Fecal Noninvasive Biomarkers Oriented Control Versus Usual Care Strategy in Ulcerative Colitis: A Multicenter, Open-Label, Randomized, Parallel Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 240
- 主要终点
- Time to Treatment Failure (Composite)
研究概览
简要总结
Design: Multicenter, Open-Label, Randomized, Parallel Controlled Allocation: 1:1 Randomization Masking: Open-label (outcome assessors blinded for endoscopy) Primary Purpose: Treatment Strategy Evaluation Phase: Phase IV (Post-Marketing Surveillance)
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Confirmed UC diagnosis ≥6 months.
- •Clinical remission: Partial Mayo Score (pMS) ≤2, with stool frequency and rectal bleeding subscores ≤
- •Endoscopic remission (MES ≤1) confirmed by colonoscopy within 12 weeks pre-screening.
- •Stable maintenance therapy (5-ASA, immunomodulators, biologics, or JAK inhibitors) ≥8 weeks.
- •Written informed consent.
排除标准
- •Indeterminate colitis or Crohn's disease.
- •History of toxic megacolon, symptomatic colonic stricture, or dysplasia. Prior colectomy.
- •Systemic/local corticosteroid use within 8 weeks.
- •Active gastrointestinal infection or chronic diarrhea from non-UC causes.
- •Pregnancy, lactation, or concurrent interventional trial participation.
研究组 & 干预措施
Tight Control (TC) Strategy
Fecal calprotectin (FC) and FIT measured at Weeks 0, 12, 24, 36.
Action: Preemptive therapy escalation based on preset thresholds (FC >250 μg/g or FIT >100 ng/mL) using the FOCUS-UC Ladder:
Level 0: Current maintenance therapy. Level 1: Optimize current therapy (e.g., dose increase, TDM-guided adjustment). Level 2: Add combination therapy (e.g., biologics + immunomodulators). Level 3: Switch to advanced therapy (different mechanism). Level 4: Study withdrawal (treatment failure).
干预措施: Preemptive therapy escalation based on preset thresholds (FC >250 μg/g or FIT >100 ng/mL) using the FOCUS-UC Ladder: (Procedure)
Conventional Management (CM) Strategy
干预措施: Therapy adjustment only upon clinical relapse (pMS increase ≥2 + rectal bleeding score ≥1). (Procedure)
结局指标
主要结局
Time to Treatment Failure (Composite)
时间窗: week 52
Time to Treatment Failure (Composite): Clinical relapse (pMS increase ≥2 + rectal bleeding ≥1). Need for corticosteroids due to UC relapse. UC-related hospitalization or surgery. Endoscopic worsening (MES \>1).
次要结局
- Endoscopic remission rate (MES ≤1).(week 52)