A randomised controlled trial to compare withdrawal of therapy versus continuing therapy in low disease states in psoriatic arthritis – feasibility study

Phase 1

• Conditions: psoriatic arthritis; Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

• Registration Number: EUCTR2012-003736-23-GB
• Lead Sponsor: niversity of Leeds

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-12-04
• Last Update Posted: 28 February 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 30

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
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

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified