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Upadacitinib Versus Infliximab as Second-Line Treatment for Acute Severe Ulcerative Colitis（UPRISE）

RecruitingPhase 4Ages 18 Years - 85 YearsAllXijing Hospital of Digestive Diseases
NCT07550673 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

This clinical trial aims to evaluate the comparative efficacy and safety of upadacitinib versus infliximab as second-line treatments for acute severe ulcerative colitis, addressing the following key questions: (1) Can upadacitinib as a second-line therapy effectively induce remission in acute severe ulcerative colitis with efficacy non-inferior to infliximab? (2) What adverse reactions may occur with upadacitinib in the treatment of acute severe ulcerative colitis? Researchers will also compare the efficacy of upadacitinib with that of corticosteroids to assess its therapeutic effect. Participants will be assigned to either the upadacitinib group (receiving upadacitinib extended-release tablets 45 mg once daily for 8 weeks, followed by 30 mg once daily) or the infliximab group (receiving an initial dose of 5 mg/kg, with additional doses at week 2, week 6, and every 8 weeks thereafter at

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📋 Eligibility rules (as published)
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 infliximab. * 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.
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What it tests

  • upadacitinib
  • Infliximab
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Where

4 sites
Ankang Central Hospital
Ankang, China
3201 Hospital
Hanzhong, China
Xijing Hosipital of Digestive Disease
Xi'an, China
Shaanxi Provincial Nuclear Industry 215 Hospital
Xianyang, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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