Open-Label Extension and Safety Study for Patients With Crohn's Disease Previously Enrolled in the Etrolizumab Phase III Study GA29144

  • Crohn's Disease
Trial Status:

Recruiting

This trial runs in
Cities
  • _eske-bud_jovice
  • Afula
  • Amiens
  • Amsterdam
  • Ankara
  • Ann Arbor
  • Ansan-si
  • Arcadia
  • Atlanta
  • Auckland
  • Barcelona
  • Barnaul
  • Bedford Park
  • Belfast
  • Beograd
  • Berlin
  • Bern
  • Białystok
  • Bruxelles
  • București
  • Budapest
  • Buenos Aires
  • Busan
  • Bydgoszcz
  • Békéscsaba
  • Caen
  • Calgary
  • cascina-perseghetto
  • Chapel Hill
  • Charlotte
  • Chernivtsi
  • Chicago
  • Christchurch
  • Ciudad de México
  • Clearwater
  • Clichy
  • Colorado Springs
  • Columbus
  • Concord
  • Coventry
  • Córdoba
  • Daegu
  • Dallas
  • Debrecen
  • Dunedin
  • Edmonton
  • Elbląg
  • Firenze
  • Fitzroy
  • Footscray
  • Frankfurt am Main
  • Fuenlabrada
  • Gainesville
  • Garran
  • Geleen
  • Germantown
  • Goiás
  • Győr
  • Halifax
  • Hamilton
  • Hannover
  • Herston
  • Hlavní město Praha
  • Holon
  • Houston
  • Hradec Králové
  • Huelva
  • Irkutsk
  • İstanbul
  • Ivano-Frankivs'k
  • İzmir
  • Jerusalem
  • Jihomoravský kraj
  • Kharkiv
  • Kielce
  • Kinston
  • Kistarcsa
  • Kocaeli
  • Ksawerów
  • Kyiv
  • L'Hospitalet de Llobregat
  • L'viv
  • Leeds
  • Leiden
  • Lille
  • London
  • Long Beach
  • Lower Hutt
  • Macon
  • Madison
  • Madrid
  • Malvern
  • Mannheim
  • Marietta
  • Melbourne
  • Memphis
  • Mentor
  • Meridian
  • Miami
  • Milano
  • Modena
  • Montréal
  • Moscow
  • Murdoch
  • Mérida
  • Nantes
  • Nashville
  • Nazareth
  • New York
  • Nice
  • Nitriansky kraj
  • Nottingham
  • Novosibirsk
  • Nowy Targ
  • Oak Lawn
  • Odesa
  • Olomouc
  • Omsk Oblast
  • Osijek
  • Ostrava
  • Paraná
  • Pessac
  • Petah Tikva
  • Pierre-Bénite
  • Pretoria
  • Pula
  • Reading
  • Reims
  • Rio de Janeiro
  • Rio Grande do Sul
  • Rochester
  • Roma
  • Rostov-on-Don
  • Rotterdam
  • Rzeszów
  • Rīga
  • Saint Petersburg
  • Saint-Priest-en-Jarez
  • Salt Lake City
  • Salzburg
  • San Antonio
  • San Carlos
  • San Diego
  • San Donato Milanese
  • San Francisco
  • Sankt-Peterburg
  • Saskatoon
  • Seattle
  • Seongnam-si
  • Seoul
  • Sevilla
  • Shreveport
  • Sofia
  • South Brisbane
  • Southampton
  • Southlake
  • Strasbourg
  • Szczecin
  • São Paulo
  • Tallinn
  • Tartu
  • Tauranga
  • Tilburg
  • Topeka
  • Toruń
  • Troy
  • Tyler
  • Ulm
  • València
  • Vilnius
  • Vinnytsia
  • Warszawa
  • westfield
  • Wien
  • Winnipeg
  • Wolverhampton
  • Wonju-si
  • Wrocław
  • Wyoming
  • Zaporizhzhia
  • Zaragoza
  • Zrenjanin
Trial Identifier:

NCT02403323 2014-003855-76 GA29145

      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 open-label extension and safety monitoring study is composed of two parts: Part 1 will evaluate the long-term safety and efficacy of continued etrolizumab treatment in participants with moderately to severely active Crohn's disease who were previously enrolled in the etrolizumab Phase III Study GA29144 (NCT02394028) and who meet eligibility criteria for enrollment into Part 1. In Part 2, participants who have stopped etrolizumab treatment (either by exiting Part 1 of this study or by entering directly from Study GA29144 [NCT02394028]) will be monitored for 92 weeks for progressive multifocal leukoencephalopathy (PML) and other safety events.

      Hoffmann-La Roche Sponsor
      Phase 3 Phase
      NCT02403323 , GA29145 , 2014-003855-76 Trial Identifier
      Etrolizumab Treatments
      Crohn Disease Condition
      Official Title

      An Open-Label Extension and Safety Monitoring Study of Patients With Moderately to Severely Active Crohn's Disease Previously Enrolled in the Etrolizumab Phase III Protocol GA29144

      Eligibility Criteria

      All Gender
      ≥ 18 Years Age
      No Healthy Volunteers
      Inclusion Criteria

      Part 1 Open-Label Extension:

      • Patients previously enrolled in etrolizumab Phase III study GA29144 (NCT02394028) who meet the eligibility criteria for open-label etrolizumab as described in the protocol

      Part 2 Safety Monitoring:

      • Patients who participated in etrolizumab Phase III study GA29144 (NCT02394028) and are not eligible or choose not to enter Part 1
      • Patients who transfer from Part 1
      • Completion of the 12-week safety follow-up period prior to entering
      Exclusion Criteria

      Part 1 Open-Label Extension:

      • Any new, significant, uncontrolled condition

      Part 2 Safety Monitoring:

      • No exclusion criteria

      About Clinical Research

      What is a clinical trial? Why should I consider taking part in a clinical trial? And why does Genentech conduct clinical trials?

      Find out now