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

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age19-80
SponsorAsan Medical Center

About this trial

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

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

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

Treatment groups

86 Participants
are divided into 2 treatment groups

Sponsors and collaborators