NL-OMON41460已完成不适用
PET imaging of arthritis by specific macrophage targeting in Rheumatoid Arthritis patients - clinical proof of concept studies - Macrophage PET imaging of arthritis in Rheumatoid Arthritis patients
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 18
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 至 99(—)
入选标准
- •1. Men or women, * 18 years old
- •2. Diagnosis of rheumatoid arthritis according to the 1987 revised criteria of the American Rheumatism Association (ARA) and/or the 2010 ACR/EULAR Rheumatoid Arthritis Classification Criteria.
- •3. Patients with obvious clinical arthritis activity assessed by a physician, in at least 2 hand, wrist or knee joints.
- •4. Treatment with disease modifying anti-rheumatic drugs (DMARDS) and oral corticosteroids up to 10 mg daily is allowed. Non-steroidal anti-inflammatory drugs (NSAID) is permitted, provided that there is a stable dose for at least 1 month. Furthermore, prior or current treatment with biologics is permitted, provided that there is a stable dosing schedule for at least 3 months.
- •5. Patients must be able to adhere to the study appointments and other protocol
- •requirements.
- •6. 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
- •1. Use of intramuscular or intravenous corticosteroids within 4 weeks prior to screening.
- •2. Treatment with any investigational drug within the previous 3 months.
- •3. Pregnancy or breast-feeding.
- •4. Previous exposure to radioactivity with a yearly cumulative dose of * 5 mSv.
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