358
Participants
Start Date
November 14, 2014
Primary Completion Date
March 2, 2020
Study Completion Date
May 25, 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 \[clinical remitters only\]).
RTS - Fundación Valle de Lili, Santiago de Cali
"City Clinic UMHAC EOOD", Sofia
Medical center CONVEX EOOD, Sofia
"Med Center of International Institute of Clinical Trials LLC; Medical Center OK!Clinic+", Kyiv
Concord Repatriation General Hospital, Concord
"Medical Centre Asklepii, OOD", Dupnitsa
Footscray Hospital; Gastroenterology, Footscray
St Vincent's Hospital Melbourne, Fitzroy
Tauranga Hospital, Tauranga
Waikato Hospital, Hamilton
Royal Adelaide Hospital, Adelaide
Flinders Medical Centre, Bedford Park
DCC Sv. Pantaleymon OOD, Pleven
Medical center Medconsult Pleven OOD, Pleven
"Medical Center Nov Rehabilitatsionen Tsentar, EOOD", Stara Zagora
MHAT - Ruse, AD, Rousse
"MHAT Hadzhi Dimitar, OOD", Sliven
MHAT 'Sv. Marina', EAD, Varna
Petz Aladar Megyei Oktato Korhaz, Győr
Clinical Hospital Sveti Duh, Zagreb
Hospital Raja Perempuan Zainab II; Department of Medicine, Kota Bharu
Private Small Enterprise Medical Center Pulse, Vinnytsia
MCIC MC LLC Health Clinic, Vinnytsia
Hospital Tengku Ampuan Afzan, Kuala Pahang
Gaziantep University Medical Faculty Sahinbey Educational Research Hospital; Medical Oncology, Gaziantep
Clinical Hospital Centre Osijek, Osijek
Center For Digestive Health, Orlando
Internal Medicine Specialists, Orlando
Haydarpasa Numune Training and Research Hospital; Gastroenterology, Istanbul
M.V. Sklifosovskyi Poltava RCH Dept of Gastroenterology HSEIU UMSA, Poltava
CI of SRC Sumy RCH Dept of Gasroenterology Sumy SU MI, Sumy
Kocaeli Universitesi Tip Fakultesi, Kocaeli
Great Lakes Gastroenterology Research, LLC, Mentor
SI inst. of Gastroenterology of NAMSU Dept of Stomach & Duodenum Diseases, D&ThN SI DMA of MoHU, Dnipropetrovsk
Hospital of Lithuanian University of Health. Sciences Kaunas Clinics, Kaunas
Pusat Perubatan Universiti Kebangsaan Malaysia, Kuala Lumpur
RCNECRCH Dept of Surgery, SHEI Ukr BSMU, Chernivtsi
University Malaya Medical Centre, Kuala Lumpur
GI L.T.Malaya Therapy National Institute of the NAMS of Ukraine, Kharkiv
Cotton-O'Neil Clinical Research Center, Digestive Health, Topeka
Zaporizhzhia SMU, Zaporizhzhia
LLC Diaservis, Zaporizhzhia
Centre Hospitalier Lyon Sud, Pierre-Bénite
CI Kherson Afanasii and Olha Tropiny City Clinical Hospital, Kherson
A.Novak Transcarpathian Regional Clinical Hospital, Uzhhorod
Klaipeda Seamen's Hospital, Public Institution, Klaipėda
Center of Emergency and Radiation Medicine; Pulmonology, Saint Petersburg
Pavlov First Saint Petersburg State Medical University, Saint Petersburg
SBIH City Clinical Hospital #31, Saint Petersburg
"SPb SHI City Hospital #9", Saint Petersburg
"FSBEI HE Stavropol State Medical University of Ministry of Healthcare of Russian Federation", Stavropol
Voronezh Regional Clinical Hospital #1, Voronezh
"FSBI Scientific Research Institute of Physyology and Basic Medicine under the SB of RAMS", Novosibirsk
BHI of Omsk region Clinical Oncology Dispensary, Omsk
SBEI HPE Altai State Medical University of MoH and SD; Out-patient Department, Barnaul
Centro de Investigaciones Medicas Mar Del Plata, Mar del Plata
Hospital Universitario Walter Cantidio - UFC, Fortaleza
Hospital Universitario Prof Edgar Santos-Ufba; Ambulatorio Magalhaes Neto 3Andar- Dermatologia, Salvador
Centro Digestivo de Curitiba, Curitiba
Hospital Ernesto Dornelles, Porto Alegre
Pesquisare Saúde Sociedade Simples, Santo André
Instituto de Coloproctologia ICO S.A.S., Medellín
Fakultni nemocnice Hradec Kralove, Hradec Králové
Hepato-Gastroenterologie HK, s.r.o., Hradec Králové
PreventaMed, s.r.o., Olomouc
Pardubicka krajska nemocnice, a.s., Pardubice
ISCARE a.s., Prague
University General Hospital of Heraklion, Heraklion
Central Outpatient Clinic, Daugavpils
Pauls Stradins Clinical University Hospital, Riga
"Digestive Diseases Center Gastro", Riga
Vilnius University Hospital Santariskiu Clinic, Public Institution; Cardiology, Vilnius
North Shore Hospital, Auckland
Shakespeare Specialist Group, Takapuna
Dunedin Hospital, Dunedin
Irkutsk State Medical Academy of Continuing Education, Irkutsk
Pro Familia Altera Sp z o.o., Katowice
Nzoz All-Medicus, Katowice
Uniwersyteckie Centrum Kliniczne im. prof. K. Gibinskiego SUM, Katowice
Centrum Opieki Zdrowotnej Orkan-Med, Ksawerów
AppleTreeClinics Sp. z o.o., Lodz
Allmedica Badania Kliniczne Sp z o.o. Sp K., Nowy Targ
Centrum Medyczne Medyk, Rzeszów
Gabinet Lekarski, Bartosz Korczowski, Rzeszów
Niepubliczny Zaklad Opieki Zdrowotnej SONOMED, Szczecin
Endoterapia PFG Sp. z o.o., Warsaw
LexMedica Osrodek Badan Klinicznych, Wroclaw
Ankara Diskapi Yildirim Beyazit Training and Research Hospital; Gastroenterology, Ankara
CNE Kyiv CCH #18, Kyiv
CI of Kyiv RC Kyiv Regional Clinical Hospital, Kyiv
Hoffmann-La Roche
INDUSTRY