2024-513538-40-02招募中2 期
Positron emission tomography with macrophage targeting to select individuals at risk for rheumatoid arthritis.
Amsterdam UMC Stichting, ZonMw3 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年12月9日最近更新:
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 3
- 主要终点
- Sensitivity
研究概览
简要总结
To determine the efficacy and measurement properties (sensitivity, specificity, positive and negative predictive value) of whole-body [18F]PEG-Folate PET (with ≥1 PET positive joint regarded as positive PET scan) for development of clinical arthritis (in at least 1 joint) in ACPA positive arthralgia individuals during one year follow-up.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Patients must be 18 years of age or older.
- •Patients must be diagnosed with arthralgia (not secondary to trauma) by a physician.
- •Patients must have a positive ACPA blood test, determined as a value of 10 U/mL or higher.
- •Patients must be able to adhere to the study appointments and other protocol requirements.
- •Patients must be capable of giving informed consent and the consent must have been obtained prior to the study related procedures.
排除标准
- •Arthritis and/or tenosynovitis as revealed by physical examination of 44 joints through the Disease Activity Score (DAS) (27) by 2 independent physicians.
- •Previous corticosteroid injection in joints.
- •Trauma involving joints in the 6 months prior to inclusion
- •Pregnancy or breast-feeding.
- •Low risk score at developing RA as calculated by a previously investigated clinical prediction rule.
结局指标
主要结局
Sensitivity
Sensitivity
Specificity
Specificity
Positive predictive value
Positive predictive value
Negative predictive value
Negative predictive value
次要结局
- Relationship of PET positivity and time to development of clinical arthritis.
- Cut-off value(s) for this/these specific outcome measure(s) in relation todevelopment of RA within one year.
研究者
Principal investigator
Scientific
Amsterdam UMC Stichting
研究点 (3)
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