Phase 3 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:

• Adults aged 18 to 64 years (male, or female who is not pregnant or breastfeeding) with a confirmed diagnosis of ulcerative colitis (UC), based on standard clinical, internal camera (endoscopy), and/or tissue examination results
• People currently admitted to hospital with a severe flare of UC that has not responded to at least 3 days of high-dose intravenous (IV) steroids, defined as having more than 8 bowel movements per day or a specific blood inflammation marker (CRP) above 45 mg/L on day 3 of steroid treatment
• People who have had or will have a bowel camera examination (colonoscopy or flexible sigmoidoscopy) either during their current hospital stay or within the 4 weeks before joining the trial, showing a certain level of disease activity on a standard scoring scale
• People who have given written consent to participate
• People who are willing and able to follow all study procedures, including safety monitoring checks as outlined in the official Canadian prescribing guidelines for the two study medications

Who may not be able to join:

• People for whom either of the two study medications (infliximab or upadacitinib) would be medically unsuitable, based on official Canadian prescribing guidelines
• People who have previously used infliximab or a similar type of medication called a JAK inhibitor to treat their UC
• People aged 65 or older
• People who are pregnant or breastfeeding
• Women who could become pregnant but are unwilling to use effective contraception during treatment and for 4 weeks after the last dose of upadacitinib
• People who currently have a bowel infection (such as Clostridioides difficile) or any other active infection, whether in a specific area of the body or throughout the body
• People who have symptoms of a blood clot, or who have a confirmed blood clot in a vein or artery
• People with active tuberculosis (TB) — note that testing for TB is required before the study medications can be considered
• People who test positive for hepatitis B or hepatitis C
• People with an untreated cancer, or who are currently receiving cancer treatment
• People taking certain other medications that strongly affect how the body processes upadacitinib (known as strong CYP3A4 inhibitors or inducers) (confirm with trial site)
• People with severe liver problems
• People with severe kidney problems (based on a specific kidney function measurement below 30 ml/min)
• People who have received a live vaccine within the 28 days before joining the trial
• People with moderate or severe heart failure (classified as NYHA Class III or IV) (confirm with trial site)
• People with a known allergy or sensitivity to infliximab, related proteins, or any of its ingredients
• People with a known allergy or sensitivity to upadacitinib or any of its ingredients

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