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:

• Adults aged 18 to 74 years with moderately-to-severely active Ulcerative Colitis (UC) — a condition causing inflammation in the large intestine
• People whose UC has not responded well enough to, or who could not tolerate, certain medicines such as steroids, thiopurines (azathioprine or 6-mercaptopurine), methotrexate, or vedolizumab — or people who did not respond to a full course of steroids
• People who are scheduled to begin treatment with a medicine called adalimumab
• People who have never previously used anti-TNF therapies or most other biologic medicines for UC (a medicine called vedolizumab is an exception and is allowed)
• People who have never used JAK inhibitor medicines (a type of medication that affects the immune system)
• People whose UC has been moderately-to-severely active for at least 3 months, confirmed by a specific scoring system and a bowel examination (endoscopy)
• People who have had a confirmed UC diagnosis for at least 3 months (various extents of bowel involvement are accepted)
• People who are taking, or able to take, an oral medicine called 5-ASA at the time of joining (unless there is a medical reason not to)
• People who stopped taking azathioprine, 6-mercaptopurine, or methotrexate at least two weeks before joining
• Women who could become pregnant and who are willing to use a contraceptive method throughout the entire trial
• People who are comfortable using a smartphone and the internet

Who may not be able to join:

• People who are unable to give their own informed consent due to their physical or mental condition
• People who have not provided written consent to participate
• People who are pregnant or breastfeeding
• People experiencing a severe sudden flare of colitis, or who are at immediate risk of needing bowel surgery
• People who have previously had bowel surgery to remove part or all of the colon (colectomy)
• People with a history of abnormal pre-cancerous cell changes in the bowel lining, or bowel polyps that have not been removed
• People whose stool test at screening shows signs of a bowel infection, including a bacteria called Clostridium difficile
• People taking oral steroid medicines at a dose higher than 40 mg of prednisone (or equivalent) per day, or whose steroid dose has not been stable for at least 7 days before joining
• People who have previously used, or are currently using, certain immune-suppressing medicines including cyclosporine, tacrolimus, anti-TNF therapies, most other biologic medicines, or JAK inhibitors — or who have used any experimental medicine within a certain timeframe before the trial (confirm with trial site)
• People for whom adalimumab (an anti-TNF medicine) is not considered safe to use, including those with: an active infection; untreated latent tuberculosis; moderate-to-severe heart failure; a cancer diagnosis within the past 5 years; a neurological disease affecting the protective covering of nerves; or a live vaccine received within the past 4 weeks
• People with a significant impairment or disability in their dominant arm that would prevent them from completing required tests
• People currently taking medicines that are not permitted in this trial (confirm with trial site)
• People who are currently participating in another clinical trial, or who are still in a follow-up period from a previous trial

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