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 States162 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 range18 Years – 75 Years
SexFEMALE
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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)
✓. 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:
✓. Temperature \> 37.5C
✓. Pulse \> 90 BPM
✓. Hemoglobin \< 10.5g/dL
✓. Erythrocyte sedimentation rate ≥ 30mm/h
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\>38C, HR \>120 BPM, WBC\>10500/µL, Hemoglobin \< 10.5mg/dL) and one of the following (dehydration, altered mental status, severe electrolyte disturbances, and hypotension)
What they're measuring
1
Proportion of randomly allocated participants to first stage of intervention
Timeframe: Approximately 100 Days (intervention plus 90 days of follow-up)
2
Proportion of randomly assigned patients who completed study period and 90-day follow-up
Timeframe: Up to 100 days (intervention plus follow-up)
3
Proportion of patients with completed CRP and daily bowel movements recorded on Day 2 or Day 3 prior to sequentially randomized allocation
Timeframe: Day 2 or Day 3 (prior to sequentially randomized allocation)
4
Proportion of patients who successfully underwent the second randomization (or transition to the second stage among those not re-randomized)
Timeframe: Up to 10 days
5
Proportion of patients reporting trial design acceptable
Timeframe: Approximately Day 10 (end of study treatment period)
6
Proportion of inpatient physicians reporting trial design acceptable
Timeframe: Approximately Day 10 (end of study treatment period)
7
Proportion of patients who complete the trial who successfully underwent the second randomization (non-responders) or continued current therapy (responders) of all enrolled patients.
✕. 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 (eg, 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)
✕. Active CMV colitis is defined as having \> 5 CMV inclusion bodies per high powered field in any one ulcer at baseline. If CMV colitis is confirmed, the patient can remain in the trial if permissible by the infectious disease and primary treatment team and if concomitant anti-viral therapy is initiated.
Timeframe: Up to 100 days (intervention plus follow-up)