A Study to Assess Whether Etrolizumab is a Safe and Efficacious Treatment for Participants With Moderately to Severely Active Crohn's Disease

PHASE3CompletedINTERVENTIONAL
Enrollment

1,035

Participants

Timeline

Start Date

March 20, 2015

Primary Completion Date

September 7, 2021

Study Completion Date

September 7, 2021

Conditions
Crohn Disease
Interventions
DRUG

Etrolizumab

Etrolizumab will be administered as per regimen specified in individual arms.

DRUG

Placebo

Etrolizumab-matching placebo will be administered as per regimen specified in individual arms.

Trial Locations (327)

1000

CHU St Pierre (St Pierre), Brussels

1023

Medical Center of Limited Liability Company Medical Clinic Blagomed, Kyiv

1036

Obudai Egeszsegugyi Centrum Kft., Budapest

1070

Hospital Erasme, Brussels

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

1407

"City Clinic UMHAC EOOD", Sofia

1431

"UMHAT Sv. Ivan Rilski, EAD", Sofia

1527

UMHAT Tsaritsa Yoanna - ISUL, EAD, Sofia

2065

The Canberra Hospital, Garran

2091

"Med Center of International Institute of Clinical Trials LLC; Medical Center OK!Clinic+", Kyiv

2139

Concord Repatriation General Hospital, Concord

2143

Pest Megyei Flor Ferenc Korhaz, Kistarcsa

2200

Bankstown-Lidcombe Hospital, Bankstown

2650

UZ Antwerpen, Edegem

3004

Alfred Hospital, Melbourne

3010

Inselspital-Universitaetsspital Bern, Bern

3011

Footscray Hospital; Gastroenterology, Footscray

3012

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

3050

Royal Melbourne Hospital; Department of Colorectal Medicine and Genetics, Parkville

3065

St Vincent's Hospital Melbourne, Fitzroy

3143

Tauranga Hospital, Tauranga

3144

St Frances Xavier Cabrini Hospital, Malvern

3168

Monash Medical Centre Clayton, Clayton

3248

Waikato Hospital, Hamilton

4029

Royal Brisbane and Women's Hospital, Herston

4032

Debreceni Egyetem, Debrecen

4073

CI of Kyiv RC Regional Clinical Hospital #2, Kyiv

4101

Mater Adult Hospital, South Brisbane

4102

Princess Alexandra Hospital, Woolloongabba

4556

University of the Sunshine Coast, Sippy Downs

5020

LKH - Universitätsklinikum der PMU Salzburg, Salzburg

5042

Flinders Medical Centre, Bedford Park

5600

Bekes Megyei Kozponti Korhaz Dr. Rethy Pal Tagkorhaza, Békéscsaba

6150

Fiona Stanley Hospital, Murdoch

7405

Dr D Epstein Practice, Cape Town

7624

Pecsi Tudomanyegyetem, Pécs

8000

Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz, Székesfehérvár

8011

Christchurch Hospital NZ, Christchurch

8091

Universitätsspital Zürich, Zurich

9000

AZ Maria Middelares, Ghent

9016

Dunedin Public Hospital, Dunedin

9024

Petz Aladar Megyei Oktato Korhaz, Győr

10000

Clinical Hospital Center Sestre Milosrdnice, Zagreb

University Hospital Center Zagreb, Zagreb

10016

Concorde Medical Group, New York

10021

Weill Cornell Medical College (WCMC) - Judith Jaffe Multiple Sclerosis Center (JJMSC), New York

10075

Lenox Hill Hospital, New York

10128

Ospedale Umberto I di Torino, Turin

10617

West Tallinn Central Hospital, Tallinn

11000

Clinical Helth Centre Zvezdara, Belgrade

11040

Military Medical Academy, Belgrade

11080

University Hospital Medical Center Bezanijska kosa, Belgrade

11923

Hanyang University Guri Hospital, Gyeonggi-do

13353

Charite-Campus Virchow Klinikum; Hepatologie und Gastroenterologie, Berlin

13419

North Estonia Medical Centre Foundation, Tallinn

13520

CHA Bundang Medical Centre; CHA university, Seongnam

13605

Seoul National University Bundang Hospital, Seongnam-si

14004

Hospital Reina Sofia; Medical Oncology, Córdoba

14033

CHU de Caen - Hopital Cote de Nacre, Caen

14163

Krankenhaus Waldfriede e. V., Berlin

15355

Korea University Ansan Hospital, Gyeonggi-do

16100

Holy Family Hospital, Nazareth

17110

Great Lakes Medical Research, LLC, Harrisburg

18101

Haemek Medical Center, Afula

20089

Istituto Clinico Humanitas, Rozzano (MI)

20097

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

20121

Asst Fatebenefratelli Sacco (Fatebenefratelli), Milan

20157

ASST FATEBENEFRATELLI SACCO (Sacco), Milan

20162

Azienda Socio Sanitaria Territoriale Niguarda (Grande Ospedale Metropolitano Niguarda), Milan

21000

Clinical Center of Vojvodina, Novi Sad

21001

Private Small Enterprise Medical Center Pulse, Vinnytsia

21005

Hospital Juan Ramón Jiménez, Huelva

21018

M.I. Pyrogov VRCH Dept of Gastroenterology M.I. Pyrogov VNMU, Vinnytsia

21029

MCIC MC LLC Health Clinic, Vinnytsia

23000

General Hospital Djordje Joanovic, Zrenjanin

23249

McGuire Research Institute; Gastroenterology, Richmond

27514

University of North Carolina At Chapel Hill, Chapel Hill

28006

Hospital Universitario de la Princesa, Madrid

28207

Charlotte Gastroenterology and Hepatology, P.L.L.C, Charlotte

28222

Hospital Universitario Puerta de Hierro Majadahonda; Hepatology studies, Majadahonda

28501

Kinston Medical Specialists, Kinston

28942

Hospital Universitario de Fuenlabrada, Madrid

29604

Innovative Clinical Research, Greenville

30033

Atlanta Center for Gastroenterology, PC, Decatur

30060

Gastrointestinal Specialists of Georgia, PC, Marietta

30308

Emory University Hospital, Atlanta

30342

Atlanta Gastroenterology Associates, Atlanta

30625

Medizinische Hochschule Hannover; Gastroenterology and Hepatology dept, Hanover

31000

Clinical Hospital Centre Osijek, Osijek

31201

Gastroenterology Associates of Central Georgia, Macon

31904

Gastrointestinal Diseases Research, Columbus

32256

Borland-Groover Clinic, Jacksonville

32610

University of Florida College of Medicine, Gainesville

32789

Shafran Gastroenterology Center, Winter Park

33025

FQL Research, LLC, Miramar

33140

IMIC, Inc, Miami Beach

33180

Innovative Medical Research of South Florida, Aventura

33604

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

33762

West Central Gastroenterology d/b/a Gastro Florida, Clearwater

34349

Acibadem Fulya Hospital; Neurology, Istanbul

34655

Advanced Research Institute, Inc., Trinity

34668

Haydarpasa Numune Training and Research Hospital; Medical Oncology, Istanbul

34722

Medeniyet University Goztepe Training and Research Hospital; Chest Diseases, Istanbul

34742

Acibadem Kozyatagi Hospital; Gastroenterology, Kozyataği

35033

CHU Rennes - Hopital Pontchaillou, Rennes

35100

Ege University Medical Faculty, Izmir

36071

Complejo Hospitalario de Pontevedra, Pontevedra

37232

Vanderbilt University Medical Center, Nashville

38138

Gastroenterology Center of the MidSouth PC, Germantown

39216

University of Mississippi Medical Center; Division of Gastroenterology, Jackson

39617

Kremenchuk first city hospital n.a. O.T. Bohaievskyi; Gastroenterology department, Kremenchuk

40124

A.O.U. Policlinico di Modena, Modena

41009

Hospital Universitario Virgen Macarena, Seville

41013

Hospital Universitario Virgen del Rocio, Seville

41380

Kocaeli Universitesi Tip Fakultesi; Infectious Diseases, Kocaeli

41944

Kyungpook National University Hospital, Daegu

42055

CHU Saint Etienne - Hôpital Nord, Saint-Etienne

44060

Great Lakes Gastroenterology Research, LLC, Mentor

44093

CHU NANTES - Hôtel Dieu; Pharmacy, Nantes

44789

Berufsgenossenschaftliches Universitaetsklinikum Bergmannsheil GmbH, Bochum

45219

Consultants for Clinical Research Inc., Cincinnati

46026

Hospital Universitari i Politecnic La Fe, Valencia

47392

Inje University Busan Paik Hospital, Busan

48098

Center for Digestive Health, Troy

48322

Henry Ford Health System, West Bloomfield

49201

Dong-A University Hospital, Busan

49241

Pusan National University Hospital, Busan

49506

Gastroenterology Associates of Western Michigan, P.L.C., Grand Rapids

50009

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

Hospital Universitario Miguel Servet, Zaragoza

50134

Azienda Ospedaliera Universitaria Careggi, Florence

50937

Universitätsklinikum Koeln, Cologne

51014

Tartu University Hospital, Tartu

51092

CHU du Reims - Hopital Robert Debré, Reims

52000

General Hospital Pula, Pula

53792

University of Wisconsin, Madison

54003

City Hospital #1, Mykolaiv

54055

Clinical Research Institute, Tlalnepantla

54511

Hôpital de Brabois Adultes, Vandœuvre-lès-Nancy

55905

Mayo Clinic - Rochester; Gastrology, Rochester

58002

RCNECRCH Dept of Surgery, SHEI Ukr BSMU, Chernivtsi

59037

Hopital Claude Huriez - CHU Lille, Lille

60590

Klinikum der Johann Wolfgang Goethe-Universitaet, Frankfurt

60611

Northwestern University-Feinberg School of Medicine; Division of Gastroenterology and Hepatology, Chicago

60637

The University of Chicago Medical Center, Chicago

61037

CHI Prof.O.O.Shalimov Kharkiv City Clinical Hospital #2, Kharkiv

61039

GI L.T.Malaya Therapy National Institute of the NAMS of Ukraine, Kharkiv

61124

CHI Kharkiv City Clinical Hospital #13, Kharkiv

61204

CI of Healthcare Kharkiv Reg Clin Hosp-Center of Med Emergency & Accident Medicine, Kharkiv

64012

Ehrhardt Clinical Research, LLC, Belton

65059

Railway Transport Odesa CH of Healthcare Ctr Branch of PJSC Ukrainian Railway Dept of Therapy #2, Odesa

66606

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

67098

Höpital Hautepierre; Pediatrie1, Strasbourg

68167

Klinikum Mannheim GmbH Universitätsklinikum, Mannheim

69104

CI City Hospital #1, Zaporizhzhia

69106

LLC Diaservis, Zaporizhzhia

69495

Centre Hospitalier Lyon Sud; Service de Gastro-Enterologie, Pierre-Bénite

70809

Gastroenterology Associates, LLC, Baton Rouge

72076

Universitaetsklinikum Tuebingen, Tübingen

73112

Digestive Disease Specialists, Inc., Oklahoma City

75231

Texas Digestive Disease Consultants - Dallas, Dallas

75475

Hôpital Saint-Louis, Paris

75701

Tyler Research Institute, LLC, Tyler

76000

Ivano-Frankivsk Regional Clinical Hospital, Ivano-Frankivsk

76092

Texas Digestive Disease Consultants - Southlake, Southlake

77030

Baylor College of Medicine; Gastroenterology, Houston

Methodist Hospital Research Institute, Houston

77652

Gemeinschaftspraxis, Offenburg

78232

Wellness Clinical Research Center, San Antonio

79010

Lviv Regional Clinical Hospital, Lviv

80054

CHU Amiens - Hopital Sud, Amiens

80907

Peak Gastroenterology Associates; Gastroenterology, Colorado Springs

83104

IBDcentrum s.r.o., Bratislava

83642

Advanced Clinical Research, Meridian

84015

Ericksen Research and Development, Clinton

84132

University of Utah School of Medicine, Salt Lake City

89081

Universitaetsklinikum Ulm, Ulm

90822

VA Long Beach Healthcare System, Long Beach

91006

Valley Gastroenterology Consultants, Arcadia

92103

SDG Clinical Research, San Diego

92110

Hôpital Beaujon, Clichy

94070

Digestive Care Associates, A Medical Corporation, San Carlos

94158

University of California at San Francisco (PARENT); Gastroenterology, Hepatology & Nutrition, San Francisco

94901

KM Management spol. s r.o., Nitra

97070

Medical Care & Research SA de CV, Mérida

98101

Digestive Disease Institute; Virginia Mason Medical Center, Seattle

127015

Yusupov Hospital, Moskva

191015

North-Western Medical University n.a. I.I. Mechnikov; Rheumatology, Saint Petersburg

194044

Federal State Military Educational Institution; High Professional Education Military Medical Acad, Saint Petersburg

194356

Baltic Medicine, Saint Petersburg

196603

Evromedservis LCC, Pushkin

197110

SBIH City Clinical Hospital #31, Saint Petersburg

280146

Hospital Universitario La Paz, Madrid

300002

Centrul de Gastroenterologie Dr. Goldis, Timișoara

344022

"SEIHPE Rostov SMU of MoH of RF", Rostov-on-Don

630007

"LLC Novosibirsk GastroCenter", Novosibirsk

630091

SBEIHPE Novosibirsk State Medical University, Novosibirsk

644013

BHI of Omsk region Clinical Oncology Dispensary, Omsk

656050

SBEI HPE Altai StateMedicalUniversityofMoH andSD, Barnaul

772202

Spitalul Clinic Colentina, Bucharest

4941492

Rabin Medical Center-Beilinson Campus, Petah Tikva

5822012

Wolfson Medical Center; Obstetrics and Gynecology, Holon

6423906

Tel Aviv Sourasky Medical Center; Pharmacy, Tel Aviv

8410101

Soroka University Medical Centre, Beersheba

9103102

Shaare Zedek Medical Center, Jerusalem

9112001

Hadassah University Hospital - Ein Kerem, Jerusalem

92093-5354

University of California San Diego Medical Center, La Jolla

60453-3767

Southwest Gastroenterology; DM Clinical Research, Oak Lawn

61801-2500

Carle Foundation Hospital, Urbana

Unknown

Louisiana Research Center, LLC, Shreveport

Irkutsk State Medical Academy of Continuing Education, Irkutsk

Centro Médico Teknon, Barcelona

02302

Commonwealth Clinical Studies, Brockton

48109-0666

University of Michigan Health System, Ann Arbor

75390-9151

University of Texas Southwestern Medical Center; Internal Medicne, Dallas

C1181ACH

Hospital Italiano, Buenos Aires

70200-730

L2IP -Instituto de Pesquisas Clínicas Ltda., Brasília

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

21941-590

Hospital Universitario Clementino Fraga Filho - UFRJ; Gastroenterologia, Rio de Janeiro

22271-100

Instituto Brasil de Pesquisa Clínica-IBPCLIN S/A, Rio de Janeiro

99010-080

Hospital São Vicente de Paulo; Institute of Education and Reseach / Cardiovascular Research Unit, Passo Fundo

90035-903

Hospital das Clinicas - UFRGS, Porto Alegre

90160-092

Hospital Ernesto Dornelles, Porto Alegre

18618-970

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

09080-000

Pesquisare Saúde Sociedade Simples, Santo André

09090-790

Praxis Pesquisa Médica, Santo André

09190-610

Hospital Estadual Mario Covas, Santo André

15090-000

Hospital de Base de Sao Jose do Rio Preto, São José do Rio Preto

01308-050

Hospital Sírio-Libanês, São Paulo

04037-002

Hospital Sao Paulo, São Paulo

04039-901

Hospital do Servidor Público Estadual/HSPE-SP, São Paulo

T2N 2T9

University of Calgary, Calgary

T6G 2X8

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

V6Z 2K5

(G.I.R.I.) GI Research Institute, Vancouver

R3A 1R9

Winnipeg Regional Health Authority, Winnipeg

B3H 1V7

Queen Elizabeth II Health Sciences Centre; Gastroenterology Research, Halifax

N6A 5A5

University Hospital - London Health Sciences Centre, London

L1H 7K4

Taunton Health Centre, Oshawa

K1H 1A2

The Ottawa Hospital - Riverside Campus; Gastrointestinal Clinical Research Unit, Ottawa

M5G 1X5

Mount Sinai Hospital, Toronto

L4L 4Y7

Toronto Digestive Disease Associates, Vaughan

H1T 2M4

Hôpital Maisonneuve - Rosemont, Montreal

H4A 3J1

McGill University Health Centre - Glen Site, Montreal

S7N 0W8

Royal University Hospital, Saskatoon

636 00

Vojenska nemocnice Brno, Brno

656 91

Fakultni nemocnice u sv. Anny v Brne, Brno

370 01

Nemocnice Ceske Budejovice a.s., České Budějovice

500 02

Gastroenterologie s.r.o., Hradec Králové

500 05

Fakultni nemocnice Hradec Kralove, Hradec Králové

500 12

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

779 00

PreventaMed, s.r.o., Olomouc

708 52

Fakultni nemocnice Ostrava, Ostrava - Poruba

110 34

Fakultni nemocnice Kralovske Vinohrady, Prague

170 00

Klinicke centrum ISCARE Lighthouse, Prague

06202

CHU Nice - Hopital de l'Archet 2, Nice

06120

Universitaetsklinikum Halle (Saale), Halle

00152

Azienda Ospedaliera San Camillo Forlanini, Rome

00168

Policlinico Universitario Agostino Gemelli; Farmacia, Rome

LV 1002

Riga East Clinical University Hospital; Clinic Gailezers, Riga

LV-1002

Pauls Stradins Clinical University Hospital, Riga

LT-08661

Vilnius University Hospital Santariskiu Clinic, Public Institution; Cardiology, Vilnius

1081 HV

Amsterdam UMC, Locatie VUMC; Neurology, Amsterdam

1105 AZ

Amsterdam UMC Location AMC, Amsterdam

2333 ZA

Leids Universitair Medisch Centrum, Leiden

6229 HX

Maastricht University Medical Center, Maastricht

3000 CA

Erasmus Medisch Centrum, Rotterdam

6162 BG

Zuyderland Medisch Centrum - Sittard Geleen, Sittard-Geleen

5042AD

ETZ TweeSteden, Tilburg

0620

North Shore Hospital, Auckland

Shakespeare Specialist Group, Takapuna

15-275

SP ZOZ Wojewodzki Szpital Zespolony im. J. Sniadeckiego, Bialystok

85-312

Nasz Lekarz Osrodek Badan Klinicznych, Bydgoszcz

82-300

Elblaski Szpital Specjalistyczny z Przychodnia SP ZOZ, Elblag

25-355

ETG Kielce, Kielce

95-054

Centrum Opieki Zdrowotnej Orkan-Med, Ksawerów

20-015

Indywidualna Specjalistyczna Praktyka Lekarska, Lublin

34-400

Allmedica Badania Kliniczne Sp z o.o. Sp K., Nowy Targ

35-055

"Centrum Medyczne MEDYK", Rzeszów

35-302

Gabinet Lekarski, Bartosz Korczowski, Rzeszów

81-756

Specjalistyczna Praktyka Lekarska Dr med. Marek Horynski; endoskopia, Sopot

70-351

Niepubliczny Zaklad Opieki Zdrowotnej SONOMED, Szczecin

71-434

Twoja Przychodnia-Szczecinskie Centrum Medyczne, Szczecin

87-100

Gastromed Kopon Zmudzinski i Wspolnicy Sp.j.Specjalistyczne Centrum Gastrologii i Endoskopii Specj, Torun

00-631

Centrum Zdrowia MDM, Warsaw

00-728

Warsaw IBD Point Profesor Kierkus, Warsaw

02-018

Zespó Przychodni Specjalistycznych PRIMA, Warsaw

52-210

PlanetMed sp. z o.o., Wroclaw

53-114

LexMedica Osrodek Badan Klinicznych, Wroclaw

54-144

EuroMediCare Szpital Specjalistyczny z Przychodnią we Wrocławiu, Wroclaw

010719

S.C MedLife S.A, Bucharest

936 01

Accout Center s.r.o., Šahy

093 01

Endomed, s.r.o., Vranov nad Topľou

0002

Emmed Research, Pretoria

705-717

Yeungnam Univ. Hospital, Daegu

03080

Seoul National University Hospital, Seoul

03181

Kangbuk Samsung Hospital, Seoul

03722

Severance Hospital, Yonsei University Health System, Seoul

05505

Asan Medical Center, Seoul

06351

Samsung Medical Center, Seoul

220-701

Yonsei University Wonju Severance Christian Hospital, Wŏnju

08907

Hospital Universitario de Bellvitge, L'Hospitalet de Llobregat

08036

Hospital Clínic i Provincial; Servicio de Farmacia, Barcelona

06100

Ankara University Medical Faculty, Ankara

Hacettepe University Medical Faculty; Gastroenterology, Ankara

06500

Gazi University Medical Faculty, Ankara

01030

Kyiv CCH #18 Dept of Proctology O. O. Bogomolets NMU, Kyiv

BT12 6BA

Royal Victoria Hospital, Belfast

CB2 0QQ

Addenbrooke's Hospital, Cambridge

CV2 2DX

University Hospital Coventry, Coventry

EX2 5DW

Royal Devon and Exeter Hospital (Wonford), Exeter

PE30 4ET

Queen Elizabeth Hospital, Kings Lynn

LS9 7TF

St James University Hospital, Leeds

L7 8XP

Royal Liverpool University Hospital, Liverpool

E11 1NR

Whipps Cross Hospital, London

NW1 - 2PG

University College London Hospital, London

M8 5RB

Fairfield General Hospital, Manchester

NE1 4LP

Royal Victoria Infirmary; Stroke unit, Newcastle upon Tyne

NG7 2UH

Nottingham University Hospitals Queen's Medical Centre, Nottingham

RG1 5AN

Royal Berkshire Hospital, Reading

SO16 6YD

Southampton General Hospital, Southampton

WV10 0QP

Royal Wolverhampton hospital; McHale Building, Wolverhampton

All Listed Sponsors
lead

Hoffmann-La Roche

INDUSTRY

NCT02394028 - A Study to Assess Whether Etrolizumab is a Safe and Efficacious Treatment for Participants With Moderately to Severely Active Crohn's Disease | Biotech Hunter | Biotech Hunter