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 239 people across three treatment groups in its first phase: 79 people received infliximab alone (IFX), 80 received azathioprine alone (AZA), and 80 received a combination of both medicines (IFX/AZA). The trial was measuring whether participants with ulcerative colitis could reach "steroid-free remission" — meaning their disease activity score was very low and they were not taking steroid medicines — after 16 weeks of treatment. The study also had a second phase planned to track participants longer-term, but the reported data notes that this trial was ended early, so the longer-term results were not collected or reported. The reported data shows that for the main question — the proportion of participants in steroid-free remission at Week 16 — the figures were 0.22 (about 22 in every 100 participants) in the IFX-alone group, 0.24 (about 24 in 100) in the AZA-alone group, and 0.40 (about 40 in 100) in the combination IFX/AZA group. For a secondary measure looking at how many participants showed a meaningful improvement in their disease activity score ("response"), the reported figures at Week 8 were 0.88, 0.66, and 0.86 for the IFX, AZA, and combination groups respectively; at Week 16 these figures were 0.69, 0.50, and 0.77. A further secondary measure looked at "mucosal healing" — meaning the lining of the bowel appeared largely normal on a camera examination — and at Week 16 the reported proportions were 0.55, 0.37, and 0.63 for the same three groups. All longer-term secondary outcome data was not reported due to the early termination of the trial. 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 24512909) ↗
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
- People who are 21 years of age or older, of any sex or race
- People who have had ulcerative colitis (UC) confirmed by a bowel camera examination (sigmoidoscopy) within the 14 days before the study start date
- People whose UC activity falls within a specific moderate-to-severe range, as measured by a standard scoring system called the Mayo score (a total score between 6 and 12)
- People whose UC did not respond well enough to steroid treatment (with or without a medication called 5-ASA) during their last or current flare
- People who are either not taking steroids, or have been on a stable steroid dose for at least 2 weeks before joining, and whose daily steroid dose is no more than the equivalent of 30 mg of prednisone
- People who have never been treated with infliximab or similar medications that target a protein called TNF-alpha
- People who have either never taken the immunosuppressant medications azathioprine (AZA) or 6-mercaptopurine (6-MP), or who stopped taking them at least 3 months before joining
- People who meet all tuberculosis (TB) safety screening requirements, including: no history of latent or active TB; no current signs or symptoms of TB; no recent close contact with someone who has active TB (or, if there has been contact, have been assessed by a TB specialist and received appropriate treatment if needed); and either a negative TB skin test or a positive skin test where active TB has been ruled out and latent TB treatment has been started
- People who have had a chest X-ray (taken within 3 months before the first dose of study medication), reviewed by a qualified radiologist, showing no signs of current or past active TB
- People who have had UC for more than 10 years must have had a full colonoscopy within the 2 years before screening to check for any abnormal cell changes
- People whose blood test results at screening and study start fall within the required ranges for blood counts and body chemistry
- People who were taking antibiotics for UC (such as ciprofloxacin or metronidazole) must have stopped them at least 3 weeks before screening
- People who are otherwise in good enough health that their other conditions would not interfere with the study, in the opinion of the study doctor
- People who are willing and able to attend all required study visits and follow the study schedule
- People who are able to understand and sign a written consent form before any study procedures begin
- Women who could become pregnant, and all men, must agree to use an approved method of contraception from before screening, throughout the study treatment period, and for 6 months after the last dose (accepted methods include male or female condoms with or without spermicide, diaphragm or cervical cap with spermicide, a medically prescribed intrauterine device, hormonal contraceptives, or surgical sterilisation); women who are not currently sexually active must agree to use contraception if they become sexually active during the study
- Women who could become pregnant must have a negative blood pregnancy test at screening and a negative urine pregnancy test at the study start date
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.
- People with very severe widespread colitis where the study doctor believes bowel removal surgery is likely to be needed within 12 weeks of the study start date
- People who have at least 4 of the following severe symptoms at screening or the study start date: more than 6 bloody bowel movements per day; severe or rebound abdominal tenderness; a fever of 37.5°C or higher lasting at least 3 days; a heart rate above 100 beats per minute; or a haemoglobin level below 8.5 g/dL (a low blood count indicating anaemia)
- People who have needed, or needed within the 2 months before the study start date, surgery for serious gut complications such as active bleeding, a perforated bowel, bowel blockage, or an abscess requiring surgical drainage
- People who have a severe, fixed narrowing of the large or small intestine causing symptoms
- People with a confirmed history of bowel obstruction caused by a narrowing (stricture) in the large bowel within the 6 months before the study start date
- People who have a history of abnormal pre-cancerous cell changes in the lining of the colon (colonic mucosal dysplasia)
- People who have polyps found in the colon at screening that have not been removed, or a history of such polyps that were not removed
- People who have a stoma (a surgically created opening in the abdomen for waste to pass through)
- People who have had a large portion of their colon removed (less than 30 cm remaining), making it difficult to assess disease activity
- People who have had a positive stool test for gut infections (bacteria, parasites, or other organisms) within 4 months before the study start date, unless they were treated and a follow-up test came back negative at least 1 week after finishing treatment
- People who have been diagnosed with heart failure, including those whose heart failure is currently managed with medication and causes no symptoms
- People who have had a serious infection (such as active hepatitis, pneumonia, or a kidney infection) within 2 months before screening
- People who have had a non-tuberculosis bacterial infection or a serious opportunistic infection (such as cytomegalovirus, Pneumocystis, or aspergillosis) within 6 months before screening
- People who are known to be infected with HIV, hepatitis B, or hepatitis C
- People who have a known allergy to mouse-derived proteins, or a known allergy or sensitivity to the study drug or its ingredients
- People who currently have signs or symptoms of lupus, or severe or uncontrolled disease affecting the kidneys, liver, blood, hormones, lungs, heart, nerves, or brain
- People who have a known history of a nerve condition such as multiple sclerosis or optic neuritis
- People who have received an organ transplant (except a corneal transplant that took place more than 3 months before screening)
- People who have a history of lymphoma or other blood cancers, or who have signs suggestive of such conditions (such as unusually enlarged lymph nodes or an enlarged spleen)
- People who have or have had any cancer within the 5 years before screening (except for certain treated skin cancers with no signs of return)
- People who have difficulty with blood draws or do not have suitable veins for the blood tests and infusions required during the study
- People who have had a substance use disorder (drugs or alcohol) within 3 years before screening
- People who regularly and frequently use anti-inflammatory pain medications (NSAIDs), meaning at least 3 days per week for a month or more (low-dose aspirin for heart protection is an exception)
- People who have other inflammatory conditions that could make it difficult to assess the UC
- People who have a history of latent or active granulomatous infections, including TB, histoplasmosis, or coccidioidomycosis
- People who have received a BCG vaccination within the 12 months before screening
- People whose chest X-ray taken within 3 months before the first study dose shows signs of possible cancer or active infection, including TB
- People who have recently used certain other medications that are not permitted in this study (confirm specific medications and washout periods with the trial site)
- People who are currently participating in another clinical trial, or who have received an experimental drug or device within 3 months before screening
- People who are staff members or close family members of staff directly involved in running this study
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
Primary endpoints
Proportion of Participants in Steroid-free Remission at Week 16; Average Remission Rate During Part 2 of the Study
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.