Feasibility Pilot Sequential Multiple Assignment Randomized Trial (SMART) for Acute Severe Ulcera… (NCT05867329) | Clinical Trial Compass
RecruitingPhase 4
Feasibility Pilot Sequential Multiple Assignment Randomized Trial (SMART) for Acute Severe Ulcerative Colitis
United States700 participantsStarted 2023-09-30
Plain-language summary
The goal of this trial is to create personalized treatments for each patient admitted to the hospital with acute severe ulcerative colitis (ASUC). The study will test the feasibility and acceptability of these treatment strategies among patients and physicians so that the study team can later do a larger trial to test whether the medication treatment pathways help patients avoid colectomy while ensuring patient's are safe.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Patient ≥ 18 to 75 years of age at baseline
. Diagnosis of ulcerative colitis (verified by a typical clinical history as well as characteristic appearance on endoscopy and histology)
. Current hospital admission for ulcerative colitis treatment (expecting IV corticosteroid initiation). Note this includes patients seen in emergency room who are expected to be admitted for UC treatment
. Meeting the following definition of acute severe ulcerative colitis as defined as having ≥ 4 bowel movements per day with visible blood and one of the following:
. Prior history of receiving at least one dose of adalimumab, certolizumab, infliximab, or golimumab originator or biosimilars or a prior history of receiving at least one approved systemic therapy in the event tumor necrosis factors blockers are clinically inadvisable
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Adherence to intervention based on the proportion of participants who received the assigned Adaptive Treatment Strategy (ATS) (without receiving added/removed therapy outside of assignment) during first stage of therapy
Timeframe: Day 3
2
Adherence to intervention based on the proportion of participants who received the assigned Adaptive Treatment Strategy (ATS) (without receiving added/removed therapy outside of assignment) during second stage of therapy
Timeframe: Days 4 through day 10 (maximum 7 days from initiation of second stage of treatment)
3
Proportion of eligible enrolled patients who were randomized during the first stage of intervention and who received treatment (regardless of ATS assignment)
Timeframe: Randomized day 0 - up to day 3
4
Proportion of eligible enrolled patients initiated on first stage therapy who were randomized during second stage of intervention and who received their assigned treatment (regardless of ATS assignment)
Timeframe: Days 4 through day 10
5
Proportion of eligible enrolled patients who initiated first stage therapy who successfully transitioned to the second stage of intervention
. Participants who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, daily bowel movement symptoms surveys, and other study procedures
. Evidence of a personally signed and dated informed consent document indicating that the participant (or a legal representative) has been informed of all pertinent aspects of the study
. Ability to take oral medication and be willing to adhere to the study intervention regimen
Exclusion criteria
. Presence of indeterminate colitis, microscopic colitis, ischemic colitis, infectious colitis, or clinical findings suggestive of Crohn's disease
. On IV corticosteroids for ≥ 72 hours prior to enrollment continuously (at any institution)
. Currently pregnant or breastfeeding
. Patients who meet diagnostic criteria for toxic megacolon during this current admission. This will be determined by the study team and inpatient treatment team according to the following supportive criteria: Having dilation of the colon \> 6m and three of the following (Temperature\>38 Celsius, Heart Rate \>120 BPM, white blood cells (WBC) \>10500/µL, Hemoglobin \< 10.5mg/dL) and one of the following (dehydration, altered mental status, severe electrolyte disturbances, and hypotension)
. Known hypersensitivity to any of the following drugs or constituents: methylprednisolone, cyclosporine, tofacitinib, or upadacitinib
. Patients who had previous exposure to upadacitinib. Previous exposure to other Janus kinase (JAK) inhibitors (e.g., tofacitinib, baricitinib, or filgotinib) are permissible.
. Patients with ongoing severe infection (as determined by the study team), including untreated or inadequately treated latent or active tuberculosis (TB)
. Patients who have received any investigational pharmacological agent or invasive investigational procedure within 30 days or five half-lives of study initiation with potential efficacy for UC or that could interact with study medications, as determined by the Principal Investigator. Participation in studies with non-invasive investigational procedures or standard-of-care invasive procedures are permitted.
Proportion of eligible enrolled patients with complete data records for C-Reactive Protein (CRP) and Ulcerative Colitis Patient reported outcomes (UC-PRO) prior to second stage allocation
Timeframe: Day 0 to Day 3 of intervention
7
Proportion of eligible patients who enroll (not including screen failures) in the trial throughout the enrollment period
Timeframe: 5 years
8
Proportion of eligible enrolled participants followed until discharge or colectomy (whichever comes first)
Timeframe: up to approximately 10 days
9
Proportion of eligible enrolled participants without colectomy that were followed for 90 days with completion of one of the required study items
Timeframe: 90 days
10
Proportion of eligible enrolled participants without colectomy that were followed for 90 days with completion of all of the required study items at Day 90
Timeframe: 90 days
11
Percentage of participants with complete colectomy status and safety data via 90-day chart review
Timeframe: 90 days
12
Proportion of eligible enrolled participants with complete UC-PROs on each day of hospitalization from enrollment to discharge or colectomy (whichever comes first regardless of intervention phase completion/ATS adherence)
Timeframe: up to approximately 10 days
13
Proportion of eligible enrolled participants without colectomy that were followed for 90 days with completion of all requested study items
Timeframe: Day 30, Day 60, Day 90
14
Proportion of participants who were enrolled prior to receiving their first dose of intravenous (IV) methylprednisolone
Timeframe: Baseline
15
Proportion of participants who were enrolled who satisfied Truelove and Witts' disease severity criteria as measured by stool frequency
Timeframe: Baseline
16
Proportion of eligible enrolled patients who initiated first stage therapy (regardless of ATS adherence) within 12 hours of randomization
Timeframe: up to 12 hours after randomization
17
Proportion of enrolled participants who completed endoscopic evaluation within 72 hours of enrollment and had an endoscopic Mayo score ≥ 2
Timeframe: up to 72 hours
18
Proportion of eligible enrolled participants reporting trial design acceptable as measured by semi-structured interviews
Timeframe: up to approximately 10 days (prior to discharge)
19
Proportion of inpatient physicians interviewed reporting trial design acceptable