A Randomized, Double-blind Trial of the Efficacy of REMICADE (Infliximab) Compared With Placebo in Subjects With Ankylosing Spondylitis Receiving Standard Anti-inflammatory Drug Therapy
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 279
- 主要终点
- The primary endpoint of this study was the proportion of subjects who achieved an ASAS 20 response at week 24.
研究概览
简要总结
A study of the safety and efficacy of Infliximab (Remicade) versus placebo in subjects with Ankylosing Spondylitis
详细描述
This is a clinical research study that will determine if there is a reduction in the signs and symptoms (such as back pain and stiffness) of patients with ankylosing spondylitis with infliximab therapy. This study will also study the safety of infliximab in patients with ankylosing spondylitis. The effect of infliximab on physical function, damage to joints and the quality of life in patients with ankylosing spondylitis will also be studied. Subjects received infusions of either placebo at weeks 0, 2, 6, 12, 18 and 5 mg/kg infliximab at weeks 24, 26, 30 and every 6 weeks through week 96, or 5 mg/kg infliximab at weeks 1, 2, 6, 12, 18 and every 6 weeks through week 96
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
- Double
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
- •Have had a diagnosis of definite Akylosing Spondylitis for at least 3 months prior to screening
- •Have active disease with spinal pain
- •receiving or intolerant to standard anti-inflammatory agents
排除标准
- •Have Rheumatoid Arthritis, systemic lupus erythematosus, or other inflammatory rheumatic disease
- •Have a documented history of fibromyalgia
- •Have total ankylosis
结局指标
主要结局
The primary endpoint of this study was the proportion of subjects who achieved an ASAS 20 response at week 24.
次要结局
- The change from baseline in BASFI at week 24, the proportion of subjects who achieved an AS major clinical response at week 24, and the change from baseline in the physical component summary score of the SF-36 at week 24