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

Primary Purpose

Crohn Disease

Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Etrolizumab
Sponsored by
Hoffmann-La Roche
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Crohn Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Arm Type

Experimental

No Intervention

Arm Label

Part 1: Etrolizumab Open-Label Extension

Part 2: Safety Monitoring

Arm Description

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.

Outcomes

Primary Outcome Measures

Part 1: Number of Participants with Crohn's Disease Activity Index (CDAI) Remission Over Time
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.
Part 1: Simple Endoscopic Score for Crohn's Disease (SES-CD) Score at 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)
Part 1: Overall Number of Participants with Adverse Events Leading to Etrolizumab Discontinuation
Part 1: Overall Number of Participants who Experienced at Least One Infection-Related Adverse Event by Severity, According to NCI-CTCAE v4.0
Part 1: Number of Infection-Related Adverse Events per Patient-Year
Part 1: Overall Number of Participants who Experienced at Least One Infection-Related Serious Adverse Event
Part 1: Overall Number of Participants who Experienced at Least One Injection-Site Reaction by Severity, According to NCI-CTCAE v4.0
Part 1: Overall Number of Participants who Develop Malignancies
Part 1: Number of Malignancies per Patient-Year
Part 1: Overall Number of Participants who Experienced at Least One Hypersensitivity Reaction by Severity, According to NCI-CTCAE v4.0
Part 1: Number of Participants with Anti-Therapeutic Antibodies (ATAs) to Etrolizumab
Part 2: Number of Participants who Experienced at Least One Suspected or Confirmed Event of Progressive Multifocal Leukoencephalopathy (PML)

Secondary Outcome Measures

Full Information

First Posted
March 26, 2015
Last Updated
August 2, 2023
Sponsor
Hoffmann-La Roche
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1. Study Identification

Unique Protocol Identification Number
NCT02403323
Brief Title
Open-Label Extension and Safety Study for Participants With Crohn's Disease Previously Enrolled in the Etrolizumab Phase III Study GA29144
Acronym
JUNIPER
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 8, 2015 (Actual)
Primary Completion Date
June 11, 2024 (Anticipated)
Study Completion Date
June 11, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche

4. Oversight

5. Study Description

Brief Summary
This open-label extension and safety monitoring study is composed of two parts: Part 1 will evaluate the long-term safety and efficacy of continued etrolizumab treatment in participants with moderately to severely active Crohn's disease who were previously enrolled in the etrolizumab Phase III Study GA29144 (NCT02394028) and who meet eligibility criteria for enrollment into Part 1. In Part 2, participants who have stopped etrolizumab treatment (either by exiting Part 1 of this study or by entering directly from Study GA29144 [NCT02394028]) will be monitored for 92 weeks for progressive multifocal leukoencephalopathy (PML) and other safety events.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Crohn Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
900 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Part 1: Etrolizumab Open-Label Extension
Arm Type
Experimental
Arm Description
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).
Arm Title
Part 2: Safety Monitoring
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Etrolizumab
Other Intervention Name(s)
RG7413
Intervention Description
105 mg etrolizumab subcutaneous administration once every 4 weeks
Primary Outcome Measure Information:
Title
Part 1: Number of Participants with Crohn's Disease Activity Index (CDAI) Remission Over Time
Time Frame
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)
Title
Part 1: Number of Participants with Clinical Remission Over Time
Description
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.
Time Frame
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)
Title
Part 1: Simple Endoscopic Score for Crohn's Disease (SES-CD) Score at Week 108
Time Frame
Week 108 (or at early withdrawal, if prior to Week 108)
Title
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)
Time Frame
From Week 0 until completion of safety follow-up, commercial availability of etrolizumab, or study termination, whichever is earliest (up to approximately 10 years)
Title
Part 1: Overall Number of Participants with Adverse Events Leading to Etrolizumab Discontinuation
Time Frame
From Week 0 until completion of safety follow-up, commercial availability of etrolizumab, or study termination, whichever is earliest (up to approximately 10 years)
Title
Part 1: Overall Number of Participants who Experienced at Least One Infection-Related Adverse Event by Severity, According to NCI-CTCAE v4.0
Time Frame
From Week 0 until completion of safety follow-up, commercial availability of etrolizumab, or study termination, whichever is earliest (up to approximately 10 years)
Title
Part 1: Number of Infection-Related Adverse Events per Patient-Year
Time Frame
From Week 0 until study completion or early withdrawal, commercial availability of etrolizumab, or study termination, whichever is earliest (up to approximately 10 years)
Title
Part 1: Overall Number of Participants who Experienced at Least One Infection-Related Serious Adverse Event
Time Frame
From Week 0 until completion of safety follow-up, commercial availability of etrolizumab, or study termination, whichever is earliest (up to approximately 10 years)
Title
Part 1: Overall Number of Participants who Experienced at Least One Injection-Site Reaction by Severity, According to NCI-CTCAE v4.0
Time Frame
From Week 0 until completion of safety follow-up, commercial availability of etrolizumab, or study termination, whichever is earliest (up to approximately 10 years)
Title
Part 1: Overall Number of Participants who Develop Malignancies
Time Frame
From Week 0 until completion of safety follow-up, commercial availability of etrolizumab, or study termination, whichever is earliest (up to approximately 10 years)
Title
Part 1: Number of Malignancies per Patient-Year
Time Frame
From Week 0 until completion of safety follow-up, commercial availability of etrolizumab, or study termination, whichever is earliest (up to approximately 10 years)
Title
Part 1: Overall Number of Participants who Experienced at Least One Hypersensitivity Reaction by Severity, According to NCI-CTCAE v4.0
Time Frame
From Week 0 until completion of safety follow-up, commercial availability of etrolizumab, or study termination, whichever is earliest (up to approximately 10 years)
Title
Part 1: Number of Participants with Anti-Therapeutic Antibodies (ATAs) to Etrolizumab
Time Frame
Weeks 0 and 12, and every 48 weeks thereafter until study completion or early withdrawal (up to approximately 10 years)
Title
Part 2: Number of Participants who Experienced at Least One Suspected or Confirmed Event of Progressive Multifocal Leukoencephalopathy (PML)
Time Frame
From end of safety follow-up until completion of 92-week safety monitoring in Part 2 (up to 92 weeks)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
Facility Information:
Facility Name
Valley Gastroenterology Consultants
City
Arcadia
State/Province
California
ZIP/Postal Code
91006
Country
United States
Facility Name
University of California San Diego Medical Center
City
La Jolla
State/Province
California
ZIP/Postal Code
92093-5354
Country
United States
Facility Name
VA Long Beach Healthcare System
City
Long Beach
State/Province
California
ZIP/Postal Code
90822
Country
United States
Facility Name
Digestive Care Associates, A Medical Corporation
City
San Carlos
State/Province
California
ZIP/Postal Code
94070
Country
United States
Facility Name
SDG Clinical Research
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
Uni. of California at San Francisco; Dept Pediatric, Div. of Gastroenterology, Hepatology & Nutri
City
San Francisco
State/Province
California
ZIP/Postal Code
94158
Country
United States
Facility Name
Peak Gastroenterology Associates
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80907
Country
United States
Facility Name
Innovative Medical Research of South Florida
City
Aventura
State/Province
Florida
ZIP/Postal Code
33180
Country
United States
Facility Name
West Central Gastroenterology d/b/a Gastro Florida
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33756
Country
United States
Facility Name
University of Florida College of Medicine
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
Facility Name
Borland-Groover Clinic
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32256
Country
United States
Facility Name
IMIC, Inc
City
Miami Beach
State/Province
Florida
ZIP/Postal Code
33140
Country
United States
Facility Name
FQL Research, LLC
City
Miramar
State/Province
Florida
ZIP/Postal Code
33025
Country
United States
Facility Name
Shafran Gastroenterology Center
City
Winter Park
State/Province
Florida
ZIP/Postal Code
32789
Country
United States
Facility Name
Emory University Hospital
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Atlanta Gastroenterology Associates
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
Columbus Regional Research Institute
City
Columbus
State/Province
Georgia
ZIP/Postal Code
31904
Country
United States
Facility Name
Atlanta Center for Gastroenterology, PC
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30033
Country
United States
Facility Name
Gastroenterology Associates of Central Georgia
City
Macon
State/Province
Georgia
ZIP/Postal Code
31201
Country
United States
Facility Name
Gastrointestinal Specialists of Georgia, PC
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Facility Name
Advanced Clinical Research
City
Spokane
State/Province
Idaho
ZIP/Postal Code
99202
Country
United States
Facility Name
Northwestern Uni-Feinberg School of Medicine
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
University of Chicago Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Southwest Gastroenterology
City
Oak Lawn
State/Province
Illinois
ZIP/Postal Code
60453
Country
United States
Facility Name
Carle Foundation Hospital
City
Urbana
State/Province
Illinois
ZIP/Postal Code
61801-2500
Country
United States
Facility Name
Cotton-O'Neil Clinical Research Center, Digestive Health
City
Topeka
State/Province
Kansas
ZIP/Postal Code
66606
Country
United States
Facility Name
Gastroenterology Associates, LLC
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70809
Country
United States
Facility Name
Louisiana Research Center, LLC
City
Shreveport
State/Province
Louisiana
Country
United States
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
Gastroenterology Associates of Western Michigan, P.L.C.
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49506
Country
United States
Facility Name
Henry Ford Health System
City
Novi
State/Province
Michigan
ZIP/Postal Code
48377-3600
Country
United States
Facility Name
Center for Digestive Health
City
Troy
State/Province
Michigan
ZIP/Postal Code
48098
Country
United States
Facility Name
Mayo Clinic - Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
University of Mississippi Medical Center
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39216
Country
United States
Facility Name
Ehrhardt Clinical Research, LLC
City
Belton
State/Province
Missouri
ZIP/Postal Code
64012
Country
United States
Facility Name
Concorde Medical Group
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Weill Cornell Medical College-New York Presbyterian Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Lenox Hill Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10075
Country
United States
Facility Name
University of North Carolina at Chapel Hill
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Facility Name
Charlotte Gastroenterology and Hepatology, P.L.L.C
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28207
Country
United States
Facility Name
Vidant Medical Group, LLC DBA Vidant Multispeciality Clinic-Kinston
City
Kinston
State/Province
North Carolina
ZIP/Postal Code
28501
Country
United States
Facility Name
Consultants for Clinical Research Inc.
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
Great Lakes Gastroenterology Research, LLC
City
Mentor
State/Province
Ohio
ZIP/Postal Code
44060
Country
United States
Facility Name
Digestive Disease Specialists, Inc.
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73112
Country
United States
Facility Name
Great Lakes Medical Research, LLC
City
Harrisburg
State/Province
Pennsylvania
ZIP/Postal Code
17110
Country
United States
Facility Name
Innovative Clinical Research
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29604
Country
United States
Facility Name
Gastro One
City
Germantown
State/Province
Tennessee
ZIP/Postal Code
38138
Country
United States
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
University of Texas Southwestern Medical Center; Internal Medicne
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390-9151
Country
United States
Facility Name
Baylor College of Medicine
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Methodist Hospital Research Institute
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Wellness Clinical Research Center
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78232
Country
United States
Facility Name
Texas Digestive Disease Consultants - Southlake
City
Southlake
State/Province
Texas
ZIP/Postal Code
76092
Country
United States
Facility Name
Digestive Health Specialists of Tyler
City
Tyler
State/Province
Texas
ZIP/Postal Code
75701
Country
United States
Facility Name
Ericksen Research and Development
City
Clinton
State/Province
Utah
ZIP/Postal Code
84015
Country
United States
Facility Name
University of Utah School of Medicine
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132
Country
United States
Facility Name
McGuire Research Institute; Gastroenterology
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23249
Country
United States
Facility Name
Digestive Disease Institute; Virginia Mason Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98101
Country
United States
Facility Name
University of Wisconsin
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53705
Country
United States
Facility Name
Hospital Italiano
City
Caba
ZIP/Postal Code
C1199ABB
Country
Argentina
Facility Name
The Canberra Hospital
City
Garran
State/Province
Australian Capital Territory
ZIP/Postal Code
2065
Country
Australia
Facility Name
Concord Repatriation General Hospital
City
Concord
State/Province
New South Wales
ZIP/Postal Code
2139
Country
Australia
Facility Name
Royal Brisbane and Women's Hospital
City
Herston
State/Province
Queensland
ZIP/Postal Code
4029
Country
Australia
Facility Name
University of the Sunshine Coast
City
Sippy Downs
State/Province
Queensland
ZIP/Postal Code
4556
Country
Australia
Facility Name
Mater Adult Hospital
City
South Brisbane
State/Province
Queensland
ZIP/Postal Code
4101
Country
Australia
Facility Name
Princess Alexandra Hospital
City
Woolloongabba
State/Province
Queensland
ZIP/Postal Code
4102
Country
Australia
Facility Name
Flinders Medical Centre
City
Bedford Park
State/Province
South Australia
ZIP/Postal Code
5042
Country
Australia
Facility Name
St Vincent's Hospital Melbourne
City
Fitzroy
State/Province
Victoria
ZIP/Postal Code
3065
Country
Australia
Facility Name
Footscray Hospital
City
Footscray
State/Province
Victoria
ZIP/Postal Code
3011
Country
Australia
Facility Name
St Frances Xavier Cabrini Hospital
City
Malvern
State/Province
Victoria
ZIP/Postal Code
3144
Country
Australia
Facility Name
Royal Melbourne Hospital; Department of Colorectal Medicine and Genetics
City
Parkville
State/Province
Victoria
ZIP/Postal Code
3050
Country
Australia
Facility Name
The Alfred Hospital
City
Prahan
State/Province
Victoria
ZIP/Postal Code
3181
Country
Australia
Facility Name
Fiona Stanley Hospital
City
Murdoch
State/Province
Western Australia
ZIP/Postal Code
6150
Country
Australia
Facility Name
LKH - Universitätsklinikum der PMU Salzburg
City
Salzburg
ZIP/Postal Code
5020
Country
Austria
Facility Name
Medizinische Universität Wien
City
Wien
ZIP/Postal Code
1090
Country
Austria
Facility Name
UZ Brussel
City
Brussel
ZIP/Postal Code
1090
Country
Belgium
Facility Name
CHU St Pierre (César de Paepe) X
City
Bruxelles
ZIP/Postal Code
1000
Country
Belgium
Facility Name
ULB Hopital Erasme; Service de Néphrologie
City
Bruxelles
ZIP/Postal Code
1070
Country
Belgium
Facility Name
UZ Antwerpen
City
Edegem
ZIP/Postal Code
2650
Country
Belgium
Facility Name
AZ Maria Middelares
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
Instituto Goiano de Gastroenterologia e Endoscopia Digestiva Ltda
City
Goiânia
State/Province
GO
ZIP/Postal Code
74535-170
Country
Brazil
Facility Name
Hospital Felicio Rocho
City
Belo Horizonte
State/Province
MG
ZIP/Postal Code
30110-068
Country
Brazil
Facility Name
Centro Digestivo de Curitiba
City
Curitiba
State/Province
PR
ZIP/Postal Code
80430-160
Country
Brazil
Facility Name
Hospital Universitario Clementino Fraga Filho - UFRJ
City
Rio de Janeiro
State/Province
RJ
ZIP/Postal Code
21941-913
Country
Brazil
Facility Name
Instituto Brasil de Pesquisa Clínica-IBPCLIN S/A
City
Rio de Janeiro
State/Province
RJ
ZIP/Postal Code
22271-100
Country
Brazil
Facility Name
Hospital Sao Vicente de Paulo
City
Passo Fundo
State/Province
RS
ZIP/Postal Code
99010-090
Country
Brazil
Facility Name
Hospital das Clinicas - UFRGS
City
Porto Alegre
State/Province
RS
ZIP/Postal Code
90035-903
Country
Brazil
Facility Name
Hospital Ernesto Dornelles
City
Porto Alegre
State/Province
RS
ZIP/Postal Code
90160-092
Country
Brazil
Facility Name
UNESP - Faculdade de Medicina da Universidade Estadual Paulista - Campus Botucatu
City
Botucatu
State/Province
SP
ZIP/Postal Code
18618-970
Country
Brazil
Facility Name
Pesquisare Saúde Sociedade Simples
City
Santo Andre
State/Province
SP
ZIP/Postal Code
09080-000
Country
Brazil
Facility Name
Praxis Pesquisa Médica
City
Santo Andre
State/Province
SP
ZIP/Postal Code
09090-790
Country
Brazil
Facility Name
Hospital Estadual Mario Covas
City
Sao Bernardo Do Campo
State/Province
SP
ZIP/Postal Code
09715-090
Country
Brazil
Facility Name
Hospital de Base de Sao Jose do Rio Preto
City
Sao Jose do Rio Preto
State/Province
SP
ZIP/Postal Code
15090-000
Country
Brazil
Facility Name
Hospital Sírio-Libanês
City
Sao Paulo
State/Province
SP
ZIP/Postal Code
01308-050
Country
Brazil
Facility Name
Universidade Federal de Sao Paulo - UNIFES
City
Sao Paulo
State/Province
SP
ZIP/Postal Code
04026-000
Country
Brazil
Facility Name
Hospital do Servidor Público Estadual/HSPE-SP
City
São Paulo
State/Province
SP
ZIP/Postal Code
04039-901
Country
Brazil
Facility Name
"City Clinic UMHAC" EOOD
City
Sofia
ZIP/Postal Code
1407
Country
Bulgaria
Facility Name
UMHAT "Sv. Ivan Rilski", EAD
City
Sofia
ZIP/Postal Code
1431
Country
Bulgaria
Facility Name
University of Calgary
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 2T9
Country
Canada
Facility Name
Zeidler Ledcor Centre - University of Alberta; Division of Gasroenterology
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2X8
Country
Canada
Facility Name
(G.I.R.I.) GI Research Institute
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6Z 2K5
Country
Canada
Facility Name
Winnipeg Regional Health Authority; Neurosurgery Department
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3A 1R9
Country
Canada
Facility Name
Queen Elizabeth II Health Sciences Centre; Gastroenterology Research
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 1V7
Country
Canada
Facility Name
University Hospital - London Health Sciences Centre
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5A5
Country
Canada
Facility Name
Taunton Health Centre
City
Oshawa
State/Province
Ontario
ZIP/Postal Code
L1H 7K4
Country
Canada
Facility Name
The Ottawa Hospital - Riverside Campus; Gastrointestinal Clinical Research Unit
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 1A2
Country
Canada
Facility Name
Mount Sinai Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1X5
Country
Canada
Facility Name
Toronto Digestive Disease Associates
City
Vaughan
State/Province
Ontario
ZIP/Postal Code
L4L 4Y7
Country
Canada
Facility Name
Hôpital Maisonneuve - Rosemont
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H1T 2M4
Country
Canada
Facility Name
McGill University Health Centre - Glen Site
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H4A 3J1
Country
Canada
Facility Name
Royal University Hospital
City
Saskatoon
State/Province
Saskatchewan
ZIP/Postal Code
S7N 0W8
Country
Canada
Facility Name
Clinical Hospital Centre Osijek
City
Osijek
ZIP/Postal Code
31000
Country
Croatia
Facility Name
General Hospital Pula
City
Pula
ZIP/Postal Code
52100
Country
Croatia
Facility Name
Clinical Hospital Center Sestre Milosrdnice
City
Zagreb
ZIP/Postal Code
10000
Country
Croatia
Facility Name
Vojenska nemocnice Brno
City
Brno
ZIP/Postal Code
636 00
Country
Czechia
Facility Name
Fakultni nemocnice u sv. Anny v Brne; I.Interni kardioangiologicka klinika
City
Brno
ZIP/Postal Code
65691
Country
Czechia
Facility Name
Nemocnice Ceske Budejovice a.s.
City
Ceske Budejovice
ZIP/Postal Code
370 01
Country
Czechia
Facility Name
Gastroenterologie s.r.o.
City
Hradec Kralove
ZIP/Postal Code
500 02
Country
Czechia
Facility Name
Fakultni nemocnice Hradec Kralove
City
Hradec Kralove
ZIP/Postal Code
500 05
Country
Czechia
Facility Name
Hepato-Gastroenterologie HK, s.r.o.
City
Hradec Kralove
ZIP/Postal Code
500 12
Country
Czechia
Facility Name
PreventaMed, s.r.o.
City
Olomouc
ZIP/Postal Code
779 00
Country
Czechia
Facility Name
Fakultni nemocnice Ostrava
City
Ostrava - Poruba
ZIP/Postal Code
708 52
Country
Czechia
Facility Name
ISCARE a.s.
City
Praha 7
ZIP/Postal Code
170 04
Country
Czechia
Facility Name
Fakultni nemocnice Kralovske Vinohrady
City
Praha
ZIP/Postal Code
100 34
Country
Czechia
Facility Name
West Tallinn Central Hospital
City
Tallinn
ZIP/Postal Code
10617
Country
Estonia
Facility Name
North Estonia Medical Centre Foundation
City
Tallinn
ZIP/Postal Code
13419
Country
Estonia
Facility Name
Tartu University Hospital
City
Tartu
ZIP/Postal Code
51014
Country
Estonia
Facility Name
CHU Amiens - Hopital Sud
City
Amiens
ZIP/Postal Code
80054
Country
France
Facility Name
CHU de Caen Hopital Cote de Nacre
City
Caen
ZIP/Postal Code
14033
Country
France
Facility Name
Hôpital Beaujon
City
Clichy cedex
ZIP/Postal Code
92110
Country
France
Facility Name
Hopital Claude Huriez - CHU Lille
City
Lille
ZIP/Postal Code
59037
Country
France
Facility Name
CHU NANTES - Hôtel Dieu; Pharmacy
City
Nantes
ZIP/Postal Code
44093
Country
France
Facility Name
CHU Nice - Hopital de l'Archet 2
City
Nice
ZIP/Postal Code
06202
Country
France
Facility Name
Hôpital Saint-Louis
City
Paris
ZIP/Postal Code
75475
Country
France
Facility Name
Groupe Hospitalier Sud - Hôpital Haut-Lévêque - USN
City
Pessac
ZIP/Postal Code
33604
Country
France
Facility Name
Centre Hospitalier Lyon Sud; Service de Gastro-Enterologie
City
Pierre-Benite
ZIP/Postal Code
69495
Country
France
Facility Name
CHU du Reims - Hopital Robert Debré
City
Reims
ZIP/Postal Code
51100
Country
France
Facility Name
CHU Saint Etienne - Hôpital Nord
City
Saint Etienne
ZIP/Postal Code
42055
Country
France
Facility Name
Höpital Hautepierre; Pediatrie1
City
Strasbourg
ZIP/Postal Code
67098
Country
France
Facility Name
Hôpital de Brabois Adultes
City
Vandoeuvre-les-nancy
ZIP/Postal Code
54511
Country
France
Facility Name
Charite-Campus Virchow Klinikum; Hepatologie und Gastroenterologie
City
Berlin
ZIP/Postal Code
13353
Country
Germany
Facility Name
Charité Campus Virchow-Klinikum; Department of Cardiology
City
Berlin
ZIP/Postal Code
13353
Country
Germany
Facility Name
Krankenhaus Waldfriede e. V.
City
Berlin
ZIP/Postal Code
14163
Country
Germany
Facility Name
Berufsgenossenschaftliches Universitaetsklinikum Bergmannsheil GmbH
City
Bochum
ZIP/Postal Code
44789
Country
Germany
Facility Name
Klinikum der Johann Wolfgang Goethe-Universitaet
City
Frankfurt
ZIP/Postal Code
60590
Country
Germany
Facility Name
Medizinische Hochschule Hannover
City
Hannover
ZIP/Postal Code
30625
Country
Germany
Facility Name
Klinikum Mannheim GmbH Universitätsklinikum
City
Mannheim
ZIP/Postal Code
68167
Country
Germany
Facility Name
Gemeinschaftspraxis
City
Schweinfurt
ZIP/Postal Code
97421
Country
Germany
Facility Name
Universitaetsklinikum Ulm
City
Ulm
ZIP/Postal Code
89081
Country
Germany
Facility Name
Bekes Megyei Kozponti Korhaz Dr. Rethy Pal Tagkorhaza
City
Bekescsaba
ZIP/Postal Code
5600
Country
Hungary
Facility Name
Obudai Egeszsegugyi Centrum Kft.
City
Budapest
ZIP/Postal Code
1036
Country
Hungary
Facility Name
Semmelweis Egyetem
City
Budapest
ZIP/Postal Code
1088
Country
Hungary
Facility Name
Szt Janos Korhaz es EbudaiEgyesitettKorhazak
City
Budapest
ZIP/Postal Code
1125
Country
Hungary
Facility Name
Pannonia Maganorvosi Centrum
City
Budapest
ZIP/Postal Code
1136
Country
Hungary
Facility Name
Debreceni Egyetem Klinikai Központ; B?rgyógyászati Klinika
City
Debrecen
ZIP/Postal Code
4012
Country
Hungary
Facility Name
Petz Aladar Megyei Oktato Korhaz
City
Gyor
ZIP/Postal Code
9024
Country
Hungary
Facility Name
Pest Megyei Flor Ferenc Korhaz
City
Kistarcsa
ZIP/Postal Code
2143
Country
Hungary
Facility Name
Haemek Medical Center
City
Afula
ZIP/Postal Code
18101
Country
Israel
Facility Name
Soroka University Medical Centre
City
Beer Sheva
ZIP/Postal Code
8410101
Country
Israel
Facility Name
Wolfson Medical Center
City
Holon
ZIP/Postal Code
5822012
Country
Israel
Facility Name
Shaare Zedek Medical Center
City
Jerusalem
ZIP/Postal Code
9103102
Country
Israel
Facility Name
Holy Family Hospital
City
Nazareth
ZIP/Postal Code
1641101
Country
Israel
Facility Name
Rabin Medical Center-Beilinson Campus
City
Petach Tikva
ZIP/Postal Code
4941492
Country
Israel
Facility Name
Tel Aviv Sourasky Medical Center; Pharmacy
City
Tel Aviv
ZIP/Postal Code
6423906
Country
Israel
Facility Name
A.O.U. Policlinico di Modena
City
Modena
State/Province
Emilia-Romagna
ZIP/Postal Code
40124
Country
Italy
Facility Name
Policlinico Universitario Agostino Gemelli; Farmacia
City
Roma
State/Province
Lazio
ZIP/Postal Code
00168
Country
Italy
Facility Name
Azienda Ospedaliera San Camillo Forlanini
City
Roma
State/Province
Lazio
ZIP/Postal Code
151
Country
Italy
Facility Name
Asst Fatebenefratelli Sacco (Fatebenefratelli)
City
Milano
State/Province
Lombardia
ZIP/Postal Code
20121
Country
Italy
Facility Name
Istituto Clinico Humanitas
City
Rozzano (MI)
State/Province
Lombardia
ZIP/Postal Code
20089
Country
Italy
Facility Name
I.R.C.C.S Policlinico San Donato
City
San Donato Milanese (MI)
State/Province
Lombardia
ZIP/Postal Code
20097
Country
Italy
Facility Name
Azienda Ospedaliera Universitaria Careggi
City
Florence
State/Province
Toscana
ZIP/Postal Code
50134
Country
Italy
Facility Name
Dong-A University Hospital
City
Busan
ZIP/Postal Code
49201
Country
Korea, Republic of
Facility Name
Kyungpook National University Hospital
City
Daegu
ZIP/Postal Code
41944
Country
Korea, Republic of
Facility Name
Yeungnam Univ. Hospital
City
Daegu
ZIP/Postal Code
705-717
Country
Korea, Republic of
Facility Name
Korea University Ansan Hospital
City
Gyeonggi-do
ZIP/Postal Code
15355
Country
Korea, Republic of
Facility Name
Seoul National University Bundang Hospital
City
Seongnam-si
ZIP/Postal Code
463-707
Country
Korea, Republic of
Facility Name
CHA Bundang Medical Centre; CHA university
City
Seongnam
ZIP/Postal Code
13520
Country
Korea, Republic of
Facility Name
Kangbuk Samsung Hospital
City
Seoul
ZIP/Postal Code
03181
Country
Korea, Republic of
Facility Name
Asan Medical Center
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
135-710
Country
Korea, Republic of
Facility Name
Yonsei University Wonju Severance Christian Hospital
City
Wonju-Si
ZIP/Postal Code
220-701
Country
Korea, Republic of
Facility Name
Pauls Stradins Clinical University Hospital
City
R?ga
ZIP/Postal Code
LV-1002
Country
Latvia
Facility Name
Riga East Clinical University Hospital, clinic "Gailezers"; Department of Endoscopy
City
Riga
ZIP/Postal Code
LV-1005
Country
Latvia
Facility Name
Hospital of Lithuanian University of Health. Sciences Kaunas Clinics
City
Kaunas
ZIP/Postal Code
50009
Country
Lithuania
Facility Name
Vilnius University Hospital Santariskiu Clinics, Public Inst; Department of Clinical Pharmacology
City
Vilnius
ZIP/Postal Code
08661
Country
Lithuania
Facility Name
Clinical Research Institute
City
Tlalnepantla de Baz
State/Province
Mexico CITY (federal District)
ZIP/Postal Code
54055
Country
Mexico
Facility Name
Medical Care & Research SA de CV
City
Mérida
State/Province
Yucatan
ZIP/Postal Code
97000
Country
Mexico
Facility Name
Amsterdam UMC, Locatie VUMC; Gastroenterology
City
Amsterdam
ZIP/Postal Code
1081 HV
Country
Netherlands
Facility Name
Amsterdam UMC Location AMC
City
Amsterdam
ZIP/Postal Code
1105 AZ
Country
Netherlands
Facility Name
Leids Universitair Medisch Centrum; Cardiology
City
Leiden
ZIP/Postal Code
2333 ZA
Country
Netherlands
Facility Name
Maastricht University Medical Center
City
Maastricht
ZIP/Postal Code
6229 HX
Country
Netherlands
Facility Name
Erasmus Medisch Centrum
City
Rotterdam
ZIP/Postal Code
3000 CA
Country
Netherlands
Facility Name
Zuyderland Medisch Centrum - Sittard Geleen
City
Sittard-Geleen
ZIP/Postal Code
6162 BG
Country
Netherlands
Facility Name
ETZ TweeSteden
City
Tilburg
ZIP/Postal Code
5042AD
Country
Netherlands
Facility Name
North Shore Hospital
City
Auckland
ZIP/Postal Code
0620
Country
New Zealand
Facility Name
Christchurch Hospital NZ
City
Christchurch
ZIP/Postal Code
8011
Country
New Zealand
Facility Name
Dunedin Public Hospital
City
Dunedin
ZIP/Postal Code
9016
Country
New Zealand
Facility Name
Waikato Hospital
City
Hamilton
ZIP/Postal Code
3248
Country
New Zealand
Facility Name
Hutt Hospital
City
Lower Hutt
ZIP/Postal Code
5010
Country
New Zealand
Facility Name
Shakespeare Specialist Group
City
Takapuna
ZIP/Postal Code
0620
Country
New Zealand
Facility Name
Tauranga Hospital
City
Tauranga
ZIP/Postal Code
3143
Country
New Zealand
Facility Name
SP ZOZ Wojewodzki Szpital Zespolony im. J. Sniadeckiego
City
Bia?ystok
ZIP/Postal Code
15-275
Country
Poland
Facility Name
Nasz Lekarz Osrodek Badan Klinicznych
City
Bydgoszcz
ZIP/Postal Code
85-312
Country
Poland
Facility Name
Elblaski Szpital Specjalistyczny z Przychodnia SP ZOZ
City
Elblag
ZIP/Postal Code
82-300
Country
Poland
Facility Name
ETG Kielce
City
Kielce
ZIP/Postal Code
25-355
Country
Poland
Facility Name
Centrum Opieki Zdrowotnej Orkan-Med
City
Ksawerow
ZIP/Postal Code
95-054
Country
Poland
Facility Name
Indywidualna Specjalistyczna Praktyka Lekarska
City
Lublin
ZIP/Postal Code
20-015
Country
Poland
Facility Name
Allmedica Badania Kliniczne Sp z o.o. Sp K.
City
Nowy Targ
ZIP/Postal Code
34-400
Country
Poland
Facility Name
Centrum Medyczne "MEDYK"
City
Rzeszow
ZIP/Postal Code
35-055
Country
Poland
Facility Name
Gabinet Lekarski, Bartosz Korczowski
City
Rzeszów
ZIP/Postal Code
35-302
Country
Poland
Facility Name
Niepubliczny Zaklad Opieki Zdrowotnej SONOMED
City
Szczecin
ZIP/Postal Code
70-351
Country
Poland
Facility Name
Twoja Przychodnia-Szczecinskie Centrum Medyczne
City
Szczecin
ZIP/Postal Code
71-434
Country
Poland
Facility Name
Gastromed Kopon Zmudzinski i Wspolnicy Sp.j.Specjalistyczne Centrum Gastrologii i Endoskopii Specj
City
Toru?
ZIP/Postal Code
87-100
Country
Poland
Facility Name
Centrum Zdrowia MDM
City
Warszawa
ZIP/Postal Code
00-635
Country
Poland
Facility Name
Zespó Przychodni Specjalistycznych PRIMA
City
Warszawa
ZIP/Postal Code
02-018
Country
Poland
Facility Name
Przychodnia EuroMediCare
City
Wroc?aw
ZIP/Postal Code
50-220
Country
Poland
Facility Name
PlanetMed sp. z o.o.
City
Wroc?aw
ZIP/Postal Code
52-210
Country
Poland
Facility Name
LexMedica Osrodek Badan Klinicznych
City
Wroclaw
ZIP/Postal Code
53-114
Country
Poland
Facility Name
S.C MedLife S.A
City
Bucuresti
ZIP/Postal Code
010719
Country
Romania
Facility Name
Spitalul Clinic Colentina
City
Sector 2
ZIP/Postal Code
020125
Country
Romania
Facility Name
Centrul de Gastroenterologie Dr. Goldis
City
Timisoara
ZIP/Postal Code
300002
Country
Romania
Facility Name
SBEI HPE Altai StateMedicalUniversityofMoH andSD
City
Barnaul
State/Province
Altaj
ZIP/Postal Code
656050
Country
Russian Federation
Facility Name
LLC "Novosibirsk GastroCenter"
City
Novosibirsk
State/Province
Altaj
ZIP/Postal Code
630007
Country
Russian Federation
Facility Name
Baltic Medicine
City
St.Petersburg
State/Province
Leningrad
ZIP/Postal Code
194356
Country
Russian Federation
Facility Name
LEC at SBIH of Moscow "City Clinical Hospital # 24"; Gastroenterology
City
Moscow
State/Province
Moskovskaja Oblast
ZIP/Postal Code
125015
Country
Russian Federation
Facility Name
SEIHPE "Rostov SMU of MoH of RF"
City
Rostov-on-Don
State/Province
Rostov
ZIP/Postal Code
344022
Country
Russian Federation
Facility Name
Evromedservis LCC
City
Pushkin
State/Province
Sankt Petersburg
ZIP/Postal Code
196603
Country
Russian Federation
Facility Name
Federal State Military Educational Inst. of High Prof. Edu Military Medical Acad; Therapy department
City
Saint-Petersburg
State/Province
Sankt Petersburg
ZIP/Postal Code
191015
Country
Russian Federation
Facility Name
North-Western Medical University n.a. I.I. Mechnikov; Rheumatology
City
Sankt-peterburg
State/Province
Sankt Petersburg
ZIP/Postal Code
191015
Country
Russian Federation
Facility Name
SBIH City Clinical Hospital #31
City
Sankt-peterburg
State/Province
Sankt Petersburg
ZIP/Postal Code
197110
Country
Russian Federation
Facility Name
Pavlov First Saint Petersburg State Medical University
City
St. Petersburg
State/Province
Sankt Petersburg
ZIP/Postal Code
197022
Country
Russian Federation
Facility Name
Irkutsk State Medical Academy of Continuing Education
City
Irkutsk
ZIP/Postal Code
664079
Country
Russian Federation
Facility Name
SBEIHPE Novosibirsk State Medical University
City
Novosibirsk
ZIP/Postal Code
630091
Country
Russian Federation
Facility Name
BHI of Omsk region Clinical Oncology Dispensary
City
Omsk
ZIP/Postal Code
644013
Country
Russian Federation
Facility Name
Clinical Center Zvezdara
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Facility Name
Military Medical Academy
City
Belgrade
ZIP/Postal Code
11040
Country
Serbia
Facility Name
General Hospital Djordje Joanovic
City
Zrenjanin
ZIP/Postal Code
23000
Country
Serbia
Facility Name
KM Management spol. s r.o.
City
Nitra
ZIP/Postal Code
94901
Country
Slovakia
Facility Name
Endomed, s.r.o.
City
Vranov Nad Top?ou
ZIP/Postal Code
093 01
Country
Slovakia
Facility Name
Accout Center s.r.o.
City
Šahy
ZIP/Postal Code
936 01
Country
Slovakia
Facility Name
Dr D Epstein Practice
City
Cape Town
ZIP/Postal Code
7405
Country
South Africa
Facility Name
Emmed Research
City
Pretoria
ZIP/Postal Code
0002
Country
South Africa
Facility Name
Hospital Universitario de Bellvitge
City
Hospitalet de Llobregat
State/Province
Barcelona
ZIP/Postal Code
08907
Country
Spain
Facility Name
Hospital Clínic i Provincial; Servicio de Farmacia
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Hospital Reina Sofia; Medical Oncology
City
Cordoba
ZIP/Postal Code
14004
Country
Spain
Facility Name
Hospital Juan Ramón Jiménez
City
Huelva
ZIP/Postal Code
21005
Country
Spain
Facility Name
Hospital Universitario de la Princesa
City
Madrid
ZIP/Postal Code
28006
Country
Spain
Facility Name
Hospital Universitario La Paz
City
Madrid
ZIP/Postal Code
280146
Country
Spain
Facility Name
Hospital Universitario de Fuenlabrada
City
Madrid
ZIP/Postal Code
28942
Country
Spain
Facility Name
Hospital Universitario Virgen Macarena
City
Sevilla
ZIP/Postal Code
41009
Country
Spain
Facility Name
Hospital Universitario Virgen del Rocio
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Facility Name
Hospital Universitari i Politecnic La Fe
City
Valencia
ZIP/Postal Code
46026
Country
Spain
Facility Name
Hospital Universitario Miguel Servet
City
Zaragoza
ZIP/Postal Code
50009
Country
Spain
Facility Name
Inselspital-Universitaetsspital Bern
City
Bern
ZIP/Postal Code
3010
Country
Switzerland
Facility Name
Crohn-Colitis Zentrum Bern - Gemeinschaftspraxis Balsiger, Seibold und Partner
City
Bern
ZIP/Postal Code
3012
Country
Switzerland
Facility Name
Universitätsspital Zürich
City
Zürich
ZIP/Postal Code
8091
Country
Switzerland
Facility Name
Hacettepe University Medical Faculty; Gastroenterology
City
Ankara
ZIP/Postal Code
06100
Country
Turkey
Facility Name
Gazi University Medical Faculty
City
Ankara
ZIP/Postal Code
06500
Country
Turkey
Facility Name
Acibadem Fulya Hospital; Neurology
City
Istanbul
ZIP/Postal Code
34349
Country
Turkey
Facility Name
Haydarpasa Numune Training and Research Hospital; Gastroenterology
City
Istanbul
ZIP/Postal Code
34668
Country
Turkey
Facility Name
Ege University Medical Faculty
City
Izmir
ZIP/Postal Code
35100
Country
Turkey
Facility Name
Medeniyet University Goztepe Training and Research Hospital.
City
Kadiköy
ZIP/Postal Code
34722
Country
Turkey
Facility Name
Kocaeli Universitesi Tip Fakultesi; Infectious Diseases
City
Kocaeli
ZIP/Postal Code
41380
Country
Turkey
Facility Name
Acibadem Kozyatagi Hospital; Gastroenterology
City
Kozyata?i
ZIP/Postal Code
34742
Country
Turkey
Facility Name
CNE Prof. O.O. Shalimov Kharkiv City Clinical Hospital #2 of KCC
City
Kharkiv
State/Province
Kharkiv Governorate
ZIP/Postal Code
61037
Country
Ukraine
Facility Name
CI of Healthcare Kharkiv Reg Clin Hosp-Center of Med Emergency & Accident Medicine
City
Kharkiv
State/Province
Kharkiv Governorate
ZIP/Postal Code
61204
Country
Ukraine
Facility Name
LLC Gastroenterology Center IBD Team
City
Zaporizhzhia
State/Province
Kharkiv Governorate
ZIP/Postal Code
69000
Country
Ukraine
Facility Name
Medical Center of Limited Liability Company Medical Clinic Blagomed
City
Kyiv
State/Province
KIEV Governorate
ZIP/Postal Code
1023
Country
Ukraine
Facility Name
Med Center of International Institute of Clinical Trials LLC; Medical Center "OK!Clinic+"
City
Kyiv
State/Province
KIEV Governorate
ZIP/Postal Code
2091
Country
Ukraine
Facility Name
CI of Kyiv RC Regional Clinical Hospital #2
City
Kyiv
State/Province
KIEV Governorate
ZIP/Postal Code
4073
Country
Ukraine
Facility Name
Lviv Regional Clinical Hospital
City
Lviv
State/Province
KIEV Governorate
ZIP/Postal Code
79010
Country
Ukraine
Facility Name
Ivano-Frankivsk Regional Clinical Hospital
City
Ivano-Frankivsk
State/Province
Kuban People's Republica
ZIP/Postal Code
76000
Country
Ukraine
Facility Name
RCI Chernivtsi RCH Dep of Surgery Bukovinian SMU
City
Chernivtsi
ZIP/Postal Code
58002
Country
Ukraine
Facility Name
CHI Kharkiv City Clinical Hospital #13
City
Kharkiv
ZIP/Postal Code
61124
Country
Ukraine
Facility Name
Railway Transport Odesa CH of Healthcare Ctr Branch of PJSC Ukrainian Railway Dept of Therapy #2
City
Odesa
ZIP/Postal Code
65059
Country
Ukraine
Facility Name
Private Small Enterprise Medical Center Pulse
City
Vinnytsia
ZIP/Postal Code
21001
Country
Ukraine
Facility Name
M.I. Pyrogov VRCH Dept of Gastroenterology M.I. Pyrogov VNMU
City
Vinnytsia
ZIP/Postal Code
21018
Country
Ukraine
Facility Name
MCIC MC LLC Health Clinic
City
Vinnytsia
ZIP/Postal Code
21029
Country
Ukraine
Facility Name
Royal Victoria Hospital
City
Belfast
ZIP/Postal Code
BT12 6BA
Country
United Kingdom
Facility Name
University Hospital Coventry
City
Coventry
ZIP/Postal Code
CV2 2DX
Country
United Kingdom
Facility Name
Royal Devon and Exeter Hospital (Wonford)
City
Exeter
ZIP/Postal Code
EX2 5DW
Country
United Kingdom
Facility Name
Queen Elizabeth Hospital
City
Kings Lynn
ZIP/Postal Code
PE30 4ET
Country
United Kingdom
Facility Name
St James University Hospital
City
Leeds
ZIP/Postal Code
LS9 7TF
Country
United Kingdom
Facility Name
Royal Liverpool University Hospital
City
Liverpool
ZIP/Postal Code
L7 8XP
Country
United Kingdom
Facility Name
Whipps Cross Hospital
City
London
ZIP/Postal Code
E11 1NR
Country
United Kingdom
Facility Name
University College London Hospital
City
London
ZIP/Postal Code
N7 9NH
Country
United Kingdom
Facility Name
Fairfield General Hospital
City
Manchester
ZIP/Postal Code
M8 5RB
Country
United Kingdom
Facility Name
Royal Victoria Infirmary; Stroke unit
City
Newcastle Upon Tyne
ZIP/Postal Code
NE1 4LP
Country
United Kingdom
Facility Name
Nottingham University Hospitals Queen's Medical Centre
City
Nottingham
ZIP/Postal Code
NG7 2UH
Country
United Kingdom
Facility Name
Royal Berkshire Hospital
City
Reading
ZIP/Postal Code
RG1 5AN
Country
United Kingdom
Facility Name
Southampton General Hospital
City
Southampton
ZIP/Postal Code
SO16 6YD
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
32445184
Citation
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.
Results Reference
derived

Learn more about this trial

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

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