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Global
A Study of the Efficacy and Safety of Etrolizumab in Ulcerative Colitis Participants Who Have Been Previously Exposed to Tumor Necrosis Factor (TNF) Inhibitors
- Ulcerative Colitis
Trial Status:
Active, not recruiting
This trial runs in
Cities
- Alcorcón
- Alexandroupolis
- Amiens Cedex01
- Amsterdam
- Ann Arbor
- Antwerpen
- Arnhem
- Asheville
- Athina
- Atlanta
- Aventura
- Bankstown
- Barcelona
- Baton Rouge
- Bedford Park
- Beer Yaacov
- Bellevue
- Berlin
- Bern
- Besançon Cedex
- Bethlehem
- Birmingham
- Bologna
- Bonheiden
- Boston
- Botucatu
- Brandenburg an der Havel
- Brasília
- Bridgewater
- Brno
- Brussel
- Brussels
- Bruxelles
- Bucuresti
- București
- Budapest
- Busan
- Bydgoszcz
- Békéscsaba
- Calgary
- Cambridge
- Campinas
- Chapel Hill
- Charleston
- Charlotte
- Charlottesville
- Chattanooga
- Chicago
- Cincinnati
- Clayton
- Clearwater
- Clichy cedex
- Clinton
- Colorado Springs
- Concord
- Cuernavaca
- Curitiba
- Daegu
- Debrecen
- Denver
- Detroit
- Downsview
- Durango
- Edmonton
- Eger
- Elblag
- Erlangen
- Essen
- Exeter
- Ferrol
- Firenze
- Fitzroy
- Footscray
- Frankfurt
- Freiburg
- Genova
- Gent
- Germantown
- Girona
- Goiania
- Great Neck
- Guelph
- Gyeonggi-do
- Gyongyos
- Gyor
- Gyula
- Hadera
- Haifa
- Halifax
- Halle
- Halle (Saale)
- Hamburg
- Hamden
- Hannover
- Heidelberg
- Herakleion
- Herentals
- Herlev
- Herston
- Hlavní město Praha
- Houston
- Hradec Králové
- Ioannina
- Itajai
- Jacksonville
- Jena
- Jerusalem
- Kansas City
- Katowice
- Kaunas
- Kiel
- Kinston
- Kistarcsa
- Klagenfurt
- Köln
- København Ø
- La Jolla
- Lakewood
- Launceston
- Le Kremlin Bicêtre cedex
- Leuven
- León
- Lille
- Linz
- Liège
- London
- Los Angeles
- Louisville
- Lévis
- Maastricht
- Macon
- Madison
- Madrid
- Magdeburg
- Maitland
- Malvern
- Manchester
- Mannheim
- Mar del Plata
- Marietta
- Marseille cedex 20
- Mentor
- Messina
- Mexico, Distrito Federal
- Milano
- Milwaukee
- Minneapolis
- Miramar
- Miskolc
- Mission Viejo
- Modena
- Modesto
- Monterrey
- Montréal
- Mosonmagyaróvár
- Murdoch
- Münster
- Naples
- Nashville
- Neustadt
- New Port Richey
- New York
- Newcastle upon Tyne
- Nice
- NL -nijmegen
- Norfolk
- Norman
- North Miami Beach
- Nottingham
- Oak Lawn
- Ogden
- Oklahoma City
- Olomouc
- Orange
- Orlando
- Oshawa
- Padova
- Pardubice
- Paris
- Parkville
- Pavia
- Pessac
- Petach Tikva
- Philadelphia
- Pilaia Thessalonikis
- Porto Alegre
- Poughkeepsie
- Praha 4 - Krc
- Praha 7
- Pécs
- Reading
- Rehovot
- Rho
- Richmond
- Rio de Janeiro
- Rochester
- Roeselare
- Roma
- Rosario
- Roseville
- Rozzano (MI)
- Rzeszów
- Saarbrücken
- Saint Louis
- Saint-Étienne
- Salisbury
- Salt Lake City
- Salzburg
- San Diego
- San Donato Milanese (MI)
- San Francisco
- Santa Monica
- Santo Andre
- Saskatoon
- Seattle
- Seoul
- Shreveport
- Sopot
- South Brisbane
- Southampton
- St. Gallen
- Stade
- Strasbourg
- Suwanee
- Suwon-si,
- Szczecin
- Szeged
- Szekszárd
- Székesfehérvár
- São Paulo
- Tel Aviv
- Tel Hashomer
- Thessaloniki
- Timisoara
- Toluca de Lerdo
- Topeka
- Toronto
- Toulouse Cedex 09
- Troy
- Tyler
- Uberlandia
- Ulm
- Urbana
- Usti Nad Labem
- València
- Vancouver
- Vandoeuvre Les Nancy
- Vilnius
- Voorhees
- Warszawa
- Whittier
- Wien
- Winnipeg
- Winter Park
- Woolloongabba
- Wroclaw
- Zaragoza
- Zürich
- Åbenrå
- Ålborg
Trial Identifier:
NCT02100696 2013-004278-88 GA28950
Trial Summary
This phase III, double blind, placebo-controlled, multicenter study will investigate the efficacy and safety of etrolizumab during induction and maintenance of remission in participants with moderately to severely active ulcerative colitis (UC) who have been previously exposed to TNF inhibitors.
Hoffmann-La Roche
Sponsor
Phase 3
Phase
NCT02100696 , GA28950 , 2013-004278-88
Trial Identifier
Etrozulimab, Placebo
Treatments
Ulcerative Colitis
Condition
Official Title
Phase III, Double Blind, Placebo-Controlled, Multicenter Study of the Efficacy and Safety of Etrolizumab During Induction and Maintenance in Patients With Moderate to Severe Active Ulcerative Colitis Who Have Been Previously Exposed to TNF Inhibitors
Eligibility Criteria
All
Gender
≥ 18 Years & ≤ 80 Years
Age
No
Healthy Volunteers
Inclusion Criteria
- Moderately to severely active UC as determined by the Mayo Clinic Score assessment (MCS)
- Washout of anti-TNF therapy for at least 8 weeks preceding Day 1
- Background regimen for UC may include oral 5-aminosalicylic acid (5-ASA), oral corticosteroids, budesonide, probiotics, azathioprine (AZA), 6-mercaptopurine (6-MP), or methotrexate (MTX) if doses have been stable during the screening period
- Use of highly effective contraception as defined by the protocol
- Must have received a colonoscopy within the past year or be willing to undergo a colonoscopy in lieu of a flexible sigmoidoscopy at screening
- Treatment within 5 years prior to screening with one or two induction regimines that contain TNF inhibitors (including TNF inhibitor biosimilars)
Exclusion Criteria
- A history of or current conditions and diseases affecting the digestive tract, such as indeterminate colitis, Crohn's disease, fistulas or abdominal abscesses, colonic mucosal dysplasia, intestinal obstruction, toxic megacolon, or unremoved adenomatous colonic polyps
- Prior or planned surgery for UC
- Past or present ileostomy or colostomy
- Any prior treatment with etrolizumab or other anti-integrin agents (including natalizumab, vedolizumab, and efalizumab) and rituximab
- Any prior treatment with anti-adhesion molecules (e.g. anti-MAdCAM-1)
- Chronic hepatitis B or C infection, human immunodeficiency virus (HIV) or tuberculosis
- Evidence of or treatment for Clostridium difficile clinically significant cytomegalovirus (CMV) colitis within 60 days prior to Day 1
For the latest version of this information please go to www.forpatients.roche.com