KCT0008205尚未招募未知
Efficacy of Infliximab treatment based on TDM (Therapeutic Drug Monitoring) in adult patients with active perianal fistulizing Crohn’s Disease
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
- 入组人数
- 86
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 19(Year) 至 80(Year)（—）
- 性别
- All
入选标准
- •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
排除标准
- •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 surgey 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 corcitosteroid 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 predinsolone is tapred 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 standeard 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 screeing period. However, even if positive for latient 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 accordig to a family tree
- •24. Subjects decided to be not eligibe for the study by investigators
研究者
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