Efficacy and Safety of Induction Therapy With Three Doses of Infliximab in Patients With Crohn Disease Aged 7-17 Years-multicenter Open Study. Efficacy and Safety of Two Regimens of Maintenance Therapy in Patients With Crohn Disease Aged 7-17 Years-multicenter Randomized Study
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Clinical disease activity
研究概览
简要总结
The aim of the study is confirmation of efficacy of induction therapy with three doses of infliximab In patients with Crohn disease aged 7-17 years, and comparison of efficacy and safety of two regiment of maintenance therapy:
- Infliximab with immunomodulation
- Infliximab alone
详细描述
Study project Screening (Days -14 do 0): Laboratory and endoscopic (up to three months before Day 0) results will be obtained to check with inclusion/exclusion criteria.
Part A (Days 1 to 71): Induction therapy with 3 doses of infliximab 5 mg/kg will be applied on days 1 - 15 - 43. Simultaneously in patients receiving steroids, steroid tapering will be performed up to 71 Day. At Day 71 clinical (PCDAI) and endoscopic assessment will be done. Patients with no clinical response will be qualified to Follow-up surveillance group. Patients with clinical response present will be randomized to two groups of maintenance therapy:
- Infliximab with immunomodulation 2. Infliximab alone
Part B (Weeks 10 - 54): Patient with both groups will have scheduled visits at Weeks 14, 22, 30, 38, 46. Infliximab infusions and laboratory tests will be performed at each visit. At Week 54 clinical (PCDAI) and endoscopic assessment will be done.
Follow Up: 4 weeks after last visit - SAE monitoring Aim of the study
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
- 7 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with severe Crohn disease (PCDAI in anamnesis more than 51 points), with PCDAI currently over 30 points, with no or loss of response for previous therapy (except biological agents). Patients may have active fistulas.
- •Efficient methods of contraception in patients of childbearing potential during study period and six months after.
- •Patients will be enrolled to Part B of the study whether they finish Part A with clinical remission or clinical response.
排除标准
- •Hypersensitivity to infliximab
- •Pregnancy and breastfeeding
- •Active tuberculosis or other severe infection: sepsis, opportunistic infections, active CMV, yersinia pseudotuberculosis, pneumocystis carini, atypical mycobacteriosis
- •VZV infection, hepatitis, pneumonia during 3 months before Day 0 of the study
- •pancytopaenia and aplastic anemia
- •moderate and severe heart insufficiency (NYHA class III/IV), or unstable coronary heart disease
- •chronic pulmonary insufficiency, chronic renal insufficiency, chronic liver insufficiency
- •HIV infection
- •Presence of severe diseases of nervous system or severe endocrinological, hematological, psychiatric diseases.
- •Demyelinisation syndrome or symptoms resembling Demyelinisation syndrome
- •Malignancy or premalignant conditions during 5 years before Day 0 of the study.
- •Severe infection currently present
- •Malignancy currently present
研究组 & 干预措施
IFX TG
干预措施: Infliximab with azathioprine (IIFX + AZA) (Drug)
IFX alone
干预措施: Infliximab (IFX alone) (Drug)
结局指标
主要结局
Clinical disease activity
时间窗: 14 week and one year
次要结局
- endoscopic disease activity(14 week and one year)
研究者
JAROSLAW KIERKUS
MD, PhD
Children's Memorial Health Institute, Poland