A Study of the Efficacy and Safety of Etrolizumab Treatment in Maintenance of Disease Remission in Ulcerative Colitis (UC) Participants Who Are Naive to Tumor Necrosis Factor (TNF) Inhibitors

PHASE3CompletedINTERVENTIONAL
Enrollment

359

Participants

Timeline

Start Date

August 12, 2014

Primary Completion Date

April 6, 2020

Study Completion Date

April 6, 2020

Conditions
Colitis, Ulcerative
Interventions
DRUG

Etrolizumab

Participants will receive 105 mg etrolizumab SC injection Q4W.

DRUG

Placebo

Participants will receive placebo (matched to etrolizumab) SC injection Q4W.

Trial Locations (104)

1136

Pannónia Klinika Magánorvosi, Budapest

2143

Pest Megyei Flor Ferenc Korhaz, Kistarcsa

2730

Herlev og Gentofte Hospital, Herlev

4032

Debreceni Egyetem Klinikai Kozpont, Debrecen

6600

Csongrad Megyei Dr. Bugyi Istvan Korhaz, Szentes

7708

Dr JP Wright Practice, Cape Town

8230

DRC Gyogyszervizsgalo Kozpont Kft, Balatonfüred

9100

Alborg Universitets Hospital, Aalborg

10016

Manhattan Clinical Research, New York

10021

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

10117

Charite Universitaetsmedizin Berlin - Campus Charite Mitte, Berlin

16100

Holy Family Hospital, Nazareth

20017

Ospedale di Circolo; Neuropsichiatria Infantile, Rho

21018

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

21339

Medizinisches Zentrum Klinikum Lueneburg, Lüneburg

23249

McGuire Research Institute; Gastroenterology, Richmond

25124

Fondazione Poliambulanza Istituto Ospedaliero, Brescia

27599

UNC at Chapel Hill - Dpt of Family Medicine; Center for Functional GI and Motility Disorders, Chapel Hill

28501

Kinston Medical Specialists, Kinston

28801

Asheville Gastroenterology Associates, P.A., Asheville

30625

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

31048

Bnei Zion Medical Center; Department of Internal Medicine B, Haifa

32789

Shafran Gastroenterology Center, Winter Park

33140

IMIC, Inc, Miami Beach

33155

Regenerate Clinical Trials, Miami

33762

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

34000

Instituto de Investigaciones Aplicadas a la Neurociencia A.C., Durango

34655

Advanced Research Institute, Inc., Trinity

36011

M.V. Sklifosovskyi Poltava RCH Dept of Gastroenterology HSEIU UMSA, Poltava

39216

University of Mississippi Medical Center, Jackson

40022

CI of SRC Sumy RCH Dept of Rheumatology Sumy SU MI, Sumy

44789

Berufsgenossenschaftliches Universitaetsklinikum Bergmannsheil GmbH, Bochum

47150

Aquiant Research, New Albany

48098

Center for Digestive Health, Troy

48202

Henry Ford Health System, Detroit

54769

Phylasis Clinicas Research S de RL de CV, Estado de México

55455

University of Minnesota, Minneapolis

60453

Southwest Gastroenterology, Oak Lawn

60590

Klinik Johann Wolfgang von Goethe Uni, Frankfurt

60611

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

64012

Ehrhardt Clinical Research, LLC, Belton

64610

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

65117

Odessa regional clinical Hospital, Odesa

65691

Fakultni nemocnice u sv. Anny v Brne; I.Interni kardioangiologicka klinika, Brno

68167

Klinikum Mannheim GmbH Universitätsklinikum, Mannheim

73479

Ärztezentrum Ellwangen; Gemeinschaftspraxis, Ellwangen

75231

Texas Digestive Disease Consultants - Dallas, Dallas

75701

Digestive Health Specialists of Tyler, Tyler

76092

Texas Digestive Disease Consultants - Southlake, Southlake

79010

Lviv Regional Clinical Hospital, Lviv

80026

Clinical Research of the Rockies, Lafayette

80907

Peak Gastroenterology Associates; Gastroenterology, Colorado Springs

84015

Ericksen Research and Development, Clinton

84132

University of Utah School of Medicine, Salt Lake City

88009

SI Divisional Clinical Hospital of Uzhgorod Station of ST&BA LZ Dep of Therapy SHEI Uzhgorod NU, Uzhhorod

88018

A.Novak Transcarpathian Regional Clinical Hospital, Uzhhorod

90127

Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone, Palermo

92103

Clinical Applications Laboratories, Inc., San Diego

92868

University of California, Irvine Medical Center, Orange

93003

Ventura Clinical Trials, Ventura

94115

University of California at San Francisco, San Francisco

98004

Northwest Gastroenterology Associates, Bellevue

110017

Pushpawati Singhania Research Institute, New Delhi

141001

Dayanand Medical College and Hospital, Ludhiana

302001

S. R. Kalla Memorial General Hospital, Jaipur

360005

Shree Giriraj Multispeciality Hospital, Rajkot

395002

Nirmal Hospital, Surat

411011

King Edward Memorial Hospital Research Centre, Pune

440012

Midas institute of Gastroenterology, Nagpur

500012

Osmania General Hospital, Hyderabad

500058

Deccan College of Medical Sciences and Allied Hospitals, Hyderabad

560054

M. S. Ramaiah Medical College and Hospital, Bengaluru

575001

Kasturba Medical College & Hospital, Mangalore

590010

K.L.E. Society's Dr. Prabhakar Kore Hospital and Medical Research Centre, Belagavi

6093000

Assaf Harofeh Medical Center, Beer Yaacov

9103102

Shaare Zedek Medical Center, Jerusalem

9112001

Hadassah University Hospital - Ein Kerem, Jerusalem

00157

Ospedale Sandro Pertini, Rome

02-018

Zespó Przychodni Specjalistycznych PRIMA, Warsaw

53-114

LexMedica Osrodek Badan Klinicznych, Wroclaw

950 01

Fakultna nemocnica Nitra, Nitra

093 01

Endomed, s.r.o., Vranov nad Topľou

0002

Emmed Research, Pretoria

04107

CI of Kyiv RC Kyiv Regional Clinical Hospital, Kyiv

Unknown

Louisiana Research Center, LLC, Shreveport

02302

Commonwealth Clinical Studies, Brockton

60430-370

Hospital Universitario Walter Cantidio - UFC, Fortaleza

80430-160

Centro Digestivo de Curitiba, Curitiba

90035-001

Hospital Moinhos de Vento, Porto Alegre

17210-190

CECIP - Centro de Estudos Clínicos do Interior Paulista, Jaú

09080-000

Pesquisare Saúde Sociedade Simples, Santo André

09190-610

Hospital Estadual Mario Covas, Santo André

01308-050

Hospital Sírio-Libanês, São Paulo

04039-901

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

V6Z 2K5

Pacific Gastroenterology Associates, Vancouver

B3H 1V7

Queen Elizabeth II Health Sciences Centre; Gastroenterology Research, Halifax

N6A 5A5

LHSC - University Hospital; Movement Disorders Program, London

N6A 5W9

London Health Sciences Centre Victoria Hospital; Research Pharmacy, London

M5G 1X5

Mount Sinai Hospital, Toronto

L4L 4Y7

Toronto Digestive Disease Associates, Vaughan

500 12

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

180 01

Nemocnice Na Bulovce, Prague

07740

Universitaetsklinikum Jena; Apotheke des Uniersitätsklinikums Jena, Jena

411 001

Ruby Hall Clinic, Pune

All Listed Sponsors
lead

Hoffmann-La Roche

INDUSTRY

NCT02165215 - A Study of the Efficacy and Safety of Etrolizumab Treatment in Maintenance of Disease Remission in Ulcerative Colitis (UC) Participants Who Are Naive to Tumor Necrosis Factor (TNF) Inhibitors | Biotech Hunter | Biotech Hunter