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drugset / Trial / NCT05867329

Feasibility Pilot Sequential Multiple Assignment Randomized Trial (SMART) for Acute Severe Ulcerative Colitis

NCT05867329 ↗

Phase 4 Recruiting 162 enrolled Berinstein, Jeffrey National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) · collab
RandomizedSequentialOpen-labelTreatment

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.

Timeline

Start
2023-09-30
Primary completion
2026-05
Completion
2026-05

Publications

Drugs

EvaluationDrugModalityDoseRoute
Subject Cyclosporine Peptide 2 mg/kg Intravenous
Subject Cyclosporine Peptide 5 mg/kg Intravenous
Subject Methylprednisolone Other / unclassified 30 mg Intravenous
Subject Upadacitinib Small molecule 15 mg Oral
Subject Upadacitinib Small molecule 30 mg Oral
Subject Upadacitinib Small molecule 45 mg Oral
Background Prednisone Other / unclassified 40 mg Oral
Background Prednisone Other / unclassified 60 mg Oral

Indications

ulcerative colitis