NCT01713842已完成2 期
Phase II Open 24 Weeks Study to Evaluate Effect and Safety of Tocilizumab as the First Line Therapy in Subjects With Polymyalgia Rheumatica (PMR)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 3
- 主要终点
- Efficacy at W12
研究概览
简要总结
Phase 1:
Patients are treated with infusions of Tocilizumab (TCZ) for 3 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).
At the end of the phase 1,the patients stop TCZ and entered in phase 2 at week 12.
Phase 2:
All the patients are included in the phase 2 and treated with glucocorticoid (GC)for 3 months. Two arms are possible according to the PMR-AS. Either the classical GC treatment (0.3mg/kg), either a low dose group of GC(0.15mg/kg) .
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
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 50 years and 75 years included
- •PMR-AS > 10
- •PMR according to the Chuang criteria
- •Evolving since less than 12 months
- •Without Horton disease
- •Able to understand and accept the study
- •Agree to sign the inform consent form
- •Without GC, or at least during 1 month and stop since 7 days before the inclusion.
- •Stable dose of Nonsteroidal anti-inflammatory since 4 weeks before the inclusion.
- •Birth controlled during all the study and 6 months after
排除标准
- •Disagree to participated
- •Unable to understand the study
- •Participation to an other study in the 3 months before the inclusion
- •Treated by GC at 0.3mg/kg/d in the past 7 days
- •Less than 50 years old or more than 75 years old
- •Uncontrolled dyslipidemia, high blood pressure or cardiovascular disease
- •Histories of important allergy
- •Historically positive test or test positive at screening for HIV-1 antibody, hepatitis B surface antigen, or hepatitis C antibody.
- •Abnormal screening blood test : leukocyte count less than 3.5 × 109 cells/L, neutrophil count less than 2 × 109 cells/L, hemoglobin level less than 85 g/L, platelet count less than 100 × 109 cells/L, or hepatic aminotransferase or alkaline phosphatase levels greater than 3 times the upper limit of normal
- •Other inflammatory rheumatic disease or connective disease
- •Clinical evidence of significant unstable or uncontrolled acute or chronic diseases not due to PMR (eg. Cardiovascular, pulmonary, hematologic, gastrointestinal, hepatic, renal, neurological, malignancy or infectious diseases)
- •Current drug or alcohol abuse
- •Patients treated with an immunosuppressive agents in the past 4 weeks
- •Live/attenuated vaccine in the past 4 weeks
- •Clinical symptoms of giant cell arteritis
- •History of infection or infestation in the past 3 months
- •Active tuberculosis
- •Planned surgical procedure
- •History of malignant neoplasm within the last 5 years, except for adequately treated cancer of the skin (basal or squamous cell)
- •History or current tumoral hematological disease
- •Severe allergic or anaphylactic reactions about one of the TCZ component
- •Pregnant women during the study and six month after the end of the study
- •Breast feeding mother
- •Dysthyroidia
- •Unstable treatment by statin in the past 3 months
- •Parkinson disease
- •Fibromyalgia
- •Peripheric arthritis
- •Articular chondrocalcinosis or hydorxyapatites rhumatisms
研究组 & 干预措施
TCZ
Experimental
Tocilizumab at week 0, week 4 and week 8 8mg/kg at each perfusion
干预措施: TCZ (Drug)
结局指标
主要结局
Efficacy at W12
时间窗: 12 Weeks
PMR-AS at week 12
次要结局
- Safety and efficacy during the study(Week 2,4,8,12,16,20 and 24)
研究者
研究点 (3)
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