Clinical trial NCT02394028: A Study to Assess Whether Etrolizumab is a Safe and Efficacious Treatment for Participants With Moderately to Severely Active Crohn's Disease
Official title: A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Etrolizumab as an Induction And Maintenance Treatment For Patients With Moderately to Severely Active Crohn's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Crohn Disease
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2015-03-20
Enrollment: 1035
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a multicenter, Phase 3, double-blind, placebo-controlled study evaluating the efficacy, safety, and tolerability of etrolizumab compared with placebo during induction and maintenance treatment of moderately to severely active Crohn's Disease (CD). The target population includes participants with CD who are refractory or intolerant to corticosteroids (CS) and/or immunosuppressant (IS) therapy and who have either not received prior anti-tumor necrosis factor (anti-TNF) therapy (TNF-naive) or who have had prior exposure to anti-TNF therapies and demonstrated inadequate responses or intolerance to anti-TNFs.

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.


Eligibility criteria: Inclusion Criteria:

* Moderately to severely active Crohn's Disease (CD) as determined by the CDAI, patient reported outcomes and endoscopically defined disease activity in the ileum and/or colon
* 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:

* A history of, or current conditions affecting the digestive tract, such as ulcerative colitis, indeterminate colitis, fistulizing disease, abdominal or perianal abscess, adenomatous colonic polyps not excised, colonic mucosal dysplasia, and short bowel syndrome
* 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

Primary outcomes:
measure: Induction Phase: Cohort 1: Percentage of Participants With Clinical Remission at Week 14
timeFrame: Week 14
measure: Induction Phase: Cohort 2 and 3: Percentage of Participants With Clinical Remission at Week 14
timeFrame: Week 14
measure: Induction Phase: Cohort 1: Percentage of Participants With Endoscopic Improvement at Week 14
timeFrame: Week 14
measure: Induction Phase: Cohort 2 and 3: Percentage of Participants With Endoscopic Improvement at Week 14
timeFrame: Week 14
measure: Maintenance Phase: Percentage of Participants With Clinical Remission at Week 66
timeFrame: Baseline and Week 66
measure: Maintenance Phase: Percentage of Participants With Endoscopic Improvement at Week 66
timeFrame: Week 66
Secondary outcomes:
measure: Induction Phase: Cohort 1: Percentage of Participants With Clinical Remission at Week 6
timeFrame: Week 6
measure: Induction Phase: Cohort 2 and 3: Percentage of Participants With Clinical Remission at Week 6
timeFrame: Week 6
measure: Induction Phase: Cohort 1: Percentage of Participants With SES-CD Score ≤4 (≤2 for Ileal Participants), With No Segment Having a Subcategory Score Greater Than (>)1, at Week 14
timeFrame: Week 14
measure: Induction Phase: Cohort 2 and 3: Percentage of Participants With SES-CD Score ≤4 (≤2 for Ileal Participants), With No Segment Having a Subcategory Score Greater Than (>)1, at Week 14
timeFrame: Week 14
measure: Induction Phase: Cohort 1: Change From Baseline in Crohn's Disease-Patient-Reported Outcome Signs and Symptoms (CD-PRO/SS) Score at Week 14
timeFrame: Baseline and Week 14
measure: Induction Phase: Cohort 2 and 3: Change From Baseline in Crohn's Disease-Patient-Reported Outcome Signs and Symptoms (CD-PRO/SS) Score at Week 14
timeFrame: Baseline and Week 14
measure: Maintenance Phase: Percentage of Participants With Clinical Remission at Week 66, Among Those Who Achieved Clinical Remission at Week 14
timeFrame: Baseline, Weeks 14 and 66
measure: Maintenance Phase: Percentage of Participants With Corticosteroid-Free Clinical Remission at Week 66, Among Those Who Were Receiving Corticosteroids at Baseline
timeFrame: Baseline and Week 66
measure: Maintenance Phase: Percentage of Participants With Endoscopic Improvement at Week 66 Among Participants Who Achieved Endoscopic Improvement at Week 14
timeFrame: Baseline, Weeks 14 and 66
measure: Maintenance Phase: Percentage of Participants With SES-CD Score ≤4 (≤2 for Ileal Participants), With No Segment Having a Subcategory Score >1, at Week 66
timeFrame: Week 66
measure: Maintenance Phase: Percentage of Participants With Durable Clinical Remission
timeFrame: Week 14 up to Week 66 (assessed at Weeks 24, 28, 32, 44, 56, and 66)
measure: Maintenance Phase: Percentage of Participants With Corticosteroid-Free Clinical Remission for at Least 24 Weeks at Week 66, Among Those Who Were Receiving Corticosteroids at Baseline
timeFrame: Baseline and from Week 14 up to Week 66
measure: Maintenance Phase: Change From Baseline in CD-PRO/SS Score at Week 66
timeFrame: Baseline and Week 66
measure: 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)
timeFrame: From Baseline up to Week 78
measure: Overall Number of Participants With Adverse Events Leading to Study Drug Discontinuation
timeFrame: From Baseline up to Week 78
measure: Overall Number of Participants Who Experienced at Least One Infection-Related Adverse Event by Severity, According to NCI-CTCAE v4.0
timeFrame: From Baseline up to Week 78
measure: Overall Number of Participants Who Experienced at Least One Infection-Related Serious Adverse Event
timeFrame: From Baseline up to Week 78
measure: Overall Number of Participants Who Experienced at Least One Injection-Site Reaction by Severity, According to NCI-CTCAE v4.0
timeFrame: From Baseline up to Week 78
measure: Overall Number of Participants Who Experienced at Least One Hypersensitivity Reaction by Severity, According to NCI-CTCAE v4.0
timeFrame: From Baseline up to Week 78
measure: Overall Number of Participants Who Develop Malignancies
timeFrame: From Baseline up to Week 78
measure: Percentage of Participants With Anti-Therapeutic Antibodies (ATAs) to Etrolizumab
timeFrame: Baseline, Pre-dose (Hour 0) on Weeks 4, 14, 24, 32, 44, 66 or early termination, 12 weeks after last dose (up to Week 78)
measure: Observed Trough Serum Concentration (Ctrough) of Etrolizumab
timeFrame: Induction Phase at Weeks 10 and 14, Maintenance Phase at Weeks 16, 24, 28, 32, 44, and 66
Other outcomes:
Locations:
city: Arcadia
country: United States
facility: Valley Gastroenterology Consultants
state: California
city: La Jolla
country: United States
facility: University of California San Diego Medical Center
state: California
city: Long Beach
country: United States
facility: VA Long Beach Healthcare System
state: California
city: San Carlos
country: United States
facility: Digestive Care Associates, A Medical Corporation
state: California
city: San Diego
country: United States
facility: SDG Clinical Research
state: California
city: San Francisco
country: United States
facility: University of California at San Francisco (PARENT); Gastroenterology, Hepatology & Nutrition
state: California
city: Colorado Springs
country: United States
facility: Peak Gastroenterology Associates; Gastroenterology
state: Colorado
city: Aventura
country: United States
facility: Innovative Medical Research of South Florida
state: Florida
city: Clearwater
country: United States
facility: West Central Gastroenterology d/b/a Gastro Florida
state: Florida
city: Gainesville
country: United States
facility: University of Florida College of Medicine
state: Florida
city: Jacksonville
country: United States
facility: Borland-Groover Clinic
state: Florida
city: Miami Beach
country: United States
facility: IMIC, Inc
state: Florida
city: Miramar
country: United States
facility: FQL Research, LLC
state: Florida
city: Trinity
country: United States
facility: Advanced Research Institute, Inc.
state: Florida
city: Winter Park
country: United States
facility: Shafran Gastroenterology Center
state: Florida
city: Atlanta
country: United States
facility: Emory University Hospital
state: Georgia
city: Atlanta
country: United States
facility: Atlanta Gastroenterology Associates
state: Georgia
city: Columbus
country: United States
facility: Gastrointestinal Diseases Research
state: Georgia
city: Decatur
country: United States
facility: Atlanta Center for Gastroenterology, PC
state: Georgia
city: Macon
country: United States
facility: Gastroenterology Associates of Central Georgia
state: Georgia
city: Marietta
country: United States
facility: Gastrointestinal Specialists of Georgia, PC
state: Georgia
city: Meridian
country: United States
facility: Advanced Clinical Research
state: Idaho
city: Chicago
country: United States
facility: Northwestern University-Feinberg School of Medicine; Division of Gastroenterology and Hepatology
state: Illinois
city: Chicago
country: United States
facility: The University of Chicago Medical Center
state: Illinois
city: Oak Lawn
country: United States
facility: Southwest Gastroenterology; DM Clinical Research
state: Illinois
city: Urbana
country: United States
facility: Carle Foundation Hospital
state: Illinois
city: Topeka
country: United States
facility: Cotton-O'Neil Clinical Research Center, Digestive Health
state: Kansas
city: Baton Rouge
country: United States
facility: Gastroenterology Associates, LLC
state: Louisiana
city: Shreveport
country: United States
facility: Louisiana Research Center, LLC
state: Louisiana
city: Brockton
country: United States
facility: Commonwealth Clinical Studies
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan Health System
state: Michigan
city: Grand Rapids
country: United States
facility: Gastroenterology Associates of Western Michigan, P.L.C.
state: Michigan
city: Troy
country: United States
facility: Center for Digestive Health
state: Michigan
city: West Bloomfield
country: United States
facility: Henry Ford Health System
state: Michigan
city: Rochester
country: United States
facility: Mayo Clinic - Rochester; Gastrology
state: Minnesota
city: Jackson
country: United States
facility: University of Mississippi Medical Center; Division of Gastroenterology
state: Mississippi
city: Belton
country: United States
facility: Ehrhardt Clinical Research, LLC
state: Missouri
city: New York
country: United States
facility: Concorde Medical Group
state: New York
city: New York
country: United States
facility: Weill Cornell Medical College (WCMC) - Judith Jaffe Multiple Sclerosis Center (JJMSC)
state: New York
city: New York
country: United States
facility: Lenox Hill Hospital
state: New York
city: Chapel Hill
country: United States
facility: University of North Carolina At Chapel Hill
state: North Carolina
city: Charlotte
country: United States
facility: Charlotte Gastroenterology and Hepatology, P.L.L.C
state: North Carolina
city: Kinston
country: United States
facility: Kinston Medical Specialists
state: North Carolina
city: Cincinnati
country: United States
facility: Consultants for Clinical Research Inc.
state: Ohio
city: Mentor
country: United States
facility: Great Lakes Gastroenterology Research, LLC
state: Ohio
city: Oklahoma City
country: United States
facility: Digestive Disease Specialists, Inc.
state: Oklahoma
city: Harrisburg
country: United States
facility: Great Lakes Medical Research, LLC
state: Pennsylvania
city: Greenville
country: United States
facility: Innovative Clinical Research
state: South Carolina
city: Germantown
country: United States
facility: Gastroenterology Center of the MidSouth PC
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Dallas
country: United States
facility: Texas Digestive Disease Consultants - Dallas
state: Texas
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center; Internal Medicne
state: Texas
city: Houston
country: United States
facility: Baylor College of Medicine; Gastroenterology
state: Texas
city: Houston
country: United States
facility: Methodist Hospital Research Institute
state: Texas
city: San Antonio
country: United States
facility: Wellness Clinical Research Center
state: Texas
city: Southlake
country: United States
facility: Texas Digestive Disease Consultants - Southlake
state: Texas
city: Tyler
country: United States
facility: Tyler Research Institute, LLC
state: Texas
city: Clinton
country: United States
facility: Ericksen Research and Development
state: Utah
city: Salt Lake City
country: United States
facility: University of Utah School of Medicine
state: Utah
city: Richmond
country: United States
facility: McGuire Research Institute; Gastroenterology
state: Virginia
city: Seattle
country: United States
facility: Digestive Disease Institute; Virginia Mason Medical Center
state: Washington
city: Madison
country: United States
facility: University of Wisconsin
state: Wisconsin
city: Buenos Aires
country: Argentina
facility: Hospital Italiano
city: Garran
country: Australia
facility: The Canberra Hospital
state: Australian Capital Territory
city: Bankstown
country: Australia
facility: Bankstown-Lidcombe Hospital
state: New South Wales
city: Concord
country: Australia
facility: Concord Repatriation General Hospital
state: New South Wales
city: Herston
country: Australia
facility: Royal Brisbane and Women's Hospital
state: Queensland
city: Sippy Downs
country: Australia
facility: University of the Sunshine Coast
state: Queensland
city: South Brisbane
country: Australia
facility: Mater Adult Hospital
state: Queensland
city: Woolloongabba
country: Australia
facility: Princess Alexandra Hospital
state: Queensland
city: Bedford Park
country: Australia
facility: Flinders Medical Centre
state: South Australia
city: Clayton
country: Australia
facility: Monash Medical Centre Clayton
state: Victoria
city: Fitzroy
country: Australia
facility: St Vincent's Hospital Melbourne
state: Victoria
city: Footscray
country: Australia
facility: Footscray Hospital; Gastroenterology
state: Victoria
city: Malvern
country: Australia
facility: St Frances Xavier Cabrini Hospital
state: Victoria
city: Melbourne
country: Australia
facility: Alfred Hospital
state: Victoria
city: Parkville
country: Australia
facility: Royal Melbourne Hospital; Department of Colorectal Medicine and Genetics
state: Victoria
city: Murdoch
country: Australia
facility: Fiona Stanley Hospital
state: Western Australia
city: Salzburg
country: Austria
facility: LKH - Universitätsklinikum der PMU Salzburg
city: Wien
country: Austria
facility: Medizinische Universität Wien
city: Brussels
country: Belgium
facility: CHU St Pierre (St Pierre)
city: Brussel
country: Belgium
facility: UZ Brussel
city: Bruxelles
country: Belgium
facility: Hospital Erasme
city: Edegem
country: Belgium
facility: UZ Antwerpen
city: Gent
country: Belgium
facility: AZ Maria Middelares
city: Brasilia
country: Brazil
facility: L2IP -Instituto de Pesquisas Clínicas Ltda.
state: DF
city: Goiânia
country: Brazil
facility: Instituto Goiano de Gastroenterologia e Endoscopia Digestiva Ltda
state: GO
city: Belo Horizonte
country: Brazil
facility: Hospital Felicio Rocho
state: MG
city: Curitiba
country: Brazil
facility: Centro Digestivo de Curitiba
state: PR
city: Rio de Janeiro
country: Brazil
facility: Hospital Universitario Clementino Fraga Filho - UFRJ; Gastroenterologia
state: RJ
city: Rio de Janeiro
country: Brazil
facility: Instituto Brasil de Pesquisa Clínica-IBPCLIN S/A
state: RJ
city: Passo Fundo
country: Brazil
facility: Hospital São Vicente de Paulo; Institute of Education and Reseach / Cardiovascular Research Unit
state: RS
city: Porto Alegre
country: Brazil
facility: Hospital das Clinicas - UFRGS
state: RS
city: Porto Alegre
country: Brazil
facility: Hospital Ernesto Dornelles
state: RS
city: Botucatu
country: Brazil
facility: UNESP - Faculdade de Medicina da Universidade Estadual Paulista - Campus Botucatu
state: SP
city: Santo Andre
country: Brazil
facility: Pesquisare Saúde Sociedade Simples
state: SP
city: Santo Andre
country: Brazil
facility: Praxis Pesquisa Médica
state: SP
city: Santo Andre
country: Brazil
facility: Hospital Estadual Mario Covas
state: SP
city: Sao Jose do Rio Preto
country: Brazil
facility: Hospital de Base de Sao Jose do Rio Preto
state: SP
city: Sao Paulo
country: Brazil
facility: Hospital Sírio-Libanês
state: SP
city: Sao Paulo
country: Brazil
facility: Hospital Sao Paulo
state: SP
city: São Paulo
country: Brazil
facility: Hospital do Servidor Público Estadual/HSPE-SP
state: SP
city: Sofia
country: Bulgaria
facility: "City Clinic UMHAC" EOOD
city: Sofia
country: Bulgaria
facility: UMHAT "Sv. Ivan Rilski", EAD
city: Sofia
country: Bulgaria
facility: UMHAT Tsaritsa Yoanna - ISUL, EAD
city: Calgary
country: Canada
facility: University of Calgary
state: Alberta
city: Edmonton
country: Canada
facility: Zeidler Ledcor Centre - University of Alberta; Division of Gasroenterology
state: Alberta
city: Vancouver
country: Canada
facility: (G.I.R.I.) GI Research Institute
state: British Columbia
city: Winnipeg
country: Canada
facility: Winnipeg Regional Health Authority
state: Manitoba
city: Halifax
country: Canada
facility: Queen Elizabeth II Health Sciences Centre; Gastroenterology Research
state: Nova Scotia
city: London
country: Canada
facility: University Hospital - London Health Sciences Centre
state: Ontario
city: Oshawa
country: Canada
facility: Taunton Health Centre
state: Ontario
city: Ottawa
country: Canada
facility: The Ottawa Hospital - Riverside Campus; Gastrointestinal Clinical Research Unit
state: Ontario
city: Toronto
country: Canada
facility: Mount Sinai Hospital
state: Ontario
city: Vaughan
country: Canada
facility: Toronto Digestive Disease Associates
state: Ontario
city: Montreal
country: Canada
facility: Hôpital Maisonneuve - Rosemont
state: Quebec
city: Montreal
country: Canada
facility: McGill University Health Centre - Glen Site
state: Quebec
city: Saskatoon
country: Canada
facility: Royal University Hospital
state: Saskatchewan
city: Osijek
country: Croatia
facility: Clinical Hospital Centre Osijek
city: Pula
country: Croatia
facility: General Hospital Pula
city: Zagreb
country: Croatia
facility: Clinical Hospital Center Sestre Milosrdnice
city: Zagreb
country: Croatia
facility: University Hospital Center Zagreb
city: Brno
country: Czechia
facility: Vojenska nemocnice Brno
city: Brno
country: Czechia
facility: Fakultni nemocnice u sv. Anny v Brne
city: Ceske Budejovice
country: Czechia
facility: Nemocnice Ceske Budejovice a.s.
city: Hradec Kralove
country: Czechia
facility: Gastroenterologie s.r.o.
city: Hradec Kralove
country: Czechia
facility: Fakultni nemocnice Hradec Kralove
city: Hradec Kralove
country: Czechia
facility: Hepato-Gastroenterologie HK, s.r.o.
city: Olomouc
country: Czechia
facility: PreventaMed, s.r.o.
city: Ostrava - Poruba
country: Czechia
facility: Fakultni nemocnice Ostrava
city: Praha 7
country: Czechia
facility: Klinicke centrum ISCARE Lighthouse
city: Praha
country: Czechia
facility: Fakultni nemocnice Kralovske Vinohrady
city: Tallinn
country: Estonia
facility: West Tallinn Central Hospital
city: Tallinn
country: Estonia
facility: North Estonia Medical Centre Foundation
city: Tartu
country: Estonia
facility: Tartu University Hospital
city: Amiens
country: France
facility: CHU Amiens - Hopital Sud
city: Caen
country: France
facility: CHU de Caen - Hopital Cote de Nacre
city: Clichy cedex
country: France
facility: Hôpital Beaujon
city: Lille
country: France
facility: Hopital Claude Huriez - CHU Lille
city: Nantes
country: France
facility: CHU NANTES - Hôtel Dieu; Pharmacy
city: Nice
country: France
facility: CHU Nice - Hopital de l'Archet 2
city: Paris
country: France
facility: Hôpital Saint-Louis
city: Pessac
country: France
facility: Groupe Hospitalier Sud - Hôpital Haut-Lévêque - USN
city: Pierre-Benite
country: France
facility: Centre Hospitalier Lyon Sud; Service de Gastro-Enterologie
city: Reims
country: France
facility: CHU du Reims - Hopital Robert Debré
city: Rennes cedex 09
country: France
facility: CHU Rennes - Hopital Pontchaillou
city: Saint Etienne
country: France
facility: CHU Saint Etienne - Hôpital Nord
city: Strasbourg
country: France
facility: Höpital Hautepierre; Pediatrie1
city: Vandoeuvre-les-nancy
country: France
facility: Hôpital de Brabois Adultes
city: Berlin
country: Germany
facility: Charite-Campus Virchow Klinikum; Hepatologie und Gastroenterologie
city: Berlin
country: Germany
facility: Krankenhaus Waldfriede e. V.
city: Bochum
country: Germany
facility: Berufsgenossenschaftliches Universitaetsklinikum Bergmannsheil GmbH
city: Frankfurt
country: Germany
facility: Klinikum der Johann Wolfgang Goethe-Universitaet
city: Halle
country: Germany
facility: Universitaetsklinikum Halle (Saale)
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover; Gastroenterology and Hepatology dept
city: Koeln
country: Germany
facility: Universitätsklinikum Koeln
city: Mannheim
country: Germany
facility: Klinikum Mannheim GmbH Universitätsklinikum
city: Offenburg
country: Germany
facility: Gemeinschaftspraxis
city: Tuebingen
country: Germany
facility: Universitaetsklinikum Tuebingen
city: Ulm
country: Germany
facility: Universitaetsklinikum Ulm
city: Bekescsaba
country: Hungary
facility: Bekes Megyei Kozponti Korhaz Dr. Rethy Pal Tagkorhaza
city: Budapest
country: Hungary
facility: Obudai Egeszsegugyi Centrum Kft.
city: Budapest
country: Hungary
facility: Semmelweis Egyetem
city: Budapest
country: Hungary
facility: Eszak-Kozep-budai Centrum, Uj Szent Janos Korhaz es Szakrendelo
city: Budapest
country: Hungary
facility: Pannonia Maganorvosi Centrum
city: Debrecen
country: Hungary
facility: Debreceni Egyetem
city: Gyor
country: Hungary
facility: Petz Aladar Megyei Oktato Korhaz
city: Kistarcsa
country: Hungary
facility: Pest Megyei Flor Ferenc Korhaz
city: Pecs
country: Hungary
facility: Pecsi Tudomanyegyetem
city: Székesfehérvár
country: Hungary
facility: Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz
city: Afula
country: Israel
facility: Haemek Medical Center
city: Beer Sheva
country: Israel
facility: Soroka University Medical Centre
city: Holon
country: Israel
facility: Wolfson Medical Center; Obstetrics and Gynecology
city: Jerusalem
country: Israel
facility: Shaare Zedek Medical Center
city: Jerusalem
country: Israel
facility: Hadassah University Hospital - Ein Kerem
city: Nazareth
country: Israel
facility: Holy Family Hospital
city: Petach Tikva
country: Israel
facility: Rabin Medical Center-Beilinson Campus
city: Tel Aviv
country: Israel
facility: Tel Aviv Sourasky Medical Center; Pharmacy
city: Modena
country: Italy
facility: A.O.U. Policlinico di Modena
state: Emilia-Romagna
city: Roma
country: Italy
facility: Azienda Ospedaliera San Camillo Forlanini
state: Lazio
city: Roma
country: Italy
facility: Policlinico Universitario Agostino Gemelli; Farmacia
state: Lazio
city: Milano
country: Italy
facility: Asst Fatebenefratelli Sacco (Fatebenefratelli)
state: Lombardia
city: Milano
country: Italy
facility: ASST FATEBENEFRATELLI SACCO (Sacco)
state: Lombardia
city: Milano
country: Italy
facility: Azienda Socio Sanitaria Territoriale Niguarda (Grande Ospedale Metropolitano Niguarda)
state: Lombardia
city: Rozzano (MI)
country: Italy
facility: Istituto Clinico Humanitas
state: Lombardia
city: San Donato Milanese (MI)
country: Italy
facility: I.R.C.C.S Policlinico San Donato
state: Lombardia
city: Torino
country: Italy
facility: Ospedale Umberto I di Torino
state: Piemonte
city: Florence
country: Italy
facility: Azienda Ospedaliera Universitaria Careggi
state: Toscana
city: Busan
country: Korea, Republic of
facility: Inje University Busan Paik Hospital
city: Busan
country: Korea, Republic of
facility: Dong-A University Hospital
city: Busan
country: Korea, Republic of
facility: Pusan National University Hospital
city: Daegu
country: Korea, Republic of
facility: Kyungpook National University Hospital
city: Daegu
country: Korea, Republic of
facility: Yeungnam Univ. Hospital
city: Gyeonggi-do
country: Korea, Republic of
facility: Hanyang University Guri Hospital
city: Gyeonggi-do
country: Korea, Republic of
facility: Korea University Ansan Hospital
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
city: Seongnam
country: Korea, Republic of
facility: CHA Bundang Medical Centre; CHA university
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Kangbuk Samsung Hospital
city: Seoul
country: Korea, Republic of
facility: Severance Hospital, Yonsei University Health System
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Wonju-Si
country: Korea, Republic of
facility: Yonsei University Wonju Severance Christian Hospital
city: Riga
country: Latvia
facility: Riga East Clinical University Hospital; Clinic Gailezers
city: Rīga
country: Latvia
facility: Pauls Stradins Clinical University Hospital
city: Kaunas
country: Lithuania
facility: Hospital of Lithuanian University of Health. Sciences Kaunas Clinics
city: Vilnius
country: Lithuania
facility: Vilnius University Hospital Santariskiu Clinic, Public Institution; Cardiology
city: Tlalnepantla de Baz
country: Mexico
facility: Clinical Research Institute
state: Mexico CITY (federal District)
city: Mérida
country: Mexico
facility: Medical Care & Research SA de CV
state: Yucatan
city: Amsterdam
country: Netherlands
facility: Amsterdam UMC, Locatie VUMC; Neurology
city: Amsterdam
country: Netherlands
facility: Amsterdam UMC Location AMC
city: Leiden
country: Netherlands
facility: Leids Universitair Medisch Centrum
city: Maastricht
country: Netherlands
facility: Maastricht University Medical Center
city: Rotterdam
country: Netherlands
facility: Erasmus Medisch Centrum
city: Sittard-Geleen
country: Netherlands
facility: Zuyderland Medisch Centrum - Sittard Geleen
city: Tilburg
country: Netherlands
facility: ETZ TweeSteden
city: Auckland
country: New Zealand
facility: North Shore Hospital
city: Christchurch
country: New Zealand
facility: Christchurch Hospital NZ
city: Dunedin
country: New Zealand
facility: Dunedin Public Hospital
city: Hamilton
country: New Zealand
facility: Waikato Hospital
city: Takapuna
country: New Zealand
facility: Shakespeare Specialist Group
city: Tauranga
country: New Zealand
facility: Tauranga Hospital
city: Białystok
country: Poland
facility: SP ZOZ Wojewodzki Szpital Zespolony im. J. Sniadeckiego
city: Bydgoszcz
country: Poland
facility: Nasz Lekarz Osrodek Badan Klinicznych
city: Elblag
country: Poland
facility: Elblaski Szpital Specjalistyczny z Przychodnia SP ZOZ
city: Kielce
country: Poland
facility: ETG Kielce
city: Ksawerow
country: Poland
facility: Centrum Opieki Zdrowotnej Orkan-Med
city: Lublin
country: Poland
facility: Indywidualna Specjalistyczna Praktyka Lekarska
city: Nowy Targ
country: Poland
facility: Allmedica Badania Kliniczne Sp z o.o. Sp K.
city: Rzeszow
country: Poland
facility: Centrum Medyczne "MEDYK"
city: Rzeszów
country: Poland
facility: Gabinet Lekarski, Bartosz Korczowski
city: Sopot
country: Poland
facility: Specjalistyczna Praktyka Lekarska Dr med. Marek Horynski; endoskopia
city: Szczecin
country: Poland
facility: Niepubliczny Zaklad Opieki Zdrowotnej SONOMED
city: Szczecin
country: Poland
facility: Twoja Przychodnia-Szczecinskie Centrum Medyczne
city: Toruń
country: Poland
facility: Gastromed Kopon Zmudzinski i Wspolnicy Sp.j.Specjalistyczne Centrum Gastrologii i Endoskopii Specj
city: Warszawa
country: Poland
facility: Centrum Zdrowia MDM
city: Warszawa
country: Poland
facility: Warsaw IBD Point Profesor Kierkus
city: Warszawa
country: Poland
facility: Zespó Przychodni Specjalistycznych PRIMA
city: Wroclaw
country: Poland
facility: LexMedica Osrodek Badan Klinicznych
city: Wroclaw
country: Poland
facility: EuroMediCare Szpital Specjalistyczny z Przychodnią we Wrocławiu
city: Wrocław
country: Poland
facility: PlanetMed sp. z o.o.
city: Bucharest
country: Romania
facility: Spitalul Clinic Colentina
city: Bucuresti
country: Romania
facility: S.C MedLife S.A
city: Timisoara
country: Romania
facility: Centrul de Gastroenterologie Dr. Goldis
city: Moskva
country: Russian Federation
facility: Yusupov Hospital
state: Adygeja
city: Novosibirsk
country: Russian Federation
facility: LLC "Novosibirsk GastroCenter"
state: Altaj
city: St.Petersburg
country: Russian Federation
facility: Baltic Medicine
state: Leningrad
city: Sankt-peterburg
country: Russian Federation
facility: North-Western Medical University n.a. I.I. Mechnikov; Rheumatology
state: Sankt Petersburg
city: Sankt-peterburg
country: Russian Federation
facility: SBIH City Clinical Hospital #31
state: Sankt Petersburg
city: Barnaul
country: Russian Federation
facility: SBEI HPE Altai StateMedicalUniversityofMoH andSD
city: Irkutsk
country: Russian Federation
facility: Irkutsk State Medical Academy of Continuing Education
city: Novosibirsk
country: Russian Federation
facility: SBEIHPE Novosibirsk State Medical University
city: Omsk
country: Russian Federation
facility: BHI of Omsk region Clinical Oncology Dispensary
city: Pushkin
country: Russian Federation
facility: Evromedservis LCC
city: Rostov-on-Don
country: Russian Federation
facility: SEIHPE "Rostov SMU of MoH of RF"
city: St. Petersburg
country: Russian Federation
facility: Federal State Military Educational Institution; High Professional Education Military Medical Acad
city: Belgrade
country: Serbia
facility: Clinical Helth Centre Zvezdara
city: Belgrade
country: Serbia
facility: Military Medical Academy
city: Belgrade
country: Serbia
facility: University Hospital Medical Center Bezanijska kosa
city: Novi Sad
country: Serbia
facility: Clinical Center of Vojvodina
city: Zrenjanin
country: Serbia
facility: General Hospital Djordje Joanovic
city: Bratislava
country: Slovakia
facility: IBDcentrum s.r.o.
city: Nitra
country: Slovakia
facility: KM Management spol. s r.o.
city: Vranov nad Topľou
country: Slovakia
facility: Endomed, s.r.o.
city: Šahy
country: Slovakia
facility: Accout Center s.r.o.
city: Cape Town
country: South Africa
facility: Dr D Epstein Practice
city: Pretoria
country: South Africa
facility: Emmed Research
city: Hospitalet de Llobregat
country: Spain
facility: Hospital Universitario de Bellvitge
state: Barcelona
city: Majadahonda
country: Spain
facility: Hospital Universitario Puerta de Hierro Majadahonda; Hepatology studies
state: Madrid
city: Barcelona
country: Spain
facility: Hospital Clínic i Provincial; Servicio de Farmacia
city: Barcelona
country: Spain
facility: Centro Médico Teknon
city: Cordoba
country: Spain
facility: Hospital Reina Sofia; Medical Oncology
city: Huelva
country: Spain
facility: Hospital Juan Ramón Jiménez
city: Madrid
country: Spain
facility: Hospital Universitario de la Princesa
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
city: Madrid
country: Spain
facility: Hospital Universitario de Fuenlabrada
city: Pontevedra
country: Spain
facility: Complejo Hospitalario de Pontevedra
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen Macarena
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen del Rocio
city: Valencia
country: Spain
facility: Hospital Universitari i Politecnic La Fe
city: Zaragoza
country: Spain
facility: Hospital Universitario Miguel Servet
city: Bern
country: Switzerland
facility: Inselspital-Universitaetsspital Bern
city: Bern
country: Switzerland
facility: Crohn-Colitis Zentrum Bern - Gemeinschaftspraxis Balsiger, Seibold und Partner
city: Zürich
country: Switzerland
facility: Universitätsspital Zürich
city: Ankara
country: Turkey
facility: Ankara University Medical Faculty
city: Ankara
country: Turkey
facility: Hacettepe University Medical Faculty; Gastroenterology
city: Ankara
country: Turkey
facility: Gazi University Medical Faculty
city: Istanbul
country: Turkey
facility: Acibadem Fulya Hospital; Neurology
city: Istanbul
country: Turkey
facility: Haydarpasa Numune Training and Research Hospital; Medical Oncology
city: Istanbul
country: Turkey
facility: Medeniyet University Goztepe Training and Research Hospital; Chest Diseases
city: Izmir
country: Turkey
facility: Ege University Medical Faculty
city: Kocaeli
country: Turkey
facility: Kocaeli Universitesi Tip Fakultesi; Infectious Diseases
city: Kozyataği
country: Turkey
facility: Acibadem Kozyatagi Hospital; Gastroenterology
city: Kharkiv
country: Ukraine
facility: CHI Prof.O.O.Shalimov Kharkiv City Clinical Hospital #2
state: Kharkiv Governorate
city: Kharkiv
country: Ukraine
facility: CI of Healthcare Kharkiv Reg Clin Hosp-Center of Med Emergency & Accident Medicine
state: Kharkiv Governorate
city: Kyiv
country: Ukraine
facility: Medical Center of Limited Liability Company Medical Clinic Blagomed
state: KIEV Governorate
city: Kyiv
country: Ukraine
facility: Med Center of International Institute of Clinical Trials LLC; Medical Center "OK!Clinic+"
state: KIEV Governorate
city: Kyiv
country: Ukraine
facility: CI of Kyiv RC Regional Clinical Hospital #2
state: KIEV Governorate
city: Lviv
country: Ukraine
facility: Lviv Regional Clinical Hospital
state: KIEV Governorate
city: Ivano-Frankivsk
country: Ukraine
facility: Ivano-Frankivsk Regional Clinical Hospital
state: Kuban People's Republica
city: Chernivtsi
country: Ukraine
facility: RCNECRCH Dept of Surgery, SHEI Ukr BSMU
state: Podolia Governorate
city: Kremenchuk
country: Ukraine
facility: Kremenchuk first city hospital n.a. O.T. Bohaievskyi; Gastroenterology department
state: Poltava Governorate
city: Zaporizhzhia
country: Ukraine
facility: CI City Hospital #1
state: Tavria Okruha
city: Kharkiv
country: Ukraine
facility: GI L.T.Malaya Therapy National Institute of the NAMS of Ukraine
city: Kharkiv
country: Ukraine
facility: CHI Kharkiv City Clinical Hospital #13
city: Kyiv
country: Ukraine
facility: Kyiv CCH #18 Dept of Proctology O. O. Bogomolets NMU
city: Mykolaiv
country: Ukraine
facility: City Hospital #1
city: Odesa
country: Ukraine
facility: Railway Transport Odesa CH of Healthcare Ctr Branch of PJSC Ukrainian Railway Dept of Therapy #2
city: Vinnytsia
country: Ukraine
facility: Private Small Enterprise Medical Center Pulse
city: Vinnytsia
country: Ukraine
facility: M.I. Pyrogov VRCH Dept of Gastroenterology M.I. Pyrogov VNMU
city: Vinnytsia
country: Ukraine
facility: MCIC MC LLC Health Clinic
city: Zaporizhzhia
country: Ukraine
facility: LLC Diaservis
city: Belfast
country: United Kingdom
facility: Royal Victoria Hospital
city: Cambridge
country: United Kingdom
facility: Addenbrooke's Hospital
city: Coventry
country: United Kingdom
facility: University Hospital Coventry
city: Exeter
country: United Kingdom
facility: Royal Devon and Exeter Hospital (Wonford)
city: Kings Lynn
country: United Kingdom
facility: Queen Elizabeth Hospital
city: Leeds
country: United Kingdom
facility: St James University Hospital
city: Liverpool
country: United Kingdom
facility: Royal Liverpool University Hospital
city: London
country: United Kingdom
facility: Whipps Cross Hospital
city: London
country: United Kingdom
facility: University College London Hospital
city: Manchester
country: United Kingdom
facility: Fairfield General Hospital
city: Newcastle Upon Tyne
country: United Kingdom
facility: Royal Victoria Infirmary; Stroke unit
city: Nottingham
country: United Kingdom
facility: Nottingham University Hospitals Queen's Medical Centre
city: Reading
country: United Kingdom
facility: Royal Berkshire Hospital
city: Southampton
country: United Kingdom
facility: Southampton General Hospital
city: Wolverhampton
country: United Kingdom
facility: Royal Wolverhampton hospital; McHale Building
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
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.