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.
Age: 19-80 years
Subjects diagnosed with perianal fistulizing Crohn's disease based on clinical, endoscopic, histological, and radiologic findings, etc.
Subjects naive to both biological drugs (anti-TNFs, anti-integrin, anti-IL12/23, etc.) and investigational new drugs
Subjects with at least one draining perianal fistula
In cases where written informed consents cannot be provided by the study subjects or the subjects' legally acceptable representative
Subject with a probability of receiving bowel surgery within 12 weeks after baseline, decided by investigators
Subjects with temporary or permanent stoma
Subjects with short bowel syndrome
Asan Medical Center
Lead sponsor