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:

• The trial doctor believes the person is able to understand and follow the study requirements.
• The person has signed and dated an electronic consent form before any study procedures begin.
• The person is between 18 and 80 years old at the time of signing the consent form.
• The person's vaccinations are up to date as required by the prescribing guidelines for the study drug (vedolizumab).
• Women who could become pregnant must agree to use at least one highly effective form of contraception from signing the consent form until at least 18 weeks after the last dose of the study drug.
• Women who could become pregnant must agree not to donate eggs during the study and for 18 weeks after the last dose of the study drug.
• Women who could become pregnant must have a negative pregnancy test within 3 days before the first dose of the study drug.
• Women who could become pregnant must agree not to breastfeed from the first dose of the study drug through 18 weeks after the last dose.
• Men who are fertile must agree to use contraception from signing the consent form until at least 18 weeks after the last dose of the study drug.
• Men who are fertile must agree not to donate sperm during the study and for 18 weeks after the last dose of the study drug.
• The person has a moderate to severe case of ulcerative colitis (UC) or Crohn's disease (CD), confirmed by specific scoring systems measured at screening (confirm with trial site).
• The UC or CD diagnosis was confirmed before screening using clinical assessment, a camera examination of the bowel, and a tissue sample report.
• The person's condition did not respond well to, stopped responding to, or caused intolerance to at least one previous treatment, such as steroids, immune-suppressing medicines, or a more advanced therapy.

Who may not be able to join:

• People who have previously received any approved or experimental anti-integrin antibody treatments, including vedolizumab, natalizumab, efalizumab, etrolizumab, or abrilumab.
• People whose condition did not respond to more than two prior advanced treatments.
• People who used steroid enemas or suppositories within 2 weeks before screening.
• People for whom the trial doctor believes the study drug (vedolizumab) is not appropriate, or who have a known allergy, hypersensitivity, or intolerance to vedolizumab or any of its ingredients.
• People who received any experimental biological therapy within 6 months before screening.
• People who received an advanced treatment (such as TNF inhibitors, IL-12/23 blockers, JAK inhibitors, or S1P receptor modulators) for a condition other than UC or CD.
• People who have signs of an active infection at the time of screening.
• People who have had a stoma (ileostomy or colostomy), severe bowel narrowing, or short bowel syndrome.
• People who had surgery requiring general anaesthesia within 3 months before screening, or who are expected to need major surgery during the study.
• People with a history of cancer, with some limited exceptions for certain treated skin cancers and cervical pre-cancers (confirm with trial site).
• People who have a history of, or symptoms suggesting, a serious brain condition called progressive multifocal leukoencephalopathy (PML), in the trial doctor's opinion.
• People who have abnormal laboratory test results during the screening period.

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