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Brief Title: A Study of the Efficacy and Safety of Etrolizumab Treatment in Maintenance of Disease Remission in Ulcerative Colitis (UC) Participants Who Are Naive to Tumor Necrosis Factor (TNF) Inhibitors
Official Title: Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy (Maintenance of Remission) and Safety of Etrolizumab Compared With Placebo in Patients With Moderate to Severe Active Ulcerative Colitis Who Are Naive to TNF Inhibitors
Study ID: NCT02165215
Brief Summary: This Phase III, randomized, double-blind, parallel-grouped, placebo-controlled, multicenter study will investigate the efficacy and safety of etrolizumab in maintenance of remission in participants with moderately to severely active UC who are naive to TNF inhibitors and refractory to or intolerant of prior immunosuppressant and/or corticosteroid treatment.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
University of California, Irvine Medical Center, Orange, California, United States
Clinical Applications Laboratories, Inc., San Diego, California, United States
University of California at San Francisco, San Francisco, California, United States
Ventura Clinical Trials, Ventura, California, United States
Peak Gastroenterology Associates; Gastroenterology, Colorado Springs, Colorado, United States
Clinical Research of the Rockies, Lafayette, Colorado, United States
West Central Gastroenterology d/b/a Gastro Florida, Clearwater, Florida, United States
IMIC, Inc, Miami Beach, Florida, United States
Regenerate Clinical Trials, Miami, Florida, United States
Advanced Research Institute, Inc., Trinity, Florida, United States
Shafran Gastroenterology Center, Winter Park, Florida, United States
Northwestern University-Feinberg School of Medicine; Division of Gastroenterology and Hepatology, Chicago, Illinois, United States
Southwest Gastroenterology, Oak Lawn, Illinois, United States
Aquiant Research, New Albany, Indiana, United States
Louisiana Research Center, LLC, Shreveport, Louisiana, United States
Commonwealth Clinical Studies, Brockton, Massachusetts, United States
Henry Ford Health System, Detroit, Michigan, United States
Center for Digestive Health, Troy, Michigan, United States
University of Minnesota, Minneapolis, Minnesota, United States
University of Mississippi Medical Center, Jackson, Mississippi, United States
Ehrhardt Clinical Research, LLC, Belton, Missouri, United States
Manhattan Clinical Research, New York, New York, United States
Weill Cornell Medical College-New York Presbyterian Hospital, New York, New York, United States
Asheville Gastroenterology Associates, P.A., Asheville, North Carolina, United States
UNC at Chapel Hill - Dpt of Family Medicine; Center for Functional GI and Motility Disorders, Chapel Hill, North Carolina, United States
Kinston Medical Specialists, Kinston, North Carolina, United States
Texas Digestive Disease Consultants - Dallas, Dallas, Texas, United States
Texas Digestive Disease Consultants - Southlake, Southlake, Texas, United States
Digestive Health Specialists of Tyler, Tyler, Texas, United States
Ericksen Research and Development, Clinton, Utah, United States
University of Utah School of Medicine, Salt Lake City, Utah, United States
McGuire Research Institute; Gastroenterology, Richmond, Virginia, United States
Northwest Gastroenterology Associates, Bellevue, Washington, United States
Hospital Universitario Walter Cantidio - UFC, Fortaleza, CE, Brazil
Centro Digestivo de Curitiba, Curitiba, PR, Brazil
Hospital Moinhos de Vento, Porto Alegre, RS, Brazil
CECIP - Centro de Estudos Clínicos do Interior Paulista, Jaú, SP, Brazil
Pesquisare Saúde Sociedade Simples, Santo Andre, SP, Brazil
Hospital Estadual Mario Covas, Santo Andre, SP, Brazil
Hospital Sírio-Libanês, Sao Paulo, SP, Brazil
Hospital do Servidor Público Estadual/HSPE-SP, São Paulo, SP, Brazil
Pacific Gastroenterology Associates, Vancouver, British Columbia, Canada
Queen Elizabeth II Health Sciences Centre; Gastroenterology Research, Halifax, Nova Scotia, Canada
LHSC - University Hospital; Movement Disorders Program, London, Ontario, Canada
London Health Sciences Centre Victoria Hospital; Research Pharmacy, London, Ontario, Canada
Mount Sinai Hospital, Toronto, Ontario, Canada
Toronto Digestive Disease Associates, Vaughan, Ontario, Canada
Fakultni nemocnice u sv. Anny v Brne; I.Interni kardioangiologicka klinika, Brno, , Czechia
Hepato-Gastroenterologie HK, s.r.o., Hradec Kralove, , Czechia
Nemocnice Na Bulovce, Prague, , Czechia
Alborg Universitets Hospital, Aalborg, , Denmark
Herlev og Gentofte Hospital, Herlev, , Denmark
Charite Universitaetsmedizin Berlin - Campus Charite Mitte, Berlin, , Germany
Berufsgenossenschaftliches Universitaetsklinikum Bergmannsheil GmbH, Bochum, , Germany
Ärztezentrum Ellwangen; Gemeinschaftspraxis, Ellwangen, , Germany
Klinik Johann Wolfgang von Goethe Uni, Frankfurt, , Germany
Medizinische Hochschule Hannover; Klinik für Gastroenterologie, Hepatologie und Endokrinologie, Hannover, , Germany
Universitaetsklinikum Jena; Apotheke des Uniersitätsklinikums Jena, Jena, , Germany
Medizinisches Zentrum Klinikum Lueneburg, Lueneburg, , Germany
Klinikum Mannheim GmbH Universitätsklinikum, Mannheim, , Germany
DRC Gyogyszervizsgalo Kozpont Kft, Balatonfured, , Hungary
Pannónia Klinika Magánorvosi, Budapest, , Hungary
Debreceni Egyetem Klinikai Kozpont, Debrecen, , Hungary
Pest Megyei Flor Ferenc Korhaz, Kistarcsa, , Hungary
Csongrad Megyei Dr. Bugyi Istvan Korhaz, Szentes, , Hungary
Osmania General Hospital, Hyderabad, Andhra Pradesh, India
Deccan College of Medical Sciences and Allied Hospitals, Hyderabad, Andhra Pradesh, India
Pushpawati Singhania Research Institute, New Delhi, Delhi, India
Shree Giriraj Multispeciality Hospital, Rajkot, Gujarat, India
Nirmal Hospital, Surat, Gujarat, India
K.L.E. Society's Dr. Prabhakar Kore Hospital and Medical Research Centre, Belgaum, Karnataka, India
M. S. Ramaiah Medical College and Hospital, Bengaluru, Karnataka, India
Midas institute of Gastroenterology, Nagpur, Maharashtra, India
Dayanand Medical College and Hospital, Ludhiana, Punjab, India
S. R. Kalla Memorial General Hospital, Jaipur, , India
Kasturba Medical College & Hospital, Mangalore, , India
Ruby Hall Clinic, Pune, , India
King Edward Memorial Hospital Research Centre, Pune, , India
Assaf Harofeh Medical Center, Beer Yaacov, , Israel
Bnei Zion Medical Center; Department of Internal Medicine B, Haifa, , Israel
Shaare Zedek Medical Center, Jerusalem, , Israel
Hadassah University Hospital - Ein Kerem, Jerusalem, , Israel
Holy Family Hospital, Nazareth, , Israel
Ospedale Sandro Pertini, Roma, Lazio, Italy
Fondazione Poliambulanza Istituto Ospedaliero, Brescia, Lombardia, Italy
Ospedale di Circolo; Neuropsichiatria Infantile, Rho, Lombardia, Italy
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone, Palermo, Sicilia, Italy
Centro Regiomontano de Estudios Clínicos Roma S.C., Monterrey, Nuevo LEON, Mexico
Instituto de Investigaciones Aplicadas a la Neurociencia A.C., Durango, , Mexico
Phylasis Clinicas Research S de RL de CV, Estado de México, , Mexico
Zespó Przychodni Specjalistycznych PRIMA, Warszawa, , Poland
LexMedica Osrodek Badan Klinicznych, Wroclaw, , Poland
Fakultna nemocnica Nitra, Nitra, , Slovakia
Endomed, s.r.o., Vranov nad Topľou, , Slovakia
Dr JP Wright Practice, Cape Town, , South Africa
Emmed Research, Pretoria, , South Africa
CI of SRC Sumy RCH Dept of Rheumatology Sumy SU MI, Sumy, Kharkiv Governorate, Ukraine
CI of Kyiv RC Kyiv Regional Clinical Hospital, Kyiv, KIEV Governorate, Ukraine
Lviv Regional Clinical Hospital, Lviv, KIEV Governorate, Ukraine
A.Novak Transcarpathian Regional Clinical Hospital, Uzhgorod, KIEV Governorate, Ukraine
Odessa regional clinical Hospital, Odessa, , Ukraine
M.V. Sklifosovskyi Poltava RCH Dept of Gastroenterology HSEIU UMSA, Poltava, , Ukraine
SI Divisional Clinical Hospital of Uzhgorod Station of ST&BA LZ Dep of Therapy SHEI Uzhgorod NU, Uzhgorod, , Ukraine
M.I. Pyrogov VRCH Dept of Gastroenterology M.I. Pyrogov VNMU, Vinnytsia, , Ukraine
Name: Clinical Trials
Affiliation: Hoffmann-La Roche
Role: STUDY_DIRECTOR