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NCT03464097

NCT03464097
Terminated Phase 3 🇦🇺 Australian site

Who may be able to join

Who might be able to join this trial:

  • You met the requirements to join the earlier part of this study (called the "induction study") and completed all required assessments at the 12-week mark.
  • At week 12 of the induction study, you were showing improvement or were in remission, meaning your symptoms — such as number of bowel movements per day and abdominal pain — were well-controlled and no worse than when you started.

Who may not be able to join:

  • You have had surgery to remove part or all of your large bowel, part of your small bowel, or have had a stoma (an opening created in the abdomen for waste) since the start of the induction study, or you have developed a new fistula (an abnormal tunnel connecting organs).
  • You have recently received certain treatments, including steroid suppositories or enemas, rectal anti-inflammatory medicines (called 5-aminosalicylates), steroid injections or infusions, immune-suppressing drugs, experimental treatments, or a blood-filtering treatment called apheresis (confirm with trial site for exact timing details).

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

For more information about this Bristol-Myers Squibb study, you can also visit: www.BMSStudyConnect.com

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
Celgene
Registry
clinicaltrials_gov
Start date
27 June 2018
Est. completion
3 October 2024

Where this trial is recruiting

🇦🇷 Argentina 🇦🇺 Australia 🇦🇹 Austria Belarus 🇧🇪 Belgium Bosnia and Herzegovina 🇧🇬 Bulgaria 🇨🇦 Canada 🇨🇱 Chile 🇨🇳 China 🇨🇴 Colombia 🇭🇷 Croatia 🇨🇿 Czechia 🇩🇰 Denmark 🇫🇮 Finland 🇫🇷 France 🇬🇪 Georgia 🇩🇪 Germany 🇬🇷 Greece Hong Kong 🇭🇺 Hungary 🇮🇳 India 🇮🇪 Ireland 🇮🇱 Israel 🇮🇹 Italy 🇱🇻 Latvia 🇱🇹 Lithuania 🇲🇽 Mexico Moldova 🇳🇱 Netherlands 🇵🇱 Poland 🇵🇹 Portugal 🇷🇴 Romania 🇷🇺 Russia 🇸🇦 Saudi Arabia Senegal 🇷🇸 Serbia 🇸🇰 Slovakia 🇸🇮 Slovenia 🇿🇦 South Africa 🇰🇷 South Korea 🇪🇸 Spain 🇸🇪 Sweden 🇨🇭 Switzerland 🇹🇼 Taiwan Turkey (Türkiye) 🇺🇦 Ukraine 🇬🇧 United Kingdom 🇺🇸 United States

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

Primary endpoints

Percentage of Participants Who Achieve Crohn's Disease Activity Index (CDAI) Score < 150 at Week 52 as Observed; Percentage of Participants With a Simple Endoscopic Score for Crohn's Disease (SES-CD) Score Decrease From Baseline ≥ 50% Based on Observed Cases and Robarts Observed Scores

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