NCT02544659已完成1 期
Unrandomized, Open Label Single-center Study to Assess the Long Term Efficacy of Intravenous Bisphosphonates for Bone Marrow Edema in Patients With SAPHO Syndrome
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 30
- 主要终点
- response to the treatment by the change of MRI result at screening, baseline, month 3 and month 6
研究概览
简要总结
This study is designed to evaluate long term efficacy of intravenous bisphosphonates for bone marrow edema in patients with SAPHO syndrome.
详细描述
The study will evaluate the long term efficacy at 3 days, 3 and 6 months after pamidronate disodium administered. Patients will be administered pamidronate disodium 1 mg/kg, IV, QD, for 3 days, and every 3 months (up to month 6).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female patients between the ages of 18 and 70 years
- •Only 1 of the 4 inclusion criteria is sufficient to arrive at a diagnosis of SAPHO syndrome：
- •Osteo-articular manifestations of acne conglobata, acne fulminans, or hidradenitis suppurativa
- •Osteo-articular manifestations of PPP
- •Hyperostosis (of the anterior chest wall, limbs or spine) with or without dermatosis
- •CRMO involving the axial or peripheral skeleton with or without dermatosis Palmoplantar pustulosis(PPP); chronic recurrent multifocal osteomyelitis(CRMO)
- •MRI shows bone marrow edema in affected site in patients
- •Blood serum of patients show the normal white blood cell count, liver and renal function
- •Patients who like to be followed up for 1 years
- •Other protocol defined inclusion criteria may apply
排除标准
- •Women in pregnancy or lactation.
- •Septic osteomyelitis
- •Infectious chest wall arthritis
- •Infections PPP
- •Palmo-plantar keratodermia
- •DISH except for fortuitous association
- •Osteoarticular manifestations of retinoid therapy
- •Other protocol defined exclusion criteria may apply
研究组 & 干预措施
pamidronate disodium
Experimental
the patients will be administered intravenous pamidronate disodium
干预措施: pamidronate disodium (Drug)
结局指标
主要结局
response to the treatment by the change of MRI result at screening, baseline, month 3 and month 6
时间窗: 3 and 6 month (up to 6 month)
次要结局
- response to the treatment by the change of ankylosing spondylitis disease activity score (ASDAS) at screening, baseline, month 3 and month 6(3 days, 3 and 6 month (up to 6 month))
- response to the treatment by the change of high sensitivity-C reaction protein (hs-CRP) at screening, baseline, month 3 and month 6(3 days, 3 and 6 month (up to 6 month))
- physician's global assessment of disease activity at screening, baseline, month 3 and month 6(3 days, 3 and 6 month (up to 6 month))
- response to the treatment by the change of bath ankylosing spondylitis disease activity index (BASDAI) at screening, baseline, month 3 and month 6(3 days, 3 and 6 month (up to 6 month))
- response to the treatment by the change of bath ankylosing spondylitis functional index (BASFI) at screening, baseline, month 3 and month 6(3 days, 3 and 6 month (up to 6 month))
- response to the treatment by the change of Visual Analogue ale/Score (VAS) at screening, baseline, month 3 and month 6(3 days, 3 and 6 month (up to 6 month))
- response to the treatment by the change of beta-Crosslaps (beta-CTx) at screening, baseline, month 3 and month 6(3 days, 3 and 6 month (up to 6 month))
- response to the treatment by the change of erythrocyte sedimentation rate (ESR) at screening, baseline, month 3 and month 6(3 days, 3 and 6 month (up to 6 month))
- response to the treatment by the change of Osteocalcin at screening, baseline, month 3 and month 6(3 days, 3 and 6 month (up to 6 month))
- response to the treatment by the change of bath ankylosing spondylitis metroloty index (BASMI) at screening, baseline, month 3 and month 6(3 days, 3 and 6 month (up to 6 month))
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