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

NCT06051253 PHASE4 RECRUITING

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.

Details

Lead sponsor	Asan Medical Center
Phase	PHASE4
Status	RECRUITING
Enrolment	86
Start date	Wed Nov 01 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
Completion	Wed Jun 30 2027 00:00:00 GMT+0000 (Coordinated Universal Time)

Conditions

• Crohn Disease
• Infliximab
• Perianal Fistula Due to Crohn's Disease
• Therapeutic Drug Monitoring
• Magnetic Resonance Novel Index for Fistula Imaging in Crohn's Disease Score

Interventions

• TDM-based infliximab intravenous therapy
• Standard infliximab intravenous therapy

Countries

South Korea