Trial in Patients With Psoriasis Treated With Methotrexate Using an Optimized Treatment Schedule (METOP) — METOP  

Psoriasis Vulgaris Clinical Trial

Official title: An International Prospective, Double-blind, Placebo-controlled Phase III Randomised Controlled Trial (RCT) in Patients With Moderate to Severe Psoriasis Are Treated With Subcutaneous (s.c.) Methotrexate Using an Optimized Treatment Schedule.

Status Completed

Clinical Trial 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)

Clinical Trial Description

The present study was initiated to further increase the knowledge about the optimal dosing regimen and to thus optimize the efficacy and safety of MTX treatment for patients with moderate to severe psoriasis. In view of the described risk-benefit profile of MTX, an initial dose of at least 15 mg per week administered subcutaneously followed by 5 mg folic acid p.o. 24 hours after MTX application seems appropriate. Since 20 mg MTX per week has been proven to be beneficial in a considerable part of patients, who did not respond sufficiently to 15 mg MTX per week, in this study the dosing starts with a dose of 17.5 mg MTX per week, administered subcutaneously. At such a starting dose, it was expected to find the highest MTX efficacy possible, but with appropriate safety margins. If in a patient, a "50% reduction of Psoriasis Area Severity Index" PASI50 response is not achieved in week 8, the dose will be increased to 22.5 mg MTX per week. All dosages used in this study lay within the approved dosing range of MTX. The study will be conducted in a double-blind, placebo controlled manner. Placebo was chosen as control since only this comparator allows a reliable interpretation of safety and efficacy data. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator)

Related Conditions & MeSH terms

• Psoriasis
• Psoriasis Vulgaris

• NCT number: NCT02902861
• Study type: Interventional
• Source: Sciderm GmbH
• Status: Completed
• Phase: Phase 3
• Start date: February 2013
• Completion date: May 2015