EUCTR2012-003736-23-GB进行中（未招募）1 期
RETREAT(F) (REmoval of Treatment for patients in REmission in psoriatic ArThritis – Feasibility study). A randomised controlled trial to compare withdrawal of therapy versus continuing therapy in low disease states in psoriatic arthritis – feasibility study, RCT Arm - RETREAT(F) RCT Arm
niversity of Leeds0 个研究点目标入组 30 人开始时间: 2012年12月4日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 30
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
入选标准
- •(a) Patients must have a diagnosis of peripheral psoriatic arthritis of more than twelve months duration (according to CASPAR Criteria)
- •(b) Patients must be in minimal disease activity (as defined by the validated MDA criteria), with stable disease for the preceding six months, as indicated by the treating physician
- •(c) Age 18years at time of commencing study
- •(d) Women of child bearing age must ensure adequate contraception for the duration of the study
- •(e) Men consenting to the trial should ensure adequate contraception for any sexual partner for the duration of the study
- •(f) Patients must have adequate screening blood tests prior to randomisation including full blood count (FBC), urea and electrolytes (U&E) and liver function tests (LFT)
- •(g) Patients must be able to adhere to the study timetable and protocol, and be able to sign an informed consent document
- •(h) Patients must have been on a stable dose of TNF or DMARD for the six month period directly preceding screening
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 20
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 10
排除标准
- •(a) Women who are pregnant, lactating or planning pregnancy within 6 months of last dose of protocol treatment
- •(b) Use of any investigational medications or products within four weeks of randomisation
- •(c) Change of DMARD or TNF dose in the six months prior to screening
- •(d) Patients with PsA with only axial involvement
研究者
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