Study Stopped
The study was terminated due to program discontinuation, based on mixed efficacy results in the parent studies. There were no safety concerns.
Open-Label Extension and Safety Study for Participants With Crohn's Disease Previously Enrolled in the Etrolizumab Phase III Study GA29144
JUNIPER
An Open-Label Extension and Safety Monitoring Study of Patients With Moderately to Severely Active Crohn's Disease Previously Enrolled in the Etrolizumab Phase III Protocol GA29144
2 other identifiers
interventional
790
31 countries
274
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jun 2015
Longer than P75 for phase_3
274 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 26, 2015
CompletedFirst Posted
Study publicly available on registry
March 31, 2015
CompletedStudy Start
First participant enrolled
June 8, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 9, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
October 9, 2023
CompletedResults Posted
Study results publicly available
December 2, 2024
CompletedDecember 2, 2024
November 1, 2024
8.3 years
March 26, 2015
October 8, 2024
November 18, 2024
Conditions
Outcome Measures
Primary Outcomes (14)
Part 1: Number of Participants With Crohn's Disease Activity Index (CDAI) Remission at 12-week Intervals
CDAI is a score obtained from composite of eight assessments: number of liquid or soft stools, abdominal pain, general well-being, presence of complications, taking lomotil (diphenoxylate/atropine) or other opiates for diarrhea, presence of an abdominal mass, hematocrit, and percentage deviation from standard weight. A decrease in CDAI over time indicates improvement in disease activity. CDAI scores range from 0 to 600. A higher score indicates worse outcome. A total score of less than 150 corresponds to remission.
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
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
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)
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)
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
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
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
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
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
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
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
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
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)
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
Study Arms (2)
Part 1: Etrolizumab Open-Label Extension
EXPERIMENTALParticipants 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).
Part 2: Safety Monitoring
NO INTERVENTIONParticipants who have stopped etrolizumab treatment (either by exiting Part 1 of this study or by entering directly from Study GA29144 \[NCT02394028\]) will be monitored for 92 weeks for progressive multifocal leukoencephalopathy (PML) and other safety events.
Interventions
105 mg etrolizumab subcutaneous administration once every 4 weeks
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Part 1 Open-Label Extension:
- Any new, significant, uncontrolled condition
- Part 2 Safety Monitoring:
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (287)
Valley Gastroenterology Consultants
Arcadia, California, 91006, United States
University of California San Diego Medical Center
La Jolla, California, 92093-5354, United States
VA Long Beach Healthcare System
Long Beach, California, 90822, United States
Digestive Care Associates, A Medical Corporation
San Carlos, California, 94070, United States
SDG Clinical Research
San Diego, California, 92103, United States
Uni. of California at San Francisco; Dept Pediatric, Div. of Gastroenterology, Hepatology & Nutri
San Francisco, California, 94158, United States
Peak Gastroenterology Associates
Colorado Springs, Colorado, 80907, United States
Innovative Medical Research of South Florida
Aventura, Florida, 33180, United States
West Central Gastroenterology d/b/a Gastro Florida
Clearwater, Florida, 33756, United States
University of Florida College of Medicine
Gainesville, Florida, 32610, United States
Borland-Groover Clinic
Jacksonville, Florida, 32256, United States
IMIC, Inc
Miami Beach, Florida, 33140, United States
FQL Research, LLC
Miramar, Florida, 33025, United States
Shafran Gastroenterology Center
Winter Park, Florida, 32789, United States
Emory University Hospital
Atlanta, Georgia, 30322, United States
Atlanta Gastroenterology Associates
Atlanta, Georgia, 30342, United States
Columbus Regional Research Institute
Columbus, Georgia, 31904, United States
Atlanta Center for Gastroenterology, PC
Decatur, Georgia, 30033, United States
Gastroenterology Associates of Central Georgia
Macon, Georgia, 31201, United States
Gastrointestinal Specialists of Georgia, PC
Marietta, Georgia, 30060, United States
Advanced Clinical Research
Spokane, Idaho, 99202, United States
Northwestern Uni-Feinberg School of Medicine
Chicago, Illinois, 60611, United States
University of Chicago Medical Center
Chicago, Illinois, 60637, United States
Southwest Gastroenterology
Oak Lawn, Illinois, 60453, United States
Carle Foundation Hospital
Urbana, Illinois, 61801-2500, United States
Cotton-O'Neil Clinical Research Center, Digestive Health
Topeka, Kansas, 66606, United States
Gastroenterology Associates, LLC
Baton Rouge, Louisiana, 70809, United States
Louisiana Research Center, LLC
Shreveport, Louisiana, United States
University of Michigan
Ann Arbor, Michigan, 48109, United States
Gastroenterology Associates of Western Michigan, P.L.C.
Grand Rapids, Michigan, 49506, United States
Henry Ford Health System
Novi, Michigan, 48377-3600, United States
Center for Digestive Health
Troy, Michigan, 48098, United States
Mayo Clinic - Rochester
Rochester, Minnesota, 55905, United States
University of Mississippi Medical Center
Jackson, Mississippi, 39216, United States
Ehrhardt Clinical Research, LLC
Belton, Missouri, 64012, United States
Concorde Medical Group
New York, New York, 10016, United States
Weill Cornell Medical College-New York Presbyterian Hospital
New York, New York, 10021, United States
Lenox Hill Hospital
New York, New York, 10075, United States
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599, United States
Charlotte Gastroenterology and Hepatology, P.L.L.C
Charlotte, North Carolina, 28207, United States
Vidant Medical Group, LLC DBA Vidant Multispeciality Clinic-Kinston
Kinston, North Carolina, 28501, United States
Consultants for Clinical Research Inc.
Cincinnati, Ohio, 45219, United States
Great Lakes Gastroenterology Research, LLC
Mentor, Ohio, 44060, United States
Digestive Disease Specialists, Inc.
Oklahoma City, Oklahoma, 73112, United States
Great Lakes Medical Research, LLC
Harrisburg, Pennsylvania, 17110, United States
Innovative Clinical Research
Greenville, South Carolina, 29604, United States
Gastro One
Germantown, Tennessee, 38138, United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37232, United States
University of Texas Southwestern Medical Center; Internal Medicne
Dallas, Texas, 75390-9151, United States
Baylor College of Medicine
Houston, Texas, 77030, United States
Methodist Hospital Research Institute
Houston, Texas, 77030, United States
Wellness Clinical Research Center
San Antonio, Texas, 78232, United States
Texas Digestive Disease Consultants - Southlake
Southlake, Texas, 76092, United States
Digestive Health Specialists of Tyler
Tyler, Texas, 75701, United States
Ericksen Research and Development
Clinton, Utah, 84015, United States
University of Utah School of Medicine
Salt Lake City, Utah, 84132, United States
McGuire Research Institute; Gastroenterology
Richmond, Virginia, 23249, United States
Digestive Disease Institute; Virginia Mason Medical Center
Seattle, Washington, 98101, United States
University of Wisconsin
Madison, Wisconsin, 53705, United States
Hospital Italiano
CABA, C1199ABB, Argentina
The Canberra Hospital
Garran, Australian Capital Territory, 2065, Australia
Concord Repatriation General Hospital
Concord, New South Wales, 2139, Australia
Royal Brisbane and Women's Hospital
Herston, Queensland, 4029, Australia
University of the Sunshine Coast
Sippy Downs, Queensland, 4556, Australia
Mater Adult Hospital
South Brisbane, Queensland, 4101, Australia
Princess Alexandra Hospital
Woolloongabba, Queensland, 4102, Australia
Flinders Medical Centre
Bedford Park, South Australia, 5042, Australia
St Vincent's Hospital Melbourne
Fitzroy, Victoria, 3065, Australia
Footscray Hospital
Footscray, Victoria, 3011, Australia
St Frances Xavier Cabrini Hospital
Malvern, Victoria, 3144, Australia
Royal Melbourne Hospital; Department of Colorectal Medicine and Genetics
Parkville, Victoria, 3050, Australia
The Alfred Hospital
Prahan, Victoria, 3181, Australia
Fiona Stanley Hospital
Murdoch, Western Australia, 6150, Australia
LKH - Universitätsklinikum der PMU Salzburg
Salzburg, 5020, Austria
Medizinische Universität Wien
Vienna, 1090, Austria
CHU St Pierre (César de Paepe) X
Brussels, 1000, Belgium
ULB Hopital Erasme; Service de Néphrologie
Brussels, 1070, Belgium
UZ Brussel
Brussels, 1090, Belgium
UZ Antwerpen
Edegem, 2650, Belgium
AZ Maria Middelares
Ghent, 9000, Belgium
Instituto Goiano de Gastroenterologia e Endoscopia Digestiva Ltda
Goiânia, Goiás, 74535-170, Brazil
Hospital Felicio Rocho
Belo Horizonte, Minas Gerais, 30110-068, Brazil
Centro Digestivo de Curitiba
Curitiba, Paraná, 80430-160, Brazil
Instituto Brasil de Pesquisa Clínica-IBPCLIN S/A
Rio de Janeiro, Rio de Janeiro, 22271-100, Brazil
Hospital Sao Vicente de Paulo
Passo Fundo, Rio Grande do Sul, 99010-090, Brazil
Hospital das Clinicas - UFRGS
Porto Alegre, Rio Grande do Sul, 90035-903, Brazil
Hospital Ernesto Dornelles
Porto Alegre, Rio Grande do Sul, 90160-092, Brazil
UNESP - Faculdade de Medicina da Universidade Estadual Paulista - Campus Botucatu
Botucatu, São Paulo, 18618-970, Brazil
Pesquisare Saúde Sociedade Simples
Santo André, São Paulo, 09080-000, Brazil
Praxis Pesquisa Médica
Santo André, São Paulo, 09090-790, Brazil
Hospital Estadual Mario Covas
São Bernardo do Campo, São Paulo, 09715-090, Brazil
Hospital de Base de Sao Jose do Rio Preto
São José do Rio Preto, São Paulo, 15090-000, Brazil
Hospital Sírio-Libanês
São Paulo, São Paulo, 01308-050, Brazil
Universidade Federal de Sao Paulo - UNIFES
São Paulo, São Paulo, 04026-000, Brazil
Hospital do Servidor Público Estadual/HSPE-SP
São Paulo, São Paulo, 04039-901, Brazil
"City Clinic UMHAC" EOOD
Sofia, 1407, Bulgaria
UMHAT "Sv. Ivan Rilski", EAD
Sofia, 1431, Bulgaria
University of Calgary
Calgary, Alberta, T2N 2T9, Canada
Zeidler Ledcor Centre - University of Alberta; Division of Gasroenterology
Edmonton, Alberta, T6G 2X8, Canada
(G.I.R.I.) GI Research Institute
Vancouver, British Columbia, V6Z 2K5, Canada
Winnipeg Regional Health Authority; Neurosurgery Department
Winnipeg, Manitoba, R3A 1R9, Canada
Queen Elizabeth II Health Sciences Centre; Gastroenterology Research
Halifax, Nova Scotia, B3H 1V7, Canada
University Hospital - London Health Sciences Centre
London, Ontario, N6A 5A5, Canada
Taunton Health Centre
Oshawa, Ontario, L1H 7K4, Canada
The Ottawa Hospital - Riverside Campus; Gastrointestinal Clinical Research Unit
Ottawa, Ontario, K1H 1A2, Canada
Mount Sinai Hospital
Toronto, Ontario, M5G 1X5, Canada
Toronto Digestive Disease Associates
Vaughan, Ontario, L4L 4Y7, Canada
Hôpital Maisonneuve - Rosemont
Montreal, Quebec, H1T 2M4, Canada
McGill University Health Centre - Glen Site
Montreal, Quebec, H4A 3J1, Canada
Royal University Hospital
Saskatoon, Saskatchewan, S7N 0W8, Canada
Clinical Hospital Centre Osijek
Osijek, 31000, Croatia
General Hospital Pula
Pula, 52100, Croatia
Clinical Hospital Center Sestre Milosrdnice
Zagreb, 10000, Croatia
Vojenska nemocnice Brno
Brno, 636 00, Czechia
Fakultni nemocnice u sv. Anny v Brne; I.Interni kardioangiologicka klinika
Brno, 65691, Czechia
Nemocnice Ceske Budejovice a.s.
České Budějovice, 370 01, Czechia
Gastroenterologie s.r.o.
Hradec Králové, 500 02, Czechia
Fakultni nemocnice Hradec Kralove
Hradec Králové, 500 05, Czechia
Hepato-Gastroenterologie HK, s.r.o.
Hradec Králové, 500 12, Czechia
PreventaMed, s.r.o.
Olomouc, 779 00, Czechia
Fakultni nemocnice Ostrava
Ostrava - Poruba, 708 52, Czechia
Fakultni nemocnice Kralovske Vinohrady
Prague, 100 34, Czechia
ISCARE a.s.
Prague, 170 04, Czechia
West Tallinn Central Hospital
Tallinn, 10617, Estonia
North Estonia Medical Centre Foundation
Tallinn, 13419, Estonia
Tartu University Hospital
Tartu, 51014, Estonia
CHU Amiens - Hopital Sud
Amiens, 80054, France
CHU de Caen Hopital Cote de Nacre
Caen, 14033, France
Hôpital Beaujon
Clichy, 92110, France
Hopital Claude Huriez - CHU Lille
Lille, 59037, France
CHU NANTES - Hôtel Dieu; Pharmacy
Nantes, 44093, France
CHU Nice - Hopital de l'Archet 2
Nice, 06202, France
Hôpital Saint-Louis
Paris, 75475, France
Groupe Hospitalier Sud - Hôpital Haut-Lévêque - USN
Pessac, 33604, France
Centre Hospitalier Lyon Sud; Service de Gastro-Enterologie
Pierre-Bénite, 69495, France
CHU du Reims - Hopital Robert Debré
Reims, 51100, France
CHU Saint Etienne - Hôpital Nord
Saint-Etienne, 42055, France
Höpital Hautepierre; Pediatrie1
Strasbourg, 67098, France
Hôpital de Brabois Adultes
Vandœuvre-lès-Nancy, 54511, France
Charite-Campus Virchow Klinikum; Hepatologie und Gastroenterologie
Berlin, 13353, Germany
Krankenhaus Waldfriede e. V.
Berlin, 14163, Germany
Berufsgenossenschaftliches Universitaetsklinikum Bergmannsheil GmbH
Bochum, 44789, Germany
Klinikum der Johann Wolfgang Goethe-Universitaet
Frankfurt, 60590, Germany
Medizinische Hochschule Hannover
Hanover, 30625, Germany
Klinikum Mannheim GmbH Universitätsklinikum
Mannheim, 68167, Germany
Gemeinschaftspraxis
Schweinfurt, 97421, Germany
Universitaetsklinikum Ulm
Ulm, 89081, Germany
Bekes Megyei Kozponti Korhaz Dr. Rethy Pal Tagkorhaza
Békéscsaba, 5600, Hungary
Obudai Egeszsegugyi Centrum Kft.
Budapest, 1036, Hungary
Semmelweis Egyetem; Belgyogyaszati es Hematologiai Klinika
Budapest, 1088, Hungary
Szt Janos Korhaz es EbudaiEgyesitettKorhazak
Budapest, 1125, Hungary
Pannonia Maganorvosi Centrum
Budapest, 1136, Hungary
Debreceni Egyetem Klinikai Központ; B?rgyógyászati Klinika
Debrecen, 4012, Hungary
Petz Aladar Megyei Oktato Korhaz
Győr, 9024, Hungary
Pest Megyei Flor Ferenc Korhaz
Kistarcsa, 2143, Hungary
Haemek Medical Center
Afula, 18101, Israel
Soroka University Medical Centre
Beersheba, 8410101, Israel
Wolfson Medical Center
Holon, 5822012, Israel
Shaare Zedek Medical Center
Jerusalem, 9103102, Israel
Holy Family Hospital
Nazareth, 1641101, Israel
Rabin Medical Center-Beilinson Campus
Petah Tikva, 4941492, Israel
Tel Aviv Sourasky Medical Center; Pharmacy
Tel Aviv, 6423906, Israel
A.O.U. Policlinico di Modena
Modena, Emilia-Romagna, 40124, Italy
Policlinico Universitario Agostino Gemelli; Farmacia
Rome, Lazio, 00168, Italy
Azienda Ospedaliera San Camillo Forlanini
Rome, Lazio, 151, Italy
Asst Fatebenefratelli Sacco (Fatebenefratelli)
Milan, Lombardy, 20121, Italy
Istituto Clinico Humanitas
Rozzano (MI), Lombardy, 20089, Italy
I.R.C.C.S Policlinico San Donato
San Donato Milanese (MI), Lombardy, 20097, Italy
Azienda Ospedaliera Universitaria Careggi
Florence, Tuscany, 50134, Italy
Pauls Stradins Clinical University Hospital
R?ga, LV-1002, Latvia
Riga East Clinical University Hospital, clinic "Gailezers"; Department of Endoscopy
Riga, LV-1005, Latvia
Hospital of Lithuanian University of Health. Sciences Kaunas Clinics
Kaunas, 50009, Lithuania
Vilnius University Hospital Santariskiu Clinics, Public Inst; Department of Clinical Pharmacology
Vilnius, 08661, Lithuania
Clinical Research Institute
Tlalnepantla, Mexico CITY (federal District), 54055, Mexico
Medical Care & Research SA de CV
Mérida, Yucatán, 97000, Mexico
Amsterdam UMC, Locatie VUMC; Gastroenterology
Amsterdam, 1081 HV, Netherlands
Amsterdam UMC Location AMC
Amsterdam, 1105 AZ, Netherlands
Leids Universitair Medisch Centrum; Cardiology
Leiden, 2333 ZA, Netherlands
Maastricht University Medical Center
Maastricht, 6229 HX, Netherlands
Erasmus Medisch Centrum
Rotterdam, 3000 CA, Netherlands
Zuyderland Medisch Centrum - Sittard Geleen
Sittard-Geleen, 6162 BG, Netherlands
ETZ TweeSteden
Tilburg, 5042AD, Netherlands
North Shore Hospital
Auckland, 0620, New Zealand
Christchurch Hospital NZ
Christchurch, 8011, New Zealand
Dunedin Public Hospital
Dunedin, 9016, New Zealand
Waikato Hospital
Hamilton, 3248, New Zealand
Hutt Hospital
Lower Hutt, 5010, New Zealand
Shakespeare Specialist Group
Takapuna, 0620, New Zealand
Tauranga Hospital
Tauranga, 3143, New Zealand
SP ZOZ Wojewodzki Szpital Zespolony im. J. Sniadeckiego
Bia?ystok, 15-275, Poland
Nasz Lekarz Osrodek Badan Klinicznych
Bydgoszcz, 85-312, Poland
Elblaski Szpital Specjalistyczny z Przychodnia SP ZOZ
Elblag, 82-300, Poland
ETG Kielce
Kielce, 25-355, Poland
Centrum Opieki Zdrowotnej Orkan-Med
Ksawerów, 95-054, Poland
Indywidualna Specjalistyczna Praktyka Lekarska
Lublin, 20-015, Poland
Allmedica Badania Kliniczne Sp z o.o. Sp K.
Nowy Targ, 34-400, Poland
Centrum Medyczne "MEDYK"
Rzeszów, 35-055, Poland
Gabinet Lekarski, Bartosz Korczowski
Rzeszów, 35-302, Poland
Niepubliczny Zaklad Opieki Zdrowotnej SONOMED
Szczecin, 70-351, Poland
Twoja Przychodnia-Szczecinskie Centrum Medyczne
Szczecin, 71-434, Poland
Gastromed Kopon Zmudzinski i Wspolnicy Sp.j.Specjalistyczne Centrum Gastrologii i Endoskopii Specj
Toru?, 87-100, Poland
Centrum Zdrowia MDM
Warsaw, 00-189, Poland
Zespó Przychodni Specjalistycznych PRIMA
Warsaw, 02-018, Poland
Przychodnia EuroMediCare
Wroc?aw, 50-220, Poland
PlanetMed sp. z o.o.
Wroc?aw, 52-210, Poland
LexMedica Osrodek Badan Klinicznych
Wroclaw, 53-114, Poland
S.C MedLife S.A
Bucharest, 010719, Romania
Spitalul Clinic Colentina
Sector 2, 020125, Romania
Centrul de Gastroenterologie Dr. Goldis
Timișoara, 300002, Romania
LLC "Novosibirsk GastroCenter"
Novosibirsk, Altaj, 630007, Russia
SBEI HPE Altai StateMedicalUniversityofMoH andSD
Barnaul, Altayskiy Kray, 656050, Russia
LEC at SBIH of Moscow "City Clinical Hospital # 24"; Gastroenterology
Moscow, Moscow Oblast, 125015, Russia
SEIHPE "Rostov SMU of MoH of RF"
Rostov-on-Don, Rostov Oblast, 344022, Russia
Evromedservis LCC
Pushkin, Sankt-Peterburg, 196603, Russia
Federal State Military Educational Inst. of High Prof. Edu Military Medical Acad; Therapy department
Saint Petersburg, Sankt-Peterburg, 191015, Russia
North-Western Medical University n.a. I.I. Mechnikov; Rheumatology
Saint Petersburg, Sankt-Peterburg, 191015, Russia
Baltic Medicine
Saint Petersburg, Sankt-Peterburg, 194356, Russia
SBIH City Clinical Hospital #31
Saint Petersburg, Sankt-Peterburg, 197110, Russia
Irkutsk State Medical Academy of Continuing Education
Irkutsk, 664079, Russia
SBEIHPE Novosibirsk State Medical University
Novosibirsk, 630091, Russia
BHI of Omsk region Clinical Oncology Dispensary
Omsk, 644013, Russia
Clinical Center Zvezdara
Belgrade, 11000, Serbia
Military Medical Academy
Belgrade, 11040, Serbia
General Hospital Djordje Joanovic
Zrenjanin, 23000, Serbia
Endomed, s.r.o.
Košice, 040 01, Slovakia
KM Management spol. s r.o.
Nitra, 94901, Slovakia
Accout Center s.r.o.
Šahy, 936 01, Slovakia
Dr D Epstein Practice
Cape Town, 7405, South Africa
Emmed Research
Pretoria, 0002, South Africa
Dong-A University Hospital
Busan, 49201, South Korea
Kyungpook National University Hospital
Daegu, 41944, South Korea
Yeungnam Univ. Hospital
Daegu, 705-717, South Korea
Korea University Ansan Hospital
Gyeonggi-do, 15355, South Korea
CHA Bundang Medical Centre; CHA university
Seongnam, 13520, South Korea
Seoul National University Bundang Hospital
Seongnam-si, 463-707, South Korea
Kangbuk Samsung Hospital
Seoul, 03181, South Korea
Asan Medical Center
Seoul, 05505, South Korea
Samsung Medical Center
Seoul, 06351, South Korea
Yonsei University Wonju Severance Christian Hospital
Wŏnju, 26426, South Korea
Hospital Universitario de Bellvitge
L'Hospitalet de Llobregat, Barcelona, 08907, Spain
Hospital Clínic i Provincial; Servicio de Farmacia
Barcelona, 08036, Spain
Hospital Reina Sofia; Medical Oncology
Córdoba, 14004, Spain
Hospital Juan Ramón Jiménez
Huelva, 21005, Spain
Hospital Universitario de la Princesa
Madrid, 28006, Spain
Hospital Universitario La Paz
Madrid, 28046, Spain
Hospital Universitario de Fuenlabrada
Madrid, 28942, Spain
Hospital Universitario Virgen Macarena
Seville, 41009, Spain
Hospital Universitario Virgen del Rocio
Seville, 41013, Spain
Hospital Universitari i Politecnic La Fe
Valencia, 46026, Spain
Hospital Universitario Miguel Servet
Zaragoza, 50009, Spain
Inselspital-Universitaetsspital Bern
Bern, 3010, Switzerland
Crohn-Colitis Zentrum Bern - Gemeinschaftspraxis Balsiger, Seibold und Partner
Bern, 3012, Switzerland
Universitätsspital Zürich
Zurich, 8091, Switzerland
Hacettepe University Medical Faculty; Gastroenterology
Ankara, 06100, Turkey (Türkiye)
Gazi University Medical Faculty
Ankara, 06500, Turkey (Türkiye)
Acibadem Fulya Hospital; Neurology
Istanbul, 34349, Turkey (Türkiye)
Haydarpasa Numune Training and Research Hospital; Gastroenterology
Istanbul, 34668, Turkey (Türkiye)
Medeniyet University Goztepe Training and Research Hospital.
Kadiköy, 34722, Turkey (Türkiye)
Kocaeli Universitesi Tip Fakultesi; Infectious Diseases
Kocaeli, 41380, Turkey (Türkiye)
Acibadem Kozyatagi Hospital; Gastroenterology
Kozyata?i, 34742, Turkey (Türkiye)
CNE Prof. O.O. Shalimov Kharkiv City Clinical Hospital #2 of KCC
Kharkiv, Kharkiv Governorate, 61037, Ukraine
CI of Healthcare Kharkiv Reg Clin Hosp-Center of Med Emergency & Accident Medicine
Kharkiv, Kharkiv Governorate, 61204, Ukraine
LLC Gastroenterology Center IBD Team
Zaporizhzhia, Kharkiv Governorate, 69000, Ukraine
Medical Center of Limited Liability Company Medical Clinic Blagomed
Kyiv, KIEV Governorate, 1023, Ukraine
Med Center of International Institute of Clinical Trials LLC; Medical Center "OK!Clinic+"
Kyiv, KIEV Governorate, 2091, Ukraine
CI of Kyiv RC Regional Clinical Hospital #2
Kyiv, KIEV Governorate, 4073, Ukraine
Lviv Regional Clinical Hospital
Lviv, KIEV Governorate, 79010, Ukraine
Ivano-Frankivsk Regional Clinical Hospital
Ivano-Frankivsk, Kuban People's Republica, 76000, Ukraine
RCI Chernivtsi RCH Dep of Surgery Bukovinian SMU
Chernivtsi, 58002, Ukraine
CHI Kharkiv City Clinical Hospital #13
Kharkiv, 61124, Ukraine
Railway Transport Odesa CH of Healthcare Ctr Branch of PJSC Ukrainian Railway Dept of Therapy #2
Odesa, 65059, Ukraine
Private Small Enterprise Medical Center Pulse
Vinnytsia, 21001, Ukraine
M.I. Pyrogov VRCH Dept of Gastroenterology M.I. Pyrogov VNMU
Vinnytsia, 21018, Ukraine
MCIC MC LLC Health Clinic
Vinnytsia, 21029, Ukraine
Royal Victoria Hospital
Belfast, BT12 6BA, United Kingdom
University Hospital Coventry
Coventry, CV2 2DX, United Kingdom
Royal Devon and Exeter Hospital (Wonford)
Exeter, EX2 5DW, United Kingdom
Queen Elizabeth Hospital
Kings Lynn, PE30 4ET, United Kingdom
St James University Hospital
Leeds, LS9 7TF, United Kingdom
Royal Liverpool University Hospital
Liverpool, L7 8XP, United Kingdom
Whipps Cross Hospital
London, E11 1NR, United Kingdom
University College London Hospital
London, N7 9NH, United Kingdom
Fairfield General Hospital
Manchester, M8 5RB, United Kingdom
Royal Victoria Infirmary; Stroke unit
Newcastle upon Tyne, NE1 4LP, United Kingdom
Nottingham University Hospitals Queen's Medical Centre
Nottingham, NG7 2UH, United Kingdom
Royal Berkshire Hospital
Reading, RG1 5AN, United Kingdom
Southampton General Hospital
Southampton, SO16 6YD, United Kingdom
Related Publications (1)
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.
PMID: 32445184DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Medical Communications
- Organization
- Hoffmann-La Roche
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 26, 2015
First Posted
March 31, 2015
Study Start
June 8, 2015
Primary Completion
October 9, 2023
Study Completion
October 9, 2023
Last Updated
December 2, 2024
Results First Posted
December 2, 2024
Record last verified: 2024-11