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.
Trial Status:
Not yet recruiting
This trial runs in
Cities
- Aabenraa
- Aalborg
- Adelaide
- Alcorcón
- Alexandroupoli
- Alexandroupolis
- Alkmaar
- Amiens
- Amsterdam
- Ankara
- Ann Arbor
- Ansan-si
- Antwerpen
- Arnhem
- Asheville
- Athens
- Athina
- Atlanta
- Auckland
- Aventura
- Bahia
- Balatonfured
- Balatonfüred
- Bankstown
- Banskobystrický kraj
- Barcelona
- Barnaul
- Baton Rouge
- Be'er Ya'akov
- Bedford Park
- Belgaum
- Bellevue
- Belton
- Bengaluru
- Beograd
- Berlin
- Bern
- Bethlehem
- Bhubaneswar
- Białystok
- Birmingham
- Bloemfontein
- Bochum
- Bologna
- Bonheiden
- Boston
- Botucatu
- Braga
- Brasília
- Bratislavský kraj
- Braunschweig
- Brescia
- Brno
- Brussel
- Brussels
- Bruxelles
- Bucuresti
- București
- Budapest
- bury
- Busan
- Bydgoszcz
- Békéscsaba
- Caen
- Calgary
- Cali
- Cambridge
- Campinas
- Cape Town
- Ceará
- Chambray-lès-Tours
- Chapel Hill
- Chatsworth
- Cherepovets
- Chernivtsi
- Chicago
- Chojnice
- Cincinnati
- Clayton
- Clearwater
- Clermont-Ferrand
- Clichy
- Clichy cedex
- Clifton
- Clinton
- Coimbra
- Colorado Springs
- Concord
- Coventry
- Creixomil
- Creteil cedex
- Créteil
- Cuautitlán Izcalli
- Curitiba
- Częstochowa
- Córdoba
- Daegu
- Dallas
- Daugavpils
- DCE
- Debrecen
- Delhi
- Denver
- Detroit
- Distrito Federal
- Dnipro
- Dnipropetrovsk
- Dunedin
- Dupnica
- Dupnitsa
- Durango
- Edmonton
- Eger
- Erlangen
- Essen
- Estado de México
- Exeter
- Ferrol
- Firenze
- Fitzroy
- Footscray
- Fortaleza
- Frankfurt
- Frankfurt am Main
- Freiburg
- Freiburg im Breisgau
- Fuenlabrada
- Gdansk
- Genova
- Gent
- Germantown
- Girona
- Goiania
- Goiás
- Great Neck
- Greenfield Park
- Guadalajara
- Guelph
- Guimaraes
- Gyeonggi-do
- Gyor
- Győr
- Haifa
- Halifax
- Halle
- Halle (Saale)
- Hamburg
- Hamilton
- Hannover
- Henderson
- Herakleion
- Herentals
- Herlev
- Herston
- Hlavní město Praha
- Hong Kong
- Hong Kong Island
- Houston
- Hradec Králové
- Humenné
- Hyderabad
- Irkutsk
- İstanbul
- Istanbul
- Jaipur
- Jaú
- Jena
- Jerusalem
- Jette
- Jihomoravský kraj
- Kansas City
- Katowice
- Kaunas
- KDT
- Kefar Sava
- Kfar- Saba
- Kharkiv
- Kherson
- Kiel
- Kinston
- Kistarcsa
- Kladno
- Klagenfurt am Wörthersee
- klagenfurt-am-worthersee
- Klaipeda
- Klaipėda
- Kocaeli
- Kolding
- Kota Bahru
- Kota Bharu
- Kozyataği
- Kragujevac
- Kraków
- Ksawerów
- Kuala Lumpur
- Kuantan
- Kyiv
- Köln
- København
- København Ø
- L'viv
- La Jolla
- Lafayette
- Las Vegas
- Launceston
- Leeds
- Leuven
- Lille
- London
- Longueuil
- Lublin
- Ludhiana
- Lviv
- Lévis
- Lørenskog
- Lübeck
- Mackay
- Macon
- Madrid
- Magdeburg
- Malvern
- Manchester
- Mangalore
- Mannheim
- Mar del Plata
- Marietta
- Medellín
- Memphis
- Mentor
- Miami
- Miami Beach
- Milano
- Minas Gerais
- Minneapolis
- Miramar
- Miskolc
- Modena
- Monterrey
- Montpellier
- Montréal
- Moravskoslezský kraj
- Moscow
- Moskva
- Murdoch
- Mykolaiv
- München
- Münster
- Nagpur
- Naples
- Nashville
- Nazareth
- Nea Ionia
- New Albany
- New Delhi
- New Port Richey
- New Territories
- New Westminster
- New York
- Newcastle upon Tyne
- Nice
- Nijmegen
- Nitra
- Nitriansky kraj
- Nizhny Novgorod
- Niš
- NL -nijmegen
- nordbyhagen
- North Carolina
- North Mackay
- Nottingham
- Novosibirsk
- Nowy Targ
- Oak Lawn
- Odessa
- Oklahoma City
- Olomouc
- Olsztyn
- Omsk
- Omsk Oblast
- Orange
- Orlando
- Oshawa
- Osijek
- Ostrava
- Padova
- Pahang
- Palermo
- Palmetto Bay
- Paraná
- Pardubice
- Pardubický kraj
- Paris
- Parkville
- Parma
- Pessac
- Petach Tiqwa
- Petah Tikva
- Pierre-Bénite
- Pisa
- Pleven
- Poltava
- Porto Alegre
- Poznań
- Praha 7
- Presov
- Pretoria
- Prešovský kraj
- Pune
- Pécs
- Rajkot
- Ramat Gan
- Rehovot
- Rennes
- Reppenstedt
- Reston
- Rho
- Richmond
- Rimavska Sobota
- Rio de Janeiro
- Rio Grande do Sul
- rishon-lezion
- Roeselare
- Roma
- Rosario
- Rostov-on-Don
- Rozzano
- Rozzano (MI)
- Ruse
- Rzeszów
- Rīga
- Saarbrücken
- Sabadell
- Saint Petersburg
- Saint-Étienne
- Salt Lake City
- Salvador
- Salzburg
- Samara
- San Antonio
- San Diego
- San Donato Milanese
- San Donato Milanese (MI)
- San Francisco
- San Giovanni Rotondo
- Sankt-peterburg
- Sankt-Peterburg
- Santo Andre
- Saskatoon
- Schweinfurt
- Seattle
- Seongnam
- Seongnam-si
- seongnam-si
- Seoul
- Setúbal
- Shreveport
- Singapore
- Sliven
- Sofia
- Sopot
- Southampton
- Southlake
- St Petersburg
- St. Petersburg
- Stara Zagora
- Stavropol
- Strasbourg
- Sumy
- Sunrise
- Surat
- Suwanee
- Suwon
- suwon-city
- Suwon-si,
- Szczecin
- Szeged
- Szentes
- Székesfehérvár
- São Paulo
- Takapuna
- Tallinn
- Tamarac
- Targu-Mures
- Tartu
- Tauranga
- Tel Hashomer
- Timisoara
- Timișoara
- Toluca de Lerdo
- Topeka
- Torino
- Toronto
- Torquay
- Toruń
- Toulouse Cedex 09
- Trinity
- Troy
- Tyler
- Târgu Mureș
- Udine
- Ulm
- Usti Nad Labem
- Uzhgorod
- Uzhhorod
- València
- Vancouver
- Vandoeuvre Les Nancy
- Vandœuvre-lès-Nancy
- Varna
- Vaughan
- Veliko Tarnovo
- Ventura
- Vilnius
- Vinnytsia
- Voronez
- Voronezh
- vranov-nad-top_ou
- Warszawa
- Whittier
- Wien
- Winter Park
- Wonju-Si
- Wonju-si
- Woolloongabba
- Wroclaw
- Wrocław
- Ypsilanti
- Zagreb
- Zalaegerszeg
- Zaporizhzhia
- Zaragoza
- Zlín
- Zrenjanin
- Zürich
- Åbenrå
- Ålborg
- 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