EUCTR2018-004429-94-NL进行中（未招募）1 期
[18F]PEG-folate PET-CT imaging for monitoring of therapy response in rheumatoid arthritis patients
VU Medical Center, department of Rheumatology0 个研究点目标入组 10 人开始时间: 2019年6月17日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 10
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
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 knee or ankle joint and have a clinical indication to start with anti-TNF (either Infliximab, Etanercept, Adalimumab or Certolizumab)
- •Prior treatment with one anti-TNF agent 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.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 10
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Use of intramuscular or intravenous corticosteroids within 4 weeks prior to screening.
- •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 inclusion
研究者
相似试验
尚未招募
不适用
[18F]PEG-Folate PET-CT imaging for monitoring of therapy response in Rheumatoid Arthritis patientsRheumatoid ArthritisNL-OMON26919GSK10
招募中
2 期
[18F]PEG-Folate PET-CT imaging for monitoring of therapy response in Rheumatoid Arthritis patientsRheumatoid arthritisNL-OMON52903Vrije Universiteit Medisch Centrum20
已完成
不适用
[18F]fluoro-PEG-folate PET/CT imaging in patients with epithelial ovarian cancerEpithelial ovarian cancer10033283NL-OMON52813eids Universitair Medisch Centrum15
进行中（未招募）
1 期
[18F]fluoro-PEG-folate PET/CT imaging in patients with epithelial ovarian cancerEUCTR2020-000112-29-NLeiden University Medical Center15
招募中
不适用
[18F]Fluoride PET-CT imaging for detection and monitoring of bone formation in spondyloarthritisNL-OMON52517Vrije Universiteit Medisch Centrum48