Analysis Of The Influence Of Metabolic Syndrome On Treatment Efficacy With Anti-Tnf In Moderate-Severe Psoriasis In Real Clinical Practice.
NCT ID: NCT01753245
Last Updated: 2014-03-13
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
UNKNOWN
Total Enrollment
300 participants
Study Classification
OBSERVATIONAL
Study Start Date
2012-12-31
Study Completion Date
2014-06-30
Brief Summary
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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.
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.
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Detailed Description
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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:
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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.
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.
Conditions
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Psoriasis Vulgaris
Metabolic Syndrome
Study Design
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Observational Model Type
COHORT
Study Time Perspective
CROSS_SECTIONAL
Study Groups
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Non-Metabolic Syndrome
Patients without Metabolic Syndrome criteria (OMS).
No interventions assigned to this group
Metabolic Syndrome
Patients with Metabolic Syndrome criteria (OMS).
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Moderate-to-severe psoriasis treated \>1 ys with anti-TNFalpha drugs
* Age \>18 ys/\<80 ys
* With or without psoriatic arthritis
* Age \>18 ys/\<80 ys
* With or without psoriatic arthritis
Exclusion Criteria
* Enrolled in another trial
* Lack of clinical information
* Pregnant
* Lack of clinical information
* Pregnant
Minimum Eligible Age
18 Years
Maximum Eligible Age
80 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Pfizer
INDUSTRY
Sponsor Role
collaborator
Juan Ruano
OTHER_GOV
Sponsor Role
lead
Responsible Party
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Juan Ruano
M.D., Ph.D., Ms.C.
Responsibility Role
SPONSOR_INVESTIGATOR
Principal Investigators
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Juan Ruano, M.D., Ph.D., Ms. C.
Role: PRINCIPAL_INVESTIGATOR
Departament of Dermatology. Reina Sofia University Hospital.
Locations
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Department of Dermatology. Reina Sofia University Hospital.
Córdoba, Cordoba, Spain
Site Status
Countries
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Spain
References
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Related Links
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http://www.juntadeandalucia.es/servicioandaluzdesalud/hrs3
Reina Sofia University Hospital
Other Identifiers
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JRR-ANT-2012-01
Identifier Type: OTHER
Identifier Source: secondary_id
JRR-ANT-2012-01
Identifier Type: -
Identifier Source: org_study_id
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