Phase 4 Crohn's Disease and Colitis Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

Phase 1 (initial part of the study):

• Children and teenagers aged 6 years old up to (but not including) 18 years old at the time of joining
• People with a suspected diagnosis of Crohn's disease (a type of inflammatory bowel condition)
• People who have had stool tests (if done) that came back negative for certain gut infections such as Salmonella, Shigella, Campylobacter, E. coli O157:H7, and a bacteria called C. difficile — or, if there is a history of C. difficile infection, at least 6 weeks must have passed since treatment started and a repeat test must be negative
• People whose parent or legal guardian has given consent, and who themselves agree to take part
• People who are able to attend follow-up appointments for up to 6 months of initial observation, plus at least 52 weeks after possibly starting a specific type of medication called anti-TNF therapy

Phase 2 (second part of the study):

• People who completed Phase 1 and met all its requirements
• People who have been confirmed to have Crohn's disease affecting the end of the small intestine and/or the large intestine, based on camera examination of the bowel and/or a special type of MRI scan
• People who had a specific MRI scan (called an MRE) within 6 weeks of their bowel camera examination and no more than 4 weeks after starting initial treatment
• People who received at least one of the following as their first treatment after diagnosis: steroid tablets, immunomodulator medicines, a type of anti-inflammatory called 5-ASA, a special nutritional therapy diet, or a biologic medicine called adalimumab or infliximab
• People who started treatment with adalimumab or infliximab — guided by a specific decision-support tool called ROADMAB™ CDST — either as their first treatment or within 180 days of diagnosis, with or without an additional immunomodulator medicine
• People who had tissue samples (biopsies) taken from the small intestine and rectum during their bowel examination — or, in certain circumstances where biopsies from the small intestine could not be taken due to inflammation or narrowing, where specific additional conditions about visible inflammation on camera and MRI findings are met (confirm with trial site)
• People whose parent or legal guardian has given consent, and who themselves agree to take part
• People who are able to attend follow-up appointments for at least 52 weeks after starting anti-TNF therapy

Who may not be able to join:

Phase 1:

• People whose Crohn's disease was first diagnosed after bowel surgery or appendix removal
• People who, in the doctor's judgement, have a greater than 50% chance of needing bowel surgery within 3 months of diagnosis — for example, due to a bowel perforation or blockage caused by narrowing
• People who have taken steroid tablets for a condition outside the gut (such as asthma) in the 4 weeks before their diagnostic assessments and sample collection
• People who have taken part in another medical trial and received an experimental drug in the 4 weeks before their diagnostic assessments and sample collection
• People who are pregnant
• People with poorly controlled ongoing health conditions such as diabetes or heart failure
• People who have previously been treated with immunomodulator medicines within one year before joining, or with anti-TNF medicines within two years before joining, for conditions other than inflammatory bowel disease (for example, a joint condition called juvenile idiopathic arthritis)
• People who have been treated with certain other biologic medicines or small molecule drugs (for non-bowel conditions) in the past 6 months — although people who have used a medicine called dupilumab (Dupixent) for asthma, eczema, or a condition called eosinophilic esophagitis are not excluded
• People who are unable to have an MRI scan — for example, due to claustrophobia or other reasons

Phase 2:

• People whose Crohn's disease was diagnosed using only a swallowable camera capsule, where both the bowel camera examination and the MRI scan were normal
• People whose Crohn's disease affects only the mouth and face area
• People whose Crohn's disease affects only the food pipe, stomach, or upper sections of the small intestine, with no involvement of the terminal ileum or large intestine
• People with severe or complex fistulising perianal disease (tunnels or connections forming near the back passage) or perianal abscesses that require or are likely to require repeated surgery — though placement of a small drainage tube (seton) or a one-time drainage procedure is not automatically excluding (confirm with trial site)
• People whose Crohn's disease affects only the area around the back passage with no disease found inside the bowel
• People who have internal fistulising disease (abnormal connections forming inside the body) at the time of diagnosis
• People whose initial treatment for inflammatory bowel disease was a biologic medicine or small molecule drug other than adalimumab or infliximab
• People who have received any anti-TNF biologic medicine other than adalimumab or infliximab
• People who, in the doctor's judgement, are unlikely to return for follow-up appointments, including bowel camera examinations or MRI scans
• People who are unable to have an MRI scan — for example, due to claustrophobia or other reasons
• People for whom a video recording of their initial bowel camera examination is not available for review by the central study team, unless an exception has been approved — adequate photographic records are required (confirm with trial site)
• People who had bowel surgery within 3 months of their diagnosis

Important: Always verify eligibility with the trial site directly before applying.