Treatment Of Giant Cell Arteritis Patients With Ultra-short Glucocorticosteroids And tociliZumab: Role of Imaging in a Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Change from baseline at 24, 52 and 76 weeks variation of PET Vascular Activity Score (PETVAS)
研究概览
简要总结
The objective of our study is to evaluate the functional and morphological imaging variations at 24 and 52 weeks compared to baseline during TCZ-treatment and 6 months after the suspension of TCZ. We will also evaluate the variations of aortic dilatation during the study period using the PET/CT in comparison with an hystorical cohort of patients with LVV treated with GCs only and longitudinally followed at our rheumatology division.
详细描述
- Trial Design Monocentric observational study, single arm, based on imaging of patients with active Large Vessel Giant Cell Arteritis (LV-GCA) , treated with Tocilizumab (TCZ) s.c. and with ultra-short glucocorticosteroids (GCs).
- Duration of study per Subject 52 weeks of observation during standard of care (SOC) and 24 weeks of follow-up
- Target Population Patients aged older than 50 years with active large vessel giant cell arteritis (LV-GCA) based on evidence of large vasculitis at imaging.
Patients with active disease will be enrolled according to the following inclusion criteria:
- PET/CT showing vascular FDG uptake ≥2 in at least one vascular district and at least one among
- ESR >40 mm/h or CRP >10 mg/l
- Cranial or systemic symptoms of GCA or symptoms of polymyalgia rheumatica (PMR)
- Primary Objectives
- To evaluate the functional and morphological imaging (PET and MRA scores) variations at 24, 52 and 76 weeks compared to baseline values.
- To evaluate the proportion of patients with relapse free remission (RFR) at week 24, 52 and 76.
- To assess agreement between of MRA and PET scores and physician-determined disease activity status.
- Secondary Objectives
- To evaluate if patients have a reduced risk of aortic dilatation compared with an hystorical cohort of patients with LVV treated with GCs only and longitudinally followed at our rheumatology division.
- immunological effects of steroid and TCZ at baseline, after 3 days, at week 24, 52 and 76
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Change from baseline at 24, 52 and 76 weeks variation of PET Vascular Activity Score (PETVAS)
时间窗: Baseline, 24, 52, 76 weeks
To evaluate the functional imaging (PET scores) variations
Change from baseline at 24, 52 and 76 weeks variation of MRA grading of large vessel vasculitis
时间窗: Baseline, 24, 52, 76 weeks
To evaluate the morphological imaging (MRA scores) variations
Change from baseline at 24, 52 and 76 weeks of the proportion of patients with relapse-free remission
时间窗: Baseline, 24, 52, 76 weeks
Remission will be defined as the absence of any clinical symptoms directly attributable to vasculitis with normalization of CRP/ESR and absence of new/worsened vascular damage at MRA and/or CT
次要结局
- Changes of concentrations of various cytokines in plasma and PBMC culture supernatants at each time point(Baseline, 3 days, 24, 52 and 76 weeks)
- Variation of Aortic diameter at each time point(24, 52, and 76 weeks)