Phase 3 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:

• You (or your child) must be between 6 and 22 years old
• You must have been diagnosed with Crohn's disease within the last 90 days (affecting the gut, or the gut along with a skin/tissue opening near the back passage that has been treated with antibiotics for at least 7 days)
• You must not have previously used certain medications that block a protein called TNF (anti-TNF therapy), and you must be about to start a medication called infliximab
• There must be signs of active Crohn's disease based on symptom scores measured in the last 60 days (confirm with trial site for exact score details)
• There must be signs of inflammation in the gut, confirmed by a scope exam in the last 60 days or a stool test result above a certain level in the last 75 days
• A blood marker of inflammation (C-reactive protein) must be above a certain level in the last 30 days, and/or a stool test must show inflammation above a certain level in the last 75 days
• You must have a negative test for tuberculosis (TB) and, if you are female and have started your period, a negative pregnancy test
• Written consent must be provided by the patient if aged 18 or over, or by a parent or legal guardian if under 18

Who may not be able to join:

• People diagnosed with ulcerative colitis or an unspecified type of inflammatory bowel disease
• People who have previously used anti-TNF medications such as infliximab, adalimumab, certolizumab pegol, or golimumab
• People who have had an internal fistula (an abnormal connection between organs inside the abdomen or pelvis) in the last 6 months
• People who have had an abscess or inflammatory mass inside the abdomen in the last 6 months
• People with an active abscess near the back passage who have been on antibiotic tablets for fewer than 7 days
• People who have a significant narrowing of the bowel and are scheduled for surgery within the next 90 days
• People who have recently tested positive for a gut infection called C. difficile or other bowel infections within the last 14 days, unless a follow-up test is negative and there are no remaining signs of infection
• People who are currently in hospital due to severe complications of Crohn's disease
• People who plan to use certain other medications (methotrexate or azathioprine/6-mercaptopurine) during the first phase of infliximab treatment (the first 3 doses)
• People who currently have a stoma bag (ileostomy or colostomy), an ileoanal pouch, have had a large portion of the small bowel removed (more than 35 cm), or have any Crohn's-related surgery planned in the next 90 days
• People with a history of certain autoimmune conditions including autoimmune hepatitis, primary sclerosing cholangitis, thyroiditis, or juvenile idiopathic arthritis
• People who have taken part in another clinical drug trial in the last 4 weeks
• People with a history of cancer, including blood cancers such as lymphoma or leukaemia
• People currently being treated for a fungal infection called histoplasmosis
• People with a history of TB, HIV, immune system disorders, a nerve/brain condition called demyelinating disease, heart failure, or who have received intravenous (IV) antibiotics for any infection in the last 14 days
• People who are currently pregnant, breastfeeding, or planning to become pregnant in the next year
• People who are unable to provide or understand consent or assent for any reason, including certain developmental disabilities

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