Methotrexate Versus Secukinumab Safety in Psoriasis Patients With Metabolic Syndrome

Sponsor
Universita di Verona
Study ID
NCT04469829
Phase
PHASE4
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Secukinumab — DRUG
    standard doses of secukinumab for psoriasis
  • Methotrexate — DRUG
    Methotrexate 15 mg/week

Study Details

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.

Key Dates

Start date
Aug 1, 2020
Status verified
Jul 2020
Primary completion
Dec 31, 2021
Completion
Dec 31, 2022

Study Design

Enrollment
70 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: secukinumab
    patients with psoriasis and metabolic syndrome candidate for treatment with secukinumab standard doses
  • Active Comparator: methotrexate
    patients with psoriasis and metabolic syndrome candidate for treatment with methotrexate dosed 15 mg/week

Primary Outcome Measure

Changes in waist circumference at month 12 [ Time Frame: 12 month ]

Central Contacts

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