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| Name | Class |
|---|---|
| Qilu Hospital of Shandong University (Qingdao) | OTHER |
| Dezhou Hospital Qilu Hospital of Shandong University | OTHER |
| Weihai Municipal Hospital | OTHER |
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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)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tight Control (TC) Strategy | Experimental | 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). |
|
| Conventional Management (CM) Strategy | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Preemptive therapy escalation based on preset thresholds (FC >250 μg/g or FIT >100 ng/mL) using the FOCUS-UC Ladder: | Procedure | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Treatment Failure (Composite) | 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). | week 52 |
| Measure | Description | Time Frame |
|---|---|---|
| Endoscopic remission rate (MES ≤1). | week 52 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yan Zhang, M.D | Contact | +86 18560089821 | qlzhangyan@sdu.edu.cn |
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| Jining First People's Hospital |
| OTHER |
| Zaozhuang Municipal Hospital | OTHER |
| Liaocheng People's Hospital | OTHER |
| Weifang People's Hospital | OTHER |
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| Therapy adjustment only upon clinical relapse (pMS increase ≥2 + rectal bleeding score ≥1). | Procedure | Therapy adjustment only upon clinical relapse (pMS increase ≥2 + rectal bleeding score ≥1). |
|
| ID | Term |
|---|---|
| D003093 | Colitis, Ulcerative |
| ID | Term |
|---|---|
| D003092 | Colitis |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D015212 | Inflammatory Bowel Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
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