Phase 3 Crohn's Disease and Colitis Trial, Not Yet Recruiting

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

Who might be able to join this trial:

• You are between 6 and 17 years old at the time of joining the study.
• You have been diagnosed with moderate or severe ulcerative colitis (UC) for at least 1 month before your first study visit, confirmed by a specific scoring system.
• You have tried at least one standard treatment (such as steroids like prednisone, or immune-suppressing drugs) and it either did not work, stopped working, or caused side effects you could not tolerate.
• If you are currently taking certain medications (5-ASA drugs, steroids, or immune-suppressing drugs), your dose must have been stable for at least 2 weeks before starting the study drug.
• Your UC affects areas of the colon beyond just the rectum (not limited to the very end of the bowel).
• A recent bowel examination (endoscopy) shows at least some active inflammation.
• Your vaccinations are up to date according to the Polish national vaccination schedule.

Who may not be able to join:

• You have previously been treated with certain biological medicines that target the immune system, including natalizumab, efalizumab, etrolizumab, or rituximab.
• You have previously been treated with a medicine called vedolizumab.
• You have previously been treated with a medicine called infliximab.
• You have a known allergy or sensitivity to any ingredient in vedolizumab or infliximab.
• You have an active brain or nervous system disease, or a history of conditions such as stroke, multiple sclerosis, brain tumour, or a serious brain infection called PML (progressive multifocal leukoencephalopathy).
• You currently need, or are expected to need, surgery for your UC during the study.
• You have already had part or all of your colon removed, or have a stoma or a known permanent narrowing of the bowel.
• You have been diagnosed with a type of colitis that doctors have not been able to clearly identify.
• You show signs of a very rare, early-onset form of inflammatory bowel disease linked to a single gene problem (confirm with trial site).
• You have another serious health condition that would make it difficult to complete the study.
• Your recent blood or stool tests show certain abnormal results, including: very low haemoglobin (below 8 g/dl), very low white blood cell count, significantly raised liver enzymes, a positive tuberculosis test, or a positive result for certain gut infections including Clostridium difficile.

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