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:

• People between 18 and 75 years of age
• People who have been diagnosed with ulcerative colitis, confirmed by their symptoms, a camera examination of the bowel, and tissue samples
• People who are currently admitted to hospital for ulcerative colitis treatment and are expected to start intravenous (IV) steroid medication
• People whose ulcerative colitis is classed as "acute severe," meaning they are having 4 or more bloody bowel movements per day, plus at least one of the following: a temperature above 37.5°C, a heart rate above 90 beats per minute, low blood count (haemoglobin below 10.5g/dL), a high inflammation marker on blood tests, weight loss of more than 5 pounds over 3 months, a raised C-reactive protein level, a high stool inflammation marker result within the past 4 weeks, or use of steroid tablets at a high dose for 14 or more days
• People who have previously received at least one dose of a specific type of biologic medication — adalimumab, certolizumab, infliximab, or golimumab (including biosimilar versions)
• People who are willing and able to attend scheduled visits, follow the treatment plan, have laboratory tests, complete daily bowel movement diaries, and take part in all study activities
• People who have signed and dated a consent form confirming they have been fully informed about the study
• People who are able to swallow tablets and are willing to follow the study medication schedule
• Women under 55 years of age with intact reproductive organs who have a negative pregnancy test on admission and who intend to use an approved, highly effective form of contraception throughout the 3-month follow-up period (confirm with trial site for the full list of accepted methods)

Who may not be able to join:

• People whose bowel condition has been identified as a type other than ulcerative colitis, such as indeterminate colitis, microscopic colitis, ischemic colitis, infectious colitis, or Crohn's disease
• People who have already been receiving continuous IV steroids for 72 hours or more before enrolling (at any hospital)
• People who are currently pregnant or breastfeeding
• People who have been diagnosed with toxic megacolon (a serious, life-threatening complication of bowel inflammation) during this current hospital admission
• People who have a known allergy or sensitivity to any of the following medications: methylprednisolone, cyclosporine, tofacitinib, or upadacitinib
• People who have previously taken the medication upadacitinib (note: prior use of other similar medications such as tofacitinib, baricitinib, or filgotinib is permitted)
• People who have a serious active infection, including untreated or inadequately treated tuberculosis (TB) — certain infections such as CMV colitis or bowel infections may be assessed individually by the study team (confirm with trial site)
• People who have taken part in another clinical trial or received an experimental treatment within the past 30 days (or within five half-lives of that treatment, whichever is longer)
• People who currently have a cancer, except for certain non-spreading skin cancers (basal cell or squamous cell carcinoma)
• People who have had surgery to remove part or all of the colon or bowel, have had a pouch or stoma created, or are planning to have bowel surgery
• People who have moderate or severe problems with their kidneys, blood, liver, heart, lungs, nervous system, or mental health — including specific blood count results, kidney function, or liver enzyme levels falling outside acceptable ranges (confirm with trial site for specific values)
• People who have liver cirrhosis with any level of liver impairment
• People who have uncontrolled high blood pressure (above 160/100 mmHg) despite taking blood pressure medication
• People who have had a stroke, heart attack, or heart stenting procedure within the past 6 months, or who have moderate-to-severe heart failure
• People who have inherited or acquired blood clotting disorders, such as antiphospholipid syndrome, Factor V Leiden mutation, or deficiencies of certain clotting proteins — note that a previous clot event that was provoked, or a recent clot being treated with blood thinners, is not automatically disqualifying (confirm with trial site)
• People whose total cholesterol is below 80 mg/dL at the start of the study
• People who have had a significant allergic reaction to the study medications or to medications in the same drug class
• People with certain active hepatitis B, hepatitis C, or HIV infections — specific details about which infection profiles are disqualifying will need to be confirmed with the trial site
• People who have had a solid organ or bone marrow transplant within the past year, or who are expected to need a transplant within 6 months
• People who have had more than one episode of shingles, or who have had shingles or cold sore virus spread widely throughout the body
• People who are currently taking certain medications that significantly raise the risk of blood clots, including hormone replacement therapy, testosterone, or tamoxifen
• People who have received a live or weakened-live vaccine within the 6 weeks before starting the study, or who are scheduled to receive one during the study or within 20 weeks after their last dose of study medication
• People who have a history of certain blood or lymph system cancers, such as lymphoma, leukaemia, or multiple myeloma, or who have signs suggesting a current blood disease
• People who have a history of a spontaneous hole or tear in the bowel (not caused by appendicitis or injury), diverticulitis (infected pouches in the bowel), or who are considered at high risk of bowel perforation
• People who are currently taking certain medications that strongly affect how the body processes drugs (strong CYP3A4 inducers or inhibitors) — this also includes grapefruit and grapefruit juice
• People who have a condition that could affect how oral medications are absorbed, such as having had part of the stomach removed or certain types of weight-loss surgery (confirm with trial site)
• People who have any other medical condition or circumstance that the study team believes would make participation unsafe or unsuitable

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