Crohn's Disease and Colitis Trial, 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 18 years old or older
• You have been diagnosed with moderate to severe Crohn's disease, based on a standard disease activity score
• Your Crohn's disease affects specific parts of your bowel (the ileum and/or colon), and this has been confirmed by a camera examination (colonoscopy) showing ulcers meeting certain levels of severity
• A stool test or blood test shows signs of significant inflammation in your body
• You have never previously been treated with any biologic medication (a type of advanced treatment made from living cells)
• You have either not responded to, cannot tolerate, or are medically unable to take standard treatments such as steroids, immune-suppressing drugs, or antibiotics
• You have freely agreed to take part and signed a consent form

Who may not be able to join:

• You have had a previous allergic reaction to humanised protein-based medicines (confirm with trial site)
• You have used steroid medications within the 8 weeks before your screening appointment
• You currently have a narrowing of the intestine or back passage causing symptoms, an untreated abscess inside the abdomen or around the back passage, have had abdominal surgery within the last 6 months, or are expected to need bowel surgery during the study — though people who have had an abscess properly drained at least 4–8 weeks before the study starts may still be eligible (confirm with trial site)
• You currently have active tuberculosis (TB) — though people who have been fully treated and confirmed cured may still be eligible (confirm with trial site)
• You have latent (inactive) TB — though people who have completed or are near completing the proper treatment for latent TB may still be eligible (confirm with trial site)
• You have tested positive for the hepatitis B surface antigen, or have certain other hepatitis B blood test results showing a high level of the virus in your blood (confirm with trial site)
• You have tested positive for hepatitis C antibodies
• You have a history of HIV infection or have tested positive for HIV
• You have a serious heart condition classified as Class III or IV (meaning significant limitations on physical activity or symptoms at rest)
• You currently have an active infection of any kind
• You have or have had cancer in the last 5 years (certain skin cancers and cervical cancer may be exceptions — confirm with trial site), or have had pre-cancerous changes in the bowel within the last 5 years
• You are currently pregnant or breastfeeding
• You are not using, or do not plan to use, a reliable form of contraception for at least 6 months after your last dose of the study drug (accepted methods include hormonal contraceptives, condoms, diaphragm, coil, or abstinence)
• The trial doctors have decided for any other reason that joining the trial would not be appropriate for you

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