AzTrials
AzTrials

Crohn DiseasePhase 3JUNIPERNCT02403323

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

A Phase 3 study testing Etrolizumab in people with Crohn Disease, run by Hoffmann-La Roche at 287 sites in 33 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Crohn Disease
What is being tested?
Etrolizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
790 participants
Where
287 sitesin 33 countries
Study dates
8 Jun 2015to 9 Oct 2023
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • Part 1 Open-Label Extension:
  • Any new, significant, uncontrolled condition
  • Part 2 Safety Monitoring:
  • No exclusion criteria

Trial locations and contacts

287 sites in 33 countries.

287 sites in 33 countries

United States59 sites

  • University of Michigan

    Ann Arbor, Michigan, 48109

  • Valley Gastroenterology Consultants

    Arcadia, California, 91006

  • Emory University Hospital

    Atlanta, Georgia, 30322

  • Atlanta Gastroenterology Associates

    Atlanta, Georgia, 30342

  • Innovative Medical Research of South Florida

    Aventura, Florida, 33180

  • Gastroenterology Associates, LLC

    Baton Rouge, Louisiana, 70809

  • Ehrhardt Clinical Research, LLC

    Belton, Missouri, 64012

  • University of North Carolina at Chapel Hill

    Chapel Hill, North Carolina, 27599

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

    Charlotte, North Carolina, 28207

  • Northwestern Uni-Feinberg School of Medicine

    Chicago, Illinois, 60611

  • University of Chicago Medical Center

    Chicago, Illinois, 60637

  • Consultants for Clinical Research Inc.

    Cincinnati, Ohio, 45219

  • West Central Gastroenterology d/b/a Gastro Florida

    Clearwater, Florida, 33756

  • Ericksen Research and Development

    Clinton, Utah, 84015

  • Peak Gastroenterology Associates

    Colorado Springs, Colorado, 80907

  • Columbus Regional Research Institute

    Columbus, Georgia, 31904

  • University of Texas Southwestern Medical Center; Internal Medicne

    Dallas, Texas, 75390-9151

  • Atlanta Center for Gastroenterology, PC

    Decatur, Georgia, 30033

  • University of Florida College of Medicine

    Gainesville, Florida, 32610

  • Gastro One

    Germantown, Tennessee, 38138

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

    Grand Rapids, Michigan, 49506

  • Innovative Clinical Research

    Greenville, South Carolina, 29604

  • Great Lakes Medical Research, LLC

    Harrisburg, Pennsylvania, 17110

  • Baylor College of Medicine

    Houston, Texas, 77030

  • Methodist Hospital Research Institute

    Houston, Texas, 77030

  • University of Mississippi Medical Center

    Jackson, Mississippi, 39216

  • Borland-Groover Clinic

    Jacksonville, Florida, 32256

  • Vidant Medical Group, LLC DBA Vidant Multispeciality Clinic-Kinston

    Kinston, North Carolina, 28501

  • University of California San Diego Medical Center

    La Jolla, California, 92093-5354

  • VA Long Beach Healthcare System

    Long Beach, California, 90822

  • Gastroenterology Associates of Central Georgia

    Macon, Georgia, 31201

  • University of Wisconsin

    Madison, Wisconsin, 53705

  • Gastrointestinal Specialists of Georgia, PC

    Marietta, Georgia, 30060

  • Great Lakes Gastroenterology Research, LLC

    Mentor, Ohio, 44060

  • IMIC, Inc

    Miami Beach, Florida, 33140

  • FQL Research, LLC

    Miramar, Florida, 33025

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232

  • Concorde Medical Group

    New York, New York, 10016

  • Weill Cornell Medical College-New York Presbyterian Hospital

    New York, New York, 10021

  • Lenox Hill Hospital

    New York, New York, 10075

  • Henry Ford Health System

    Novi, Michigan, 48377-3600

  • Southwest Gastroenterology

    Oak Lawn, Illinois, 60453

  • Digestive Disease Specialists, Inc.

    Oklahoma City, Oklahoma, 73112

  • McGuire Research Institute; Gastroenterology

    Richmond, Virginia, 23249

  • Mayo Clinic - Rochester

    Rochester, Minnesota, 55905

  • University of Utah School of Medicine

    Salt Lake City, Utah, 84132

  • Wellness Clinical Research Center

    San Antonio, Texas, 78232

  • Digestive Care Associates, A Medical Corporation

    San Carlos, California, 94070

  • SDG Clinical Research

    San Diego, California, 92103

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

    San Francisco, California, 94158

  • Digestive Disease Institute; Virginia Mason Medical Center

    Seattle, Washington, 98101

  • Louisiana Research Center, LLC

    Shreveport, Louisiana

  • Texas Digestive Disease Consultants - Southlake

    Southlake, Texas, 76092

  • Advanced Clinical Research

    Spokane, Idaho, 99202

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

    Topeka, Kansas, 66606

  • Center for Digestive Health

    Troy, Michigan, 48098

  • Digestive Health Specialists of Tyler

    Tyler, Texas, 75701

  • Carle Foundation Hospital

    Urbana, Illinois, 61801-2500

  • Shafran Gastroenterology Center

    Winter Park, Florida, 32789

Other trials in United States

Poland17 sites

  • SP ZOZ Wojewodzki Szpital Zespolony im. J. Sniadeckiego

    Bia?ystok, 15-275

  • Nasz Lekarz Osrodek Badan Klinicznych

    Bydgoszcz, 85-312

  • Elblaski Szpital Specjalistyczny z Przychodnia SP ZOZ

    Elblag, 82-300

  • ETG Kielce

    Kielce, 25-355

  • Centrum Opieki Zdrowotnej Orkan-Med

    Ksawerów, 95-054

  • Indywidualna Specjalistyczna Praktyka Lekarska

    Lublin, 20-015

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

    Nowy Targ, 34-400

  • Centrum Medyczne "MEDYK"

    Rzeszów, 35-055

  • Gabinet Lekarski, Bartosz Korczowski

    Rzeszów, 35-302

  • Niepubliczny Zaklad Opieki Zdrowotnej SONOMED

    Szczecin, 70-351

  • Twoja Przychodnia-Szczecinskie Centrum Medyczne

    Szczecin, 71-434

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

    Toru?, 87-100

  • Centrum Zdrowia MDM

    Warsaw, 00-189

  • Zespó Przychodni Specjalistycznych PRIMA

    Warsaw, 02-018

  • Przychodnia EuroMediCare

    Wroc?aw, 50-220

  • PlanetMed sp. z o.o.

    Wroc?aw, 52-210

  • LexMedica Osrodek Badan Klinicznych

    Wroclaw, 53-114

Other trials in Poland

Brazil15 sites

  • Hospital Felicio Rocho

    Belo Horizonte, Minas Gerais, 30110-068

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

    Botucatu, São Paulo, 18618-970

  • Centro Digestivo de Curitiba

    Curitiba, Paraná, 80430-160

  • Instituto Goiano de Gastroenterologia e Endoscopia Digestiva Ltda

    Goiânia, Goiás, 74535-170

  • Hospital Sao Vicente de Paulo

    Passo Fundo, Rio Grande do Sul, 99010-090

  • Hospital das Clinicas - UFRGS

    Porto Alegre, Rio Grande do Sul, 90035-903

  • Hospital Ernesto Dornelles

    Porto Alegre, Rio Grande do Sul, 90160-092

  • Instituto Brasil de Pesquisa Clínica-IBPCLIN S/A

    Rio de Janeiro, Rio de Janeiro, 22271-100

  • Pesquisare Saúde Sociedade Simples

    Santo André, São Paulo, 09080-000

  • Praxis Pesquisa Médica

    Santo André, São Paulo, 09090-790

  • Hospital Estadual Mario Covas

    São Bernardo do Campo, São Paulo, 09715-090

  • Hospital de Base de Sao Jose do Rio Preto

    São José do Rio Preto, São Paulo, 15090-000

  • Hospital Sírio-Libanês

    São Paulo, São Paulo, 01308-050

  • Universidade Federal de Sao Paulo - UNIFES

    São Paulo, São Paulo, 04026-000

  • Hospital do Servidor Público Estadual/HSPE-SP

    São Paulo, São Paulo, 04039-901

Other trials in Brazil

Ukraine14 sites

  • RCI Chernivtsi RCH Dep of Surgery Bukovinian SMU

    Chernivtsi, 58002

  • Ivano-Frankivsk Regional Clinical Hospital

    Ivano-Frankivsk, Kuban People's Republica, 76000

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

    Kharkiv, Kharkiv Governorate, 61037

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

    Kharkiv, Kharkiv Governorate, 61204

  • CHI Kharkiv City Clinical Hospital #13

    Kharkiv, 61124

  • Medical Center of Limited Liability Company Medical Clinic Blagomed

    Kyiv, KIEV Governorate, 1023

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

    Kyiv, KIEV Governorate, 2091

  • CI of Kyiv RC Regional Clinical Hospital #2

    Kyiv, KIEV Governorate, 4073

  • Lviv Regional Clinical Hospital

    Lviv, KIEV Governorate, 79010

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

    Odesa, 65059

  • Private Small Enterprise Medical Center Pulse

    Vinnytsia, 21001

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

    Vinnytsia, 21018

  • MCIC MC LLC Health Clinic

    Vinnytsia, 21029

  • LLC Gastroenterology Center IBD Team

    Zaporizhzhya, Kharkiv Governorate, 69000

Other trials in Ukraine

Australia13 sites

  • Flinders Medical Centre

    Bedford Park, South Australia, 5042

  • Concord Repatriation General Hospital

    Concord, New South Wales, 2139

  • St Vincent's Hospital Melbourne

    Fitzroy, Victoria, 3065

  • Footscray Hospital

    Footscray, Victoria, 3011

  • The Canberra Hospital

    Garran, Australian Capital Territory, 2065

  • Royal Brisbane and Women's Hospital

    Herston, Queensland, 4029

  • St Frances Xavier Cabrini Hospital

    Malvern, Victoria, 3144

  • Fiona Stanley Hospital

    Murdoch, Western Australia, 6150

  • Royal Melbourne Hospital; Department of Colorectal Medicine and Genetics

    Parkville, Victoria, 3050

  • The Alfred Hospital

    Prahan, Victoria, 3181

  • University of the Sunshine Coast

    Sippy Downs, Queensland, 4556

  • Mater Adult Hospital

    South Brisbane, Queensland, 4101

  • Princess Alexandra Hospital

    Woolloongabba, Queensland, 4102

Other trials in Australia

Canada13 sites

  • University of Calgary

    Calgary, Alberta, T2N 2T9

  • Zeidler Ledcor Centre - University of Alberta; Division of Gasroenterology

    Edmonton, Alberta, T6G 2X8

  • Queen Elizabeth II Health Sciences Centre; Gastroenterology Research

    Halifax, Nova Scotia, B3H 1V7

  • University Hospital - London Health Sciences Centre

    London, Ontario, N6A 5A5

  • Hôpital Maisonneuve - Rosemont

    Montreal, Quebec, H1T 2M4

  • McGill University Health Centre - Glen Site

    Montreal, Quebec, H4A 3J1

  • Taunton Health Centre

    Oshawa, Ontario, L1H 7K4

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

    Ottawa, Ontario, K1H 1A2

  • Royal University Hospital

    Saskatoon, Saskatchewan, S7N 0W8

  • Mount Sinai Hospital

    Toronto, Ontario, M5G 1X5

  • (G.I.R.I.) GI Research Institute

    Vancouver, British Columbia, V6Z 2K5

  • Toronto Digestive Disease Associates

    Vaughan, Ontario, L4L 4Y7

  • Winnipeg Regional Health Authority; Neurosurgery Department

    Winnipeg, Manitoba, R3A 1R9

Other trials in Canada

France13 sites

  • CHU Amiens - Hopital Sud

    Amiens, 80054

  • CHU de Caen Hopital Cote de Nacre

    Caen, 14033

  • Hôpital Beaujon

    Clichy, 92110

  • Hopital Claude Huriez - CHU Lille

    Lille, 59037

  • CHU NANTES - Hôtel Dieu; Pharmacy

    Nantes, 44093

  • CHU Nice - Hopital de l'Archet 2

    Nice, 06202

  • Hôpital Saint-Louis

    Paris, 75475

  • Groupe Hospitalier Sud - Hôpital Haut-Lévêque - USN

    Pessac, 33604

  • Centre Hospitalier Lyon Sud; Service de Gastro-Enterologie

    Pierre-Bénite, 69495

  • CHU du Reims - Hopital Robert Debré

    Reims, 51100

  • CHU Saint Etienne - Hôpital Nord

    Saint-Etienne, 42055

  • Höpital Hautepierre; Pediatrie1

    Strasbourg, 67098

  • Hôpital de Brabois Adultes

    Vandœuvre-lès-Nancy, 54511

Other trials in France

United Kingdom13 sites

  • Royal Victoria Hospital

    Belfast, BT12 6BA

  • University Hospital Coventry

    Coventry, CV2 2DX

  • Royal Devon and Exeter Hospital (Wonford)

    Exeter, EX2 5DW

  • Queen Elizabeth Hospital

    Kings Lynn, PE30 4ET

  • St James University Hospital

    Leeds, LS9 7TF

  • Royal Liverpool University Hospital

    Liverpool, L7 8XP

  • Whipps Cross Hospital

    London, E11 1NR

  • University College London Hospital

    London, N7 9NH

  • Fairfield General Hospital

    Manchester, M8 5RB

  • Royal Victoria Infirmary; Stroke unit

    Newcastle upon Tyne, NE1 4LP

  • Nottingham University Hospitals Queen's Medical Centre

    Nottingham, NG7 2UH

  • Royal Berkshire Hospital

    Reading, RG1 5AN

  • Southampton General Hospital

    Southampton, SO16 6YD

Other trials in United Kingdom

Russia12 sites

  • SBEI HPE Altai StateMedicalUniversityofMoH andSD

    Barnaul, Altayskiy Kray, 656050

  • Irkutsk State Medical Academy of Continuing Education

    Irkutsk, 664079

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

    Moscow, Moscow Oblast, 125015

  • LLC "Novosibirsk GastroCenter"

    Novosibirsk, Altaj, 630007

  • SBEIHPE Novosibirsk State Medical University

    Novosibirsk, 630091

  • BHI of Omsk region Clinical Oncology Dispensary

    Omsk, 644013

  • Evromedservis LCC

    Pushkin, Sankt-Peterburg, 196603

  • SEIHPE "Rostov SMU of MoH of RF"

    Rostov-on-Don, Rostov Oblast, 344022

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

    Saint Petersburg, Sankt-Peterburg, 191015

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

    Saint Petersburg, Sankt-Peterburg, 191015

  • Baltic Medicine

    Saint Petersburg, Sankt-Peterburg, 194356

  • SBIH City Clinical Hospital #31

    Saint Petersburg, Sankt-Peterburg, 197110

Other trials in Russia

Spain11 sites

  • Hospital Clínic i Provincial; Servicio de Farmacia

    Barcelona, 08036

  • Hospital Reina Sofia; Medical Oncology

    Córdoba, 14004

  • Hospital Juan Ramón Jiménez

    Huelva, 21005

  • Hospital Universitario de Bellvitge

    L'Hospitalet de Llobregat, Barcelona, 08907

  • Hospital Universitario de la Princesa

    Madrid, 28006

  • Hospital Universitario La Paz

    Madrid, 28046

  • Hospital Universitario de Fuenlabrada

    Madrid, 28942

  • Hospital Universitario Virgen Macarena

    Seville, 41009

  • Hospital Universitario Virgen del Rocio

    Seville, 41013

  • Hospital Universitari i Politecnic La Fe

    Valencia, 46026

  • Hospital Universitario Miguel Servet

    Zaragoza, 50009

Other trials in Spain

Czechia10 sites

  • Vojenska nemocnice Brno

    Brno, 636 00

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

    Brno, 65691

  • Nemocnice Ceske Budejovice a.s.

    České Budějovice, 370 01

  • Gastroenterologie s.r.o.

    Hradec Králové, 500 02

  • Fakultni nemocnice Hradec Kralove

    Hradec Králové, 500 05

  • Hepato-Gastroenterologie HK, s.r.o.

    Hradec Králové, 500 12

  • PreventaMed, s.r.o.

    Olomouc, 779 00

  • Fakultni nemocnice Ostrava

    Ostrava - Poruba, 708 52

  • Fakultni nemocnice Kralovske Vinohrady

    Prague, 100 34

  • ISCARE a.s.

    Prague, 170 04

Other trials in Czechia

South Korea10 sites

  • Dong-A University Hospital

    Busan, 49201

  • Kyungpook National University Hospital

    Daegu, 41944

  • Yeungnam Univ. Hospital

    Daegu, 705-717

  • Korea University Ansan Hospital

    Gyeonggi-do, 15355

  • CHA Bundang Medical Centre; CHA university

    Seongnam, 13520

  • Seoul National University Bundang Hospital

    Seongnam-si, 463-707

  • Kangbuk Samsung Hospital

    Seoul, 03181

  • Asan Medical Center

    Seoul, 05505

  • Samsung Medical Center

    Seoul, 06351

  • Yonsei University Wonju Severance Christian Hospital

    Wŏnju, 26426

Other trials in South Korea

Germany8 sites

  • Charite-Campus Virchow Klinikum; Hepatologie und Gastroenterologie

    Berlin, 13353

  • Krankenhaus Waldfriede e. V.

    Berlin, 14163

  • Berufsgenossenschaftliches Universitaetsklinikum Bergmannsheil GmbH

    Bochum, 44789

  • Klinikum der Johann Wolfgang Goethe-Universitaet

    Frankfurt, 60590

  • Medizinische Hochschule Hannover

    Hanover, 30625

  • Klinikum Mannheim GmbH Universitätsklinikum

    Mannheim, 68167

  • Gemeinschaftspraxis

    Schweinfurt, 97421

  • Universitaetsklinikum Ulm

    Ulm, 89081

Other trials in Germany

Hungary8 sites

  • Bekes Megyei Kozponti Korhaz Dr. Rethy Pal Tagkorhaza

    Békéscsaba, 5600

  • Obudai Egeszsegugyi Centrum Kft.

    Budapest, 1036

  • Semmelweis Egyetem; Belgyogyaszati es Hematologiai Klinika

    Budapest, 1088

  • Szt Janos Korhaz es EbudaiEgyesitettKorhazak

    Budapest, 1125

  • Pannonia Maganorvosi Centrum

    Budapest, 1136

  • Debreceni Egyetem Klinikai Központ; B?rgyógyászati Klinika

    Debrecen, 4012

  • Petz Aladar Megyei Oktato Korhaz

    Győr, 9024

  • Pest Megyei Flor Ferenc Korhaz

    Kistarcsa, 2143

Other trials in Hungary

Israel7 sites

  • Haemek Medical Center

    Afula, 18101

  • Soroka University Medical Centre

    Beersheba, 8410101

  • Wolfson Medical Center

    Holon, 5822012

  • Shaare Zedek Medical Center

    Jerusalem, 9103102

  • Holy Family Hospital

    Nazareth, 1641101

  • Rabin Medical Center-Beilinson Campus

    Petah Tikva, 4941492

  • Tel Aviv Sourasky Medical Center; Pharmacy

    Tel Aviv, 6423906

Other trials in Israel

Italy7 sites

  • Azienda Ospedaliera Universitaria Careggi

    Florence, Tuscany, 50134

  • Asst Fatebenefratelli Sacco (Fatebenefratelli)

    Milan, Lombardy, 20121

  • A.O.U. Policlinico di Modena

    Modena, Emilia-Romagna, 40124

  • Policlinico Universitario Agostino Gemelli; Farmacia

    Rome, Lazio, 00168

  • Azienda Ospedaliera San Camillo Forlanini

    Rome, Lazio, 151

  • Istituto Clinico Humanitas

    Rozzano (MI), Lombardy, 20089

  • I.R.C.C.S Policlinico San Donato

    San Donato Milanese (MI), Lombardy, 20097

Other trials in Italy

Netherlands7 sites

  • Amsterdam UMC, Locatie VUMC; Gastroenterology

    Amsterdam, 1081 HV

  • Amsterdam UMC Location AMC

    Amsterdam, 1105 AZ

  • Leids Universitair Medisch Centrum; Cardiology

    Leiden, 2333 ZA

  • Maastricht University Medical Center

    Maastricht, 6229 HX

  • Erasmus Medisch Centrum

    Rotterdam, 3000 CA

  • Zuyderland Medisch Centrum - Sittard Geleen

    Sittard-Geleen, 6162 BG

  • ETZ TweeSteden

    Tilburg, 5042AD

Other trials in Netherlands

New Zealand7 sites

  • North Shore Hospital

    Auckland, 0620

  • Christchurch Hospital NZ

    Christchurch, 8011

  • Dunedin Public Hospital

    Dunedin, 9016

  • Waikato Hospital

    Hamilton, 3248

  • Hutt Hospital

    Lower Hutt, 5010

  • Shakespeare Specialist Group

    Takapuna, 0620

  • Tauranga Hospital

    Tauranga, 3143

Other trials in New Zealand

Turkey (Türkiye)7 sites

  • Hacettepe University Medical Faculty; Gastroenterology

    Ankara, 06100

  • Gazi University Medical Faculty

    Ankara, 06500

  • Acibadem Fulya Hospital; Neurology

    Istanbul, 34349

  • Haydarpasa Numune Training and Research Hospital; Gastroenterology

    Istanbul, 34668

  • Medeniyet University Goztepe Training and Research Hospital.

    Kadiköy, 34722

  • Kocaeli Universitesi Tip Fakultesi; Infectious Diseases

    Kocaeli, 41380

  • Acibadem Kozyatagi Hospital; Gastroenterology

    Kozyata?i, 34742

Other trials in Turkey (Türkiye)

Belgium5 sites

  • CHU St Pierre (César de Paepe) X

    Brussels, 1000

  • ULB Hopital Erasme; Service de Néphrologie

    Brussels, 1070

  • UZ Brussel

    Brussels, 1090

  • UZ Antwerpen

    Edegem, 2650

  • AZ Maria Middelares

    Ghent, 9000

Other trials in Belgium

Croatia3 sites

  • Clinical Hospital Centre Osijek

    Osijek, 31000

  • General Hospital Pula

    Pula, 52100

  • Clinical Hospital Center Sestre Milosrdnice

    Zagreb, 10000

Other trials in Croatia

Estonia3 sites

  • West Tallinn Central Hospital

    Tallinn, 10617

  • North Estonia Medical Centre Foundation

    Tallinn, 13419

  • Tartu University Hospital

    Tartu, 51014

Other trials in Estonia

Romania3 sites

  • S.C MedLife S.A

    Bucharest, 010719

  • Spitalul Clinic Colentina

    Sector 2, 020125

  • Centrul de Gastroenterologie Dr. Goldis

    Timișoara, 300002

Other trials in Romania

Serbia3 sites

  • Clinical Center Zvezdara

    Belgrade, 11000

  • Military Medical Academy

    Belgrade, 11040

  • General Hospital Djordje Joanovic

    Zrenjanin, 23000

Other trials in Serbia

Slovakia3 sites

  • Endomed, s.r.o.

    Košice, 040 01

  • KM Management spol. s r.o.

    Nitra, 94901

  • Accout Center s.r.o.

    Šahy, 936 01

Other trials in Slovakia

Switzerland3 sites

  • Inselspital-Universitaetsspital Bern

    Bern, 3010

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

    Bern, 3012

  • Universitätsspital Zürich

    Zurich, 8091

Other trials in Switzerland

Austria2 sites

  • LKH - Universitätsklinikum der PMU Salzburg

    Salzburg, 5020

  • Medizinische Universität Wien

    Vienna, 1090

Other trials in Austria

Bulgaria2 sites

  • "City Clinic UMHAC" EOOD

    Sofia, 1407

  • UMHAT "Sv. Ivan Rilski", EAD

    Sofia, 1431

Other trials in Bulgaria

Latvia2 sites

  • Pauls Stradins Clinical University Hospital

    R?ga, LV-1002

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

    Riga, LV-1005

Other trials in Latvia

Lithuania2 sites

  • Hospital of Lithuanian University of Health. Sciences Kaunas Clinics

    Kaunas, 50009

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

    Vilnius, 08661

Other trials in Lithuania

Mexico2 sites

  • Medical Care & Research SA de CV

    Mérida, Yucatán, 97000

  • Clinical Research Institute

    Tlalnepantla, Mexico CITY (federal District), 54055

Other trials in Mexico

South Africa2 sites

  • Dr D Epstein Practice

    Cape Town, 7405

  • Emmed Research

    Pretoria, 0002

Other trials in South Africa

Argentina1 site

  • Hospital Italiano

    CABA, C1199ABB

Other trials in Argentina

About this study

Official title: An Open-Label Extension and Safety Monitoring Study of Patients With Moderately to Severely Active Crohn's Disease Previously Enrolled in the Etrolizumab Phase III Protocol GA29144

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
Being tested
Etrolizumab
Medical subject headings
Crohn Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EtrolizumabDrug

    Also called RG7413

    105 mg etrolizumab subcutaneous administration once every 4 weeks

Study groups in NCT02403323
Study groupRoleWhat they receive
Part 1: Etrolizumab Open-Label ExtensionExperimentalParticipants 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).
Receives: Drug: Etrolizumab
Part 2: Safety MonitoringNo interventionParticipants 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Part 1: Number of Participants With Crohn's Disease Activity Index (CDAI) Remission at 12-week Intervals

    CDAI is a score obtained from composite of eight assessments: number of liquid or soft stools, abdominal pain, general well-being, presence of complications, taking lomotil (diphenoxylate/atropine) or other opiates for diarrhea, presence of an abdominal mass, hematocrit, and percentage deviation from standard weight. A decrease in CDAI over time indicates improvement in disease activity. CDAI scores range from 0 to 600. A higher score indicates worse outcome. A total score of less than 150 corresponds to remission.

    Measured: Day 1 and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240 and 252 of OLE

  2. Part 1: Number of Participants With Clinical Remission at 12-week Intervals

    Clinical remission was defined as a liquid/soft stool frequency (SF) mean daily score ≤3 and an abdominal pain (AP) mean daily score ≤1 with no worsening in either subscore compared to baseline, where the average was taken over 7 days prior to visit. Abdominal pain severity was assessed using the abdominal pain questionnaire which is an 11-point numeric rating scale with score ranging from 0 (no pain) to 10 (worse pain). Liquid/soft stool frequency was reported using the bristol stool form scale which classifies stools into seven groups based on its consistency i.e., type 1- separate hard lumps, type 2- sausage-shaped but lumpy, type 3- like a sausage but with cracks on the surface, type 4- like a sausage or snake, smooth and soft, type 5- soft blobs with clear-cut edges, type 6- fluffy pieces with ragged edges and type 7- entirely liquid with no solid pieces.

    Measured: Day 1 and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240 and 252 of OLE

  3. Part 1: Number of Participants With Improvement in Simple Endoscopic Score for Crohn's Disease (SES-CD) Score at Week 108

    SES-CD is an endoscopic score composite of 4 variables (ulcers size, percentage of ulcerated surface, inflamed surface, and presence of narrowing) in up to 5 ileocolonic segments (ileum right, colon, transverse colon, left colon, rectum) and scored on a scale of 0-3, with total score from 0-60. Higher score indicates higher ulcer surface/size in the 4 variables. Endoscopic improvement was defined as ≥50% reduction in SES-CD score compared to baseline.

    Measured: At OLE Week 108

  4. Part 1: Number of Participants With Adverse Event (AE) and Severity of AEs as Assessed Using National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 (NCI-CTCAE v4.0)

    An AE is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. AEs were graded as per NCI CTCAE v4.0. Grade 1=Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; or intervention not indicated; Grade 2=Moderate; minimal, local or non-invasive intervention indicated; or limiting age-appropriate instrumental activities of daily living; Grade 3=Severe or medically significant, but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; or limiting self-care activities of daily living. Grade 4=Life threatening consequences, urgent intervention indicated; Grade 5=Death related to AE. Multiple occurrences of AEs in the same category at the worst (highest) NCIC-CTCAE grade for an individual are counted only once.

    Measured: From Day 1 up to end of 12-week safety follow-up in OLE (approximately 6.3 years)

  5. Part 1: Number of Participants With Serious Adverse Events (SAEs)

    An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and regardless of causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigation, whether or not considered related to the medicinal (investigational) product. A SAE is any significant hazard, contraindication, side effect that is fatal or life-threatening, requires hospitalization or prolongation of an existing hospitalization, results in persistent or significant disability/ incapacity, is a congenital anomaly/ birth defect, is medically significant or requires intervention to prevent one or other of the outcomes listed above.

    Measured: From Day 1 up to end of 12-week safety follow up in OLE (approximately 6.3 years)

  6. Part 1: Number of Participants With Infection Related AEs and Severity of Infection-Related AEs Assessed Using NCI CTCAE v4.0

    AE=untoward medical occurrence in participant administered a pharmaceutical product \& regardless of causal relationship with this treatment. AEs were graded per NCI CTCAE v4.0. Grade 1=Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; or intervention not indicated; Grade 2=Moderate; minimal, local or non-invasive intervention indicated; or limiting age-appropriate instrumental activities of daily living; Grade 3=Severe or medically significant, but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; or limiting self-care activities of daily living; Grade 4=Life-threatening consequences/urgent intervention indicated; Grade 5=Death related to adverse event. If a participant experienced multiple occurrences of AEs at different grades, they were counted in each grade where they had at least one AE of that grade.

    Measured: From Day 1 up to end of 12-week safety follow up in OLE (approximately 6.3 years)

  7. Part 1: Incidence Rate of Infection-related Adverse Event

    An AE is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not considered related to the medicinal (investigational) product. AE rate (per 100 participant years) = [Total number of AEs (in OLE only) / Total number of participant years at risk (in OLE only)]*100. Total participant-years at risk is the sum over all participants of the time intervals (in years) from the first dose of study treatment in Part 1 (OLE) until the participant completes/withdraws from the study (including the 12-week safety follow-up, if applicable).

    Measured: From Day 1 up to end of 12-week safety follow up in OLE (approximately 6.3 years)

  8. Part 1: Number of Participants With Serious Infection Related AES

    An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and regardless of causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigation, whether or not considered related to the medicinal (investigational) product. A SAE is any significant hazard, contraindication, side effect that is fatal or life-threatening, requires hospitalization or prolongation of an existing hospitalization, results in persistent or significant disability/ incapacity, is a congenital anomaly/ birth defect, is medically significant or requires intervention to prevent one or other of the outcomes listed above.

    Measured: From Day 1 up to end of 12-week safety follow up in OLE (approximately 6.3 years)

  9. Part 1: Number of Participants With Injection Site Reactions and Severity of Injection Site Reactions Assessed Using NCI CTCAE v4.0

    AE=untoward medical occurrence in participant administered a pharmaceutical product \& regardless of causal relationship with this treatment. AE can therefore be any unfavorable \& unintended sign (including an abnormal laboratory finding), symptom/disease temporally associated with use of investigational product, whether or not considered related to investigational product. Injection-site reaction=any local reaction occurring at the site of injection following study drug administration. Signs (e.g., erythema, induration/swelling at injection site) and symptoms (e.g., pain, pruritus at injection site). Injection site reactions were graded per NCI CTCAE v4.0. Grade 1=Tenderness with or without associated symptoms (e.g., warmth, erythema, itching); Grade 2=Pain; lipodystrophy; edema; phlebitis; Grade 3=Ulceration or necrosis; severe tissue damage; operative intervention indicated; Grade 4=life-threatening consequences or urgent intervention indicated; Grade=5 death related to AE.

    Measured: From Day 1 up to end of safety 12-week follow-up in OLE (approximately 6.3 years)

  10. Part 1: Number of Participants With Adverse Events Leading to Etrolizumab Discontinuation

    An AE is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not considered related to the medicinal (investigational) product. Number of participants who discontinued etrolizumab treatment during the OLE period have been reported here.

    Measured: From Day 1 up to end of 12-week safety follow up in OLE (approximately 6.3 years)

  11. Part 1: Number of Participants With Malignancies

    An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and regardless of causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not considered related to the medicinal (investigational) product. Number of participants who developed malignancies during the OLE period have been reported here.

    Measured: From Day 1 up to end of 12-week safety follow up in OLE (approximately 6.3 years)

  12. Part 1: Incidence Rate of Malignancies

    Malignancy rate (per 100 participant years) = [Total number of malignancies (in OLE only) / Total number of participant years at risk (in OLE only)]*100. Total participant-years at risk is the sum over all participants of the time intervals (in years) from the first dose of study treatment in Part 1 (OLE) until the participant completes/withdraws from the study (including the 12-week safety follow-up, if applicable).

    Measured: From Day 1 up to end of 12-week safety follow up in OLE (approximately 6.3 years)

  13. Part 1: Number of Participants With Hypersensitivity Reactions and Severity of Hypersensitivity Assessed Using NCI-CTCAE v4.0

    Hypersensitivity was reported using the MedDRA anaphylactic reaction standard MedDRA query (SMQ) and Sampson's criteria. Hypersensitivity was assessed as per NCI CTCAE v4.0. Grade 1 = Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; or intervention not indicated; Grade 2 = Moderate; minimal, local or non-invasive intervention indicated; or limiting age-appropriate instrumental activities of daily living; Grade 3 = Severe or medically significant, but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; or limiting self-care activities of daily living.

    Measured: From Day 1 up to end of 12-week safety follow up in OLE (approximately 6.3 years)

  14. Part 2: Number of Participants With Confirmed or Suspected Progressive Multifocal Leukoencephalopathy (PML)

    PML was assessed by the PML Subjective Checklist (symptom assessment) and the PML Objective Checklist (neurologic evaluation).

    Measured: From end of safety follow-up in Part 1 or study GA29144 up to maximum of 92 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Mar 2015 (estimated)
  2. Study start8 Jun 2015
  3. Primary completion9 Oct 2023
  4. Study completion9 Oct 2023

Why it stopped: The study was terminated due to program discontinuation, based on mixed efficacy results in the parent studies. There were no safety concerns.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
790 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02403323
Sponsor's protocol ID
GA29145
Other IDs
2014-003855-76, 2014
Acronym
JUNIPER
Status last verified
Nov 2024
First submitted
26 Mar 2015
Last updated
2 Dec 2024

Publications

  • 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.

    PubMed 32445184

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Etrolizumab in people with Crohn Disease, run by Hoffmann-La Roche at 287 sites in 33 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 2 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 287 sites in United States, Poland, Brazil, Ukraine, Australia and 28 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 2 Dec 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Part 1: Number of Participants With Crohn's Disease Activity Index (CDAI) Remission at 12-week Intervals (time frame: Day 1 and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240 and 252 of OLE). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02403323, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2024.

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