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临床试验/NL-OMON52903
NL-OMON52903招募中2 期

[18F]PEG-Folate PET-CT imaging for monitoring of therapy response in Rheumatoid Arthritis patients - Monitoring of therapy response with PET-CT imaging in RA

Vrije Universiteit Medisch Centrum0 个研究点目标入组 20 人开始时间: 待定最近更新:
适应症

试验速览

阶段
2 期
状态
招募中
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
Observational

入排标准

年龄范围
18 至 64(—)

入选标准

  • Patients must be at least 30 years of age
  • Diagnosis of rheumatoid arthritis according to the 1987 revised criteria of
  • the American Rheumatism Association (ARA)13 and/or the 2010 ACR/EULAR
  • Rheumatoid Arthritis classification criteria.
  • Patients with clinically active disease as assessed by a physician; with
  • arthritis in at least one synovial biopsy accessible joint and have a clinical
  • indication to start or restart (if stopped >12 weeks) with anti-TNF (either
  • Infliximab, Etanercept, Adalimumab or Certolizumab).
  • Prior treatment with one anti-TNF agent (Adalimumab, Certolizumab,
  • Etanercept, Golimumab or Infliximab) is permitted, but may not be a primary
  • failure to any anti-TNF agent (defined as no response within the first 12 weeks
  • of treatment)
  • Treatment with disease modifying anti-rheumatic drugs (DMARDS) and oral
  • corticosteroid up to 10 mg daily is allowed, provided that there is a stable
  • dose for at least 4 weeks prior to inclusion and during the study up to 12
  • weeks of follow up.
  • Non-steroidal anti-inflammatory drugs (NSAID) is permitted, provided that
  • there is a stable dose for at least 4 weeks prior to inclusion and during the
  • study up to 12 weeks of follow up.
  • 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

  • Use of intramuscular or intravenous corticosteroids within 4 weeks prior to
  • Patients who received methotrexate and folic acid less than 7 days before
  • tracer injection.
  • Treatment with any investigational drug within the previous 3 months
  • Known pregnancy or breast feeding
  • Research related radiation exposure (cumulative >=5 mSv) in the year before

研究者

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