Infliximab treatment for Crohn's disease with drug monitoring
Efficacy of Infliximab Treatment Based on TDM (Therapeutic Drug Monitoring) in Adult Patients With Active Perianal Fistulizing Crohn's Disease
This study is testing if adjusting infliximab treatment based on drug levels helps people with active perianal fistulizing Crohn's disease feel better compared to standard fixed dosing.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 86 (estimated) |
| Ages | 19 Years to 80 Years |
| Sex | All |
| Sponsor | Asan Medical Center Academic / other |
| Drugs / interventions | infliximab |
| Locations | 1 site (Seoul) |
| Trial ID | NCT06051253 on ClinicalTrials.gov |
What this trial studies
This study compares the efficacy and safety of therapeutic drug monitoring (TDM)-based infliximab therapy against standard infliximab therapy for patients suffering from active perianal fistulizing Crohn's disease. Patients in the TDM group will receive infliximab intravenously with dosage adjustments based on drug levels, while the standard group will receive fixed doses without adjustments based on monitoring. The study aims to assess clinical remission and changes in fistula imaging scores over a specified period. Participants will be monitored closely to evaluate the effectiveness of the TDM approach compared to standard treatment.
Who should consider this trial
Good fit: Ideal candidates are adults aged 19-80 with perianal fistulizing Crohn's disease who have not responded to conventional treatments.
Not a fit: Patients who have previously received biological drugs or those requiring bowel surgery within 12 weeks may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to more effective management of Crohn's disease, improving patient outcomes and quality of life.
How similar studies have performed: Other studies have shown promising results with TDM approaches in inflammatory bowel diseases, suggesting potential for success in this novel application.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Seoul
- Asan Medical Center — Seoul, South Korea (Recruiting)
Study contacts
- Principal investigator: Byong Duk Ye, MD, PhD — Asan Medical Center
- Study coordinator: Byong Duk Ye, MD, PhD
- Email: bdye@amc.seoul.kr
- Phone: 82-2-3010-3181
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.