An interventional study of Preemptive therapy escalation based on preset thresholds (FC >250 μg/g or FIT >100 ng/mL) using the FOCUS-UC Ladder: and Therapy adjustment only upon clinical relapse (pMS increase ≥2 + rectal bleeding score ≥1). in Noninvasive Biomarkers and Ulcerative Colitis (UC), sponsored by Qilu Hospital of Shandong University. Not yet recruiting. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-02-11.
Sponsored by Qilu Hospital of Shandong University · Not applicable, Interventional, and Treatment
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)
1,492 studies on the registry are indexed under Colitis, Ulcerative; 399 are open to participants now.
This study's planned enrollment of 240 is above the median of 71 across 1,042 interventional studies indexed under Colitis, Ulcerative.
Browse Colitis, Ulcerative studies →Qilu Hospital of Shandong University is the lead sponsor of 299 studies on the registry; 181 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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).
Procedure: Preemptive therapy escalation based on preset thresholds (FC >250 μg/g or FIT >100 ng/mL) using the FOCUS-UC Ladder:
Procedure: Therapy adjustment only upon clinical relapse (pMS increase ≥2 + rectal bleeding score ≥1).
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).
Therapy adjustment only upon clinical relapse (pMS increase ≥2 + rectal bleeding score ≥1).
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).
Time frame: week 52
Endoscopic remission rate (MES ≤1).
Time frame: week 52
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.
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Qilu Hospital of Shandong University