NCT01213017已完成3 期
The Effect of Certolizumab Pegol in Combination With Methotrexate on MRI Synovitis and Bone Edema and Patient Reported Outcomes as Measured Using an Automated Visit Manager System in Moderate to Severe Rheumatoid Arthritis Patients
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- the change from baseline in synovitis and bone edema RAMRIS score.
研究概览
简要总结
The purpose of this study is to determine whether Certolizumab pegol can rapidly reduce the inflammatory changes and inhibit erosions on hand and wrist MRI in patients with active moderate to severe rheumatoid arthritis.
详细描述
The primary objective of this study is to evaluate the efficacy of CSP used in combination with MTX in patients with active moderate to severe RA by evaluating change from baseline in synovitis and bone edema MRI scores at week 6.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •moderate to severe RA (DAS > 4.4)
- •at least two swollen and tender joints in one of the hand/ wrist
- •patients must have failed at least one non-biologic or biologic DMARDs
- •currently receiving MTX therapy
排除标准
- •concomitant diseases or pathological conditions that could interfere and impact the assessment of the study treatment
研究组 & 干预措施
Certolizumab pegol
Experimental
干预措施: certolizumab pegol (Drug)
结局指标
主要结局
the change from baseline in synovitis and bone edema RAMRIS score.
时间窗: 6 weeks
次要结局
- the change from baseline in RAMRIS erosion score(16 and 52 weeks)
研究者
研究点 (2)
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