Non Randomized Parallel-group Clinical Study to Compare the Efficacy of Periarticular Bone Structure in Patients Treated With Either Tocilizumab or Tumor Necrosis Factor Blockers.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- Change in erosion volume in the HR-pQCT
研究概览
简要总结
Comparing the structural effects of TNFi and tocilizumab on the periarticular bone by performing a comprehensive analysis of the periarticular bone changes in RA patients treated with either TNFi or tocilizumab in a longitudinal Setting, using high-resolution peripheral quantitative computed tomography (HR-pQCT), a very sensitive method for visualizing and quantifying bone microstructure in RA patients. Quantitatively assessing the changes of erosions volume, osteophytes size and the area of cortical fenestration in a group of TNFi-treated and a group of tocilizumab- treated RA patients.
详细描述
Inhibition of tumor necrosis factor alpha (TNF-α) and of interleukin- 6 receptor (IL-6R) emerged as highly effective cytokine blocking strategies in the treatment of rheumatoid arthritis (RA) in the last years. Both, inhibition of TNF-α (TNFi) and of the interleukin-6 receptor by tocilizumab ameliorate the signs and symptoms, reverse the elevated acute phase response and inhibit the progression of bone erosion in RA patients (1). Despite striking similarities with respect to their efficacy and safety in the treatment of RA, TNFi and tocilizumab are two entirely distinct approaches for targeting chronic inflammatory diseases in humans. This concept is highlighted by the differential response to TNFi and tocilizumab in other chronic inflammatory diseases such as psoriasis, psoriatic arthritis and spondyloarthritis, with clinical efficacy of the former but not the latter treatment modality (2). On the other hand, tocilizumab has a direct effect on the acute phase response and iron metabolism, which is not found with TNFi. Therefore, subtle differences may exist between TNFi and tocilizumab, which are relevant for the long-term treatment of RA patients.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
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
- •Females and males with RA erosions in the wrist and/or MCP joints
- •Must be aged ≥ 18 years at time of consent
- •Stable treatment with conventional DMARDs of at least 3 months
排除标准
- •Patients exposed to abatacept or rituximab in the last 12 months
- •Patients receiving glucocorticoids over 5 mg prednisolone per day
- •Patients who are younger than 18 years
- •Pregnant or lactating females
- •Patients having received an HR-pQCT examination during the last 6 months before screening
研究组 & 干预措施
Tocilizumab
Drug administration of Tocilizumab s.c. or i.v. depending on the preference of the patient and/or physician according to the label
干预措施: Tocilizumab (Drug)
Tocilizumab
Drug administration of Tocilizumab s.c. or i.v. depending on the preference of the patient and/or physician according to the label
干预措施: TNF-alpha Inhibitor (Drug)
TNF-alpha Inhibitor
Drug administration s.c. or i.v. of the TNF-Alpha Inhibitor depending on the preference of the patient and/or physician according to the label
干预措施: Tocilizumab (Drug)
TNF-alpha Inhibitor
Drug administration s.c. or i.v. of the TNF-Alpha Inhibitor depending on the preference of the patient and/or physician according to the label
干预措施: TNF-alpha Inhibitor (Drug)
结局指标
主要结局
Change in erosion volume in the HR-pQCT
时间窗: 12 months
次要结局
- Change in the Clinical Disease Activity Index (CDAI)(12 months)
- Change in the Disease activity score 28 (DAS28)(12months)
- Change in the Health Assessment Questionnaire (HAQ)(12 months)
- Number of patients in Remission (DAS28 < 2.6)(12 months)
- Number of patients in Low Disease Activity (DAS28 ≥ 2.6 und ≤ 3.2)(12 months)
- Changes in the Simple Disease Activity Index (SDAI)(12 months)