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

StatusRecruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗
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.

Record History

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  1. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Start date changed from estimate of Oct 2, 2023 to Nov 1, 2023
    v4
  2. Secondary endpoints: details revised at 1 of 6 entriesv3
  3. Primary endpoints revised (2)
    • Secondary endpoints revised (6)
    v2
  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06051253
Lead Sponsor Asan Medical Center
Conditions
(from sponsor)		 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
Related terms Crohn Disease
Enrollment 86 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov