EUCTR2017-004850-40-NL进行中（未招募）1 期
[18F]Fluoride PET-CT imaging for detection and monitoring of bone formation in spondyloarthritis - [18F]Fluoride PET in SpA
VU Medical Center, department of Rheumatology0 个研究点目标入组 48 人开始时间: 2018年2月28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
- 48
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
- •Diagnosis of psoriatic arthritis according to the 2006 Classification Criteria for Psoriatic Arthritis (CASPAR) or ankylosing spondylitis according to the modified New York criteria
- •Patients with clinically active disease as assessed by a physician;
- •o In PsA defined as clinically active disease with at least one clinically active enthesitis site and a clinical indication to start with Secukinumab
- •oIn AS defined as a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) of 4 or higher and a clinical indication to start with Secukinumab.
- •Treatment with disease modifying anti-rheumatic drugs (DMARDS) and 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.
- •Treatment with oral corticosteroids up to 10mg daily 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.
- •Prior treatment with one anti-TNF agent is permitted with the exception of the anti-TNF control PsA group: they will have no prior anti-TNF treatment and have a clinical indication to start anti-TNF treatment.
- •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 48
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Treatment with any investigational drug within the previous 3 months.
- •Pregnancy or breast-feeding
研究者
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