Spots Global Cancer Trial Database for A Study Comparing the Efficacy and Safety of Etrolizumab With Adalimumab and Placebo in Participants With Moderate to Severe Ulcerative Colitis (UC) in Participants Naive to Tumor Necrosis Factor (TNF) Inhibitors
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Trial Identification
Brief Title: A Study Comparing the Efficacy and Safety of Etrolizumab With Adalimumab and Placebo in Participants With Moderate to Severe Ulcerative Colitis (UC) in Participants Naive to Tumor Necrosis Factor (TNF) Inhibitors
Official Title: Phase III, Randomized, Double-Blind, Double-Dummy, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy (Induction of Remission) and Safety of Etrolizumab Compared With Adalimumab and Placebo in Patients With Moderate to Severe Ulcerative Colitis Who Are Naive to TNF Inhibitors
Study ID: NCT02163759
Conditions
Study Description
Brief Summary: This Phase III, double-blind, placebo and active-comparator controlled, multicenter study will investigate the efficacy and safety of etrolizumab in induction of remission in participants with moderately to severely active ulcerative colitis (UC) who are naÏve to tumor necrosis factor (TNF) inhibitors and refractory to or intolerant of prior immunosuppressant and/or corticosteroid treatment. In addition to this study, a second Phase III trial with identical study design (GA28949; NCT02171429) was independently conducted.
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Rocky Mountain Gastroenterology Associates, P.L.L.C.; Gastroenterology, Lakewood, Colorado, United States
Center for Advanced Gastroenterology, Maitland, Florida, United States
Gastroenterology Group of Naples, Naples, Florida, United States
Gastroenterology Associates of Central Georgia, Macon, Georgia, United States
University of Chicago Medical Center, Chicago, Illinois, United States
Center for Digestive Health, Troy, Michigan, United States
Huron Gastroenterology Associates, Ypsilanti, Michigan, United States
Wellness Clinical Research Center, San Antonio, Texas, United States
Tyler Research Institute, LLC, Tyler, Texas, United States
Instituto Medico DAMIC, Cordoba, , Argentina
Bankstown-Lidcombe Hospital, Bankstown, New South Wales, Australia
Royal Brisbane and Women's Hospital, Herston, Queensland, Australia
Mater Hospital Brisbane, South Brisbane, Queensland, Australia
Princess Alexandra Hospital, Woolloongabba, Queensland, Australia
Monash Medical Centre, Clayton, Victoria, Australia
Fiona Stanley Hospital, Murdoch, Western Australia, Australia
CCBR - Brasilia, Brasilia, DF, Brazil
Instituto Goiano de Gastroenterologia e Endoscopia Digestiva Ltda, Goiânia, GO, Brazil
Hospital Felicio Rocho, Belo Horizonte, MG, Brazil
Hospital Universitario Clementino Fraga Filho - UFRJ, Rio de Janeiro, RJ, Brazil
Hospital das Clinicas - UFRGS, Porto Alegre, RS, Brazil
UNESP - Faculdade de Medicina da Universidade Estadual Paulista - Campus Botucatu, Botucatu, SP, Brazil
UMHAT "Sv. Ivan Rilski", EAD, Sofia, , Bulgaria
UMHAT Tsaritsa Yoanna - ISUL, EAD, Sofia, , Bulgaria
MC Medica Plus, Veliko Tarnovo, , Bulgaria
OÜ Innomedica, Tallinn, , Estonia
East Tallinn Central Hospital, Tallinn, , Estonia
West Tallinn Central Hospital, Tallinn, , Estonia
North Estonia Medical Centre Foundation, Tallinn, , Estonia
Tartu University Hospital, Tartu, , Estonia
Hôpital Beaujon, Clichy cedex, , France
CHU Nice - Hopital de l'Archet 2, Nice, , France
University of Hong Kong, Hong Kong, , Hong Kong
Centro Integral en Reumatología S.A. de C.V. (CIRSA), Guadalajara, Jalisco, Mexico
Accelerium S. de R.L. de C.V., Monterrey, , Mexico
Hospital Universitario Dr Jose Eleuterio Gonzalez; Universidad Autónoma de Nuevo León, Monterrey, , Mexico
Centrum Medyczne Sw. Lukasza, Częstochowa, , Poland
7 Szpital Marynarki Wojennej z Przychodnia SPZOZ im. W. Lasinskiego, Gdansk, , Poland
NZOZ Centrum Medyczne ProMiMed, Krakow, , Poland
Med-Gastr Przychodnia Specjalistyczna, Lodz, , Poland
Indywidualna Specjalistyczna Praktyka Lekarska, Lublin, , Poland
GASTROMED Sp. z o.o., Lublin, , Poland
Wojewodzki Specjalistyczny Szpital w Olsztynie, Olsztyn, , Poland
SOLUMED Centrum Medyczne, Poznań, , Poland
Specjalistyczna Praktyka Lekarska Dr med. Marek Horynski; endoskopia, Sopot, , Poland
Twoja Przychodnia-Szczecinskie Centrum Medyczne, Szczecin, , Poland
Centrum Zdrowia MDM, Warszawa, , Poland
Narodowy Instytut Onkologii im. Marii Skłodowskiej-Curie - Państwowy Instytut Badawczy, Warszawa, , Poland
EMC Instytut Medyczny S.A., Wrocław, , Poland
PlanetMed, Wrocław, , Poland
AppleTreeClinics Sp. z o.o., Łódź, , Poland
Yusupov Hospital, Moskva, Adygeja, Russian Federation
Baltic Medicine, St.Petersburg, Leningrad, Russian Federation
SPb SBIH "City Multy-field Hospital # 2"; Intensive Pulmonology and Thoracal Surgery, Sankt-peterburg, Sankt Petersburg, Russian Federation
Medical and Sanitary Division of Severstal, Cherepovets, Vologda, Russian Federation
SBEI HPE Altai State Medical University of MoH and SD; Out-patient Department, Barnaul, , Russian Federation
FSBIH Central Clinical Hospital of RAS, Moscow, , Russian Federation
FSBI "State Scientific Centre of Coloproctology" of the MoH of RF; Gastroenterology, Moscow, , Russian Federation
SBHI of NN region "RCH of NN n.a. N.A.Semashko", Nizhny Novgorod, , Russian Federation
SBEI of HPE "Omsk SMA" Ministry of healthcare of RF", Omsk, , Russian Federation
SEIHPE "Rostov SMU of MoH of RF", Rostov-on-Don, , Russian Federation
City Hospital #26, St Petersburg, , Russian Federation
LLC International Medical Centre "SOGAZ", St-Petersburg, , Russian Federation
FSMEI HPE "Military Medical Academy n.a. S.M.Kirov"of Minist, St. Petersburg, , Russian Federation
Stavropol Regional Clinical Diagnostic Consultative Center, Stavropol, , Russian Federation
Clinical Center Zvezdara, Belgrade, , Serbia
Military Medical Academy, Belgrade, , Serbia
Clinical Center Bezanijska Kosa, Belgrade, , Serbia
Clinical Center Zemun, Belgrade, , Serbia
Clinical Center Kragujevac, Kragujevac, , Serbia
General Hospital "Djordje Joanovic"; Gastroenterology, Zrenjanin, , Serbia
Fakultna nemocnica s poliklinikou F.D. Roosevelta, Banska Bystrica, , Slovakia
Nemocnica A.Lena Humenne, n.o., Humenné, , Slovakia
KM Management spol. s r.o., Nitra, , Slovakia
Gastro I, s.r.o., Prešov, , Slovakia
Svet zdravia a.s., Rimavská Sobota, , Slovakia
Accout Center s.r.o., Šahy, , Slovakia
CNE Prof. O.O. Shalimov Kharkiv City Clinical Hospital #2 of KCC, Kharkiv, Kharkiv Governorate, Ukraine
Communal Non-commercial Enterprise of Kharkiv Regional Council Regional Clinical Hospital, Kharkiv, Kharkiv Governorate, Ukraine
Communal Institution of Kyiv Regional Council Kyiv Regional Clinical Hospital, Kyiv, Kharkiv Governorate, Ukraine
Medical Center of Limited Liability Company Medical Clinic Blagomed, Kyiv, KIEV Governorate, Ukraine
CI of Kyiv RC Regional Clinical Hospital #2, Kyiv, KIEV Governorate, Ukraine
CI City Hospital #1, Zaporizhzhia, Tavria Okruha, Ukraine
RCI Chernivtsi RCH Gastroenterology Bukovinsky SMU, Chernivtsi, , Ukraine
CHI Kharkiv City Clinical Hospital #13, Kharkiv, , Ukraine
CNI Consultative and Diagnostic Center of Desnianskyi District of Kyiv, Kyiv, , Ukraine
M.V. Sklifosovskyi Poltava RCH Outpatient UMSA HSEIU Ukrainian Medical Stomatological Academy, Poltava, , Ukraine
CI City Hospital #7, Zaporizhzhia, , Ukraine
Contact Details
Name: Clinical Trials
Affiliation: Hoffmann-La Roche
Role: STUDY_DIRECTOR
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