Trial in Patients With Psoriasis Treated With Methotrexate Using an Optimized Treatment Schedule (METOP)
Status:
Completed
Trial end date:
2015-05-01
Target enrollment:
Participant gender:
Summary
This is a multicenter, multinational (12 centers planned, in Germany 9 centers and in France,
the Netherlands and the United Kingdom (UK) 1 center in each country respectively),
randomized, double-blinded, placebo-controlled study. The primary objective is to evaluate
the efficacy of methotrexate (MTX) in patients with moderate to severe Psoriasis compared to
Placebo as assessed by the primary endpoint "75% reduction of Psoriasis Area Severity Index"
(PASI 75 ) during a 16 week treatment phase. As secondary objectives the safety and efficacy
of the optimized treatment schedule will be assessed using multiple methods (e.g. (Serious)
Adverse Events ((S)AE) occurrence and questionnaires)