A Study of the Efficacy and Safety of Etrolizumab in Participants With Ulcerative Colitis Who Have Been Previously Exposed to Tumor Necrosis Factor (TNF) Inhibitors

PHASE3CompletedINTERVENTIONAL
Enrollment

609

Participants

Timeline

Start Date

May 21, 2014

Primary Completion Date

April 16, 2020

Study Completion Date

April 16, 2020

Conditions
Ulcerative Colitis
Interventions
DRUG

Etrozulimab

Participants will receive 105 mg etrolizumab administered by SC injection Q4W.

DRUG

Placebo

Participants will receive placebo (matched with etrolizumab) administered by SC injection Q4W.

Trial Locations (184)

1000

CHU St Pierre (St Pierre), Brussels

1036

Obudai Egeszsegugyi Centrum Kft., Budapest

1083

Semmelweis Egyetem, Budapest

1090

Medizinische Universität Wien, Vienna

UZ Brussel, Brussels

1125

Eszak-Kozep-budai Centrum, Uj Szent Janos Korhaz es Szakrendelo, Budapest

1135

Pannonia Maganorvosi Centrum, Budapest

2000

Hospital Provincial del Centenario, Rosario

2100

Rigshospitalet; Medicinsk gastroenterologisk klinik, København Ø

2200

AZ Sint Elisabeth Herentals, Herentals

2820

Imeldaziekenhuis, Bonheiden

3000

UZ Leuven; Neurology, Leuven

3010

Inselspital-Universitaetsspital Bern; Institut fuer Spitalpharmazie, Bern

3011

Footscray Hospital; Gastroenterology, Footscray

3012

Cliniques Universitaires Saint-Luc; Nephrology, Bern

Crohn-Colitis Zentrum Bern - Gemeinschaftspraxis Balsiger, Seibold und Partner, Bern

3065

St Vincent's Hospital Melbourne, Fitzroy

3144

St Frances Xavier Cabrini Hospital, Malvern

3300

Markhot Ferenc Oktato Korhaz es Rendelointezet, Eger

3526

Borsod-Abauj-Zemplen Megyei Korhaz es Egyetemi Oktato Korhaz; II. Belgyogyaszat, Miskolc

4000

CHU de Liège; Tour de Pathologie, Liège

4029

Royal Brisbane and Women's Hospital, Herston

4032

Debreceni Egyetem, Debrecen

4101

Mater Adult Hospital, South Brisbane

4102

Princess Alexandra Hospital, Woolloongabba

5020

LKH - Universitätsklinikum der PMU Salzburg, Salzburg

5600

Bekes Megyei Kozponti Korhaz Dr. Rethy Pal Tagkorhaza, Békéscsaba

6150

Fiona Stanley Hospital, Murdoch

7250

Launceston General Hospital; Gastroenterology Research, Launceston

7624

Pecsi Tudomanyegyetem, Pécs

8000

Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz, Székesfehérvár

8800

AZ Delta (Stedelijk Ziekenhuis), Roeselare

9000

UZ Gent, Ghent

Ålborg Universitets Hospital; Gastromedicinsk, Aalborg

9020

Klinikum Klagenfurt am Wörtersee; Acute geriatric care, Klagenfurt

9024

Petz Aladar Megyei Oktato Korhaz, Győr

10021

Weill Cornell Medical College-New York Presbyterian Hospital, New York

10117

Charite Universitaetsmedizin Berlin - Campus Charite Mitte, Berlin

11021

Clinica Peruano Americana S.A., Great Neck

13605

Seoul National University Bundang Hospital, Seongnam-si

13915

Hôpital Nord - CHU Marseille; Gastroenterology and Hepatology, Marseille

14050

DRK Kliniken Berlin Westend, Berlin

15355

Korea University Ansan Hospital, Gyeonggi-do

17007

Hospital Universitari de Girona Dr Josep Trueta, Girona

20017

Ospedale di Circolo; Neuropsichiatria Infantile, Rho

20089

Istituto Clinico Humanitas, Rozzano (MI)

20097

I.R.C.C.S Policlinico San Donato, San Donato Milanese (MI)

20148

Hamburgisches Forschungsinstitut fuer CED, Hamburg

20246

Universitätsklinikum Hamburg-Eppendorf, Hamburg

20249

Gastroenterologie Eppendorfer Baum, Hamburg

23249

McGuire Research Institute; Gastroenterology, Richmond

23502

Digestive and Liver Disease Specialists, Ltd., Norfolk

24116

Universitaetsklinikum Schleswig-Holstein, Campus Kiel, Kiel

27599

University of North Carolina at Chapel Hill, Chapel Hill

28006

Hospital Universitario de la Princesa, Madrid

28922

Fundacion Hospital de Alcorcon; Servicio de Digestivo, Alcorcón

28942

Hospital Universitario de Fuenlabrada, Madrid

30024

Atlanta Gastroenterology Specialists, PC, Suwanee

30060

Gastrointestinal Specialists of Georgia, PC, Marietta

30625

Medizinische Hochschule Hannover; Klinik für Gastroenterologie, Hepatologie und Endokrinologie, Hanover

31059

CHU de Toulouse - Hôpital Rangueil, Toulouse

31201

Gastroenterology Associates of Central Georgia, Macon

32789

Shafran Gastroenterology Center, Winter Park

32803

Center For Digestive Health, Orlando

32806

Internal Medicine Specialists, Orlando

33025

FQL Research, LLC, Miramar

33604

Groupe Hospitalier Sud - Hôpital Haut-Lévêque - USN, Pessac

35128

Azienda Ospedaliera Di Padova, Padua

35294

University of Alabama at Birmingham, Birmingham

37232

Vanderbilt University Medical Center, Nashville

38120

Gastroenterology Center of the Midsouth, P.C., Memphis

40124

A.O.U. Policlinico di Modena, Modena

40138

Azienda Ospedaliera S. Orsola-Malpighi, Bologna

42055

CHU Saint Etienne - Hôpital Nord, Saint-Etienne

44060

Great Lakes Gastroenterology Research, LLC, Mentor

45219

Consultants for Clinical Research Inc., Cincinnati

UC Health, LLC., Cincinnati

46026

Hospital Universitari i Politecnic La Fe, Valencia

48098

Center for Digestive Health, Troy

48109

University of Michigan; Michigan Institute for Clinical and Health Research (MICHR), Ann Arbor

48149

Universitaetsklinikum Muenster, Münster

48202

Henry Ford Health System, Detroit

49100

Rabin Medical Center-Beilinson Campus; Gaucher Clinic, Genetics Institute, Petach Tiqwa

50009

Hospital of Lithuanian University of Health. Sciences Kaunas Clinics, Kaunas

Hospital Universitario Miguel Servet, Zaragoza

50141

Azienda Ospedaliera Universitaria Careggi, Florence

54007

"Anticancer Hospital of Thessaliniki Theagenio", Thessaloniki

54511

Hôpital de Brabois Adultes, Vandœuvre-lès-Nancy

59037

Hopital Claude Huriez - CHU Lille, Lille

60453

Southwest Gastroenterology, Oak Lawn

60590

Klinikum der Johann Wolfgang Goethe-Universitaet, Frankfurt

60611

Northwestern University Feinberg School Of Medicine, Chicago

64131

Kansas City Research Institute, LLC, Kansas City

64610

Centro Regiomontano de Estudios Clínicos Roma S.C., Monterrey

66606

Cotton-O'Neil Clinical Research Center, Digestive Health, Topeka

67098

Höpital Hautepierre; Pediatrie1, Strasbourg

68167

Klinikum Mannheim GmbH Universitätsklinikum, Mannheim

70809

Gastroenterology Associates, LLC, Baton Rouge

75475

Hôpital Saint-Louis, Paris

75701

Tyler Research Institute, LLC, Tyler

79106

Universitätsklinikum Freiburg; Innere Medizin I; Hämatologie, Onkologie und Stammzelltransplantation, Freiburg im Breisgau

80054

CHU Amiens - Hopital Sud; Pharmacie - Secteur des Essais cliniques, Amiens Cedex01

80215

Rocky Mountain Gastroenterology Associates, P.L.L.C.; Gastroenterology, Lakewood

80222

Rocky Mountain Gastroenterology Associates, Denver

84015

Ericksen Research and Development, Clinton

84132

University of Utah School of Medicine, Salt Lake City

89081

Universitaetsklinikum Ulm, Ulm

91054

Universitaetsklinikum Erlangen, Erlangen

92103

Clinical Applications Laboratories, Inc., San Diego

92110

Hôpital Beaujon, Clichy

92114

Precision Research Institute, LLC, San Diego

94115

University of California at San Francisco, San Francisco

98004

Washington Gastroenterology, Bellevue

7505001

Assaf Harofeh, Rishon LeZiyyon

7610001

Kaplan Medical Center, Rehovot

9103102

Shaare Zedek Medical Center, Jerusalem

9112001

Hadassah University Hospital - Ein Kerem; Neurosurgery, Jerusalem

92093-5354

University of California San Diego Medical Center, La Jolla

Unknown

Louisiana Research Center, LLC, Shreveport

Hospital de Clínicas de Porto Alegre X, Porto Alegre

Azienda Socio Sanitaria Territoriale Fatebenefratelli (Presidio Ospedale Sacco), Milan

02114

Massachusetts General Hospital; Crohn's & Colitis Center, Boston

74535-170

Instituto Goiano de Gastroenterologia e Endoscopia Digestiva Ltda, Goiânia

30110-068

Hospital Felicio Rocho, Belo Horizonte

80430-160

Centro Digestivo de Curitiba, Curitiba

21941-913

Hospital Universitario Clementino Fraga Filho - UFRJ, Rio de Janeiro

90035-001

Hospital Moinhos de Vento, Porto Alegre

18618-970

UNESP - Faculdade de Medicina da Universidade Estadual Paulista - Campus Botucatu, Botucatu

13087-567

CAEP - Centro Avancado de Estudos e Pesquisas Ltda., Campinas

09190-610

Hospital Estadual Mario Covas, Santo André

T2N 4Z6

University of Calgary; Heritage Medical Research Clinic, Calgary

T6G 2X8

Zeidler Ledcor Centre - University of Alberta; Division of Gasroenterology, Edmonton

V6Z 2K5

Pacific Gastroenterology Associates, Vancouver

B3H 1V7

Queen Elizabeth II Health Sciences Centre; Gastroenterology Research, Halifax

L1H 7K4

Taunton Health Centre, Oshawa

M5G 1X5

Mount Sinai Hospital, Toronto

M6H 3M1

Toronto Liver Centre, Toronto

L4L 4Y7

Toronto Digestive Disease Associates, Vaughan

G6V 3Z1

Hotel Dieu de Levis, Lévis

H1T 2M4

Hôpital Maisonneuve - Rosemont, Montreal

625 00

Fakultni nemocnice Brno; Interni kardiologicka klinika, Brno

500 12

Hepato-Gastroenterologie HK, s.r.o., Hradec Králové

532 03

Pardubicka krajska nemocnice, a.s., Pardubice

170 04

ISCARE a.s., Prague

180 01

Nemocnice Na Bulovce, Prague

401 13

Krajska zdravotni, a.s. - Masarykova nemocnice v Usti nad Labem, o.z., Ocni oddeleni, Ústí nad Labem

06202

CHU Nice - Hopital de l'Archet 2, Nice

06120

Universitaetsklinikum Halle (Saale), Halle

H-1077

Magyar Honvedseg Egeszsegugyi Kozpont; Fázis I-es Klinikai Farmakológiai Vizsgálóhely, Budapest

00133

Azienda Ospedaliera Universitaria Policlinico Tor Vergata, Rome

00152

Azienda Ospedaliera San Camillo Forlanini, Rome

00168

Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Rome

08661

Vilnius University Hospital Santariskiu Clinic Public Insti, Vilnius

1081 HV

Amsterdam UMC, Locatie VUMC; Neurology, Amsterdam

1105 AZ

Amsterdam UMC Location AMC, Amsterdam

6815 AD

Rijnstate; Internal Medicine Department, Arnhem

6525 GA

Radboudumc, NL -nijmegen

85-312

Nasz Lekarz Osrodek Badan Klinicznych, Bydgoszcz

40-660

Nzoz All-Medicus, Katowice

35-302

Gabinet Lekarski, Bartosz Korczowski, Rzeszów

70-351

Niepubliczny Zaklad Opieki Zdrowotnej SONOMED, Szczecin

00-631

Centrum Zdrowia MDM, Warsaw

02-781

Narodowy Instytut Onkologii im. Marii Skłodowskiej-Curie - Państwowy Instytut Badawczy, Warsaw

03-580

Nzoz Vivamed, Warsaw

52-210

PlanetMed, Wroclaw

53-114

LexMedica Osrodek Badan Klinicznych, Wroclaw

54-144

EuroMediCare Szpital Specjalistyczny z Przychodnią we Wrocławiu, Wroclaw

014461

SC Euroclinic Hospital SA, Bucharest

700-721

Kyungpook National University Hospital; Opthalmology, Daegu

03080

Seoul National University Hospital, Seoul

03722

Severance Hospital, Yonsei University, Seoul

06531

Samsung Medical Center, Seoul

138-736

Asan Medical Center., Seoul

442-723

The Catholic University of Korea St. Vincent's Hospital, Suwon

CB2 0QQ

Addenbrooke's Hospital, Cambridge

EX2 5DW

Royal Devon and Exeter Hospital (Wonford), Exeter

E1 2ES

The Royal London Hospital, London

NW1 - 2PG

University College London Hospital, London

SE1 7EH

St Thomas Hospital, London

SE5 9NU

King's College London, London

M8 5RB

Fairfield General Hospital, Manchester

NE1 4LP

Royal Victoria Infirmary, Newcastle upon Tyne

NG7 2UH

Nottingham University Hospitals; QMC Campus, Nottingham

SO16 6YD

Southampton General Hospital, Southampton

All Listed Sponsors
lead

Hoffmann-La Roche

INDUSTRY

NCT02100696 - A Study of the Efficacy and Safety of Etrolizumab in Participants With Ulcerative Colitis Who Have Been Previously Exposed to Tumor Necrosis Factor (TNF) Inhibitors | Biotech Hunter | Biotech Hunter