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临床试验/NL-OMON52517
NL-OMON52517招募中不适用

[18F]Fluoride PET-CT imaging for detection and monitoring of bone formation in spondyloarthritis - [18F]Fluoride PET in SpA

Vrije Universiteit Medisch Centrum0 个研究点目标入组 48 人开始时间: 待定最近更新:

试验速览

阶段
不适用
状态
招募中
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

入排标准

年龄范围
18 至 64(—)

入选标准

  • Diagnosis of psoriatic arthritis according to the 2006 Classification
  • Criteria for Psoriatic Arthritis (CASPAR) or ankylosing spondylitis according
  • to the ASAS 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
  • o 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
  • The AS biopsy group: start with either biological or NSAID therapy is
  • 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

研究者

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