TDM-based Infliximab Treatment for Active Perianal Fistulizing Crohn's Disease (NCT06051253) | Clinical Trial Compass
RecruitingPhase 4
TDM-based Infliximab Treatment for Active Perianal Fistulizing Crohn's Disease
South Korea86 participantsStarted 2023-11-01
Plain-language 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.
Who can participate
Age range19 Years – 80 Years
SexALL
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Inclusion criteria
✓. 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
✓. Subjects not responding to two or more conventional treatments (antibiotics, drainage, immunosuppressants, etc.)
✓. 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
✕. 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
✕. Subjects not eligible due to significant bowel strictures or intra-abdominal abscesses
✕. Subjects who received bowel surgery within 6 months of baseline or subjects who were admitted due to complications associated with bowel strictures or intra-abdominal abscesses within 3 months of baseline
What they're measuring
1
Proportion of participants in clinical remission
Timeframe: Both week 50 and 54
2
Change of the MAGNIFI-CD (Magnetic Resonance Novel Index for Fistula Imaging in Crohn's Disease) score