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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

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

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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