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
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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