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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.

This study is currently recruiting participants.
Verified December 2012 by Hospital Universitario Reina Sofia
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Juan Ruano, Hospital Universitario Reina Sofia
ClinicalTrials.gov Identifier:
NCT01753245
First received: December 17, 2012
Last updated: December 19, 2012
Last verified: December 2012
History of Changes
  Purpose

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
Psoriasis Vulgaris
Metabolic Syndrome

Study Type: Observational
Study Design: 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.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Hospital Universitario Reina Sofia:

Primary Outcome Measures:
  • Role of Metabolic Syndrome on anti-TNF-drug efficacy. [ Time Frame: After one year of treatment ] [ Designated as safety issue: No ]
    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:
  • Effect of 'Wnt pathway' genetic polymorphisms on anti-TNF-drug efficacy [ Time Frame: First year of treament ] [ Designated as safety issue: No ]
    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:
  • Cardiovascular disease factors [ Time Frame: First year of treatment ] [ Designated as safety issue: No ]
    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.


Biospecimen Retention:   Samples With DNA

whole blood, serum, plasma.


Estimated Enrollment: 230
Study Start Date: December 2012
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Non-Metabolic Syndrome
Patients without Metabolic Syndrome criteria (OMS).
Metabolic Syndrome
Patients with Metabolic Syndrome criteria (OMS).

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:
    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.
  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

-Moderate-to-severe psoriasis treated >1 ys with anti-TNFalpha drugs at Reina Sofia University Hospital

Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01753245

Contacts
Contact: Juan Ruano, M.D., Ph. D. Ms. C. 3495701 ext 1214 juanruanoruiz@mac.com

Locations
Spain
Department of Dermatology. Reina Sofia University Hospital. Recruiting
Cordoba, Spain, 14004
Sub-Investigator: Jose Carlos Moreno-Gimenez, M.D., Ph.D.            
Sub-Investigator: Antonio Velez, M.D., Ph.D.            
Sub-Investigator: Rafael Jimenez-Puya, M.D.            
Sub-Investigator: Enrique Casas, M.D.            
Sub-Investigator: Francisco Gomez-Garcia, M.D.            
Sub-Investigator: Rafael Salido-Vallejo, M.D.            
Sub-Investigator: Gloria Garnacho-Saucedo, M.D.            
Sub-Investigator: Ana Rodriguez-Martin, M.D.            
Sub-Investigator: Jose Espejo-Alvarez, M.D.            
Sub-Investigator: Beatriz Isla-Tejera, PharmD            
Sub-Investigator: Pedro Carmona-Fernandez, B.S.            
Sub-Investigator: Isabel Pantoja-Diez, B.S.            
Sub-Investigator: Sergio Sanchez-Ortiz, B.S.            
Principal Investigator: Juan Ruano, M.D., Ph.D., Ms.C.            
Sponsors and Collaborators
Juan Ruano
Pfizer
Investigators
Principal Investigator: Juan Ruano, M.D., Ph.D., Ms. C. Departament of Dermatology. Reina Sofia University Hospital.
  More Information

Additional Information:
Reina Sofia University Hospital  This link exits the ClinicalTrials.gov site

Publications:

Responsible Party: Juan Ruano, M.D., Ph.D., Ms.C., Hospital Universitario Reina Sofia
ClinicalTrials.gov Identifier: NCT01753245     History of Changes
Other Study ID Numbers: JRR-ANT-2012-01
Study First Received: December 17, 2012
Last Updated: December 19, 2012
Health Authority: Spain: Agencia Española de Medicamentos y Productos Sanitarios
Spain: Comité Ético de Investigación Clínica

Keywords provided by Hospital Universitario Reina Sofia:
Anti-TNF drugs efficacy
Moderate-to-severe psoriasis vulgaris
Gene polymorphism

Additional relevant MeSH terms:
Psoriasis
Metabolic Syndrome X
Skin Diseases, Papulosquamous
Skin Diseases
 Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on May 19, 2013