Status:
RECRUITING
TDM-based Infliximab Treatment for Active Perianal Fistulizing Crohn's Disease
Lead Sponsor:
Asan Medical Center
Conditions:
Crohn Disease
Infliximab
Eligibility:
All Genders
19-80 years
Phase:
PHASE4
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) intraven...
Detailed Description
The TDM-based group: At week 0,2, and 6, infliximab (RemsimaTM) is intravenously administered at a dose of 5 mg/kg. From week 14 to 46 (at week 14, 22, 30, 38, and 46), infliximab dose can be increase...
Eligibility Criteria
Inclusion
- 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
- 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
- Subjects with enterovaginal fistula, enterocutaneous fistula, or enteroenteric fistula
- Subjects previously exposed to biologics (anti-TNFs, anti-integrin, anti-IL12/23, etc.) or investigational new drugs
- Subjects with a history of hypersensitivity to monoclonal antibody
- Subjects requiring corticosteroid therapy. However, if oral corticosteroid dose lower or equivalent to prednisolone 20 mg/day before baseline is given and tapering of oral corticoseroid from baseline is planned, that subjects can be included in the study. Oral corticoseroid is tapered at a schedule of prednisolone 5 mg/7 days (example: if the subject was on oral prednisolone 20 mg/day before baseline, oral prednisolone is tapered as follows: 15 mg/day x 7 days -\> 10 mg/day x 7 days -\> 5 mg/day x 7 days -\> stopping of prednisolone)
- Subjects with active tuberculosis. However, if the subject has a history of tuberculosis, which was cured with standard anti-tuberculosis therapy according to the standard anti-tuberculosis treatment guidelines, that subject can be included
- Subjects with latent tuberculosis: Subjects determined to be positive for latent tuberculosis by the pulmonology specialist after history taking, physical examination, chest X-ray, and interferon gamma release assay during the screening period. However, even if positive for latent tuberculosis, if 4 week-treatment for latent tuberculosis is completed and if further treatment for latent tuberculosis is planned to be completed, that subject can be included
- Subjects positive for HBsAg. In cases of HBsAg (-), but with IgG Anti-HBc (+), real time quantitative PCR for HBV DNA is required. If HBV DNA is 10 IU/mL or over, that subject should be excluded
- Subjects positive for anti-HCV antibody
- Subjects with a history of infection with HIV or subject positive for HIV Ag
- Subjects positive for Clostridioides difficile toxin assay or Clostridioides difficile culture assay
- Subjects with a heart disease of NYHA Class III/IV
- Subjects with current or previous demyelinating disease
- Subject with a history of malignancy (excluding skin basal cell carcinoma, skin squamous cell carcinoma, and uterine cervix cancer) within 5 years or with a history of dysplasia of colon or small bowel within 5 years.
- Subjects with symptoms or signs of active infection or with a history of treatment for infection within 8 weeks
- Subjects with a history of organ transplantation
- Pregnant or lactating women
- Non-Korean ethnicity according to a family tree
- Subjects decided to be not eligible for the study by investigators
Key Trial Info
Start Date :
November 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2027
Estimated Enrollment :
86 Patients enrolled
Trial Details
Trial ID
NCT06051253
Start Date
November 1 2023
End Date
June 30 2027
Last Update
May 14 2024
Active Locations (1)
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1
Asan Medical Center
Seoul, South Korea, 05505