NCT00451971已完成4 期
Objective Study in Rheumatoid Arthritis
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 249
- 试验地点
- 1
- 主要终点
- Long Term Objective (damage) is the MRI which will be undertaken at baseline, 12 months and 24 months.
研究概览
简要总结
Primary Objectives
- To test the feasibility, in patients with active rheumatoid arthritis, of using an 'aggressive' treatment algorithm to bring a short term treatment objective (STO) within the normal or an arbitrarily defined 'desirable' range.
- To determine whether patients with active rheumatoid arthritis randomly allocated to a particular STO show a reduced rate of Magnetic resonance imaging damage progression at two years compared to those randomly allocated to usual care.
Secondary Objectives
- To establish the relationship between achieving a given STO or combination of STOs and damage progression.
- To identify the characteristics of responders and non-responders with respect to STO achievement and predictors of greater and lesser degrees of damage progression.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Rheumatoid Arthritis as defined by the American College of Rhemuatology criteria and either
- •Active disease: ≥6/28 swollen joints or
- •Erythrocyte sedimantation or C-Reactive Protein > normal
- •Disease duration ≤ 15 yrs
- •Any therapy
- •Females of child-bearing potential must be adequate contraception
排除标准
- •Frailty, limiting co-morbidity
- •Obesity limiting ability to have MRI
- •Geographical difficulty preventing follow-up and visits
- •Women at risk of becoming pregnant
- •The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
结局指标
主要结局
Long Term Objective (damage) is the MRI which will be undertaken at baseline, 12 months and 24 months.
The Short Term Objectives are: swollen joint count - target:(28) ≤ 2 joints
C-Reactive Protein - target: within the normal range (provided elevation is not due clinically to an intercurrent event)
次要结局
- Safety: Full blood count and erythrocyte sedimentation, blood urea, electrolytes, creatinine and Liver function test
研究者
研究点 (1)
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