EUCTR2012-003736-23-GB
Active, not recruiting
Phase 1
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 sites30 target enrollmentDecember 4, 2012
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- psoriatic arthritis
- Sponsor
- niversity of Leeds
- Enrollment
- 30
- Status
- Active, not recruiting
- Last Updated
- 7 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •(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
Exclusion Criteria
- •(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
Outcomes
Primary Outcomes
Not specified
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