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
GARDENIA
Phase III, Randomized, Multicenter Double-Blind, Double Dummy Study to Evaluate the Efficacy and Safety of Etrolizumab Compared With Infliximab in Patients With Moderate to Severe Active Ulcerative Colitis Who Are Naive to TNF Inhibitors
2 other identifiers
interventional
397
20 countries
119
Brief Summary
This is a multicenter, Phase III, randomized, double-blind, double-dummy, parallel-group study to evaluate the safety, efficacy, and tolerability of etrolizumab compared with infliximab in treating participants with moderate to severe ulcerative colitis (UC) who are naive to tumor necrosis factor (TNF) inhibitors. Participants will be randomized in a 1:1 ratio to receive either etrolizumab 105 milligrams (mg) by subcutaneous (SC) injection once every 4 weeks (Q4W) + placebo (intravenous \[IV\] infusion at Weeks 0, 2, and 6, then once every 8 weeks \[Q8W\]) or infliximab 5 milligrams/kilogram (mg/kg) IV at Weeks 0, 2, and 6, then Q8W) + placebo (SC Q4W). Time on treatment is 54 weeks.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Dec 2014
Longer than P75 for phase_3
119 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 15, 2014
CompletedFirst Posted
Study publicly available on registry
May 12, 2014
CompletedStudy Start
First participant enrolled
December 24, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 23, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
June 23, 2020
CompletedResults Posted
Study results publicly available
August 13, 2021
CompletedDecember 3, 2021
December 1, 2021
5.5 years
April 15, 2014
June 18, 2021
December 1, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Percentage of Participants With Both Clinical Response at Week 10 and Clinical Remission at Week 54, as Determined by the Mayo Clinic Score (MCS)
Mayo Clinic Score (MCS) is a composite of 4 assessments, each rated from 0-3: stool frequency, rectal bleeding, endoscopy, and physician's global assessment. Higher scores indicate more severe disease. Clinical Response is MCS with ≥3-point decrease and 30% reduction from baseline as well as ≥1-point decrease in rectal bleeding subscore or an absolute rectal bleeding score of 0 or 1. Clinical Remission is MCS ≤2 with individual subscores ≤1.
Week 10, Week 54
Secondary Outcomes (21)
Percentage of Participants Achieving Clinical Remission at Week 10, Defined as MCS ≤2 With Individual Subscores ≤1
Week 10
Percentage of Participants Achieving Clinical Remission at Week 54, as Determined by the MCS
Week 54
Percentage of Participants Achieving Clinical Remission at Both Week 10 and Week 54, as Determined by the MCS
Week 10 and Week 54
Percentage of Participants Achieving Clinical Remission at Week 54 Among Those With a Clinical Response at Week 10, as Determined by the MCS
Week 10 and Week 54
Percentage of Participants With Improvement in Endoscopic Appearance of the Mucosa at Week 10, Determined by the MCS
Baseline to Week 10
- +16 more secondary outcomes
Study Arms (2)
Etrolizumab + Placebo (IV)
EXPERIMENTALParticipants will receive ertolizumab (SC) Q4W until Week 52 along with placebo matched to infliximab as IV infusion until Week 46.
Infliximab + Placebo (Injection)
ACTIVE COMPARATORParticipants 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.
Interventions
105 mg administered by subcutaneous (SC) injection once every 4 weeks (Q4W) until Week 52.
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.
Administered by (IV) infusion at Weeks 0, 2, and 6 and then every 8 weeks until Week 46.
Administered by SC injection Q4W until Week 52
Eligibility Criteria
You may qualify if:
- Moderately to severely active UC as determined by the Mayo Clinic Score assessment (MCS)
- 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
You may not qualify if:
- A history of or current conditions and diseases affecting the digestive tract, such as indeterminate colitis, suspicion of ischemic, radiation 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
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (119)
LKH - Universitätsklinikum der PMU Salzburg
Salzburg, 5020, Austria
GZA Ziekenhuizen - Campus Sint-Vincentius
Antwerp, 2018, Belgium
Imeldaziekenhuis
Bonheiden, 2820, Belgium
CHU St Pierre (St Pierre)
Brussels, 1000, Belgium
Universitair Ziekenhuis Brussel; Neurology
Brussels, 1090, Belgium
Cliniques Universitaires Saint-Luc; Pharmacy
Brussels, 1200, Belgium
UZ Gent
Ghent, 9000, Belgium
AZ Sint Elisabeth Herentals
Herentals, 2200, Belgium
University of Calgary; Heritage Medical Research Clinic
Calgary, Alberta, T2N 4Z6, Canada
Zeidler Ledcor Centre - University of Alberta; Division of Gasroenterology
Edmonton, Alberta, T6G 2X8, Canada
Guelph GI & Surgery Clinic
Guelph, Ontario, N1H 3R3, Canada
Centre de santé et de services sociaux Champlain-Charles-Le Moyne
Greenfield Park, Quebec, J4V 2H1, Canada
Hôpital Maisonneuve - Rosemont
Montreal, Quebec, H1T 2M4, Canada
Royal University Hospital
Saskatoon, Saskatchewan, S7N 0W8, Canada
Vojenska nemocnice Brno
Brno, 636 00, Czechia
Fakultni nemocnice Hradec Kralove
Hradec Králové, 500 05, Czechia
Oblastni nemocnice Kladno, a.s., nemocnice Stredoces. kraje; Endoskopicke centrum
Kladno, 272 59, Czechia
Mestska Nemocnice Ostrava
Ostrava, 728 80, Czechia
Pardubicka krajska nemocnice, a.s.
Pardubice, 532 03, Czechia
ISCARE a.s.
Prague, 170 04, Czechia
Krajska zdravotni, a.s. - Masarykova nemocnice v Usti nad Labem, o.z., Ocni oddeleni
Ústí nad Labem, 401 13, Czechia
Krajska nemocnice T. Bati, a.s.
Zlín, 76001, Czechia
CHU de Caen - Hopital Cote de Nacre
Caen, 14033, France
CHU Tours - Hôpital Trousseau
Chambray-lès-Tours, 37170, France
CHU Clermont Ferrand - Hôtel Dieu
Clermont-Ferrand, 63000, France
Hôpital Beaujon
Clichy, 92110, France
CHU Hopital Saint Eloi
Montpellier, 34295, France
CHU Nice - Hopital de l'Archet 2
Nice, 06202, France
Centre Hospitalier Lyon Sud; Service de Gastro-Enterologie
Pierre-Bénite, 69495, France
Hôpital de Brabois Adultes
Vandœuvre-lès-Nancy, 54511, France
Charite Universitaetsmedizin Berlin - Campus Benjamin Franklin
Berlin, 12200, Germany
DRK Kliniken Berlin Westend
Berlin, 14050, Germany
Krankenhaus Waldfriede e. V.
Berlin, 14163, Germany
Universitätsklinikum Koeln
Cologne, 50937, Germany
Universitätsklinikum Freiburg; Innere Medizin I; Hämatologie, Onkologie und Stammzelltransplantation
Freiburg im Breisgau, 79106, Germany
Gastroenterologie Eppendorfer Baum
Hamburg, 20249, Germany
Universitaetsklinikum Schleswig-Holstein, Campus Kiel
Kiel, 24116, Germany
Bekes Megyei Kozponti Korhaz Dr. Rethy Pal Tagkorhaza
Békéscsaba, 5600, Hungary
Semmelweis Egyetem
Budapest, 1083, Hungary
Eszak-Kozep-budai Centrum, Uj Szent Janos Korhaz es Szakrendelo
Budapest, 1125, Hungary
Magyar Honvedseg Egeszsegugyi Kozpont; Fázis I-es Klinikai Farmakológiai Vizsgálóhely
Budapest, H-1077, Hungary
Vasutegeszsegugyi Nonprofit KiemeltenKozhasznu Kft
Debrecen, 4025, Hungary
Markhot Ferenc Oktato Korhaz es Rendelointezet
Eger, 3300, Hungary
Petz Aladar Megyei Oktato Korhaz
Győr, 9024, Hungary
Borsod-Abauj-Zemplen Megyei Korhaz es Egyetemi Oktato Korhaz; II. Belgyogyaszat
Miskolc, 3526, Hungary
Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont
Szeged, 6720, Hungary
Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz
Székesfehérvár, 8000, Hungary
Rabin Medical Center-Beilinson Campus
Petah Tikva, 4941492, Israel
Chaim Sheba Medical Center; Pediatrics B North and Pediatric Endocrinology Unit
Tel Litwinsky, 52621, Israel
Azienda Ospedaliero Universitaria di Parma
Parma, Emilia-Romagna, 43100, Italy
Azienda Ospedaliera Universitaria Policlinico Tor Vergata
Rome, Lazio, 00133, Italy
Azienda Ospedaliera San Camillo Forlanini
Rome, Lazio, 00152, Italy
Asst Fatebenefratelli Sacco (Fatebenefratelli)
Milan, Lombardy, 20121, Italy
Azienda Socio Sanitaria Territoriale Niguarda (Grande Ospedale Metropolitano Niguarda)
Milan, Lombardy, 20162, Italy
Azienda Socio Sanitaria Territoriale Fatebenefratelli (Presidio Ospedale Sacco)
Milan, Lombardy, Italy
Istituto Clinico Humanitas
Rozzano (MI), Lombardy, 20089, Italy
I.R.C.C.S Policlinico San Donato
San Donato Milanese (MI), Lombardy, 20097, Italy
IRCCS Ospedale Casa Sollievo della Soffenza; Stru Comp di Gastroenterologia ed Endoscopia digest
San Giovanni Rotondo, Lombardy, 71013, Italy
Ospedale Mauriziano Umberto I
Turin, Piedmont, 10128, Italy
Azienda Ospedaliera Universitaria Careggi
Florence, Tuscany, 50141, Italy
Azienda Ospedaliero Universitaria Pisana
Pisa, Tuscany, 56100, Italy
Azienda Ospedaliera Di Padova
Padua, Veneto, 35128, Italy
Amsterdam UMC Location VUMC
Amsterdam, 1081 HV, Netherlands
Amsterdam UMC Location AMC
Amsterdam, 1105 AZ, Netherlands
Maastricht University Medical Center
Maastricht, 6229 HX, Netherlands
Radboudumc
NL -nijmegen, 6525 GA, Netherlands
Akershus universitetssykehus HF
Lørenskog, 1478, Norway
Hospital de Braga
Braga, 4710-243, Portugal
Hospital da Senhora da Oliveira Guimarães
Guimarães, 4835-044, Portugal
S.C MedLife S.A
Bucharest, 010719, Romania
Institutul Clinic Fundeni Bucuresti
Bucharest, 022328, Romania
Centrul Medical Unirea SRL
Bucharest, 040055, Romania
Spitalul Clinic Colentina
Bucharest, 772202, Romania
Spitalul Clinic Judetean Mures
Târgu Mureş, 540103, Romania
Centrul de Gastroenterologie Dr. Goldis
Timișoara, 300002, Romania
Singapore General Hospital
Singapore, 169608, Singapore
Netcare Universitas Private Hospital
Bloemfontein, 9301, South Africa
Dr MJ Prins Practice
Cape Town, 7500, South Africa
Dr Corne Kruger Inc.
Cape Town, 7550, South Africa
Dong-A University Hospital
Busan, 49201, South Korea
Pusan National University Hospital
Busan, 49241, South Korea
Kyungpook National University Chilgok Hospital
Daegu, 41404, South Korea
Keimyung University Dongsan Medical Center
Daegu, 41931, South Korea
Kyungpook National University Hospital
Daegu, 41944, South Korea
Yeungnam Univ. Hospital
Daegu, 705-717, South Korea
Korea University Ansan Hospital
Gyeonggi-do, 15355, South Korea
CHA Bundang Medical Centre; CHA university
Seongnam, 13520, South Korea
Seoul National University Bundang Hospital
Seongnam-si, 13605, South Korea
Kyung Hee University Hospital
Seoul, 02447, South Korea
Seoul National University Hospital
Seoul, 03080, South Korea
Kangbuk Samsung Hospital
Seoul, 03181, South Korea
Severance Hospital, Yonsei University
Seoul, 03722, South Korea
Asan Medical Center
Seoul, 05505, South Korea
Samsung Medical Center
Seoul, 06351, South Korea
The Catholic University of Korea St. Vincent's Hospital
Suwon, 442-723, South Korea
Ajou University Hospital
Suwon, 443-721, South Korea
Yonsei University Wonju Severance Christian Hospital
Wŏnju, 220-701, South Korea
Corporacio Sanitaria Parc Tauli
Sabadell, Barcelona, 08208, Spain
Complejo Hospitalario Universitario de Ferrol
Ferrol, LA Coruña, 15405, Spain
Fundacion Hospital de Alcorcon; Servicio de Digestivo
Alcorcón, Madrid, 28922, Spain
Centro Médico Teknon
Barcelona, Spain
Hospital Universitario de la Princesa
Madrid, 28006, Spain
Hospital Universitario La Paz
Madrid, 280146, Spain
Hospital Universitari i Politecnic La Fe
Valencia, 46026, Spain
Danderyds Sjukhus AB
Stockholm, 18288, Sweden
Inselspital-Universitaetsspital Bern
Bern, 3010, Switzerland
Universitätsspital Zürich
Zurich, 8091, Switzerland
The Royal Bournemouth Hospital
Bournemouth, BH7 7DW, United Kingdom
Addenbrooke's Hospital
Cambridge, CB2 0QQ, United Kingdom
University Hospital Coventry
Coventry, CV2 2DX, United Kingdom
Royal Devon and Exeter Hospital (Wonford)
Exeter, EX2 5DW, United Kingdom
St James University Hospital
Leeds, LS9 7TF, United Kingdom
The Royal London Hospital
London, E1 1FR, United Kingdom
St Thomas Hospital
London, SE1 7EH, United Kingdom
King's College London
London, SE5 9NU, United Kingdom
Fairfield General Hospital
Manchester, M8 5RB, United Kingdom
Royal Victoria Infirmary
Newcastle upon Tyne, NE1 4LP, United Kingdom
Nottingham University Hospitals NHS Trust
Nottingham, NG7 2UH, United Kingdom
Southampton General Hospital
Southampton, SO16 6YD, United Kingdom
Related Publications (2)
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.
PMID: 34798038DERIVEDSandborn 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.
PMID: 32445184DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Medical Communications
- Organization
- Hoffmann-La Roche
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 15, 2014
First Posted
May 12, 2014
Study Start
December 24, 2014
Primary Completion
June 23, 2020
Study Completion
June 23, 2020
Last Updated
December 3, 2021
Results First Posted
August 13, 2021
Record last verified: 2021-12
Data Sharing
- IPD Sharing
- Will share
Qualified researchers may request access to individual patient level data through the request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on Sharing of Clinical Study Information and how to request access to related clinical study documents, see here (https://www.roche.com/research\_and\_development/who\_we\_are\_how\_we\_work/clinical\_trials/our\_commitment\_to\_data\_sharing.htm).