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Back to Crohns Disease And Colitis
Crohn's Disease and Colitis Trial, Recruiting
NCT07385131
Who may 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 might be able to join this trial:
- You are between 14 and 80 years old.
- You have been formally diagnosed with Crohn's disease (CD) or ulcerative colitis (UC) based on thorough testing, including blood tests, imaging, scopes, and tissue samples, with other causes of bowel inflammation ruled out.
- Your Crohn's disease or ulcerative colitis is rated as moderate to severe, based on specific scoring tools used by your doctor (the exact score required depends on your age and condition type — confirm with trial site).
- You are not currently taking immunosuppressant medicines (such as azathioprine) and do not plan to start any within the next two months.
- You are currently taking a low dose of steroid medication (no more than 10 tablets) and have a clear plan to gradually stop taking steroids completely within the next two months.
- You are due to receive your first dose of infliximab (a biologic medicine) within the next two weeks.
Who may not be able to join:
- Your doctor believes your condition is severe enough that you may need a change or increase in biologic treatment, or surgery, within the next two months — for example, if you have significant narrowing, tearing, or tunnelling of the bowel causing blockage, bleeding, or infection.
- You have a history of a reaction during an infusion (drip) of any biologic medicine, or you have had allergic reactions to medicines such as penicillin, certain antibiotics, anti-inflammatory painkillers, or contrast dye used in scans.
- You have a known food allergy, or a past history of asthma or hives (urticaria).
- You regularly take daily antihistamine (anti-allergy) medicines such as loratadine, cetirizine, or similar drugs.
- You have certain conditions that make biologic medicines less safe, such as active tuberculosis (TB), a strongly positive TB skin or blood test, or a history of heart attack, heart failure, or certain nerve diseases in the past 5 years (confirm with trial site).
- You have certain conditions that make steroid medicines less safe, such as active TB, serious infection, or stomach/gut ulcers.
- You currently have or have previously had certain cancers, including solid tumours, lymphoma, or melanoma, or you are currently receiving chemotherapy or radiotherapy.
- You have serious complications such as heavy gut bleeding, severe liver or kidney problems, active bacterial or viral infection, shock, uncontrollable vomiting, or severe difficulty absorbing nutrients.
- You have a psychiatric condition or difficulty understanding the study information fully.
- You are currently pregnant or breastfeeding.
- Your condition is rapidly worsening, in a final stage, or your vital signs (such as blood pressure and heart rate) are seriously unstable.
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.
This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.
GP referral letter
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Trial details
Status
Recruiting
Phase
Not Applicable
Registry
ClinicalTrials.gov
Start date
8 October 2025
Est. completion
31 December 2028
Where this trial is recruiting
🇨🇳 China
Primary endpoints
The proportion of patients experiencing infusion reactions
Can't join this trial?
Data last synced from ClinicalTrials.gov: 2 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.
Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.