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

Launched by ASAN MEDICAL CENTER · Sep 20, 2023

Keywords

ClinConnect Summary

This clinical trial is looking at two different ways of treating active perianal fistulizing Crohn's disease, a condition that can cause painful openings around the anus. The trial will compare the effectiveness and safety of a special treatment approach called therapeutic drug monitoring (TDM) with the standard infliximab treatment. Infliximab is a medication given through an IV that helps reduce inflammation. The goal is to see if the TDM approach can lead to better outcomes for patients who haven’t found relief from other treatments.

To be eligible for this trial, participants need to be between 19 and 80 years old, have been diagnosed with perianal fistulizing Crohn's disease, and must have at least one draining fistula. They should also have tried and not responded to two or more conventional treatments. Participants can expect to receive either the TDM-based treatment or the standard treatment, and will be monitored closely throughout the study. It's important for potential participants to know that certain health conditions or recent treatments may exclude them from joining the trial, so a thorough screening will be done before enrollment.

Gender

ALL

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 bowel syndrome
• • 5. Subjects not eligible due to significant bowel strictures or intra-abdominal abscesses
• • 6. 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
• • 7. Subjects with enterovaginal fistula, enterocutaneous fistula, or enteroenteric fistula
• • 8. Subjects previously exposed to biologics (anti-TNFs, anti-integrin, anti-IL12/23, etc.) or investigational new drugs
• • 9. Subjects with a history of hypersensitivity to monoclonal antibody
• • 10. 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)
• • 11. 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
• • 12. 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
• • 13. 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
• • 14. Subjects positive for anti-HCV antibody
• • 15. Subjects with a history of infection with HIV or subject positive for HIV Ag
• • 16. Subjects positive for Clostridioides difficile toxin assay or Clostridioides difficile culture assay
• • 17. Subjects with a heart disease of NYHA Class III/IV
• • 18. Subjects with current or previous demyelinating disease
• • 19. 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.
• • 20. Subjects with symptoms or signs of active infection or with a history of treatment for infection within 8 weeks
• • 21. Subjects with a history of organ transplantation
• • 22. Pregnant or lactating women
• • 23. Non-Korean ethnicity according to a family tree
• • 24. Subjects decided to be not eligible for the study by investigators