EUCTR2019-004078-24-ES进行中（未招募）1 期
Effect of Sarilumab on atherosclerotic disease measured by PET/CT (Positron Emission Tomography/Computed Tomography) in Rheumatoid Arthritis - SARIPET
IDIVA0 个研究点目标入组 20 人开始时间: 2020年2月21日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 20
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- Patients = 18 years diagnosed with active RA: DAS28>3.2 and levels of CRP of at least 1 mg/dl.
- •- Naïve to biologic DMARDs (bDMARDs) or refractory to a single bDMARD different from anti-
- •IL-6 agents.
- •- Only patients with plaques assessed by carotid US will be included in the PET/CT study. Plaques will be detected by US (for this purpose of at least 1.5 mm).
- •- Patients who are candidates for sarilumab according to summary of product characteristics (SmPC).
- •- Patients must sign informed consent.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 20
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •- Patients with previous history of CV events.
- •- Patients with history of diabetes or chronic renal failure.
- •- Patients with an absolute neutrophil count (ANC) less than 2 x 109/L.
- •- Patients with platelet count below 150 x 103/µL.
- •- Patients with elevated transaminases, ALT or AST greater than 1.5 x ULN.
- •- Patients with an active infection, including localized infections.
- •- Patients who are not candidates for sarilumab according to SmPC.
- •- Patients enrolled in other clinical trial or research project.
- •- Patients who do not sign the informed consent.
- •-Women who are pregnant or breastfeeding, or those of child-bearing who are not using an effective method of contraception
研究者
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