A Sequential Multiple Assignment Randomized Trial (SMART) Feasibility Pilot Developing and Optimizing Patient-Tailored Adaptive Treatment Strategies (ATS) for Acute Severe Ulcerative Colitis (ASUC)
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.
• 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
⁃ Weight loss \> 5 lbs over 3 months
⁃ C-reactive protein ≥ 3.0mg/dL
⁃ Fecal calprotectin \>782 mg/kg (within 4 weeks)
⁃ Oral corticosteroid use for ≥ 14 days at a dose equivalent to ≥ 30mg/day
• Prior history of receiving at least one dose of adalimumab, certolizumab, infliximab, or golimumab originator or biosimilars
• 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
• For females of reproductive potential (i.e., females \<55 years of age with intact ovaries and fallopian tubes): A negative pregnancy test on admission and intent to use highly effective contraception during 3-month follow-up period which include the following.
‣ Combined (estrogen and progestogen containing) hormonal contraception (oral, intravaginal, transdermal, injectable) associated with the inhibition of ovulation, initiated at least 30 days prior to study baseline
⁃ Progestogen-only hormonal contraception (oral, injectable, implantable) associated with inhibition of ovulation, initiated at least 30 days prior to study baseline
⁃ Bilateral tubal occlusion/ligation (could be via hysteroscopy, provided a hysterosalpingogram confirmed success of the procedure)
⁃ Vasectomized partner(s) provided the vasectomized partner had received medical confirmation of the surgical success and was the sole sexual partner of the trial participant
⁃ Intrauterine device or intrauterine hormone-releasing system
⁃ Lifestyle abstinence (refraining from heterosexual intercourse when this is in line with the preferred and usual lifestyle of the patient)
⁃ Periodic abstinence (eg, calendar, ovulation, symptothermal, postovulation methods)
⁃ Consistent use of barrier contraception
∙ 1\. Clinicians (Internal medicine residents, gastroenterology fellows, and attending gastroenterologists or colorectal surgeons) caring for the patients enrolled in the clinical trial