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Analysis Of The Influence Of Metabolic Syndrome On Treatment Efficacy With Anti-Tnf In Moderate-Severe Psoriasis In Real Clinical Practice.

Sponsor
Juan Ruano (Other)
Overall Status
Unknown status
CT.gov ID
NCT01753245
Collaborator
Pfizer (Industry)
300
Enrollment
1
Location
18
Duration (Months)
16.7
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase

    Detailed 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:

    5. -Enrolled in another clinical trial.

    6. -Lack of clinical information at the hospital database.

    7. 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.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    300 participants
    Observational Model:
    Cohort
    Time Perspective:
    Cross-Sectional
    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.
    Study Start Date :
    Dec 1, 2012
    Anticipated Primary Completion Date :
    Apr 1, 2014
    Anticipated Study Completion Date :
    Jun 1, 2014

    Arms and Interventions

    Arm Intervention/Treatment
    Non-Metabolic Syndrome

    Patients without Metabolic Syndrome criteria (OMS).
    Metabolic Syndrome

    Patients with Metabolic Syndrome criteria (OMS).

    Outcome Measures

    Primary Outcome Measures

    1. Role of Metabolic Syndrome on anti-TNF-drug efficacy. [After one year of treatment]

      Evaluate the efficacy of anti-TNF-drugs in themoderate-to-severe plaque psoriasis, with or without associated psoriatic arthritis, in terms of the presence or absence of cardiovascular risk factors, including metabolic syndrome.

    Secondary Outcome Measures

    1. Effect of 'Wnt pathway' genetic polymorphisms on anti-TNF-drug efficacy [First year of treament]

      Analyze the possible modulatory role of genetic factors, such as Wnt polymorphisms, and nongenetic factors on responsiveness to treatment with anti-TNF drugs in the overall study population and in the subgroup of patients with metabolic syndrome.

    Other Outcome Measures

    1. Cardiovascular disease factors [First year of treatment]

      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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Department of Dermatology. Reina Sofia University Hospital. Cordoba Spain 14004

    Sponsors and Collaborators

    • Juan Ruano
    • Pfizer

    Investigators

    • Principal Investigator: Juan Ruano, M.D., Ph.D., Ms. C., Departament of Dermatology. Reina Sofia University Hospital.

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    Responsible Party:
    Juan Ruano, M.D., Ph.D., Ms.C., Hospital Universitario Reina Sofia de Cordoba
    ClinicalTrials.gov Identifier:
    NCT01753245
    Other Study ID Numbers:
    • JRR-ANT-2012-01
    • JRR-ANT-2012-01
    First Posted:
    Dec 20, 2012
    Last Update Posted:
    Mar 13, 2014
    Last Verified:
    Mar 1, 2014
    Keywords provided by Juan Ruano, M.D., Ph.D., Ms.C., Hospital Universitario Reina Sofia de Cordoba
    Anti-TNF drugs efficacy
    Moderate-to-severe psoriasis vulgaris
    Gene polymorphism
    Additional relevant MeSH terms:
    Psoriasis
    Metabolic Syndrome
    Syndrome

    Study Results

    No Results Posted as of Mar 13, 2014