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NCT01316939

NCT01316939
Terminated Phase 3 🇦🇺 Australian site

Who may be able to join

Who might be able to join this trial:

  • You must have already taken part in a related induction study (Study CCX114151 or another GSK-sponsored study) and shown improvement in your Crohn's disease symptoms or reached remission during that study
  • You must be willing and able to sign a consent form before any procedures in this study begin
  • If you are a woman who could become pregnant, you must either not be sexually active or agree to use a reliable form of contraception that has less than a 1% chance of failing
  • Any medications you are already taking for Crohn's disease must be at a stable, unchanged dose
  • If you are currently taking steroid medications, you must be willing to gradually reduce your steroid dose during the study

Who may not be able to join:

  • Women who are pregnant, who test positive for pregnancy, or who are breastfeeding
  • People who are known or suspected to have coeliac disease, or who test positive for a related antibody — this will need to be checked with a blood test before joining (confirm with trial site)
  • People who have a known or suspected blockage in the small bowel that is causing symptoms
  • People who have certain types of abnormal connections or tunnels between the bowel and the skin or other nearby areas that are likely to need surgery during the study
  • People who currently have a serious infection or blood poisoning that requires intravenous (drip) antibiotics for more than 2 weeks
  • People who have signs of liver problems, liver disease, or a hepatitis (liver) infection

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
GlaxoSmithKline
Registry
clinicaltrials_gov
Start date
9 May 2011
Est. completion
23 October 2013

Where this trial is recruiting

🇦🇺 Australia 🇦🇹 Austria 🇧🇪 Belgium 🇧🇬 Bulgaria 🇨🇦 Canada 🇨🇱 Chile 🇨🇿 Czechia 🇩🇰 Denmark 🇪🇪 Estonia 🇫🇷 France 🇩🇪 Germany Hong Kong 🇭🇺 Hungary 🇮🇱 Israel 🇮🇹 Italy 🇯🇵 Japan 🇳🇱 Netherlands 🇳🇿 New Zealand 🇳🇴 Norway 🇵🇱 Poland 🇵🇹 Portugal 🇷🇺 Russia 🇸🇰 Slovakia 🇿🇦 South Africa 🇰🇷 South Korea 🇪🇸 Spain 🇸🇪 Sweden 🇨🇭 Switzerland 🇹🇼 Taiwan Turkey (Türkiye) 🇺🇦 Ukraine 🇬🇧 United Kingdom 🇺🇸 United States

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

Primary endpoints

Percentage of Participants in Clinical Remission (Crohn's Disease Activity Index , CDAI Score <150 Points) at Both Weeks 28 and 52 of the 52-week Treatment Period

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