Effect of Spacing of Anti-TNF Drugs in Ankylosing Spondylitis With Low Disease Activity: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 398
- 试验地点
- 1
- 主要终点
- Proportion of patients remaining in low disease activity
研究概览
简要总结
Patients with spondyloarthritis, already treated by TNF blocker (adalimumab, etanercept or infliximab), and in stable low disease activity for at least 6 months, will be randomized into 2 groups: either keeping on their usual treatment with stable doses or progressive spacing of injections of their treatment. Follow-up will be done every 3 months during 12 months, with regular monitoring of disease activity and, in patients from the group "spacing", modification of the rhythm of injections according to health state and predefined protocol.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients with spondyloarthritis according to ASAS criteria
- •Stable low disease activity for at least 6 months
- •Already treated by TNF blocking drug (adalimumab, etanercept or infliximab)
排除标准
- •Raised acute phase reactants
- •participation in another clinical trial
- •Structural progression of peripheral joint damage
- •Scheduled surgery within 12 months
- •pregnancy
研究组 & 干预措施
Maintain
Continuation of usual treatment with fixed intervals according to standard recommendations
干预措施: Adalimumab, Etanercept, Golimumab or infliximab (Drug)
Spacing
Progressive spacing of injections according to disease activity observed during follow-up and predefined protocol.
干预措施: Adalimumab, Etanercept, Golimumab or infliximab (Drug)
结局指标
主要结局
Proportion of patients remaining in low disease activity
时间窗: 12 months
次要结局
- Medico-economic comparison of arms(12 months)