Clinical Trial Details

NCT ID: NCT02171429
Date Last Changed: March 9, 2017

Overview

Research Study Summary

A clinical trial to evaluate treatments using adalimumab, adalimumab placebo, etrolizumab and etrolizumab placebo for patients with Ulcerative Colitis

Purpose

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 UC who are naïve to TNF inhibitors and refractory to or intolerant of prior immunosuppressant and/or corticosteroid treatment.

To Learn more

Recruitment Details

Phase
3
Gender
All
Age
18 to 80 Years
Overall Status
Recruiting
Lead Sponsor
Hoffmann-La Roche
Duration
40 Months
Facility Type
N/A
Compensation

Eligibility

All ages 18 Years to 80 Years

Inclusion Criteria:

  • Diagnosis of UC established at least 6 months prior to randomization

  • Moderately to severely active UC as determined by the MCS

  • Naive to treatment with any anti-TNF therapy

  • An inadequate response, loss of response, or intolerance to prior corticosteroid and/or immunosuppressant treatment

  • Background UC therapy may include oral 5-aminosalisylate (ASA), oral corticosteroids, budesonide multi-matrix system (MMX), probiotics, azathioprine (AZA), 6-mercaptopurine (MP), or methotrexate (MTX) if doses have been stable for the 8 weeks immediately prior to randomization

  • Use of highly effective contraception method as defined by the protocol

  • Have received a colonoscopy within the past year or be willing to undergo a colonoscopy in lieu of a flexible sigmoidoscopy at screening

Exclusion Criteria:

  • A history of or current conditions and diseases affecting the digestive tract, such as indeterminate colitis, suspicion of ischemic, radiation or microscopic colitis, Crohn's disease, fistulas or abdominal abscesses, colonic mucosal dysplasia, stricture (stenosis) of the colon, toxic megacolon, or unremoved adenomatous colonic polyps

  • Prior or planned surgery for UC

  • Past or present ileostomy or colostomy

  • Have received non-permitted inflammatory bowel disease (IBD) anti-integrin therapies (including natalizumab, vedolizumab, and efalizumab) as stated in the protocol

  • Congenital or acquired immune deficiency, chronic hepatitis B or C infection, HIV positive

  • Evidence of or treatment for Clostridium difficile within 60 days prior to randomization or other intestinal pathogens within 30 days prior to randomization

  • History of active or latent tuberculosis (TB), recurrent opportunistic infections, severe disseminated viral infections and organ transplant

  • Any major episode of infection requiring hospitalization or treatment with intravenous (IV) antibiotics within 8 weeks prior to screening or oral antibiotics within 4 weeks prior to screening

  • Received a live attenuated vaccine within 4 weeks prior to randomization

Site Locations (83)

Country State City Zip Facility and Contact
United States Colorado Denver 80222 Rocky Mountain Gastroenterology Associates
United States Georgia Decatur 30033 Atlanta Center for Gastroenterology, PC
United States Kansas Topeka 66606 Cotton-O'Neil Clinical Research Center, Digestive Health
United States Missouri Kansas City 64131 Kansas City Research Institute, LLC
United States New Jersey Egg Harbor Township 08234 Atlantic Gastroenterology Associates
United States New Jersey Teaneck 07666 MS Comprehensive Care Center
United States New York Manhasset 11030 North Shore University Hospital
United States New York Poughkeepsie 12601 Premier Medical Group of the Hudson Valley PC
United States Ohio Mentor 44060 Great Lakes Gastroenterology Research, LLC
United States Tennessee Nashville 37211 Quality Medical Research
Argentina Mar del Plata B7600DHK Centro de Investigaciones Medicas Mar Del Plata
Argentina Quilmes B1878DVB Instituto Medico CER
Australia New South Wales Concord 2139 Concord Repatriation General Hospital
Australia South Australia Adelaide 5000 Royal Adelaide Hospital
Australia South Australia Bedford Park 5042 Flinders Medical Centre
Australia Victoria Fitzroy 3065 St Vincent's Hospital Melbourne
Australia Victoria Footscray 3011 Footscray Hospital; Gastroenterology
Brazil MG Juiz de Fora 36010-570 CMiP - Centro Mineiro de Pesquisa
Brazil MG Juiz de Fora 36036-330 Fundação Imepen - Instituto Mineiro de Estudos e Pesquisas em Nefrologia
Brazil RS Porto Alegre 90160-092 Hospital Ernesto Dornelles
Bulgaria Dupnitsa 2600 Medical Centre "Asklepii", OOD
Bulgaria Pleven 5800 DCC Sv. Pantaleymon OOD
Bulgaria Ruse 7002 MHAT - Ruse, AD
Bulgaria Sofia 1336 MHAT "Lyulin", EAD
Bulgaria Sofia 1407 "City Clinic UMHAC" EOOD
Bulgaria Sofia 1407 MHAT Tokuda Hospital Sofia, AD
Bulgaria Stara Zagora 6000 Medical Center "Nov Rehabilitatsionen Tsentar", EOOD
Bulgaria Varna 9010 MHAT 'Sv. Marina', EAD
Colombia Bogota Clinica Universitaria Colombia
Colombia Cali 0 RTS - Fundación Valle de Lili
Croatia Osijek 31000 Clinical Hospital Centre Osijek
Croatia Pula 52100 General Hospital Pula
Croatia Zagreb 10000 Clinical Hospital Centre Zagreb
Croatia Zagreb 10000 Clinical Hospital Dubrava
Croatia Zagreb 10000 Clinical Hospital Sveti Duh
Greece Alexandroupolis 68100 University General Hospital of Alexandroupolis
Greece Athens 10676 General Hospital of Athens "Evangelismos"
Greece Athens 11527 District General Hospital of Athens Laiko; 1st Internal Medicine Clinic
Latvia Riga LV-1005 Latvian Maritime Medical Centre; Department of Endoscopy
Latvia Riga LV-1006 Digestive Diseases Center "Gastro"
Latvia Riga LV1002 Pauls Stradins Clinical University Hospital
Lithuania Kaunas 50009 Hospital of Lithuanian University of Health. Sciences Kaunas Clinics
Lithuania Klaipeda 92288 Klaipeda Seamen's Hospital, Public Institution
Lithuania Vilnius 08661 Vilnius University Hospital Santariskiu Clinic Public Insti
Malaysia Kota Bahru 15586 Hospital Raja Perempuan Zainab II; Department of Medicine
Malaysia Kuala Lumpur 56000 Pusat Perubatan Universiti Kebangsaan Malaysia
Malaysia Kuala Lumpur 59100 University Malaya Medical Centre
Malaysia Kuantan 25100 Hospital Tengku Ampuan Afzan; Department of Internal Medicine (MOPD)
New Zealand Dunedin Dunedin Hospital
New Zealand Hamilton 3248 Waikato Hospital
New Zealand Lower Hutt 5010 Hutt Hospital
New Zealand Takapuna 0620 Shakespeare Specialist Group
New Zealand Tauranga 3143 Tauranga Hospital
Poland Katowice 40-645 Pro Familia Altera Sp z o.o.
Poland Katowice SP CSK im. prof. K. Gibinskiego SUM
Poland Rzeszow 35-055 Centrum Medyczne Medyk
Poland Szczecin 70-351 Niepubliczny Zaklad Opieki Zdrowotnej SONOMED
Poland Warszawa 02-653 Endoterapia PFG Sp. z o.o.
Poland Wroclaw 53-114 LexMedica Osrodek Badan Klinicznych
Russian Federation Moskovskaja Oblast Moscow 119192 CJSC Nasledniki
Russian Federation Barnaul 656038 SBEI HPE Altai State Medical University of MoH and SD; Out-patient Department
Russian Federation Irkutsk Irkutsk State Medical Academy of Continuing Education
Russian Federation Moscow 129128 SBEI HPE "Moscow State Medical and Dentistry Uni n.a. A. I. Evdmov" of the MoH of the RF
Russian Federation Novosibirsk 630117 FSBI "Scientific Research Institute of Physyology and Basic Medicine" under the SB of RAMS
Russian Federation Omsk 644013 BHI of Omsk region Clinical Oncology Dispensary
Russian Federation Saratov 410053 Regional Clinical Hospital
Russian Federation St. Petersburg 194044 Center of Emergency and Radiation Medicine; Pulmonology
Russian Federation St. Petersburg 197022 Pavlov First Saint Petersburg State Medical University
Russian Federation St. Petersburg 197110 SPb SHI "City Hospital #9"
Russian Federation Stavropol 355017 SBEI HPE "Stavropol State Medical Academy"
Turkey Ankara 06110 Ankara Diskapi Yildirim Beyazit Training and Research Hospital; Gastroenterology
Turkey Istanbul 34668 Haydarpasa Numune Training and Research Hospital; Hemodialysis Center
Turkey Istanbul 34890 Marmara University Pendik Training and Research Hospital
Turkey Kocaeli 41380 Kocaeli University Medical Faculty
Ukraine Chernivtsi 58002 RCI Chernivtsi RCH Dep of Urology Bukovinian SMU
Ukraine Dnipropetrovsk 49074 SI inst. of Gastroenterology of NAMSU Dept of Stomach & Duodenum Diseases, D&ThN SI DMA of MoHU
Ukraine Kharkiv 61039 GI L.T.Malaya Therapy National Institute of the NAMS of Ukraine
Ukraine Kherson 73000 CI Kherson Afanasii and Olha Tropiny City Clinical Hospital
Ukraine Kyiv 01030 Kyiv CCH #18 Dept of Proctology O. O. Bogomolets NMU
Ukraine Vinnytsia 21001 Private Small Enterprise Medical Center Pulse
Ukraine Vinnytsia 21029 MCIC MC LLC Health Clinic
Ukraine Zaporizhzhia 69104 Zaporizhzhia Medical University; DCH st Zap2 SI "Pridnipr railw.",Dept.of surg.
Ukraine Zaporizhzhia 69106 LLC Diaservis

Contact

Reference Study ID Number: GA28949 www.roche.com/about_roche/roche_worldwide.htm
888-662-6728 (U.S. and Canada)
E-mail:

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