Methotrexate Versus Secukinumab Safety in Psoriasis Patients With Metabolic Syndrome
NCT04469829 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 70
Last updated 2020-07-14
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.
Conditions
- Psoriasis
- Metabolic Syndrome
Interventions
- DRUG
-
Secukinumab
standard doses of secukinumab for psoriasis
- DRUG
-
Methotrexate
Methotrexate 15 mg/week
Sponsors & Collaborators
-
Universita di Verona
lead OTHER
Principal Investigators
-
Paolo Gisondi, MD · Universita di Verona
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2020-08-01
- Primary Completion
- 2021-12-31
- Completion
- 2022-12-31
Countries
- Italy
Study Locations
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