Open-Label Extension and Safety Study for Participants With Crohn's Disease Previously Enrolled in the Etrolizumab Phase III Study GA29144 (JUNIPER)
November 18, 2024 updated by: Hoffmann-La Roche
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
Study Type
Interventional
Enrollment (Actual)
790
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Caba, Argentina, C1199ABB
- Hospital Italiano
-
-
-
-
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
-
-
-
-
-
Salzburg, Austria, 5020
- LKH - Universitätsklinikum der PMU Salzburg
-
Wien, Austria, 1090
- Medizinische Universität Wien
-
-
-
-
-
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
-
-
-
-
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
-
-
RS
-
Passo Fundo, RS, Brazil, 99010-090
- Hospital Sao 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 Sírio-Libanês
-
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
-
-
-
-
-
Sofia, Bulgaria, 1407
- "City Clinic UMHAC" EOOD
-
Sofia, Bulgaria, 1431
- UMHAT "Sv. Ivan Rilski", EAD
-
-
-
-
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
-
-
-
-
-
Osijek, Croatia, 31000
- Clinical Hospital Centre Osijek
-
Pula, Croatia, 52100
- General Hospital Pula
-
Zagreb, Croatia, 10000
- Clinical Hospital Center Sestre Milosrdnice
-
-
-
-
-
Brno, Czechia, 636 00
- Vojenská 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
- Fakultni Nemocnice Hradec Kralove
-
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
- Fakultni nemocnice Kralovske Vinohrady
-
Praha 7, Czechia, 170 04
- ISCARE a.s.
-
-
-
-
-
Tallinn, Estonia, 10617
- West Tallinn Central Hospital
-
Tallinn, Estonia, 13419
- North Estonia Medical Centre Foundation
-
Tartu, Estonia, 51014
- Tartu University Hospital
-
-
-
-
-
Amiens, France, 80054
- CHU Amiens - Hopital Sud
-
Caen, France, 14033
- CHU de Caen Hopital Cote de Nacre
-
Clichy cedex, France, 92110
- Hôpital Beaujon
-
Lille, France, 59037
- Hopital Claude Huriez - CHU Lille
-
Nantes, France, 44093
- CHU NANTES - Hôtel Dieu; Pharmacy
-
Nice, France, 06202
- CHU Nice - Hopital 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 - Hôpital Nord
-
Strasbourg, France, 67098
- Höpital Hautepierre; Pediatrie1
-
Vandoeuvre-les-nancy, France, 54511
- Hôpital de Brabois Adultes
-
-
-
-
-
Berlin, Germany, 14163
- Krankenhaus Waldfriede e. V.
-
Berlin, Germany, 13353
- Charite-Campus Virchow Klinikum; Hepatologie und Gastroenterologie
-
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
-
-
-
-
-
Bekescsaba, Hungary, 5600
- Bekes Megyei Kozponti Korhaz Dr. Rethy Pal Tagkorhaza
-
Budapest, Hungary, 1136
- Pannonia Maganorvosi Centrum
-
Budapest, Hungary, 1036
- Obudai Egeszsegugyi Centrum Kft.
-
Budapest, Hungary, 1125
- Szt Janos Korhaz es EbudaiEgyesitettKorhazak
-
Budapest, Hungary, 1088
- Semmelweis Egyetem; Belgyogyaszati es Hematologiai Klinika
-
Debrecen, Hungary, 4012
- Debreceni Egyetem Klinikai Központ; B?rgyógyászati Klinika
-
Gyor, Hungary, 9024
- Petz Aladár Megyei Oktató Kórház
-
Kistarcsa, Hungary, 2143
- Pest Megyei Flor Ferenc Korhaz
-
-
-
-
-
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
-
-
-
-
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
-
-
-
-
-
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, 26426
- Yonsei University Wonju Severance Christian Hospital
-
-
-
-
-
R?ga, Latvia, LV-1002
- Pauls Stradins Clinical University Hospital
-
Riga, Latvia, LV-1005
- Riga East Clinical University Hospital, clinic "Gailezers"; Department of Endoscopy
-
-
-
-
-
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 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
-
-
-
-
-
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
-
-
-
-
-
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
-
-
-
-
-
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, 02-018
- Zespó Przychodni Specjalistycznych PRIMA
-
Warszawa, Poland, 00-189
- Centrum Zdrowia MDM
-
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
-
-
-
-
-
Bucuresti, Romania, 010719
- S.C MedLife S.A
-
Sector 2, Romania, 020125
- Spitalul Clinic Colentina
-
Timisoara, Romania, 300002
- Centrul de Gastroenterologie Dr. Goldis
-
-
-
-
-
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
-
-
-
-
-
Belgrade, Serbia, 11000
- Clinical Center Zvezdara
-
Belgrade, Serbia, 11040
- Military Medical Academy
-
Zrenjanin, Serbia, 23000
- General Hospital Djordje Joanovic
-
-
-
-
-
Košice, Slovakia, 040 01
- Endomed, s.r.o.
-
Nitra, Slovakia, 94901
- KM Management spol. s r.o.
-
Šahy, Slovakia, 936 01
- Accout Center s.r.o.
-
-
-
-
-
Cape Town, South Africa, 7405
- Dr D Epstein Practice
-
Pretoria, South Africa, 0002
- Emmed Research
-
-
-
-
-
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, 28046
- Hospital Universitario La Paz
-
Madrid, Spain, 28006
- Hospital Universitario de la Princesa
-
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
-
-
-
-
-
Bern, Switzerland, 3010
- Inselspital-Universitaetsspital Bern
-
Bern, Switzerland, 3012
- Crohn-Colitis Zentrum Bern - Gemeinschaftspraxis Balsiger, Seibold und Partner
-
Zürich, Switzerland, 8091
- Universitatsspital Zurich
-
-
-
-
-
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
-
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
-
-
-
-
-
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
-
-
-
-
-
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
-
-
-
-
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
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
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
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
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).
|
105 mg etrolizumab subcutaneous administration once every 4 weeks
Other Names:
|
|
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 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
|
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.
|
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
|
|
Part 1: Number of Participants With Clinical 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
|
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.
|
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
|
|
Part 1: Number of Participants With Improvement in Simple Endoscopic Score for Crohn's Disease (SES-CD) Score at Week 108
Time Frame: At OLE 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.
|
At OLE Week 108
|
|
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)
Time Frame: From Day 1 up to end of 12-week safety follow-up in OLE (approximately 6.3 years)
|
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.
|
From Day 1 up to end of 12-week safety follow-up in OLE (approximately 6.3 years)
|
|
Part 1: Number of Participants With Serious Adverse Events (SAEs)
Time Frame: From Day 1 up to end of 12-week safety follow up in OLE (approximately 6.3 years)
|
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.
|
From Day 1 up to end of 12-week safety follow up in OLE (approximately 6.3 years)
|
|
Part 1: Number of Participants With Infection Related AEs and Severity of Infection-Related AEs Assessed Using NCI CTCAE v4.0
Time Frame: From Day 1 up to end of 12-week safety follow up in OLE (approximately 6.3 years)
|
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.
|
From Day 1 up to end of 12-week safety follow up in OLE (approximately 6.3 years)
|
|
Part 1: Incidence Rate of Infection-related Adverse Event
Time Frame: From Day 1 up to end of 12-week safety follow up in OLE (approximately 6.3 years)
|
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).
|
From Day 1 up to end of 12-week safety follow up in OLE (approximately 6.3 years)
|
|
Part 1: Number of Participants With Serious Infection Related AES
Time Frame: From Day 1 up to end of 12-week safety follow up in OLE (approximately 6.3 years)
|
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.
|
From Day 1 up to end of 12-week safety follow up in OLE (approximately 6.3 years)
|
|
Part 1: Number of Participants With Injection Site Reactions and Severity of Injection Site Reactions Assessed Using NCI CTCAE v4.0
Time Frame: From Day 1 up to end of safety 12-week follow-up in OLE (approximately 6.3 years)
|
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.
|
From Day 1 up to end of safety 12-week follow-up in OLE (approximately 6.3 years)
|
|
Part 1: Number of Participants With Adverse Events Leading to Etrolizumab Discontinuation
Time Frame: From Day 1 up to end of 12-week safety follow up in OLE (approximately 6.3 years)
|
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.
|
From Day 1 up to end of 12-week safety follow up in OLE (approximately 6.3 years)
|
|
Part 1: Number of Participants With Malignancies
Time Frame: From Day 1 up to end of 12-week safety follow up in OLE (approximately 6.3 years)
|
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.
|
From Day 1 up to end of 12-week safety follow up in OLE (approximately 6.3 years)
|
|
Part 1: Incidence Rate of Malignancies
Time Frame: From Day 1 up to end of 12-week safety follow up in OLE (approximately 6.3 years)
|
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).
|
From Day 1 up to end of 12-week safety follow up in OLE (approximately 6.3 years)
|
|
Part 1: Number of Participants With Hypersensitivity Reactions and Severity of Hypersensitivity Assessed Using NCI-CTCAE v4.0
Time Frame: From Day 1 up to end of 12-week safety follow up in OLE (approximately 6.3 years)
|
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.
|
From Day 1 up to end of 12-week safety follow up in OLE (approximately 6.3 years)
|
|
Part 2: Number of Participants With Confirmed or Suspected Progressive Multifocal Leukoencephalopathy (PML)
Time Frame: From end of safety follow-up in Part 1 or study GA29144 up to maximum of 92 weeks
|
PML was assessed by the PML Subjective Checklist (symptom assessment) and the PML Objective Checklist (neurologic evaluation).
|
From end of safety follow-up in Part 1 or study GA29144 up to maximum of 92 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Clinical Trials, Hoffmann-La Roche
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
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 (Estimated)
December 2, 2024
Last Update Submitted That Met QC Criteria
November 18, 2024
Last Verified
November 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- GA29145
- 2014-003855-76 (EudraCT Number)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Crohn Disease
-
Turku University HospitalUniversity of TurkuRecruitingInflammatory Bowel Diseases | Crohn Disease | Crohn Colitis | Crohn's Ileocolitis | Crohn Disease in Remission | Crohn Disease of Small IntestineFinland
-
Tzaneio General HospitalRecruitingCrohn Disease (CD) | Crohn Disease of Ileum | Kono S Anastomosis | Extended Mesenteric ExcisionGreece
-
L2 Bio, LLCFDAMap; Akan Biosciences, Inc.Not yet recruitingCrohn&Amp;#39;s | Crohn&Amp;#39;s Disease (CD)
-
Shmuel Kivity, MDRecruiting
-
University Hospital, Clermont-FerrandNot yet recruiting
-
Central Hospital, Nancy, FranceNot yet recruitingCrohn Disease (CD)France
-
GLSMED Learning Health S.A.Not yet recruiting
-
University Hospital, Clermont-FerrandActive, not recruiting
-
Assistance Publique Hopitaux De MarseilleRecruiting
-
Direct Biologics, LLCNot yet recruiting
Clinical Trials on Etrolizumab
-
Hoffmann-La RocheCompletedUlcerative ColitisAustralia, Czechia, France, Russian Federation, Malaysia, Bulgaria, United States, Croatia, Poland, Ukraine, Hungary, Colombia, New Zealand, Argentina, Turkey, Latvia, Brazil, Lithuania, Greece
-
Hoffmann-La RocheCompletedUlcerative ColitisUnited States, Australia, Serbia, Hong Kong, Brazil, Bulgaria, Estonia, Poland, Russian Federation, Mexico, Ukraine, Argentina, France, Slovakia
-
Genentech, Inc.CompletedUlcerative ColitisUnited States, Israel, Belgium, Australia, Czechia, New Zealand, Canada, Spain, Germany, United Kingdom, Hungary
-
Hoffmann-La RocheCompletedCrohn DiseaseUnited States, Israel, Spain, United Kingdom, Korea, Republic of, Canada, Australia, Austria, Czechia, France, Hungary, Italy, Netherlands, New Zealand, Russian Federation, Belgium, Brazil, Argentina, Bulgaria, Croatia, Germany, P... and more
-
Genentech, Inc.CompletedUlcerative ColitisBelgium, Spain, New Zealand, United States, Czech Republic, Germany, Australia, United Kingdom, Israel, Hungary, Canada
-
Hoffmann-La RocheTerminatedCrohn's Disease | Ulcerative ColitisPoland, United Kingdom, Belgium, Spain
-
Hoffmann-La RocheTerminatedUlcerative ColitisIsrael, Spain, United States, United Kingdom, Belgium, Korea, Republic of, Canada, Australia, Austria, Czechia, France, Italy, Netherlands, New Zealand, Russian Federation, Hungary, Singapore, India, Portugal, Serbia, Hong Kong, B... and more
-
Genentech, Inc.CompletedUlcerative ColitisBelgium, United States, Canada, Germany, Netherlands, United Kingdom
-
Genentech, Inc.Completed
-
Hoffmann-La RocheCompletedUlcerative ColitisIsrael, Spain, United States, United Kingdom, Belgium, Korea, Republic of, Australia, Austria, France, Hungary, Italy, Netherlands, Canada, Germany, Poland, Brazil, Argentina, Czechia, Lithuania, Switzerland, Mexico, Denmark, Greece, ...