Filling Bone Erosions: a Longitudinal Multicentric HR-pQCT Study of 12 Months Subcutaneous Tocilizumab in Rheumatoid Arthritis Phase IV Prospective Multicentrique Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 4
- 主要终点
- Bone erosion change after 12 months of subcutaneous tocilizumab
研究概览
简要总结
Rheumatoid arthritis (RA) is a chronic inflammatory disease mediated by the production of several cytokines, which leads to the destruction of bone and cartilage tissue in multiple joints and to bone loss. Conventional radiographs (CR) are considered as the gold standard for diagnosis and follow up of joint changes in RA. But this method has low sensitivity to detect early erosive changes and is unable to evaluate periarticular bone loss.
High Resolution peripheral QCT (HRpQCT) enables the detection of erosions less than 0.5 mm in width or depth at metacarpo-phalangeal (MCP) joints. Using 3-D high resolution analysis of cortical bone erosions, this one is also able to evaluate the volumes of erosion and the evolution under treatments IL6 (6- interleukin) plays a major role in inflammatory process and bone damages related to RA. Tocilizumab (TCZ) is a humanized anti-IL-6R monoclonal antibody, developed and investigated in several clinical trials in RA. This biotherapy, in association with methotrexate (MTX) or given in monotherapy, is efficient in RA with inadequate response to MTX or anti-TNF b (tumor necrosis factor). TCZ reduces dramatically systemic inflammation, structural progression and improves clinical symptoms and quality of life.
Tocilizumab may help reducing bone erosions, periarticular osteopenia and systemic bone loss.
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Active RA, < 10 years disease duration, diagnosed according to the ACR-EULAR 2010 classification criteria
- •DAS 28 superior or equal to 3.2 despite DMARD or biological treatment (other than tocilizumab)
- •Superior or equal to one joint erosion at the right or left MCP 2, 3 on X-rays
- •Oral corticosteroid ≤ 10 mg/day prednisone or equivalent stable for at least one month
- •RA patients eligible to subcutaneous Tocilizumab monotherapy
排除标准
- •Treatment with zoledronic acid or denosumab (less than one year)
- •Intra-articular injection of corticosteroids at the MCP in the previous three months
- •Tocilizumab contra-indications in accordance with SPC (Summary of Product Characteristics) :Hypersensitivity to the active substance or to any of the excipients Active, severe infections including active tuberculosis Diverticulitis Active hepatic disease and hepatic Impairment including viral hepatitis Elevated Alanine Aminotransferase or Aspartate Aminotransferase >5×ULN Absolute neutrophil count < 0.5 × 10 exp 9 /L Platelet count < 50×10 exp 3 /μL,
- •Absence of informed consent
- •Prior or planned joint surgery of the hands which might impact the interpretation of imaging assessments.
研究组 & 干预措施
Roactemra
subcutaneous tocilizumab
干预措施: subcutaneous tocilizumab (Drug)
结局指标
主要结局
Bone erosion change after 12 months of subcutaneous tocilizumab
时间窗: baseline and 12 months
changes of volume measured by HRpQCT.
次要结局
- Effect of Tocilizumab on synovitis/tenosynovitis assessed by US and agreement with disease activity scores(Predictors baseline, 1 and 3 months of clinical remission and / or ultrasound at 6 and 12 months)
- Associated factors with erosion changes assessed by HRqQCT(baseline, 3 months, 12 months)
- Effect of 12 months of tocilizumab on bone density in the PR(baseline, 12 months)
- Effect of 12 months of tocilizumab on bone microarchitecture in the PR(baseline, 12 months)