A Study to Assess Whether Etrolizumab is a Safe and Efficacious Treatment for Participants With Moderately to Severely Active Crohn's Disease
NCT ID: NCT02394028
Last Updated: 2022-11-16
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
1035 participants
INTERVENTIONAL
2015-03-20
2021-09-07
Brief Summary
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The study period will consist of a Screening Phase (up to 35 days) plus (+) a 14-week Induction Phase + a 52-week Maintenance Phase + a 12-week Safety Follow-up Phase. At Week 14 (end of Induction Phase), participants achieving a decrease from baseline of at least 70 points in the Crohn's Disease Activity Index (CDAI) score (CDAI-70 response) without the use of rescue therapy will continue to the Maintenance Phase.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Induction Phase - Cohort 1 (Exploratory): Etrolizumab 210 mg
Cohort 1 enrolled participants first before Cohorts 2 and 3 in order to conduct an exploratory analysis on induction data. Participants randomized to this arm will receive one subcutaneous (SC) injection of etrolizumab (210 mg) at Weeks 0, 2, 4, 8, and 12 during the 14-week Induction Phase. In order to preserve the masking, participants will also receive one SC injection of etrolizumab-matching placebo at Weeks 0, 4, 8, and 12.
Etrolizumab
Etrolizumab will be administered as per regimen specified in individual arms.
Placebo
Etrolizumab-matching placebo will be administered as per regimen specified in individual arms.
Induction Phase - Cohort 1 (Exploratory): Etrolizumab 105 mg
Cohort 1 enrolled participants first before Cohorts 2 and 3 in order to conduct an exploratory analysis on induction data. Participants randomized to this arm will receive one SC injection of etrolizumab (105 mg) at Weeks 0, 4, 8, 12 and one SC injection of etrolizumab-matching placebo at Week 2 during the 14-week Induction Phase. In order to preserve the masking, participants will also receive one SC injection of etrolizumab-matching placebo at Weeks 0, 4, 8, and 12.
Etrolizumab
Etrolizumab will be administered as per regimen specified in individual arms.
Placebo
Etrolizumab-matching placebo will be administered as per regimen specified in individual arms.
Induction Phase - Cohort 1 (Exploratory): Placebo
Cohort 1 enrolled participants first before Cohorts 2 and 3 in order to conduct an exploratory analysis on induction data. Participants randomized to this arm will receive two SC injections of etrolizumab-matching placebo at Weeks 0, 4, 8, and 12 (and one SC injection of etrolizumab-matching placebo at Week 2) during the 14-week Induction Phase, in order to preserve the masking.
Placebo
Etrolizumab-matching placebo will be administered as per regimen specified in individual arms.
Induction Phase - Cohort 2 (Open-Label): Etrolizumab 210 mg
Cohort 2 is enrolling participants after Cohort 1 and is considered a "feeder" cohort to help achieve the necessary sample size for the Maintenance Phase. Participants randomized to this arm will receive one SC injection of open-label etrolizumab (210 mg) at Weeks 0, 2, 4, 8, and 12 during the 14-week Induction Phase. In order to preserve the masking for the dose of etrolizumab, participants will also receive one SC injection of etrolizumab-matching placebo at Weeks 0, 4, 8, and 12.
Etrolizumab
Etrolizumab will be administered as per regimen specified in individual arms.
Placebo
Etrolizumab-matching placebo will be administered as per regimen specified in individual arms.
Induction Phase - Cohort 2 (Open-Label): Etrolizumab 105 mg
Cohort 2 is enrolling participants after Cohort 1 and is considered a "feeder" cohort to help achieve the necessary sample size for the Maintenance Phase. Participants randomized to this arm will receive one SC injection of open-label etrolizumab (105 mg) at Weeks 0, 4, 8, 12 and one SC injection of etrolizumab-matching placebo at Week 2 during the 14-week Induction Phase. In order to preserve the masking of the dose of etrolizumab, participants will also receive one SC injection of etrolizumab-matching placebo at Weeks 0, 4, 8, and 12.
Etrolizumab
Etrolizumab will be administered as per regimen specified in individual arms.
Placebo
Etrolizumab-matching placebo will be administered as per regimen specified in individual arms.
Induction Phase - Cohort 3 (Pivotal): Etrolizumab 210 mg
Cohort 3 is the last to enroll participants (after Cohort 2) and will be the pivotal cohort for the Induction Phase. Participants randomized to this arm will receive one SC injection of etrolizumab (210 mg) at Weeks 0, 2, 4, 8, and 12 during the 14-week Induction Phase. In order to preserve the masking, participants will also receive one SC injection of etrolizumab-matching placebo at Weeks 0, 4, 8, and 12.
Etrolizumab
Etrolizumab will be administered as per regimen specified in individual arms.
Placebo
Etrolizumab-matching placebo will be administered as per regimen specified in individual arms.
Induction Phase - Cohort 3 (Pivotal): Etrolizumab 105 mg
Cohort 3 is the last to enroll participants (after Cohort 2) and will be the pivotal cohort for the Induction Phase. Participants randomized to this arm will receive one SC injection of etrolizumab (105 mg) at Weeks 0, 4, 8, 12 and one SC injection of etrolizumab-matching placebo at Week 2 during the 14-week Induction Phase. In order to preserve the masking, participants will also receive one SC injection of etrolizumab-matching placebo at Weeks 0, 4, 8, and 12.
Etrolizumab
Etrolizumab will be administered as per regimen specified in individual arms.
Placebo
Etrolizumab-matching placebo will be administered as per regimen specified in individual arms.
Induction Phase - Cohort 3 (Pivotal): Placebo
Cohort 3 is the last to enroll participants (after Cohort 2) and will be the pivotal cohort for the Induction Phase. Participants randomized to this arm will receive two SC injections of etrolizumab-matching placebo at Weeks 0, 4, 8, and 12 (and one SC injection of etrolizumab-matching placebo at Week 2) during the 14-week Induction Phase, in order to preserve the masking.
Placebo
Etrolizumab-matching placebo will be administered as per regimen specified in individual arms.
Maintenance Phase - Placebo Responders: Placebo
Participants who received placebo during the Induction Phase (from Cohorts 1 and 3) and achieved a CDAI-70 response at Week 14 will undergo a sham randomization into the Maintenance Phase. Placebo responders from induction will receive blinded maintenance treatment with an SC injection of placebo once every 4 weeks (q4w) from Week 16 to Week 64.
Placebo
Etrolizumab-matching placebo will be administered as per regimen specified in individual arms.
Maintenance Phase - Etrolizumab Responders: Placebo
Participants who received etrolizumab during the Induction Phase (from Cohorts 1-3) and achieved a CDAI-70 response at Week 14 without the use of rescue therapy will be re-randomized into the Maintenance Phase. Etrolizumab responders from induction who are re-randomized to this arm will receive blinded maintenance treatment with an SC injection of placebo q4w from Week 16 to Week 64.
Placebo
Etrolizumab-matching placebo will be administered as per regimen specified in individual arms.
Maintenance Phase - Etrolizumab Responders: Etrolizumab 105 mg
Participants who received etrolizumab during the Induction Phase (from Cohorts 1-3) and achieved a CDAI-70 response at Week 14 without the use of rescue therapy will be re-randomized into the Maintenance Phase. Etrolizumab responders from induction who are re-randomized to this arm will receive blinded maintenance treatment with an SC injection of etrolizumab (105 mg) q4w from Week 16 to Week 64.
Etrolizumab
Etrolizumab will be administered as per regimen specified in individual arms.
Interventions
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Etrolizumab
Etrolizumab will be administered as per regimen specified in individual arms.
Placebo
Etrolizumab-matching placebo will be administered as per regimen specified in individual arms.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Intolerance, refractory disease, or no response to corticosteroids (CS), immunosuppressants (IS), or anti-TNF therapy within 5 years from screening. Participants who have not previously demonstrated inadequate response or intolerance to one or more anti-TNF therapies are eligible to participate in the study provided they are intolerant or refractory to CS or IS therapy
* Use of effective contraception as defined by the protocol
Exclusion Criteria
* Planned surgery for CD
* Ileostomy or colostomy
* Has received non-permitted inflammatory bowel disease (IBD) therapies (including natalizumab, vedolizumab, and efalizumab, as stated in the protocol)
* Any prior treatment with ustekinumab within 14 weeks prior to randomization
* Chronic hepatitis B or C infection, human immunodeficiency virus (HIV), active or latent tuberculosis (participants with prior history of Bacillus Calmette-Guérin \[BCG\] vaccination must pass protocol-defined screening criteria)
* Sinus tract with evidence for infection (e.g., purulent discharge) in the clinical judgment of the investigator. Fistulas related to CD are not exclusionary
* Any prior treatment with anti-adhesion molecules (e.g., anti-mucosal addressin cell adhesion molecule \[anti-MAdCAM-1\])
* Any major episode of infection requiring treatment with intravenous antibiotics ≤8 weeks prior to screening or oral antibiotics ≤4 weeks prior to screening. Treatment with antibiotics as adjunctive therapy for CD in the absence of documented infection is not exclusionary
* Hospitalization (other than for elective reasons) within 4 weeks prior to randomization
18 Years
80 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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Valley Gastroenterology Consultants
Arcadia, California, United States
University of California San Diego Medical Center
La Jolla, California, United States
VA Long Beach Healthcare System
Long Beach, California, United States
Digestive Care Associates, A Medical Corporation
San Carlos, California, United States
SDG Clinical Research
San Diego, California, United States
University of California at San Francisco (PARENT); Gastroenterology, Hepatology & Nutrition
San Francisco, California, United States
Peak Gastroenterology Associates; Gastroenterology
Colorado Springs, Colorado, United States
Innovative Medical Research of South Florida
Aventura, Florida, United States
West Central Gastroenterology d/b/a Gastro Florida
Clearwater, Florida, United States
University of Florida College of Medicine
Gainesville, Florida, United States
Borland-Groover Clinic
Jacksonville, Florida, United States
IMIC, Inc
Miami Beach, Florida, United States
FQL Research, LLC
Miramar, Florida, United States
Advanced Research Institute, Inc.
Trinity, Florida, United States
Shafran Gastroenterology Center
Winter Park, Florida, United States
Emory University Hospital
Atlanta, Georgia, United States
Atlanta Gastroenterology Associates
Atlanta, Georgia, United States
Gastrointestinal Diseases Research
Columbus, Georgia, United States
Atlanta Center for Gastroenterology, PC
Decatur, Georgia, United States
Gastroenterology Associates of Central Georgia
Macon, Georgia, United States
Gastrointestinal Specialists of Georgia, PC
Marietta, Georgia, United States
Advanced Clinical Research
Meridian, Idaho, United States
Northwestern University-Feinberg School of Medicine; Division of Gastroenterology and Hepatology
Chicago, Illinois, United States
The University of Chicago Medical Center
Chicago, Illinois, United States
Southwest Gastroenterology; DM Clinical Research
Oak Lawn, Illinois, United States
Carle Foundation Hospital
Urbana, Illinois, United States
Cotton-O'Neil Clinical Research Center, Digestive Health
Topeka, Kansas, United States
Gastroenterology Associates, LLC
Baton Rouge, Louisiana, United States
Louisiana Research Center, LLC
Shreveport, Louisiana, United States
Commonwealth Clinical Studies
Brockton, Massachusetts, United States
University of Michigan Health System
Ann Arbor, Michigan, United States
Gastroenterology Associates of Western Michigan, P.L.C.
Grand Rapids, Michigan, United States
Center for Digestive Health
Troy, Michigan, United States
Henry Ford Health System
West Bloomfield, Michigan, United States
Mayo Clinic - Rochester; Gastrology
Rochester, Minnesota, United States
University of Mississippi Medical Center; Division of Gastroenterology
Jackson, Mississippi, United States
Ehrhardt Clinical Research, LLC
Belton, Missouri, United States
Concorde Medical Group
New York, New York, United States
Weill Cornell Medical College (WCMC) - Judith Jaffe Multiple Sclerosis Center (JJMSC)
New York, New York, United States
Lenox Hill Hospital
New York, New York, United States
University of North Carolina At Chapel Hill
Chapel Hill, North Carolina, United States
Charlotte Gastroenterology and Hepatology, P.L.L.C
Charlotte, North Carolina, United States
Kinston Medical Specialists
Kinston, North Carolina, United States
Consultants for Clinical Research Inc.
Cincinnati, Ohio, United States
Great Lakes Gastroenterology Research, LLC
Mentor, Ohio, United States
Digestive Disease Specialists, Inc.
Oklahoma City, Oklahoma, United States
Great Lakes Medical Research, LLC
Harrisburg, Pennsylvania, United States
Innovative Clinical Research
Greenville, South Carolina, United States
Gastroenterology Center of the MidSouth PC
Germantown, Tennessee, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Texas Digestive Disease Consultants - Dallas
Dallas, Texas, United States
University of Texas Southwestern Medical Center; Internal Medicne
Dallas, Texas, United States
Baylor College of Medicine; Gastroenterology
Houston, Texas, United States
Methodist Hospital Research Institute
Houston, Texas, United States
Wellness Clinical Research Center
San Antonio, Texas, United States
Texas Digestive Disease Consultants - Southlake
Southlake, Texas, United States
Tyler Research Institute, LLC
Tyler, Texas, United States
Ericksen Research and Development
Clinton, Utah, United States
University of Utah School of Medicine
Salt Lake City, Utah, United States
McGuire Research Institute; Gastroenterology
Richmond, Virginia, United States
Digestive Disease Institute; Virginia Mason Medical Center
Seattle, Washington, United States
University of Wisconsin
Madison, Wisconsin, United States
Hospital Italiano
Buenos Aires, , Argentina
The Canberra Hospital
Garran, Australian Capital Territory, Australia
Bankstown-Lidcombe Hospital
Bankstown, New South Wales, Australia
Concord Repatriation General Hospital
Concord, New South Wales, Australia
Royal Brisbane and Women's Hospital
Herston, Queensland, Australia
University of the Sunshine Coast
Sippy Downs, Queensland, Australia
Mater Adult Hospital
South Brisbane, Queensland, Australia
Princess Alexandra Hospital
Woolloongabba, Queensland, Australia
Flinders Medical Centre
Bedford Park, South Australia, Australia
Monash Medical Centre Clayton
Clayton, Victoria, Australia
St Vincent's Hospital Melbourne
Fitzroy, Victoria, Australia
Footscray Hospital; Gastroenterology
Footscray, Victoria, Australia
St Frances Xavier Cabrini Hospital
Malvern, Victoria, Australia
Alfred Hospital
Melbourne, Victoria, Australia
Royal Melbourne Hospital; Department of Colorectal Medicine and Genetics
Parkville, Victoria, Australia
Fiona Stanley Hospital
Murdoch, Western Australia, Australia
LKH - Universitätsklinikum der PMU Salzburg
Salzburg, , Austria
Medizinische Universität Wien
Vienna, , Austria
CHU St Pierre (St Pierre)
Brussels, , Belgium
Hospital Erasme
Brussels, , Belgium
UZ Brussel
Brussels, , Belgium
UZ Antwerpen
Edegem, , Belgium
AZ Maria Middelares
Ghent, , Belgium
L2IP -Instituto de Pesquisas Clínicas Ltda.
Brasília, Federal District, Brazil
Instituto Goiano de Gastroenterologia e Endoscopia Digestiva Ltda
Goiânia, Goiás, Brazil
Hospital Felicio Rocho
Belo Horizonte, Minas Gerais, Brazil
Centro Digestivo de Curitiba
Curitiba, Paraná, Brazil
Hospital Universitario Clementino Fraga Filho - UFRJ; Gastroenterologia
Rio de Janeiro, Rio de Janeiro, Brazil
Instituto Brasil de Pesquisa Clínica-IBPCLIN S/A
Rio de Janeiro, Rio de Janeiro, Brazil
Hospital São Vicente de Paulo; Institute of Education and Reseach / Cardiovascular Research Unit
Passo Fundo, Rio Grande do Sul, Brazil
Hospital das Clinicas - UFRGS
Porto Alegre, Rio Grande do Sul, Brazil
Hospital Ernesto Dornelles
Porto Alegre, Rio Grande do Sul, Brazil
UNESP - Faculdade de Medicina da Universidade Estadual Paulista - Campus Botucatu
Botucatu, São Paulo, Brazil
Pesquisare Saúde Sociedade Simples
Santo André, São Paulo, Brazil
Praxis Pesquisa Médica
Santo André, São Paulo, Brazil
Hospital Estadual Mario Covas
Santo André, São Paulo, Brazil
Hospital de Base de Sao Jose do Rio Preto
São José do Rio Preto, São Paulo, Brazil
Hospital Sírio-Libanês
São Paulo, São Paulo, Brazil
Hospital Sao Paulo
São Paulo, São Paulo, Brazil
Hospital do Servidor Público Estadual/HSPE-SP
São Paulo, São Paulo, Brazil
"City Clinic UMHAC" EOOD
Sofia, , Bulgaria
UMHAT "Sv. Ivan Rilski", EAD
Sofia, , Bulgaria
UMHAT Tsaritsa Yoanna - ISUL, EAD
Sofia, , Bulgaria
University of Calgary
Calgary, Alberta, Canada
Zeidler Ledcor Centre - University of Alberta; Division of Gasroenterology
Edmonton, Alberta, Canada
(G.I.R.I.) GI Research Institute
Vancouver, British Columbia, Canada
Winnipeg Regional Health Authority
Winnipeg, Manitoba, Canada
Queen Elizabeth II Health Sciences Centre; Gastroenterology Research
Halifax, Nova Scotia, Canada
University Hospital - London Health Sciences Centre
London, Ontario, Canada
Taunton Health Centre
Oshawa, Ontario, Canada
The Ottawa Hospital - Riverside Campus; Gastrointestinal Clinical Research Unit
Ottawa, Ontario, Canada
Mount Sinai Hospital
Toronto, Ontario, Canada
Toronto Digestive Disease Associates
Vaughan, Ontario, Canada
Hôpital Maisonneuve - Rosemont
Montreal, Quebec, Canada
McGill University Health Centre - Glen Site
Montreal, Quebec, Canada
Royal University Hospital
Saskatoon, Saskatchewan, Canada
Clinical Hospital Centre Osijek
Osijek, , Croatia
General Hospital Pula
Pula, , Croatia
Clinical Hospital Center Sestre Milosrdnice
Zagreb, , Croatia
University Hospital Center Zagreb
Zagreb, , Croatia
Vojenska nemocnice Brno
Brno, , Czechia
Fakultni nemocnice u sv. Anny v Brne
Brno, , Czechia
Nemocnice Ceske Budejovice a.s.
České Budějovice, , Czechia
Gastroenterologie s.r.o.
Hradec Králové, , Czechia
Fakultni nemocnice Hradec Kralove
Hradec Králové, , Czechia
Hepato-Gastroenterologie HK, s.r.o.
Hradec Králové, , Czechia
PreventaMed, s.r.o.
Olomouc, , Czechia
Fakultni nemocnice Ostrava
Ostrava - Poruba, , Czechia
Fakultni nemocnice Kralovske Vinohrady
Prague, , Czechia
Klinicke centrum ISCARE Lighthouse
Prague, , Czechia
West Tallinn Central Hospital
Tallinn, , Estonia
North Estonia Medical Centre Foundation
Tallinn, , Estonia
Tartu University Hospital
Tartu, , Estonia
CHU Amiens - Hopital Sud
Amiens, , France
CHU de Caen - Hopital Cote de Nacre
Caen, , France
Hôpital Beaujon
Clichy, , France
Hopital Claude Huriez - CHU Lille
Lille, , France
CHU NANTES - Hôtel Dieu; Pharmacy
Nantes, , France
CHU Nice - Hopital de l'Archet 2
Nice, , France
Hôpital Saint-Louis
Paris, , France
Groupe Hospitalier Sud - Hôpital Haut-Lévêque - USN
Pessac, , France
Centre Hospitalier Lyon Sud; Service de Gastro-Enterologie
Pierre-Bénite, , France
CHU du Reims - Hopital Robert Debré
Reims, , France
CHU Rennes - Hopital Pontchaillou
Rennes, , France
CHU Saint Etienne - Hôpital Nord
Saint-Etienne, , France
Höpital Hautepierre; Pediatrie1
Strasbourg, , France
Hôpital de Brabois Adultes
Vandœuvre-lès-Nancy, , France
Charite-Campus Virchow Klinikum; Hepatologie und Gastroenterologie
Berlin, , Germany
Krankenhaus Waldfriede e. V.
Berlin, , Germany
Berufsgenossenschaftliches Universitaetsklinikum Bergmannsheil GmbH
Bochum, , Germany
Universitätsklinikum Koeln
Cologne, , Germany
Klinikum der Johann Wolfgang Goethe-Universitaet
Frankfurt, , Germany
Universitaetsklinikum Halle (Saale)
Halle, , Germany
Medizinische Hochschule Hannover; Gastroenterology and Hepatology dept
Hanover, , Germany
Klinikum Mannheim GmbH Universitätsklinikum
Mannheim, , Germany
Gemeinschaftspraxis
Offenburg, , Germany
Universitaetsklinikum Tuebingen
Tübingen, , Germany
Universitaetsklinikum Ulm
Ulm, , Germany
Bekes Megyei Kozponti Korhaz Dr. Rethy Pal Tagkorhaza
Békéscsaba, , Hungary
Obudai Egeszsegugyi Centrum Kft.
Budapest, , Hungary
Semmelweis Egyetem
Budapest, , Hungary
Eszak-Kozep-budai Centrum, Uj Szent Janos Korhaz es Szakrendelo
Budapest, , Hungary
Pannonia Maganorvosi Centrum
Budapest, , Hungary
Debreceni Egyetem
Debrecen, , Hungary
Petz Aladar Megyei Oktato Korhaz
Győr, , Hungary
Pest Megyei Flor Ferenc Korhaz
Kistarcsa, , Hungary
Pecsi Tudomanyegyetem
Pécs, , Hungary
Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz
Székesfehérvár, , Hungary
Haemek Medical Center
Afula, , Israel
Soroka University Medical Centre
Beersheba, , Israel
Wolfson Medical Center; Obstetrics and Gynecology
Holon, , Israel
Shaare Zedek Medical Center
Jerusalem, , Israel
Hadassah University Hospital - Ein Kerem
Jerusalem, , Israel
Holy Family Hospital
Nazareth, , Israel
Rabin Medical Center-Beilinson Campus
Petah Tikva, , Israel
Tel Aviv Sourasky Medical Center; Pharmacy
Tel Aviv, , Israel
A.O.U. Policlinico di Modena
Modena, Emilia-Romagna, Italy
Azienda Ospedaliera San Camillo Forlanini
Rome, Lazio, Italy
Policlinico Universitario Agostino Gemelli; Farmacia
Rome, Lazio, Italy
Asst Fatebenefratelli Sacco (Fatebenefratelli)
Milan, Lombardy, Italy
ASST FATEBENEFRATELLI SACCO (Sacco)
Milan, Lombardy, Italy
Azienda Socio Sanitaria Territoriale Niguarda (Grande Ospedale Metropolitano Niguarda)
Milan, Lombardy, Italy
Istituto Clinico Humanitas
Rozzano (MI), Lombardy, Italy
I.R.C.C.S Policlinico San Donato
San Donato Milanese (MI), Lombardy, Italy
Ospedale Umberto I di Torino
Turin, Piedmont, Italy
Azienda Ospedaliera Universitaria Careggi
Florence, Tuscany, Italy
Riga East Clinical University Hospital; Clinic Gailezers
Riga, , Latvia
Pauls Stradins Clinical University Hospital
Riga, , Latvia
Hospital of Lithuanian University of Health. Sciences Kaunas Clinics
Kaunas, , Lithuania
Vilnius University Hospital Santariskiu Clinic, Public Institution; Cardiology
Vilnius, , Lithuania
Clinical Research Institute
Tlalnepantla, Mexico CITY (federal District), Mexico
Medical Care & Research SA de CV
Mérida, Yucatán, Mexico
Amsterdam UMC, Locatie VUMC; Neurology
Amsterdam, , Netherlands
Amsterdam UMC Location AMC
Amsterdam, , Netherlands
Leids Universitair Medisch Centrum
Leiden, , Netherlands
Maastricht University Medical Center
Maastricht, , Netherlands
Erasmus Medisch Centrum
Rotterdam, , Netherlands
Zuyderland Medisch Centrum - Sittard Geleen
Sittard-Geleen, , Netherlands
ETZ TweeSteden
Tilburg, , Netherlands
North Shore Hospital
Auckland, , New Zealand
Christchurch Hospital NZ
Christchurch, , New Zealand
Dunedin Public Hospital
Dunedin, , New Zealand
Waikato Hospital
Hamilton, , New Zealand
Shakespeare Specialist Group
Takapuna, , New Zealand
Tauranga Hospital
Tauranga, , New Zealand
SP ZOZ Wojewodzki Szpital Zespolony im. J. Sniadeckiego
Bialystok, , Poland
Nasz Lekarz Osrodek Badan Klinicznych
Bydgoszcz, , Poland
Elblaski Szpital Specjalistyczny z Przychodnia SP ZOZ
Elblag, , Poland
ETG Kielce
Kielce, , Poland
Centrum Opieki Zdrowotnej Orkan-Med
Ksawerów, , Poland
Indywidualna Specjalistyczna Praktyka Lekarska
Lublin, , Poland
Allmedica Badania Kliniczne Sp z o.o. Sp K.
Nowy Targ, , Poland
Centrum Medyczne "MEDYK"
Rzeszów, , Poland
Gabinet Lekarski, Bartosz Korczowski
Rzeszów, , Poland
Specjalistyczna Praktyka Lekarska Dr med. Marek Horynski; endoskopia
Sopot, , Poland
Niepubliczny Zaklad Opieki Zdrowotnej SONOMED
Szczecin, , Poland
Twoja Przychodnia-Szczecinskie Centrum Medyczne
Szczecin, , Poland
Gastromed Kopon Zmudzinski i Wspolnicy Sp.j.Specjalistyczne Centrum Gastrologii i Endoskopii Specj
Torun, , Poland
Centrum Zdrowia MDM
Warsaw, , Poland
Warsaw IBD Point Profesor Kierkus
Warsaw, , Poland
Zespó Przychodni Specjalistycznych PRIMA
Warsaw, , Poland
PlanetMed sp. z o.o.
Wroclaw, , Poland
LexMedica Osrodek Badan Klinicznych
Wroclaw, , Poland
EuroMediCare Szpital Specjalistyczny z Przychodnią we Wrocławiu
Wroclaw, , Poland
S.C MedLife S.A
Bucharest, , Romania
Spitalul Clinic Colentina
Bucharest, , Romania
Centrul de Gastroenterologie Dr. Goldis
Timișoara, , Romania
Yusupov Hospital
Moskva, Adygeya Republic, Russia
LLC "Novosibirsk GastroCenter"
Novosibirsk, Altaj, Russia
North-Western Medical University n.a. I.I. Mechnikov; Rheumatology
Saint Petersburg, Sankt-Peterburg, Russia
Baltic Medicine
Saint Petersburg, Sankt-Peterburg, Russia
SBIH City Clinical Hospital #31
Saint Petersburg, Sankt-Peterburg, Russia
SBEI HPE Altai StateMedicalUniversityofMoH andSD
Barnaul, , Russia
Irkutsk State Medical Academy of Continuing Education
Irkutsk, , Russia
SBEIHPE Novosibirsk State Medical University
Novosibirsk, , Russia
BHI of Omsk region Clinical Oncology Dispensary
Omsk, , Russia
Evromedservis LCC
Pushkin, , Russia
SEIHPE "Rostov SMU of MoH of RF"
Rostov-on-Don, , Russia
Federal State Military Educational Institution; High Professional Education Military Medical Acad
Saint Petersburg, , Russia
Clinical Helth Centre Zvezdara
Belgrade, , Serbia
Military Medical Academy
Belgrade, , Serbia
University Hospital Medical Center Bezanijska kosa
Belgrade, , Serbia
Clinical Center of Vojvodina
Novi Sad, , Serbia
General Hospital Djordje Joanovic
Zrenjanin, , Serbia
IBDcentrum s.r.o.
Bratislava, , Slovakia
KM Management spol. s r.o.
Nitra, , Slovakia
Accout Center s.r.o.
Šahy, , Slovakia
Endomed, s.r.o.
Vranov nad Topľou, , Slovakia
Dr D Epstein Practice
Cape Town, , South Africa
Emmed Research
Pretoria, , South Africa
Inje University Busan Paik Hospital
Busan, , South Korea
Dong-A University Hospital
Busan, , South Korea
Pusan National University Hospital
Busan, , South Korea
Kyungpook National University Hospital
Daegu, , South Korea
Yeungnam Univ. Hospital
Daegu, , South Korea
Hanyang University Guri Hospital
Gyeonggi-do, , South Korea
Korea University Ansan Hospital
Gyeonggi-do, , South Korea
CHA Bundang Medical Centre; CHA university
Seongnam, , South Korea
Seoul National University Bundang Hospital
Seongnam-si, , South Korea
Seoul National University Hospital
Seoul, , South Korea
Kangbuk Samsung Hospital
Seoul, , South Korea
Severance Hospital, Yonsei University Health System
Seoul, , South Korea
Asan Medical Center
Seoul, , South Korea
Samsung Medical Center
Seoul, , South Korea
Yonsei University Wonju Severance Christian Hospital
Wŏnju, , South Korea
Hospital Universitario de Bellvitge
L'Hospitalet de Llobregat, Barcelona, Spain
Hospital Universitario Puerta de Hierro Majadahonda; Hepatology studies
Majadahonda, Madrid, Spain
Hospital Clínic i Provincial; Servicio de Farmacia
Barcelona, , Spain
Centro Médico Teknon
Barcelona, , Spain
Hospital Reina Sofia; Medical Oncology
Córdoba, , Spain
Hospital Juan Ramón Jiménez
Huelva, , Spain
Hospital Universitario de la Princesa
Madrid, , Spain
Hospital Universitario La Paz
Madrid, , Spain
Hospital Universitario de Fuenlabrada
Madrid, , Spain
Complejo Hospitalario de Pontevedra
Pontevedra, , Spain
Hospital Universitario Virgen Macarena
Seville, , Spain
Hospital Universitario Virgen del Rocio
Seville, , Spain
Hospital Universitari i Politecnic La Fe
Valencia, , Spain
Hospital Universitario Miguel Servet
Zaragoza, , Spain
Inselspital-Universitaetsspital Bern
Bern, , Switzerland
Crohn-Colitis Zentrum Bern - Gemeinschaftspraxis Balsiger, Seibold und Partner
Bern, , Switzerland
Universitätsspital Zürich
Zurich, , Switzerland
Ankara University Medical Faculty
Ankara, , Turkey (Türkiye)
Hacettepe University Medical Faculty; Gastroenterology
Ankara, , Turkey (Türkiye)
Gazi University Medical Faculty
Ankara, , Turkey (Türkiye)
Acibadem Fulya Hospital; Neurology
Istanbul, , Turkey (Türkiye)
Haydarpasa Numune Training and Research Hospital; Medical Oncology
Istanbul, , Turkey (Türkiye)
Medeniyet University Goztepe Training and Research Hospital; Chest Diseases
Istanbul, , Turkey (Türkiye)
Ege University Medical Faculty
Izmir, , Turkey (Türkiye)
Kocaeli Universitesi Tip Fakultesi; Infectious Diseases
Kocaeli, , Turkey (Türkiye)
Acibadem Kozyatagi Hospital; Gastroenterology
Kozyataği, , Turkey (Türkiye)
CHI Prof.O.O.Shalimov Kharkiv City Clinical Hospital #2
Kharkiv, Kharkiv Governorate, Ukraine
CI of Healthcare Kharkiv Reg Clin Hosp-Center of Med Emergency & Accident Medicine
Kharkiv, Kharkiv Governorate, Ukraine
Medical Center of Limited Liability Company Medical Clinic Blagomed
Kyiv, KIEV Governorate, Ukraine
Med Center of International Institute of Clinical Trials LLC; Medical Center "OK!Clinic+"
Kyiv, KIEV Governorate, Ukraine
CI of Kyiv RC Regional Clinical Hospital #2
Kyiv, KIEV Governorate, Ukraine
Lviv Regional Clinical Hospital
Lviv, KIEV Governorate, Ukraine
Ivano-Frankivsk Regional Clinical Hospital
Ivano-Frankivsk, Kuban People's Republica, Ukraine
RCNECRCH Dept of Surgery, SHEI Ukr BSMU
Chernivtsi, Podolia Governorate, Ukraine
Kremenchuk first city hospital n.a. O.T. Bohaievskyi; Gastroenterology department
Kremenchuk, Poltava Governorate, Ukraine
CI City Hospital #1
Zaporizhzhia, Tavria Okruha, Ukraine
GI L.T.Malaya Therapy National Institute of the NAMS of Ukraine
Kharkiv, , Ukraine
CHI Kharkiv City Clinical Hospital #13
Kharkiv, , Ukraine
Kyiv CCH #18 Dept of Proctology O. O. Bogomolets NMU
Kyiv, , Ukraine
City Hospital #1
Mykolaiv, , Ukraine
Railway Transport Odesa CH of Healthcare Ctr Branch of PJSC Ukrainian Railway Dept of Therapy #2
Odesa, , Ukraine
Private Small Enterprise Medical Center Pulse
Vinnytsia, , Ukraine
M.I. Pyrogov VRCH Dept of Gastroenterology M.I. Pyrogov VNMU
Vinnytsia, , Ukraine
MCIC MC LLC Health Clinic
Vinnytsia, , Ukraine
LLC Diaservis
Zaporizhzhia, , Ukraine
Royal Victoria Hospital
Belfast, , United Kingdom
Addenbrooke's Hospital
Cambridge, , United Kingdom
University Hospital Coventry
Coventry, , United Kingdom
Royal Devon and Exeter Hospital (Wonford)
Exeter, , United Kingdom
Queen Elizabeth Hospital
Kings Lynn, , United Kingdom
St James University Hospital
Leeds, , United Kingdom
Royal Liverpool University Hospital
Liverpool, , United Kingdom
Whipps Cross Hospital
London, , United Kingdom
University College London Hospital
London, , United Kingdom
Fairfield General Hospital
Manchester, , United Kingdom
Royal Victoria Infirmary; Stroke unit
Newcastle upon Tyne, , United Kingdom
Nottingham University Hospitals Queen's Medical Centre
Nottingham, , United Kingdom
Royal Berkshire Hospital
Reading, , United Kingdom
Southampton General Hospital
Southampton, , United Kingdom
Royal Wolverhampton hospital; McHale Building
Wolverhampton, , United Kingdom
Countries
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References
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Sandborn WJ, Panes J, Danese S, Sharafali Z, Hassanali A, Jacob-Moffatt R, Eden C, Daperno M, Valentine JF, Laharie D, Baia C, Atreya R, Panaccione R, Rydzewska G, Aguilar H, Vermeire S; BERGAMOT Study Group. Etrolizumab as induction and maintenance therapy in patients with moderately to severely active Crohn's disease (BERGAMOT): a randomised, placebo-controlled, double-blind, phase 3 trial. Lancet Gastroenterol Hepatol. 2023 Jan;8(1):43-55. doi: 10.1016/S2468-1253(22)00303-X. Epub 2022 Oct 12.
Dai B, Hackney JA, Ichikawa R, Nguyen A, Elstrott J, Orozco LD, Sun KH, Modrusan Z, Gogineni A, Scherl A, Gubatan J, Habtezion A, Deswal M, Somsouk M, Faubion WA, Chai A, Sharafali Z, Hassanali A, Oh YS, Tole S, McBride J, Keir ME, Yi T. Dual targeting of lymphocyte homing and retention through alpha4beta7 and alphaEbeta7 inhibition in inflammatory bowel disease. Cell Rep Med. 2021 Aug 17;2(8):100381. doi: 10.1016/j.xcrm.2021.100381. eCollection 2021 Aug 17.
Reinisch W, Mishkin DS, Oh YS, Schreiber S, Hussain F, Jacob R, Hassanali A, Daperno M. Impact of various central endoscopy reading models on treatment outcome in Crohn's disease using data from the randomized, controlled, exploratory cohort arm of the BERGAMOT trial. Gastrointest Endosc. 2021 Jan;93(1):174-182.e2. doi: 10.1016/j.gie.2020.05.020. Epub 2020 May 25.
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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2014-003824-36
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
GA29144
Identifier Type: -
Identifier Source: org_study_id
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