358
Participants
Start Date
November 4, 2014
Primary Completion Date
February 19, 2020
Study Completion Date
March 19, 2020
Adalimumab
Adalimumab 160 milligrams (mg) will be administered subcutaneously (SC) at Week 0; 80 mg SC at Week 2; 40 mg SC at Weeks 4, 6, and 8.
Adalimumab Placebo
Placebo matching to adalimumab will be administered SC at Weeks 0, 2, 4, 6, and 8.
Etrolizumab
Etrolizumab 105 mg will be administered SC every 4 weeks (Q4W) up to Week 12 (at Weeks 0 \[Day 1\], 4, 8, and 12 \[clinical remitters only\]).
Etrolizumab Placebo
Placebo matching to etrolizumab will be administered SC once every 4 weeks (Q4W) up to Week 12 (at Weeks 0 \[Day 1\], 4, 8, and 12 \[clinical remitters only\]).
Medical Center of Limited Liability Company Medical Clinic Blagomed, Kyiv
"UMHAT Sv. Ivan Rilski, EAD", Sofia
UMHAT Tsaritsa Yoanna - ISUL, EAD, Sofia
Bankstown-Lidcombe Hospital, Bankstown
Monash Medical Centre, Clayton
Royal Brisbane and Women's Hospital, Herston
CI of Kyiv RC Regional Clinical Hospital #2, Kyiv
Mater Hospital Brisbane, South Brisbane
Princess Alexandra Hospital, Woolloongabba
MC Medica Plus, Veliko Tarnovo
Fiona Stanley Hospital, Murdoch
OÜ Innomedica, Tallinn
East Tallinn Central Hospital, Tallinn
West Tallinn Central Hospital, Tallinn
Clinical Center Zvezdara, Belgrade
Military Medical Academy, Belgrade
Clinical Center Bezanijska Kosa, Belgrade
Clinical Center Zemun, Belgrade
North Estonia Medical Centre Foundation, Tallinn
"General Hospital Djordje Joanovic; Gastroenterology", Zrenjanin
Gastroenterology Associates of Central Georgia, Macon
Center for Advanced Gastroenterology, Maitland
Clinical Center Kragujevac, Kragujevac
Gastroenterology Group of Naples, Naples
M.V. Sklifosovskyi Poltava RCH Outpatient UMSA HSEIU Ukrainian Medical Stomatological Academy, Poltava
Centro Integral en Reumatología S.A. de C.V. (CIRSA), Guadalajara
Center for Digestive Health, Troy
Huron Gastroenterology Associates, Ypsilanti
Tartu University Hospital, Tartu
RCI Chernivtsi RCH Gastroenterology Bukovinsky SMU, Chernivtsi
University of Chicago Medical Center, Chicago
CNE Prof. O.O. Shalimov Kharkiv City Clinical Hospital #2 of KCC, Kharkiv
Communal Non-commercial Enterprise of Kharkiv Regional Council Regional Clinical Hospital, Kharkiv
CHI Kharkiv City Clinical Hospital #13, Kharkiv
Accelerium S. de R.L. de C.V., Monterrey
Hospital Universitario Dr Jose Eleuterio Gonzalez; Universidad Autónoma de Nuevo León, Monterrey
CI City Hospital #1, Zaporizhzhia
CI City Hospital #7, Zaporizhzhia
Tyler Research Institute, LLC, Tyler
Wellness Clinical Research Center, San Antonio
Rocky Mountain Gastroenterology Associates, P.L.L.C.; Gastroenterology, Lakewood
Hôpital Beaujon, Clichy
KM Management spol. s r.o., Nitra
FSBIH Central Clinical Hospital of RAS, Moscow
"FSBI State Scientific Centre of Coloproctology of the MoH of RF; Gastroenterology", Moscow
Yusupov Hospital, Moskva
Medical and Sanitary Division of Severstal, Cherepovets
"FSMEI HPE Military Medical Academy n.a. S.M.Kirovof Minist", Saint Petersburg
"SPb SBIH City Multy-field Hospital # 2; Intensive Pulmonology and Thoracal Surgery", Saint Petersburg
Baltic Medicine, Saint Petersburg
City Hospital #26, Saint Petersburg
"LLC International Medical Centre SOGAZ", Saint Petersburg
"SEIHPE Rostov SMU of MoH of RF", Rostov-on-Don
Stavropol Regional Clinical Diagnostic Consultative Center, Stavropol
"SBHI of NN region RCH of NN n.a. N.A.Semashko", Nizhny Novgorod
"SBEI of HPE Omsk SMA Ministry of healthcare of RF", Omsk
SBEI HPE Altai State Medical University of MoH and SD; Out-patient Department, Barnaul
Instituto Medico DAMIC, Córdoba
CCBR - Brasilia, Brasília
Instituto Goiano de Gastroenterologia e Endoscopia Digestiva Ltda, Goiânia
Hospital Felicio Rocho, Belo Horizonte
Hospital Universitario Clementino Fraga Filho - UFRJ, Rio de Janeiro
Hospital das Clinicas - UFRGS, Porto Alegre
UNESP - Faculdade de Medicina da Universidade Estadual Paulista - Campus Botucatu, Botucatu
CHU Nice - Hopital de l'Archet 2, Nice
University of Hong Kong, Hong Kong
Centrum Medyczne Sw. Lukasza, Częstochowa
7 Szpital Marynarki Wojennej z Przychodnia SPZOZ im. W. Lasinskiego, Gdansk
NZOZ Centrum Medyczne ProMiMed, Krakow
AppleTreeClinics Sp. z o.o., Lodz
Med-Gastr Przychodnia Specjalistyczna, Lodz
Indywidualna Specjalistyczna Praktyka Lekarska, Lublin
GASTROMED Sp. z o.o., Lublin
Wojewodzki Specjalistyczny Szpital w Olsztynie, Olsztyn
SOLUMED Centrum Medyczne, Poznan
Specjalistyczna Praktyka Lekarska Dr med. Marek Horynski; endoskopia, Sopot
Twoja Przychodnia-Szczecinskie Centrum Medyczne, Szczecin
Centrum Zdrowia MDM, Warsaw
Narodowy Instytut Onkologii im. Marii Skłodowskiej-Curie - Państwowy Instytut Badawczy, Warsaw
EMC Instytut Medyczny S.A., Wroclaw
PlanetMed, Wroclaw
Fakultna nemocnica s poliklinikou F.D. Roosevelta, Banská Bystrica
Nemocnica A.Lena Humenne, n.o., Humenné
Gastro I, s.r.o., Prešov
Svet zdravia a.s., Rimavská Sobota
Accout Center s.r.o., Šahy
Communal Institution of Kyiv Regional Council Kyiv Regional Clinical Hospital, Kyiv
CNI Consultative and Diagnostic Center of Desnianskyi District of Kyiv, Kyiv
Hoffmann-La Roche
INDUSTRY