ACTRN12621000023853尚未招募4 期
A Prospective Randomised Controlled Trial investigating the effect of optimised therapeutic infliximab levels guided by proactive therapeutic drug monitoring on fistula healing in adults with perianal fistulising Crohn's Disease: PROACTIVE Trial
Associate Professor Susan Connor0 个研究点目标入组 138 人开始时间: 2021年1月14日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 138
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
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 80 Years（—）
- 性别
- All
入选标准
- •Adult patients aged 18-80 years
- •Patients with complex perianal fistulising Crohn's disease (cpfCD) who have single or multiple externally draining perianal fistulas who are eligible for initiation of infliximab as per Pharmaceutical Benefits Scheme criteria. This incorporates patients with confirmed cpfCD 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 an externally draining perianal fistula.
- •Patients unexposed to infliximab within 12 months of study inclusion
- •Patients with previous infliximab exposure > 12 months prior to study inclusion are eligible provided they were infliximab responsive at the time of cessation or non-responsive with below target maintenance infliximab trough level (< 10 µg/mL), and if anti-infliximab antibodies were present, titres were low (=< 60 ng/mL, using Ridascreen assay).
- •Patients previously treated with adalimumab, if non-responsive with below target trough adalimumab levels (< 5 µg/mL), with or without detectable anti-adalimumab antibody titres.
- •Patients with cpfCD and concurrent luminal disease or patients with isolated perianal fistulising Crohn’s disease without luminal disease. Isolated cpfCD 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 with controlled perianal sepsis on colorectal surgeon review
- •Patients who are able to understand and willing to sign the informed consent as approved by the Human Research Ethics Committee. Patients must have read and understood the Patient Information and Consent Form, must fully understand the requirements of the study, and must be willing to comply with all study visits and assessments
排除标准
- •Presence of a current diverting ileostomy or colostomy
- •Patients likely to undergo faecal stream diversion surgery in the next 3 months
- •Rectovaginal fistula or rectovesical fistulae
- •Uncontrolled perianal sepsis, as determined by colorectal surgeon review
- •Past failure to infliximab therapy with target maintenance infliximab trough level (>= 10µg/mL)
- •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
- •Conditions interfering with treatment compliance
- •Pregnancy or expected pregnancy in the next 54 weeks; breast-feeding
- •Participants who cannot read or understand the Patient Information and Consent Form may not be enrolled in the study by a guardian or any other individual
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