Psoriatic arthritis Skin and Connective Tissue Diseases Arthropathic psoriasis
Conditions
Interventions
This feasibility study is designed to inform the sample size calculation for a full randomised controlled trial of treatment withdrawal in patients with psoriatic arthritis by assessing patient willin
Sponsors
University of Leeds (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| For this feasibility study we wish to know the proportion of eligible patients who are willing to undergo treatment withdrawal and the proportion remaining in minimal disease at the end of the study period. Within the three month treatment withdrawal period, a minimal disease activity (MDA) score of 5 or more (achievement of the minimal disease activity criteria) will be used to confirm continuing low disease activity. | — |
Secondary
| Measure | Time frame |
|---|---|
| Although no attempt will be made to stratify recruitment, relapse rate by drug withdrawn will be recorded. It is anticipated that the majority of patients will be taking TNF inhibitors at enrollment, but up to one third may be taking methotrexate alone. | — |
Countries
United Kingdom
Outcome results
None listed