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
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Change in the scope of disease activity as assessed by the patient- a decrease in the overall disease activity on the Visual Analogue Scale by min. 50 percent and a decrease in pain assessed by the patient on the Visual Analogue Scale by min. 50 percent
研究概览
简要总结
The study includes adult patients with SAPHO syndrome (ORPHA: 793), meeting the modified classification criteria according to Kahn (2003), with the ineffectiveness of standard treatment (patient's global assessment of the disease on the VAS scale greater than or equal to 4 cm with accompanying pain on the VAS scale greater than or equal to 4 cm) treated with non-steroidal anti-inflammatory drugs in a stable dose for at least 4 weeks and/or classical disease-modifying antirheumatic drugs in stable doses for at least 12 weeks.
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 (Participant, Investigator)
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
- •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), bisphosphonates and/or antibiotics in the last 4 weeks.
- •Any medical condition that the investigator judges to contraindicate etanercept treatment.
研究组 & 干预措施
Etanercept
treatment with etanercept in addition to NSAID treatment and/or classic Disease Modifying Antirheumatic Drugs
干预措施: Etanercept (Drug)
Placebo
treatment with placeboin addition to NSAID treatment and/or classic Disease Modifying Antirheumatic Drugs
干预措施: Placebo (Drug)
结局指标
主要结局
Change in the scope of disease activity as assessed by the patient- a decrease in the overall disease activity on the Visual Analogue Scale by min. 50 percent and a decrease in pain assessed by the patient on the Visual Analogue Scale by min. 50 percent
时间窗: 12 weeks (day 85)
Change 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 Visual Analogue Scale by min. 50 percent after 12 weeks from randomization day and a decrease in pain assessed by the patient on the Visual Analogue Scale by min. 50 percent after 12 weeks from randomization day. The minimum value is - 0, and the maximum value is - 100 mm. The higher scores mean a worse outcome. A decrease by a minimum of 50 percent means a better outcome.
次要结局
- Occurrence of the patient acceptable symptom state (PASS score)(after 4, 8 and 12 weeks)
- Change in patient-assessed disease activity(after 4 and 8 weeks)
- Occurrence of partial remission(after 4, 8 and 12 weeks)
- decrease in Ankylosing Spondylitis Disease Activity Score (ASDAS- C-reactive protein) ≥1.1(after 4, 8 and 12 weeks)
- Occurrence of remission(after 4, 8 and 12 weeks)
- Change in quality of life on the Short Form-36 health survey(at 4, 8 and 12 weeks)
- decrease in the Bath Ankylosing Spondylitis Functional Index (BASFI) by a minimum of 50 percent(after 4, 8 and 12 weeks)
- Change in physician-assessed disease activity(at 4, 8 and 12 week)
- Change in the C-reactive Protein from Randomization Day Score(at Weeks 4, 8 and 12)
- Change in the Erythrocyte Sedimentation Rate from Randomization Day Score(at Weeks 4, 8 and 12)
- a decrease in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score of at least 50 percent(after 4, 8 and 12 weeks)
- Change in the Work Productivity and Activity Impairments (WPAI) from the Randomization Day Score(after 4, 8 and 12 weeks)
- status of remission- Ankylosing Spondylitis Disease Activity Score (ASDAS- C-reactive protein) below 1.3(after 4, 8 and 12 weeks)
- decrease in the Dermatology Life Quality Index (DLQI) by at least 50 percent from the result on the day of randomization(after 4, 8 and 12 weeks)
- decrease in Body Surface Area (BSA) index by a minimum of 50 percent from the score on the day of randomization after 4, 8 and 12 weeks(after 4, 8 and 12 weeks)
- decrease in the Dermatology Life Quality Index (DLQI) by a minimum of 50 percent(after 4, 8 and 12 weeks)