A Study Comparing the Efficacy and Safety of Etrolizumab to Infliximab in Participants With Moderate to Severe Ulcerative Colitis Who Are Naïve to Tumor Necrosis Factor (TNF) Inhibitors
NCT ID: NCT02136069
Last Updated: 2021-12-03
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
397 participants
INTERVENTIONAL
2014-12-24
2020-06-23
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Etrolizumab + Placebo (IV)
Participants will receive ertolizumab (SC) Q4W until Week 52 along with placebo matched to infliximab as IV infusion until Week 46.
Etrolizumab
105 mg administered by subcutaneous (SC) injection once every 4 weeks (Q4W) until Week 52.
Placebo (IV)
Administered by (IV) infusion at Weeks 0, 2, and 6 and then every 8 weeks until Week 46.
Infliximab + Placebo (Injection)
Participants will receive IV infusion of infliximab at Weeks 0,2, and 6, then every 8 weeks until Week 46 partnered with placebo matched to etrolizumab by SC injection Q4W until Week 52.
Infliximab
5 mg/kg of infliximab will be administered by intravenous (IV) infusion at Weeks 0, 2, and 6 and then every 8 weeks until Week 46.
Placebo (Injection)
Administered by SC injection Q4W until Week 52
Interventions
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Etrolizumab
105 mg administered by subcutaneous (SC) injection once every 4 weeks (Q4W) until Week 52.
Infliximab
5 mg/kg of infliximab will be administered by intravenous (IV) infusion at Weeks 0, 2, and 6 and then every 8 weeks until Week 46.
Placebo (IV)
Administered by (IV) infusion at Weeks 0, 2, and 6 and then every 8 weeks until Week 46.
Placebo (Injection)
Administered by SC injection Q4W until Week 52
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Naive to treatment with any anti-TNF inhibitor therapy (including TNF inhibitor biosimilars)
* An inadequate response to or intolerance of prior corticosteroid and/or immunosuppressant treatment
* Background regimen for UC may include oral 5-aminosalicylate (5-ASA), oral corticosteroids, budenoside multi-matrix system (MMX), probiotics, azathioprine (AZA), 6-mercaptopurine (6-MP), or methotrexate (MTX) if doses have been stable during the screening period
* Use of highly effective contraception during and at least 24 weeks after the last dose of study drug
Exclusion Criteria
* Prior or planned surgery for UC
* Past or present ileostomy or colostomy
* Have received non-permitted inflammatory bowel disease (IBD) therapies (including natalizumab, vedolizumab, efalizumab, and tofactinib)
* History of moderate or severe allergic or anaphylactic/anaphylactoid reactions to chimeric, human, or humanized antibodies; fusion proteins, or murine proteins; hypersensitivity to etrolizumab or any of its excipients
* Chronic hepatitis B or C infection, Human deficiency virus (HIV) or tuberculosis (active or latent)
18 Years
80 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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LKH - Universitätsklinikum der PMU Salzburg
Salzburg, , Austria
GZA Ziekenhuizen - Campus Sint-Vincentius
Antwerp, , Belgium
Imeldaziekenhuis
Bonheiden, , Belgium
CHU St Pierre (St Pierre)
Brussels, , Belgium
Universitair Ziekenhuis Brussel; Neurology
Brussels, , Belgium
Cliniques Universitaires Saint-Luc; Pharmacy
Brussels, , Belgium
UZ Gent
Ghent, , Belgium
AZ Sint Elisabeth Herentals
Herentals, , Belgium
University of Calgary; Heritage Medical Research Clinic
Calgary, Alberta, Canada
Zeidler Ledcor Centre - University of Alberta; Division of Gasroenterology
Edmonton, Alberta, Canada
Guelph GI & Surgery Clinic
Guelph, Ontario, Canada
Centre de santé et de services sociaux Champlain-Charles-Le Moyne
Greenfield Park, Quebec, Canada
Hôpital Maisonneuve - Rosemont
Montreal, Quebec, Canada
Royal University Hospital
Saskatoon, Saskatchewan, Canada
Vojenska nemocnice Brno
Brno, , Czechia
Fakultni nemocnice Hradec Kralove
Hradec Králové, , Czechia
Oblastni nemocnice Kladno, a.s., nemocnice Stredoces. kraje; Endoskopicke centrum
Kladno, , Czechia
Mestska Nemocnice Ostrava
Ostrava, , Czechia
Pardubicka krajska nemocnice, a.s.
Pardubice, , Czechia
ISCARE a.s.
Prague, , Czechia
Krajska zdravotni, a.s. - Masarykova nemocnice v Usti nad Labem, o.z., Ocni oddeleni
Ústí nad Labem, , Czechia
Krajska nemocnice T. Bati, a.s.
Zlín, , Czechia
CHU de Caen - Hopital Cote de Nacre
Caen, , France
CHU Tours - Hôpital Trousseau
Chambray-lès-Tours, , France
CHU Clermont Ferrand - Hôtel Dieu
Clermont-Ferrand, , France
Hôpital Beaujon
Clichy, , France
CHU Hopital Saint Eloi
Montpellier, , France
CHU Nice - Hopital de l'Archet 2
Nice, , France
Centre Hospitalier Lyon Sud; Service de Gastro-Enterologie
Pierre-Bénite, , France
Hôpital de Brabois Adultes
Vandœuvre-lès-Nancy, , France
Charite Universitaetsmedizin Berlin - Campus Benjamin Franklin
Berlin, , Germany
DRK Kliniken Berlin Westend
Berlin, , Germany
Krankenhaus Waldfriede e. V.
Berlin, , Germany
Universitätsklinikum Koeln
Cologne, , Germany
Universitätsklinikum Freiburg; Innere Medizin I; Hämatologie, Onkologie und Stammzelltransplantation
Freiburg im Breisgau, , Germany
Gastroenterologie Eppendorfer Baum
Hamburg, , Germany
Universitaetsklinikum Schleswig-Holstein, Campus Kiel
Kiel, , Germany
Bekes Megyei Kozponti Korhaz Dr. Rethy Pal Tagkorhaza
Békéscsaba, , Hungary
Semmelweis Egyetem
Budapest, , Hungary
Eszak-Kozep-budai Centrum, Uj Szent Janos Korhaz es Szakrendelo
Budapest, , Hungary
Magyar Honvedseg Egeszsegugyi Kozpont; Fázis I-es Klinikai Farmakológiai Vizsgálóhely
Budapest, , Hungary
Vasutegeszsegugyi Nonprofit KiemeltenKozhasznu Kft
Debrecen, , Hungary
Markhot Ferenc Oktato Korhaz es Rendelointezet
Eger, , Hungary
Petz Aladar Megyei Oktato Korhaz
Győr, , Hungary
Borsod-Abauj-Zemplen Megyei Korhaz es Egyetemi Oktato Korhaz; II. Belgyogyaszat
Miskolc, , Hungary
Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont
Szeged, , Hungary
Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz
Székesfehérvár, , Hungary
Rabin Medical Center-Beilinson Campus
Petah Tikva, , Israel
Chaim Sheba Medical Center; Pediatrics B North and Pediatric Endocrinology Unit
Tel Litwinsky, , Israel
Azienda Ospedaliero Universitaria di Parma
Parma, Emilia-Romagna, Italy
Azienda Ospedaliera Universitaria Policlinico Tor Vergata
Rome, Lazio, Italy
Azienda Ospedaliera San Camillo Forlanini
Rome, Lazio, Italy
Asst Fatebenefratelli Sacco (Fatebenefratelli)
Milan, Lombardy, Italy
Azienda Socio Sanitaria Territoriale Niguarda (Grande Ospedale Metropolitano Niguarda)
Milan, Lombardy, Italy
Azienda Socio Sanitaria Territoriale Fatebenefratelli (Presidio Ospedale Sacco)
Milan, Lombardy, Italy
Istituto Clinico Humanitas
Rozzano (MI), Lombardy, Italy
I.R.C.C.S Policlinico San Donato
San Donato Milanese (MI), Lombardy, Italy
IRCCS Ospedale Casa Sollievo della Soffenza; Stru Comp di Gastroenterologia ed Endoscopia digest
San Giovanni Rotondo, Lombardy, Italy
Ospedale Mauriziano Umberto I
Turin, Piedmont, Italy
Azienda Ospedaliera Universitaria Careggi
Florence, Tuscany, Italy
Azienda Ospedaliero Universitaria Pisana
Pisa, Tuscany, Italy
Azienda Ospedaliera Di Padova
Padua, Veneto, Italy
Amsterdam UMC Location VUMC
Amsterdam, , Netherlands
Amsterdam UMC Location AMC
Amsterdam, , Netherlands
Maastricht University Medical Center
Maastricht, , Netherlands
Radboudumc
NL -nijmegen, , Netherlands
Akershus universitetssykehus HF
Lørenskog, , Norway
Hospital de Braga
Braga, , Portugal
Hospital da Senhora da Oliveira Guimarães
Guimarães, , Portugal
S.C MedLife S.A
Bucharest, , Romania
Institutul Clinic Fundeni Bucuresti
Bucharest, , Romania
Centrul Medical Unirea SRL
Bucharest, , Romania
Spitalul Clinic Colentina
Bucharest, , Romania
Spitalul Clinic Judetean Mures
Târgu Mureş, , Romania
Centrul de Gastroenterologie Dr. Goldis
Timișoara, , Romania
Singapore General Hospital
Singapore, , Singapore
Netcare Universitas Private Hospital
Bloemfontein, , South Africa
Dr MJ Prins Practice
Cape Town, , South Africa
Dr Corne Kruger Inc.
Cape Town, , South Africa
Dong-A University Hospital
Busan, , South Korea
Pusan National University Hospital
Busan, , South Korea
Kyungpook National University Chilgok Hospital
Daegu, , South Korea
Keimyung University Dongsan Medical Center
Daegu, , South Korea
Kyungpook National University Hospital
Daegu, , South Korea
Yeungnam Univ. Hospital
Daegu, , South Korea
Korea University Ansan Hospital
Gyeonggi-do, , South Korea
CHA Bundang Medical Centre; CHA university
Seongnam, , South Korea
Seoul National University Bundang Hospital
Seongnam-si, , South Korea
Kyung Hee University Hospital
Seoul, , South Korea
Seoul National University Hospital
Seoul, , South Korea
Kangbuk Samsung Hospital
Seoul, , South Korea
Severance Hospital, Yonsei University
Seoul, , South Korea
Asan Medical Center
Seoul, , South Korea
Samsung Medical Center
Seoul, , South Korea
The Catholic University of Korea St. Vincent's Hospital
Suwon, , South Korea
Ajou University Hospital
Suwon, , South Korea
Yonsei University Wonju Severance Christian Hospital
Wŏnju, , South Korea
Corporacio Sanitaria Parc Tauli
Sabadell, Barcelona, Spain
Complejo Hospitalario Universitario de Ferrol
Ferrol, LA Coruña, Spain
Fundacion Hospital de Alcorcon; Servicio de Digestivo
Alcorcón, Madrid, Spain
Centro Médico Teknon
Barcelona, , Spain
Hospital Universitario de la Princesa
Madrid, , Spain
Hospital Universitario La Paz
Madrid, , Spain
Hospital Universitari i Politecnic La Fe
Valencia, , Spain
Danderyds Sjukhus AB
Stockholm, , Sweden
Inselspital-Universitaetsspital Bern
Bern, , Switzerland
Universitätsspital Zürich
Zurich, , Switzerland
The Royal Bournemouth Hospital
Bournemouth, , United Kingdom
Addenbrooke's Hospital
Cambridge, , United Kingdom
University Hospital Coventry
Coventry, , United Kingdom
Royal Devon and Exeter Hospital (Wonford)
Exeter, , United Kingdom
St James University Hospital
Leeds, , United Kingdom
The Royal London Hospital
London, , United Kingdom
St Thomas Hospital
London, , United Kingdom
King's College London
London, , United Kingdom
Fairfield General Hospital
Manchester, , United Kingdom
Royal Victoria Infirmary
Newcastle upon Tyne, , United Kingdom
Nottingham University Hospitals NHS Trust
Nottingham, , United Kingdom
Southampton General Hospital
Southampton, , United Kingdom
Countries
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References
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Danese S, Colombel JF, Lukas M, Gisbert JP, D'Haens G, Hayee B, Panaccione R, Kim HS, Reinisch W, Tyrrell H, Oh YS, Tole S, Chai A, Chamberlain-James K, Tang MT, Schreiber S; GARDENIA Study Group. Etrolizumab versus infliximab for the treatment of moderately to severely active ulcerative colitis (GARDENIA): a randomised, double-blind, double-dummy, phase 3 study. Lancet Gastroenterol Hepatol. 2022 Feb;7(2):118-127. doi: 10.1016/S2468-1253(21)00294-6. Epub 2021 Nov 17.
Sandborn WJ, Vermeire S, Tyrrell H, Hassanali A, Lacey S, Tole S, Tatro AR; Etrolizumab Global Steering Committee. Etrolizumab for the Treatment of Ulcerative Colitis and Crohn's Disease: An Overview of the Phase 3 Clinical Program. Adv Ther. 2020 Jul;37(7):3417-3431. doi: 10.1007/s12325-020-01366-2. Epub 2020 May 22.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2013-004282-14
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
GA29103
Identifier Type: -
Identifier Source: org_study_id