A multicenter, randomized, double-blind clinical trial evaluating the efficacy and safety of etanercept versus placebo in the treatment of patients with SAPHO syndrome
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 3
- 主要终点
- Improvement in the scope of disease activity as assessed by the patient - a decrease in the overall disease activity as assessed by the patient on the VAS scale by min. 50% after 12 weeks and a decrease in pain assessed by the patient on the VAS scale by min. 50% after 12 weeks
研究概览
简要总结
The aim of the proposed clinical trial is to evaluate the efficacy and safety of etanercept therapy compared to placebo in patients with SAPHO syndrome who continue to receive standard treatment with NSAIDs and / or conventional disease-modifying antirheumatic drugs.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 是
入选标准
- •Diagnosis of SAPHO syndrome according to modified Kahn criteria from
- •Patient overall disease and pain assessment on VAS both ≥ 4 cm.
- •Expressing informed consent to participate in the study.
排除标准
- •According to the Summary of Product Characteristics (SmPC) for Enbrel.
- •Pregnancy, breastfeeding, inability to use effective contraception during the examination.
- •Change in the dose of NSAIDs treatment in the last 4 weeks.
- •Dose modification of disease-modifying antirheumatic drugs (DMARDs) over the past 12 weeks.
- •Use of biological drugs / synthetic targeted drugs in the last 12 weeks.
- •Use of corticosteroids (orally or local injections) in the last 4 weeks.
- •Any medical condition that the investigator judges to contraindicate etanercept treatment.
结局指标
主要结局
Improvement in the scope of disease activity as assessed by the patient - a decrease in the overall disease activity as assessed by the patient on the VAS scale by min. 50% after 12 weeks and a decrease in pain assessed by the patient on the VAS scale by min. 50% after 12 weeks
Improvement in the scope of disease activity as assessed by the patient - a decrease in the overall disease activity as assessed by the patient on the VAS scale by min. 50% after 12 weeks and a decrease in pain assessed by the patient on the VAS scale by min. 50% after 12 weeks
次要结局
未报告次要终点
研究者
Centrum Wsparcia Badań Klinicznych
Scientific
Narodowy Instytut Geriatrii Reumatologii I Rehabilitacji Im Prof. Dr Hab. Med. Eleonory Reicher