Upadacitinib Versus Infliximab as Second-Line Treatment for Acute Severe Ulcerative Colitis: Multicenter, Open-Label, Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 226
- 试验地点
- 4
- 主要终点
- Clinical response by day 7
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients diagnosed with ASUC
- •Aged 18 years or older.
- •No gender restriction.
排除标准
- •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.
研究组 & 干预措施
Upadacitinib group
Upadacitinib extended-release tablets 45 mg once daily for 8 weeks, then adjusted to 30 mg once daily.
干预措施: upadacitinib (Drug)
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
干预措施: Infliximab (Drug)
结局指标
主要结局
Clinical response by day 7
时间窗: The primary outcome was assessed by the investigator between days 3 and 7, with patients recorded as clinical responders if they had the primary outcome on any day in this assessment window.
clinical response by day 7 (defined as a reduction in Lichtiger score to \<10 points with a decrease of ≥3 points from baseline improvement in rectal bleeding, and decreased stool frequency to ≤4 per day).
次要结局
- Endoscopic+clinical response(day 90)
- Clinical +FcP remission(day 90)
- clinical response by day 14(day 14)
- clinical remission by day 28, day 42, and day 90(day 28, day 42, and day 90)
- Endoscopic response by day 90(day 90)
- Endoscopic remission by day 90(day 90)
- Clinical +CRP remission(day 90)
- Histologic remission(day 90)
- Histologic improvement(day 90)
- Adverse Reactions(day 90)
- IBD questionnaire scores(day 0 and day 90)
- PROMIS-Fatigue SF-7a(day 0 and day 90)
研究者
Yongquan Shi
Professor
Xijing Hospital of Digestive Diseases