EUS Guided Treatment With Humira for Crohn's Perianal Fistulas
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- Number of Participants With Durable Fistula Healing
研究概览
简要总结
This study is to assess whether utilizing endoscopic ultrasound(EUS) to guide treatment can improve durable fistula healing in patients with Crohn's perianal fistulas and to get preliminary information regarding the effectiveness of Adalimumab for Crohn's perianal fistulas.
详细描述
Prospective randomized trial to assess the effectiveness of rectal EUS to guide perianal fistula treatment. Our hypothesis is that using imaging, in this case endoscopic ultrasound (EUS), to initially evaluate and then guide therapy with an anti-TNF agent (adalimumab) for fistulizing disease will lead to better short- and long-term outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Care Provider)
盲法说明
Surgeon did not have access to EUS data for the control group prior to exam under anesthesia (EUA) and surgical intervention.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A patient may be considered for study participation if all of the following apply:
- •Male and Female aged 18 years or older; and
- •A confirmed diagnosis of Crohn's disease and one or more identifiable perianal fistulas.
排除标准
- •A patient will be excluded from the study if one or more of the following apply:
- •Females who are pregnant or breast feeding;
- •Infliximab received within 6 weeks prior to study entry;
- •Patients who cannot take, or refuse to take concomitant immunosuppressive therapy with either azathioprine, 6-mercaptopurine, or methotrexate; Unless patient has been intolerant of these therapies in the past or is contraindicated as determined by the investigator;
- •Patients who cannot take, or refuse to take concomitant antibiotic therapy;
- •Patients with severe anal stenosis or tenderness which would preclude colonoscopy and / or rectal EUS;
- •Patients who cannot take or refuse to take adalimumab;
- •Patients with active or latent tuberculosis;
- •Patients who have had systemic antibiotic, antiviral or antifungal treatment(s) within 3 weeks prior to Screening for all non-Crohn's related infections;
- •Patients concurrently taking anakinra (Kineret);
- •Patients with a history of cancer or lymphoproliferative disease other than a successfully and completely treated cutaneous squamous cell or basal cell carcinoma or carcinoma in-situ of the cervix;
- •Patients with chronic hematologic problems such as bleeding dyscrasias;
- •Patients with a history of demyelinating disease (i.e. multiple sclerosis); and
- •Patients with congestive heart failure.
研究组 & 干预措施
Adalimumab with EUS guided therapy
Patients will be randomized to adalimumab treatment with EUS guided therapy decisions. Colorectal surgeon will have access to EUS data prior to EUA with possible seton placement.
干预措施: EUA with seton placement if necessary (Procedure)
Adalimumab with EUS guided therapy
Patients will be randomized to adalimumab treatment with EUS guided therapy decisions. Colorectal surgeon will have access to EUS data prior to EUA with possible seton placement.
干预措施: adalimumab (Drug)
Adalimumab with EUS guided therapy
Patients will be randomized to adalimumab treatment with EUS guided therapy decisions. Colorectal surgeon will have access to EUS data prior to EUA with possible seton placement.
干预措施: EUS (Procedure)
Adalimumab
Patients will be randomized to adalimumab treatment. Colorectal surgeon will not have access to EUS data prior to EUA with possible seton placement.
干预措施: EUA with seton placement if necessary (Procedure)
Adalimumab
Patients will be randomized to adalimumab treatment. Colorectal surgeon will not have access to EUS data prior to EUA with possible seton placement.
干预措施: adalimumab (Drug)
结局指标
主要结局
Number of Participants With Durable Fistula Healing
时间窗: at week 48
Complete cessation of fistula drainage at 48 weeks
次要结局
- Changes in Disease Activity(Baseline and 48 Weeks)
- Changes in Perianal Disease Activity Index (PDAI)(Baseline and 48 Weeks)
研究者
David Schwartz
Principal Investigator
Vanderbilt University Medical Center