federation FSBMEI HPE "Military Medical Academy n.a. S.M. Kirov" of the MoD of the RF; Therapy St. Petersburg Sankt Petersburg
Russian Federation Pavlov First Saint Petersburg State Medical University St. Petersburg Sankt Petersburg
Russian Federation SPb SHI "City Hospital #9" St. Petersburg Sankt Petersburg
Russian Federation Baltic Medicine St.Petersburg Leningrad
Russian Federation FSBEI HE "Stavropol State Medical University" of Ministry of Healthcare of Russian Federation Stavropol
Russian Federation Stavropol Regional Clinical Diagnostic Consultative Center Stavropol
Russian Federation SBEI HPE "Voronezh State Medical University n.a. N.N. Burdenko" of the MoH of the RF Voronezh Voronez
Serbia Clinical Center Zemun Belgrade
Serbia Clinical Center Zvezdara Belgrade
Serbia Military Medical Academy Belgrade
Serbia Clinical Center Kragujevac Kragujevac
Serbia General Hospital Djordje Joanovic Zrenjanin
Singapore Singapore General Hospital Singapore
Slovakia Accout Center s.r.o. Šahy
Slovakia Fakultna nemocnica s poliklinikou F.D. Roosevelta Banska Bystrica
Slovakia Nemocnica A.Lena Humenne, n.o. Humenné
Slovakia KM Management spol. s r.o. Nitra
Slovakia Gastro I, s.r.o. Prešov
Slovakia Svet zdravia a.s. Rimavská Sobota
Slovakia Endomed, s.r.o. Vranov Nad Top?ou
South Africa Netcare Universitas Private Hospital Bloemfontein
South Africa Dr JP Wright Practice Cape Town
South Africa Dr MJ Prins Practice Cape Town
South Africa Emmed Research Pretoria
Spain Fundacion Hospital de Alcorcon; Servicio de Digestivo Alcorcon Madrid
Spain Centro Médico Teknon Barcelona
Spain Hospital Universitari de Girona Dr Josep Trueta Girona
Spain Hospital Universitario de Fuenlabrada Madrid
Spain Hospital Universitario de la Princesa Madrid
Spain Hospital Universitario La Paz Madrid
Spain Corporacio Sanitaria Parc Tauli Sabadell Barcelona
Spain Hospital Universitari i Politecnic La Fe Valencia
Spain Hospital Universitario Miguel Servet Zaragoza
Switzerland Crohn-Colitis Zentrum Bern - Gemeinschaftspraxis Balsiger, Seibold und Partner Bern
Switzerland Inselspital-Universitaetsspital Bern Bern
Turkey Gazi University Medical Faculty; Gastroenterology Ankara
Turkey Haydarpasa Numune Training and Research Hospital; Medical Oncology Istanbul
Turkey Kocaeli Universitesi Tip Fakultesi; Infectious Diseases Kocaeli
Ukraine RCI Chernivtsi RCH Gastroenterology Bukovinsky SMU Chernivtsi
Ukraine RCNECRCH Dept of Surgery, SHEI Ukr BSMU Chernivtsi Podolia Governorate
Ukraine SI Dnipropetrovsk MA of MOHU SI Institute of gastroenterology of AMSU Dnipropetrovsk
Ukraine CI of Healthcare Kharkiv CCH #13 Kharkiv
Ukraine 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 GI L.T.Malaya Therapy National Institute of the NAMS of Ukraine Kharkiv
Ukraine CI Kherson Afanasii and Olha Tropiny City Clinical Hospital Kherson
Ukraine CI of Kyiv RC Kyiv Regional Clinical Hospital Kyiv KIEV Governorate
Ukraine CI of Kyiv RC Regional Clinical Hospital #2 Kyiv KIEV Governorate
Ukraine CNE Kyiv CCH #18 Kyiv KIEV Governorate
Ukraine CNI Consultative and Diagnostic Center of Desnianskyi District of Kyiv Kyiv
Ukraine Communal Institution of Kyiv Regional Council Kyiv Regional Clinical Hospital Kyiv Kharkiv Governorate
Ukraine Med Center of International Institute of Clinical Trials LLC; Medical Center "OK!Clinic+" Kyiv KIEV Governorate
Ukraine Medical Center of Limited Liability Company Medical Clinic Blagomed Kyiv KIEV Governorate
Ukraine Lviv Regional Clinical Hospital Lviv KIEV Governorate
Ukraine Odessa regional clinical Hospital Odessa
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 CI of SRC Sumy RCH Dept of Gasroenterology Sumy SU MI Sumy Kharkiv Governorate
Ukraine A.Novak Transcarpathian Regional Clinical Hospital Uzhgorod KIEV Governorate
Ukraine CI UDH Dept of Ther SHEI Fac of PGE&Pre-Univ Training Uzhgorod KIEV Governorate
Ukraine M.I. Pyrogov VRCH Dept of Gastroenterology M.I. Pyrogov VNMU Vinnytsia
Ukraine MCIC Health Clinic BO LTD TPC Slaomed Vinnytsia
Ukraine Private Small Enterprise Medical Center Pulse Vinnytsia
Ukraine CI City Hospital #1 Zaporizhzhia Tavria Okruha
Ukraine CI City Hospital #7 Zaporizhzhia
Ukraine Co Ltd. Diaservice Zaporizhzhia
Ukraine LLC Gastroenterology Center IBD Team Zaporizhzhia Kharkiv Governorate
United Kingdom 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 King's College London London
United Kingdom St Thomas Hospital London
United Kingdom The Royal London Hospital London
United Kingdom University College London Hospital 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 States University of Michigan Ann Arbor Michigan
United States Asheville Gastroenterology Associates, P.A. Asheville North Carolina
United States Atlanta Gastroenterology Associates Atlanta Georgia
United States Innovative Medical Research of South Florida, Inc. Aventura Florida
United States Gastroenterology Associates, LLC Baton Rouge Louisiana
United States Washington Gastroenterology Bellevue Washington
United States Ehrhardt Clinical Research, LLC Belton Missouri
United States University of Alabama Medical Center Birmingham Alabama
United States Massachusetts General Hospital; Crohn's & Colitis Center Boston Massachusetts
United States University of North Carolina at Chapel Hill Chapel Hill North Carolina
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 Consultants for Clin. Rsrch Cincinnati Ohio
United States UC Health Clinical Trials Office; Division of Digestive Diseases Cincinnati Ohio
United States West Central Gastroenterology d/b/a Gastro Florida Clearwater Florida
United States Ericksen Research and Development Clinton Utah
United States Peak Gastroenterology Associates Colorado Springs Colorado
United States Texas Digestive Disease Consultants - Dallas Dallas Texas
United States Henry Ford Health System Detroit Michigan
United States Clinica Peruano Americana S.A. Great Neck New York
United States University of Mississippi Medical Center Jackson Mississippi
United States Kansas City Research Institute, LLC Kansas City Missouri
United States Kinston Medical Specialists Kinston North Carolina
United States University of California San Diego Medical Center La Jolla California
United States Clinical Research of the Rockies Lafayette Colorado
United States Gastroenterology Associates of Central Georgia Macon Georgia
United States Gastrointestinal Specialists of Georgia, PC Marietta Georgia
United States Gastroenterology Center of the Midsouth, P.C. Memphis Tennessee
United States Great Lakes Gastroenterology Research, LLC Mentor Ohio
United States Regenerate Clinical Trials Miami Florida
United States IMIC, Inc Miami Beach Florida
United States Regents of the University of Minnesota Minneapolis Minnesota
United States FQL Research, LLC Miramar Florida
United States Gastroenterology Group of Naples Naples Florida
United States Vanderbilt University Medical Center Nashville Tennessee
United States Aquiant Research New Albany Indiana
United States Advanced Research Institute, Inc. New Port Richey Florida
United States Concorde Medical Group New York 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 Southwest Gastroenterology Oak Lawn Illinois
United States University of California, Irvine Medical Center Orange California
United States Internal Medicine Specialists Orlando Florida
United States McGuire Research Institute; Gastroenterology Richmond Virginia
United States University of Utah School of Medicine Salt Lake City Utah
United States Wellness Clinical Research Center San Antonio Texas
United States SDG Clinical Research San Diego California
United States University of California at San Francisco San Francisco California
United States Louisiana Research Center, LLC Shreveport Louisiana
United States Texas Digestive Disease Consultants - Southlake Southlake Texas
United States Atlanta Gastroenterology Specialists, PC Suwanee Georgia
United States Cotton-O'Neil Clinical Research Center, Digestive Health Topeka Kansas
United States Center for Digestive Health Troy Michigan
United States Tyler Research Institute, LLC Tyler Texas
United States Ventura Clinical Trials Ventura California
United States Rocky Mountain Gastroenterology Associates Wheat Ridge Colorado
United States Shafran Gastroenterology Center Winter Park Florida
United States Huron Gastroenterology Associates Ypsilanti Michigan

Sponsors (1)

Lead Sponsor Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Austria,  Belgium,  Brazil,  Bulgaria,  Canada,  Colombia,  Croatia,  Czechia,  Denmark,  Estonia,  France,  Germany,  Greece,  Hong Kong,  Hungary,  India,  Israel,  Italy,  Korea, Republic of,  Latvia,  Lithuania,  Malaysia,  Mexico,  Netherlands,  New Zealand,  Norway,  Poland,  Portugal,  Romania,  Russian Federation,  Serbia,  Singapore,  Slovakia,  South Africa,  Spain,  Switzerland,  Turkey,  Ukraine,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Percentage of Participants With Clinical Remission as Determined by the Partial Mayo Clinic Score (pMCS) - Part 1 Baseline up to 9 years (assessed at Baseline, Week 4, 8, 12 thereafter every 12 weeks up to 9 years after the first participant is enrolled or until commercial availability, whichever is earlier, or until sponsor's decision to terminate the study)
Primary Percentage of Participants With Remission as Determined by the Mayo Clinic Score (MCS) - Part 1 Week 108
Primary Percentage of Participants With Endoscopic Remission Week 108
Primary Percentage of Participants With Anti-therapeutic Antibodies to Etrolizumab - Part 1 Baseline, Week 12, every 48 weeks, week 108, at early withdrawal from treatment up to 9 years after first participant enrolled or until commercial availability, whichever is earlier, or until sponsor's decision to terminate the study)
Primary Percentage of Participants With Adverse Events - Part 1 Baseline up to 9 years after the first participant is enrolled or until commercial availability, whichever is earlier, or until the Sponsor's decision to terminate the study
Primary Percentage of Participants With Progressive Multifocal Leukoencephalopathy (PML) - Part 2 104 weeks
Primary Change From Baseline in pMCS at Year 9 Baseline, Year 9
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