psoriatic arthritis
Conditions
Interventions
Trade Name: Methotrexate
Product Name: methotrexate po
Pharmaceutical Form: Tablet
INN or Proposed INN: methotrexate
Trade Name: Salazo
Sponsors
University of Leeds
Eligibility
Sex/Gender
All
Inclusion 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 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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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. A person not achieving the MDA criteria at any of the monthly assessment time points will be deemed to be experiencing a flare of their disease. The proportion of patients who flare will also be used to inform the full study. ;Secondary Objective: 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.;Primary end point(s): Number successfully withdrawn from treatment. MDA score at baseline and at full treatment withdrawal.;Timepoint(s) of evaluation of this end point: 4 months after consent | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): disease flair;Timepoint(s) of evaluation of this end point: anytime during the trial that participant expereinces disease flare | — |
Countries
United Kingdom
Contacts
Public ContactDr P Helliwell
University for Leeds
Outcome results
None listed