Effect of Biological Disease Modifying Anti Rheumatic Drug (bDMARD) Treatment on Spinal Fracture Incidence in Patients With Ankylosing Spondylitis (AS)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 9,858
- 主要终点
- Spinal fracture
研究概览
简要总结
Ankylosing spondylitis (AS) is a rheumatoid disease affecting all segments of the axial skeleton, leading to the complete fusion of all spinal segments - the bamboo-spine. During the last decade biological disease modifying anti-rheumatic drugs (bDMARD) have been successfully introduced to reduce the disease activity. It is unclear whether bDMARD treatment had an effect on spinal fracture risk related to AS. This national registry study will investigate the effect of bDMARD treatment on spinal fracture risk in a national cohort of patients with AS.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 30 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age 30-60 years
- •registered diagnosis of ankylosing spondylitis
排除标准
- •age <30 or >60 years
研究组 & 干预措施
AS patients
Patients registered in the Swedish Patient Registry with active AS treated with or without biological DMARD according to the Swedish Prescribed Drugs Registry, with or without spinal fractures
干预措施: bDMARD treatment (Drug)
结局指标
主要结局
Spinal fracture
时间窗: 10 years
Censored data with occurrence of spinal fracture within 10 years observation
次要结局
未报告次要终点