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

PHASE4RecruitingINTERVENTIONAL
Enrollment

86

Participants

Timeline

Start Date

November 1, 2023

Primary Completion Date

June 30, 2026

Study Completion Date

June 30, 2027

Conditions
Crohn DiseaseInfliximabPerianal Fistula Due to Crohn's DiseaseTherapeutic Drug MonitoringMagnetic 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.

Trial Locations (1)

05505

RECRUITING

Asan Medical Center, Seoul

Sponsors
All Listed Sponsors
lead

Asan Medical Center

OTHER

NCT06051253 - TDM-based Infliximab Treatment for Active Perianal Fistulizing Crohn's Disease | Biotech Hunter | Biotech Hunter