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

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.

Study Overview

• Status: Terminated
• Conditions: Crohn Disease
• Intervention / Treatment: Drug: Etrolizumab

• Study Type: Interventional
• Enrollment (Estimated): 900
• Phase: Phase 3

Contacts and Locations

Study Locations

• Argentina
  • Caba, Argentina, C1199ABB
    • Hospital Italiano
• Australia
  • Australian Capital Territory
    • Garran, Australian Capital Territory, Australia, 2065
      • The Canberra Hospital
  • New South Wales
    • Concord, New South Wales, Australia, 2139
      • Concord Repatriation General Hospital
  • Queensland
    • Herston, Queensland, Australia, 4029
      • Royal Brisbane and Women's Hospital
    • Sippy Downs, Queensland, Australia, 4556
      • University of the Sunshine Coast
    • South Brisbane, Queensland, Australia, 4101
      • Mater Adult Hospital
    • Woolloongabba, Queensland, Australia, 4102
      • Princess Alexandra Hospital
  • South Australia
    • Bedford Park, South Australia, Australia, 5042
      • Flinders Medical Centre
  • Victoria
    • Fitzroy, Victoria, Australia, 3065
      • St Vincent's Hospital Melbourne
    • Footscray, Victoria, Australia, 3011
      • Footscray Hospital
    • Malvern, Victoria, Australia, 3144
      • St Frances Xavier Cabrini Hospital
    • Parkville, Victoria, Australia, 3050
      • Royal Melbourne Hospital; Department of Colorectal Medicine and Genetics
    • Prahan, Victoria, Australia, 3181
      • The Alfred Hospital
  • Western Australia
    • Murdoch, Western Australia, Australia, 6150
      • Fiona Stanley Hospital
• Austria
  • Salzburg, Austria, 5020
    • LKH - Universitätsklinikum der PMU Salzburg
  • Wien, Austria, 1090
    • Medizinische Universitat Wien
• Belgium
  • Brussel, Belgium, 1090
    • UZ Brussel
  • Bruxelles, Belgium, 1000
    • CHU St Pierre (César de Paepe) X
  • Bruxelles, Belgium, 1070
    • ULB Hopital Erasme; Service de Néphrologie
  • Edegem, Belgium, 2650
    • UZ Antwerpen
  • Gent, Belgium, 9000
    • AZ Maria Middelares
• Brazil
  • GO
    • Goiânia, GO, Brazil, 74535-170
      • Instituto Goiano de Gastroenterologia e Endoscopia Digestiva Ltda
  • MG
    • Belo Horizonte, MG, Brazil, 30110-068
      • Hospital Felicio Rocho
  • PR
    • Curitiba, PR, Brazil, 80430-160
      • Centro Digestivo de Curitiba
  • RJ
    • Rio de Janeiro, RJ, Brazil, 22271-100
      • Instituto Brasil de Pesquisa Clínica-IBPCLIN S/A
    • Rio de Janeiro, RJ, Brazil, 21941-913
      • Hospital Universitario Clementino Fraga Filho - UFRJ
  • RS
    • Passo Fundo, RS, Brazil, 99010-090
      • Hospital São Vicente de Paulo
    • Porto Alegre, RS, Brazil, 90035-903
      • Hospital das Clinicas - UFRGS
    • Porto Alegre, RS, Brazil, 90160-092
      • Hospital Ernesto Dornelles
  • SP
    • Botucatu, SP, Brazil, 18618-970
      • UNESP - Faculdade de Medicina da Universidade Estadual Paulista - Campus Botucatu
    • Santo Andre, SP, Brazil, 09080-000
      • Pesquisare Saúde Sociedade Simples
    • Santo Andre, SP, Brazil, 09090-790
      • Praxis Pesquisa Medica
    • Sao Bernardo Do Campo, SP, Brazil, 09715-090
      • Hospital Estadual Mario Covas
    • Sao Jose do Rio Preto, SP, Brazil, 15090-000
      • Hospital de Base de Sao Jose do Rio Preto
    • Sao Paulo, SP, Brazil, 01308-050
      • Hospital Sirio-Libanes
    • Sao Paulo, SP, Brazil, 04026-000
      • Universidade Federal de Sao Paulo - UNIFES
    • São Paulo, SP, Brazil, 04039-901
      • Hospital do Servidor Público Estadual/HSPE-SP
• Bulgaria
  • Sofia, Bulgaria, 1407
    • "City Clinic UMHAC" EOOD
  • Sofia, Bulgaria, 1431
    • UMHAT "Sv. Ivan Rilski", EAD
• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2N 2T9
      • University of Calgary
    • Edmonton, Alberta, Canada, T6G 2X8
      • Zeidler Ledcor Centre - University of Alberta; Division of Gasroenterology
  • British Columbia
    • Vancouver, British Columbia, Canada, V6Z 2K5
      • (G.I.R.I.) GI Research Institute
  • Manitoba
    • Winnipeg, Manitoba, Canada, R3A 1R9
      • Winnipeg Regional Health Authority; Neurosurgery Department
  • Nova Scotia
    • Halifax, Nova Scotia, Canada, B3H 1V7
      • Queen Elizabeth II Health Sciences Centre; Gastroenterology Research
  • Ontario
    • London, Ontario, Canada, N6A 5A5
      • University Hospital - London Health Sciences Centre
    • Oshawa, Ontario, Canada, L1H 7K4
      • Taunton Health Centre
    • Ottawa, Ontario, Canada, K1H 1A2
      • The Ottawa Hospital - Riverside Campus; Gastrointestinal Clinical Research Unit
    • Toronto, Ontario, Canada, M5G 1X5
      • Mount Sinai Hospital
    • Vaughan, Ontario, Canada, L4L 4Y7
      • Toronto Digestive Disease Associates
  • Quebec
    • Montreal, Quebec, Canada, H4A 3J1
      • McGill University Health Centre - Glen Site
    • Montreal, Quebec, Canada, H1T 2M4
      • Hôpital Maisonneuve - Rosemont
  • Saskatchewan
    • Saskatoon, Saskatchewan, Canada, S7N 0W8
      • Royal University Hospital
• Croatia
  • Osijek, Croatia, 31000
    • Clinical Hospital Centre Osijek
  • Pula, Croatia, 52100
    • General Hospital Pula
  • Zagreb, Croatia, 10000
    • Clinical Hospital Center Sestre Milosrdnice
• Czechia
  • Brno, Czechia, 636 00
    • Vojenska nemocnice Brno
  • Brno, Czechia, 65691
    • Fakultni nemocnice u sv. Anny v Brne; I.Interni kardioangiologicka klinika
  • Ceske Budejovice, Czechia, 370 01
    • Nemocnice Ceske Budejovice a.s.
  • Hradec Kralove, Czechia, 500 05
    • Fakultní nemocnice Hradec Králové
  • Hradec Kralove, Czechia, 500 12
    • Hepato-Gastroenterologie HK, s.r.o.
  • Hradec Kralove, Czechia, 500 02
    • Gastroenterologie s.r.o.
  • Olomouc, Czechia, 779 00
    • PreventaMed, s.r.o.
  • Ostrava - Poruba, Czechia, 708 52
    • Fakultni nemocnice Ostrava
  • Praha, Czechia, 100 34
    • Fakultní nemocnice Královské Vinohrady
  • Praha 7, Czechia, 170 04
    • ISCARE a.s.
• Estonia
  • Tallinn, Estonia, 10617
    • West Tallinn Central Hospital
  • Tallinn, Estonia, 13419
    • North Estonia Medical Centre Foundation
  • Tartu, Estonia, 51014
    • Tartu University Hospital
• France
  • Amiens, France, 80054
    • CHU Amiens - Hopital Sud
  • Caen, France, 14033
    • CHU de Caen Hôpital Cote de Nacre
  • Clichy cedex, France, 92110
    • Hopital Beaujon
  • Lille, France, 59037
    • Hopital Claude Huriez - CHU Lille
  • Nantes, France, 44093
    • CHU NANTES - Hôtel Dieu; Pharmacy
  • Nice, France, 06202
    • CHU Nice - Hôpital de l'Archet 2
  • Paris, France, 75475
    • Hôpital Saint-Louis
  • Pessac, France, 33604
    • Groupe Hospitalier Sud - Hôpital Haut-Lévêque - USN
  • Pierre-Benite, France, 69495
    • Centre Hospitalier Lyon Sud; Service de Gastro-Enterologie
  • Reims, France, 51100
    • CHU du Reims - Hopital Robert Debré
  • Saint Etienne, France, 42055
    • CHU Saint Etienne - Hopital Nord
  • Strasbourg, France, 67098
    • Höpital Hautepierre; Pediatrie1
  • Vandoeuvre-les-nancy, France, 54511
    • Hôpital de Brabois Adultes
• Germany
  • Berlin, Germany, 14163
    • Krankenhaus Waldfriede e. V.
  • Berlin, Germany, 13353
    • Charite-Campus Virchow Klinikum; Hepatologie und Gastroenterologie
  • Berlin, Germany, 13353
    • Charité Campus Virchow-Klinikum; Department of Cardiology
  • Bochum, Germany, 44789
    • Berufsgenossenschaftliches Universitaetsklinikum Bergmannsheil GmbH
  • Frankfurt, Germany, 60590
    • Klinikum der Johann Wolfgang Goethe-Universitaet
  • Hannover, Germany, 30625
    • Medizinische Hochschule Hannover
  • Mannheim, Germany, 68167
    • Klinikum Mannheim GmbH Universitätsklinikum
  • Schweinfurt, Germany, 97421
    • Gemeinschaftspraxis
  • Ulm, Germany, 89081
    • Universitaetsklinikum Ulm
• Hungary
  • Bekescsaba, Hungary, 5600
    • Bekes Megyei Kozponti Korhaz Dr. Rethy Pal Tagkorhaza
  • Budapest, Hungary, 1088
    • Semmelweis Egyetem
  • Budapest, Hungary, 1136
    • Pannonia Maganorvosi Centrum
  • Budapest, Hungary, 1036
    • Obudai Egeszsegugyi Centrum Kft.
  • Budapest, Hungary, 1125
    • Szt Janos Korhaz es EbudaiEgyesitettKorhazak
  • Debrecen, Hungary, 4012
    • Debreceni Egyetem Klinikai Központ; B?rgyógyászati Klinika
  • Gyor, Hungary, 9024
    • Petz Aladar Megyei Oktato Korhaz
  • Kistarcsa, Hungary, 2143
    • Pest Megyei Flor Ferenc Korhaz
• Israel
  • Afula, Israel, 18101
    • HaEmek Medical Center
  • Beer Sheva, Israel, 8410101
    • Soroka University Medical Centre
  • Holon, Israel, 5822012
    • Wolfson Medical Center
  • Jerusalem, Israel, 9103102
    • Shaare Zedek Medical Center
  • Nazareth, Israel, 1641101
    • Holy Family Hospital
  • Petach Tikva, Israel, 4941492
    • Rabin Medical Center-Beilinson Campus
  • Tel Aviv, Israel, 6423906
    • Tel Aviv Sourasky Medical Center; Pharmacy
• Italy
  • Emilia-Romagna
    • Modena, Emilia-Romagna, Italy, 40124
      • A.O.U. Policlinico di Modena
  • Lazio
    • Roma, Lazio, Italy, 151
      • Azienda Ospedaliera San Camillo Forlanini
    • Roma, Lazio, Italy, 00168
      • Policlinico Universitario Agostino Gemelli; Farmacia
  • Lombardia
    • Milano, Lombardia, Italy, 20121
      • Asst Fatebenefratelli Sacco (Fatebenefratelli)
    • Rozzano (MI), Lombardia, Italy, 20089
      • Istituto Clinico Humanitas
    • San Donato Milanese (MI), Lombardia, Italy, 20097
      • I.R.C.C.S Policlinico San Donato
  • Toscana
    • Florence, Toscana, Italy, 50134
      • Azienda ospedaliera universitaria Careggi
• Korea, Republic of
  • Busan, Korea, Republic of, 49201
    • Dong-A University Hospital
  • Daegu, Korea, Republic of, 41944
    • Kyungpook National University Hospital
  • Daegu, Korea, Republic of, 705-717
    • Yeungnam Univ. Hospital
  • Gyeonggi-do, Korea, Republic of, 15355
    • Korea University Ansan Hospital
  • Seongnam, Korea, Republic of, 13520
    • CHA Bundang Medical Centre; CHA university
  • Seongnam-si, Korea, Republic of, 463-707
    • Seoul National University Bundang Hospital
  • Seoul, Korea, Republic of, 05505
    • Asan Medical Center
  • Seoul, Korea, Republic of, 06351
    • Samsung Medical Center
  • Seoul, Korea, Republic of, 03181
    • Kangbuk Samsung Hospital
  • Wonju-Si, Korea, Republic of, 220-701
    • Yonsei University Wonju Severance Christian Hospital
• Latvia
  • R?ga, Latvia, LV-1002
    • Pauls Stradins Clinical University Hospital
  • Riga, Latvia, LV-1005
    • Riga East Clinical University Hospital, clinic "Gailezers"; Department of Endoscopy
• Lithuania
  • Kaunas, Lithuania, 50009
    • Hospital of Lithuanian University of Health. Sciences Kaunas Clinics
  • Vilnius, Lithuania, 08661
    • Vilnius University Hospital Santariskiu Clinics, Public Inst; Department of Clinical Pharmacology
• Mexico
  • Mexico CITY (federal District)
    • Tlalnepantla de Baz, Mexico CITY (federal District), Mexico, 54055
      • Clinical Research Institute
  • Yucatan
    • Mérida, Yucatan, Mexico, 97000
      • Medical Care & Research SA de CV
• Netherlands
  • Amsterdam, Netherlands, 1105 AZ
    • Amsterdam UMC location AMC
  • Amsterdam, Netherlands, 1081 HV
    • Amsterdam UMC, Locatie VUMC; Gastroenterology
  • Leiden, Netherlands, 2333 ZA
    • Leids Universitair Medisch Centrum; Cardiology
  • Maastricht, Netherlands, 6229 HX
    • Maastricht University Medical Center
  • Rotterdam, Netherlands, 3000 CA
    • Erasmus Medisch Centrum
  • Sittard-Geleen, Netherlands, 6162 BG
    • Zuyderland Medisch Centrum - Sittard Geleen
  • Tilburg, Netherlands, 5042AD
    • ETZ TweeSteden
• New Zealand
  • Auckland, New Zealand, 0620
    • North Shore Hospital
  • Christchurch, New Zealand, 8011
    • Christchurch Hospital NZ
  • Dunedin, New Zealand, 9016
    • Dunedin Public Hospital
  • Hamilton, New Zealand, 3248
    • Waikato Hospital
  • Lower Hutt, New Zealand, 5010
    • Hutt Hospital
  • Takapuna, New Zealand, 0620
    • Shakespeare Specialist Group
  • Tauranga, New Zealand, 3143
    • Tauranga Hospital
• Poland
  • Bia?ystok, Poland, 15-275
    • SP ZOZ Wojewodzki Szpital Zespolony im. J. Sniadeckiego
  • Bydgoszcz, Poland, 85-312
    • Nasz Lekarz Osrodek Badan Klinicznych
  • Elblag, Poland, 82-300
    • Elblaski Szpital Specjalistyczny z Przychodnia SP ZOZ
  • Kielce, Poland, 25-355
    • ETG Kielce
  • Ksawerow, Poland, 95-054
    • Centrum Opieki Zdrowotnej Orkan-Med
  • Lublin, Poland, 20-015
    • Indywidualna Specjalistyczna Praktyka Lekarska
  • Nowy Targ, Poland, 34-400
    • Allmedica Badania Kliniczne Sp z o.o. Sp K.
  • Rzeszow, Poland, 35-055
    • Centrum Medyczne "MEDYK"
  • Rzeszów, Poland, 35-302
    • Gabinet Lekarski, Bartosz Korczowski
  • Szczecin, Poland, 71-434
    • Twoja Przychodnia-Szczecinskie Centrum Medyczne
  • Szczecin, Poland, 70-351
    • Niepubliczny Zaklad Opieki Zdrowotnej SONOMED
  • Toru?, Poland, 87-100
    • Gastromed Kopon Zmudzinski i Wspolnicy Sp.j.Specjalistyczne Centrum Gastrologii i Endoskopii Specj
  • Warszawa, Poland, 00-635
    • Centrum Zdrowia MDM
  • Warszawa, Poland, 02-018
    • Zespó Przychodni Specjalistycznych PRIMA
  • Wroc?aw, Poland, 50-220
    • Przychodnia EuroMediCare
  • Wroc?aw, Poland, 52-210
    • PlanetMed Sp. z o.o.
  • Wroclaw, Poland, 53-114
    • LexMedica Osrodek Badan Klinicznych
• Romania
  • Bucuresti, Romania, 010719
    • S.C MedLife S.A
  • Sector 2, Romania, 020125
    • Spitalul Clinic Colentina
  • Timisoara, Romania, 300002
    • Centrul de Gastroenterologie Dr. Goldis
• Russian Federation
  • Irkutsk, Russian Federation, 664079
    • Irkutsk State Medical Academy of Continuing Education
  • Novosibirsk, Russian Federation, 630091
    • SBEIHPE Novosibirsk State Medical University
  • Omsk, Russian Federation, 644013
    • Bhi of Omsk Region Clinical Oncology Dispensary
  • Altaj
    • Barnaul, Altaj, Russian Federation, 656050
      • SBEI HPE Altai StateMedicalUniversityofMoH andSD
    • Novosibirsk, Altaj, Russian Federation, 630007
      • LLC "Novosibirsk GastroCenter"
  • Leningrad
    • St.Petersburg, Leningrad, Russian Federation, 194356
      • Baltic Medicine
  • Moskovskaja Oblast
    • Moscow, Moskovskaja Oblast, Russian Federation, 125015
      • LEC at SBIH of Moscow "City Clinical Hospital # 24"; Gastroenterology
  • Rostov
    • Rostov-on-Don, Rostov, Russian Federation, 344022
      • SEIHPE "Rostov SMU of MoH of RF"
  • Sankt Petersburg
    • Pushkin, Sankt Petersburg, Russian Federation, 196603
      • Evromedservis LCC
    • Saint-Petersburg, Sankt Petersburg, Russian Federation, 191015
      • Federal State Military Educational Inst. of High Prof. Edu Military Medical Acad; Therapy department
    • Sankt-peterburg, Sankt Petersburg, Russian Federation, 191015
      • North-Western Medical University n.a. I.I. Mechnikov; Rheumatology
    • Sankt-peterburg, Sankt Petersburg, Russian Federation, 197110
      • SBIH City Clinical Hospital #31
    • St. Petersburg, Sankt Petersburg, Russian Federation, 197022
      • Pavlov First Saint Petersburg State Medical University
• Serbia
  • Belgrade, Serbia, 11000
    • Clinical Center Zvezdara
  • Belgrade, Serbia, 11040
    • Military Medical Academy
  • Zrenjanin, Serbia, 23000
    • General Hospital Djordje Joanovic
• Slovakia
  • Nitra, Slovakia, 94901
    • KM Management spol. s r.o.
  • Vranov Nad Top?ou, Slovakia, 093 01
    • Endomed, s.r.o.
  • Šahy, Slovakia, 936 01
    • Accout Center s.r.o.
• South Africa
  • Cape Town, South Africa, 7405
    • Dr D Epstein Practice
  • Pretoria, South Africa, 0002
    • Emmed Research
• Spain
  • Barcelona, Spain, 08036
    • Hospital Clínic i Provincial; Servicio de Farmacia
  • Cordoba, Spain, 14004
    • Hospital Reina Sofia; Medical Oncology
  • Huelva, Spain, 21005
    • Hospital Juan Ramón Jimenez
  • Madrid, Spain, 28006
    • Hospital Universitario de La Princesa
  • Madrid, Spain, 280146
    • Hospital Universitario La Paz
  • Madrid, Spain, 28942
    • Hospital Universitario de Fuenlabrada
  • Sevilla, Spain, 41009
    • Hospital Universitario Virgen Macarena
  • Sevilla, Spain, 41013
    • Hospital Universitario Virgen Del Rocio
  • Valencia, Spain, 46026
    • Hospital Universitari I Politecnic La Fe
  • Zaragoza, Spain, 50009
    • Hospital Universitario Miguel Servet
  • Barcelona
    • Hospitalet de Llobregat, Barcelona, Spain, 08907
      • Hospital Universitario de Bellvitge
• Switzerland
  • Bern, Switzerland, 3010
    • Inselspital-Universitaetsspital Bern
  • Bern, Switzerland, 3012
    • Crohn-Colitis Zentrum Bern - Gemeinschaftspraxis Balsiger, Seibold und Partner
  • Zürich, Switzerland, 8091
    • Universitatsspital Zurich
• Turkey
  • Ankara, Turkey, 06500
    • Gazi University Medical Faculty
  • Ankara, Turkey, 06100
    • Hacettepe University Medical Faculty; Gastroenterology
  • Istanbul, Turkey, 34349
    • Acibadem Fulya Hospital; Neurology
  • Istanbul, Turkey, 34668
    • Haydarpasa Numune Training and Research Hospital; Gastroenterology
  • Izmir, Turkey, 35100
    • Ege University Medical Faculty
  • Kadiköy, Turkey, 34722
    • Medeniyet University Goztepe Training and Research Hospital.
  • Kocaeli, Turkey, 41380
    • Kocaeli Universitesi Tip Fakultesi; Infectious Diseases
  • Kozyata?i, Turkey, 34742
    • Acibadem Kozyatagi Hospital; Gastroenterology
• Ukraine
  • Chernivtsi, Ukraine, 58002
    • RCI Chernivtsi RCH Dep of Surgery Bukovinian SMU
  • Kharkiv, Ukraine, 61124
    • CHI Kharkiv City Clinical Hospital #13
  • Odesa, Ukraine, 65059
    • Railway Transport Odesa CH of Healthcare Ctr Branch of PJSC Ukrainian Railway Dept of Therapy #2
  • Vinnytsia, Ukraine, 21018
    • M.I. Pyrogov VRCH Dept of Gastroenterology M.I. Pyrogov VNMU
  • Vinnytsia, Ukraine, 21001
    • Private Small Enterprise Medical Center Pulse
  • Vinnytsia, Ukraine, 21029
    • MCIC MC LLC Health Clinic
  • KIEV Governorate
    • Kyiv, KIEV Governorate, Ukraine, 1023
      • Medical Center of Limited Liability Company Medical Clinic Blagomed
    • Kyiv, KIEV Governorate, Ukraine, 2091
      • Med Center of International Institute of Clinical Trials LLC; Medical Center "OK!Clinic+"
    • Kyiv, KIEV Governorate, Ukraine, 4073
      • CI of Kyiv RC Regional Clinical Hospital #2
    • Lviv, KIEV Governorate, Ukraine, 79010
      • Lviv Regional Clinical Hospital
  • Kharkiv Governorate
    • Kharkiv, Kharkiv Governorate, Ukraine, 61204
      • CI of Healthcare Kharkiv Reg Clin Hosp-Center of Med Emergency & Accident Medicine
    • Kharkiv, Kharkiv Governorate, Ukraine, 61037
      • CNE Prof. O.O. Shalimov Kharkiv City Clinical Hospital #2 of KCC
    • Zaporizhzhia, Kharkiv Governorate, Ukraine, 69000
      • LLC Gastroenterology Center IBD Team
  • Kuban People's Republica
    • Ivano-Frankivsk, Kuban People's Republica, Ukraine, 76000
      • Ivano-Frankivsk Regional Clinical Hospital
• United Kingdom
  • Belfast, United Kingdom, BT12 6BA
    • Royal Victoria Hospital
  • Coventry, United Kingdom, CV2 2DX
    • University Hospital Coventry
  • Exeter, United Kingdom, EX2 5DW
    • Royal Devon and Exeter Hospital (Wonford)
  • Kings Lynn, United Kingdom, PE30 4ET
    • Queen Elizabeth Hospital
  • Leeds, United Kingdom, LS9 7TF
    • St James University Hospital
  • Liverpool, United Kingdom, L7 8XP
    • Royal Liverpool University Hospital
  • London, United Kingdom, N7 9NH
    • University College London Hospital
  • London, United Kingdom, E11 1NR
    • Whipps Cross Hospital
  • Manchester, United Kingdom, M8 5RB
    • Fairfield General Hospital
  • Newcastle Upon Tyne, United Kingdom, NE1 4LP
    • Royal Victoria Infirmary; Stroke unit
  • Nottingham, United Kingdom, NG7 2UH
    • Nottingham University Hospitals Queen's Medical Centre
  • Reading, United Kingdom, RG1 5AN
    • Royal Berkshire Hospital
  • Southampton, United Kingdom, SO16 6YD
    • Southampton General Hospital
• United States
  • California
    • Arcadia, California, United States, 91006
      • Valley Gastroenterology Consultants
    • La Jolla, California, United States, 92093-5354
      • University of California San Diego Medical Center
    • Long Beach, California, United States, 90822
      • VA Long Beach Healthcare System
    • San Carlos, California, United States, 94070
      • Digestive Care Associates, A Medical Corporation
    • San Diego, California, United States, 92103
      • SDG Clinical Research
    • San Francisco, California, United States, 94158
      • Uni. of California at San Francisco; Dept Pediatric, Div. of Gastroenterology, Hepatology & Nutri
  • Colorado
    • Colorado Springs, Colorado, United States, 80907
      • Peak Gastroenterology Associates
  • Florida
    • Aventura, Florida, United States, 33180
      • Innovative Medical Research of South Florida
    • Clearwater, Florida, United States, 33756
      • West Central Gastroenterology d/b/a Gastro Florida
    • Gainesville, Florida, United States, 32610
      • University of Florida College of Medicine
    • Jacksonville, Florida, United States, 32256
      • Borland-Groover Clinic
    • Miami Beach, Florida, United States, 33140
      • IMIC, Inc
    • Miramar, Florida, United States, 33025
      • FQL Research, LLC
    • Winter Park, Florida, United States, 32789
      • Shafran Gastroenterology Center
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Emory University Hospital
    • Atlanta, Georgia, United States, 30342
      • Atlanta Gastroenterology Associates
    • Columbus, Georgia, United States, 31904
      • Columbus Regional Research Institute
    • Decatur, Georgia, United States, 30033
      • Atlanta Center for Gastroenterology, PC
    • Macon, Georgia, United States, 31201
      • Gastroenterology Associates of Central Georgia
    • Marietta, Georgia, United States, 30060
      • Gastrointestinal Specialists of Georgia, PC
  • Idaho
    • Spokane, Idaho, United States, 99202
      • Advanced Clinical Research
  • Illinois
    • Chicago, Illinois, United States, 60637
      • University of Chicago Medical Center
    • Chicago, Illinois, United States, 60611
      • Northwestern Uni-Feinberg School of Medicine
    • Oak Lawn, Illinois, United States, 60453
      • Southwest Gastroenterology
    • Urbana, Illinois, United States, 61801-2500
      • Carle Foundation Hospital
  • Kansas
    • Topeka, Kansas, United States, 66606
      • Cotton-O'Neil Clinical Research Center, Digestive Health
  • Louisiana
    • Baton Rouge, Louisiana, United States, 70809
      • Gastroenterology Associates, LLC
    • Shreveport, Louisiana, United States
      • Louisiana Research Center, LLC
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan
    • Grand Rapids, Michigan, United States, 49506
      • Gastroenterology Associates of Western Michigan, P.L.C.
    • Novi, Michigan, United States, 48377-3600
      • Henry Ford Health System
    • Troy, Michigan, United States, 48098
      • Center for Digestive Health
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic - Rochester
  • Mississippi
    • Jackson, Mississippi, United States, 39216
      • University of Mississippi Medical Center
  • Missouri
    • Belton, Missouri, United States, 64012
      • Ehrhardt Clinical Research, LLC
  • New York
    • New York, New York, United States, 10075
      • Lenox Hill Hospital
    • New York, New York, United States, 10016
      • Concorde Medical Group
    • New York, New York, United States, 10021
      • Weill Cornell Medical College-New York Presbyterian Hospital
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • University of North Carolina at Chapel Hill
    • Charlotte, North Carolina, United States, 28207
      • Charlotte Gastroenterology and Hepatology, P.L.L.C
    • Kinston, North Carolina, United States, 28501
      • Vidant Medical Group, LLC DBA Vidant Multispeciality Clinic-Kinston
  • Ohio
    • Cincinnati, Ohio, United States, 45219
      • Consultants for Clinical Research Inc.
    • Mentor, Ohio, United States, 44060
      • Great Lakes Gastroenterology Research, LLC
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73112
      • Digestive Disease Specialists, Inc.
  • Pennsylvania
    • Harrisburg, Pennsylvania, United States, 17110
      • Great Lakes Medical Research, LLC
  • South Carolina
    • Greenville, South Carolina, United States, 29604
      • Innovative Clinical Research
  • Tennessee
    • Germantown, Tennessee, United States, 38138
      • Gastro One
    • Nashville, Tennessee, United States, 37232
      • Vanderbilt University Medical Center
  • Texas
    • Dallas, Texas, United States, 75390-9151
      • University of Texas Southwestern Medical Center; Internal Medicne
    • Houston, Texas, United States, 77030
      • Baylor College of Medicine
    • Houston, Texas, United States, 77030
      • Methodist Hospital Research Institute
    • San Antonio, Texas, United States, 78232
      • Wellness Clinical Research Center
    • Southlake, Texas, United States, 76092
      • Texas Digestive Disease Consultants - Southlake
    • Tyler, Texas, United States, 75701
      • Digestive Health Specialists of Tyler
  • Utah
    • Clinton, Utah, United States, 84015
      • Ericksen Research and Development
    • Salt Lake City, Utah, United States, 84132
      • University Of Utah School Of Medicine
  • Virginia
    • Richmond, Virginia, United States, 23249
      • McGuire Research Institute; Gastroenterology
  • Washington
    • Seattle, Washington, United States, 98101
      • Digestive Disease Institute; Virginia Mason Medical Center
  • Wisconsin
    • Madison, Wisconsin, United States, 53705
      • University of Wisconsin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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:

• No exclusion criteria

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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).	Drug: Etrolizumab; 105 mg etrolizumab subcutaneous administration once every 4 weeks; Other Names: RG7413
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Part 1: Number of Participants with Crohn's Disease Activity Index (CDAI) Remission Over Time		Weeks 0, 12, 24, and every 12 weeks thereafter until study completion or early withdrawal, commercial availability of etrolizumab, or study termination, whichever is earliest (up to approximately 10 years)
Part 1: Number of Participants with Clinical Remission Over Time	Clinical remission is defined by a loose/soft stool frequency (SF) mean daily score ≤3 and an abdominal pain mean daily score ≤1 with no worsening in either subscore compared to baseline, averaged over 7 days prior to visit.	Weeks 0, 12, 24, and every 12 weeks thereafter until study completion or early withdrawal, commercial availability of etrolizumab, or study termination, whichever is earlier (up to approximately 10 years)
Part 1: Simple Endoscopic Score for Crohn's Disease (SES-CD) Score at Week 108		Week 108 (or at early withdrawal, if prior to Week 108)
Part 1: Overall Number of Participants who Experienced at Least One Adverse Event by Severity, According to National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 (NCI-CTCAE v4.0)		From Week 0 until completion of safety follow-up, commercial availability of etrolizumab, or study termination, whichever is earliest (up to approximately 10 years)
Part 1: Overall Number of Participants with Adverse Events Leading to Etrolizumab Discontinuation		From Week 0 until completion of safety follow-up, commercial availability of etrolizumab, or study termination, whichever is earliest (up to approximately 10 years)
Part 1: Overall Number of Participants who Experienced at Least One Infection-Related Adverse Event by Severity, According to NCI-CTCAE v4.0		From Week 0 until completion of safety follow-up, commercial availability of etrolizumab, or study termination, whichever is earliest (up to approximately 10 years)
Part 1: Number of Infection-Related Adverse Events per Patient-Year		From Week 0 until study completion or early withdrawal, commercial availability of etrolizumab, or study termination, whichever is earliest (up to approximately 10 years)
Part 1: Overall Number of Participants who Experienced at Least One Infection-Related Serious Adverse Event		From Week 0 until completion of safety follow-up, commercial availability of etrolizumab, or study termination, whichever is earliest (up to approximately 10 years)
Part 1: Overall Number of Participants who Experienced at Least One Injection-Site Reaction by Severity, According to NCI-CTCAE v4.0		From Week 0 until completion of safety follow-up, commercial availability of etrolizumab, or study termination, whichever is earliest (up to approximately 10 years)
Part 1: Overall Number of Participants who Develop Malignancies		From Week 0 until completion of safety follow-up, commercial availability of etrolizumab, or study termination, whichever is earliest (up to approximately 10 years)
Part 1: Number of Malignancies per Patient-Year		From Week 0 until completion of safety follow-up, commercial availability of etrolizumab, or study termination, whichever is earliest (up to approximately 10 years)
Part 1: Overall Number of Participants who Experienced at Least One Hypersensitivity Reaction by Severity, According to NCI-CTCAE v4.0		From Week 0 until completion of safety follow-up, commercial availability of etrolizumab, or study termination, whichever is earliest (up to approximately 10 years)
Part 1: Number of Participants with Anti-Therapeutic Antibodies (ATAs) to Etrolizumab		Weeks 0 and 12, and every 48 weeks thereafter until study completion or early withdrawal (up to approximately 10 years)
Part 2: Number of Participants who Experienced at Least One Suspected or Confirmed Event of Progressive Multifocal Leukoencephalopathy (PML)		From end of safety follow-up until completion of 92-week safety monitoring in Part 2 (up to 92 weeks)

Collaborators and Investigators

• Sponsor: Hoffmann-La Roche
• Investigators: Study Director: Clinical Trials, Hoffmann-La Roche

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 8, 2015
• Primary Completion (Actual): October 9, 2023
• Study Completion (Actual): October 9, 2023

Study Registration Dates

• First Submitted: March 26, 2015
• First Submitted That Met QC Criteria: March 26, 2015
• First Posted (Estimated): March 31, 2015

Study Record Updates

• Last Update Posted (Actual): November 1, 2023
• Last Update Submitted That Met QC Criteria: October 30, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Intestinal Diseases; Inflammatory Bowel Diseases; Crohn Disease; Physiological Effects of Drugs; Immunologic Factors; Gastrointestinal Agents; Etrolizumab
• Other Study ID Numbers: GA29145; 2014-003855-76 (EudraCT Number)