Comparative Effectiveness of Upadacitinib vs Corticosteroids as First-Line Therapy for Acute Severe Ulcerative Colitis: Multicenter, Open-label, Non-inferiority, Randomized Controlled Study
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 46
- 试验地点
- 4
- 主要终点
- Primary Outcome Measure
研究概览
简要总结
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:
- Whether upadacitinib can effectively induce remission in acute severe ulcerative colitis with an efficacy non-inferior to that of corticosteroids.
- 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:
- Upadacitinib group: Upadacitinib extended-release tablets 45 mg once daily for 8 weeks, then adjusted to 30 mg once daily.
- Corticosteroid group: Methylprednisolone for injection 60 mg/day. If clinical response is achieved, switch to oral prednisone acetate tablets after 5 days (calculated at 0.75 mg/kg/day), followed by a weekly prednisone taper of 5 mg. When the dose is reduced to 20 mg, taper by 2.5 mg weekly until discontinued, with mesalazine 4 g/day as maintenance therapy.
- Take drug Upadacitinib or Corticosteroid every day for 3 months
- Visit the clinic once every 2 weeks for checkups and tests
- Record the patient's bowel movements and the presence of symptoms such as abdominal pain, while performing colonoscopy, ultrasound examination, and blood tests at the 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 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.
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)
Corticosteroid group
Methylprednisolone for injection 60 mg/day. If clinical response is achieved, switch to oral prednisone acetate tablets after 5 days (calculated at 0.75 mg/kg/day), followed by a weekly prednisone taper of 5 mg. When the dose is reduced to 20 mg, taper by 2.5 mg weekly until discontinued, with mesalazine 4 g/day as maintenance therapy.
干预措施: Corticosteroid (Drug)
结局指标
主要结局
Primary Outcome Measure
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
- 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)
- Endoscopic+clinical response(day 90)
- Clinical +FcP remission(day 90)
- Clinical +CRP remission(day 90)
- Histologic remission(day 90)
- Histologic improvement(day 90)
- Adverse Reactions(day 90)
- IBDQ and fatigue questionnaire scores(day 0 and day 90)
研究者
Yongquan Shi
Professor
Xijing Hospital of Digestive Diseases