Kinetics of C-Reactive Protein in Giant Cell Arteritis Following Glucocorticoid Initiation: A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 主要终点
- CRP testing
研究概览
简要总结
We propose to analyze the kinetics of the main marker of inflammation in GCA in order to understand its links with initial clinical manifestations and the possible appearance of complications and/or relapses.
Early assessment of the rate of CRP normalization would enable us to adapt the therapeutic strategy in order to avoid complications and/or relapses.
详细描述
Giant cell arteritis (GCA) is a chronic systemic vasculitis of the large vessels characterized by a significant inflammatory syndrome, correlated with disease activity and various inflammatory biomarkers, including CRP, which more effectively reflects disease activity.
Relapses remain frequent, with rates of up to 45.7%. Recommended treatments involve long-term corticosteroid therapy and/or sparing therapies, which are associated with adverse events.
Identifying relapsing patients is therefore crucial, in order to best adapt initial treatment and patient follow-up.
We therefore propose to study CRP kinetics at diagnosis and at initiation of corticosteroid therapy, to determine the link with disease progression.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
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
- •Adult patients aged 18 or older hospitalized in the internal medicine department with a new diagnosis of ACG
- •Personne affiliée ou bénéficiaire d'un régime de sécurité sociale
- •Free and informed consent signed by the participant and the investigator
排除标准
- •Patients scheduled to be placed on a sparing regimen during hospitalization
- •Patients with renal insufficiency (eGFR ≤ 60 mL/min/1.73 m²)
- •Patients with a history of corticosteroid-treated pseudopolyarthritis
- •Patients with ACG and visual impairment (severity criterion)
- •Patients on immunosuppressants or biologic therapy
- •HIV infection or progressive malignancy
- •Known poor treatment adherence
- •Pregnant or breastfeeding women
- •Patients under legal guardianship
结局指标
主要结局
CRP testing
时间窗: 1 year
1. Immediately before starting corticosteroids 2. Every day immediately before taking the morning dose of corticosteroids, for 5 days, and up to 7 days if levels do not return to normal 3. Then once a week for up to 1 month after starting corticosteroids 4. Then monthly for 8 months during follow-up visits 5. Then every 2 months for up to 1 year
次要结局
- Determining Corticosteroid Dosages and Estimating Their Half-Lives(5 days)