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NCT02403323

NCT02403323
Terminated Phase 3 🇦🇺 Australian site

Who may be able to join

Who might be able to join this trial:

  • You previously took part in a related etrolizumab study (called GA29144 / NCT02394028) and meet the requirements to continue receiving the open-label treatment in Part 1 of this trial
  • You took part in the related etrolizumab study (GA29144 / NCT02394028) but are either not eligible for, or have chosen not to enter, the treatment part of this trial (Part 1), and would join the safety monitoring part instead
  • You are moving from the treatment part of this trial (Part 1) into the safety monitoring part (Part 2)
  • You have completed a 12-week safety check-up period before entering the safety monitoring part (Part 2)

Who may not be able to join:

  • For the treatment part (Part 1): you have developed a new, serious health condition that is not well controlled (confirm with trial site)
  • For the safety monitoring part (Part 2): there are currently no listed reasons that would prevent you from joining this part of the trial

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

Phase 3: approximately ~65% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.

Trial details

Status
Terminated
Phase
Phase 3
Sponsor
Hoffmann-La Roche
Registry
clinicaltrials_gov
Start date
8 June 2015
Est. completion
9 October 2023

Where this trial is recruiting

🇦🇷 Argentina 🇦🇺 Australia 🇦🇹 Austria 🇧🇪 Belgium 🇧🇷 Brazil 🇧🇬 Bulgaria 🇨🇦 Canada 🇭🇷 Croatia 🇨🇿 Czechia 🇪🇪 Estonia 🇫🇷 France 🇩🇪 Germany 🇭🇺 Hungary 🇮🇱 Israel 🇮🇹 Italy 🇱🇻 Latvia 🇱🇹 Lithuania 🇲🇽 Mexico 🇳🇱 Netherlands 🇳🇿 New Zealand 🇵🇱 Poland 🇷🇴 Romania 🇷🇺 Russia 🇷🇸 Serbia 🇸🇰 Slovakia 🇿🇦 South Africa 🇰🇷 South Korea 🇪🇸 Spain 🇨🇭 Switzerland Turkey (Türkiye) 🇺🇦 Ukraine 🇬🇧 United Kingdom 🇺🇸 United States

13 site(s) in Australia. Confirm current status and contact details directly with the trial site.

Primary endpoints

Part 1: Number of Participants With Crohn's Disease Activity Index (CDAI) Remission at 12-week Intervals; Part 1: Number of Participants With Clinical Remission at 12-week Intervals; Part 1: Number of Participants With Improvement in Simple Endoscopic Score for Crohn's Disease (SES-CD) Score at Week 108; Part 1: Number of Participants With Adverse Event (AE) and Severity of AEs as Assessed Using National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 (NCI-CTCAE v4.0); Part 1: Number of Participants With Serious Adverse Events (SAEs); Part 1: Number of Participants...

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 30 June 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

View original record on ClinicalTrials.gov