Select Your Region
Global
Study for Participants With Ulcerative Colitis Previously Enrolled in Etrolizumab Phase II/III Studies
- Autoimmune Disorder
- Inflammatory Bowel Disease (IBD)
- Ulcerative Colitis
Please note that the recruitment status of the trial at your site may differ from the overall study status because some study sites may recruit earlier than others.
Trial Status:
Terminated
This trial runs in
Cities
- Aalborg
- Adelaide
- Alcorcón
- Amiens
- Amsterdam
- Ankara
- Ann Arbor
- Ansan-si
- Antwerpen
- Asheville
- Atlanta
- Auckland
- Bahia
- Balatonfüred
- Bankstown
- Banskobystrický kraj
- Barcelona
- Barnaul
- Baton Rouge
- Be'er Ya'akov
- Bedford Park
- Bellevue
- Belton
- Bengaluru
- Beograd
- Berlin
- Bern
- Birmingham
- Bloemfontein
- Bochum
- Bologna
- Bonheiden
- Boston
- Botucatu
- Braga
- Brescia
- Brno
- Bruxelles
- București
- Budapest
- bury
- Busan
- Bydgoszcz
- Békéscsaba
- Caen
- Calgary
- Cali
- Cambridge
- Cape Town
- cascina-perseghetto
- Ceará
- Chambray-lès-Tours
- Chapel Hill
- cheras
- Cherepovets
- Chernivtsi
- Chicago
- Chojnice
- Cincinnati
- Clayton
- Clearwater
- Clichy
- Clinton
- Colorado Springs
- Concord
- Coventry
- Creixomil
- Cuautitlán Izcalli
- Częstochowa
- Córdoba
- Daegu
- Dallas
- Daugavpils
- Debrecen
- Detroit
- Distrito Federal
- Dnipro
- Dunedin
- Dupnica
- Edmonton
- Eger
- El Cajon
- Erlangen
- Exeter
- Firenze
- Fitzroy
- Footscray
- Frankfurt
- Freiburg im Breisgau
- Fuenlabrada
- Gdańsk
- Genova
- Gent
- Girona
- Goiás
- Great Neck
- Guadalajara
- Guelph
- Győr
- Haifa
- Halifax
- Halle (Saale)
- Hamburg
- Hamilton
- Hannover
- Henderson
- Herentals
- Herlev
- Herston
- Hlavní město Praha
- Hollywood
- Hong Kong Island
- Hyderabad
- Iraklio
- Irkutsk
- İstanbul
- Jaipur
- Jerusalem
- Jette
- Jihomoravský kraj
- Kansas City
- Katowice
- Kaunas
- Kharkiv
- Kherson
- Kiel
- Kinston
- Kistarcsa
- Kladno
- Kocaeli
- Kota Bharu
- Kragujevac
- Kraków
- Královéhradecký kraj
- Ksawerów
- Kuantan
- Kyiv
- København
- Lafayette
- Launceston
- Leeds
- Leuven
- Lille
- London
- Longueuil
- Lublin
- Ludhiana
- Lviv
- Lévis
- Macon
- Madrid
- Malvern
- Mangaluru
- Mannheim
- Marietta
- Medellín
- Memphis
- Mentor
- Miami
- Miami Beach
- Milano
- Minas Gerais
- Minneapolis
- Miskolc
- Modena
- Monterrey
- Montpellier
- Montréal
- Moscow
- Moskva
- Murdoch
- Münster
- Nagpur
- Naples
- Nashville
- Nazareth
- New Albany
- New Port Richey
- New York
- Newcastle upon Tyne
- Nice
- Nijmegen
- Nitriansky kraj
- Nizhny Novgorod
- nordbyhagen
- North Mackay
- Nottingham
- Novosibirsk
- Nowy Targ
- Oak Lawn
- Odesa
- olomouc-9
- Olsztyn
- Omsk
- Omsk Oblast
- Orange
- Orlando
- Oshawa
- Osijek
- Ostrava
- oullins-pierre-benite
- Padova
- palanga
- Palermo
- Paraná
- Pardubice
- Paris
- Parkville
- Parma
- Pessac
- Petah Tikva
- petaling-jaya
- Pleven
- Poltava
- Porto Alegre
- Poznań
- Pretoria
- Prešovský kraj
- Pune
- Pécs
- Rehovot
- Reppenstedt
- Rho
- Richmond
- Rimavska Sobota
- Rio de Janeiro
- Rio Grande do Sul
- Roeselare
- Roma
- Rostov-on-Don
- Ruse
- Rzeszów
- Rīga
- Sabadell
- Saint Petersburg
- Saint-Priest-en-Jarez
- Salt Lake City
- Salzburg
- San Antonio
- San Diego
- San Donato Milanese
- San Francisco
- San Giovanni Rotondo
- Sankt-Peterburg
- Santa Fe
- Saskatoon
- Schweinfurt
- Seongnam-si
- Seoul
- Shreveport
- Singapore
- Sliven
- Sofia
- Sopot
- Southampton
- Southlake
- Stara Zagora
- State of São Paulo
- Stavropol
- Strasbourg
- Sumy
- Surat
- Suwanee
- Suwon
- Suwon-si
- Szczecin
- Szentes
- Székesfehérvár
- São Paulo
- Tallinn
- Tartu
- Tauranga
- Tel Aviv District
- Timișoara
- Topeka
- Torino
- Toronto
- Toulouse
- Troy
- Tyler
- Ulm
- Uzhhorod
- València
- Vancouver
- Vandœuvre-lès-Nancy
- Varna
- Vaughan
- Veliko Tarnovo
- Ventura
- Vilnius
- Vinnytsia
- Voronezh
- Warszawa
- Wheat Ridge
- Wien
- Winter Park
- Wonju-si
- Woolloongabba
- Wrocław
- Ypsilanti
- Zagreb
- Zaporizhzhia
- Zaragoza
- zlin-1
- Zrenjanin
- Ústecký kraj
- Łódź
- Šahy
Trial Identifier:
NCT02118584 2013-004435-72 GA28951
Trial Summary
This two-part, part 1: open-label extension (OLE) and part 2: safety monitoring (SM) study will examine the efficacy and safety of continued etrolizumab treatment in moderate to severe ulcerative colitis (UC) participants previously enrolled in etrolizumab Phase II/III studies. Participants with moderate to severe UC who were enrolled in the Phase II OLE study (GA27927 [NCT01461317]) or the Phase III studies (GA28948 [NCT02163759], GA28949 [NCT02171429], GA28950 [NCT02100696], GA29102 [NCT02165215], and GA29103 [NCT02136069]) were included. Participants from the Phase II OLE study or the Phase III studies who are not eligible or willing to receive etrolizumab in the OLE-SM study, and who have completed the 12-week safety follow-up period will be enrolled in Part 2. Part 1 of OLE-SM will continue for up to 9 years after the first participant is enrolled into the study. Following Part 1, participants will enter Part 2 for a period of 92 weeks.
Hoffmann-La Roche
Sponsor
Phase 3
Phase
NCT02118584, GA28951, 2013-004435-72
Trial Identifier
Etrolizumab
Treatments
Ulcerative Colitis
Condition
Official Title
An Open-Label Extension and Safety Monitoring Study of Moderate to Severe Ulcerative Colitis Patients Previously Enrolled in Etrolizumab Phase II/III Studies
Eligibility Criteria
All
Gender
≥ 18 Years
Age
No
Healthy Volunteers
Inclusion Criteria
Part 1 (Open-label Extension)
- Participants previously enrolled in the Phase II OLE study or Phase III controlled studies who meet the eligibility criteria for open-label etrolizumab for those studies as described in the protocol
Part 2 (Safety Monitoring)
- Participants whose safety follow-up or PML follow-up is not completed within Study GA27927 and participants who had their last dose of etrolizumab in July 2016 in Study GA27927 and are not eligible or willing to enroll in Part 1 (OLE)
- Participants who participated in one of the etrolizumab Phase III studies and are not eligible or willing to enter Part 1 (OLE)
- Participants who transfer from Part 1 (OLE)
- Completion of the 12-week safety follow-up prior to entering.
Exclusion Criteria
Part 1 (Open-label Extension)
- Withdrawal of consent from and participant not compliant in the Phase II OLE study or any of the Phase III studies
- Participant who discontinued etrolizumab/etrolizumab placebo prior to Week 10 or did not perform the Week 10 visit of the Phase III Studies GA28948, GA28949, GA29102, and GA29103
- Participant who discontinued etrolizumab/etrolizumab placebo prior to Week 14 or did not perform the Week 14 visit of the Phase III Study GA28950
- Any new, significant, uncontrolled condition
For the latest version of this information please go to www.forpatients.roche.com