Actively Recruiting
Feasibility Pilot Sequential Multiple Assignment Randomized Trial (SMART) for Acute Severe Ulcerative Colitis
Led by Berinstein, Jeffrey · Updated on 2025-04-15
162
Participants Needed
1
Research Sites
134 weeks
Total Duration
On this page
Sponsors
B
Berinstein, Jeffrey
Lead Sponsor
N
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Feasibility Pilot Sequential Multiple Assignment Randomized Trial (SMART) for Acute Severe Ulcerative Colitis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient is between 18 and 75 years old at baseline
- Diagnosis of ulcerative colitis confirmed by clinical history, endoscopy, and histology
- Currently hospitalized for ulcerative colitis treatment with expected start of IV corticosteroids
- Meets acute severe ulcerative colitis criteria with 4 or more bloody bowel movements per day plus at least one of: temperature > 37.5C, pulse > 90 BPM, hemoglobin < 10.5g/dL, erythrocyte sedimentation rate ≥ 30mm/h, weight loss > 5 lbs in 3 months, C-reactive protein ≥ 3.0mg/dL, fecal calprotectin >782 mg/kg within 4 weeks, or oral corticosteroid use ≥ 14 days at ≥ 30mg/day
- Prior treatment with at least one dose of adalimumab, certolizumab, infliximab, or golimumab (originator or biosimilars)
- Willing and able to comply with study visits, treatment, lab tests, and daily symptom surveys
- Signed informed consent obtained
- Ability to take oral medication and willingness to follow study treatment
- For females under 55 with intact ovaries: negative pregnancy test and use of highly effective contraception during 3-month follow-up
You will not qualify if you...
- Presence of indeterminate colitis, microscopic colitis, ischemic colitis, infectious colitis, or signs suggesting Crohn's disease
- Continuous IV corticosteroids use for 72 hours or more before enrollment
- Currently pregnant or breastfeeding
- Diagnosis of toxic megacolon during current admission
- Known allergy to methylprednisolone, cyclosporine, tofacitinib, or upadacitinib
- Previous exposure to upadacitinib
- Active severe infection including untreated tuberculosis; patients with CMV colitis or positive stool pathogens only if treated
- Use of investigational agents within 30 days or enrollment in other interventional studies
- Current malignancy except non-metastatic skin cancers
- History or planned bowel surgery like colectomy or ileostomy
- Moderate or severe renal, hematologic, metabolic, endocrine, pulmonary, cardiac, neurological, or psychiatric disorders including low blood counts and liver impairment
- Cirrhosis with Child-Pugh score 5 or more
- Uncontrolled hypertension
- Recent serious cardiovascular events or severe heart failure
- History of inherited or acquired hypercoagulable conditions except remote or treated thrombotic events
- Low total cholesterol below 80 mg/dL
- Allergic reactions to study medications or related products
- Active hepatitis B, hepatitis C, or HIV with specific criteria
- Recent organ or bone marrow transplant or planned transplant
- History of multiple or disseminated herpes zoster or herpes simplex
- Use of medications increasing risk of blood clots such as hormone replacement therapy, testosterone, or tamoxifen
- Recent or planned live vaccinations during study period
- History of lymphoproliferative disorders or current hematologic disease
- History of spontaneous gastrointestinal perforation or high risk for perforation
- Use of strong CYP3A4 inducers or inhibitors including grapefruit
- Conditions affecting oral drug absorption such as certain surgeries
- Any other significant medical condition or reason judged unsuitable by the investigator for study participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
University of Michigan
Ann Arbor, Michigan, United States, 48109
Actively Recruiting
Research Team
Q
Queen Saunyama
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
9
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