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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.

NCT01753245 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 300

Last updated 2014-03-13

No results posted yet for this study

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.

Conditions

  • Psoriasis Vulgaris
  • Metabolic Syndrome

Sponsors & Collaborators

  • Pfizer

    collaborator INDUSTRY

  • Juan Ruano

    lead OTHER_GOV

Principal Investigators

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

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-12-31
Primary Completion
2014-04-30
Completion
2014-06-30

Countries

  • Spain

Study Locations

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Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01753245 on ClinicalTrials.gov