Clinical Trial

TDM-based Infliximab Treatment for Active Perianal Fistulizing Crohn's Disease

Recruiting Phase 4
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Record status
This record was last updated May 14, 2024 (before its estimated June 30, 2026 completion). Its status may not reflect the trial's current state.
Summary
This study will compare the efficacy and safety of TDM (therapeutic drug monitoring)-based infliximab (CT-P13, RemsimaTM) intravenous therapy compared with the standard infliximab (RemsimaTM) intravenous therapy for patients with active perianal fistulzing Crohn's disease.
Protocol Amendment History 3 amendments
This ClinicalTrials.gov record has been amended 3 times since 2023-09-20; most recent amendment 2024-05-11.
Status change: Not Yet Recruiting → Recruiting 2024-05-11
Trial Details
NCT Number NCT06051253
Lead Sponsor Asan Medical Center
Conditions Crohn Disease, Infliximab, Perianal Fistula Due to Crohn's Disease, Therapeutic Drug Monitoring, Magnetic Resonance Novel Index for Fistula Imaging in Crohn's Disease Score
Enrollment 86 participants
Start Date 2023-11-01
Primary Completion 2026-06-30 (estimated)
Study Completion 2027-06-30 (estimated)
Updated on ClinicalTrials.gov 2024-05-14