NCT00216177Unknown4 期
Randomised, Multicenter, Open-label, Parallel-group Study Comparing Adalimumab 40 mg s.c. Eow Versus Infliximab 3 mg/kg i.v. Every 6 Weeks in Rheumatoid Arthritis Patients With Unsustainable Clinical Response to Infliximab 3 mg/kg Every 8 Weeks
适应症
相关药物
试验速览
- 阶段
- 4 期
- 入组人数
- 112
- 试验地点
- 8
- 主要终点
- Proportion of patients achieving combined good or moderate EULAR responses at week 24
研究概览
简要总结
The purpose of this study is to establish whether RA patients with moderate to severe disease activity with unsustainable response to infliximab 3 mg/kg every 8 weeks have better efficacy with adalimumab 40 mg s.c. eow compared to infliximab 3 mg/kg i.v. every 6 weeks.
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
- •ACR criteria fulfilled,DAS28-3(CRP > 3.2
- •> 6 months prior treatment with infliximab 3 mg/kg i.v. every 8 week with initial response
- •Fading clinical response to infliximab
- •Negative pregnancy test (women with childbearing potential)
- •Use of reliable method of contraception (women with childbearing potential)
- •Informed consent
排除标准
- •Age less than 18 years
- •Lack of co-operability
- •Positive serology for hepatitis B or C
- •History of positive HIV status
- •History of TB or untreated latent TB
- •Histoplasmosis or Listeriosis
- •Pregnancy or breastfeeding
- •Persistent or recurrent infections
- •History of cancer
- •Uncontrolled diabetes
- •Ischaemic heart disease
- •Congestive heart failure (NYHA 3-4)
- •Active inflammatory bowel disease
- •Recent stroke (within 3 months)
- •History of or current inflammatory joint disease other than RA
- •Previous diagnosis or signs of central nervous system demyelinating disease
结局指标
主要结局
Proportion of patients achieving combined good or moderate EULAR responses at week 24
时间窗: six months
次要结局
- ACR20/50/70 response at week 2, 6, 12, 18 and 24(six months)
研究者
研究点 (8)
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