Spots Global Cancer Trial Database for 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
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Trial Identification
Brief Title: 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
Official Title: 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
Study ID: NCT02136069
Conditions
Study Description
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.
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
LKH - Universitätsklinikum der PMU Salzburg, Salzburg, , Austria
GZA Ziekenhuizen - Campus Sint-Vincentius, Antwerpen, , Belgium
Imeldaziekenhuis, Bonheiden, , Belgium
CHU St Pierre (St Pierre), Brussels, , Belgium
Universitair Ziekenhuis Brussel; Neurology, Bruxelles, , Belgium
Cliniques Universitaires Saint-Luc; Pharmacy, Bruxelles, , Belgium
UZ Gent, Gent, , 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 Kralove, , 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., Praha 7, , Czechia
Krajska zdravotni, a.s. - Masarykova nemocnice v Usti nad Labem, o.z., Ocni oddeleni, Usti Nad Labem, , Czechia
Krajska nemocnice T. Bati, a.s., Zlin, , Czechia
CHU de Caen - Hopital Cote de Nacre, Caen, , France
CHU Tours - Hôpital Trousseau, Chambray les Tours, , France
CHU Clermont Ferrand - Hôtel Dieu, Clermont-Ferrand, , France
Hôpital Beaujon, Clichy cedex, , 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-Benite, , France
Hôpital de Brabois Adultes, Vandoeuvre-les-nancy, , France
Charite Universitaetsmedizin Berlin - Campus Benjamin Franklin, Berlin, , Germany
DRK Kliniken Berlin Westend, Berlin, , Germany
Krankenhaus Waldfriede e. V., Berlin, , Germany
Universitätsklinikum Freiburg; Innere Medizin I; Hämatologie, Onkologie und Stammzelltransplantation, Freiburg, , Germany
Gastroenterologie Eppendorfer Baum, Hamburg, , Germany
Universitaetsklinikum Schleswig-Holstein, Campus Kiel, Kiel, , Germany
Universitätsklinikum Koeln, Koeln, , Germany
Bekes Megyei Kozponti Korhaz Dr. Rethy Pal Tagkorhaza, Bekescsaba, , 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, Gyor, , 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, Petach Tikva, , Israel
Chaim Sheba Medical Center; Pediatrics B North and Pediatric Endocrinology Unit, Tel Hashomer, , Israel
Azienda Ospedaliero Universitaria di Parma, Parma, Emilia-Romagna, Italy
Azienda Ospedaliera Universitaria Policlinico Tor Vergata, Roma, Lazio, Italy
Azienda Ospedaliera San Camillo Forlanini, Roma, Lazio, Italy
Asst Fatebenefratelli Sacco (Fatebenefratelli), Milano, Lombardia, Italy
Azienda Socio Sanitaria Territoriale Niguarda (Grande Ospedale Metropolitano Niguarda), Milano, Lombardia, Italy
Azienda Socio Sanitaria Territoriale Fatebenefratelli (Presidio Ospedale Sacco), Milano, Lombardia, Italy
Istituto Clinico Humanitas, Rozzano (MI), Lombardia, Italy
I.R.C.C.S Policlinico San Donato, San Donato Milanese (MI), Lombardia, Italy
IRCCS Ospedale Casa Sollievo della Soffenza; Stru Comp di Gastroenterologia ed Endoscopia digest, San Giovanni Rotondo, Lombardia, Italy
Ospedale Mauriziano Umberto I, Torino, Piemonte, Italy
Azienda Ospedaliera Universitaria Careggi, Firenze, Toscana, Italy
Azienda Ospedaliero Universitaria Pisana, Pisa, Toscana, Italy
Azienda Ospedaliera Di Padova, Padova, Veneto, Italy
Dong-A University Hospital, Busan, , Korea, Republic of
Pusan National University Hospital, Busan, , Korea, Republic of
Kyungpook National University Chilgok Hospital, Daegu, , Korea, Republic of
Keimyung University Dongsan Medical Center, Daegu, , Korea, Republic of
Kyungpook National University Hospital, Daegu, , Korea, Republic of
Yeungnam Univ. Hospital, Daegu, , Korea, Republic of
Korea University Ansan Hospital, Gyeonggi-do, , Korea, Republic of
Seoul National University Bundang Hospital, Seongnam-si, , Korea, Republic of
CHA Bundang Medical Centre; CHA university, Seongnam, , Korea, Republic of
Kyung Hee University Hospital, Seoul, , Korea, Republic of
Seoul National University Hospital, Seoul, , Korea, Republic of
Kangbuk Samsung Hospital, Seoul, , Korea, Republic of
Severance Hospital, Yonsei University, Seoul, , Korea, Republic of
Asan Medical Center, Seoul, , Korea, Republic of
Samsung Medical Center, Seoul, , Korea, Republic of
Ajou University Hospital, Suwon City, , Korea, Republic of
The Catholic University of Korea St. Vincent's Hospital, Suwon-si,, , Korea, Republic of
Yonsei University Wonju Severance Christian Hospital, Wonju-Si, , Korea, Republic of
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
Institutul Clinic Fundeni Bucuresti, Bucharest, , Romania
Spitalul Clinic Colentina, Bucharest, , Romania
S.C MedLife S.A, Bucuresti, , Romania
Centrul Medical Unirea SRL, Bucuresti, , Romania
Spitalul Clinic Judetean Mures, Targu Mures, , Romania
Centrul de Gastroenterologie Dr. Goldis, Timisoara, , 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
Corporacio Sanitaria Parc Tauli, Sabadell, Barcelona, Spain
Complejo Hospitalario Universitario de Ferrol, Ferrol, LA Coruña, Spain
Fundacion Hospital de Alcorcon; Servicio de Digestivo, Alcorcon, 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, Zürich, , 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
Contact Details
Name: Clinical Trials
Affiliation: Hoffmann-La Roche
Role: STUDY_DIRECTOR
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