ACTRN12622001310752尚未招募未知
ISOMETRIC CD (Efficacy of subcutaneous infliximab maintenance therapy in perianal Crohn’s disease
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
- 入组人数
- 75
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Treatment
入排标准
- 年龄范围
- 18 Years 至 75 Years（—）
- 性别
- All
入选标准
- •Adult patients, male or female aged 18 years to 75 years old
- •Patients with pfCD who have or have had single or multiple externally draining perianal fistulas who are eligible for maintenance therapy infliximab as per Pharmaceutical Benefits Scheme criteria. This incorporates patients with confirmed pfCD treated by a gastroenterologist or a consultant physician in either internal or general medicine specialising in gastroenterology; with Crohn's disease confirmed by standard clinical, endoscopic or radiological assessment; and who have/had an externally draining perianal fistula.
- •Patients on a stable dose of infliximab for 3 months (between 5mg/kg and 10mg/kg every 8 weeks (as maximum dosing)).
- •Patients with pfCD and concurrent luminal disease or patients with isolated perianal fistulising Crohn's disease without luminal disease. Isolated pfCD will be defined as perianal fistulas with typical histological features of Crohn's disease
- •Patients with or without a seton in situ
- •Patients with concurrent or previous therapies for Crohn's disease including 5-aminosalicylic acids, thiopurines, methotrexate and corticosteroids
- •Patients who have previously trialled non-anti-TNF biologic or small molecule agents
- •Patients without presence of an abscess or perianal fistula on physical exam
- •Patients with rectovaginal, rectovesical, and/or enteroenteric fistulas with at least one separate perianal (anorectal) fistula with active external draining or that was previously draining/present
排除标准
- •Patients who have commenced infliximab within the last 3 months
- •Patients who have undergone escalation of infliximab within the last 3 months
- •Patients on more than 20mg of prednisolone
- •Patients planned to undergo faecal stream diversion surgery in the next 3 months
- •Uncontrolled perianal sepsis, as determined by colorectal surgeon review
- •Usual Pharmaceutical Benefits Scheme exclusions to infliximab therapy including active systemic infections, untreated latent tuberculosis, malignancy in the last 5 years with the exception of non-melanoma skin cancer, untreated Clostridium difficile infection, moderate to severe heart failure, known systemic lupus erythematosus or connective tissue disorder, and autoimmune demyelinating conditions
研究者
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