2022-502263-38-00招募中2 期
Infliximab for non-Crohn Anal Fistulas
Aarhus University Hospital2 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2023年2月9日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 44
- 试验地点
- 2
- 主要终点
- Improvement in fistula disease after 15 months of treatment to a degree where it enables surgical closure of fistula
研究概览
简要总结
To investigate the efficacy of adjuvant anti-TNFα treatment to standard surgical treatment of complex cryptoglandular anal fistulas.
入排标准
- 年龄范围
- 18 years 至 64 years（18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Complex (i.e. intershincteric or low transsphincteric fistulas with extension, high transsphincteric- ,supra- or ekstrasphincteric fistulas cryptoglandular fistulas that persist in spite of 6 months seton drainage and repeated curettage every 8- 12 weeks and where the presence of extensions and/or inflammatory activity contradicts surgical closure of the fistula
- •Not diagnosed with Crohn´s disease implying a. Normal ileocolonoscopy < 6 months b. Normal capsule endoscopy of the small bowel < 6 months c. No granulomas in tissue samples from external fistula opening
- •Age 18-65 years
- •Speaks and understands Danish
- •Received surgical standard treatment (repeated curettage and seton) for at least 6 months
排除标准
- •Smoker or non-smoker for < 8 weeks
- •Anti-TNFα treatment contradicted (chronic infections or malignancy)
- •MRI-scan contradicted
- •Females of child-bearing age not using contraception
结局指标
主要结局
Improvement in fistula disease after 15 months of treatment to a degree where it enables surgical closure of fistula
Improvement in fistula disease after 15 months of treatment to a degree where it enables surgical closure of fistula
次要结局
- Drop in Perianal Disease Activity index > 2 after 6, 12 and 15 months of treatment
- Improvement evaluated by MRI after 15 and 30 months of treatment or prior
- Improvement of Quality of Life (CAF-QOL-score) after 6, 12, 15 and 30 months
- Patients who fulfill primary endpoint and achieve fistula healing 3, 6 and 12 months after fistula closure
- Time from treatment start to achieved primary endpoint
- Changes in fistula classification and activity
- Complications to the medical treatment
研究者
Anders Dige
Scientific
Aarhus University Hospital
研究点 (2)
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