Comparing Therapeutic Drug Monitoring-Based and Standard Infliximab Treatment for Adults with Active Perianal Fistulizing Crohns Disease

What this Trial Is About

The trial investigates the effectiveness and safety of two different infliximab intravenous therapies in adult patients with active perianal fistulizing Crohns disease. It compares a therapeutic drug monitoring TDM-based approach, where infliximab dosing is adjusted based on drug levels, against a standard dosing regimen without dose adjustment based on monitoring. This research focuses on improving treatment outcomes for this specific Crohns disease complication. Participants in the TDM-based group receive infliximab at 5 mgkg intravenously at weeks 0, 2, and 6. From week 14 through 46, dosing can be increased to 10 mgkg based on infliximab trough levels, aiming for 10 mcgmL or higher. The standard group receives a fixed 5 mgkg dose at weeks 0, 2, 6, 14, 22, 30, 38, and 46, with drug levels monitored but not used to change dosing. Both groups follow these schedules to assess differences in clinical remission and imaging scores. During the study, participants are evaluated for clinical remission at weeks 50 and 54 and undergo imaging with the MAGNIFI-CD score to assess fistula status at week 54. Additional assessments include clinical response, biochemical remission, infliximab levels, quality of life via IBDQ, and safety monitoring through adverse event tracking up to week 54. The study lasts approximately one year from initial treatment through follow-up assessments.

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