Overview

Methotrexate Versus Secukinumab Safety in Psoriasis Patients With Metabolic Syndrome

Status:
Not yet recruiting
Trial end date:
2022-12-31
Target enrollment:
0
Participant gender:
All
Summary
A prospective, controlled, open trial in psoriasis patients with metabolic syndrome, candidate to methotrexate or secukinumab was conducted between January 2019 and May 2020. The primary end point of the study was investigating any variations in waist circumference, body mass index (BMI), blood pressure, fasting glucose, total cholesterol, low density lipoprotein (LDL)-cholesterol, high density lipoprotein (HDL)-cholesterol, triglycerides, aspartate aminotransferase (AST), alanine aminotransferase (ALT), creatinine levels between baseline and month-6 and 12 of follow-up.
Phase:
Phase 4
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Universita di Verona
Treatments:
Methotrexate
Criteria
Inclusion Criteria:

- age ≥ 18 years

- being affected by moderate to severe chronic plaque psoriasis and concomitant
metabolic syndrome

- being candidate to systemic treatment with methotrexate or secukinumab according to
the Italian guideline for psoriasis

Exclusion Criteria:

- being affected by psoriatic arthritis, pregnancy, breast feeding,

- having initiated a systemic treatment for psoriasis in the previous 3 months and
having a clinical condition that could affect the metabolic parameters other than
metabolic syndrome.