Predictive Factors of ANTI-TNF Response in Luminal Crohn's Disease Complicated by Abscess A Multicenter Prospective, Observational Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 125
- 试验地点
- 2
- 主要终点
- Identification of predictive factors of adalimumab (anti TNF) failure at Week 24.
研究概览
简要总结
To identify predictive factors of adalimumab (anti TNF) response in patients with luminal Crohn's disease complicated by intra-abdominal and/or pelvic abscess after complete resolution of infection.
详细描述
Multicenter prospective observational cohort.
Initial management of sepsis and abscess (Before anti-TNF therapy initiation) i. Antibiotics. ii. Percutaneous drainage will be performed every time when possible iii. Surgical drainage will be performed if percutaneous drainage is not accessible or fails iv.
Concomitant medications :
- Steroids will be rapidly tapered and stopped.
- Azathioprine, 6-mercaptopurtine, 5-ASA derivatives and methotrexate will be maintained at a stable dose.
- If not present at inclusion, immunosuppressors could be introduced at the discretion of investigator
- Antibiotics could be used if needed for infections not related to intra-abdominal abscess recurrence and Crohn's disease. v.
Supportive care including artificial nutrition will be started if necessary.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Age greater than 18 years.
- •Diagnosis of Crohn's disease (confirmed by clinical evaluation and a combination of endoscopic, histological, radiological, and/or biochemical investigations according to European guidelines)
- •AND diagnosis of spontaneous intra-abdominal and/or pelvic abscess according to radiologic criteria confirmed by US, CT or magnetic resonance enterography (MRE).
- •In patients who have not responded despite a full and adequate course of therapy with a corticosteroid and/or an immunosuppressant or who are intolerant to or have medical contraindications for such therapies
- •Written consent MAIN
排除标准
- •Age under 18 years. - Absence of written consent. - Post-operative abscess (occurring within 12 weeks after intestinal resection). - Isolated intra-parietal abscess of small intestine or colon. - Need for immediate surgery including irreversible bowel obstruction, peritonitis or uncontrolled sepsis. - Perineal abscess complicating perianal Crohn's disease. - Abscess developing under anti-TNF therapy. - Previous failure or intolerance to adalimumab. - Contraindication to anti-TNF therapy.
结局指标
主要结局
Identification of predictive factors of adalimumab (anti TNF) failure at Week 24.
时间窗: Week 24
W24 adalimumab failure in this context is defined as: o Need for intestinal resection, o or Need to begin steroids after 12 weeks of adalimumab treatment, o or Abscess recurrence confirmed by MRE, o or Clinical relapse defined as CDAI \> 220 or HBI \> 4 (table 3) and CRP \> 10 mg/L at two consecutive visits
次要结局
- Clinical Remission(Week 48)
- Monitoring of obstructive symptoms(Week 48)
- Evolution of items measured by MRE(Week 24)
- hospital stay(Week 48)
- SAE(Week 48)
- Death(Week 24)