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临床试验/NCT02134613
NCT02134613Unknown2 期

99mTc-anti-TNF-alpha Scintigraphy in the Evaluation of Inflammatory Processes Activity

Universidade Federal do Rio de Janeiro2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2009年1月最近更新:
适应症

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Bianca Gutfilen

Associate Professor

Universidade Federal do Rio de Janeiro

研究点 (2)

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