Evaluation of the Clinical and Immunological Impact of Two Therapeutic Strategies (Increasing the Infliximab Dose or Introduction of Immunosuppressive Therapy) in Patients Chronic Inflammatory Bowel Diseases in Loss of Response to Infliximab
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- Number of patients in Clinical remission
研究概览
简要总结
This study evaluates 2 therapeutic strategies (increase infliximab dose or add an immunosuppressant) in patients with inflammatory bowel disease in loss of response to infliximab. Addition of an immunosuppressant may be more efficient at long term and is less expensive.
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
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients with ulcerative colitis or crohn's disease
- •treated with infliximab (5mg/kg per 8 weeks) and with loss of response after at least 4 infusions of infliximab
- •active disease ( HBI > 5 for CD patients or SCCAI> 6 for UC patients)
- •patients treated with infliximab only at the time of loss of response
排除标准
- •Patients with CD with ano perineal lesions and without luminal activity
- •patients treated with cortico steroids and having had history of intolerance to azathioprin, 6-mercaptopurine or methotrexate
- •patients with acute severe flare (HBI>12 for CD patients and Lichtiger score > 10 for UC patients)
- •pregnant female
- •patients with anal disease alone
研究组 & 干预措施
Optimisation strategy
increase of Infliximab dose from 5mg/kg every 8 weeks to Infliximab 10 mg/kg every 8 weeks
干预措施: Infliximab (Drug)
Addition strategy
same dose of Infliximab ( 5mg/kg every 8 weeks) with addition of immunosuppressive agent: Azathioprine or Mercaptopurine
干预措施: Mercaptopurine (Drug)
Addition strategy
same dose of Infliximab ( 5mg/kg every 8 weeks) with addition of immunosuppressive agent: Azathioprine or Mercaptopurine
干预措施: Azathioprine (Drug)
Addition strategy
same dose of Infliximab ( 5mg/kg every 8 weeks) with addition of immunosuppressive agent: Azathioprine or Mercaptopurine
干预措施: Infliximab (Drug)
结局指标
主要结局
Number of patients in Clinical remission
时间窗: At Week 52
the clinical remission is defined by Harvey Bradshaw (HBI) Index \< 4 for Crohn's disease or Simple Clinical Colitis Activity Index (SCCAI)\<4 for ulcerative colitis.
次要结局
- economic criteria(At week 52)
- Number of patients in deep remission(At Week 52)
- Number of patient in remission and clinical response(At week 16)
- infliximab blood concentration(Baseline, week 16 ad week 52)
- infliximab antibodies concentration(Baseline, week 16 ad week 52)
- number of patient with adverse effects and allergic reactions with infliximab(At week 52)
- Inflammatory bowel disease questionnaire (score IBDQ)(Baseline and week 52)