Safety and Efficacy of tocilizuMAb Versus Placebo in Polymyalgia rHeumatica With glucocORticoid dEpendence SEMAPHORE
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 113
- 试验地点
- 17
- 主要终点
- Low disease activity (PMR-AS<10) with steroid independence (GCs ≤5 mg absolute value) or decrease ≥ 10 mg from week 0 to week 24).
研究概览
简要总结
Patients are treated with infusions of Tocilizumab (TCZ) or placebo for 5 months. Clinical evaluation is performed using PMR-AS.
The PMR-AS is computed by summing the 5 variables after multiplying by 0.1 for weighting purposes: PMR-AS (activity scale = AS) = C reactive protein (CRP) (mg/dl) + patient scale (VASp) (0-10 scale) + physician scale (VASph) (0-10 scale) + morning stiffness(MST) [min]×0.1) + elevation of upper limbs (EUL) (0-3 scale).
All the patients included are treated with glucocorticoid (GC).GC are reduced at each visit until the end of the study, depending on response to treatment and PMR-AS.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age older than 50 years
- •Fulfilled the Chuang criteria
- •And currently:
- •PMR-AS> 10
- •Absence of signs or symptoms of other musculoskeletal or connective tissue conditions
- •Able to give informed consent
- •Concomitant treatments with methotrexate or hydroxy-chloroquine are permitted if stable dose since 3 months.
排除标准
- •Clinical symptoms of giant cell arteritis
- •Uncontrolled dyslipidemia, high blood pressure or cardiovascular disease
- •History of major organ or haematopoietic stem cell/marrow transplant
- •Clinical evidence of significant unstable or uncontrolled acute or chronic diseases not due to PMR
- •Planned surgical procedure within 12 months after randomization.
- •History of malignant neoplasm within the last 5 years.
- •Current active infection
- •Patient with elevated ALT or AST> 5 ULN
研究组 & 干预措施
Tocilizumab
6 Intravenous infusions of tocilizumab in a dosage of 8 mg/kg (or 4 mg/kg depending on biological results as mentioned by the SPC of Tocilizumab for the rheumatoid arthritis) every 4 weeks.
干预措施: Tocilizumab (Drug)
Placebo
6 Intravenous infusions of placebo (sterile sodium chloride solution) every 4 weeks
干预措施: Placebo (Drug)
结局指标
主要结局
Low disease activity (PMR-AS<10) with steroid independence (GCs ≤5 mg absolute value) or decrease ≥ 10 mg from week 0 to week 24).
时间窗: From week 0 to week 24
PMR-AS measure
次要结局
- PMR-AS and proportion of patients with PMR-AS < 1.5; 10; 17.(From inclusion to week 32)
- Cumulative dosages of GCs at Week 32(Week 32)
- Proportion of patients with (PMR-AS>17) in both arm(From Week 24 to Week 32)