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

NCT06051253 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 86

Last updated 2024-05-14

No results posted yet for this study

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.

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

Interventions

DRUG

TDM-based infliximab intravenous therapy

Infliximab (CT-P13, RemsimaTM) is intravenously given as an induction therapy at a dose of 5 mg/kg at week 0, 2, and 6. From week 14 to 46 (at week 14, 22, 30, 38, and 46), infliximab dose can be increased to 10 mg/kg, targeting trough level (TL) of infliximab 10 mcg/mL or over (If TL is 10 mcg/mL or over under treatment with 5 mg/kg infliximab, 5 mg/kg of infliximab is continued. If TL is lower than 10 mcg/mL, infliximab dose is increased to 10 mg/kg). Once infliximab dose was increased to 10 mg/kg, the next doses are fixed to 10 mg/kg.

DRUG

Standard infliximab intravenous therapy

Infliximab (CT-P13, RemsimaTM) is intravenously administered at a dose of 5 mg/kg at week 0, 2, 6, 14, 22, 30, 38, and 46. Therapeutic dose monitoring (TDM, checking trough levels of infliximab) is performed at week 14, 22, 30, 38, and 46, but TDM results are not reflected in determining doses of infliximab.

Sponsors & Collaborators

  • Asan Medical Center

    lead OTHER

Principal Investigators

  • Byong Duk Ye, MD, PhD · Asan Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-11-01
Primary Completion
2026-06-30
Completion
2027-06-30

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06051253 on ClinicalTrials.gov