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: NCT02171429
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 naIve 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 (GA28948; NCT02163759) was independently conducted.
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Center For Digestive Health, Orlando, Florida, United States
Internal Medicine Specialists, Orlando, Florida, United States
Cotton-O'Neil Clinical Research Center, Digestive Health, Topeka, Kansas, United States
Great Lakes Gastroenterology Research, LLC, Mentor, Ohio, United States
Centro de Investigaciones Medicas Mar Del Plata, Mar del Plata, , Argentina
Concord Repatriation General Hospital, Concord, New South Wales, Australia
Royal Adelaide Hospital, Adelaide, South Australia, Australia
Flinders Medical Centre, Bedford Park, South Australia, Australia
St Vincent's Hospital Melbourne, Fitzroy, Victoria, Australia
Footscray Hospital; Gastroenterology, Footscray, Victoria, Australia
Hospital Universitario Prof Edgar Santos-Ufba; Ambulatorio Magalhaes Neto 3Andar- Dermatologia, Salvador, BA, Brazil
Hospital Universitario Walter Cantidio - UFC, Fortaleza, CE, Brazil
Centro Digestivo de Curitiba, Curitiba, PR, Brazil
Hospital Ernesto Dornelles, Porto Alegre, RS, Brazil
Pesquisare Saúde Sociedade Simples, Santo Andre, SP, Brazil
Medical Centre "Asklepii", OOD, Dupnitsa, , Bulgaria
DCC Sv. Pantaleymon OOD, Pleven, , Bulgaria
Medical center Medconsult Pleven OOD, Pleven, , Bulgaria
MHAT - Ruse, AD, Ruse, , Bulgaria
MHAT "Hadzhi Dimitar", OOD, Sliven, , Bulgaria
"City Clinic UMHAC" EOOD, Sofia, , Bulgaria
Medical center CONVEX EOOD, Sofia, , Bulgaria
Medical Center "Nov Rehabilitatsionen Tsentar", EOOD, Stara Zagora, , Bulgaria
MHAT 'Sv. Marina', EAD, Varna, , Bulgaria
RTS - Fundación Valle de Lili, Cali, , Colombia
Instituto de Coloproctologia ICO S.A.S., Medellin, , Colombia
Clinical Hospital Centre Osijek, Osijek, , Croatia
Clinical Hospital Sveti Duh, Zagreb, , Croatia
Fakultni nemocnice Hradec Kralove, Hradec Kralove, , Czechia
Hepato-Gastroenterologie HK, s.r.o., Hradec Kralove, , Czechia
PreventaMed, s.r.o., Olomouc, , Czechia
Pardubicka krajska nemocnice, a.s., Pardubice, , Czechia
ISCARE a.s., Praha 7, , Czechia
Centre Hospitalier Lyon Sud, Pierre Benite, , France
University General Hospital of Heraklion, Herakleion, , Greece
Petz Aladar Megyei Oktato Korhaz, Gyor, , Hungary
Central Outpatient Clinic, Daugavpils, , Latvia
Pauls Stradins Clinical University Hospital, Rīga, , Latvia
Digestive Diseases Center "Gastro", Rīga, , Latvia
Hospital of Lithuanian University of Health. Sciences Kaunas Clinics, Kaunas, , Lithuania
Klaipeda Seamen's Hospital, Public Institution, Klaipeda, , Lithuania
Vilnius University Hospital Santariskiu Clinic, Public Institution; Cardiology, Vilnius, , Lithuania
Hospital Raja Perempuan Zainab II; Department of Medicine, Kota Bahru, , Malaysia
Pusat Perubatan Universiti Kebangsaan Malaysia, Kuala Lumpur, , Malaysia
University Malaya Medical Centre, Kuala Lumpur, , Malaysia
Hospital Tengku Ampuan Afzan, Pahang, , Malaysia
North Shore Hospital, Auckland, , New Zealand
Dunedin Hospital, Dunedin, , New Zealand
Waikato Hospital, Hamilton, , New Zealand
Shakespeare Specialist Group, Takapuna, , New Zealand
Tauranga Hospital, Tauranga, , New Zealand
Pro Familia Altera Sp z o.o., Katowice, , Poland
Nzoz All-Medicus, Katowice, , Poland
Uniwersyteckie Centrum Kliniczne im. prof. K. Gibinskiego SUM, Katowice, , Poland
Centrum Opieki Zdrowotnej Orkan-Med, Ksawerow, , Poland
Allmedica Badania Kliniczne Sp z o.o. Sp K., Nowy Targ, , Poland
Centrum Medyczne Medyk, Rzeszow, , Poland
Gabinet Lekarski, Bartosz Korczowski, Rzeszów, , Poland
Niepubliczny Zaklad Opieki Zdrowotnej SONOMED, Szczecin, , Poland
Endoterapia PFG Sp. z o.o., Warszawa, , Poland
LexMedica Osrodek Badan Klinicznych, Wroclaw, , Poland
AppleTreeClinics Sp. z o.o., Łódź, , Poland
SBIH City Clinical Hospital #31, Sankt-peterburg, Sankt Petersburg, Russian Federation
SBEI HPE Altai State Medical University of MoH and SD; Out-patient Department, Barnaul, , Russian Federation
Irkutsk State Medical Academy of Continuing Education, Irkutsk, , Russian Federation
FSBI "Scientific Research Institute of Physyology and Basic Medicine" under the SB of RAMS, Novosibirsk, , Russian Federation
BHI of Omsk region Clinical Oncology Dispensary, Omsk, , Russian Federation
Center of Emergency and Radiation Medicine; Pulmonology, St. Petersburg, , Russian Federation
Pavlov First Saint Petersburg State Medical University, St. Petersburg, , Russian Federation
SPb SHI "City Hospital #9", St. Petersburg, , Russian Federation
FSBEI HE "Stavropol State Medical University" of Ministry of Healthcare of Russian Federation, Stavropol, , Russian Federation
Voronezh Regional Clinical Hospital #1, Voronezh, , Russian Federation
Ankara Diskapi Yildirim Beyazit Training and Research Hospital; Gastroenterology, Ankara, , Turkey
Gaziantep University Medical Faculty Sahinbey Educational Research Hospital; Medical Oncology, Gaziantep, , Turkey
Haydarpasa Numune Training and Research Hospital; Gastroenterology, Istanbul, , Turkey
Kocaeli Universitesi Tip Fakultesi, Kocaeli, , Turkey
CI of SRC Sumy RCH Dept of Gasroenterology Sumy SU MI, Sumy, Kharkiv Governorate, Ukraine
CNE Kyiv CCH #18, Kyiv, KIEV Governorate, Ukraine
CI of Kyiv RC Kyiv Regional Clinical Hospital, Kyiv, KIEV Governorate, Ukraine
Med Center of International Institute of Clinical Trials LLC; Medical Center "OK!Clinic+", Kyiv, KIEV Governorate, Ukraine
A.Novak Transcarpathian Regional Clinical Hospital, Uzhgorod, KIEV Governorate, Ukraine
RCNECRCH Dept of Surgery, SHEI Ukr BSMU, Chernivtsi, Podolia Governorate, Ukraine
SI inst. of Gastroenterology of NAMSU Dept of Stomach & Duodenum Diseases, D&ThN SI DMA of MoHU, Dnipropetrovsk, , Ukraine
GI L.T.Malaya Therapy National Institute of the NAMS of Ukraine, Kharkiv, , Ukraine
CI Kherson Afanasii and Olha Tropiny City Clinical Hospital, Kherson, , Ukraine
M.V. Sklifosovskyi Poltava RCH Dept of Gastroenterology HSEIU UMSA, Poltava, , Ukraine
Private Small Enterprise Medical Center Pulse, Vinnytsia, , Ukraine
MCIC MC LLC Health Clinic, Vinnytsia, , Ukraine
Zaporizhzhia SMU, Zaporizhzhia, , Ukraine
LLC Diaservis, Zaporizhzhia, , Ukraine
Contact Details
Name: Clinical Trials
Affiliation: Hoffmann-La Roche
Role: STUDY_DIRECTOR
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