REmoval of Treatment for patients in REmission in psoriatic ArThritis - Feasibility study [RETREAT(F)]: a randomised controlled feasibility study to compare withdrawal of therapy versus continuing therapy in low disease states in psoriatic arthritis

niversity of Leeds (UK)0 个研究点目标入组 30 人开始时间: 2012年11月7日最近更新: 2018年2月19日

适应症

试验速览

•1. Patients must have a diagnosis of peripheral psoriatic arthritis of more than 12 months duration (according to CASPAR Criteria)
•2. Patients must be in minimal disease activity (as defined by the validated MDA criteria) with physician indicated stability of disease for the six months preceding screening
•3. Age > 18 years at time of commencing study, either male or female patients
•4. Women of childbearing age must ensure adequate contraception for the duration of the study, including those who are randomised to the withdrawal arm, in case of need to re-treat if disease flare should occur
•5. Men consenting to the trial should ensure adequate contraception for any sexual partner for the duration of the study
•6. Patients must have adequate screening blood tests prior to randomisation including FBC, U&E and LFT
•7. Patients must be able to adhere to the study timetable and protocol, and be able to sign an informed consent document
•8. Patients must have been on a stable dose of TNF or DMARD for the six month period directly preceding screening

•1. Women who are pregnant, lactating or planning pregnancy within 6 months of last dose of protocol treatment
•2. Use of any investigational medications or products within four weeks of randomisation
•3. Change on DMARD or TNF dose in the six months prior to screening

发起方

niversity of Leeds (UK)