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:

• People who are 18 years of age or older at the time of agreeing to take part.
• People who have a confirmed diagnosis of Crohn's disease (CD) affecting the small intestine, large intestine, or both (this may be confirmed at the start of the study).
• People whose Crohn's disease is currently active, based on specific scores measured by symptom questionnaires and a camera examination of the bowel (confirm with trial site for exact score thresholds).
• People whose treating doctor considers them suitable to receive either vedolizumab (VDZ) or ustekinumab (UST) as a treatment for Crohn's disease, in line with the approved use of these medicines.
• People who meet all the standard local requirements for starting a biologic medicine, including having no serious ongoing infections such as HIV, tuberculosis, cytomegalovirus, hepatitis B or C, or a bowel infection called Clostridioides difficile, and who are up to date with any required vaccinations.
• People who are not currently pregnant or breastfeeding; people who could become pregnant must agree to use appropriate contraception and agree to avoid becoming pregnant from the time of consent until Week 26 of the study, following local guidelines for biologic medicines.
• People who are already taking non-biologic bowel medications such as thiopurines or methotrexate, provided these were started at least 3 months before screening and the dose has been stable for at least 2 weeks before screening.
• People taking oral steroid medicines (such as prednisone up to 40 mg/day or budesonide up to 9 mg/day), provided the dose has been stable for at least 2 weeks before screening and the person is willing to start reducing the steroid dose within 2 weeks of beginning the biologic treatment.
• People who, in the investigator's view, are able to understand and follow all study requirements, including taking the assigned treatment as directed.
• People who are able to participate fully in all parts of the study and who have given their informed consent (or whose legal representative has done so) in a language they fully understand.

Who may not be able to join:

• People who have previously been treated with vedolizumab (VDZ) or ustekinumab (UST).
• People who have previously been treated with more than one advanced therapy for Crohn's disease, including biologic medicines (such as anti-TNF, anti-interleukin, or anti-integrin medicines) or certain oral medicines called JAK inhibitors.
• People who have Crohn's disease complications that the investigator believes would interfere with the study, including certain types of bowel surgery (such as removal of the rectum or large portions of the bowel), short bowel syndrome, any stoma (bowel opening on the abdomen), significant narrowings in the bowel causing symptoms, or an untreated abscess in the abdomen or around the back passage.
• People who have, or have had, a diagnosis of ulcerative colitis, indeterminate colitis, idiopathic colitis, microscopic colitis, or certain pre-cancerous changes in the lining of the bowel (unless any of these diagnoses were made in error).
• People who have an increased risk of serious infections, such as those with a recent severe bacterial infection, an immune system condition (present from birth or developed later), or a history of organ, bone marrow, or stem cell transplant.
• People who have used any rectal (suppository or enema) treatment for Crohn's disease within 2 weeks before the bowel camera examination at screening.
• People who regularly take anti-inflammatory pain medicines (NSAIDs), except for a specific type called celecoxib.
• People who have had a faecal microbiota transplant (a procedure involving transfer of bowel bacteria) within 4 weeks before being assigned to a treatment group.
• People who have had major surgery within 8 weeks before being assigned to a treatment group, or who have major surgery planned during the study period.
• People whose alcohol or drug use, in the investigator's opinion, may affect their ability to follow the study procedures.
• People who have other serious health conditions that, in the investigator's opinion, could affect their safety or their ability to take part fully, such as a history of cancer, major neurological conditions, unstable medical conditions, or any known reason why the study medicines would not be suitable for them.

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