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A Study to Assess Whether Etrolizumab is a Safe and Efficacious Treatment for Participants With Moderately to Severely Active Crohn's Disease (BERGAMOT)

Primary Purpose

Crohn Disease

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

About this trial

This is an interventional treatment trial for Crohn Disease

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Valley Gastroenterology Consultants
  • University of California San Diego Medical Center
  • VA Long Beach Healthcare System
  • Digestive Care Associates, A Medical Corporation
  • SDG Clinical Research
  • University of California at San Francisco (PARENT); Gastroenterology, Hepatology & Nutrition
  • Peak Gastroenterology Associates; Gastroenterology
  • Innovative Medical Research of South Florida
  • West Central Gastroenterology d/b/a Gastro Florida
  • University of Florida College of Medicine
  • Borland-Groover Clinic
  • IMIC, Inc
  • FQL Research, LLC
  • Advanced Research Institute, Inc.
  • Shafran Gastroenterology Center
  • Emory University Hospital
  • Atlanta Gastroenterology Associates
  • Gastrointestinal Diseases Research
  • Atlanta Center for Gastroenterology, PC
  • Gastroenterology Associates of Central Georgia
  • Gastrointestinal Specialists of Georgia, PC
  • Advanced Clinical Research
  • Northwestern University-Feinberg School of Medicine; Division of Gastroenterology and Hepatology
  • The University of Chicago Medical Center
  • Southwest Gastroenterology; DM Clinical Research
  • Carle Foundation Hospital
  • Cotton-O'Neil Clinical Research Center, Digestive Health
  • Gastroenterology Associates, LLC
  • Louisiana Research Center, LLC
  • Commonwealth Clinical Studies
  • University of Michigan Health System
  • Gastroenterology Associates of Western Michigan, P.L.C.
  • Center for Digestive Health
  • Henry Ford Health System
  • Mayo Clinic - Rochester; Gastrology
  • University of Mississippi Medical Center; Division of Gastroenterology
  • Ehrhardt Clinical Research, LLC
  • Concorde Medical Group
  • Weill Cornell Medical College (WCMC) - Judith Jaffe Multiple Sclerosis Center (JJMSC)
  • Lenox Hill Hospital
  • University of North Carolina At Chapel Hill
  • Charlotte Gastroenterology and Hepatology, P.L.L.C
  • Kinston Medical Specialists
  • Consultants for Clinical Research Inc.
  • Great Lakes Gastroenterology Research, LLC
  • Digestive Disease Specialists, Inc.
  • Great Lakes Medical Research, LLC
  • Innovative Clinical Research
  • Gastroenterology Center of the MidSouth PC
  • Vanderbilt University Medical Center
  • Texas Digestive Disease Consultants - Dallas
  • University of Texas Southwestern Medical Center; Internal Medicne
  • Baylor College of Medicine; Gastroenterology
  • Methodist Hospital Research Institute
  • Wellness Clinical Research Center
  • Texas Digestive Disease Consultants - Southlake
  • Tyler Research Institute, LLC
  • Ericksen Research and Development
  • University of Utah School of Medicine
  • McGuire Research Institute; Gastroenterology
  • Digestive Disease Institute; Virginia Mason Medical Center
  • University of Wisconsin
  • Hospital Italiano
  • The Canberra Hospital
  • Bankstown-Lidcombe Hospital
  • Concord Repatriation General Hospital
  • Royal Brisbane and Women's Hospital
  • University of the Sunshine Coast
  • Mater Adult Hospital
  • Princess Alexandra Hospital
  • Flinders Medical Centre
  • Monash Medical Centre Clayton
  • St Vincent's Hospital Melbourne
  • Footscray Hospital; Gastroenterology
  • St Frances Xavier Cabrini Hospital
  • Alfred Hospital
  • Royal Melbourne Hospital; Department of Colorectal Medicine and Genetics
  • Fiona Stanley Hospital
  • LKH - Universitätsklinikum der PMU Salzburg
  • Medizinische Universität Wien
  • CHU St Pierre (St Pierre)
  • UZ Brussel
  • Hospital Erasme
  • UZ Antwerpen
  • AZ Maria Middelares
  • L2IP -Instituto de Pesquisas Clínicas Ltda.
  • Instituto Goiano de Gastroenterologia e Endoscopia Digestiva Ltda
  • Hospital Felicio Rocho
  • Centro Digestivo de Curitiba
  • Hospital Universitario Clementino Fraga Filho - UFRJ; Gastroenterologia
  • Instituto Brasil de Pesquisa Clínica-IBPCLIN S/A
  • Hospital São Vicente de Paulo; Institute of Education and Reseach / Cardiovascular Research Unit
  • Hospital das Clinicas - UFRGS
  • Hospital Ernesto Dornelles
  • UNESP - Faculdade de Medicina da Universidade Estadual Paulista - Campus Botucatu
  • Pesquisare Saúde Sociedade Simples
  • Praxis Pesquisa Médica
  • Hospital Estadual Mario Covas
  • Hospital de Base de Sao Jose do Rio Preto
  • Hospital Sírio-Libanês
  • Hospital Sao Paulo
  • Hospital do Servidor Público Estadual/HSPE-SP
  • "City Clinic UMHAC" EOOD
  • UMHAT "Sv. Ivan Rilski", EAD
  • UMHAT Tsaritsa Yoanna - ISUL, EAD
  • University of Calgary
  • Zeidler Ledcor Centre - University of Alberta; Division of Gasroenterology
  • (G.I.R.I.) GI Research Institute
  • Winnipeg Regional Health Authority
  • Queen Elizabeth II Health Sciences Centre; Gastroenterology Research
  • University Hospital - London Health Sciences Centre
  • Taunton Health Centre
  • The Ottawa Hospital - Riverside Campus; Gastrointestinal Clinical Research Unit
  • Mount Sinai Hospital
  • Toronto Digestive Disease Associates
  • Hôpital Maisonneuve - Rosemont
  • McGill University Health Centre - Glen Site
  • Royal University Hospital
  • Clinical Hospital Centre Osijek
  • General Hospital Pula
  • Clinical Hospital Center Sestre Milosrdnice
  • University Hospital Center Zagreb
  • Vojenska nemocnice Brno
  • Fakultni nemocnice u sv. Anny v Brne
  • Nemocnice Ceske Budejovice a.s.
  • Gastroenterologie s.r.o.
  • Fakultni nemocnice Hradec Kralove
  • Hepato-Gastroenterologie HK, s.r.o.
  • PreventaMed, s.r.o.
  • Fakultni nemocnice Ostrava
  • Klinicke centrum ISCARE Lighthouse
  • Fakultni nemocnice Kralovske Vinohrady
  • West Tallinn Central Hospital
  • North Estonia Medical Centre Foundation
  • Tartu University Hospital
  • CHU Amiens - Hopital Sud
  • CHU de Caen - Hopital Cote de Nacre
  • Hôpital Beaujon
  • Hopital Claude Huriez - CHU Lille
  • CHU NANTES - Hôtel Dieu; Pharmacy
  • CHU Nice - Hopital de l'Archet 2
  • Hôpital Saint-Louis
  • Groupe Hospitalier Sud - Hôpital Haut-Lévêque - USN
  • Centre Hospitalier Lyon Sud; Service de Gastro-Enterologie
  • CHU du Reims - Hopital Robert Debré
  • CHU Rennes - Hopital Pontchaillou
  • CHU Saint Etienne - Hôpital Nord
  • Höpital Hautepierre; Pediatrie1
  • Hôpital de Brabois Adultes
  • Charite-Campus Virchow Klinikum; Hepatologie und Gastroenterologie
  • Krankenhaus Waldfriede e. V.
  • Berufsgenossenschaftliches Universitaetsklinikum Bergmannsheil GmbH
  • Klinikum der Johann Wolfgang Goethe-Universitaet
  • Universitaetsklinikum Halle (Saale)
  • Medizinische Hochschule Hannover; Gastroenterology and Hepatology dept
  • Universitätsklinikum Koeln
  • Klinikum Mannheim GmbH Universitätsklinikum
  • Gemeinschaftspraxis
  • Universitaetsklinikum Tuebingen
  • Universitaetsklinikum Ulm
  • Bekes Megyei Kozponti Korhaz Dr. Rethy Pal Tagkorhaza
  • Obudai Egeszsegugyi Centrum Kft.
  • Semmelweis Egyetem
  • Eszak-Kozep-budai Centrum, Uj Szent Janos Korhaz es Szakrendelo
  • Pannonia Maganorvosi Centrum
  • Debreceni Egyetem
  • Petz Aladar Megyei Oktato Korhaz
  • Pest Megyei Flor Ferenc Korhaz
  • Pecsi Tudomanyegyetem
  • Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz
  • Haemek Medical Center
  • Soroka University Medical Centre
  • Wolfson Medical Center; Obstetrics and Gynecology
  • Shaare Zedek Medical Center
  • Hadassah University Hospital - Ein Kerem
  • Holy Family Hospital
  • Rabin Medical Center-Beilinson Campus
  • Tel Aviv Sourasky Medical Center; Pharmacy
  • A.O.U. Policlinico di Modena
  • Azienda Ospedaliera San Camillo Forlanini
  • Policlinico Universitario Agostino Gemelli; Farmacia
  • Asst Fatebenefratelli Sacco (Fatebenefratelli)
  • ASST FATEBENEFRATELLI SACCO (Sacco)
  • Azienda Socio Sanitaria Territoriale Niguarda (Grande Ospedale Metropolitano Niguarda)
  • Istituto Clinico Humanitas
  • I.R.C.C.S Policlinico San Donato
  • Ospedale Umberto I di Torino
  • Azienda Ospedaliera Universitaria Careggi
  • Inje University Busan Paik Hospital
  • Dong-A University Hospital
  • Pusan National University Hospital
  • Kyungpook National University Hospital
  • Yeungnam Univ. Hospital
  • Hanyang University Guri Hospital
  • Korea University Ansan Hospital
  • Seoul National University Bundang Hospital
  • CHA Bundang Medical Centre; CHA university
  • Seoul National University Hospital
  • Kangbuk Samsung Hospital
  • Severance Hospital, Yonsei University Health System
  • Asan Medical Center
  • Samsung Medical Center
  • Yonsei University Wonju Severance Christian Hospital
  • Riga East Clinical University Hospital; Clinic Gailezers
  • Pauls Stradins Clinical University Hospital
  • Hospital of Lithuanian University of Health. Sciences Kaunas Clinics
  • Vilnius University Hospital Santariskiu Clinic, Public Institution; Cardiology
  • Clinical Research Institute
  • Medical Care & Research SA de CV
  • Amsterdam UMC, Locatie VUMC; Neurology
  • Amsterdam UMC Location AMC
  • Leids Universitair Medisch Centrum
  • Maastricht University Medical Center
  • Erasmus Medisch Centrum
  • Zuyderland Medisch Centrum - Sittard Geleen
  • ETZ TweeSteden
  • North Shore Hospital
  • Christchurch Hospital NZ
  • Dunedin Public Hospital
  • Waikato Hospital
  • Shakespeare Specialist Group
  • Tauranga Hospital
  • SP ZOZ Wojewodzki Szpital Zespolony im. J. Sniadeckiego
  • Nasz Lekarz Osrodek Badan Klinicznych
  • Elblaski Szpital Specjalistyczny z Przychodnia SP ZOZ
  • ETG Kielce
  • Centrum Opieki Zdrowotnej Orkan-Med
  • Indywidualna Specjalistyczna Praktyka Lekarska
  • Allmedica Badania Kliniczne Sp z o.o. Sp K.
  • Centrum Medyczne "MEDYK"
  • Gabinet Lekarski, Bartosz Korczowski
  • Specjalistyczna Praktyka Lekarska Dr med. Marek Horynski; endoskopia
  • Niepubliczny Zaklad Opieki Zdrowotnej SONOMED
  • Twoja Przychodnia-Szczecinskie Centrum Medyczne
  • Gastromed Kopon Zmudzinski i Wspolnicy Sp.j.Specjalistyczne Centrum Gastrologii i Endoskopii Specj
  • Centrum Zdrowia MDM
  • Warsaw IBD Point Profesor Kierkus
  • Zespó Przychodni Specjalistycznych PRIMA
  • LexMedica Osrodek Badan Klinicznych
  • EuroMediCare Szpital Specjalistyczny z Przychodnią we Wrocławiu
  • PlanetMed sp. z o.o.
  • Spitalul Clinic Colentina
  • S.C MedLife S.A
  • Centrul de Gastroenterologie Dr. Goldis
  • Yusupov Hospital
  • LLC "Novosibirsk GastroCenter"
  • Baltic Medicine
  • North-Western Medical University n.a. I.I. Mechnikov; Rheumatology
  • SBIH City Clinical Hospital #31
  • SBEI HPE Altai StateMedicalUniversityofMoH andSD
  • Irkutsk State Medical Academy of Continuing Education
  • SBEIHPE Novosibirsk State Medical University
  • BHI of Omsk region Clinical Oncology Dispensary
  • Evromedservis LCC
  • SEIHPE "Rostov SMU of MoH of RF"
  • Federal State Military Educational Institution; High Professional Education Military Medical Acad
  • Clinical Helth Centre Zvezdara
  • Military Medical Academy
  • University Hospital Medical Center Bezanijska kosa
  • Clinical Center of Vojvodina
  • General Hospital Djordje Joanovic
  • IBDcentrum s.r.o.
  • KM Management spol. s r.o.
  • Endomed, s.r.o.
  • Accout Center s.r.o.
  • Dr D Epstein Practice
  • Emmed Research
  • Hospital Universitario de Bellvitge
  • Hospital Universitario Puerta de Hierro Majadahonda; Hepatology studies
  • Hospital Clínic i Provincial; Servicio de Farmacia
  • Centro Médico Teknon
  • Hospital Reina Sofia; Medical Oncology
  • Hospital Juan Ramón Jiménez
  • Hospital Universitario de la Princesa
  • Hospital Universitario La Paz
  • Hospital Universitario de Fuenlabrada
  • Complejo Hospitalario de Pontevedra
  • Hospital Universitario Virgen Macarena
  • Hospital Universitario Virgen del Rocio
  • Hospital Universitari i Politecnic La Fe
  • Hospital Universitario Miguel Servet
  • Inselspital-Universitaetsspital Bern
  • Crohn-Colitis Zentrum Bern - Gemeinschaftspraxis Balsiger, Seibold und Partner
  • Universitätsspital Zürich
  • Ankara University Medical Faculty
  • Hacettepe University Medical Faculty; Gastroenterology
  • Gazi University Medical Faculty
  • Acibadem Fulya Hospital; Neurology
  • Haydarpasa Numune Training and Research Hospital; Medical Oncology
  • Medeniyet University Goztepe Training and Research Hospital; Chest Diseases
  • Ege University Medical Faculty
  • Kocaeli Universitesi Tip Fakultesi; Infectious Diseases
  • Acibadem Kozyatagi Hospital; Gastroenterology
  • CHI Prof.O.O.Shalimov Kharkiv City Clinical Hospital #2
  • CI of Healthcare Kharkiv Reg Clin Hosp-Center of Med Emergency & Accident Medicine
  • Medical Center of Limited Liability Company Medical Clinic Blagomed
  • Med Center of International Institute of Clinical Trials LLC; Medical Center "OK!Clinic+"
  • CI of Kyiv RC Regional Clinical Hospital #2
  • Lviv Regional Clinical Hospital
  • Ivano-Frankivsk Regional Clinical Hospital
  • RCNECRCH Dept of Surgery, SHEI Ukr BSMU
  • Kremenchuk first city hospital n.a. O.T. Bohaievskyi; Gastroenterology department
  • CI City Hospital #1
  • GI L.T.Malaya Therapy National Institute of the NAMS of Ukraine
  • CHI Kharkiv City Clinical Hospital #13
  • Kyiv CCH #18 Dept of Proctology O. O. Bogomolets NMU
  • City Hospital #1
  • Railway Transport Odesa CH of Healthcare Ctr Branch of PJSC Ukrainian Railway Dept of Therapy #2
  • Private Small Enterprise Medical Center Pulse
  • M.I. Pyrogov VRCH Dept of Gastroenterology M.I. Pyrogov VNMU
  • MCIC MC LLC Health Clinic
  • LLC Diaservis
  • Royal Victoria Hospital
  • Addenbrooke's Hospital
  • University Hospital Coventry
  • Royal Devon and Exeter Hospital (Wonford)
  • Queen Elizabeth Hospital
  • St James University Hospital
  • Royal Liverpool University Hospital
  • Whipps Cross Hospital
  • University College London Hospital
  • Fairfield General Hospital
  • Royal Victoria Infirmary; Stroke unit
  • Nottingham University Hospitals Queen's Medical Centre
  • Royal Berkshire Hospital
  • Southampton General Hospital
  • Royal Wolverhampton hospital; McHale Building

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm 10

Arm 11

Arm Type

Experimental

Experimental

Placebo Comparator

Experimental

Experimental

Experimental

Experimental

Placebo Comparator

Placebo Comparator

Placebo Comparator

Experimental

Arm Label

Induction Phase - Cohort 1 (Exploratory): Etrolizumab 210 mg

Induction Phase - Cohort 1 (Exploratory): Etrolizumab 105 mg

Induction Phase - Cohort 1 (Exploratory): Placebo

Induction Phase - Cohort 2 (Open-Label): Etrolizumab 210 mg

Induction Phase - Cohort 2 (Open-Label): Etrolizumab 105 mg

Induction Phase - Cohort 3 (Pivotal): Etrolizumab 210 mg

Induction Phase - Cohort 3 (Pivotal): Etrolizumab 105 mg

Induction Phase - Cohort 3 (Pivotal): Placebo

Maintenance Phase - Placebo Responders: Placebo

Maintenance Phase - Etrolizumab Responders: Placebo

Maintenance Phase - Etrolizumab Responders: Etrolizumab 105 mg

Arm Description

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

Outcomes

Primary Outcome Measures

Induction Phase: Cohort 1: Percentage of Participants With Clinical Remission at Week 14
Clinical remission is defined as liquid/soft stool frequency (SF) mean daily score less than or equal (≤)3 and abdominal pain mean daily score ≤1, with no worsening in either subscore compared to baseline, averaged over the 7 days prior to visit.
Induction Phase: Cohort 2 and 3: Percentage of Participants With Clinical Remission at Week 14
Clinical remission is defined as liquid/soft stool frequency (SF) mean daily score less than or equal (≤)3 and abdominal pain mean daily score ≤1, with no worsening in either subscore compared to baseline, averaged over the 7 days prior to visit.
Induction Phase: Cohort 1: Percentage of Participants With Endoscopic Improvement at Week 14
Endoscopic improvement is defined as 50 percent (%) reduction from baseline in Simplified Endoscopic Index for Crohn's Disease (SES-CD) score.
Induction Phase: Cohort 2 and 3: Percentage of Participants With Endoscopic Improvement at Week 14
Endoscopic improvement is defined as 50 percent (%) reduction from baseline in Simplified Endoscopic Index for Crohn's Disease (SES-CD) score.
Maintenance Phase: Percentage of Participants With Clinical Remission at Week 66
Clinical remission is defined as SF mean daily score ≤3 and abdominal pain mean daily score ≤1, with no worsening in either subscore compared to baseline, averaged over the 7 days prior to visit. Maintenance phase participants were evaluated.
Maintenance Phase: Percentage of Participants With Endoscopic Improvement at Week 66
Endoscopic improvement is defined as 50% reduction from baseline in SES-CD score. Maintenance phase participants were evaluated.

Secondary Outcome Measures

Induction Phase: Cohort 1: Percentage of Participants With Clinical Remission at Week 6
Clinical remission is defined as SF mean daily score ≤3 and abdominal pain mean daily score ≤1, with no worsening in either subscore compared to baseline, averaged over the 7 days prior to visit.
Induction Phase: Cohort 2 and 3: Percentage of Participants With Clinical Remission at Week 6
Clinical remission is defined as SF mean daily score ≤3 and abdominal pain mean daily score ≤1, with no worsening in either subscore compared to baseline, averaged over the 7 days prior to visit.
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
Endoscopic Remission is defined as SES-CD total score <=4 (<=2 for ileal only patients), with no segment having a subcategory score >1. SES-CD = Simple Endoscopic Score for Crohn's Disease. A composite of four assessments, each rated from 0 to 3: size of ulcers, proportion of the surface covered by ulcers, proportion of the surface with any other lesions, and presence of narrowings (stenosis). The SES-CD total score ranges from 0 to 60, a higher score indicates worse disease activity.
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
Endoscopic Remission is defined as SES-CD total score <=4 (<=2 for ileal only patients), with no segment having a subcategory score >1. SES-CD = Simple Endoscopic Score for Crohn's Disease. A composite of four assessments, each rated from 0 to 3: size of ulcers, proportion of the surface covered by ulcers, proportion of the surface with any other lesions, and presence of narrowings (stenosis). The SES-CD total score ranges from 0 to 60, a higher score indicates worse disease activity.
Induction Phase: Cohort 1: Change From Baseline in Crohn's Disease-Patient-Reported Outcome Signs and Symptoms (CD-PRO/SS) Score at Week 14
CD-PRO/SS: Crohn's Disease Patient Reported Outcomes Signs and Symptoms. For each item, the score is taken as the average across 4-7 days eDiary data within a 9 day window from visit, else the score is considered missing. The CD-PRO/SS Bowel domain is a total score summed across 3 items and ranges from 0 - 16. The Functional domain score is a total score summed across 3 items and ranges from 0 - 12. A higher CD-PRO/SS score indicates worse quality of life. Participants are included in the analysis if they have both Baseline and at least one post-baseline score available.
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
CD-PRO/SS: Crohn's Disease Patient Reported Outcomes Signs and Symptoms. For each item, the score is taken as the average across 4-7 days eDiary data within a 9 day window from visit, else the score is considered missing. The CD-PRO/SS Bowel domain is a total score summed across 3 items and ranges from 0 - 16. The Functional domain score is a total score summed across 3 items and ranges from 0 - 12. A higher CD-PRO/SS score indicates worse quality of life. Participants are included in the analysis if they have both Baseline and at least one post-baseline score available.
Maintenance Phase: Percentage of Participants With Clinical Remission at Week 66, Among Those Who Achieved Clinical Remission at Week 14
Clinical remission is defined as SF mean daily score ≤3 and abdominal pain mean daily score ≤1, with no worsening in either subscore compared to baseline, averaged over the 7 days prior to visit. Induction Phase Cohorts are not included
Maintenance Phase: Percentage of Participants With Corticosteroid-Free Clinical Remission at Week 66, Among Those Who Were Receiving Corticosteroids at Baseline
Clinical remission is defined as SF mean daily score ≤3 and abdominal pain mean daily score ≤1, with no worsening in either subscore compared to baseline, averaged over the 7 days prior to visit. Induction Phase Cohorts are not included
Maintenance Phase: Percentage of Participants With Endoscopic Improvement at Week 66 Among Participants Who Achieved Endoscopic Improvement at Week 14
Endoscopic improvement is defined as 50% reduction from baseline in SES-CD score. Induction Phase Cohorts are not included
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
Endoscopic Remission is defined as SES-CD total score <=4 (<=2 for ileal only patients), with no segment having a subcategory score >1. SES-CD = Simple Endoscopic Score for Crohn's Disease. A composite of four assessments, each rated from 0 to 3: size of ulcers, proportion of the surface covered by ulcers, proportion of the surface with any other lesions, and presence of narrowings (stenosis). The SES-CD total score ranges from 0 to 60, a higher score indicates worse disease activity.
Maintenance Phase: Percentage of Participants With Durable Clinical Remission
Clinical remission is defined as SF mean daily score ≤3 and abdominal pain mean daily score ≤1, with no worsening in either subscore compared to baseline, averaged over the 7 days prior to visit. Durable clinical remission was defined as clinical remission at ≥4 of the 6 in-clinic assessment visits conducted during the Maintenance Phase at Weeks 24, 28, 32, 44, 56, and 66. Induction Phase Cohorts are not included
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
Clinical remission is defined as SF mean daily score ≤3 and abdominal pain mean daily score ≤1, with no worsening in either subscore compared to baseline, averaged over the 7 days prior to visit. Percentage of participants with clinical remission who will be off corticosteroids for at least 24 weeks prior to Week 66 will be reported. Induction Phase Cohorts are not included
Maintenance Phase: Change From Baseline in CD-PRO/SS Score at Week 66
CD-PRO/SS: Crohn's Disease Patient Reported Outcomes Signs and Symptoms. For each item, the score is taken as the average across 4-7 days eDiary data within a 9 day window from visit, else the score is considered missing. The CD-PRO/SS Bowel domain is a total score summed across 3 items and ranges from 0 - 16. The Functional domain score is a total score summed across 3 items and ranges from 0 - 12. A higher CD-PRO/SS score indicates worse quality of life. Participants are included in the analysis if they have both Baseline and at least one post-baseline score available.
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)
Investigator text for AEs is coded using MedDRA version 24.0. For participants counts, multiple occurrences of AEs in the same category for an individual are counted only once. For event counts, multiple occurrences of AEs in the same category for an individual are counted separately. Severity Grades from 1 to 5.
Overall Number of Participants With Adverse Events Leading to Study Drug Discontinuation
Number of participants who discontinued the study due to the adverse events is reported.
Overall Number of Participants Who Experienced at Least One Infection-Related Adverse Event by Severity, According to NCI-CTCAE v4.0
Participants who Experienced at Least One Infection-Related Adverse Event by Severity, According to NCI-CTCAE v4.0 are reported. 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 indicated; disabling; or limiting self-care activities of daily living. Grade 4 = life-threatening consequences or urgent intervention indicated. Grade 5 = Death. The terms 'severe' and 'serious' are not synonymous and are independently assessed for each AE. Multiple occurrences of AEs are counted only once per participant at the highest (worst) grade. Infections are identified by Primary System Organ Class term 'Infections and Infestations'
Overall Number of Participants Who Experienced at Least One Infection-Related Serious Adverse Event
Investigator text for AEs is coded using MedDRA version 24.0. Infections are identified by primary System Organ Class term 'Infections and Infestations'. The terms 'severe' and 'serious' are not synonymous and are independently assessed for each AE. Multiple occurrences of AEs in the same category for an individual are counted only once
Overall Number of Participants Who Experienced at Least One Injection-Site Reaction by Severity, According to NCI-CTCAE v4.0
Investigator test for AEs is coding using MedDRA version 24.0. Injection-Site Reactions are identified by eCRF checkbox for local injection site reactions, and/or primary or secondary HLT Injection Site Reactions. Multiple occurrences of AEs for an individual are counted only once, under the worst grade reported.
Overall Number of Participants Who Experienced at Least One Hypersensitivity Reaction by Severity, According to NCI-CTCAE v4.0
Investigator text for AEs is coded using MedDRA version 24.0. Multiple occurrences of AEs for an individual are counted only once, under the worst grade reported.
Overall Number of Participants Who Develop Malignancies
Participants with malignancies are reported. 'Malignancies are identified by SMQ Malignant and unspecified tumors (narrow)
Percentage of Participants With Anti-Therapeutic Antibodies (ATAs) to Etrolizumab
Participants who received at least one dose of study treatment and had at least one baseline or post-baseline ATA result. Induction: treatment groups were pooled across cohorts 1-3. Maintenance: treatment group is stratified by induction dose
Observed Trough Serum Concentration (Ctrough) of Etrolizumab
Serum Etrolizumab Trough Concentration

Full Information

First Posted
February 27, 2015
Last Updated
October 21, 2022
Sponsor
Hoffmann-La Roche
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1. Study Identification

Unique Protocol Identification Number
NCT02394028
Brief Title
A Study to Assess Whether Etrolizumab is a Safe and Efficacious Treatment for Participants With Moderately to Severely Active Crohn's Disease
Acronym
BERGAMOT
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

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
March 20, 2015 (Actual)
Primary Completion Date
September 7, 2021 (Actual)
Study Completion Date
September 7, 2021 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
1035 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Induction Phase - Cohort 1 (Exploratory): Etrolizumab 210 mg
Arm Type
Experimental
Arm Description
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.
Arm Title
Induction Phase - Cohort 1 (Exploratory): Etrolizumab 105 mg
Arm Type
Experimental
Arm Description
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.
Arm Title
Induction Phase - Cohort 1 (Exploratory): Placebo
Arm Type
Placebo Comparator
Arm Description
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.
Arm Title
Induction Phase - Cohort 2 (Open-Label): Etrolizumab 210 mg
Arm Type
Experimental
Arm Description
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.
Arm Title
Induction Phase - Cohort 2 (Open-Label): Etrolizumab 105 mg
Arm Type
Experimental
Arm Description
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.
Arm Title
Induction Phase - Cohort 3 (Pivotal): Etrolizumab 210 mg
Arm Type
Experimental
Arm Description
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.
Arm Title
Induction Phase - Cohort 3 (Pivotal): Etrolizumab 105 mg
Arm Type
Experimental
Arm Description
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.
Arm Title
Induction Phase - Cohort 3 (Pivotal): Placebo
Arm Type
Placebo Comparator
Arm Description
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.
Arm Title
Maintenance Phase - Placebo Responders: Placebo
Arm Type
Placebo Comparator
Arm Description
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.
Arm Title
Maintenance Phase - Etrolizumab Responders: Placebo
Arm Type
Placebo Comparator
Arm Description
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.
Arm Title
Maintenance Phase - Etrolizumab Responders: Etrolizumab 105 mg
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Etrolizumab
Other Intervention Name(s)
RO5490261, RG7413
Intervention Description
Etrolizumab will be administered as per regimen specified in individual arms.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Etrolizumab-matching placebo will be administered as per regimen specified in individual arms.
Primary Outcome Measure Information:
Title
Induction Phase: Cohort 1: Percentage of Participants With Clinical Remission at Week 14
Description
Clinical remission is defined as liquid/soft stool frequency (SF) mean daily score less than or equal (≤)3 and abdominal pain mean daily score ≤1, with no worsening in either subscore compared to baseline, averaged over the 7 days prior to visit.
Time Frame
Week 14
Title
Induction Phase: Cohort 2 and 3: Percentage of Participants With Clinical Remission at Week 14
Description
Clinical remission is defined as liquid/soft stool frequency (SF) mean daily score less than or equal (≤)3 and abdominal pain mean daily score ≤1, with no worsening in either subscore compared to baseline, averaged over the 7 days prior to visit.
Time Frame
Week 14
Title
Induction Phase: Cohort 1: Percentage of Participants With Endoscopic Improvement at Week 14
Description
Endoscopic improvement is defined as 50 percent (%) reduction from baseline in Simplified Endoscopic Index for Crohn's Disease (SES-CD) score.
Time Frame
Week 14
Title
Induction Phase: Cohort 2 and 3: Percentage of Participants With Endoscopic Improvement at Week 14
Description
Endoscopic improvement is defined as 50 percent (%) reduction from baseline in Simplified Endoscopic Index for Crohn's Disease (SES-CD) score.
Time Frame
Week 14
Title
Maintenance Phase: Percentage of Participants With Clinical Remission at Week 66
Description
Clinical remission is defined as SF mean daily score ≤3 and abdominal pain mean daily score ≤1, with no worsening in either subscore compared to baseline, averaged over the 7 days prior to visit. Maintenance phase participants were evaluated.
Time Frame
Baseline and Week 66
Title
Maintenance Phase: Percentage of Participants With Endoscopic Improvement at Week 66
Description
Endoscopic improvement is defined as 50% reduction from baseline in SES-CD score. Maintenance phase participants were evaluated.
Time Frame
Week 66
Secondary Outcome Measure Information:
Title
Induction Phase: Cohort 1: Percentage of Participants With Clinical Remission at Week 6
Description
Clinical remission is defined as SF mean daily score ≤3 and abdominal pain mean daily score ≤1, with no worsening in either subscore compared to baseline, averaged over the 7 days prior to visit.
Time Frame
Week 6
Title
Induction Phase: Cohort 2 and 3: Percentage of Participants With Clinical Remission at Week 6
Description
Clinical remission is defined as SF mean daily score ≤3 and abdominal pain mean daily score ≤1, with no worsening in either subscore compared to baseline, averaged over the 7 days prior to visit.
Time Frame
Week 6
Title
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
Description
Endoscopic Remission is defined as SES-CD total score <=4 (<=2 for ileal only patients), with no segment having a subcategory score >1. SES-CD = Simple Endoscopic Score for Crohn's Disease. A composite of four assessments, each rated from 0 to 3: size of ulcers, proportion of the surface covered by ulcers, proportion of the surface with any other lesions, and presence of narrowings (stenosis). The SES-CD total score ranges from 0 to 60, a higher score indicates worse disease activity.
Time Frame
Week 14
Title
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
Description
Endoscopic Remission is defined as SES-CD total score <=4 (<=2 for ileal only patients), with no segment having a subcategory score >1. SES-CD = Simple Endoscopic Score for Crohn's Disease. A composite of four assessments, each rated from 0 to 3: size of ulcers, proportion of the surface covered by ulcers, proportion of the surface with any other lesions, and presence of narrowings (stenosis). The SES-CD total score ranges from 0 to 60, a higher score indicates worse disease activity.
Time Frame
Week 14
Title
Induction Phase: Cohort 1: Change From Baseline in Crohn's Disease-Patient-Reported Outcome Signs and Symptoms (CD-PRO/SS) Score at Week 14
Description
CD-PRO/SS: Crohn's Disease Patient Reported Outcomes Signs and Symptoms. For each item, the score is taken as the average across 4-7 days eDiary data within a 9 day window from visit, else the score is considered missing. The CD-PRO/SS Bowel domain is a total score summed across 3 items and ranges from 0 - 16. The Functional domain score is a total score summed across 3 items and ranges from 0 - 12. A higher CD-PRO/SS score indicates worse quality of life. Participants are included in the analysis if they have both Baseline and at least one post-baseline score available.
Time Frame
Baseline and Week 14
Title
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
Description
CD-PRO/SS: Crohn's Disease Patient Reported Outcomes Signs and Symptoms. For each item, the score is taken as the average across 4-7 days eDiary data within a 9 day window from visit, else the score is considered missing. The CD-PRO/SS Bowel domain is a total score summed across 3 items and ranges from 0 - 16. The Functional domain score is a total score summed across 3 items and ranges from 0 - 12. A higher CD-PRO/SS score indicates worse quality of life. Participants are included in the analysis if they have both Baseline and at least one post-baseline score available.
Time Frame
Baseline and Week 14
Title
Maintenance Phase: Percentage of Participants With Clinical Remission at Week 66, Among Those Who Achieved Clinical Remission at Week 14
Description
Clinical remission is defined as SF mean daily score ≤3 and abdominal pain mean daily score ≤1, with no worsening in either subscore compared to baseline, averaged over the 7 days prior to visit. Induction Phase Cohorts are not included
Time Frame
Baseline, Weeks 14 and 66
Title
Maintenance Phase: Percentage of Participants With Corticosteroid-Free Clinical Remission at Week 66, Among Those Who Were Receiving Corticosteroids at Baseline
Description
Clinical remission is defined as SF mean daily score ≤3 and abdominal pain mean daily score ≤1, with no worsening in either subscore compared to baseline, averaged over the 7 days prior to visit. Induction Phase Cohorts are not included
Time Frame
Baseline and Week 66
Title
Maintenance Phase: Percentage of Participants With Endoscopic Improvement at Week 66 Among Participants Who Achieved Endoscopic Improvement at Week 14
Description
Endoscopic improvement is defined as 50% reduction from baseline in SES-CD score. Induction Phase Cohorts are not included
Time Frame
Baseline, Weeks 14 and 66
Title
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
Description
Endoscopic Remission is defined as SES-CD total score <=4 (<=2 for ileal only patients), with no segment having a subcategory score >1. SES-CD = Simple Endoscopic Score for Crohn's Disease. A composite of four assessments, each rated from 0 to 3: size of ulcers, proportion of the surface covered by ulcers, proportion of the surface with any other lesions, and presence of narrowings (stenosis). The SES-CD total score ranges from 0 to 60, a higher score indicates worse disease activity.
Time Frame
Week 66
Title
Maintenance Phase: Percentage of Participants With Durable Clinical Remission
Description
Clinical remission is defined as SF mean daily score ≤3 and abdominal pain mean daily score ≤1, with no worsening in either subscore compared to baseline, averaged over the 7 days prior to visit. Durable clinical remission was defined as clinical remission at ≥4 of the 6 in-clinic assessment visits conducted during the Maintenance Phase at Weeks 24, 28, 32, 44, 56, and 66. Induction Phase Cohorts are not included
Time Frame
Week 14 up to Week 66 (assessed at Weeks 24, 28, 32, 44, 56, and 66)
Title
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
Description
Clinical remission is defined as SF mean daily score ≤3 and abdominal pain mean daily score ≤1, with no worsening in either subscore compared to baseline, averaged over the 7 days prior to visit. Percentage of participants with clinical remission who will be off corticosteroids for at least 24 weeks prior to Week 66 will be reported. Induction Phase Cohorts are not included
Time Frame
Baseline and from Week 14 up to Week 66
Title
Maintenance Phase: Change From Baseline in CD-PRO/SS Score at Week 66
Description
CD-PRO/SS: Crohn's Disease Patient Reported Outcomes Signs and Symptoms. For each item, the score is taken as the average across 4-7 days eDiary data within a 9 day window from visit, else the score is considered missing. The CD-PRO/SS Bowel domain is a total score summed across 3 items and ranges from 0 - 16. The Functional domain score is a total score summed across 3 items and ranges from 0 - 12. A higher CD-PRO/SS score indicates worse quality of life. Participants are included in the analysis if they have both Baseline and at least one post-baseline score available.
Time Frame
Baseline and Week 66
Title
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)
Description
Investigator text for AEs is coded using MedDRA version 24.0. For participants counts, multiple occurrences of AEs in the same category for an individual are counted only once. For event counts, multiple occurrences of AEs in the same category for an individual are counted separately. Severity Grades from 1 to 5.
Time Frame
From Baseline up to Week 78
Title
Overall Number of Participants With Adverse Events Leading to Study Drug Discontinuation
Description
Number of participants who discontinued the study due to the adverse events is reported.
Time Frame
From Baseline up to Week 78
Title
Overall Number of Participants Who Experienced at Least One Infection-Related Adverse Event by Severity, According to NCI-CTCAE v4.0
Description
Participants who Experienced at Least One Infection-Related Adverse Event by Severity, According to NCI-CTCAE v4.0 are reported. 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 indicated; disabling; or limiting self-care activities of daily living. Grade 4 = life-threatening consequences or urgent intervention indicated. Grade 5 = Death. The terms 'severe' and 'serious' are not synonymous and are independently assessed for each AE. Multiple occurrences of AEs are counted only once per participant at the highest (worst) grade. Infections are identified by Primary System Organ Class term 'Infections and Infestations'
Time Frame
From Baseline up to Week 78
Title
Overall Number of Participants Who Experienced at Least One Infection-Related Serious Adverse Event
Description
Investigator text for AEs is coded using MedDRA version 24.0. Infections are identified by primary System Organ Class term 'Infections and Infestations'. The terms 'severe' and 'serious' are not synonymous and are independently assessed for each AE. Multiple occurrences of AEs in the same category for an individual are counted only once
Time Frame
From Baseline up to Week 78
Title
Overall Number of Participants Who Experienced at Least One Injection-Site Reaction by Severity, According to NCI-CTCAE v4.0
Description
Investigator test for AEs is coding using MedDRA version 24.0. Injection-Site Reactions are identified by eCRF checkbox for local injection site reactions, and/or primary or secondary HLT Injection Site Reactions. Multiple occurrences of AEs for an individual are counted only once, under the worst grade reported.
Time Frame
From Baseline up to Week 78
Title
Overall Number of Participants Who Experienced at Least One Hypersensitivity Reaction by Severity, According to NCI-CTCAE v4.0
Description
Investigator text for AEs is coded using MedDRA version 24.0. Multiple occurrences of AEs for an individual are counted only once, under the worst grade reported.
Time Frame
From Baseline up to Week 78
Title
Overall Number of Participants Who Develop Malignancies
Description
Participants with malignancies are reported. 'Malignancies are identified by SMQ Malignant and unspecified tumors (narrow)
Time Frame
From Baseline up to Week 78
Title
Percentage of Participants With Anti-Therapeutic Antibodies (ATAs) to Etrolizumab
Description
Participants who received at least one dose of study treatment and had at least one baseline or post-baseline ATA result. Induction: treatment groups were pooled across cohorts 1-3. Maintenance: treatment group is stratified by induction dose
Time Frame
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)
Title
Observed Trough Serum Concentration (Ctrough) of Etrolizumab
Description
Serum Etrolizumab Trough Concentration
Time Frame
Induction Phase at Weeks 10 and 14, Maintenance Phase at Weeks 16, 24, 28, 32, 44, and 66

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
Facility Information:
Facility Name
Valley Gastroenterology Consultants
City
Arcadia
State/Province
California
ZIP/Postal Code
91006
Country
United States
Facility Name
University of California San Diego Medical Center
City
La Jolla
State/Province
California
ZIP/Postal Code
92093-5354
Country
United States
Facility Name
VA Long Beach Healthcare System
City
Long Beach
State/Province
California
ZIP/Postal Code
90822
Country
United States
Facility Name
Digestive Care Associates, A Medical Corporation
City
San Carlos
State/Province
California
ZIP/Postal Code
94070
Country
United States
Facility Name
SDG Clinical Research
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
University of California at San Francisco (PARENT); Gastroenterology, Hepatology & Nutrition
City
San Francisco
State/Province
California
ZIP/Postal Code
94158
Country
United States
Facility Name
Peak Gastroenterology Associates; Gastroenterology
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80907
Country
United States
Facility Name
Innovative Medical Research of South Florida
City
Aventura
State/Province
Florida
ZIP/Postal Code
33180
Country
United States
Facility Name
West Central Gastroenterology d/b/a Gastro Florida
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33762
Country
United States
Facility Name
University of Florida College of Medicine
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
Facility Name
Borland-Groover Clinic
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32256
Country
United States
Facility Name
IMIC, Inc
City
Miami Beach
State/Province
Florida
ZIP/Postal Code
33140
Country
United States
Facility Name
FQL Research, LLC
City
Miramar
State/Province
Florida
ZIP/Postal Code
33025
Country
United States
Facility Name
Advanced Research Institute, Inc.
City
Trinity
State/Province
Florida
ZIP/Postal Code
34655
Country
United States
Facility Name
Shafran Gastroenterology Center
City
Winter Park
State/Province
Florida
ZIP/Postal Code
32789
Country
United States
Facility Name
Emory University Hospital
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30308
Country
United States
Facility Name
Atlanta Gastroenterology Associates
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
Gastrointestinal Diseases Research
City
Columbus
State/Province
Georgia
ZIP/Postal Code
31904
Country
United States
Facility Name
Atlanta Center for Gastroenterology, PC
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30033
Country
United States
Facility Name
Gastroenterology Associates of Central Georgia
City
Macon
State/Province
Georgia
ZIP/Postal Code
31201
Country
United States
Facility Name
Gastrointestinal Specialists of Georgia, PC
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Facility Name
Advanced Clinical Research
City
Meridian
State/Province
Idaho
ZIP/Postal Code
83642
Country
United States
Facility Name
Northwestern University-Feinberg School of Medicine; Division of Gastroenterology and Hepatology
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
The University of Chicago Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Southwest Gastroenterology; DM Clinical Research
City
Oak Lawn
State/Province
Illinois
ZIP/Postal Code
60453-3767
Country
United States
Facility Name
Carle Foundation Hospital
City
Urbana
State/Province
Illinois
ZIP/Postal Code
61801-2500
Country
United States
Facility Name
Cotton-O'Neil Clinical Research Center, Digestive Health
City
Topeka
State/Province
Kansas
ZIP/Postal Code
66606
Country
United States
Facility Name
Gastroenterology Associates, LLC
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70809
Country
United States
Facility Name
Louisiana Research Center, LLC
City
Shreveport
State/Province
Louisiana
Country
United States
Facility Name
Commonwealth Clinical Studies
City
Brockton
State/Province
Massachusetts
ZIP/Postal Code
02302
Country
United States
Facility Name
University of Michigan Health System
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109-0666
Country
United States
Facility Name
Gastroenterology Associates of Western Michigan, P.L.C.
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49506
Country
United States
Facility Name
Center for Digestive Health
City
Troy
State/Province
Michigan
ZIP/Postal Code
48098
Country
United States
Facility Name
Henry Ford Health System
City
West Bloomfield
State/Province
Michigan
ZIP/Postal Code
48322
Country
United States
Facility Name
Mayo Clinic - Rochester; Gastrology
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
University of Mississippi Medical Center; Division of Gastroenterology
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39216
Country
United States
Facility Name
Ehrhardt Clinical Research, LLC
City
Belton
State/Province
Missouri
ZIP/Postal Code
64012
Country
United States
Facility Name
Concorde Medical Group
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Weill Cornell Medical College (WCMC) - Judith Jaffe Multiple Sclerosis Center (JJMSC)
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Lenox Hill Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10075
Country
United States
Facility Name
University of North Carolina At Chapel Hill
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27514
Country
United States
Facility Name
Charlotte Gastroenterology and Hepatology, P.L.L.C
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28207
Country
United States
Facility Name
Kinston Medical Specialists
City
Kinston
State/Province
North Carolina
ZIP/Postal Code
28501
Country
United States
Facility Name
Consultants for Clinical Research Inc.
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
Great Lakes Gastroenterology Research, LLC
City
Mentor
State/Province
Ohio
ZIP/Postal Code
44060
Country
United States
Facility Name
Digestive Disease Specialists, Inc.
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73112
Country
United States
Facility Name
Great Lakes Medical Research, LLC
City
Harrisburg
State/Province
Pennsylvania
ZIP/Postal Code
17110
Country
United States
Facility Name
Innovative Clinical Research
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29604
Country
United States
Facility Name
Gastroenterology Center of the MidSouth PC
City
Germantown
State/Province
Tennessee
ZIP/Postal Code
38138
Country
United States
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
Texas Digestive Disease Consultants - Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
University of Texas Southwestern Medical Center; Internal Medicne
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390-9151
Country
United States
Facility Name
Baylor College of Medicine; Gastroenterology
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Methodist Hospital Research Institute
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Wellness Clinical Research Center
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78232
Country
United States
Facility Name
Texas Digestive Disease Consultants - Southlake
City
Southlake
State/Province
Texas
ZIP/Postal Code
76092
Country
United States
Facility Name
Tyler Research Institute, LLC
City
Tyler
State/Province
Texas
ZIP/Postal Code
75701
Country
United States
Facility Name
Ericksen Research and Development
City
Clinton
State/Province
Utah
ZIP/Postal Code
84015
Country
United States
Facility Name
University of Utah School of Medicine
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132
Country
United States
Facility Name
McGuire Research Institute; Gastroenterology
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23249
Country
United States
Facility Name
Digestive Disease Institute; Virginia Mason Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98101
Country
United States
Facility Name
University of Wisconsin
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States
Facility Name
Hospital Italiano
City
Buenos Aires
ZIP/Postal Code
C1181ACH
Country
Argentina
Facility Name
The Canberra Hospital
City
Garran
State/Province
Australian Capital Territory
ZIP/Postal Code
2065
Country
Australia
Facility Name
Bankstown-Lidcombe Hospital
City
Bankstown
State/Province
New South Wales
ZIP/Postal Code
2200
Country
Australia
Facility Name
Concord Repatriation General Hospital
City
Concord
State/Province
New South Wales
ZIP/Postal Code
2139
Country
Australia
Facility Name
Royal Brisbane and Women's Hospital
City
Herston
State/Province
Queensland
ZIP/Postal Code
4029
Country
Australia
Facility Name
University of the Sunshine Coast
City
Sippy Downs
State/Province
Queensland
ZIP/Postal Code
4556
Country
Australia
Facility Name
Mater Adult Hospital
City
South Brisbane
State/Province
Queensland
ZIP/Postal Code
4101
Country
Australia
Facility Name
Princess Alexandra Hospital
City
Woolloongabba
State/Province
Queensland
ZIP/Postal Code
4102
Country
Australia
Facility Name
Flinders Medical Centre
City
Bedford Park
State/Province
South Australia
ZIP/Postal Code
5042
Country
Australia
Facility Name
Monash Medical Centre Clayton
City
Clayton
State/Province
Victoria
ZIP/Postal Code
3168
Country
Australia
Facility Name
St Vincent's Hospital Melbourne
City
Fitzroy
State/Province
Victoria
ZIP/Postal Code
3065
Country
Australia
Facility Name
Footscray Hospital; Gastroenterology
City
Footscray
State/Province
Victoria
ZIP/Postal Code
3011
Country
Australia
Facility Name
St Frances Xavier Cabrini Hospital
City
Malvern
State/Province
Victoria
ZIP/Postal Code
3144
Country
Australia
Facility Name
Alfred Hospital
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3004
Country
Australia
Facility Name
Royal Melbourne Hospital; Department of Colorectal Medicine and Genetics
City
Parkville
State/Province
Victoria
ZIP/Postal Code
3050
Country
Australia
Facility Name
Fiona Stanley Hospital
City
Murdoch
State/Province
Western Australia
ZIP/Postal Code
6150
Country
Australia
Facility Name
LKH - Universitätsklinikum der PMU Salzburg
City
Salzburg
ZIP/Postal Code
5020
Country
Austria
Facility Name
Medizinische Universität Wien
City
Wien
ZIP/Postal Code
1090
Country
Austria
Facility Name
CHU St Pierre (St Pierre)
City
Brussels
ZIP/Postal Code
1000
Country
Belgium
Facility Name
UZ Brussel
City
Brussel
ZIP/Postal Code
1090
Country
Belgium
Facility Name
Hospital Erasme
City
Bruxelles
ZIP/Postal Code
1070
Country
Belgium
Facility Name
UZ Antwerpen
City
Edegem
ZIP/Postal Code
2650
Country
Belgium
Facility Name
AZ Maria Middelares
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
L2IP -Instituto de Pesquisas Clínicas Ltda.
City
Brasilia
State/Province
DF
ZIP/Postal Code
70200-730
Country
Brazil
Facility Name
Instituto Goiano de Gastroenterologia e Endoscopia Digestiva Ltda
City
Goiânia
State/Province
GO
ZIP/Postal Code
74535-170
Country
Brazil
Facility Name
Hospital Felicio Rocho
City
Belo Horizonte
State/Province
MG
ZIP/Postal Code
30110-068
Country
Brazil
Facility Name
Centro Digestivo de Curitiba
City
Curitiba
State/Province
PR
ZIP/Postal Code
80430-160
Country
Brazil
Facility Name
Hospital Universitario Clementino Fraga Filho - UFRJ; Gastroenterologia
City
Rio de Janeiro
State/Province
RJ
ZIP/Postal Code
21941-590
Country
Brazil
Facility Name
Instituto Brasil de Pesquisa Clínica-IBPCLIN S/A
City
Rio de Janeiro
State/Province
RJ
ZIP/Postal Code
22271-100
Country
Brazil
Facility Name
Hospital São Vicente de Paulo; Institute of Education and Reseach / Cardiovascular Research Unit
City
Passo Fundo
State/Province
RS
ZIP/Postal Code
99010-080
Country
Brazil
Facility Name
Hospital das Clinicas - UFRGS
City
Porto Alegre
State/Province
RS
ZIP/Postal Code
90035-903
Country
Brazil
Facility Name
Hospital Ernesto Dornelles
City
Porto Alegre
State/Province
RS
ZIP/Postal Code
90160-092
Country
Brazil
Facility Name
UNESP - Faculdade de Medicina da Universidade Estadual Paulista - Campus Botucatu
City
Botucatu
State/Province
SP
ZIP/Postal Code
18618-970
Country
Brazil
Facility Name
Pesquisare Saúde Sociedade Simples
City
Santo Andre
State/Province
SP
ZIP/Postal Code
09080-000
Country
Brazil
Facility Name
Praxis Pesquisa Médica
City
Santo Andre
State/Province
SP
ZIP/Postal Code
09090-790
Country
Brazil
Facility Name
Hospital Estadual Mario Covas
City
Santo Andre
State/Province
SP
ZIP/Postal Code
09190-610
Country
Brazil
Facility Name
Hospital de Base de Sao Jose do Rio Preto
City
Sao Jose do Rio Preto
State/Province
SP
ZIP/Postal Code
15090-000
Country
Brazil
Facility Name
Hospital Sírio-Libanês
City
Sao Paulo
State/Province
SP
ZIP/Postal Code
01308-050
Country
Brazil
Facility Name
Hospital Sao Paulo
City
Sao Paulo
State/Province
SP
ZIP/Postal Code
04037-002
Country
Brazil
Facility Name
Hospital do Servidor Público Estadual/HSPE-SP
City
São Paulo
State/Province
SP
ZIP/Postal Code
04039-901
Country
Brazil
Facility Name
"City Clinic UMHAC" EOOD
City
Sofia
ZIP/Postal Code
1407
Country
Bulgaria
Facility Name
UMHAT "Sv. Ivan Rilski", EAD
City
Sofia
ZIP/Postal Code
1431
Country
Bulgaria
Facility Name
UMHAT Tsaritsa Yoanna - ISUL, EAD
City
Sofia
ZIP/Postal Code
1527
Country
Bulgaria
Facility Name
University of Calgary
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 2T9
Country
Canada
Facility Name
Zeidler Ledcor Centre - University of Alberta; Division of Gasroenterology
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2X8
Country
Canada
Facility Name
(G.I.R.I.) GI Research Institute
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6Z 2K5
Country
Canada
Facility Name
Winnipeg Regional Health Authority
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3A 1R9
Country
Canada
Facility Name
Queen Elizabeth II Health Sciences Centre; Gastroenterology Research
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 1V7
Country
Canada
Facility Name
University Hospital - London Health Sciences Centre
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5A5
Country
Canada
Facility Name
Taunton Health Centre
City
Oshawa
State/Province
Ontario
ZIP/Postal Code
L1H 7K4
Country
Canada
Facility Name
The Ottawa Hospital - Riverside Campus; Gastrointestinal Clinical Research Unit
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 1A2
Country
Canada
Facility Name
Mount Sinai Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1X5
Country
Canada
Facility Name
Toronto Digestive Disease Associates
City
Vaughan
State/Province
Ontario
ZIP/Postal Code
L4L 4Y7
Country
Canada
Facility Name
Hôpital Maisonneuve - Rosemont
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H1T 2M4
Country
Canada
Facility Name
McGill University Health Centre - Glen Site
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H4A 3J1
Country
Canada
Facility Name
Royal University Hospital
City
Saskatoon
State/Province
Saskatchewan
ZIP/Postal Code
S7N 0W8
Country
Canada
Facility Name
Clinical Hospital Centre Osijek
City
Osijek
ZIP/Postal Code
31000
Country
Croatia
Facility Name
General Hospital Pula
City
Pula
ZIP/Postal Code
52000
Country
Croatia
Facility Name
Clinical Hospital Center Sestre Milosrdnice
City
Zagreb
ZIP/Postal Code
10000
Country
Croatia
Facility Name
University Hospital Center Zagreb
City
Zagreb
ZIP/Postal Code
10000
Country
Croatia
Facility Name
Vojenska nemocnice Brno
City
Brno
ZIP/Postal Code
636 00
Country
Czechia
Facility Name
Fakultni nemocnice u sv. Anny v Brne
City
Brno
ZIP/Postal Code
656 91
Country
Czechia
Facility Name
Nemocnice Ceske Budejovice a.s.
City
Ceske Budejovice
ZIP/Postal Code
370 01
Country
Czechia
Facility Name
Gastroenterologie s.r.o.
City
Hradec Kralove
ZIP/Postal Code
500 02
Country
Czechia
Facility Name
Fakultni nemocnice Hradec Kralove
City
Hradec Kralove
ZIP/Postal Code
500 05
Country
Czechia
Facility Name
Hepato-Gastroenterologie HK, s.r.o.
City
Hradec Kralove
ZIP/Postal Code
500 12
Country
Czechia
Facility Name
PreventaMed, s.r.o.
City
Olomouc
ZIP/Postal Code
779 00
Country
Czechia
Facility Name
Fakultni nemocnice Ostrava
City
Ostrava - Poruba
ZIP/Postal Code
708 52
Country
Czechia
Facility Name
Klinicke centrum ISCARE Lighthouse
City
Praha 7
ZIP/Postal Code
170 00
Country
Czechia
Facility Name
Fakultni nemocnice Kralovske Vinohrady
City
Praha
ZIP/Postal Code
110 34
Country
Czechia
Facility Name
West Tallinn Central Hospital
City
Tallinn
ZIP/Postal Code
10617
Country
Estonia
Facility Name
North Estonia Medical Centre Foundation
City
Tallinn
ZIP/Postal Code
13419
Country
Estonia
Facility Name
Tartu University Hospital
City
Tartu
ZIP/Postal Code
51014
Country
Estonia
Facility Name
CHU Amiens - Hopital Sud
City
Amiens
ZIP/Postal Code
80054
Country
France
Facility Name
CHU de Caen - Hopital Cote de Nacre
City
Caen
ZIP/Postal Code
14033
Country
France
Facility Name
Hôpital Beaujon
City
Clichy cedex
ZIP/Postal Code
92110
Country
France
Facility Name
Hopital Claude Huriez - CHU Lille
City
Lille
ZIP/Postal Code
59037
Country
France
Facility Name
CHU NANTES - Hôtel Dieu; Pharmacy
City
Nantes
ZIP/Postal Code
44093
Country
France
Facility Name
CHU Nice - Hopital de l'Archet 2
City
Nice
ZIP/Postal Code
06202
Country
France
Facility Name
Hôpital Saint-Louis
City
Paris
ZIP/Postal Code
75475
Country
France
Facility Name
Groupe Hospitalier Sud - Hôpital Haut-Lévêque - USN
City
Pessac
ZIP/Postal Code
33604
Country
France
Facility Name
Centre Hospitalier Lyon Sud; Service de Gastro-Enterologie
City
Pierre-Benite
ZIP/Postal Code
69495
Country
France
Facility Name
CHU du Reims - Hopital Robert Debré
City
Reims
ZIP/Postal Code
51092
Country
France
Facility Name
CHU Rennes - Hopital Pontchaillou
City
Rennes cedex 09
ZIP/Postal Code
35033
Country
France
Facility Name
CHU Saint Etienne - Hôpital Nord
City
Saint Etienne
ZIP/Postal Code
42055
Country
France
Facility Name
Höpital Hautepierre; Pediatrie1
City
Strasbourg
ZIP/Postal Code
67098
Country
France
Facility Name
Hôpital de Brabois Adultes
City
Vandoeuvre-les-nancy
ZIP/Postal Code
54511
Country
France
Facility Name
Charite-Campus Virchow Klinikum; Hepatologie und Gastroenterologie
City
Berlin
ZIP/Postal Code
13353
Country
Germany
Facility Name
Krankenhaus Waldfriede e. V.
City
Berlin
ZIP/Postal Code
14163
Country
Germany
Facility Name
Berufsgenossenschaftliches Universitaetsklinikum Bergmannsheil GmbH
City
Bochum
ZIP/Postal Code
44789
Country
Germany
Facility Name
Klinikum der Johann Wolfgang Goethe-Universitaet
City
Frankfurt
ZIP/Postal Code
60590
Country
Germany
Facility Name
Universitaetsklinikum Halle (Saale)
City
Halle
ZIP/Postal Code
06120
Country
Germany
Facility Name
Medizinische Hochschule Hannover; Gastroenterology and Hepatology dept
City
Hannover
ZIP/Postal Code
30625
Country
Germany
Facility Name
Universitätsklinikum Koeln
City
Koeln
ZIP/Postal Code
50937
Country
Germany
Facility Name
Klinikum Mannheim GmbH Universitätsklinikum
City
Mannheim
ZIP/Postal Code
68167
Country
Germany
Facility Name
Gemeinschaftspraxis
City
Offenburg
ZIP/Postal Code
77652
Country
Germany
Facility Name
Universitaetsklinikum Tuebingen
City
Tuebingen
ZIP/Postal Code
72076
Country
Germany
Facility Name
Universitaetsklinikum Ulm
City
Ulm
ZIP/Postal Code
89081
Country
Germany
Facility Name
Bekes Megyei Kozponti Korhaz Dr. Rethy Pal Tagkorhaza
City
Bekescsaba
ZIP/Postal Code
5600
Country
Hungary
Facility Name
Obudai Egeszsegugyi Centrum Kft.
City
Budapest
ZIP/Postal Code
1036
Country
Hungary
Facility Name
Semmelweis Egyetem
City
Budapest
ZIP/Postal Code
1083
Country
Hungary
Facility Name
Eszak-Kozep-budai Centrum, Uj Szent Janos Korhaz es Szakrendelo
City
Budapest
ZIP/Postal Code
1125
Country
Hungary
Facility Name
Pannonia Maganorvosi Centrum
City
Budapest
ZIP/Postal Code
1135
Country
Hungary
Facility Name
Debreceni Egyetem
City
Debrecen
ZIP/Postal Code
4032
Country
Hungary
Facility Name
Petz Aladar Megyei Oktato Korhaz
City
Gyor
ZIP/Postal Code
9024
Country
Hungary
Facility Name
Pest Megyei Flor Ferenc Korhaz
City
Kistarcsa
ZIP/Postal Code
2143
Country
Hungary
Facility Name
Pecsi Tudomanyegyetem
City
Pecs
ZIP/Postal Code
7624
Country
Hungary
Facility Name
Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz
City
Székesfehérvár
ZIP/Postal Code
8000
Country
Hungary
Facility Name
Haemek Medical Center
City
Afula
ZIP/Postal Code
18101
Country
Israel
Facility Name
Soroka University Medical Centre
City
Beer Sheva
ZIP/Postal Code
8410101
Country
Israel
Facility Name
Wolfson Medical Center; Obstetrics and Gynecology
City
Holon
ZIP/Postal Code
5822012
Country
Israel
Facility Name
Shaare Zedek Medical Center
City
Jerusalem
ZIP/Postal Code
9103102
Country
Israel
Facility Name
Hadassah University Hospital - Ein Kerem
City
Jerusalem
ZIP/Postal Code
9112001
Country
Israel
Facility Name
Holy Family Hospital
City
Nazareth
ZIP/Postal Code
16100
Country
Israel
Facility Name
Rabin Medical Center-Beilinson Campus
City
Petach Tikva
ZIP/Postal Code
4941492
Country
Israel
Facility Name
Tel Aviv Sourasky Medical Center; Pharmacy
City
Tel Aviv
ZIP/Postal Code
6423906
Country
Israel
Facility Name
A.O.U. Policlinico di Modena
City
Modena
State/Province
Emilia-Romagna
ZIP/Postal Code
40124
Country
Italy
Facility Name
Azienda Ospedaliera San Camillo Forlanini
City
Roma
State/Province
Lazio
ZIP/Postal Code
00152
Country
Italy
Facility Name
Policlinico Universitario Agostino Gemelli; Farmacia
City
Roma
State/Province
Lazio
ZIP/Postal Code
00168
Country
Italy
Facility Name
Asst Fatebenefratelli Sacco (Fatebenefratelli)
City
Milano
State/Province
Lombardia
ZIP/Postal Code
20121
Country
Italy
Facility Name
ASST FATEBENEFRATELLI SACCO (Sacco)
City
Milano
State/Province
Lombardia
ZIP/Postal Code
20157
Country
Italy
Facility Name
Azienda Socio Sanitaria Territoriale Niguarda (Grande Ospedale Metropolitano Niguarda)
City
Milano
State/Province
Lombardia
ZIP/Postal Code
20162
Country
Italy
Facility Name
Istituto Clinico Humanitas
City
Rozzano (MI)
State/Province
Lombardia
ZIP/Postal Code
20089
Country
Italy
Facility Name
I.R.C.C.S Policlinico San Donato
City
San Donato Milanese (MI)
State/Province
Lombardia
ZIP/Postal Code
20097
Country
Italy
Facility Name
Ospedale Umberto I di Torino
City
Torino
State/Province
Piemonte
ZIP/Postal Code
10128
Country
Italy
Facility Name
Azienda Ospedaliera Universitaria Careggi
City
Florence
State/Province
Toscana
ZIP/Postal Code
50134
Country
Italy
Facility Name
Inje University Busan Paik Hospital
City
Busan
ZIP/Postal Code
47392
Country
Korea, Republic of
Facility Name
Dong-A University Hospital
City
Busan
ZIP/Postal Code
49201
Country
Korea, Republic of
Facility Name
Pusan National University Hospital
City
Busan
ZIP/Postal Code
49241
Country
Korea, Republic of
Facility Name
Kyungpook National University Hospital
City
Daegu
ZIP/Postal Code
41944
Country
Korea, Republic of
Facility Name
Yeungnam Univ. Hospital
City
Daegu
ZIP/Postal Code
705-717
Country
Korea, Republic of
Facility Name
Hanyang University Guri Hospital
City
Gyeonggi-do
ZIP/Postal Code
11923
Country
Korea, Republic of
Facility Name
Korea University Ansan Hospital
City
Gyeonggi-do
ZIP/Postal Code
15355
Country
Korea, Republic of
Facility Name
Seoul National University Bundang Hospital
City
Seongnam-si
ZIP/Postal Code
13605
Country
Korea, Republic of
Facility Name
CHA Bundang Medical Centre; CHA university
City
Seongnam
ZIP/Postal Code
13520
Country
Korea, Republic of
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Facility Name
Kangbuk Samsung Hospital
City
Seoul
ZIP/Postal Code
03181
Country
Korea, Republic of
Facility Name
Severance Hospital, Yonsei University Health System
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of
Facility Name
Asan Medical Center
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
Facility Name
Yonsei University Wonju Severance Christian Hospital
City
Wonju-Si
ZIP/Postal Code
220-701
Country
Korea, Republic of
Facility Name
Riga East Clinical University Hospital; Clinic Gailezers
City
Riga
ZIP/Postal Code
LV 1002
Country
Latvia
Facility Name
Pauls Stradins Clinical University Hospital
City
Rīga
ZIP/Postal Code
LV-1002
Country
Latvia
Facility Name
Hospital of Lithuanian University of Health. Sciences Kaunas Clinics
City
Kaunas
ZIP/Postal Code
50009
Country
Lithuania
Facility Name
Vilnius University Hospital Santariskiu Clinic, Public Institution; Cardiology
City
Vilnius
ZIP/Postal Code
LT-08661
Country
Lithuania
Facility Name
Clinical Research Institute
City
Tlalnepantla de Baz
State/Province
Mexico CITY (federal District)
ZIP/Postal Code
54055
Country
Mexico
Facility Name
Medical Care & Research SA de CV
City
Mérida
State/Province
Yucatan
ZIP/Postal Code
97070
Country
Mexico
Facility Name
Amsterdam UMC, Locatie VUMC; Neurology
City
Amsterdam
ZIP/Postal Code
1081 HV
Country
Netherlands
Facility Name
Amsterdam UMC Location AMC
City
Amsterdam
ZIP/Postal Code
1105 AZ
Country
Netherlands
Facility Name
Leids Universitair Medisch Centrum
City
Leiden
ZIP/Postal Code
2333 ZA
Country
Netherlands
Facility Name
Maastricht University Medical Center
City
Maastricht
ZIP/Postal Code
6229 HX
Country
Netherlands
Facility Name
Erasmus Medisch Centrum
City
Rotterdam
ZIP/Postal Code
3000 CA
Country
Netherlands
Facility Name
Zuyderland Medisch Centrum - Sittard Geleen
City
Sittard-Geleen
ZIP/Postal Code
6162 BG
Country
Netherlands
Facility Name
ETZ TweeSteden
City
Tilburg
ZIP/Postal Code
5042AD
Country
Netherlands
Facility Name
North Shore Hospital
City
Auckland
ZIP/Postal Code
0620
Country
New Zealand
Facility Name
Christchurch Hospital NZ
City
Christchurch
ZIP/Postal Code
8011
Country
New Zealand
Facility Name
Dunedin Public Hospital
City
Dunedin
ZIP/Postal Code
9016
Country
New Zealand
Facility Name
Waikato Hospital
City
Hamilton
ZIP/Postal Code
3248
Country
New Zealand
Facility Name
Shakespeare Specialist Group
City
Takapuna
ZIP/Postal Code
0620
Country
New Zealand
Facility Name
Tauranga Hospital
City
Tauranga
ZIP/Postal Code
3143
Country
New Zealand
Facility Name
SP ZOZ Wojewodzki Szpital Zespolony im. J. Sniadeckiego
City
Białystok
ZIP/Postal Code
15-275
Country
Poland
Facility Name
Nasz Lekarz Osrodek Badan Klinicznych
City
Bydgoszcz
ZIP/Postal Code
85-312
Country
Poland
Facility Name
Elblaski Szpital Specjalistyczny z Przychodnia SP ZOZ
City
Elblag
ZIP/Postal Code
82-300
Country
Poland
Facility Name
ETG Kielce
City
Kielce
ZIP/Postal Code
25-355
Country
Poland
Facility Name
Centrum Opieki Zdrowotnej Orkan-Med
City
Ksawerow
ZIP/Postal Code
95-054
Country
Poland
Facility Name
Indywidualna Specjalistyczna Praktyka Lekarska
City
Lublin
ZIP/Postal Code
20-015
Country
Poland
Facility Name
Allmedica Badania Kliniczne Sp z o.o. Sp K.
City
Nowy Targ
ZIP/Postal Code
34-400
Country
Poland
Facility Name
Centrum Medyczne "MEDYK"
City
Rzeszow
ZIP/Postal Code
35-055
Country
Poland
Facility Name
Gabinet Lekarski, Bartosz Korczowski
City
Rzeszów
ZIP/Postal Code
35-302
Country
Poland
Facility Name
Specjalistyczna Praktyka Lekarska Dr med. Marek Horynski; endoskopia
City
Sopot
ZIP/Postal Code
81-756
Country
Poland
Facility Name
Niepubliczny Zaklad Opieki Zdrowotnej SONOMED
City
Szczecin
ZIP/Postal Code
70-351
Country
Poland
Facility Name
Twoja Przychodnia-Szczecinskie Centrum Medyczne
City
Szczecin
ZIP/Postal Code
71-434
Country
Poland
Facility Name
Gastromed Kopon Zmudzinski i Wspolnicy Sp.j.Specjalistyczne Centrum Gastrologii i Endoskopii Specj
City
Toruń
ZIP/Postal Code
87-100
Country
Poland
Facility Name
Centrum Zdrowia MDM
City
Warszawa
ZIP/Postal Code
00-631
Country
Poland
Facility Name
Warsaw IBD Point Profesor Kierkus
City
Warszawa
ZIP/Postal Code
00-728
Country
Poland
Facility Name
Zespó Przychodni Specjalistycznych PRIMA
City
Warszawa
ZIP/Postal Code
02-018
Country
Poland
Facility Name
LexMedica Osrodek Badan Klinicznych
City
Wroclaw
ZIP/Postal Code
53-114
Country
Poland
Facility Name
EuroMediCare Szpital Specjalistyczny z Przychodnią we Wrocławiu
City
Wroclaw
ZIP/Postal Code
54-144
Country
Poland
Facility Name
PlanetMed sp. z o.o.
City
Wrocław
ZIP/Postal Code
52-210
Country
Poland
Facility Name
Spitalul Clinic Colentina
City
Bucharest
ZIP/Postal Code
772202
Country
Romania
Facility Name
S.C MedLife S.A
City
Bucuresti
ZIP/Postal Code
010719
Country
Romania
Facility Name
Centrul de Gastroenterologie Dr. Goldis
City
Timisoara
ZIP/Postal Code
300002
Country
Romania
Facility Name
Yusupov Hospital
City
Moskva
State/Province
Adygeja
ZIP/Postal Code
127015
Country
Russian Federation
Facility Name
LLC "Novosibirsk GastroCenter"
City
Novosibirsk
State/Province
Altaj
ZIP/Postal Code
630007
Country
Russian Federation
Facility Name
Baltic Medicine
City
St.Petersburg
State/Province
Leningrad
ZIP/Postal Code
194356
Country
Russian Federation
Facility Name
North-Western Medical University n.a. I.I. Mechnikov; Rheumatology
City
Sankt-peterburg
State/Province
Sankt Petersburg
ZIP/Postal Code
191015
Country
Russian Federation
Facility Name
SBIH City Clinical Hospital #31
City
Sankt-peterburg
State/Province
Sankt Petersburg
ZIP/Postal Code
197110
Country
Russian Federation
Facility Name
SBEI HPE Altai StateMedicalUniversityofMoH andSD
City
Barnaul
ZIP/Postal Code
656050
Country
Russian Federation
Facility Name
Irkutsk State Medical Academy of Continuing Education
City
Irkutsk
Country
Russian Federation
Facility Name
SBEIHPE Novosibirsk State Medical University
City
Novosibirsk
ZIP/Postal Code
630091
Country
Russian Federation
Facility Name
BHI of Omsk region Clinical Oncology Dispensary
City
Omsk
ZIP/Postal Code
644013
Country
Russian Federation
Facility Name
Evromedservis LCC
City
Pushkin
ZIP/Postal Code
196603
Country
Russian Federation
Facility Name
SEIHPE "Rostov SMU of MoH of RF"
City
Rostov-on-Don
ZIP/Postal Code
344022
Country
Russian Federation
Facility Name
Federal State Military Educational Institution; High Professional Education Military Medical Acad
City
St. Petersburg
ZIP/Postal Code
194044
Country
Russian Federation
Facility Name
Clinical Helth Centre Zvezdara
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Facility Name
Military Medical Academy
City
Belgrade
ZIP/Postal Code
11040
Country
Serbia
Facility Name
University Hospital Medical Center Bezanijska kosa
City
Belgrade
ZIP/Postal Code
11080
Country
Serbia
Facility Name
Clinical Center of Vojvodina
City
Novi Sad
ZIP/Postal Code
21000
Country
Serbia
Facility Name
General Hospital Djordje Joanovic
City
Zrenjanin
ZIP/Postal Code
23000
Country
Serbia
Facility Name
IBDcentrum s.r.o.
City
Bratislava
ZIP/Postal Code
83104
Country
Slovakia
Facility Name
KM Management spol. s r.o.
City
Nitra
ZIP/Postal Code
94901
Country
Slovakia
Facility Name
Endomed, s.r.o.
City
Vranov nad Topľou
ZIP/Postal Code
093 01
Country
Slovakia
Facility Name
Accout Center s.r.o.
City
Šahy
ZIP/Postal Code
936 01
Country
Slovakia
Facility Name
Dr D Epstein Practice
City
Cape Town
ZIP/Postal Code
7405
Country
South Africa
Facility Name
Emmed Research
City
Pretoria
ZIP/Postal Code
0002
Country
South Africa
Facility Name
Hospital Universitario de Bellvitge
City
Hospitalet de Llobregat
State/Province
Barcelona
ZIP/Postal Code
08907
Country
Spain
Facility Name
Hospital Universitario Puerta de Hierro Majadahonda; Hepatology studies
City
Majadahonda
State/Province
Madrid
ZIP/Postal Code
28222
Country
Spain
Facility Name
Hospital Clínic i Provincial; Servicio de Farmacia
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Centro Médico Teknon
City
Barcelona
Country
Spain
Facility Name
Hospital Reina Sofia; Medical Oncology
City
Cordoba
ZIP/Postal Code
14004
Country
Spain
Facility Name
Hospital Juan Ramón Jiménez
City
Huelva
ZIP/Postal Code
21005
Country
Spain
Facility Name
Hospital Universitario de la Princesa
City
Madrid
ZIP/Postal Code
28006
Country
Spain
Facility Name
Hospital Universitario La Paz
City
Madrid
ZIP/Postal Code
280146
Country
Spain
Facility Name
Hospital Universitario de Fuenlabrada
City
Madrid
ZIP/Postal Code
28942
Country
Spain
Facility Name
Complejo Hospitalario de Pontevedra
City
Pontevedra
ZIP/Postal Code
36071
Country
Spain
Facility Name
Hospital Universitario Virgen Macarena
City
Sevilla
ZIP/Postal Code
41009
Country
Spain
Facility Name
Hospital Universitario Virgen del Rocio
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Facility Name
Hospital Universitari i Politecnic La Fe
City
Valencia
ZIP/Postal Code
46026
Country
Spain
Facility Name
Hospital Universitario Miguel Servet
City
Zaragoza
ZIP/Postal Code
50009
Country
Spain
Facility Name
Inselspital-Universitaetsspital Bern
City
Bern
ZIP/Postal Code
3010
Country
Switzerland
Facility Name
Crohn-Colitis Zentrum Bern - Gemeinschaftspraxis Balsiger, Seibold und Partner
City
Bern
ZIP/Postal Code
3012
Country
Switzerland
Facility Name
Universitätsspital Zürich
City
Zürich
ZIP/Postal Code
8091
Country
Switzerland
Facility Name
Ankara University Medical Faculty
City
Ankara
ZIP/Postal Code
06100
Country
Turkey
Facility Name
Hacettepe University Medical Faculty; Gastroenterology
City
Ankara
ZIP/Postal Code
06100
Country
Turkey
Facility Name
Gazi University Medical Faculty
City
Ankara
ZIP/Postal Code
06500
Country
Turkey
Facility Name
Acibadem Fulya Hospital; Neurology
City
Istanbul
ZIP/Postal Code
34349
Country
Turkey
Facility Name
Haydarpasa Numune Training and Research Hospital; Medical Oncology
City
Istanbul
ZIP/Postal Code
34668
Country
Turkey
Facility Name
Medeniyet University Goztepe Training and Research Hospital; Chest Diseases
City
Istanbul
ZIP/Postal Code
34722
Country
Turkey
Facility Name
Ege University Medical Faculty
City
Izmir
ZIP/Postal Code
35100
Country
Turkey
Facility Name
Kocaeli Universitesi Tip Fakultesi; Infectious Diseases
City
Kocaeli
ZIP/Postal Code
41380
Country
Turkey
Facility Name
Acibadem Kozyatagi Hospital; Gastroenterology
City
Kozyataği
ZIP/Postal Code
34742
Country
Turkey
Facility Name
CHI Prof.O.O.Shalimov Kharkiv City Clinical Hospital #2
City
Kharkiv
State/Province
Kharkiv Governorate
ZIP/Postal Code
61037
Country
Ukraine
Facility Name
CI of Healthcare Kharkiv Reg Clin Hosp-Center of Med Emergency & Accident Medicine
City
Kharkiv
State/Province
Kharkiv Governorate
ZIP/Postal Code
61204
Country
Ukraine
Facility Name
Medical Center of Limited Liability Company Medical Clinic Blagomed
City
Kyiv
State/Province
KIEV Governorate
ZIP/Postal Code
1023
Country
Ukraine
Facility Name
Med Center of International Institute of Clinical Trials LLC; Medical Center "OK!Clinic+"
City
Kyiv
State/Province
KIEV Governorate
ZIP/Postal Code
2091
Country
Ukraine
Facility Name
CI of Kyiv RC Regional Clinical Hospital #2
City
Kyiv
State/Province
KIEV Governorate
ZIP/Postal Code
4073
Country
Ukraine
Facility Name
Lviv Regional Clinical Hospital
City
Lviv
State/Province
KIEV Governorate
ZIP/Postal Code
79010
Country
Ukraine
Facility Name
Ivano-Frankivsk Regional Clinical Hospital
City
Ivano-Frankivsk
State/Province
Kuban People's Republica
ZIP/Postal Code
76000
Country
Ukraine
Facility Name
RCNECRCH Dept of Surgery, SHEI Ukr BSMU
City
Chernivtsi
State/Province
Podolia Governorate
ZIP/Postal Code
58002
Country
Ukraine
Facility Name
Kremenchuk first city hospital n.a. O.T. Bohaievskyi; Gastroenterology department
City
Kremenchuk
State/Province
Poltava Governorate
ZIP/Postal Code
39617
Country
Ukraine
Facility Name
CI City Hospital #1
City
Zaporizhzhia
State/Province
Tavria Okruha
ZIP/Postal Code
69104
Country
Ukraine
Facility Name
GI L.T.Malaya Therapy National Institute of the NAMS of Ukraine
City
Kharkiv
ZIP/Postal Code
61039
Country
Ukraine
Facility Name
CHI Kharkiv City Clinical Hospital #13
City
Kharkiv
ZIP/Postal Code
61124
Country
Ukraine
Facility Name
Kyiv CCH #18 Dept of Proctology O. O. Bogomolets NMU
City
Kyiv
ZIP/Postal Code
01030
Country
Ukraine
Facility Name
City Hospital #1
City
Mykolaiv
ZIP/Postal Code
54003
Country
Ukraine
Facility Name
Railway Transport Odesa CH of Healthcare Ctr Branch of PJSC Ukrainian Railway Dept of Therapy #2
City
Odesa
ZIP/Postal Code
65059
Country
Ukraine
Facility Name
Private Small Enterprise Medical Center Pulse
City
Vinnytsia
ZIP/Postal Code
21001
Country
Ukraine
Facility Name
M.I. Pyrogov VRCH Dept of Gastroenterology M.I. Pyrogov VNMU
City
Vinnytsia
ZIP/Postal Code
21018
Country
Ukraine
Facility Name
MCIC MC LLC Health Clinic
City
Vinnytsia
ZIP/Postal Code
21029
Country
Ukraine
Facility Name
LLC Diaservis
City
Zaporizhzhia
ZIP/Postal Code
69106
Country
Ukraine
Facility Name
Royal Victoria Hospital
City
Belfast
ZIP/Postal Code
BT12 6BA
Country
United Kingdom
Facility Name
Addenbrooke's Hospital
City
Cambridge
ZIP/Postal Code
CB2 0QQ
Country
United Kingdom
Facility Name
University Hospital Coventry
City
Coventry
ZIP/Postal Code
CV2 2DX
Country
United Kingdom
Facility Name
Royal Devon and Exeter Hospital (Wonford)
City
Exeter
ZIP/Postal Code
EX2 5DW
Country
United Kingdom
Facility Name
Queen Elizabeth Hospital
City
Kings Lynn
ZIP/Postal Code
PE30 4ET
Country
United Kingdom
Facility Name
St James University Hospital
City
Leeds
ZIP/Postal Code
LS9 7TF
Country
United Kingdom
Facility Name
Royal Liverpool University Hospital
City
Liverpool
ZIP/Postal Code
L7 8XP
Country
United Kingdom
Facility Name
Whipps Cross Hospital
City
London
ZIP/Postal Code
E11 1NR
Country
United Kingdom
Facility Name
University College London Hospital
City
London
ZIP/Postal Code
NW1 - 2PG
Country
United Kingdom
Facility Name
Fairfield General Hospital
City
Manchester
ZIP/Postal Code
M8 5RB
Country
United Kingdom
Facility Name
Royal Victoria Infirmary; Stroke unit
City
Newcastle Upon Tyne
ZIP/Postal Code
NE1 4LP
Country
United Kingdom
Facility Name
Nottingham University Hospitals Queen's Medical Centre
City
Nottingham
ZIP/Postal Code
NG7 2UH
Country
United Kingdom
Facility Name
Royal Berkshire Hospital
City
Reading
ZIP/Postal Code
RG1 5AN
Country
United Kingdom
Facility Name
Southampton General Hospital
City
Southampton
ZIP/Postal Code
SO16 6YD
Country
United Kingdom
Facility Name
Royal Wolverhampton hospital; McHale Building
City
Wolverhampton
ZIP/Postal Code
WV10 0QP
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
36240801
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.
Results Reference
derived
PubMed Identifier
34467254
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.
Results Reference
derived
PubMed Identifier
32464142
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.
Results Reference
derived
PubMed Identifier
32445184
Citation
Sandborn WJ, Vermeire S, Tyrrell H, Hassanali A, Lacey S, Tole S, Tatro AR; Etrolizumab Global Steering Committee. Etrolizumab for the Treatment of Ulcerative Colitis and Crohn's Disease: An Overview of the Phase 3 Clinical Program. Adv Ther. 2020 Jul;37(7):3417-3431. doi: 10.1007/s12325-020-01366-2. Epub 2020 May 22.
Results Reference
derived

Learn more about this trial

A Study to Assess Whether Etrolizumab is a Safe and Efficacious Treatment for Participants With Moderately to Severely Active Crohn's Disease

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