Comparative Effectiveness of Upadacitinib vs Corticosteroids as First-Line Therapy for Acu
The goal of this clinical trial is to learn comparative effectiveness and safety of Upadacitinib vs Corticosteroids as First-Line Therapy for Acute Severe Ulcerative Colitis. The main questions it aims to answer are: 1. Whether upadacitinib can effectively induce remission in acute severe ulcerative colitis with an eff
| Condition(s) | Acute Severe Ulcerative Colitis |
|---|---|
| Status | Recruiting |
| Phase | Phase 4 |
| Study type | Interventional |
| Summary | The goal of this clinical trial is to learn comparative effectiveness and safety of Upadacitinib vs Corticosteroids as First-Line Therapy for Acute Severe Ulcerative Colitis. The main questions it aims to answer are: 1. Whether upadacitinib can effectively induce remission in acute severe ulcerative colitis with an efficacy non-inferior to that of corticosteroids. 2. What adverse reactions may occur with upadacitinib in the treatment of acute severe ulcerative colitis? Researchers will compare upadacitinib with corticosteroids to evaluate the efficacy of upadacitinib in the treatment of acute severe ulcerative colitis.Participants will: 1. Upadacitinib group: Upadacitinib extended-release tablets 45 mg once daily for 8 weeks, then adjusted to 30 mg once daily. 2. Corticosteroid group: Meth |
| Who can participate | Inclusion Criteria: * Patients diagnosed with ASUC * Aged 18 years or older. * No gender restriction. Exclusion Criteria: * Presence of contraindications, allergy, or intolerance to upadacitinib or glucocorticoids. * Patients requiring immediate colectomy; diagnosis of Crohn's disease; confirmed intestinal infection; hemodynamic instability; clinically significant cytomegalovirus infection; current malignancy. * Presence of severe underlying systemic diseases involving the heart, lungs, liver, kidneys, hematologic system, or other organ systems. * Pregnant or breastfeeding women. * Unwilling to participate in the clinical study. |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Lead sponsor | Yongquan Shi |
| Locations | Ankang, Shaanxi, China; Hanzhong, Shaanxi, China; Xi'an, Shaanxi, China; Xianyang, Shaanxi, China |
| Start date | 2026-03-23 |
| NCT ID | NCT07546097 |
| Official listing | https://clinicaltrials.gov/study/NCT07546097 |