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

NCT02902861 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2016-09-16

No results posted yet for this study

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)

Conditions

  • Psoriasis Vulgaris

Interventions

DRUG

Methotrexate

methotrexate 50 mg/ml in syringes for sub-cutaneous injection; Once weekly (every 7 days) s.c. administration of 17.5 mg MTX; If PASI50 is not reached after 8 weeks, the dosing will be increased to 22.5 mg

DRUG

Placebo ( for Methotrexate)

NaCl-Solution manufactured to mimic Methotrexate

Sponsors & Collaborators

  • Prof. Kristian Reich

    lead INDUSTRY

Principal Investigators

  • Ulrich Mrowietz, Professor · Psoriasis-Zentrum, Universitäts-Hautklinik Kiel

Study Design

Allocation
RANDOMIZED
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-02-28
Primary Completion
2014-09-30
Completion
2015-05-31

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02902861 on ClinicalTrials.gov