Comparing upadacitinib and infliximab for severe ulcerative colitis flares
Compares upadacitinib with infliximab in adults with severe ulcerative colitis flares.
Plain-language title generated from the registry record
Registry title: Upadacitinib Versus Infliximab as Second-Line Treatment for Acute Severe Ulcerative Colitis（UPRISE）
Key facts
- Where
- Ankang, Hanzhong, Xi'an, and Xianyang, ChinaSee the 4 sites
- Phase
- Phase 4
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 85 years old?
Source: NCT07550673, who can take part
Where in China
- Ankang Central HospitalAnkang, ChinaTaking people
- 3201 HospitalHanzhong, ChinaTaking people
- Xijing Hosipital of Digestive DiseaseXi'an, ChinaTaking people
- Shaanxi Provincial Nuclear Industry 215 HospitalXianyang, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Xijing Hospital of Digestive Diseases
- Trial code
- NCT07550673
- Record updated
- 24 April 2026
- Original description
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 the same dose). The treatment duration is 3 months, with outpatient visits for examinations and tests every two weeks. Patients will record their bowel movements and symptoms such as abdominal pain, and undergo colonoscopy, ultrasound examinations, and blood tests at specified time points.Read full original descriptionShow less
Upadacitinib Versus Infliximab as Second-Line Treatment for Acute Severe Ulcerative Colitis: Multicenter, Open-Label, Randomized Controlled Trial
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 the same dose). The treatment duration is 3 months, with outpatient visits for examinations and tests every two weeks. Patients will record their bowel movements and symptoms such as abdominal pain, and undergo colonoscopy, ultrasound examinations, and blood tests at specified time points.
Inclusion: Patients diagnosed with ASUC; Aged 18 years or older; No gender restriction.
Exclusion: 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.