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 enrolled 777 people, all of whom received the medication adalimumab as an open-label treatment (meaning everyone knew what they were receiving — there was no comparison or placebo group). The trial was studying Crohn's disease, a long-term bowel condition, and the main thing it was measuring was whether participants reached "clinical remission." Remission was defined using a scoring tool called the Crohn's Disease Activity Index (CDAI), which combines eight different health factors measured over a week — a lower score means less severe disease, and a score below 150 was the threshold used to count someone as being in remission. Of the 777 people who started, 400 completed the study and 377 did not. The reported data shows that for the primary (main) outcome, 69.5% of participants were recorded as reaching clinical remission at the relevant time point. The secondary (additional) outcomes reported three further remission figures at different time points during the study: 59.4%, 68.8%, and 46.7% of participants. The reported data also shows that 91.2% of participants had their CDAI score drop by at least 70 points from their starting score (called a CR-70 response), and 85.7% had their score drop by at least 100 points (called a CR-100 response) — both of these are ways of measuring how much a participant's score changed, rather than whether they crossed the remission threshold. It is worth noting that because there was only one group in this trial and no comparison group, the reported numbers describe what was observed in participants taking adalimumab but cannot be directly compared to an untreated or differently treated group. 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 29380251) ↗
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 successfully completed one of two specific earlier clinical trials (called M02-404 or M04-691) to be eligible for this study
- You have been diagnosed with Crohn's disease
- You are willing and able to agree to take part and sign a consent form
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 been diagnosed with ulcerative colitis
- You are currently pregnant or breastfeeding
- You have had a previous infection with listeria (a type of food-borne bacteria) or have tuberculosis that has not been treated
- You have a history of cancer, unless it was a skin cancer that was successfully treated or a very early-stage cervical condition (called carcinoma-in-situ) that was successfully treated
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: Anne Camez, MD, Abbott
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 4 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 Subjects Achieving Clinical Remission
Other options
Data last synced from ClinicalTrials.gov: 23 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.