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RecruitingPhase 4NCT06051253

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

Efficacy of Infliximab Treatment Based on TDM (Therapeutic Drug Monitoring) in Adult Patients With Active Perianal Fistulizing Crohn's Disease

Sponsor

Asan Medical Center

Enrollment

86 participants

Start Date

Nov 1, 2023

Study Type

INTERVENTIONAL

Conditions

Crohn DiseasePerianal Fistula Due to Crohn's DiseaseInfliximabTherapeutic Drug MonitoringMagnetic Resonance Novel Index for Fistula Imaging in Crohn's Disease Score

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.

Eligibility

Min Age: 19 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study tests a personalized dosing approach for infliximab — a biologic medication — in treating perianal fistulas caused by Crohn's disease. Instead of standard fixed dosing, the dose is adjusted based on blood drug levels (therapeutic drug monitoring) to improve results. **You may be eligible if...** - You are between 19 and 80 years old - You have been diagnosed with perianal fistulizing Crohn's disease - You have at least one draining fistula (abnormal tunnel) near your anus - You have tried and not responded to two or more standard treatments (antibiotics, drainage surgery, immune suppressants) - You have never used biologic drugs for Crohn's disease before **You may NOT be eligible if...** - You cannot provide written informed consent - You have active tuberculosis, serious infections, or other significant health conditions that make biologic therapy unsafe - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGTDM-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.

DRUGStandard 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.

Locations(1)

Asan Medical Center

Seoul, South Korea

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NCT06051253

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