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Spots Global Cancer Trial Database for 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

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Trial Identification

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

Interventions

Etrolizumab
Placebo

Study Description

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:

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

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

Contact Details

Name: Clinical Trials

Affiliation: Hoffmann-La Roche

Role: STUDY_DIRECTOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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