Noninvasive Biomarkers, Ulcerative Colitis (UC)
Conditions
Brief summary
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)
Interventions
PROCEDUREPreemptive therapy escalation based on preset thresholds (FC >250 μg/g or FIT >100 ng/mL) using the FOCUS-UC Ladder:
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).
PROCEDURETherapy adjustment only upon clinical relapse (pMS increase ≥2 + rectal bleeding score ≥1).
Therapy adjustment only upon clinical relapse (pMS increase ≥2 + rectal bleeding score ≥1).
Sponsors
Qilu Hospital of Shandong University
Qilu Hospital of Shandong University (Qingdao)
Dezhou Hospital Qilu Hospital of Shandong University
Weihai Municipal Hospital
Jining First People's Hospital
Zaozhuang Municipal Hospital
Liaocheng People's Hospital
Weifang People's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Confirmed UC diagnosis ≥6 months. 2. Clinical remission: Partial Mayo Score (pMS) ≤2, with stool frequency and rectal bleeding subscores ≤1. 3. Endoscopic remission (MES ≤1) confirmed by colonoscopy within 12 weeks pre-screening. 4. Stable maintenance therapy (5-ASA, immunomodulators, biologics, or JAK inhibitors) ≥8 weeks. 5. Written informed consent.
Exclusion criteria
1. Indeterminate colitis or Crohn's disease. 2. History of toxic megacolon, symptomatic colonic stricture, or dysplasia. Prior colectomy. 3. Systemic/local corticosteroid use within 8 weeks. 4. Active gastrointestinal infection or chronic diarrhea from non-UC causes. 5. Pregnancy, lactation, or concurrent interventional trial participation.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to Treatment Failure (Composite) | 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). |
Secondary
| Measure | Time frame |
|---|---|
| Endoscopic remission rate (MES ≤1). | week 52 |
Contacts
CONTACTYan Zhang, M.D
Outcome results
None listed