NL-OMON23538招募中不适用
[18F]Fluoride PET-CT imaging for detection and monitoring of bone fomration in spondyloarthritis
ovartis, Foreum, Pfizer0 个研究点目标入组 48 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 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
- Observational
入排标准
入选标准
- •Patients must be at least 18 years of age.
- •- 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;
- •- In PsA defined as clinically active disease with at least one clinically active enthesitis site and a clinical indication to start with Secukinumab.
- •- In 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. The anti-TNF control PsA group: prior treatment with one anti-TNF is permitted, given that the patient was intolerant for this anti-TNF (no primary failure)
- •- The AS biopsy group: start or treatment with either biological, NSAID and/or DMARD therapy is permitted. 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
- •- Prior Treatment with anti-IL-17 (for Secukinumab starters)
- •- Treatment with any investigational drug within the previous 3 months.
- •- Pregnancy or breast-feeding
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