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 or older who are male, or female and not currently pregnant or breastfeeding (women who could become pregnant will need a negative pregnancy test before joining)
• People who have been formally diagnosed with Crohn's disease (CD) using standard medical criteria
• People who have had a colonoscopy within the last 3 months showing specific levels of ulceration and inflammation in the small intestine, confirmed by documentation such as photos or video
• People whose Crohn's disease symptoms score at a certain level of severity on a standard rating scale called the Harvey-Bradshaw Index (a score of 5 or higher) (confirm with trial site)
• People who have never previously received a biologic medication for Crohn's disease
• People whose doctor would otherwise have recommended starting a biologic medication for moderate-to-severe Crohn's disease as part of their normal care
• People who are willing and able to take part fully in all parts of the trial, including following the study plan and treatment guidelines
• People who are willing to provide written consent to participate

Who may not be able to join:

• People who have a medical condition that makes any of the biologic medications used in this trial unsafe for them
• People who have Crohn's disease complications such as severe bowel narrowing or abscesses that require urgent surgery, as determined by the treating doctor
• People with a current or past history of abnormal or cancerous cell changes in the colon, a severely inflamed colon (toxic megacolon), or a sudden severe flare of colitis
• People who have had bowel surgery within the 3 months before the screening period
• People with an active gut infection, such as bacterial (including C. difficile), viral, or parasitic infections detected through stool testing
• People with known active hepatitis B, hepatitis C, or HIV infection
• People who have an active COVID-19 infection during the screening period
• People who have tested positive for tuberculosis (TB) through standard testing at screening, or who have a history of untreated TB
• People who have had a cancer diagnosis within the past 5 years, except for certain fully treated and resolved skin cancers or cervical carcinoma in-situ
• People who have an active infection requiring treatment with antibiotics, antivirals, antifungals, or similar medications during the screening period
• People with a serious health condition other than Crohn's disease that, in the doctor's opinion, could interfere with full participation in the trial
• People who are not willing to avoid medications that are not permitted during the trial
• People who have previously received or are currently receiving certain types of biologic or immune-modifying treatments, including TNF antagonists, anti-integrins, IL-12/23 or IL-23 antibodies, JAK inhibitors, or S1P receptor modulators, for any condition
• People with a history of alcohol or drug misuse that, in the doctor's opinion, could affect their ability to follow the study procedures

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