Overview

This trial is active, not recruiting.

Conditions psoriasis vulgaris, metabolic syndrome
Sponsor Juan Ruano
Collaborator Pfizer
Start date December 2012
End date April 2014
Trial size 300 participants
Trial identifier NCT01753245, JRR-ANT-2012-01

Summary

It has been reported in various epidemiological studies that patients with moderate-to-severe plaque psoriasis, with or without associated psoriatic arthritis, have an increased frequency of cardiovascular risk factors, such as hypertension, obesity, type-2 diabetes mellitus (T2DM, and metabolic syndrome (MetS). The presence of endothelial dysfunction in early stages, especially in moderate-to-severe plaque psoriasis forms, could explain the higher prevalence of cardiovascular disease and mortality observed in this population. Existing evidence showing improvement in psoriasis after correcting some factors, such as obesity or hypercholesterolemia, and the reduction of certain surrogate markers of cardiovascular risk with different modalities of psoriasis treatment suggest a biological interaction between the two diseases beyond mere epidemiological association. Recently published results support this hypothesis and suggest that the link between psoriasis and cardiovascular disease could be the existence of an inflammatory state in different organs, including skin, joints, adipose and hepatic tissue, and vascular endothelium (16). Patients with MetS have an increased risk of developing T2DM and cardiovascular disease. This syndrome is characterized by the association of an adipose tissue inflammatory state and diminished sensitivity to insulin. In recent years, a new mechanism participating in the development of MetS has been added: the Wnt signaling pathway. Polymorphisms in genes of the Wnt signaling pathway have been associated with metabolic abnormalities that predispose to cardiovascular disease, the development of moderate-to-severe plaque psoriasis, with or without associated psoriatic arthritis, and response to treatment with anti-TNF-alpha.

This study aims to describe the cardiovascular risk factors of a Spanish population of patients with moderate-to-severe plaque psoriasis, with or without associated psoriatic arthritis,treated with anti-TNF under routine clinical practice conditions. Possible differences in efficacy relative to the presence or absence of criteria of metabolic syndrome will be analyzed. Similarly, we will explore the role of markers of inflammatory activity and genetic polymorphisms in the Wnt pathway in predicting response to treatment during the first year.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective cross-sectional
Arm
Patients without Metabolic Syndrome criteria (OMS).
Patients with Metabolic Syndrome criteria (OMS).

Primary Outcomes

Measure
Role of Metabolic Syndrome on anti-TNF-drug efficacy.
time frame: After one year of treatment

Secondary Outcomes

Measure
Effect of 'Wnt pathway' genetic polymorphisms on anti-TNF-drug efficacy
time frame: First year of treament

Eligibility Criteria

Male or female participants from 18 years up to 80 years old.

Inclusion Criteria: - Moderate-to-severe psoriasis treated >1 ys with anti-TNFalpha drugs - Age >18 ys/<80 ys - With or without psoriatic arthritis Exclusion Criteria: - Enrolled in another trial - Lack of clinical information - Pregnant

Additional Information

Official title CARDIOVASCULAR RISK FACTORS IN A SPANISH POPULATION OF PATIENTS WITH MODERATE-TO-SEVERE PSORIASIS VULGARIS, WITH OR WITHOUT ARTHRITIS, TREATED WITH ANTI-TNF IN REAL CLINICAL PRACTICE. ANALYSIS OF THE INFLUENCE OF METABOLIC SYNDROME ON TREATMENT EFFICACY.
Principal investigator Juan Ruano, M.D., Ph.D., Ms. C.
Description 1. Eligibility criteria: 1.1. Inclusion criteria: 1. -Age >18 ys. 2. -Male and female. 3. -Moderate-to-severe psoriasis vulgaris, with or without psoriatic arthritis. 4. -Treated with anti-TNF drugs (infliximab, etanercept, adalimumab). 1.2. Exclusion criteria: 1. -Enrolled in another clinical trial. 2. -Lack of clinical information at the hospital database. 2. Objectives: 2.1. Primary objective: Evaluate the efficacy of anti-TNF- drugs in the treatment of patients with moderate-to-severe plaque psoriasis, with or without associated psoriatic arthritis, in terms of the presence or absence of cardiovascular risk factors, including metabolic syndrome. 2.2. Secondary objectives: - 2.2.1. Analyze the possible modulatory role of genetic factors, such as Wnt pathway's gene polymorphisms, and other nongenetic factors on responsiveness to treatment with anti-TNF drugs in the overall study population and in the subgroup of patients with metabolic syndrome. - 2.2.2. Describe the cardiovascular risk factors in patients with moderate-to-severe plaque psoriasis, with or without associated psoriatic arthritis, treated with anti-TNF- in the Spanish population under routine clinical practice conditions.
Trial information was received from ClinicalTrials.gov and was last updated in March 2014.
Information provided to ClinicalTrials.gov by Hospital Universitario Reina Sofia.