Effects of Treatment With Biological Agents on Vascular and Cardiac Function in Psoriasis

Sponsor
University of Athens
Study ID
NCT02144857
Phase
PHASE4
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Accepted

Interventions

  • etanercept — DRUG
    50 mg
  • ustekinumab — DRUG
    45 mg
  • cyclosporine — DRUG
    Cyclosporine 2.5-3 mg/kgr
  • Secukinumab — DRUG
    300 mg
  • Apremilast — DRUG
    30mg

Study Details

Psoriasis has been associated with an increasing risk for atherosclerosis. The investigators investigated whether surrogate markers of subclinical atherosclerosis, vascular dysfunction and myocardial dysfunction are impaired in patients with psoriasis compared to normal controls ,coronary artery disease patients and untreated hypertension subjects. The investigators also examined the effect of treatment with biological vs no biological agents on vascular and LV function in psoriasis.

Key Dates

Start date
May 30, 2014
Status verified
May 2023
Primary completion
Sep 30, 2023
Completion
Dec 31, 2023

Study Design

Enrollment
200 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Anti-TNFa regimen
    Etanercept 50 mg
  • Active Comparator: Anti IL12/23 regimen
    ustekinumab 45 mg
  • Active Comparator: Cyclosporine regimen
    Cyclosporine 2.5-3 mg/kg
  • Active Comparator: anti-interleukin 17 A regimen
    secukinumab 300 mg
  • Active Comparator: inhibitor of phosphodiesterase-4
    apremilast 30mg

Primary Outcome Measure

Comparison of effect (improvement or deterioration) of treatment with biological vs. non biological agents on endothelial function in psoriasis [ Time Frame: 12 weeks ]

Central Contacts

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