Open-Label Extension and Safety Study for Participants With Crohn's Disease Previously Enrolled in the Etrolizumab Phase III Study GA29144 (JUNIPER)
Crohn Disease
About this trial
This is an interventional treatment trial for Crohn Disease
Eligibility Criteria
Inclusion Criteria:
Part 1 Open-Label Extension:
- Patients previously enrolled in etrolizumab Phase III study GA29144 (NCT02394028) who meet the eligibility criteria for open-label etrolizumab as described in the protocol
Part 2 Safety Monitoring:
- Patients who participated in etrolizumab Phase III study GA29144 (NCT02394028) and are not eligible or choose not to enter Part 1
- Patients who transfer from Part 1
- Completion of the 12-week safety follow-up period prior to entering
Exclusion Criteria:
Part 1 Open-Label Extension:
- Any new, significant, uncontrolled condition
Part 2 Safety Monitoring:
- No exclusion criteria
Sites / Locations
- Valley Gastroenterology Consultants
- University of California San Diego Medical Center
- VA Long Beach Healthcare System
- Digestive Care Associates, A Medical Corporation
- SDG Clinical Research
- Uni. of California at San Francisco; Dept Pediatric, Div. of Gastroenterology, Hepatology & Nutri
- Peak Gastroenterology Associates
- Innovative Medical Research of South Florida
- West Central Gastroenterology d/b/a Gastro Florida
- University of Florida College of Medicine
- Borland-Groover Clinic
- IMIC, Inc
- FQL Research, LLC
- Shafran Gastroenterology Center
- Emory University Hospital
- Atlanta Gastroenterology Associates
- Columbus Regional Research Institute
- Atlanta Center for Gastroenterology, PC
- Gastroenterology Associates of Central Georgia
- Gastrointestinal Specialists of Georgia, PC
- Advanced Clinical Research
- Northwestern Uni-Feinberg School of Medicine
- University of Chicago Medical Center
- Southwest Gastroenterology
- Carle Foundation Hospital
- Cotton-O'Neil Clinical Research Center, Digestive Health
- Gastroenterology Associates, LLC
- Louisiana Research Center, LLC
- University of Michigan
- Gastroenterology Associates of Western Michigan, P.L.C.
- Henry Ford Health System
- Center for Digestive Health
- Mayo Clinic - Rochester
- University of Mississippi Medical Center
- Ehrhardt Clinical Research, LLC
- Concorde Medical Group
- Weill Cornell Medical College-New York Presbyterian Hospital
- Lenox Hill Hospital
- University of North Carolina at Chapel Hill
- Charlotte Gastroenterology and Hepatology, P.L.L.C
- Vidant Medical Group, LLC DBA Vidant Multispeciality Clinic-Kinston
- Consultants for Clinical Research Inc.
- Great Lakes Gastroenterology Research, LLC
- Digestive Disease Specialists, Inc.
- Great Lakes Medical Research, LLC
- Innovative Clinical Research
- Gastro One
- Vanderbilt University Medical Center
- University of Texas Southwestern Medical Center; Internal Medicne
- Baylor College of Medicine
- Methodist Hospital Research Institute
- Wellness Clinical Research Center
- Texas Digestive Disease Consultants - Southlake
- Digestive Health Specialists of Tyler
- Ericksen Research and Development
- University of Utah School of Medicine
- McGuire Research Institute; Gastroenterology
- Digestive Disease Institute; Virginia Mason Medical Center
- University of Wisconsin
- Hospital Italiano
- The Canberra Hospital
- Concord Repatriation General Hospital
- Royal Brisbane and Women's Hospital
- University of the Sunshine Coast
- Mater Adult Hospital
- Princess Alexandra Hospital
- Flinders Medical Centre
- St Vincent's Hospital Melbourne
- Footscray Hospital
- St Frances Xavier Cabrini Hospital
- Royal Melbourne Hospital; Department of Colorectal Medicine and Genetics
- The Alfred Hospital
- Fiona Stanley Hospital
- LKH - Universitätsklinikum der PMU Salzburg
- Medizinische Universität Wien
- UZ Brussel
- CHU St Pierre (César de Paepe) X
- ULB Hopital Erasme; Service de Néphrologie
- UZ Antwerpen
- AZ Maria Middelares
- Instituto Goiano de Gastroenterologia e Endoscopia Digestiva Ltda
- Hospital Felicio Rocho
- Centro Digestivo de Curitiba
- Hospital Universitario Clementino Fraga Filho - UFRJ
- Instituto Brasil de Pesquisa Clínica-IBPCLIN S/A
- Hospital Sao Vicente de Paulo
- Hospital das Clinicas - UFRGS
- Hospital Ernesto Dornelles
- UNESP - Faculdade de Medicina da Universidade Estadual Paulista - Campus Botucatu
- Pesquisare Saúde Sociedade Simples
- Praxis Pesquisa Médica
- Hospital Estadual Mario Covas
- Hospital de Base de Sao Jose do Rio Preto
- Hospital Sírio-Libanês
- Universidade Federal de Sao Paulo - UNIFES
- Hospital do Servidor Público Estadual/HSPE-SP
- "City Clinic UMHAC" EOOD
- UMHAT "Sv. Ivan Rilski", EAD
- University of Calgary
- Zeidler Ledcor Centre - University of Alberta; Division of Gasroenterology
- (G.I.R.I.) GI Research Institute
- Winnipeg Regional Health Authority; Neurosurgery Department
- Queen Elizabeth II Health Sciences Centre; Gastroenterology Research
- University Hospital - London Health Sciences Centre
- Taunton Health Centre
- The Ottawa Hospital - Riverside Campus; Gastrointestinal Clinical Research Unit
- Mount Sinai Hospital
- Toronto Digestive Disease Associates
- Hôpital Maisonneuve - Rosemont
- McGill University Health Centre - Glen Site
- Royal University Hospital
- Clinical Hospital Centre Osijek
- General Hospital Pula
- Clinical Hospital Center Sestre Milosrdnice
- Vojenska nemocnice Brno
- Fakultni nemocnice u sv. Anny v Brne; I.Interni kardioangiologicka klinika
- Nemocnice Ceske Budejovice a.s.
- Gastroenterologie s.r.o.
- Fakultni nemocnice Hradec Kralove
- Hepato-Gastroenterologie HK, s.r.o.
- PreventaMed, s.r.o.
- Fakultni nemocnice Ostrava
- ISCARE a.s.
- Fakultni nemocnice Kralovske Vinohrady
- West Tallinn Central Hospital
- North Estonia Medical Centre Foundation
- Tartu University Hospital
- CHU Amiens - Hopital Sud
- CHU de Caen Hopital Cote de Nacre
- Hôpital Beaujon
- Hopital Claude Huriez - CHU Lille
- CHU NANTES - Hôtel Dieu; Pharmacy
- CHU Nice - Hopital de l'Archet 2
- Hôpital Saint-Louis
- Groupe Hospitalier Sud - Hôpital Haut-Lévêque - USN
- Centre Hospitalier Lyon Sud; Service de Gastro-Enterologie
- CHU du Reims - Hopital Robert Debré
- CHU Saint Etienne - Hôpital Nord
- Höpital Hautepierre; Pediatrie1
- Hôpital de Brabois Adultes
- Charite-Campus Virchow Klinikum; Hepatologie und Gastroenterologie
- Charité Campus Virchow-Klinikum; Department of Cardiology
- Krankenhaus Waldfriede e. V.
- Berufsgenossenschaftliches Universitaetsklinikum Bergmannsheil GmbH
- Klinikum der Johann Wolfgang Goethe-Universitaet
- Medizinische Hochschule Hannover
- Klinikum Mannheim GmbH Universitätsklinikum
- Gemeinschaftspraxis
- Universitaetsklinikum Ulm
- Bekes Megyei Kozponti Korhaz Dr. Rethy Pal Tagkorhaza
- Obudai Egeszsegugyi Centrum Kft.
- Semmelweis Egyetem
- Szt Janos Korhaz es EbudaiEgyesitettKorhazak
- Pannonia Maganorvosi Centrum
- Debreceni Egyetem Klinikai Központ; B?rgyógyászati Klinika
- Petz Aladar Megyei Oktato Korhaz
- Pest Megyei Flor Ferenc Korhaz
- Haemek Medical Center
- Soroka University Medical Centre
- Wolfson Medical Center
- Shaare Zedek Medical Center
- Holy Family Hospital
- Rabin Medical Center-Beilinson Campus
- Tel Aviv Sourasky Medical Center; Pharmacy
- A.O.U. Policlinico di Modena
- Policlinico Universitario Agostino Gemelli; Farmacia
- Azienda Ospedaliera San Camillo Forlanini
- Asst Fatebenefratelli Sacco (Fatebenefratelli)
- Istituto Clinico Humanitas
- I.R.C.C.S Policlinico San Donato
- Azienda Ospedaliera Universitaria Careggi
- Dong-A University Hospital
- Kyungpook National University Hospital
- Yeungnam Univ. Hospital
- Korea University Ansan Hospital
- Seoul National University Bundang Hospital
- CHA Bundang Medical Centre; CHA university
- Kangbuk Samsung Hospital
- Asan Medical Center
- Samsung Medical Center
- Yonsei University Wonju Severance Christian Hospital
- Pauls Stradins Clinical University Hospital
- Riga East Clinical University Hospital, clinic "Gailezers"; Department of Endoscopy
- Hospital of Lithuanian University of Health. Sciences Kaunas Clinics
- Vilnius University Hospital Santariskiu Clinics, Public Inst; Department of Clinical Pharmacology
- Clinical Research Institute
- Medical Care & Research SA de CV
- Amsterdam UMC, Locatie VUMC; Gastroenterology
- Amsterdam UMC Location AMC
- Leids Universitair Medisch Centrum; Cardiology
- Maastricht University Medical Center
- Erasmus Medisch Centrum
- Zuyderland Medisch Centrum - Sittard Geleen
- ETZ TweeSteden
- North Shore Hospital
- Christchurch Hospital NZ
- Dunedin Public Hospital
- Waikato Hospital
- Hutt Hospital
- Shakespeare Specialist Group
- Tauranga Hospital
- SP ZOZ Wojewodzki Szpital Zespolony im. J. Sniadeckiego
- Nasz Lekarz Osrodek Badan Klinicznych
- Elblaski Szpital Specjalistyczny z Przychodnia SP ZOZ
- ETG Kielce
- Centrum Opieki Zdrowotnej Orkan-Med
- Indywidualna Specjalistyczna Praktyka Lekarska
- Allmedica Badania Kliniczne Sp z o.o. Sp K.
- Centrum Medyczne "MEDYK"
- Gabinet Lekarski, Bartosz Korczowski
- Niepubliczny Zaklad Opieki Zdrowotnej SONOMED
- Twoja Przychodnia-Szczecinskie Centrum Medyczne
- Gastromed Kopon Zmudzinski i Wspolnicy Sp.j.Specjalistyczne Centrum Gastrologii i Endoskopii Specj
- Centrum Zdrowia MDM
- Zespó Przychodni Specjalistycznych PRIMA
- Przychodnia EuroMediCare
- PlanetMed sp. z o.o.
- LexMedica Osrodek Badan Klinicznych
- S.C MedLife S.A
- Spitalul Clinic Colentina
- Centrul de Gastroenterologie Dr. Goldis
- SBEI HPE Altai StateMedicalUniversityofMoH andSD
- LLC "Novosibirsk GastroCenter"
- Baltic Medicine
- LEC at SBIH of Moscow "City Clinical Hospital # 24"; Gastroenterology
- SEIHPE "Rostov SMU of MoH of RF"
- Evromedservis LCC
- Federal State Military Educational Inst. of High Prof. Edu Military Medical Acad; Therapy department
- North-Western Medical University n.a. I.I. Mechnikov; Rheumatology
- SBIH City Clinical Hospital #31
- Pavlov First Saint Petersburg State Medical University
- Irkutsk State Medical Academy of Continuing Education
- SBEIHPE Novosibirsk State Medical University
- BHI of Omsk region Clinical Oncology Dispensary
- Clinical Center Zvezdara
- Military Medical Academy
- General Hospital Djordje Joanovic
- KM Management spol. s r.o.
- Endomed, s.r.o.
- Accout Center s.r.o.
- Dr D Epstein Practice
- Emmed Research
- Hospital Universitario de Bellvitge
- Hospital Clínic i Provincial; Servicio de Farmacia
- Hospital Reina Sofia; Medical Oncology
- Hospital Juan Ramón Jiménez
- Hospital Universitario de la Princesa
- Hospital Universitario La Paz
- Hospital Universitario de Fuenlabrada
- Hospital Universitario Virgen Macarena
- Hospital Universitario Virgen del Rocio
- Hospital Universitari i Politecnic La Fe
- Hospital Universitario Miguel Servet
- Inselspital-Universitaetsspital Bern
- Crohn-Colitis Zentrum Bern - Gemeinschaftspraxis Balsiger, Seibold und Partner
- Universitätsspital Zürich
- Hacettepe University Medical Faculty; Gastroenterology
- Gazi University Medical Faculty
- Acibadem Fulya Hospital; Neurology
- Haydarpasa Numune Training and Research Hospital; Gastroenterology
- Ege University Medical Faculty
- Medeniyet University Goztepe Training and Research Hospital.
- Kocaeli Universitesi Tip Fakultesi; Infectious Diseases
- Acibadem Kozyatagi Hospital; Gastroenterology
- CNE Prof. O.O. Shalimov Kharkiv City Clinical Hospital #2 of KCC
- CI of Healthcare Kharkiv Reg Clin Hosp-Center of Med Emergency & Accident Medicine
- LLC Gastroenterology Center IBD Team
- Medical Center of Limited Liability Company Medical Clinic Blagomed
- Med Center of International Institute of Clinical Trials LLC; Medical Center "OK!Clinic+"
- CI of Kyiv RC Regional Clinical Hospital #2
- Lviv Regional Clinical Hospital
- Ivano-Frankivsk Regional Clinical Hospital
- RCI Chernivtsi RCH Dep of Surgery Bukovinian SMU
- CHI Kharkiv City Clinical Hospital #13
- Railway Transport Odesa CH of Healthcare Ctr Branch of PJSC Ukrainian Railway Dept of Therapy #2
- Private Small Enterprise Medical Center Pulse
- M.I. Pyrogov VRCH Dept of Gastroenterology M.I. Pyrogov VNMU
- MCIC MC LLC Health Clinic
- Royal Victoria Hospital
- University Hospital Coventry
- Royal Devon and Exeter Hospital (Wonford)
- Queen Elizabeth Hospital
- St James University Hospital
- Royal Liverpool University Hospital
- Whipps Cross Hospital
- University College London Hospital
- Fairfield General Hospital
- Royal Victoria Infirmary; Stroke unit
- Nottingham University Hospitals Queen's Medical Centre
- Royal Berkshire Hospital
- Southampton General Hospital
Arms of the Study
Arm 1
Arm 2
Experimental
No Intervention
Part 1: Etrolizumab Open-Label Extension
Part 2: Safety Monitoring
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).
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.