Open-Label Extension and Safety Study for Participants With Crohn's Disease Previously Enrolled in the Etrolizumab Phase III Study GA29144

NCT ID: NCT02403323

Last Updated: 2024-12-02

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 790 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-06-08
• Study Completion Date: 2023-10-09

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.

Conditions

Crohn Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Part 1: Etrolizumab Open-Label Extension

Participants will receive open-label treatment with etrolizumab once every 4 weeks until commercial availability in their country or sponsor's decision to terminate the study, whichever is earlier (up to approximately 10 years after the first patient is enrolled).

Group Type: EXPERIMENTAL

Etrolizumab

Intervention Type: DRUG

105 mg etrolizumab subcutaneous administration once every 4 weeks

Part 2: Safety Monitoring

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Etrolizumab

105 mg etrolizumab subcutaneous administration once every 4 weeks

Intervention Type: DRUG

Other Intervention Names

RG7413

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:

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hoffmann-La Roche

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

Medeniyet University Goztepe Training and Research Hospital.

Kadiköy, , Turkey (Türkiye)

Valley Gastroenterology Consultants

Arcadia, California, United States

University of California San Diego Medical Center

La Jolla, California, United States

VA Long Beach Healthcare System

Long Beach, California, United States

Digestive Care Associates, A Medical Corporation

San Carlos, California, United States

SDG Clinical Research

San Diego, California, United States

Uni. of California at San Francisco; Dept Pediatric, Div. of Gastroenterology, Hepatology & Nutri

San Francisco, California, United States

Peak Gastroenterology Associates

Colorado Springs, Colorado, United States

Innovative Medical Research of South Florida

Aventura, Florida, United States

West Central Gastroenterology d/b/a Gastro Florida

Clearwater, Florida, United States

University of Florida College of Medicine

Gainesville, Florida, United States

Borland-Groover Clinic

Jacksonville, Florida, United States

IMIC, Inc

Miami Beach, Florida, United States

FQL Research, LLC

Miramar, Florida, United States

Shafran Gastroenterology Center

Winter Park, Florida, United States

Emory University Hospital

Atlanta, Georgia, United States

Atlanta Gastroenterology Associates

Atlanta, Georgia, United States

Columbus Regional Research Institute

Columbus, Georgia, United States

Atlanta Center for Gastroenterology, PC

Decatur, Georgia, United States

Gastroenterology Associates of Central Georgia

Macon, Georgia, United States

Gastrointestinal Specialists of Georgia, PC

Marietta, Georgia, United States

Advanced Clinical Research

Spokane, Idaho, United States

Northwestern Uni-Feinberg School of Medicine

Chicago, Illinois, United States

University of Chicago Medical Center

Chicago, Illinois, United States

Southwest Gastroenterology

Oak Lawn, Illinois, United States

Carle Foundation Hospital

Urbana, Illinois, United States

Cotton-O'Neil Clinical Research Center, Digestive Health

Topeka, Kansas, United States

Gastroenterology Associates, LLC

Baton Rouge, Louisiana, United States

Louisiana Research Center, LLC

Shreveport, Louisiana, United States

University of Michigan

Ann Arbor, Michigan, United States

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

Grand Rapids, Michigan, United States

Henry Ford Health System

Novi, Michigan, United States

Center for Digestive Health

Troy, Michigan, United States

Mayo Clinic - Rochester

Rochester, Minnesota, United States

University of Mississippi Medical Center

Jackson, Mississippi, United States

Ehrhardt Clinical Research, LLC

Belton, Missouri, United States

Concorde Medical Group

New York, New York, United States

Weill Cornell Medical College-New York Presbyterian Hospital

New York, New York, United States

Lenox Hill Hospital

New York, New York, United States

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States

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

Charlotte, North Carolina, United States

Vidant Medical Group, LLC DBA Vidant Multispeciality Clinic-Kinston

Kinston, North Carolina, United States

Consultants for Clinical Research Inc.

Cincinnati, Ohio, United States

Great Lakes Gastroenterology Research, LLC

Mentor, Ohio, United States

Digestive Disease Specialists, Inc.

Oklahoma City, Oklahoma, United States

Great Lakes Medical Research, LLC

Harrisburg, Pennsylvania, United States

Innovative Clinical Research

Greenville, South Carolina, United States

Gastro One

Germantown, Tennessee, United States

Vanderbilt University Medical Center

Nashville, Tennessee, United States

University of Texas Southwestern Medical Center; Internal Medicne

Dallas, Texas, United States

Baylor College of Medicine

Houston, Texas, United States

Methodist Hospital Research Institute

Houston, Texas, United States

Wellness Clinical Research Center

San Antonio, Texas, United States

Texas Digestive Disease Consultants - Southlake

Southlake, Texas, United States

Digestive Health Specialists of Tyler

Tyler, Texas, United States

Ericksen Research and Development

Clinton, Utah, United States

University of Utah School of Medicine

Salt Lake City, Utah, United States

McGuire Research Institute; Gastroenterology

Richmond, Virginia, United States

Digestive Disease Institute; Virginia Mason Medical Center

Seattle, Washington, United States

University of Wisconsin

Madison, Wisconsin, United States

Hospital Italiano

CABA, , Argentina

The Canberra Hospital

Garran, Australian Capital Territory, Australia

Concord Repatriation General Hospital

Concord, New South Wales, Australia

Royal Brisbane and Women's Hospital

Herston, Queensland, Australia

University of the Sunshine Coast

Sippy Downs, Queensland, Australia

Mater Adult Hospital

South Brisbane, Queensland, Australia

Princess Alexandra Hospital

Woolloongabba, Queensland, Australia

Flinders Medical Centre

Bedford Park, South Australia, Australia

St Vincent's Hospital Melbourne

Fitzroy, Victoria, Australia

Footscray Hospital

Footscray, Victoria, Australia

St Frances Xavier Cabrini Hospital

Malvern, Victoria, Australia

Royal Melbourne Hospital; Department of Colorectal Medicine and Genetics

Parkville, Victoria, Australia

The Alfred Hospital

Prahan, Victoria, Australia

Fiona Stanley Hospital

Murdoch, Western Australia, Australia

LKH - Universitätsklinikum der PMU Salzburg

Salzburg, , Austria

Medizinische Universität Wien

Vienna, , Austria

CHU St Pierre (César de Paepe) X

Brussels, , Belgium

ULB Hopital Erasme; Service de Néphrologie

Brussels, , Belgium

UZ Brussel

Brussels, , Belgium

UZ Antwerpen

Edegem, , Belgium

AZ Maria Middelares

Ghent, , Belgium

Instituto Goiano de Gastroenterologia e Endoscopia Digestiva Ltda

Goiânia, Goiás, Brazil

Hospital Felicio Rocho

Belo Horizonte, Minas Gerais, Brazil

Centro Digestivo de Curitiba

Curitiba, Paraná, Brazil

Instituto Brasil de Pesquisa Clínica-IBPCLIN S/A

Rio de Janeiro, Rio de Janeiro, Brazil

Hospital Sao Vicente de Paulo

Passo Fundo, Rio Grande do Sul, Brazil

Hospital das Clinicas - UFRGS

Porto Alegre, Rio Grande do Sul, Brazil

Hospital Ernesto Dornelles

Porto Alegre, Rio Grande do Sul, Brazil

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

Botucatu, São Paulo, Brazil

Pesquisare Saúde Sociedade Simples

Santo André, São Paulo, Brazil

Praxis Pesquisa Médica

Santo André, São Paulo, Brazil

Hospital Estadual Mario Covas

São Bernardo do Campo, São Paulo, Brazil

Hospital de Base de Sao Jose do Rio Preto

São José do Rio Preto, São Paulo, Brazil

Hospital Sírio-Libanês

São Paulo, São Paulo, Brazil

Universidade Federal de Sao Paulo - UNIFES

São Paulo, São Paulo, Brazil

Hospital do Servidor Público Estadual/HSPE-SP

São Paulo, São Paulo, Brazil

"City Clinic UMHAC" EOOD

Sofia, , Bulgaria

UMHAT "Sv. Ivan Rilski", EAD

Sofia, , Bulgaria

University of Calgary

Calgary, Alberta, Canada

Zeidler Ledcor Centre - University of Alberta; Division of Gasroenterology

Edmonton, Alberta, Canada

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

Vancouver, British Columbia, Canada

Winnipeg Regional Health Authority; Neurosurgery Department

Winnipeg, Manitoba, Canada

Queen Elizabeth II Health Sciences Centre; Gastroenterology Research

Halifax, Nova Scotia, Canada

University Hospital - London Health Sciences Centre

London, Ontario, Canada

Taunton Health Centre

Oshawa, Ontario, Canada

The Ottawa Hospital - Riverside Campus; Gastrointestinal Clinical Research Unit

Ottawa, Ontario, Canada

Mount Sinai Hospital

Toronto, Ontario, Canada

Toronto Digestive Disease Associates

Vaughan, Ontario, Canada

Hôpital Maisonneuve - Rosemont

Montreal, Quebec, Canada

McGill University Health Centre - Glen Site

Montreal, Quebec, Canada

Royal University Hospital

Saskatoon, Saskatchewan, Canada

Clinical Hospital Centre Osijek

Osijek, , Croatia

General Hospital Pula

Pula, , Croatia

Clinical Hospital Center Sestre Milosrdnice

Zagreb, , Croatia

Vojenska nemocnice Brno

Brno, , Czechia

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

Brno, , Czechia

Nemocnice Ceske Budejovice a.s.

České Budějovice, , Czechia

Gastroenterologie s.r.o.

Hradec Králové, , Czechia

Fakultni nemocnice Hradec Kralove

Hradec Králové, , Czechia

Hepato-Gastroenterologie HK, s.r.o.

Hradec Králové, , Czechia

PreventaMed, s.r.o.

Olomouc, , Czechia

Fakultni nemocnice Ostrava

Ostrava - Poruba, , Czechia

Fakultni nemocnice Kralovske Vinohrady

Prague, , Czechia

ISCARE a.s.

Prague, , Czechia

West Tallinn Central Hospital

Tallinn, , Estonia

North Estonia Medical Centre Foundation

Tallinn, , Estonia

Tartu University Hospital

Tartu, , Estonia

CHU Amiens - Hopital Sud

Amiens, , France

CHU de Caen Hopital Cote de Nacre

Caen, , France

Hôpital Beaujon

Clichy, , France

Hopital Claude Huriez - CHU Lille

Lille, , France

CHU NANTES - Hôtel Dieu; Pharmacy

Nantes, , France

CHU Nice - Hopital de l'Archet 2

Nice, , France

Hôpital Saint-Louis

Paris, , France

Groupe Hospitalier Sud - Hôpital Haut-Lévêque - USN

Pessac, , France

Centre Hospitalier Lyon Sud; Service de Gastro-Enterologie

Pierre-Bénite, , France

CHU du Reims - Hopital Robert Debré

Reims, , France

CHU Saint Etienne - Hôpital Nord

Saint-Etienne, , France

Höpital Hautepierre; Pediatrie1

Strasbourg, , France

Hôpital de Brabois Adultes

Vandœuvre-lès-Nancy, , France

Charite-Campus Virchow Klinikum; Hepatologie und Gastroenterologie

Berlin, , Germany

Krankenhaus Waldfriede e. V.

Berlin, , Germany

Berufsgenossenschaftliches Universitaetsklinikum Bergmannsheil GmbH

Bochum, , Germany

Klinikum der Johann Wolfgang Goethe-Universitaet

Frankfurt, , Germany

Medizinische Hochschule Hannover

Hanover, , Germany

Klinikum Mannheim GmbH Universitätsklinikum

Mannheim, , Germany

Gemeinschaftspraxis

Schweinfurt, , Germany

Universitaetsklinikum Ulm

Ulm, , Germany

Bekes Megyei Kozponti Korhaz Dr. Rethy Pal Tagkorhaza

Békéscsaba, , Hungary

Obudai Egeszsegugyi Centrum Kft.

Budapest, , Hungary

Semmelweis Egyetem; Belgyogyaszati es Hematologiai Klinika

Budapest, , Hungary

Szt Janos Korhaz es EbudaiEgyesitettKorhazak

Budapest, , Hungary

Pannonia Maganorvosi Centrum

Budapest, , Hungary

Debreceni Egyetem Klinikai Központ; B?rgyógyászati Klinika

Debrecen, , Hungary

Petz Aladar Megyei Oktato Korhaz

Győr, , Hungary

Pest Megyei Flor Ferenc Korhaz

Kistarcsa, , Hungary

Haemek Medical Center

Afula, , Israel

Soroka University Medical Centre

Beersheba, , Israel

Wolfson Medical Center

Holon, , Israel

Shaare Zedek Medical Center

Jerusalem, , Israel

Holy Family Hospital

Nazareth, , Israel

Rabin Medical Center-Beilinson Campus

Petah Tikva, , Israel

Tel Aviv Sourasky Medical Center; Pharmacy

Tel Aviv, , Israel

A.O.U. Policlinico di Modena

Modena, Emilia-Romagna, Italy

Policlinico Universitario Agostino Gemelli; Farmacia

Rome, Lazio, Italy

Azienda Ospedaliera San Camillo Forlanini

Rome, Lazio, Italy

Asst Fatebenefratelli Sacco (Fatebenefratelli)

Milan, Lombardy, Italy

Istituto Clinico Humanitas

Rozzano (MI), Lombardy, Italy

I.R.C.C.S Policlinico San Donato

San Donato Milanese (MI), Lombardy, Italy

Azienda Ospedaliera Universitaria Careggi

Florence, Tuscany, Italy

Pauls Stradins Clinical University Hospital

R?ga, , Latvia

Riga East Clinical University Hospital, clinic "Gailezers"; Department of Endoscopy

Riga, , Latvia

Hospital of Lithuanian University of Health. Sciences Kaunas Clinics

Kaunas, , Lithuania

Vilnius University Hospital Santariskiu Clinics, Public Inst; Department of Clinical Pharmacology

Vilnius, , Lithuania

Clinical Research Institute

Tlalnepantla, Mexico CITY (federal District), Mexico

Medical Care & Research SA de CV

Mérida, Yucatán, Mexico

Amsterdam UMC, Locatie VUMC; Gastroenterology

Amsterdam, , Netherlands

Amsterdam UMC Location AMC

Amsterdam, , Netherlands

Leids Universitair Medisch Centrum; Cardiology

Leiden, , Netherlands

Maastricht University Medical Center

Maastricht, , Netherlands

Erasmus Medisch Centrum

Rotterdam, , Netherlands

Zuyderland Medisch Centrum - Sittard Geleen

Sittard-Geleen, , Netherlands

ETZ TweeSteden

Tilburg, , Netherlands

North Shore Hospital

Auckland, , New Zealand

Christchurch Hospital NZ

Christchurch, , New Zealand

Dunedin Public Hospital

Dunedin, , New Zealand

Waikato Hospital

Hamilton, , New Zealand

Hutt Hospital

Lower Hutt, , New Zealand

Shakespeare Specialist Group

Takapuna, , New Zealand

Tauranga Hospital

Tauranga, , New Zealand

SP ZOZ Wojewodzki Szpital Zespolony im. J. Sniadeckiego

Bia?ystok, , Poland

Nasz Lekarz Osrodek Badan Klinicznych

Bydgoszcz, , Poland

Elblaski Szpital Specjalistyczny z Przychodnia SP ZOZ

Elblag, , Poland

ETG Kielce

Kielce, , Poland

Centrum Opieki Zdrowotnej Orkan-Med

Ksawerów, , Poland

Indywidualna Specjalistyczna Praktyka Lekarska

Lublin, , Poland

Allmedica Badania Kliniczne Sp z o.o. Sp K.

Nowy Targ, , Poland

Centrum Medyczne "MEDYK"

Rzeszów, , Poland

Gabinet Lekarski, Bartosz Korczowski

Rzeszów, , Poland

Niepubliczny Zaklad Opieki Zdrowotnej SONOMED

Szczecin, , Poland

Twoja Przychodnia-Szczecinskie Centrum Medyczne

Szczecin, , Poland

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

Toru?, , Poland

Centrum Zdrowia MDM

Warsaw, , Poland

Zespó Przychodni Specjalistycznych PRIMA

Warsaw, , Poland

Przychodnia EuroMediCare

Wroc?aw, , Poland

PlanetMed sp. z o.o.

Wroc?aw, , Poland

LexMedica Osrodek Badan Klinicznych

Wroclaw, , Poland

S.C MedLife S.A

Bucharest, , Romania

Spitalul Clinic Colentina

Sector 2, , Romania

Centrul de Gastroenterologie Dr. Goldis

Timișoara, , Romania

LLC "Novosibirsk GastroCenter"

Novosibirsk, Altaj, Russia

SBEI HPE Altai StateMedicalUniversityofMoH andSD

Barnaul, Altayskiy Kray, Russia

LEC at SBIH of Moscow "City Clinical Hospital # 24"; Gastroenterology

Moscow, Moscow Oblast, Russia

SEIHPE "Rostov SMU of MoH of RF"

Rostov-on-Don, Rostov Oblast, Russia

Evromedservis LCC

Pushkin, Sankt-Peterburg, Russia

Federal State Military Educational Inst. of High Prof. Edu Military Medical Acad; Therapy department

Saint Petersburg, Sankt-Peterburg, Russia

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

Saint Petersburg, Sankt-Peterburg, Russia

Baltic Medicine

Saint Petersburg, Sankt-Peterburg, Russia

SBIH City Clinical Hospital #31

Saint Petersburg, Sankt-Peterburg, Russia

Irkutsk State Medical Academy of Continuing Education

Irkutsk, , Russia

SBEIHPE Novosibirsk State Medical University

Novosibirsk, , Russia

BHI of Omsk region Clinical Oncology Dispensary

Omsk, , Russia

Clinical Center Zvezdara

Belgrade, , Serbia

Military Medical Academy

Belgrade, , Serbia

General Hospital Djordje Joanovic

Zrenjanin, , Serbia

Endomed, s.r.o.

Košice, , Slovakia

KM Management spol. s r.o.

Nitra, , Slovakia

Accout Center s.r.o.

Šahy, , Slovakia

Dr D Epstein Practice

Cape Town, , South Africa

Emmed Research

Pretoria, , South Africa

Dong-A University Hospital

Busan, , South Korea

Kyungpook National University Hospital

Daegu, , South Korea

Yeungnam Univ. Hospital

Daegu, , South Korea

Korea University Ansan Hospital

Gyeonggi-do, , South Korea

CHA Bundang Medical Centre; CHA university

Seongnam, , South Korea

Seoul National University Bundang Hospital

Seongnam-si, , South Korea

Kangbuk Samsung Hospital

Seoul, , South Korea

Asan Medical Center

Seoul, , South Korea

Samsung Medical Center

Seoul, , South Korea

Yonsei University Wonju Severance Christian Hospital

Wŏnju, , South Korea

Hospital Universitario de Bellvitge

L'Hospitalet de Llobregat, Barcelona, Spain

Hospital Clínic i Provincial; Servicio de Farmacia

Barcelona, , Spain

Hospital Reina Sofia; Medical Oncology

Córdoba, , Spain

Hospital Juan Ramón Jiménez

Huelva, , Spain

Hospital Universitario de la Princesa

Madrid, , Spain

Hospital Universitario La Paz

Madrid, , Spain

Hospital Universitario de Fuenlabrada

Madrid, , Spain

Hospital Universitario Virgen Macarena

Seville, , Spain

Hospital Universitario Virgen del Rocio

Seville, , Spain

Hospital Universitari i Politecnic La Fe

Valencia, , Spain

Hospital Universitario Miguel Servet

Zaragoza, , Spain

Inselspital-Universitaetsspital Bern

Bern, , Switzerland

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

Bern, , Switzerland

Universitätsspital Zürich

Zurich, , Switzerland

Hacettepe University Medical Faculty; Gastroenterology

Ankara, , Turkey (Türkiye)

Gazi University Medical Faculty

Ankara, , Turkey (Türkiye)

Acibadem Fulya Hospital; Neurology

Istanbul, , Turkey (Türkiye)

Haydarpasa Numune Training and Research Hospital; Gastroenterology

Istanbul, , Turkey (Türkiye)

Kocaeli Universitesi Tip Fakultesi; Infectious Diseases

Kocaeli, , Turkey (Türkiye)

Acibadem Kozyatagi Hospital; Gastroenterology

Kozyata?i, , Turkey (Türkiye)

CNE Prof. O.O. Shalimov Kharkiv City Clinical Hospital #2 of KCC

Kharkiv, Kharkiv Governorate, Ukraine

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

Kharkiv, Kharkiv Governorate, Ukraine

LLC Gastroenterology Center IBD Team

Zaporizhzhia, Kharkiv Governorate, Ukraine

Medical Center of Limited Liability Company Medical Clinic Blagomed

Kyiv, KIEV Governorate, Ukraine

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

Kyiv, KIEV Governorate, Ukraine

CI of Kyiv RC Regional Clinical Hospital #2

Kyiv, KIEV Governorate, Ukraine

Lviv Regional Clinical Hospital

Lviv, KIEV Governorate, Ukraine

Ivano-Frankivsk Regional Clinical Hospital

Ivano-Frankivsk, Kuban People's Republica, Ukraine

RCI Chernivtsi RCH Dep of Surgery Bukovinian SMU

Chernivtsi, , Ukraine

CHI Kharkiv City Clinical Hospital #13

Kharkiv, , Ukraine

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

Odesa, , Ukraine

Private Small Enterprise Medical Center Pulse

Vinnytsia, , Ukraine

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

Vinnytsia, , Ukraine

MCIC MC LLC Health Clinic

Vinnytsia, , Ukraine

Royal Victoria Hospital

Belfast, , United Kingdom

University Hospital Coventry

Coventry, , United Kingdom

Royal Devon and Exeter Hospital (Wonford)

Exeter, , United Kingdom

Queen Elizabeth Hospital

Kings Lynn, , United Kingdom

St James University Hospital

Leeds, , United Kingdom

Royal Liverpool University Hospital

Liverpool, , United Kingdom

Whipps Cross Hospital

London, , United Kingdom

University College London Hospital

London, , United Kingdom

Fairfield General Hospital

Manchester, , United Kingdom

Royal Victoria Infirmary; Stroke unit

Newcastle upon Tyne, , United Kingdom

Nottingham University Hospitals Queen's Medical Centre

Nottingham, , United Kingdom

Royal Berkshire Hospital

Reading, , United Kingdom

Southampton General Hospital

Southampton, , United Kingdom

Countries

United States; Argentina; Australia; Austria; Belgium; Brazil; Bulgaria; Canada; Croatia; Czechia; Estonia; France; Germany; Hungary; Israel; Italy; Latvia; Lithuania; Mexico; Netherlands; New Zealand; Poland; Romania; Russia; Serbia; Slovakia; South Africa; South Korea; Spain; Switzerland; Turkey (Türkiye); Ukraine; United Kingdom

References

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.

Reference Type: DERIVED

PMID: 32445184 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

2014-003855-76

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

GA29145

Identifier Type: -

Identifier Source: org_study_id