99mTc-anti-TNF-alpha Scintigraphy in the Evaluation of Inflammatory Processes Activity
试验速览
- 阶段
- 2 期
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Percentage of Participants with 99mTc-anti-TNF-alpha joint and skin uptake
研究概览
简要总结
Rheumatoid and psoriatic arthritis patients benefit from anti-TNF-α therapy, once it is effective in reducing joint and skin manifestations in 60-70% of patients with inflammatory articular joint and skin diseases. Thus, identifying the presence and amount of TNF-α in the joint or skin in these patients may help in guiding the course of treatment more efficiently. The investigators research group has developed a novel approach to label anti-TNF-α with technetium-99m. Here the investigators compare the results obtained with scintigraphy and MRI in rheumatoid and psoriatic arthritis. The 99mTc-anti-TNF-α scintigraphy might recognize the molecule involved in the inflammatory process and provide crucial information to help physicians taking decisions about the drugs to be used based on biological evidence and which are cost-effective and appropriate for the treatment of choice. It allows direct identification of the monoclonal antibody anti-TNF-α in the articular joints and skin while it also ensures that the drug has reached its therapeutic target. It also allows correlation between the presence of the drug and clinical responses.
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 75 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Rheumatoid Arthritis (RA) patients must have 1 joint with edema.
- •Inflammatory lumbalgia
- •ankylosing spondylitis
- •Psoriatic arthritis with active disease and skin lesion
排除标准
- •Patients that do not return to scintigraphy
- •Pregnancy, Lactation, active infection, severe concomitant disease and medication allergy history
结局指标
主要结局
Percentage of Participants with 99mTc-anti-TNF-alpha joint and skin uptake
时间窗: 1 week
次要结局
- Percentage of Participants with decreased 99mTc-anti-TNF-alpha uptake after follow-up(5 months)
研究者
Bianca Gutfilen
Associate Professor
Universidade Federal do Rio de Janeiro
