Study for Participants With Ulcerative Colitis Previously Enrolled in Etrolizumab Phase II/III Studies
- Autoimmune Disorder
- Inflammatory Bowel Disease (IBD)
- Ulcerative Colitis
Terminated
- Aalborg
- Adelaide
- Alcorcón
- Amsterdam
- Ankara
- Ann Arbor
- Ansan-si
- Antwerpen
- Asheville
- Atlanta
- Auckland
- Balatonfüred
- Bankstown
- Banskobystrický kraj
- Barcelona
- Barnaul
- Baton Rouge
- 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
- Chernivtsi
- Chicago
- Chojnice
- Cincinnati
- Clayton
- Clearwater
- Clichy
- Clinton
- Colorado Springs
- Concord
- Coventry
- Creixomil
- Cuautitlán Izcalli
- Częstochowa
- Córdoba
- Daegu
- Dallas
- Debrecen
- Detroit
- Distrito Federal
- Dnipro
- Dunedin
- Edmonton
- Eger
- El Cajon
- Erlangen
- Exeter
- Firenze
- Fitzroy
- Footscray
- Frankfurt
- Freiburg im Breisgau
- Fuenlabrada
- Gdańsk
- Genova
- Gent
- Girona
- Great Neck
- Guadalajara
- Guelph
- Győr
- Haifa
- Halifax
- Halle (Saale)
- Hamburg
- Hamilton
- Hannover
- Henderson
- Herentals
- Herlev
- Herston
- Hlavní město Praha
- Hong Kong Island
- Hyderabad
- Iraklio
- Irkutsk
- Jaipur
- Jerusalem
- Jette
- Jihomoravský kraj
- Kansas City
- Katowice
- Kaunas
- Kharkiv
- Kherson
- Kiel
- Kinston
- Kistarcsa
- Kladno
- Kocaeli
- 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
- Memphis
- Mentor
- Miami
- Miami Beach
- Milano
- Minas Gerais
- Minneapolis
- Miskolc
- Modena
- Monterrey
- Montpellier
- Montréal
- Moscow
- Moskva
- Murdoch
- Münster
- Nagpur
- Naples
- Nashville
- 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
- 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
- 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
- Sofia
- Sopot
- Southampton
- Southlake
- Stara Zagora
- 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
- 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
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.
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
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.
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