TDM-based Infliximab Treatment for Active Perianal Fistulizing Crohn's Disease
Trial Parameters
Brief 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 Criteria
* Inclusion Criteria: 1. Age: 19-80 years 2. Subjects diagnosed with perianal fistulizing Crohn's disease based on clinical, endoscopic, histological, and radiologic findings, etc. 3. Subjects naive to both biological drugs (anti-TNFs, anti-integrin, anti-IL12/23, etc.) and investigational new drugs 4. Subjects with at least one draining perianal fistula 5. Subjects not responding to two or more conventional treatments (antibiotics, drainage, immunosuppressants, etc.) 6. Women with a childbearing potential: Those who agree to follow contraception during study drug administration and for at least 6 months from the last dosing of the study medication * Exclusion Criteria: 1. In cases where written informed consents cannot be provided by the study subjects or the subjects' legally acceptable representative 2. Subject with a probability of receiving bowel surgery within 12 weeks after baseline, decided by investigators 3. Subjects with temporary or permanent stoma 4. Subjects with short bo