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 (NCT03596645) looked at two medicines — golimumab and infliximab — in people with ulcerative colitis, a condition causing inflammation in the large bowel. A total of 69 participants were enrolled in the golimumab group and 15 in the infliximab group. The main thing the trial was measuring was the proportion of golimumab participants whose disease reached "remission" (very low disease activity, based on a scoring system called the Mayo score) at six weeks. A number of additional measurements were also taken out to 54 weeks, using both the Mayo score and a separate scoring tool designed for younger patients (called the PUCAI score). The reported data shows that for the golimumab group, approximately 31.9% of participants met the definition of remission at six weeks using the Mayo score. Using the PUCAI tool at the same six-week point, the reported figure was 33.3%. When looking at a broader measure called "clinical response" at six weeks — meaning a meaningful drop in disease activity score, even if full remission was not reached — the reported figure was 56.5%. It is worth noting that no outcome figures were reported for the infliximab group for any of these measures. The reported data also shows results at 54 weeks for the golimumab group: approximately 31.7% met the Mayo score remission definition, 34.1% met the PUCAI remission definition, and 39.0% met the definition for "symptomatic remission" (based on stool frequency and rectal bleeding scores only). The data submitted shows that none of the participants were recorded as having formally "completed" the study in either group, though the reasons for this are not explained in the structured results. 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 41503939) ↗
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, Active, Not Recruiting
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 are currently taking, have tried without success, or cannot take (for medical reasons) at least one of these medications: corticosteroids (taken by mouth or through a vein), 6-mercaptopurine, methotrexate, or azathioprine — OR you have been unable to stop taking corticosteroids without your ulcerative colitis (UC) symptoms coming back — OR you have needed more than 3 courses of corticosteroids in the past year
- You have moderate to severe ulcerative colitis, confirmed by a specific scoring system and a camera examination of your bowel (such as a colonoscopy or sigmoidoscopy) showing significant inflammation
- If you are receiving nutrition through a tube into your digestive system, you must have been on a stable routine for at least 2 weeks before the trial starts (confirm with trial site)
- You have no history of tuberculosis (TB), either active or dormant
- Your vaccinations are fully up to date (including measles, mumps, rubella, and chickenpox) according to current guidelines for people with a weakened immune system
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 significant history of liver, kidney, heart, blood vessel, lung, hormone, nerve, blood, joint, psychiatric (including thoughts of suicide), or metabolism problems
- You have a history of cancer, or certain rare but serious immune system conditions (macrophage activation syndrome or hemophagocytic lymphohistiocytosis)
- Your ulcerative colitis affects only the rectum or less than 20% of your colon
- You have a stoma (a surgically created opening from the bowel to the outside of the body)
- You have, or have had, a fistula (an abnormal channel or tunnel connecting body parts that are not normally connected)
- You have a medical reason why you cannot take the study drugs golimumab, infliximab, or similar anti-inflammatory medicines called anti-TNF therapies
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.
If you need support right now
This page includes language about suicide and self-harm, because that is how the trial's eligibility criteria are written. If reading it has been hard, you do not have to keep going. The services below are free, confidential, and answered by people trained for exactly this.
If you or someone else is in immediate danger, call 000.
- Lifeline — 24/7 crisis support: 13 11 14
- Suicide Call Back Service — 24/7 counselling: 1300 659 467
- 13YARN — 24/7, for Aboriginal and Torres Strait Islander people: 13 92 76
- Beyond Blue — 24/7 mental health support: 1300 22 4636
- Emergency: 000
Outside Australia? The numbers above are Australian and will not work from overseas. Find a Helpline is a free directory of crisis lines in over 130 countries, run by ThroughLine with the International Association for Suicide Prevention. If you are in immediate danger, call your local emergency number.
Voxsanity is not a crisis service, and nothing on this page is medical advice. More Australian services are listed on our support lines page.
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
Percentage of Participants With Clinical Remission at Week 6 as Assessed by the Mayo Score
Other options
Data last synced from ClinicalTrials.gov: 24 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.