Trial results
AI generated results summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
According to the results reported on ClinicalTrials.gov, this trial (NCT01190839) enrolled 297 people with Crohn's disease — 150 in the placebo group and 147 in the infliximab 5 mg/kg group — who had recently had bowel surgery. The trial was measuring whether Crohn's disease came back (called "clinical recurrence") over roughly 76 weeks (about 18 months) and 104 weeks (about 2 years), as well as whether signs of the disease returned when the bowel was examined with a camera (called "endoscopic recurrence"). It is worth noting that the reported data shows zero participants were recorded as having completed the study, and all participants were listed as "not completed," though the outcome results were still reported. The reported data shows that by around 76 weeks, 20.0% of participants in the placebo group and 12.9% in the infliximab group were recorded as having a clinical recurrence of Crohn's disease. When the bowel was examined by camera at or before 76 weeks, 60.0% of the placebo group and 30.6% of the infliximab group were recorded as having signs of the disease returning. By around 104 weeks (two years), the reported clinical recurrence figures were 25.3% in the placebo group and 17.7% in the infliximab group. These numbers describe what was recorded and counted during the trial; they do not tell us about individual experiences, and the reported data does not include further detail on how the results were analysed statistically. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View full results on ClinicalTrials.gov ↗ · Read the linked publication on PubMed (PMID 26946343) ↗
These are the results as reported to ClinicalTrials.gov, not medical advice. Verify independently with the trial site and discuss what they mean for you with your doctor.
Phase 3 Crohn's Disease and Colitis Trial, Terminated
voxsanity.com.au · Eligibility summary from public government registries · 18 August 2026 · not medical advice
Who may and may not be able to join
AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
Who may be able to join
- You have been officially diagnosed with Crohn's disease, confirmed through camera examinations of the gut, tissue samples, and/or imaging scans before or during surgery
- You have had surgery to remove part of your small intestine and colon (ileocolonic resection)
- You are considered to be at a higher-than-average risk of your Crohn's disease coming back after surgery
- You have either never taken infliximab (a medication used to treat Crohn's disease) or have taken it before but did not have to stop due to side effects — previous use of similar medications (adalimumab or certolizumab) is allowed
- You have been tested for hepatitis B virus (HBV) before starting the trial
- Your Crohn's disease activity score (a measure of how active your symptoms are) is below 200, meaning your disease is currently not in an active flare
- Your blood and liver test results are within an acceptable range
Who may not be able to join
Each point below is a reason the trial team may not be able to accept someone. It is not a list of requirements to meet.
- You have a history of certain serious fungal or bacterial infections, including histoplasmosis or coccidioidomycosis, before the screening period
- Your chest X-ray (taken within the last 3 months) shows any concerning findings, such as signs of cancer, infection, or tuberculosis (TB)
- You still had active Crohn's disease areas in your gut that were not removed during your surgery
- You do not meet the specific criteria for being at increased risk of Crohn's disease returning after surgery
- You currently have an active infection, or you have had a serious infection unrelated to Crohn's disease (such as hepatitis, pneumonia, or a kidney infection) within the past 6 months
- You have had a serious opportunistic infection (such as shingles, cytomegalovirus, or certain fungal or bacterial infections) within the past 6 months
- You have, or have had, any form of cancer within the past 5 years — with the exception of certain minor skin cancers that were fully removed and have not come back
- You have any other health condition that the trial doctor believes could put your wellbeing at risk or prevent you from fully participating in 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.
Trial contact details on record
Principal Investigator: Janssen Biotech Inc. Clinical Trial, Janssen Biotech, Inc.
Australian sites
This trial is not accepting new participants. These are the contact details ClinicalTrials.gov holds for it, kept here for reference. They are not an invitation to enrol, and the sites listed may no longer be running this trial.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Where this trial was run
These are the locations recorded on the registry, including 6 in Australia. They are a historical record: this trial is not enrolling, so they are not places you can join it.
Primary endpoints
Percentage of Participants With Clinical Recurrence (CR) of Crohn's Disease (CD) Prior to or at Week 76
Other options
Data last synced from ClinicalTrials.gov: 21 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.