Study for Participants With Ulcerative Colitis Previously Enrolled in Etrolizumab Phase II/III Studies

  • Ulcerative Colitis
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

      Show trial locations

      The source of the below information is the publicly available website ClinicalTrials.gov. It has been summarised and edited into simpler language.

      The below information is taken directly from the publicly available website ClinicalTrials.gov within a week of any updates, and has not been edited.

      Results Disclaimer

      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

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