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 (NCT00333788) enrolled 233 people with Crohn's disease — a condition causing inflammation in the digestive tract. All participants received injections of a medicine called certolizumab pegol at a dose of 400 mg. The trial was a long-term follow-on study, running for up to around 164 weeks (just over three years). Of the 233 people who started, 71 completed the full study and 162 left early for various reasons. The study was measuring things like unwanted side effects, and whether participants' Crohn's disease symptoms stayed under control over time. Symptoms were tracked using a scoring system called the Crohn's Disease Activity Index (CDAI), where a score of 150 or below indicates remission (very low disease activity) and a score above 450 indicates extremely severe disease. The reported data shows that 92.6% of participants experienced at least one adverse event (an unwanted or unexpected health event) during the study period. Regarding symptom control, among those who had already shown a meaningful response to the medication before this study began, 61.8% were reported to have maintained that response at their last recorded visit. Across all participants, 53.3% met the threshold for a clinical response at their last visit — meaning their CDAI score had dropped by at least 100 points from where it started — and 40.6% were reported to be in remission (a CDAI score of 150 or below) at their last visit. On average, participants' CDAI scores were reported to be 121.52 points lower at their last visit compared to the starting point of the earlier linked study. The reported data also shows that, among those who had responded to treatment at the start of this study, the average time before losing that response was reported as approximately 169.5 days (roughly five and a half months). It is worth noting that because many participants left the study before it ended, these figures reflect each person's last available measurement, which may have been recorded at different points in time across the study. 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 ↗
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, Completed
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 must have already completed a specific previous clinical trial called study C87042 (NCT00308581), which involved treatment with a medicine called infliximab.
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 withdrew or dropped out of the previous study (C87042/NCT00308581) before completing it.
- You received treatments during the previous study that were not certolizumab pegol or other medications that were officially allowed in that study.
- You live in a country where the medicine certolizumab pegol has already been officially approved for treating Crohn's disease.
- You are a woman who could become pregnant and are not using effective birth control in your doctor's opinion — all women who could become pregnant must also have a negative pregnancy blood test before joining the trial, and a negative urine pregnancy test before every dose of the study medicine.
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.
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, and they are a historical record: this trial is not enrolling, so they are not places you can join it.
Primary endpoints
Occurrence of at Least One Study-emergent Adverse Event During the Study (Maximum 164 Weeks)
Other options
Data last synced from ClinicalTrials.gov: 28 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.