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NCT02743806

NCT02743806
Terminated Phase 4 🇦🇺 Australian site

Who may be able to join

Who might be able to join this trial:

  • You previously received vedolizumab (not a placebo or comparison drug) as part of an earlier qualifying clinical study.
  • Your doctor believes you are still benefiting from vedolizumab and that continuing it is important, either because there is no similar alternative available to you, or because stopping treatment could cause your condition to get worse.
  • If you are a man who is not sterilized and is sexually active with a woman who could become pregnant, you agree to use reliable contraception from the start of the study until 18 weeks after your last dose.
  • If you are a woman who could become pregnant and are sexually active with a man who is not sterilized, you agree to use reliable contraception from the start of the study until 18 weeks after your last dose.

Who may not be able to join:

  • Vedolizumab is already available to you through normal commercial means, such as through insurance or other reimbursement programs.
  • You have a medical condition or have had a previous treatment that your doctor believes would make it unsafe or unsuitable for you to participate in this study.
  • If you are a woman who is currently pregnant, breastfeeding, or planning to become pregnant or donate eggs during the study or within 18 weeks after your last dose.
  • If you are a man who plans to donate sperm during the study or within 18 weeks after your last dose.
  • You have received a live vaccine in the past 18 weeks, or you will need a live vaccine during the study or within 18 weeks after your last dose.

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 4: approximately Approved 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 4
Sponsor
Takeda
Registry
clinicaltrials_gov
Start date
1 August 2016
Est. completion
3 January 2023

Where this trial is recruiting

🇦🇺 Australia 🇧🇬 Bulgaria 🇨🇿 Czechia 🇪🇪 Estonia 🇭🇺 Hungary 🇮🇳 India 🇮🇹 Italy 🇱🇻 Latvia 🇲🇾 Malaysia 🇳🇿 New Zealand 🇵🇱 Poland 🇷🇴 Romania 🇷🇺 Russia 🇷🇸 Serbia 🇿🇦 South Africa 🇰🇷 South Korea Turkey (Türkiye) 🇺🇦 Ukraine

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

Primary endpoints

Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs); Percentage of Participants With Adverse Events of Special Interest (AESIs)

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