Clinical trial NCT02100696: A Study of the Efficacy and Safety of Etrolizumab in Participants With Ulcerative Colitis Who Have Been Previously Exposed to Tumor Necrosis Factor (TNF) Inhibitors
Official title: Phase III, Double-Blind, Placebo-Controlled, Multicenter Study of the Efficacy and Safety of Etrolizumab During Induction and Maintenance in Patients With Moderate to Severe Active Ulcerative Colitis Who Have Been Previously Exposed to TNF Inhibitors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Ulcerative Colitis
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2014-04-01
Enrollment: 609
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This Phase III, double-blind, placebo-controlled, multicenter study will investigate the efficacy and safety of etrolizumab during induction and maintenance of remission compared with placebo in the treatment of participants with moderately to severely active ulcerative colitis (UC) who have been previously exposed to TNF inhibitors.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of UC established at least 3 months prior to Day 1
* Moderately to severely active UC as determined by the Mayo Clinic Score (MCS) assessment
* Treatment within 5 years prior to screening with one or two induction regimens that contain TNF inhibitors (including TNF inhibitor biosimilars)
* Washout of anti-TNF therapy for at least 8 weeks preceding Day 1
* Background regimen for UC may include oral 5-aminosalicylic acid (5-ASA), oral corticosteroids, budesonide, probiotics, azathioprine (AZA), 6-mercaptopurine (6-MP), or methotrexate (MTX) if doses have been stable during the screening period
* Use of highly effective contraception as defined by the protocol
* Must have received a colonoscopy within the past year or be willing to undergo a colonoscopy in lieu of a flexible sigmoidoscopy at screening

Exclusion Criteria:

* A history of or current conditions and diseases affecting the digestive tract, such as indeterminate colitis, suspicion of ischemic colitis, radiation colitis, or microscopic colitis, Crohn's disease, fistulas or abdominal abscesses, colonic mucosal dysplasia, intestinal obstruction, toxic megacolon, or unremoved adenomatous colonic polyps
* Prior or planned surgery for UC
* Past or present ileostomy or colostomy
* Any prior treatment with etrolizumab or other anti-integrin agents (including natalizumab, vedolizumab, and efalizumab)
* Any prior treatment with anti-adhesion molecules (e.g. anti-MAdCAM-1)
* Any prior treatment with rituximab
* Any treatment with tofacitinib during screening
* Congenital or acquired immune deficiency, chronic hepatitis B or C infection, human immunodeficiency virus (HIV) positive, or history of tuberculosis (active or latent)
* Evidence of or treatment for Clostridium difficile or clinically significant cytomegalovirus (CMV) colitis within 60 days prior to Day 1
* Evidence of or treatment for other intestinal pathogens within 30 days prior to Day 1
* History of recurrent opportunistic infections and/or severe disseminated viral infections
* History of organ transplant
* Any major episode of infection requiring treatment with intravenous (IV) antibiotics within 8 weeks prior to screening or oral antibiotics within 4 weeks prior to screening
* Received a live attenuated vaccine within 4 weeks prior to Day 1

Primary outcomes:
measure: Induction Phase: Percentage of Participants With Remission at Week 14, as Determined by the Mayo Clinic Score (MCS)
timeFrame: Week 14
measure: Maintenance Phase: Percentage of Participants With Remission at Week 66 Among Participants Who Had Achieved a Clinical Response at Week 14, as Determined by the MCS
timeFrame: Week 66
Secondary outcomes:
measure: Induction Phase: Percentage of Participants With Clinical Remission at Week 14, as Determined by the MCS
timeFrame: Week 14
measure: Induction Phase: Percentage of Participants With Clinical Response at Week 14, as Determined by the MCS
timeFrame: Week 14
measure: Induction Phase: Percentage of Participants With Improvement From Baseline in Endoscopic Appearance of the Mucosa at Week 14, as Determined by the MCS Endoscopic Subscore
timeFrame: Baseline and Week 14
measure: Induction Phase: Percentage of Participants With Endoscopic Remission at Week 14, as Determined by the MCS Endoscopic Subscore
timeFrame: Week 14
measure: Induction Phase: Percentage of Participants With Histologic Remission at Week 14, as Determined by the Nancy Histological Index
timeFrame: Week 14
measure: Induction Phase: Change From Baseline to Week 6 in MCS Rectal Bleed Subscore
timeFrame: Baseline and Week 6
measure: Induction Phase: Change From Baseline to Week 6 in MCS Stool Frequency Subscore
timeFrame: Baseline and Week 6
measure: Induction Phase: Change From Baseline to Week 14 in UC Bowel Movement Signs and Symptoms, as Assessed by the Ulcerative Colitis Patient-Reported Outcome Signs and Symptoms (UC-PRO/SS) Questionnaire
timeFrame: Baseline and Week 14
measure: Induction Phase: Change From Baseline to Week 14 in UC Functional Symptoms, as Assessed by the UC-PRO/SS Questionnaire
timeFrame: Baseline and Week 14
measure: Induction Phase: Change From Baseline to Week 14 in Health-Related Quality of Life, as Assessed by the Overall Score of the Inflammatory Bowel Disease Questionnaire (IBDQ)
timeFrame: Baseline and Week 14
measure: Maintenance Phase: Percentage of Participants With Clinical Remission at Week 66 Among Participants Who Had Achieved Clinical Remission at Week 14, as Determined by the MCS
timeFrame: Week 66
measure: Maintenance Phase: Percentage of Participants With Clinical Remission at Week 66, as Determined by the MCS
timeFrame: Week 66
measure: Maintenance Phase: Percentage of Participants With Remission at Week 66 Among Participants Who Had Achieved Remission at Week 14, as Determined by the MCS
timeFrame: Week 66
measure: Maintenance Phase: Percentage of Participants With Improvement From Baseline in Endoscopic Appearance of the Mucosa at Week 66, as Determined by the MCS Endoscopic Subscore
timeFrame: Baseline and Week 66
measure: Maintenance Phase: Percentage of Participants With Histologic Remission at Week 66, as Determined by the Nancy Histological Index
timeFrame: Week 66
measure: Maintenance Phase: Percentage of Participants With Endoscopic Remission at Week 66, as Determined by the MCS Endoscopic Subscore
timeFrame: Week 66
measure: Maintenance Phase: Percentage of Participants With Corticosteroid-Free Clinical Remission at Week 66 Among Participants Who Were Receiving Corticosteroids at Baseline, as Determined by the MCS
timeFrame: Week 66
measure: Maintenance Phase: Percentage of Participants With Corticosteroid-Free Remission at Week 66 Among Participants Who Were Receiving Corticosteroids at Baseline, as Determined by the MCS
timeFrame: Week 66
measure: Maintenance Phase: Change From Baseline to Week 66 in UC Bowel Movement Signs and Symptoms, as Assessed by the UC-PRO/SS Questionnaire
timeFrame: Baseline and Week 66
measure: Maintenance Phase: Change From Baseline to Week 66 in UC Functional Symptoms, as Assessed by the UC-PRO/SS Questionnaire
timeFrame: Baseline and Week 66
measure: Maintenance Phase: Change From Baseline to Week 66 in Health-Related Quality of Life, as Assessed by the Overall Score of the IBDQ
timeFrame: Baseline and Week 66
measure: Number of Participants With at Least One Adverse Event by Severity, According to National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 (NCI-CTCAE v4.0)
timeFrame: From Baseline up to Week 78
measure: Number of Participants With Adverse Events Leading to Study Drug Discontinuation
timeFrame: From Baseline up to Week 78
measure: Number of Participants With Serious Infection-Related Adverse Events
timeFrame: From Baseline up to Week 78
measure: Number of Participants With Infection-Related Adverse Events
timeFrame: From Baseline up to Week 78
measure: Number of Participants With Injection-Site Reaction-Related Adverse Events
timeFrame: From Baseline up to Week 78
measure: Number of Participants With Hypersensitivity Reaction-Related Adverse Events
timeFrame: From Baseline up to Week 78
measure: Number of Participants With Malignancies
timeFrame: From Baseline up to Week 78
measure: Number of Participants With Anti-Therapeutic Antibodies to Etrolizumab at Baseline and During the Study
timeFrame: Pre-dose at Baseline, Weeks 4, 14, 24, 44, and 66, and Early Termination/End of Safety Follow-Up (up to Week 78)
measure: Etrolizumab Serum Trough Concentration (for Arms/Timepoints Above LLOQ)
timeFrame: Pre-dose (0 hour) at Baseline and Weeks 14, 24, 44 and 66
measure: Etrolizumab Serum Trough Concentration (for Arms/Timepoints Below LLOQ)
timeFrame: Weeks 44 and 66
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: La Jolla
country: United States
facility: University of California San Diego Medical Center
state: California
city: San Diego
country: United States
facility: Clinical Applications Laboratories, Inc.
state: California
city: San Diego
country: United States
facility: Precision Research Institute, LLC
state: California
city: San Francisco
country: United States
facility: University of California at San Francisco
state: California
city: Denver
country: United States
facility: Rocky Mountain Gastroenterology Associates
state: Colorado
city: Lakewood
country: United States
facility: Rocky Mountain Gastroenterology Associates, P.L.L.C.; Gastroenterology
state: Colorado
city: Miramar
country: United States
facility: FQL Research, LLC
state: Florida
city: Orlando
country: United States
facility: Center For Digestive Health
state: Florida
city: Orlando
country: United States
facility: Internal Medicine Specialists
state: Florida
city: Winter Park
country: United States
facility: Shafran Gastroenterology Center
state: Florida
city: Macon
country: United States
facility: Gastroenterology Associates of Central Georgia
state: Georgia
city: Marietta
country: United States
facility: Gastrointestinal Specialists of Georgia, PC
state: Georgia
city: Suwanee
country: United States
facility: Atlanta Gastroenterology Specialists, PC
state: Georgia
city: Chicago
country: United States
facility: Northwestern University Feinberg School Of Medicine
state: Illinois
city: Oak Lawn
country: United States
facility: Southwest Gastroenterology
state: Illinois
city: Topeka
country: United States
facility: Cotton-O'Neil Clinical Research Center, Digestive Health
state: Kansas
city: Baton Rouge
country: United States
facility: Gastroenterology Associates, LLC
state: Louisiana
city: Shreveport
country: United States
facility: Louisiana Research Center, LLC
state: Louisiana
city: Boston
country: United States
facility: Massachusetts General Hospital; Crohn's & Colitis Center
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan; Michigan Institute for Clinical and Health Research (MICHR)
state: Michigan
city: Detroit
country: United States
facility: Henry Ford Health System
state: Michigan
city: Troy
country: United States
facility: Center for Digestive Health
state: Michigan
city: Kansas City
country: United States
facility: Kansas City Research Institute, LLC
state: Missouri
city: Great Neck
country: United States
facility: Clinica Peruano Americana S.A.
state: New York
city: New York
country: United States
facility: Weill Cornell Medical College-New York Presbyterian Hospital
state: New York
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill
state: North Carolina
city: Cincinnati
country: United States
facility: Consultants for Clinical Research Inc.
state: Ohio
city: Cincinnati
country: United States
facility: UC Health, LLC.
state: Ohio
city: Mentor
country: United States
facility: Great Lakes Gastroenterology Research, LLC
state: Ohio
city: Memphis
country: United States
facility: Gastroenterology Center of the Midsouth, P.C.
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Tyler
country: United States
facility: Tyler Research Institute, LLC
state: Texas
city: Clinton
country: United States
facility: Ericksen Research and Development
state: Utah
city: Salt Lake City
country: United States
facility: University of Utah School of Medicine
state: Utah
city: Norfolk
country: United States
facility: Digestive and Liver Disease Specialists, Ltd.
state: Virginia
city: Richmond
country: United States
facility: McGuire Research Institute; Gastroenterology
state: Virginia
city: Bellevue
country: United States
facility: Washington Gastroenterology
state: Washington
city: Rosario
country: Argentina
facility: Hospital Provincial del Centenario
city: Herston
country: Australia
facility: Royal Brisbane and Women's Hospital
state: Queensland
city: South Brisbane
country: Australia
facility: Mater Adult Hospital
state: Queensland
city: Woolloongabba
country: Australia
facility: Princess Alexandra Hospital
state: Queensland
city: Launceston
country: Australia
facility: Launceston General Hospital; Gastroenterology Research
state: Tasmania
city: Fitzroy
country: Australia
facility: St Vincent's Hospital Melbourne
state: Victoria
city: Footscray
country: Australia
facility: Footscray Hospital; Gastroenterology
state: Victoria
city: Malvern
country: Australia
facility: St Frances Xavier Cabrini Hospital
state: Victoria
city: Murdoch
country: Australia
facility: Fiona Stanley Hospital
state: Western Australia
city: Klagenfurt
country: Austria
facility: Klinikum Klagenfurt am Wörtersee; Acute geriatric care
city: Salzburg
country: Austria
facility: LKH - Universitätsklinikum der PMU Salzburg
city: Wien
country: Austria
facility: Medizinische Universität Wien
city: Bonheiden
country: Belgium
facility: Imeldaziekenhuis
city: Brussels
country: Belgium
facility: CHU St Pierre (St Pierre)
city: Brussel
country: Belgium
facility: UZ Brussel
city: Gent
country: Belgium
facility: UZ Gent
city: Herentals
country: Belgium
facility: AZ Sint Elisabeth Herentals
city: Leuven
country: Belgium
facility: UZ Leuven; Neurology
city: Liège
country: Belgium
facility: CHU de Liège; Tour de Pathologie
city: Roeselare
country: Belgium
facility: AZ Delta (Stedelijk Ziekenhuis)
city: Goiânia
country: Brazil
facility: Instituto Goiano de Gastroenterologia e Endoscopia Digestiva Ltda
state: GO
city: Belo Horizonte
country: Brazil
facility: Hospital Felicio Rocho
state: MG
city: Curitiba
country: Brazil
facility: Centro Digestivo de Curitiba
state: PR
city: Rio de Janeiro
country: Brazil
facility: Hospital Universitario Clementino Fraga Filho - UFRJ
state: RJ
city: Porto Alegre
country: Brazil
facility: Hospital Moinhos de Vento
state: RS
city: Porto Alegre
country: Brazil
facility: Hospital de Clínicas de Porto Alegre X
state: RS
city: Botucatu
country: Brazil
facility: UNESP - Faculdade de Medicina da Universidade Estadual Paulista - Campus Botucatu
state: SP
city: Campinas
country: Brazil
facility: CAEP - Centro Avancado de Estudos e Pesquisas Ltda.
state: SP
city: Santo Andre
country: Brazil
facility: Hospital Estadual Mario Covas
state: SP
city: Calgary
country: Canada
facility: University of Calgary; Heritage Medical Research Clinic
state: Alberta
city: Edmonton
country: Canada
facility: Zeidler Ledcor Centre - University of Alberta; Division of Gasroenterology
state: Alberta
city: Vancouver
country: Canada
facility: Pacific Gastroenterology Associates
state: British Columbia
city: Halifax
country: Canada
facility: Queen Elizabeth II Health Sciences Centre; Gastroenterology Research
state: Nova Scotia
city: Oshawa
country: Canada
facility: Taunton Health Centre
state: Ontario
city: Toronto
country: Canada
facility: Mount Sinai Hospital
state: Ontario
city: Toronto
country: Canada
facility: Toronto Liver Centre
state: Ontario
city: Vaughan
country: Canada
facility: Toronto Digestive Disease Associates
state: Ontario
city: Levis
country: Canada
facility: Hotel Dieu de Levis
state: Quebec
city: Montreal
country: Canada
facility: Hôpital Maisonneuve - Rosemont
state: Quebec
city: Brno
country: Czechia
facility: Fakultni nemocnice Brno; Interni kardiologicka klinika
city: Hradec Kralove
country: Czechia
facility: Hepato-Gastroenterologie HK, s.r.o.
city: Pardubice
country: Czechia
facility: Pardubicka krajska nemocnice, a.s.
city: Prague
country: Czechia
facility: Nemocnice Na Bulovce
city: Praha 7
country: Czechia
facility: ISCARE a.s.
city: Usti Nad Labem
country: Czechia
facility: Krajska zdravotni, a.s. - Masarykova nemocnice v Usti nad Labem, o.z., Ocni oddeleni
city: København Ø
country: Denmark
facility: Rigshospitalet; Medicinsk gastroenterologisk klinik
city: Ålborg
country: Denmark
facility: Ålborg Universitets Hospital; Gastromedicinsk
city: Amiens Cedex01
country: France
facility: CHU Amiens - Hopital Sud; Pharmacie - Secteur des Essais cliniques
city: Clichy cedex
country: France
facility: Hôpital Beaujon
city: Lille
country: France
facility: Hopital Claude Huriez - CHU Lille
city: Marseille cedex 20
country: France
facility: Hôpital Nord - CHU Marseille; Gastroenterology and Hepatology
city: Nice
country: France
facility: CHU Nice - Hopital de l'Archet 2
city: Paris
country: France
facility: Hôpital Saint-Louis
city: Pessac
country: France
facility: Groupe Hospitalier Sud - Hôpital Haut-Lévêque - USN
city: Saint Etienne
country: France
facility: CHU Saint Etienne - Hôpital Nord
city: Strasbourg
country: France
facility: Höpital Hautepierre; Pediatrie1
city: Toulouse Cedex 09
country: France
facility: CHU de Toulouse - Hôpital Rangueil
city: Vandoeuvre-les-nancy
country: France
facility: Hôpital de Brabois Adultes
city: Berlin
country: Germany
facility: Charite Universitaetsmedizin Berlin - Campus Charite Mitte
city: Berlin
country: Germany
facility: DRK Kliniken Berlin Westend
city: Erlangen
country: Germany
facility: Universitaetsklinikum Erlangen
city: Frankfurt
country: Germany
facility: Klinikum der Johann Wolfgang Goethe-Universitaet
city: Freiburg
country: Germany
facility: Universitätsklinikum Freiburg; Innere Medizin I; Hämatologie, Onkologie und Stammzelltransplantation
city: Halle
country: Germany
facility: Universitaetsklinikum Halle (Saale)
city: Hamburg
country: Germany
facility: Hamburgisches Forschungsinstitut fuer CED
city: Hamburg
country: Germany
facility: Universitätsklinikum Hamburg-Eppendorf
city: Hamburg
country: Germany
facility: Gastroenterologie Eppendorfer Baum
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover; Klinik für Gastroenterologie, Hepatologie und Endokrinologie
city: Kiel
country: Germany
facility: Universitaetsklinikum Schleswig-Holstein, Campus Kiel
city: Mannheim
country: Germany
facility: Klinikum Mannheim GmbH Universitätsklinikum
city: Muenster
country: Germany
facility: Universitaetsklinikum Muenster
city: Ulm
country: Germany
facility: Universitaetsklinikum Ulm
city: Thessaloniki
country: Greece
facility: Anticancer Hospital of Thessaliniki " Theagenio"
city: Bekescsaba
country: Hungary
facility: Bekes Megyei Kozponti Korhaz Dr. Rethy Pal Tagkorhaza
city: Budapest
country: Hungary
facility: Obudai Egeszsegugyi Centrum Kft.
city: Budapest
country: Hungary
facility: Semmelweis Egyetem
city: Budapest
country: Hungary
facility: Eszak-Kozep-budai Centrum, Uj Szent Janos Korhaz es Szakrendelo
city: Budapest
country: Hungary
facility: Pannonia Maganorvosi Centrum
city: Budapest
country: Hungary
facility: Magyar Honvedseg Egeszsegugyi Kozpont; Fázis I-es Klinikai Farmakológiai Vizsgálóhely
city: Debrecen
country: Hungary
facility: Debreceni Egyetem
city: Eger
country: Hungary
facility: Markhot Ferenc Oktato Korhaz es Rendelointezet
city: Gyor
country: Hungary
facility: Petz Aladar Megyei Oktato Korhaz
city: Miskolc
country: Hungary
facility: Borsod-Abauj-Zemplen Megyei Korhaz es Egyetemi Oktato Korhaz; II. Belgyogyaszat
city: Pecs
country: Hungary
facility: Pecsi Tudomanyegyetem
city: Székesfehérvár
country: Hungary
facility: Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz
city: Jerusalem
country: Israel
facility: Shaare Zedek Medical Center
city: Jerusalem
country: Israel
facility: Hadassah University Hospital - Ein Kerem; Neurosurgery
city: Petach Tiqwa
country: Israel
facility: Rabin Medical Center-Beilinson Campus; Gaucher Clinic, Genetics Institute
city: Rehovot
country: Israel
facility: Kaplan Medical Center
city: Rishon Lezion
country: Israel
facility: Assaf Harofeh
city: Bologna
country: Italy
facility: Azienda Ospedaliera S. Orsola-Malpighi
state: Emilia-Romagna
city: Modena
country: Italy
facility: A.O.U. Policlinico di Modena
state: Emilia-Romagna
city: Roma
country: Italy
facility: Azienda Ospedaliera Universitaria Policlinico Tor Vergata
state: Lazio
city: Roma
country: Italy
facility: Azienda Ospedaliera San Camillo Forlanini
state: Lazio
city: Roma
country: Italy
facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
state: Lazio
city: Milano
country: Italy
facility: Azienda Socio Sanitaria Territoriale Fatebenefratelli (Presidio Ospedale Sacco)
state: Lombardia
city: Rho
country: Italy
facility: Ospedale di Circolo; Neuropsichiatria Infantile
state: Lombardia
city: Rozzano (MI)
country: Italy
facility: Istituto Clinico Humanitas
state: Lombardia
city: San Donato Milanese (MI)
country: Italy
facility: I.R.C.C.S Policlinico San Donato
state: Lombardia
city: Firenze
country: Italy
facility: Azienda Ospedaliera Universitaria Careggi
state: Toscana
city: Padova
country: Italy
facility: Azienda Ospedaliera Di Padova
state: Veneto
city: Daegu
country: Korea, Republic of
facility: Kyungpook National University Hospital; Opthalmology
city: Gyeonggi-do
country: Korea, Republic of
facility: Korea University Ansan Hospital
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Severance Hospital, Yonsei University
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center.
city: Suwon-si,
country: Korea, Republic of
facility: The Catholic University of Korea St. Vincent's Hospital
city: Kaunas
country: Lithuania
facility: Hospital of Lithuanian University of Health. Sciences Kaunas Clinics
city: Vilnius
country: Lithuania
facility: Vilnius University Hospital Santariskiu Clinic Public Insti
city: Monterrey
country: Mexico
facility: Centro Regiomontano de Estudios Clínicos Roma S.C.
state: Nuevo LEON
city: Amsterdam
country: Netherlands
facility: Amsterdam UMC, Locatie VUMC; Neurology
city: Amsterdam
country: Netherlands
facility: Amsterdam UMC Location AMC
city: Arnhem
country: Netherlands
facility: Rijnstate; Internal Medicine Department
city: NL -nijmegen
country: Netherlands
facility: Radboudumc
city: Bydgoszcz
country: Poland
facility: Nasz Lekarz Osrodek Badan Klinicznych
city: Katowice
country: Poland
facility: Nzoz All-Medicus
city: Rzeszów
country: Poland
facility: Gabinet Lekarski, Bartosz Korczowski
city: Szczecin
country: Poland
facility: Niepubliczny Zaklad Opieki Zdrowotnej SONOMED
city: Warszawa
country: Poland
facility: Centrum Zdrowia MDM
city: Warszawa
country: Poland
facility: Narodowy Instytut Onkologii im. Marii Skłodowskiej-Curie - Państwowy Instytut Badawczy
city: Warszawa
country: Poland
facility: Nzoz Vivamed
city: Wroclaw
country: Poland
facility: LexMedica Osrodek Badan Klinicznych
city: Wroclaw
country: Poland
facility: EuroMediCare Szpital Specjalistyczny z Przychodnią we Wrocławiu
city: Wrocław
country: Poland
facility: PlanetMed
city: Bucuresti
country: Romania
facility: SC Euroclinic Hospital SA
city: Alcorcon
country: Spain
facility: Fundacion Hospital de Alcorcon; Servicio de Digestivo
state: Madrid
city: Girona
country: Spain
facility: Hospital Universitari de Girona Dr Josep Trueta
city: Madrid
country: Spain
facility: Hospital Universitario de la Princesa
city: Madrid
country: Spain
facility: Hospital Universitario de Fuenlabrada
city: Valencia
country: Spain
facility: Hospital Universitari i Politecnic La Fe
city: Zaragoza
country: Spain
facility: Hospital Universitario Miguel Servet
city: Bern
country: Switzerland
facility: Inselspital-Universitaetsspital Bern; Institut fuer Spitalpharmazie
city: Bern
country: Switzerland
facility: Cliniques Universitaires Saint-Luc; Nephrology
city: Bern
country: Switzerland
facility: Crohn-Colitis Zentrum Bern - Gemeinschaftspraxis Balsiger, Seibold und Partner
city: Cambridge
country: United Kingdom
facility: Addenbrooke's Hospital
city: Exeter
country: United Kingdom
facility: Royal Devon and Exeter Hospital (Wonford)
city: London
country: United Kingdom
facility: The Royal London Hospital
city: London
country: United Kingdom
facility: University College London Hospital
city: London
country: United Kingdom
facility: St Thomas Hospital
city: London
country: United Kingdom
facility: King's College London
city: Manchester
country: United Kingdom
facility: Fairfield General Hospital
city: Newcastle upon Tyne
country: United Kingdom
facility: Royal Victoria Infirmary
city: Nottingham
country: United Kingdom
facility: Nottingham University Hospitals; QMC Campus
city: Southampton
country: United Kingdom
facility: Southampton General Hospital
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Peyrin-Biroulet L, Hart A, Bossuyt P, Long M, Allez M, Juillerat P, Armuzzi A, Loftus EV Jr, Ostad-Saffari E, Scalori A, Oh YS, Tole S, Chai A, Pulley J, Lacey S, Sandborn WJ; HICKORY Study Group. Etrolizumab as induction and maintenance therapy for ulcerative colitis in patients previously treated with tumour necrosis factor inhibitors (HICKORY): a phase 3, randomised, controlled trial. Lancet Gastroenterol Hepatol. 2022 Feb;7(2):128-140. doi: 10.1016/S2468-1253(21)00298-3. Epub 2021 Nov 17.
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.