Calcium Pyrophosphate Deposition (CPPD) Disease : Clinical and Paraclinical Profile, Gene Expression and Metabolomics of the Acute and Chronic Clinical Phenotype
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 137
- 试验地点
- 2
- 主要终点
- Transcriptomic profile
研究概览
简要总结
The goal of this clinical trial is to describe the transcriptomic and metabolomic profile of patients with chronic Calcium Pyrophosphate Deposition (CPPD) compared to those with acute CPPD.
The hypotheses are as follows :
- It is hypothesised that there is a transcriptomic and metabolomic signature of CPPD which explains why therapeutic responses to different anti-inflammatory treatments differ from one phenotype to another one
- It is hypothesised that the acute and chronic clinical phenotypes of CPPD have different clinical, biological and imaging characteristics, as well as a differing predisposition toward crystalline deposition and inflammatory pathway activation.
The management of participants with chronic forms of the disease included in this research was modelled on the usual recommended management, including a biological workup, joint puncture, ultrasound and radiographic workup. Double-energy CT scans and transcriptomic and metabolomic analyses on plasma are not routine tests.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Acute forms of CPPD: retrospective part of the study
- •Cases included in the COLCHICORT cohort (NCT03128905), for whom this was the first acute episode of CPPD
- •Inclusion Criteria - Chronical forms of CPPD : prospective part of the study
- •Patients affiliated to the French social security system
- •Age ≥ 65 years
- •Diagnosis of chronic CPPD (recurrent acute or persistent arthritis), meeting ACR/EULAR 2023,11 classification criteria after evaluation by a rheumatologist in the rheumatology department
- •Progression of CPPD rheumatism for at least 3 months and still active CPPD rheumatism, defined by a visual analogue scale (VAS) of disease activity ≥ 40 and/or presentation of at least 1 crisis over the last 3 months
- •Glomerular Filtration Rate (GFR) in Chronic Kidney Disease Epidemiology (CKD EPI Collaboration) ≥ 30ml/min/1.73m2
- •Minimum time between the last intake of a crisis treatment and inclusion in the study, depending on their half-life, in order to not interfere with the results of the omics analyses: 2 weeks (Nonsteroidal Anti-Inflammatory Drugs Per Os (PO) or Intramuscular (IM) or Intravenous (IV); corticosteroids PO or IV; colchicine PO; anakinra Subcutaneous (SC), 1 month (methotrexate PO, tocilizumab SC), 3 months (canakinumab SC, tocilizumab IV)
- •Signed written consent for study participation
排除标准
- •Acute forms of CPPD:
- •Missing data concerning transcriptomic and metabolomic analyses.
- •Opposition
- •Exclusion Criteria - For chronic forms of CPPD:
- •History of gout or presence of monosodium urate (MSU) crystals on joint fluid,
- •Cognitive decline (confusion and neurodegenerative diseases)
- •Inability to provide informed consent and disease VAS
- •Patient under guardianship or curatorship
结局指标
主要结局
Transcriptomic profile
时间窗: 2 weeks
-Quantitative transcriptomic profiling (expression of the genes involved) and qualitative profiling (analysis of the sequence of variants expressed)
Metabolomic profile
时间窗: 2 weeks
- Metabolomic profile: quantitative assessment of the metabolites involved in each phenotype, then qualitatively grouped by activated metabolic pathway
次要结局
未报告次要终点