Psoriasis Vulgaris Methotrexate Optimised Treatment Schedule (METOP)
Research type
Research Study
Full title
An international prospective, double-blind, placebo-controlled phase III RCT in which patients with moderate to severe psoriasis vulgaris are treated with s.c. methotrexate using an optimised treatment schedule.
IRAS ID
104466
Contact name
richard warren
Sponsor organisation
c/o SCIderm GmbH
Eudract number
2012-002716-10
ISRCTN Number
n/a
Research summary
Oral methotrexate (MTX) is a recommended first line therapy for the treatment of moderate to severe psoriasis vulgaris in adults. However despite its common use, no recommendations exist for a standardised dosing regimen for MTX in psoriasis and the present study is designed to further increase knowledge about the optimal dosing regimen for MTX and to optimise efficacy (not at the expense of safety) and safety of MTX treatment in this patient population. Importantly however MTX is being administered subcutaneously in this study (i.e. injected into the skin) and as such this trial represents one of the first studies to investigate sub-cutaneous MTX administration in psoriasis patients. The subcutaneous route of administration should result in better efficacy, since MTX bioavailability is difficult to predict when taken orally, and may also lead to better gastrointestinal tolerability. This study will be conducted in a double-blind, placebo-controlled manner to enable reliable interpretation of safety and efficacy data. The efficacy of subcutaneous MTX will be evaluated by the primary endpoint PASI 75 during a 16 week treatment phase. Secondary objectives will be long term safety and efficacy of MTX used according to the optimised treatment schedule using multiple methods ((S)AE occurrence and questionnaires), evaluated at up to 52 weeks.
REC name
South Central - Hampshire A Research Ethics Committee
REC reference
13/SC/0077
Date of REC Opinion
27 Mar 2013
REC opinion
Further Information Favourable Opinion