TREATMENT OF FIBROUS DYSPLASIA OF BONE WITH TOCILIZUMAB AMONG PATIENTS WHO DO NOT RESPOND TO BISPHOSPHONATES. THE TOCIDYS TRIAL.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 19
- 试验地点
- 3
- 主要终点
- serum CTX (type 1 collagen C-terminal breakdown product)
研究概览
简要总结
Bone pain due to fibrous dysplasia of bone is usually treated with bisphosphonates. A small proportion of patients fail to respond adequately. Mutated bone cells produce large amounts of Interleukin-6 (IL-6), with increased bone resorption as a result. Inhibition of IL-6 may be of interest to reduce bone resorption and therefore bone pain. TOCIDYS is a placebo-controlled randomized cross-over trial to test the hypothesis that tocilizumab can reduce bone resorption in those patients with fibrous dysplasia who have already received bisphosphonates.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •fibrous dysplasia of bone
- •previously treated with IV bisphosphonates
- •persistent bone pain and increased bone remodeling
排除标准
- •Chronic renal failure
- •serious infectious diseases
- •liver enzymes abnormality
- •pregnancy
- •dyslipidemia
研究组 & 干预措施
Tocilizumab first, then placebo
one IV infusion per month of Tocilizumab for 6 months followed by 1 infusion per month of placebo, for 6 months.
干预措施: Tocilizumab (Drug)
Tocilizumab first, then placebo
one IV infusion per month of Tocilizumab for 6 months followed by 1 infusion per month of placebo, for 6 months.
干预措施: Placebo (Drug)
Placebo first, then Tocilizumab
one IV infusion per month of Placebo for 6 months followed by 1 infusion per month of Tocilizumab, for 6 months.
干预措施: Tocilizumab (Drug)
Placebo first, then Tocilizumab
one IV infusion per month of Placebo for 6 months followed by 1 infusion per month of Tocilizumab, for 6 months.
干预措施: Placebo (Drug)
结局指标
主要结局
serum CTX (type 1 collagen C-terminal breakdown product)
时间窗: 6 months
次要结局
- Bone pain(6 months)
- serum ICTP (Carboxyterminal Telopeptide of Type I Collagen)(6 months)
- bone alkaline phosphatase(6 months)
- radiographs of mostly affected area(12 months)